Infutest 2000

Series E
Dual Channel Infusion Pump Analyzer

Operating Manual
 Infutest 2000 Series E
Dual Channel Infusion Pump Analyzer
Operating Manual

© 2005-2014 Datrend Systems Inc.

Unit 130 - 4020 Viking Way
Richmond, BC • CANADA. • V6V 2L4
Tel 604.291.7747 or 800.667.6557 • Fax 604.294.2355
e-mail customerservice@[Link]
To order this manual, use Part Number 6100-109 Revision History
Revision Description Date

E Corporate Address Update 2011-Jul-21

F Update Power Requirements 2014-Nov-04

Copyright
Datrend Systems Inc. (“DSI”) agrees to a limited copyright release that allows you to reproduce manuals and other
printed materials for use in service training programs and other technical publications. If you would like other
reproductions or distributions, submit a written request to Datrend Systems Inc.

Unpacking and Inspection

Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If
damage is found, stop unpacking the instrument. Notify the freight carrier and ask for an agent to be present while
the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the
instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or
scratches.

Claims
Our routine method of shipment is via common carrier. Upon delivery, if physical damage is found, retain all packing
materials in their original condition and contact the carrier immediately to file a claim.
If the instrument is delivered in good physical condition but does not operate within specifications, or if there are any
other problems not caused by shipping damage, please contact your local sales representative or DSI immediately.

Standard Terms and Conditions

Refunds & Credits

Please note only serialized products (products labelled with a distinct serial number) and accessories are eligible for
partial refund and/or credit. Non-serialized parts and accessory items (cables, carrying cases, auxiliary modules,
etc.) are not eligible for return or refund. In order to receive a partial refund/credit, the product must not have been
damaged, and must be returned complete (meaning all manuals, cables, accessories, etc.) within 90 days of original
purchase and in “as new” and resalable condition. The Return Procedure must be followed.

Return Procedure
Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number,
obtained from Datrend Customer Service. All items being returned must be sent prepaid (freight, duty, brokerage,
and taxes ) to our factory location.

Restocking Charges
Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15%. Products
returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20%.
Additional charges for damage and/or missing parts and accessories will be applied to all returns. Products which
are not in “as new” and resalable condition, are not eligible for credit return and will be returned to the customer at
their expense.

Certification
This instrument was thoroughly tested and inspected and found to meet DSI’s manufacturing specifications when it
was shipped from the factory. Calibration measurements are traceable to the National Research Council of Canada
(NRC) and/or the National Institute of Standards and Technology (NIST). Devices for which there are no NRC/NIST
calibration standards are measured against in-house performance standards using accepted test procedures.

Page i
Warranty

Datrend Systems Inc. ("DSI") warrants this instrument to be free from defects in materials and workmanship under
normal use and service for one (1) year from the date of original purchase. This warranty will be automatically
extended to a maximum of five (5) years from the date of original purchase provided that calibration is performed
on an annual basis by a Datrend Authorized Service Center (refer to Appendix C of this manual).

This warranty is subject to the following limitations:

! Occluder Valves: 1 year limited warranty
! Pressure Transducers: 1 year limited warranty
! Standard Accessories: 90 day limited warranty
! Re-calibration of the instrument, which has a recommended annual calibration frequency, is not covered under
the warranty.

During the warranty period DSI will, at our option, either repair or replace a product at no charge that proves to be
defective; provided you return the product (shipping, duty, brokerage and taxes prepaid) to DSI. Any and all
transportation charges incurred are the responsibility of the purchaser and are not included within this warranty. This
warranty extends only to the original purchaser and does not cover damage from abuse, neglect, accident or misuse
or as the result of service or modification by other than DSI. IN NO EVENT SHALL DATREND SYSTEMS INC. BE
LIABLE FOR CONSEQUENTIAL DAMAGES.

No warranty shall apply when damage is caused by any of the following:

! Introduction of fluids not specified in the instruction manual,
! Application of excessive pressure or vacuum/suction to the device inputs,
! Failure to rinse or clear the fluid flow path as instructed in the manual,
! Power failure, surges, or spikes,
! Damage in transit or when moving the instrument,
! Improper power supply such as low voltage, incorrect voltage, defective wiring or inadequate fuses,
! Accident, alteration, abuse or misuse of the instrument,
! Fire, water damage, theft, war, riot, hostility, acts of God, such as hurricanes, floods, etc.

Only serialized products (those items bearing a distinct serial number tag) and their accessory items are covered
under this warranty. PHYSICAL DAMAGE CAUSED BY MISUSE OR PHYSICAL ABUSE IS NOT COVERED
UNDER THE WARRANTY. Items such as cables and non-serialized modules are not covered under this warranty.

This warranty gives you specific legal rights and you may have other rights, which vary from province to province,
state to state, or country to country. This warranty is limited to repairing the instrument to DSI's specifications.

When you return an instrument to DSI for service, repair or calibration, we recommend shipment using the original
shipping foam and container. If the original packing materials are not available, we recommend the following guide
for repackaging:
! Use a double-walled carton of sufficient strength for the weight being shipped.
! Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive material around all projecting
parts.
! Use at least four inches of tightly packed, industrial-approved, shock-absorbent material all around the
instrument.

DSI will not be responsible for lost shipments or instruments received in damaged condition due to improper
packaging or handling. All warranty claim shipments must be made on a prepaid basis (freight, duty, brokerage, and
taxes). No returns will be accepted without a Return Materials Authorization ("RMA”) number. Please contact
Datrend at 1-800-667-6557 to obtain an RMA number and receive help with shipping/customs documentation.

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Warranty Disclaimer
Should you elect to have your instrument serviced and/or calibrated by someone other than Datrend Systems,
please be advised that the original warranty covering your product becomes void when the tamper-resistant Quality
Seal is removed or broken without proper factory authorization. We strongly recommend, therefore, that you send
your instrument to Datrend Systems for service and calibration, especially during the original warranty period.
In all cases, breaking the tamper-resistant Quality Seal should be avoided at all cost, as this seal is the key to your
original instrument warranty. In the event that the seal must be broken to gain internal access to the instrument (e.g.,
in the case of a customer-installed firmware upgrade), you must first contact Datrend Systems at 1-800-667-6557.
You will be required to provide us with the serial number for your instrument as well as a valid reason for breaking
the Quality Seal. You should break this seal only after you have received factory authorization. Do not break the
Quality Seal before you have contacted us! Following these steps will help ensure that you will retain the original
warranty on your instrument without interruption.

WARNING
Unauthorized user modifications or application beyond the published specifications may result in electrical shock
hazards or improper operation. Datrend Systems will not be responsible for any injuries sustained due to
unauthorized equipment modifications.

DSI DISCLAIMS ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR APPLICATION.

THIS PRODUCT CONTAINS NO USER-SERVICEABLE COMPONENTS.

UNAUTHORIZED REMOVAL OF THE INSTRUMENT COVER SHALL VOID
THIS AND ALL OTHER EXPRESSED OR IMPLIED WARRANTIES.

Fluke® is a registered trademark of Fluke Corporation

MS-DOS, QBasic, Visual Basic, and Visual C++, Microsoft, and Windows are registered trademarks of Microsoft Corp.

Brita® is a registered trademark of BRITA Worldwide.

Jet Dry® is a registered trademark of Reckitt Benckiser plc

Page iii
Page iv
INFUTEST 2000E OPERATING MANUAL

Table of Contents

1. PERFORMANCE SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1 Single Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1.1 Continuous Flow Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
1.1.2 Pulsatile Flow Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
1.2 Dual Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.2.1 Continuous Flow Conditions ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1.3 PCA Pump Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.3.1 Continuous Flow Conditions ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
1.4 Occlusion Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.1 Pressure Measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.4.2 Nurse Call Detection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.5 Data Logger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.7 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

2. OVERVIEW OF INSTRUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.1 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
2.2 Description of Test Procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.1 Single Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.2 Dual Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.3 PCA Pump Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.4 Occlusion Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.3 Test Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

3. INITIAL SET-UP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.1 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
3.2 Priming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
3.3 Optional Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

4. OPERATION AND RELATED DISPLAYS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

4.1 Powering Up and Setting the Clock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
4.2 S Setting Up a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Test Measurement Concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.1 SynchroStart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.2 End-of-Infusion Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.3.3 Flow Pattern Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
4.4 Starting a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
4.5 Running a Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
4.6 Viewing the Test Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.6.1 SUMMARY Screen for Single-Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . 36
4.6.2 SUMMARY Screen for Dual-Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . 37
4.6.3 SUMMARY Screen for PCA Pump Test . . . . . . . . . . . . . . . . . . . . . . . . . 37

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INFUTEST 2000E OPERATING MANUAL

4.6.4 SUMMARY Screen for Occlusion Pressure Test . . . . . . . . . . . . . . . . . . 38

4.6.5 SUMMARY Screen Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
4.7 Viewing the Data Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.7.1 Data Log Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.7.2 DATA Screen Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
4.8 Output of Summary and Data Logs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
4.9 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.9.1 Nonrecoverable Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.9.2 Recoverable Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
4.10 AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

5. TEST USAGE GUIDELINES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.1 General Rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.1.1 Test Fluids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
5.1.2 Pump IV Sets and Syringes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
5.1.3 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
5.1.4 Input and Output Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
5.1.5 Flushing Prior to Test Startup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
5.2 Single Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.2.1 Test Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
5.2.2 Test Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
5.3 Dual-Rate Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
5.3.1 Testing Piggyback Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
5.3.2 Testing Titrated Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
5.3.3 Testing KVO Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66
5.3.4 Testing Bolus-Plus-Basal Mode Operation . . . . . . . . . . . . . . . . . . . . . . . 66
5.3.5 Dual-Rate “PULSATILE” Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
5.4 PCA Pump Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5.4.1 Test Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68
5.4.2 Test Usage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
5.4.3 PCA Pump “PULSATILE” Warning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
5.5 Occlusion Pressure Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
5.5.1 Measuring Occlusion Pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
5.5.2 Checking the Nurse Call Alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
5.6 AutoSequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.6.1 Running Default Test Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
5.6.2 Reloading Default Test Sequences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
5.6.3 Adding the Occlusion Test to Sequences . . . . . . . . . . . . . . . . . . . . . . . . 75
5.7 Understanding Your Test Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

6. REMOTE CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.1 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
6.2 Connections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.3 Command Syntax . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
6.4 Command Types and Return Values . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
6.5 Command List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

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INFUTEST 2000E OPERATING MANUAL

6.6 Command Descriptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

6.6.1 Test Control Commands - RUN TEST . . . . . . . . . . . . . . . . . . . . . . . . . . 84
6.6.2 Test Control Commands - RUN AUTOSEQUENCE . . . . . . . . . . . . . . . . 85
6.6.3 Test Control Commands - STOP TEST/ABORT AUTOSEQUENCE . . . 86
6.6.4 Report Output Control - PRINT REPORT . . . . . . . . . . . . . . . . . . . . . . . . 86
6.6.5 Report Output Control - DOWNLOAD REPORT . . . . . . . . . . . . . . . . . . . 86
6.6.6 Get Data Commands - GET TEST SUMMARY . . . . . . . . . . . . . . . . . . . . 87
6.6.7 Get Data Commands - GET REAL-TIME DATA . . . . . . . . . . . . . . . . . . . 88
6.7 Programming Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
6.7.1 QBasic Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90
6.7.2 medTester Programming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

APPENDIX A. BACK PRESSURE TESTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

APPENDIX B. OPERATIONAL OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

B.1 General Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
B.2 Flow Measurement System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
B.3 Pressure Measurement System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108

APPENDIX C. CALIBRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

C.1Annual Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
C.2Calibration Verification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110
C.2.1 Pressure Accuracy Verification - Field Test . . . . . . . . . . . . . . . . . . . . . 110
C.2.2 Flow Accuracy Verification - Field Test . . . . . . . . . . . . . . . . . . . . . . . . . 110

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INFUTEST 2000E OPERATING MANUAL

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INFUTEST 2000E OPERATING MANUAL

Introduction
This chapter provides the performance specifications of the Infutest
2000E (Infutest) Infusion Device Analyzer.

1. PERFORMANCE SPECIFICATIONS
The following specifications apply to both channels of the Infutest 2000 Series E Dual
Channel Infusion Device Analyzer.

1.1 Single Rate Test

1.1.1 Continuous Flow Conditions

I. Flow Measurement
a. Nominal range: 0.1 - 1200 ml/hr
b. Maximum flow measurable and displayed: 1700 ml/hr
c. Minimum flow measurable and displayed: 0.04 ml/hr
d. Maximum display resolution: 0.001 ml/hr
e. Measuring time: 10 min. at 0.1 ml/hr
20 sec. max. above 6 ml/hr
f. Accuracy
Average flow: +/- 1%, 0.1-1200ml/hr

g. Ranges: LOW - 0.1 to 170 ml/h

HIGH - 170 to 1200 ml/h
h. Range selection: Automatic
i. Internal nominal effective
collection volume: LOW range: 0.014 ml
HIGH range: 1.1 ml

Introduction/Chapter 1 # Page 1
INFUTEST 2000E OPERATING MANUAL

II. Volume Measurement

a. Range: 0 - 9999 ml
b. Maximum display resolution: 0.001 ml
c. Accuracy: +/- 1%

III. Back Pressure Measurement

a. Range: 0 - 300 mmHg
b. Zero offset error: +/- 5 mmHg
c. Display resolution: 1 mmHg
d. Accuracy: +/- 1% FS,
+/- zero offset error

IV. Elapsed Time Measurement

a. Range: 0 - 100 hours
b. Display format: hh:mm:ss
c. Accuracy: +0, -1second

1.1.2 Pulsatile Flow Conditions

I. Flow Measurement
a. Nominal range: 5 - 1200 ml/hr
b. Maximum flow measurable and displayed: 1700 ml/hr
c. Minimum flow measurable and displayed: 2.75 ml/hr
d. Maximum display resolution: 0.001 ml/hr
e. Measuring time: 14 min. at 5 ml/hr
20 sec. max. above 200 ml/hr
f. Accuracy:
Average flow +/- 1%
g. Ranges: HIGH range only
(internally selected)
h. Internal nominal effective
collection volume: 1.1 ml

II. Volume Measurement

a. Range: 0 - 9999 ml
b. Maximum display resolution: 0.001 ml
c. Accuracy: +/- 1%

Introduction/Chapter 1 # Page 2
INFUTEST 2000E OPERATING MANUAL

III. Back Pressure Measurement

- Same as for Continuous Flow Measurement

IV. Elapsed Time Measurement

-Same as for Continuous Flow Measurement

1.2 Dual Rate Test

1.2.1 Continuous Flow Conditions ONLY

I. Flow Measurement
a. Nominal range: 0.1 - 170 ml/hr
b. Maximum flow measurable and displayed: 200 ml/hr
c. Minimum flow measurable and displayed: 0.04 ml/hr
d. Maximum display resolution: 0.001 ml/hr
e. Measuring time: 10 min. at 0.1 ml/hr
20 sec. max. above 6 ml/hr
f. Accuracy:
Average flow: +/- 1%
g. Ranges: LOW range only
h. Delivery period determination: Automatic
i. Internal nominal effective collection volume: 0.014 ml

II. Volume Measurement

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

III. Back Pressure

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

IV. Elapsed Time Measurement

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

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1.3 PCA Pump Test

1.3.1 Continuous Flow Conditions ONLY

I. Flow Measurement, Bolus Delivery period

a. Nominal range: 0.1 - 170 ml/hr
b. Maximum flow measurable and displayed: 200 ml/hr
c. Minimum flow measurable and displayed: 0.04 ml/hr
d. Maximum display resolution: 0.001 ml/hr
e. Measuring time: 10 min. at 0.1 ml/hr
20 sec. max. above 6 ml/hr
f. Accuracy:
Average flow: +/- 1%
g. Ranges: LOW range only
h. Lockout detection: Automatic
i. Internal nominal effective collection volume: 0.014 ml

II. Volume Measurement

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

III. Back Pressure Measurement

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

IV. Elapsed Time Measurement

- See 1.1 SINGLE RATE TEST, Continuous Flow Measurement

V. Lockout Time Measurement

a. Range: 0 - 100 minutes
b. Display format: mm:ss
c. Accuracy: +/- 2 seconds

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INFUTEST 2000E OPERATING MANUAL

1.4 Occlusion Pressure Test

1.4.1 Pressure Measurement

a. Display Units: mmHg, psi

b. Range: 0 - 2586 mmHg(0 - 50 psi)
c. Display resolution: 1 mmHg(0.1 psi)
d. Measuring time: 2 seconds
e. Zero offset error: +/- 5 mmHg (0.1 psi)
f. Accuracy: +/- 1% +/- zero offset error

1.4.2 Nurse Call Detection

a. Nurse Call signal from pump sampled once per second.

b. Nurse Call signal can be produced by any of: relay contacts, open
collector output, TTL output, RS-232 level, or 20 mA current loop.
c. Nurse Call signal may be in either logical state at start of Occlusion
Pressure Test.

1.5 Data Logger

I. Memory Type:
NVRAM (battery-backed)

II. Capacity:
2 channel 900 flow measurements per channel
700 pressure measurements per channel
4 channel 450 flow measurements per channel
350 pressure measurements per channel

III. Data Output:

Directable to printer or serial port following
completion of a test or AutoSequence.

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1.6 Interface
I. User Interface:
40-character by 8-line backlit LCD
4 front panel soft-keys
Internal beeper
LCD contrast control (rear panel)

II. Fluid interface:

Inputs A and B: Delrin twistlock, self-sealing
Common output A&B: Delrin twistlock

III. PCA Pump Trigger Outputs:

Mechanical - One 1/4" female stereo phono
jack per channel
Electrical - Relay contacts rated at 120 VAC, 1 A;
normally open and normally
closed contacts available.

IV. Nurse Call Inputs:

Mechanical - One 1/4" female stereo phono
jack per channel
Electrical - 50K-ohm differential input impedance.

V. Parallel Port:
Centronix standard printer interface,
DB-25 female connector

VI. Printer Driver:

Epson MX/FX Series, 80 cps
80 columns and 66 lines per page

VII. Serial Port:

Mechanical - DB-25 male connector
Electrical - RS-232C; bidirectional; CTS handshaking;
9600 baud, 8 data bits, no parity bit, 1 stop bit

VIII. Power Supply:

Input: 100-240VAC 50/60 Hz
Output: 12 VDC @ 1A Min.

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IX. Environment:
Operating Temperature 15EC to 40EC
Operating Relative Humidity Range 10% to 90% RH
Storage Temperature 0EC to 40EC
Storage Relative Humidity Range max 90% RH
Indoor Use Only
Category II
Pollution Degree 2

X. Dimensions:
12" W x 12" D x 6" H
30.5 cm W x 30.5 cm D x 15.2 cm H

XI. Weight:
10 lbs.
4.5 kg

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1.7 Accessories
I. Standard Accessories:

AC line cord (Country / Voltage specific)

Universal Voltage Power Supply, P/N 3000-472

I/O tubing set, comprising two IEC1 recommended 21 gauge flow restrictors,
two three-way stop cocks and two Luer-lock to Delrin twistlock extension sets,
P/N 7300-005

Flushing syringe (60cc)

Universal Product USB Drive, including Infutest 2000 Operating Manual in

Adobe PDF format, and Data Transfer and Graphing Program (DTP) for
Windows, P/N 6950-021.

RS-232 Serial Port cable, DB25F - DB9F, P/N 3140-040

II. Optional Accessories:

For a complete list of available accessories, visit [Link] or contact

Datrend Customer Service (see Appendix C for contact details)

1
IEC 601-2-24, Part 2, Particular requirements for safety of infusion pumps and controllers

Introduction/Chapter 1 # Page 8
INFUTEST 2000E OPERATING MANUAL

Overview
This chapter gives an overview of the capabilities of the Infutest, the tests
performed and test fluid recommendations.

2. OVERVIEW OF INSTRUMENT

2.1 General Description

The Infutest is an automated, self-contained system for performing flow rate, effused
volume, and occlusion pressure tests on medical infusion devices. In addition to the
Single Rate test, Infutest is also capable of automatically checking Patient-Controlled
Analgesia (PCA) pumps for correct lockout operation, and for testing pumps capable of
delivering dual rates - two preset volumes at differing flow rates (i.e. primary/secondary
delivery or delivery "piggybacking").

The Infutest has two independently-functioning channels, designated A and B, for

simultaneously performing any of four basic, selectable test procedures on up to two
infusion devices. Tests performed simultaneously may be different for each infusion
device being evaluated. For example, a Single Rate Test may be performed on a syringe
pump connected to Channel A while a PCA pump is undergoing a lockout time
measurement on Channel B. In addition to the manual selection of the four basic tests
(Single Rate, Dual-Rate, PCA and Occlusion Pressure), Infutest has the ability to create
pump test protocols, termed AutoSequences. The nine (9) test sequences are user
configurable to automate testing and data collection based on manufacturer or user test
protocols. AutoSequences may greatly improve on productivity by standardizing on
test protocols, and minimizing user setup time.

In addition to the two channel Infutest, a Remote Sensor Module (RSM) may be added
to expand the Infutest to a four channel system. Throughout the manual, wherever
reference is made to the capabilities of Channel A or B, or switching from Channel A
to B, this may be extended to include channels C and D if an RSM is connected. All
actions of the RSM are controlled by the Infutest base unit and all results are presented
on the Infutest LCD display.

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On its front panel, the Infutest provides a menu-driven user interface which is
implemented with a liquid crystal display (LCD) and four multi-function, software-
defined push buttons ("soft keys"). The left panel of the Infutest (Figure 1) provides
both a Centronix-standard parallel port (DB25 female) for connection to an Epson FX
Series or compatible printer, and a RS-232 serial port (DB25 male) for data output to a
personal computer or other data collection instrument. Also located on the left panel
are two Delrin twistlock, self -sealing connectors which serve as a fluid inputs for
Channels A and B. Fluid exits the Infutest via a Delrin twistlock connector which
provides the Channel A & B common output (Figure 2). Inputs for pump Nurse Call
signals and outputs for triggering PCA pumps are provided on the Infutest rear panel
(Figure 3).

Figure 1 - Infutest left panel

Figure 2 - Infutest right panel

Overview/Chapter 2 # Page 10
INFUTEST 2000E OPERATING MANUAL

Figure 3 - Infutest rear panel

The Infutest incorporates a time/date clock and a data logger capable of storing up to
900 flow measurements and 700 occlusion pressure measurements per channel. A "flow
measurement" comprises elapsed time (in hours, minutes and seconds), flow rate,
average flow, total effused volume and back pressure for the Single Rate, Dual-Rate and
PCA Pump Tests. A “pressure measurement” comprises elapsed time, occlusion
pressure and Nurse Call Alarm status for the Occlusion Pressure Test.

When an RSM is connected to the Infutest, the data log is initialized to 450 flow and 350
pressure measurements for each of the four channels.

The Infutest also provides a Summary for each channel. A Summary condenses the raw
data obtained from a test into a few important values, such as the average flow measured
during the test, and the total volume of fluid that was effused. An Occlusion Pressure
Summary is also included to provide a synopsis of Occlusion Pressure Test results.

Upon completion of a test, contents of the channel Data Log, the channel Summary, or
both may be output to a printer or downloaded to a personal computer via the serial
port. Multiple copies of the test results may be output in succession, and each copy may
be directed to either the printer or the serial port at the user's option.

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To accommodate long-term testing or special testing needs, the Infutest may be

controlled remotely via RS-232C using the Infutest Remote Control (IRC) command set
(see Section 6). This command set allows the Infutest to be setup and controlled by a
user designed program. Data may be collected in real-time, allowing long-term testing
and data collection.

The Infutest incorporates a non-volatile memory which allows the instrument to be

disconnected from the line and transported without losing previously acquired test
results. At power-up, the user may select to view or output the contents of a channel’s
Data Log or Summary, which are both retained in the non-volatile memory. Initial test
settings are also preserved when the AC supply is disconnected.

A Windows based software accessory, available from Datrend Systems (the Infutest Data
Transfer Program - DTP), facilitates transfer of test results from the Infutest to a
personal computer, and conversion of Infutest Data Log and Test Summary Report files
to numeric data files suitable for importing into most spreadsheet or database programs.
DTP also has the ability to graphically display and print flow versus time graphs and
trumpet (error bounds) graphs.

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2.2 Description of Test Procedures

Each channel of the Infutest is capable of making the following measurements:

I Flow Rate ranging from 0.1 up to 1200 milliliters per hour;

ii Effused Volume up to 9999 milliliters;
iii Pulsatile Flow ranging from 5 up to 1200 milliliters per hour;
iv Keep-Vein-Open (KVO) Rate following primary delivery;
v PCA pump Delivery Rate during bolus infusion, ranging from 0.1 up
to 170 milliliters per hour;
vi Bolus Volume delivered by PCA pump;
vii Number of Boluses delivered from PCA pump, up to 255;
viii Lockout Time between PCA pump bolus deliveries, in minutes and
seconds;
ix PCA pump Basal Rate following bolus delivery (using Dual-Rate Test);
x Back Pressure applied to infusion device, up to 300 mmHg;
xi Occlusion Pressure produced by infusion device, up to 2586 mmHg
(50 psi); and
xii Status of Nurse Call Alarm from infusion device (ON or OFF).

The above measurements are organized into four basic test protocols. These
test protocols are:

2.2.1 Single Rate Test

Use the Single Rate Test to evaluate the basic performance of all medical
infusion devices. The Single Rate Test measures Flow Rate (instantaneous and
average), Effused Volume, and Back Pressure.

In addition to accommodating continuous flow infusion devices, the Single Rate

test also incorporates automated detection and averaging of pulsatile flow for
increased measurement accuracy of bolus-discharge and other non-continuous
pumping devices.

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2.2.2 Dual Rate Test

Use the Dual-Rate Test to evaluate infusion devices capable of

primary/secondary delivery or delivery "piggybacking", that is, delivery of a first
preset volume at a first rate followed by delivery of a second preset volume at a
second rate. The Dual-Rate Test measures Flow Rate (instantaneous and
average), Effused Volume, and Back Pressure for each delivery programmed
into the Dual-Rate pump.

Also use the Dual-Rate Test to evaluate Keep-Vein-Open (KVO) operation and
PCA Bolus-Plus-Basal mode delivery with infusion devices which incorporate
these features.

2.2.3 PCA Pump Test

Use the PCA Pump Test to evaluate the basic performance of Patient-Controlled
infusion devices. The PCA Pump Test measures Flow Rate (instantaneous and
average) and Bolus Volume for each bolus delivery, the Lockout Time between
bolus deliveries, and the Number of Boluses delivered during the test. Back
Pressure is also measured.

2.2.4 Occlusion Pressure Test

Use the Occlusion Pressure Test to measure the maximum pressure generated
by an infusion device when its output is occluded. Also use the Occlusion
Pressure Test to check the operation of the Nurse Call Alarm on pumps which
incorporate this feature.

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2.3 Test Fluids

The following test fluids are acceptable for use with the Infutest:

1. DISTILLED WATER

2. CLEAN DOMESTIC WATER (i.e. "tap water")

Common distilled water is the preferred test fluid. If domestic water is employed,
occasional flushing with distilled water may be required following use, depending on
hardness and quality of the local water. The test fluid should be colourless and should
not contain visible particulate matter. An agent for reducing surface tension of the test
fluid is normally not required for routine use. However a wetting agent, such as Jet Dry,
may be added if required. In the case of Jet Dry, a concentration of 1.0 ml per litre of
test fluid is recommended as a starting point. Wetting agent concentration may have to
be varied depending the purity of the test fluid.

IMPORTANT:

THE USE OF SALINE SOLUTION AS A TEST FLUID IS STRONGLY DISCOURAGED,

AND WILL VOID THE WARRANTY. IN THE EVENT SALINE SOLUTION IS
ACCIDENTALLY USED, THE INFUTEST SHOULD BE FLUSHED WITH DISTILLED
WATER.

DO NOT USE DEXTROSE IN WATER (eg. D5W, D25W) OR OTHER VISCOUS TEST
FLUIDS WITH THE INFUTEST. USE OF SUCH FLUIDS WILL VOID THE WARRANTY.

If the instrument is in daily use, both channels should be kept primed between tests
provided that distilled water or low hardness domestic water is employed. If the
instrument is to be stored for several months or transported, fluid should be drained
from the unit by forcing air into each channel input with a large syringe while the
alternate input is blocked. The instrument should then be carefully blown out from the
A and B inputs to the common output using clean, dry compressed air.

For the remainder of this manual, the test fluid is assumed to be distilled water or low-
hardness domestic water, and is referred to generically as "water".

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IMPORTANT:
IV sets which have or may have come in contact with
saline or dextrose or other IV fluids should not be used on
the Infutest. If an administration set must be re-used (i.e.
as part of an incident investigation), ensure the set has
been flushed out thoroughly with clean water before
connecting the set to the Infutest. Most IV fluids contain
salts and sugars which can degrade and potentially ruin
the high-precision flow sensors inside the Infutest.

It is always best to use a new administration set when

testing a pump. However, the same administration set may
be re-used to test several pumps provided the set is primed
only with distilled or “sterile” water. Change IV set per
the manufacturer’s recommendations to ensure that test
results reflect clinical use of the infusion device.

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Set-up
This chapter describes the initial set-up of the Infutest, describes the basic
fluid connections, fluid priming, and serial and parallel output
connections.

3. INITIAL SET-UP

3.1 Connections
a. Place the instrument on a stable, horizontally level surface. Connect electrical
power to the unit by inserting the power cable into the rear panel receptacle
(Figure 3) and connecting the cable to a grounded outlet.

b. Connect the input tubing set (consisting of the IEC recommended 21 gauge
flow restrictor, three-way stop cock, and extension set) to the Channel A fluid
input (Figure 1, Figure 4). Similarly, connect the second input tubing set to
Channel B. This arrangement is recommended for proper instrument
operation.

c. Connect the output extension set to the Channel A & B common output
(Figure 2, Figure 7). The A & B Output should drain into a collection vessel
of appropriate volume ideally located on the bench near the Infutest. A small
(250 to 500 ml) beaker will suffice for most test situations.

The collection vessel should not be located more than 36" below the level of
the A & B Output. This will prevent a vacuum from being applied to the
Infutest which could damage the internal pressure sensors, or cause a
pressure zero error when the Infutest is powered up.

Refer to the instructions in Appendix A if a Back Pressure is to be applied to the Infutest to oppose
the flow from the infusion device.

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3.2 Priming
Figure 4, Figure 5 and Figure 6 on the following page show the three possible
positions of the stop cock connected to a channel input. As illustrated, the three
positions are referred to as ON, PRIME or FLUSH, and OFF.

Figure 4 - Connection of stop cock to channel input, channel ON.

Figure 5 - Stop cock position for priming / flushing

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Figure 6 - Stop Cock position for channel OFF.

Figure 7 - Connection to A & B Output

To prime a dry instrument:

a. Rotate the Channel A stop cock to PRIME (Figure 5) and the Channel B
stop cock to OFF (Figure 6). Fill the 60 cc syringe supplied with the Infutest
with 60 cc of water, connect the syringe to the open port on the Channel A
stop cock and discharge the syringe into the fluid channel. Rotate the Channel
A stop cock to OFF, and disconnect and refill the syringe. Repeat this priming
action at least five times. Eventually, water will begin to drain out of the A &
B Output, as air is forced out of the Channel A fluid system and reservoir.

Set-up/Chapter 3 # Page 19
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b. Now rotate the Channel A stop cock to OFF and the Channel B stop cock to
PRIME. Repeat (a) above for Channel B.

c. Prepare the device under test (DUT) by loading the device with an
administration set and priming the set with water according to the
manufacturer's instructions. Connect the primed set to the Channel A stop
cock and set the stop cock to ON.

d. Prepare a second DUT as above and connect it to Channel B.

e. To test a single infusion device, connect the device to either Channel A or

Channel B as desired and set the other channel's stop cock to OFF. This will
prevent water from draining out the unused channel's input if any pressure is
developed within the internal fluid system. If the input tubing set is not
connected, the Delrin twistlock input connector has an internal seal which will
prevent fluid backflow.

f. If normal saline solution must be used as a test fluid (against Datrend’s

recommended practice), prime as described above and flush the channel with
distilled water immediately following the test. Under no circumstances
should an instrument channel be used or left primed with saline for an
extended period of time.

g. Unless the Infutest is stored for several months at a time, leave the instrument
primed between uses. Following use, flush the Infutest with distilled water,
set both channel stop cocks to OFF, and store the instrument in the
horizontal position.

IMPORTANT:
It is best to use a new administration set when testing an infusion device, or at least change the
set periodically according to the manufacturer’s recommendations. Use of IV sets which have
or may have been used with saline, dextrose or other IV fluids should be avoided. See section
2.3 , Test Fluids.

IMPORTANT:
After powering-up, Infutest will attempt to obtain a zero pressure reference. To avoid a
“pressure zero" alarm, ensure no pressure is applied at the Infutest inputs or output when
applying power to the unit. Install the IV set in the DUT and leave the DUT on standby while
the Infutest performs its self-test routines, to prevent a “pressure zero” alarm.

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IMPORTANT:
When testing a syringe pump, always use a new disposable syringe. Prelubricate the syringe
by drawing on the plunger a few times before loading the syringe with water and installing it in
the pump.

After priming and connecting the administration set to a channel, always flush the
channel before starting the test using a technique similar to that described to prime the
Infutest. Injecting about 5 cc of water should be sufficient to remove any air bubbles in
the channel. The Infutest reminds the user to do this via the LCD prior to starting a
test.

If a test is already running on one channel, flush or prime the other channel by injecting
water into it gradually rather than rapidly; discharge about 10 cc of water into the
channel over 5 seconds. Gradually priming a channel in this way will prevent
disturbances appearing on the other channel.

The Infutest may be used to test infusion devices immediately after priming both
channels as described above. However, after shipping the Infutest, or following a period
of dry storage, optimum results are obtained if the internal flow sensors are first
"wetted" before performing tests.

The Infutest may be wetted by first priming the instrument, then running Single Rate
Tests on Channels A and B at approximately 500 ml/hr for 10 to 15 minutes (refer to
Section 4, Operation and Related Displays).

The preferred method of wetting, however, is to flush the instrument with Sudsy
Ammonia solution and distilled water, following the cleaning procedure given in Section
5.1.3, Cleaning.

Wetting is optional, however, cleaning the instrument regularly is recommended,

depending on usage. For instruments in daily use with distilled or domestic water,
cleaning is recommended monthly. A thorough cleaning is essential if the instrument
becomes contaminated with fluids other than water (dextrose, saline, etc.). The
procedure for cleaning the Infutest and RSM is given in Section 5.1.3, Cleaning.

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3.3 Optional Connections

a. If complete test results are to be retained for documentation purposes,
connect an Epson FX-compatible printer (80 columns and 66 lines per page,
80 characters per second) to the Infutest parallel Printer Port (Figure 1). The
parallel Printer Port accepts a DB-25 male.

b. As an alternative or in addition to (a) above, a personal computer (PC) or

other data collection instrument may be connected to the Infutest Serial Port
(Figure 1). The Infutest Serial Port is configured as Data Communications
Equipment (DCE), except that the Infutest Serial Port accepts a DB-25 female
to distinguish it from the parallel Printer port.

Connect the Infutest to the COM port of a personal computer with a RS-232
cable having a DB-25 female at the Infutest end and a DB-25 (or DB-9)
female at the computer end. Each pin on the computer's DB-25 connects to
the same pin on the Infutest's DB-25; do not use a null modem adaptor or a
null modem cable.

Alternatively, you may use a conventional computer-to-modem RS-232 cable

with a double-female gender changer attached at the male end of the cable.

RS-232 cables for connecting the Infutest to a personal computer are available
as accessories from Datrend Systems (See Section 1.7).

The Infutest Serial Port both transmits and receives, and is configured as
follows:

9600 baud, No parity, 8 bits/character, 1 stop bit.

Infutest - PC communications rely on hardware handshaking via the CTS

lines. The Infutest holds the CTS line high continuously.

c. The Infutest Serial Port may also be connected to an external controlling

device to facilitate remote test control and data down loading. For example,
the Infutest Serial Port may be connected to COM2 of a Fluke Biomedical
medTester 5000C. Use of a SSC -1 accessory cable is recommended. The
same CTS handshaking rules described above for the PC interface apply to
external controllers such as the medTester.

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d. The pin connections for the serial interface cables are as follows:

Infutest Computer

DB25F DB25F DB9F

2 (TXD) 2 3

3 (RXD) 3 2

4 (RTS) 4 7

7 (GND) 7 5

All other pin connections are open circuit.

e. In order to download test results from the Infutest Serial Port, you must run a
terminal emulator program on your PC (eg. Windows HyperTerminal).
Datrend Systems can provide a Windows based software program (DTP)
which has been specially designed for this purpose. In addition to the serial
interface connection, DTP incorporates a number of additional utilities for
viewing, editing and printing test data, or converting test data to spreadsheet
or database compatible files, as well as producing Flow versus Time graphing,
and Trumpet (error) graphs.

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Operation
This chapter describes the operation of the Infutest controls and the
associated LCD screen displays. In addition, you are instructed how to
modify the default settings and AutoSequence protocols.

4. OPERATION AND RELATED DISPLAYS

4.1 Powering Up and Setting the Clock

a. Set the Infutest power switch on the rear panel (Figure 1) to ON. The
Infutest LCD will display a power-up screen while performing a number of
internal self-tests.

b. If required, adjust the LCD contrast control on the rear panel (Figure 3)
using a trimpot adjustment tool.

c. If an abnormal condition is detected during the power-on self-test, the

Infutest will report the fault by means of an alarm tone and message on the
display. Refer to Section 4.9 - Alarms, if this should happen.

d. Upon successful completion of the self-test, the screen illustrated in Figure 8

will appear. The label displayed above each front panel key corresponds to
the function of the key for the currently viewed screen. These keys are
referred to as 'soft keys'.

e. A real-time clock appears in the upper right hand corner of the LCD on most
menus and screens as shown in Figure 8. The clock has 24-hour format and
may be displayed as:

MONTH DAY hours:min (USA) or;

DAY MONTH hours:min (EUR and ISO)

Operation/Chapter 4 # Page 25
INFUTEST 2000E OPERATING MANUAL

Jun 10 09:35

Datrend Systems Inc.

INFUTEST 2000 Series E

Version:3.7/3.2 © DSI 2005

START LOGS EDIT SEQ UTILITY

Figure 8 - Power-on screen following successful self-test.

f. Press the LOGS soft key to recall previously acquired test results stored in the
non-volatile Summary and Data Log; or,

g. Press the EDIT SEQ soft key to create, edit and enable up to nine (9)
automated test sequences. Refer to section 4.10 for complete instructions on
the setup and use of automated sequence testing; or,

h. Press the START soft key to set up and start a new test.

i. Press the UTILITY key to display the screen of Figure 9, which allows
setting of the internal time/date clock, or entry of a user-defined test
equipment identification number for the Infutest.

UTILITY:

-> DATE: Jun 01 2005

TIME: 09:36
FORMAT: USA
ID No.: EDC05080651

EXIT MODIFY SELECT

Figure 9 - UTILITY screen

Operation/Chapter 4 # Page 26
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j. To set the date, press the SELECT key until the º prompt is pointing to
DATE:. Press MODIFY to change the DATE. The editing keys of Figure 10
will then appear at the bottom of the screen.

ENTER SET- SET+ SELECT

Figure 10 - DATE; TIME; and ID No. editing keys.

k. Press SELECT to move the editing cursor between the month, day and year
displayed on the screen. Press SET+ to increment the highlighted item, or
SET- to decrement the highlighted item. SET+ and SET- may be held down
to continuously increment or decrement the selected item. Press ENTER to
input the displayed DATE into the Infutest clock. The clock will support all
dates for years 1999 through 2098, including Feb. 29 of leap years.

l. Press SELECT to move the º prompt to the TIME: displayed on the

screen. Press MODIFY to change the TIME. The editing keys of Figure 10
will appear and will operate in a manner similar to setting the date. The clock
employs a 24-hour format.

m. Press SELECT to move the º prompt to FORMAT on the utility screen.

Press MODIFY to select one of the three available formats for the clock date,
as follows:
USA Month-Day-Year
EUR(ope) Day-Month-Year
ISO Year-Month-Day

n. Press SELECT to move the º prompt to ID No. on the utility screen. For
Infutests shipped from the factory, the default ID No. is the unit serial
number. If desired, press MODIFY to edit the ID number displayed on the
screen. The keys will change to the editing keys of Figure 10, allowing each
character of the ID No. to be changed individually. Up to 12 characters may
be input using SET+ and SET-. Once editing is complete, press ENTER to
save the ID No. in memory.

The ID No. shown on the utility screen is provided as a test equipment

identification number, and as such will appear in each Test Summary or Data
Log report printed or downloaded from the Infutest. This allows each test
document to be traced to the Infutest which produced the document, a
requirement for ISO 9000-compliant institutions and service providers.

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o. Once the DATE, TIME, date FORMAT and Infutest ID No. have been set as
desired, press the EXIT key to quit the utility function and return to the
power-up screen of Figure 8. All utility settings will be retained in the battery-
backed memory of the Infutest when the power is off.

4.2 S Setting Up a Test

Pressing the START soft key on the power-up screen causes the START menu for
Channel A to be displayed (Figure 11). This screen is used to select the particular test
type or test AutoSequence before starting a test.

START: CHAN A Jan 10 09:37

FLUSH channel to purge air bubbles

Set test, Push GO, Then start pump
TEST: AutoSeq #1 IVAC 565
Set pump rate to 50 ml/h
GO CHANNEL+ SET TEST <more>

Figure 11 - START menu, Channel A.

a. Press the SET TEST soft key to select one of four manual tests: Single Rate,
Dual Rate, PCA Test or Occlusion Test; or one of up to nine AutoSequences.
Auto Sequences must be enabled via the EDIT SEQ screen, before they can
be selected using the SET TEST key.

b. Each of the manual tests will run until STOPped by the operator. The
AutoSequences can be set up to run a flow rate test, an occlusion test, and
print or serially download the results automatically, to increase the test
productivity.

Prior to starting a test, you may:

c. Press the CHANNEL+ soft key to display a screen reflecting the current status
of Channel B, C, or D; or,

d. Press the <more> , then EDIT SEQ soft keys to access AutoSequence
editing; or,

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e. Press the <more>, then PREV TST (Previous Test) soft keys to pre-empt
the new test and recall results obtained from the last test executed on Channel
A. Note the Data Log and Summary of the Infutest channel are NOT erased
until the "GO" key is pressed the START screen. At any time before this, the
user may abort the start of a new test and recall the Summary and/or Data
Logs for the previous test by means of the PREV TST soft key on the
START screen.

f. Note: This following Menu item is not available in the German

language version.

Press <more> and then SET RATE to view the SET RATE menu (Figure
12). By means of this menu, Infutest can be enabled to calculate a percentage
error between a Set Rate value in milliliters per hour and the Average Flow
Rate as measured and reported by Infutest upon conclusion of a Single Rate
Test.

SET RATE: CHAN A

-> RATE ERROR: Enable

SET RATE: 100 ml/h

EXIT MODIFY SELECT

Figure 12 - SET RATE menu, Channel A.

You can use the menu of Figure 12 to input the flow rate setting of the
infusion device which is being tested. While viewing the SET RATE menu,
press SELECT to toggle the º prompt between RATE ERROR: and SET
RATE:, then press MODIFY to change the indicated item

RATE ERROR may be set to either Enable or Disable the per-cent error
calculation which is performed at the end of a Single Rate Test.

With the º prompt at SET RATE, pressing MODIFY causes the editing
keys of Figure 13 to appear at the bottom of the screen.

ENTER SET- SET+ SELECT

Figure 13 - Rate editing keys.

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Press SELECT to move the editing cursor to each digit of the displayed rate.
Press SET+ to increment the highlighted digit, or SET- to decrement the
highlighted digit. Press ENTER to input the displayed SET RATE. Infutest
will accept rate values ranging from 1 ml/h to 1200 ml/h.

Percentage error calculation can be enabled on each Infutest channel

independently, and each channel can have a different SET RATE value.

Percentage error calculation applies only to the Single Rate Test, or to any
AutoSequence test which incorporates a Single Rate Test as part of the test
sequence. The rate error calculation is not performed for Dual Rate, PCA
Pump or Occlusion Pressure Tests, even if RATE ERROR on the menu of
Figure 12 is set to Enable.

With the calculation enabled, the percent error will be shown to the right of
the Average Rate measurement which is displayed on the SUMMARY screen
for the Single Rate Test (refer to Section 4.6.1). In this case, the Set Rate value
from the menu of Figure 12 will also be incorporated into the Test Summary
Report that may be printed or downloaded from Infutest (refer to Section
4.8).

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4.3 Test Measurement Concepts

The Series E Infutest introduces a number of new concepts to improve measurement
accuracy and allow Infutest to more readily deal with pulsatile pumps.

4.3.1 SynchroStart

When a test is started, the Infutest prompt reads “Push GO, then start
pump”. At first, this may seem backwards, however, Infutest will not start its
first measurement until after it detects actual fluid flow. This synchronizes the
flow measurements with the beginning of fluid flow, which is important on
pumps which have a pulsatile flow pattern.

4.3.2 End-of-Infusion Analysis

End-of-Infusion Analysis (EIA) calculates the volume infused at the instant the
STOP key is depressed, or the automatic sequence reaches the end of the preset
test time. The only caveat with this calculation is it will be in error if the pump is
stopped before the test is stopped. To bring this to the user’s attention, the
“Volume Infused” displayed on SUMMARY screens will flash on and off to
remind the user that this value may be in error. If there is any question about the
accuracy of this value, the full test DATA LOG may be reviewed, and the second
last value used.

4.3.3 Flow Pattern Classification

Different flow measurement algorithms are used, based on the type of flow
pattern detected. During initial flow detection, and continuously thereafter, the
flow pattern is analyzed to determine if it is smooth, pulsatile or very pulsatile.
The flow pattern classification is indicated on the display in the STATUS
indicator on the upper right corner of the screen. If the flow is smooth and
continuous, the STATUS indicator will be LOW or HI, depending on the rate. If
the flow is delivered in very small ‘spurts’ the indicator will be PUL. If the flow is
delivered in large pulses (as in many home care pumps) the indicator will be VPF,
and the rate will be measured on the HI range sensor. This may increase the flow
measurement times for pulsatile pumps measured at low flow rates.

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4.4 Starting a Test

Following the prompts on the START screen, the flow sensor for the channel in use
should be primed, then simply press the GO soft key and start the infusion pump to
begin the test. The infusion pump under test does not need to be started until the
GO key has been pressed. If the pump has an unusual, high flow condition that
appears only on startup, the pump may be started first. This may avoid the
automatic selection of the high range flow sensor when the pump is running at
low rates.

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4.5 Running a Test

A running test will produce a display similar to that illustrated in Figure 14. As shown
in the figure, the top line of the TEST screen is reserved for the name of the test on the
left (SINGLE RATE; DUAL-RATE; PCA PUMP; or OCCL. PR.), the channel
identifier label in the center (CHAN A or CHAN B), and the current test status on the
right (BOLUS#, or RATE #; plus the flashing flow status indicator: one of LOW, HI,
PUL, VPF, or LOCKOUT).

SINGLE RATE: CHAN A LOW

))) FLOW ••••• AVG FLOW
Time: [Link] 35.0S
Flow: 23.31 ml/h
Avg.: 25.41 ml/h 25.0S
Vol.: 0.671 ml
Back Pr.: 3 mmHg 15.0S t
CHANNEL+ OCCL PR RESTART

Figure 14 - TEST screen for Single Rate Test, Channel A.

The definitions of the displayed mnemonics on the left half of the screen are:
Time: is the total time elapsed since the start of the test, in hours, minutes
and seconds (hh:mm:ss).
For Single Rate, Dual-Rate, and PCA Pump Tests...
Flow: is the "instantaneous" flow rate in milliliters per hour, obtained by
measuring a small volume of effused test fluid over a fixed interval
of time, ranging from a minimum of 4 seconds to a maximum of
approximately 10 minutes.
Avg.: is the average flow rate from the start of the test, in milliliters per
hour, derived by calculating the ratio of the total effused volume to
the total elapsed time.
Vol.: is the total volume of fluid which has been effused through since the
test was started, in milliliters.
Back Pr.: is the back pressure in mmHg appearing at the input, which is
approximately equal to the positive pressure optionally applied by
the user at the Infutest A&B Output to oppose the flow from the
infusion device (see Appendix A, Back Pressure Testing).

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For the Occlusion Pressure Test, the TEST screen will appear as in Figure 15.

OCCL. PRES.: CHAN A

mmHg psi
Time: 00:46 500S 10

Pressure: 250S 5
5.2 psi
268 mmHg 0S t
CHANNEL+ STOP RESTART

Figure 15 - TEST screen for an Occlusion Pressure Test, Channel A

Pressure: is the pressure obtained at the input at time mm:ss, after the
channel has been internally occluded, in units of psi and mmHg.

The right half of the TEST screen is reserved for the real-time graph of either
instantaneous and average flow, or occlusion pressure. The vertical axis is scaled
automatically based on graph type and initial measurement data. Rather than absolute
time in minutes, the horizontal 't' axis represents time in number of measurements, each
tick indicating three consecutive data points. As the test proceeds, the graph scrolls to
display data from the most recent 15 measurements.

The top right corner of the TEST screen is reserved for displaying test status messages
and the blinking flow status indicator, which indicates the test is in progress. The Dual-
Rate, PCA Pump and Occlusion Pressure Tests have a number of status messages which
appear at this location in addition to the flow status indicator shown in Figure 14.

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The test status messages are:

Test Status Message

Dual-Rate RATE #N -
the infusion device is currently operating at preprogrammed flow rate
number N, where N = 1 or 2.

WARNING! - PUL
the infusion device produces pulsatile flow. Switch from RATE #1 to RATE
#2 will not be detected. Flow and volume measurements may be low (see
Section 5.3.5).

PCA Pump BOLUS #NNN -

The triggered delivery of bolus number NNN from the PCA pump is in
progress or has been completed, NNN = 1 to 255. After delivery, the
average delivery rate and the volume of the bolus are posted beside the
"Avg.:" and "Vol.:" labels respectively.

WARNING! - PUL
the infusion device produces pulsatile flow. Flow and volume
measurements may be low (see Section 5.4.3).

MM:SS [flow status indicator = Lockout]

The lockout time between bolus deliveries number NNN and number
NNN+1 measured in mm:ss [minutes and seconds.]

The screen shown in Figure 14 is for an AutoSequence test, with an occlusion pressure
test enabled. In a manually selected test, or if the pressure test has not been enabled in
the AutoSequence, the OCCL PR soft key will read STOP. To operate the Infutest,
proceed as follows when viewing the TEST screen:

a. Press the RESTART soft key to cause the test or AutoSequence to abort,
and return to the START screen.

b. Press the CHANNEL+ soft key to cause a Channel B screen to be displayed;

if the channel is not running a test the Channel B STARTscreen will appear,
allowing the user to set up and start a test on Channel B (see Section 4.2,
Setting Up a Test).

c. Press the STOP soft key to cause the test to stop running and the
SUMMARY screen to be displayed; or, if the OCCL PR soft key is displayed,
press it to jump to the occlusion pressure portion of the automatic test
sequence. In the occlusion pressure test screen, Figure 15, the operator
will be presented with the STOP soft key to end the test prior to the preset
time of the AutoSequence, and start the automatic data output - if data
output is enabled.

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4.6 Viewing the Test Summary

4.6.1 SUMMARY Screen for Single-Rate Test

Figure 16 is a SUMMARY screen for a Single Rate Test performed on Channel A.

SUMMARY: CHAN A Jan 10 09:51

SINGLE RATE + OCCL PRESSURE TEST

Infusion Time: [Link]
Volume Infused: 2.642 ml
Average Rate: 9.900 ml/h
Back Pressure: 5 mmHg
OUTPUT CHANNEL+ OCCL PR START

Figure 16 - SUMMARY screen for Single Rate plus Occlusion Pressure Test, Channel A.

The definition of the mnemonics displayed on the screen is:

Test is the type of test that was executed (SINGLE RATE; DUAL-
RATE; PCA PUMP; or OCCLUSION PRESSURE). If an
Occlusion Pressure Test was enabled in an AutoSequence for a
Single Rate, Dual-Rate or PCA Pump Test, the label "+ OCCL
PRESSURE TEST” will appear with the title of the initial test as
shown in Figure 16.
Infusion is the duration of the test, in hours, minutes and seconds
Time
Volume is the total volume of test fluid that was effused during the test, in
Infused milliliters
Average is the flow rate averaged over the duration of the test, in milliliters
Rate per hour. If percent error calculation has been enabled on the
Infutest channel, a percent error value will be displayed to the
right of the Average Rate (see Section 4.2, paragraph f).
Back is the back pressure measured at the end of the test, in mmHg
Pressure

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The SUMMARY screen shown in Figure 16 is from an AutoSequence with an

Occlusion Pressure test enabled. In this case, pressing the OCCL PR key displays
the summary for the Occlusion Pressure test (see Section 4.6.4). For manually run
Single Rate, Dual-Rate or PCA pump tests, or if the occlusion test is not enabled
in the AutoSequence, the OCCL PR key is labelled DATA. Pressing the DATA key
displays the contents of the data log.

4.6.2 SUMMARY Screen for Dual-Rate Test

The SUMMARY screen for a Dual-Rate Test is shown in Figure 17.

SUMMARY: CHAN B Jan 10 10:21

DUAL RATE TEST

RATE #1 RATE #2 Back Pr:
[Link]: [Link] [Link] 1 mmHg
[Link].: 1.604 ml 0.116 ml
[Link]: 45.09 ml/h 4.905 ml/h
OUTPUT CHANNEL+ DATA START

Figure 17 - SUMMARY screen for Dual-Rate Test, Channel B.

As with the Single Rate Test, if an Occlusion Pressure Test is started by an

AutoSequence, the DATA soft key will be replaced by OCCL PR. Pressing the
OCCL PR key will access the pressure summary screen.

If the user chooses to stop a Dual-Rate Test before the infusion device switches to
Rate #2, no values will appear on the right half of the SUMMARY screen.

4.6.3 SUMMARY Screen for PCA Pump Test

The SUMMARY screen for a PCA Pump Test is shown in Figure 18. The data
displayed are averages, calculated from the individual values of each of the
respective measurements, from the beginning of the test. If a [?] appears at the
end of the ‘Average Bolus Volume’ line, this indicates that one or more
individual bolus volumes has exceeded the first measured bolus by +/- 10%.
Similarly, a [?] on the ‘Average Lockout Time’ line indicates a variation in
excess of +/- 10% in the measured lockout times, with the first lockout time used
as a reference. To review the complete data for the test, press the DATA soft key
to access the complete log of measurement data.

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SUMMARY: CHAN A Jan 10 10:29

P.C.A. PUMP TEST

Average Bolus Volume: 1.438 ml [?]
Average Delivery Rate: 92.68 ml/h
Average Lockout Time: 05:02 mm:ss [?]
Number of Deliveries: 3
OUTPUT CHANNEL+ DATA START

Figure 18 - SUMMARY screen for PCA Pump Test, Channel A.

The ‘Number of Deliveries’ refers to the number of complete bolus

deliveries. If a test is STOPped during a lockout time measurement, the ‘Number
of Deliveries’ will include the last bolus measured.

4.6.4 SUMMARY Screen for Occlusion Pressure Test

The SUMMARY screen for an Occlusion Pressure Test, initially selected on the
SETUP menu or executed as part of an AutoSequence for a Single Rate, Dual-
Rate or PCA Pump Test, is shown in Figure 19.

SUMMARY: CHAN B Jan 10 11:02

OCCLUSION PRESSURE TEST

Max. Occlusion Pr.: 3.6psi 186 mmHg

measured at time: 00:52 mm:ss

OUTPUT CHANNEL+ DATA START

Figure 19 - SUMMARY screen for Occlusion Pressure Test, Channel B.

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This summary screen will include one of the following:

Max. is the maximum pressure detected, during the test, in psi and
Occlusion mmHg. The time displayed corresponds to the time of the
Pr detected maximum.
Nrs Call is the pressure measured at the time the nurse call signal was
Alarm Pr. activated. The time displayed also coincides with the
detection of the nurse call signal.
Overpressr indicates that the maximum system pressure of 50 psi was
Reading exceeded during the test, and the test was terminated. The
time displayed corresponds to the time of the overpressure
condition.

4.6.5 SUMMARY Screen Usage

Operate the Infutest as follows when viewing the SUMMARY screens shown in
Figure 16 to Figure 20:

a. Press the OUTPUT soft key to cause the channel’s output submenu to be
displayed. This menu may be used to output the Summary and/or Data Log to
either the printer or serial port; or,

b. Press the CHANNEL+ soft key to cause the next channel's screen to be
displayed; if the channel is not running a test the channel's SETUP menu will
appear, allowing the user to set up and start a test on the channel (see Section
4.2, Setting Up a Test); or,

c. Press the DATA soft key to cause the channel’s Data Log sub-screen to be
displayed. This screen allows the user to scroll through the raw data which was
acquired during the test. If an occlusion pressure test was performed as part of
an AutoSequence, the DATA key will be replaced with OCCL PR. The DATA
selection will then be available from the Occlusion Pressure Summary screen;
or,

d. Press the START soft key to return to the START menu to set up and start a
new test. If this key is pressed accidentally, the SUMMARY screen may be
restored by means of the PREV TST soft key on the channel’s
START/<more> screen.

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4.7 Viewing the Data Log

4.7.1 Data Log Description

Measurements acquired during a test and displayed on the TEST screen are saved
in the Data Log. The Data Log is non-volatile and has a maximum capacity
of 900 flow measurements per channel (450 measurements in four-channel mode).
This corresponds to approximately 2 hours and 15 minutes of Single Rate Test
data at a flow of 100 ml/hr. The pressure Data Log may hold up to 700 data
points (350 in four-channel mode).

The Data Log is based on a circular memory, which means that after the
Data Log has been filled up with 900 flow measurements, the Infutest data
logger will continue to save newly acquired flow data in the Data Log by
overwriting the oldest data, that is, the data which was first acquired at the start of
the test. This will continue until the user stops the test. The Data Log
therefore retains the most recently acquired 900 flow measurements. Similarly, the
most recent 700 pressure measurements will be maintained in the pressure Data
Log.

For longer tests of more than 900 measurements, the Infutest provides real-time
data output through the use of the computer interfacing commands (IRC). In this
case, all measurements obtained may be sent both to the Data Log and to the
Serial Port.

4.7.2 DATA Screen Usage

Pressing the DATA soft key of the SUMMARY screen will cause the channel’s
Data Log to be displayed in tabular format as shown in Figure 20. The DATA
screen allows the user to scroll line by line through the contents of the channel’s
Data Log. The [Link] illustrated in the example of Figure 20 represent
arbitrary numerical data.

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DATA: CHAN A
Elapsed Flow Avg Flow Volume [Link]
Time (ml/h) (ml/h) (ml) (mmHg)
hh:mm:ss [Link] [Link] [Link] XXX
hh:mm:ss XXX.X [Link] [Link] XXX
hh:mm:ss [Link] [Link] [Link] XX
hh:mm:ss XXX.X XXX.X [Link] XX
SUMMARY SCROLL+ SCROLL-

Figure 20 - Data table for Single Rate, Dual Rate, and PCA Pump Tests; no event markers.

a. Press the SCROLL+ soft key to scroll forward through the Data Log line by
line. If the key is pressed and held, the data will continuously scroll until the
key is released

b. Press the SCROLL- soft key to scroll backward through the Data Log line
by line. If the key is pressed and held, the data will continuously scroll until the
key is released

c. Press the SUMMARY soft key to return to the SUMMARY screen.

d. While scrolling through the log with the SCROLL+ and SCROLL- soft keys,
event markers will appear in-line with the numerical data for the Dual-Rate,
PCA Pump and Occlusion Pressure Tests. Refer to Figure 21 for an example
of BOLUS and LOCKOUT event markers which are inserted into the Data
Log of the PCA Pump Test.

DATA: CHAN A
Elapsed Flow Avg Flow Volume [Link]
Time (ml/h) (ml/h) (ml) (mmHg)
hh:mm:ss [Link] [Link] [Link] X
LOCKOUT TIME = 06:01
BEGIN BOLUS # 2
hh:mm:ss XXX.X XXX.X [Link] X
SUMMARY SCROLL+ SCROLL-

Figure 21 - Data table for PCA Pump Test, showing BOLUS and
LOCKOUTTIME event markers.

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e. If an Occlusion Pressure Test was conducted manually, or as part of an

AutoSequence, the DATA screen will appear as shown in Figure 22.

DATA: CHAN A
Elapsed Time Occlusion Pressure
(psi) (mmHg)
[Link] 0.0 0
[Link] 0.1 5
[Link] 0.2 10
[Link] 0.3 15
SUMMARY SCROLL+ SCROLL-

Figure 22 - Data table showing Occlusion Pressure Test data.

f. When the DATA screen has been scrolled to the end of the Data Log, the
END OF LOG message will be displayed as shown in Figure 23.

DATA: CHAN A
Elapsed Flow Avg Flow Volume [Link]
Time (ml/h) (ml/h) (ml) (mmHg)
hh:mm:ss [Link] [Link] [Link] X
END OF LOG

SUMMARY SCROLL+ SCROLL-

Figure 23 - Data table showing the end of the Data Log has been reached.

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4.8 Output of Summary and Data Logs

Pressing the OUTPUT soft key on a channel’s SUMMARY screen causes the OUTPUT
submenu for the channel to be displayed (Figure 24). This submenu is used for sending
the Summary and/or Data Log to either the parallel Printer Port or the Serial Port, or
both, if desired.

a. To set the type of report to be output, press the SELECT key until the º
prompt is pointing to REPORT:. Press MODIFY to change the report type to
"Summary"; "Data Log"; or "Port Tst".

OUTPUT: CHAN A
REPORT: Summary <- ID TYPE: Contrl No.
PORT: Printer PUMP ID: ECN1234567
STATUS: READY

SUMMARY GO MODIFY SELECT

Figure 24 - OUTPUT submenu

With REPORT set to "Summary", a Test Summary Report, which will list the
contents of the Summary Log, will be output to the selected PORT. If
REPORT is set to "Data Log", the entire contents of the Data Log (up to 2000
lines of measurement data) will be output to the selected PORT. If REPORT is
set to "Port Tst", two lines of characters will be sent to the selected PORT,
allowing the user to ensure the receiving device is on-line and functioning as
expected.

b. Press SELECT so that the º prompt moves to the "PORT:" parameter.

Press MODIFY to select either "Printer" or "Serial" as the output destination.
If the selected PORT is not already busy outputting data, the STATUS line will
indicate READY as shown in Figure 24.

c. Press SELECT so that the º prompt moves to the "ID TYPE:" parameter.
Press MODIFY to select either "Control No.", "Serial No.", or "None" as the
pump ID TYPE.

The ID TYPE refers to the pump being tested, and allows the user to enter
either the serial number or control number of the pump on the "PUMP ID:"
line. If the ID TYPE is set to "Control No." or "Serial No.", the PUMP ID

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will appear in the appropriate area of the report when the Summary or Data
Log is printed or downloaded from the Infutest. If there is no desire to include
a pump serial number or control number in the report document, press
MODIFY to set the ID TYPE to "None".

d. If "ID TYPE" has been set to either "Control No." or "Serial No.", press
SELECT so that the º prompt moves to the "PUMP ID:" parameter. Press
MODIFY to edit the displayed PUMP ID. The keys will change to the editing
keys of Figure 25, allowing each character of the PUMP ID to be changed
individually. Up to 10 characters may be input using SET+ and SET-. Note
that SET+ and SET- may be held down to continuously scroll through the
character set. Once editing is complete, press ENTER to save the PUMP ID in
memory.

ENTER SET- SET+ SELECT

Figure 25 - PUMP ID editing keys

e. The PUMP ID is continuously retained in the battery-backed memory of the

Infutest with power on or power off, until the ID is changed by the user. To
prevent the displayed PUMP ID from appearing in the Summary or Data Log
output without actually editing or erasing the PUMP ID, simply set ID TYPE
to "None".

f. If output to a personal computer via the Infutest Serial Port is desired, the user
must first run a terminal emulation/communication program after connecting
the Infutest to one of the PC's COM ports. Set up the COM port as follows:

9600 baud, No parity, 8 bits/character, 1 stop bit

Ensure that the correct COM port on the PC has been selected, otherwise the
download will not be initiated. Refer to Section 3.3 for complete serial interface
details.

g. Once the REPORT, PORT, ID TYPE and, if applicable, the PUMP ID have
been set as desired, press GO to initiate the printout or download of the
Summary or Data Log report.

h. The data output system incorporates an output queue to handle all data output.
If the Infutest is already outputting data on either the serial or parallel port, the
STATUS line will read BUSY, and the GO soft key will be changed to QUEUE.
Pressing the QUEUE key will place the output job into the output queue and
the STATUS line will change to QUEUED. If there is nothing already in the

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output queue, pressing the GO key will change the STATUS line to
PRINTING or DOWN LOADING, depending on the output port selected.
Refer to Figure 26 for an example of an output screen.

OUTPUT: CHAN A

REPORT: Summary <- ID TYPE: Contrl No.

PORT: Printer PUMP ID: ECN1234567
STATUS: PRINTING

SUMMARY CANCEL

Figure 26 - OUTPUT submenu showing print job in progress.

i. To terminate an output job in progress, press the CANCEL key.

j. The Infutest will detect if the Printer is off-line within approximately 10

seconds. For the case of the Printer being off-line or out of paper, an alarm
tone will be produced and the STATUS line will appear as shown in Figure
27. As instructed by the screen, press the O.K. soft key when the problem
has been corrected, or press KILL ALL to abort the selected output job(s).

OUTPUT: CHAN A
REPORT: Summary <- ID TYPE: Contrl No.
PORT: Printer PUMP ID: ECN1234567
STATUS: Printer OFF LINE
Push O.K. when ON LINE
KILL ALL O.K.

Figure 27 - OUTPUT submenu showing Printer is off-line.

k. When the selected output job is complete, the OUTPUT screen will return
to its initial state as illustrated in Figure 24. The user may now modify the
OUTPUT and SEND TO parameters to output additional copies of the
Summary or the Data Log to either the Printer or Serial Port as desired.

l. Output jobs are run as background processes. After pressing the GO (or
QUEUE) soft key, the user may press the SUMMARY soft key and then recall
other screens while the Infutest outputs to the Printer Port or Serial Port.

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m. An example of a Test Summary Report corresponding to the OUTPUT screen

is provided in Figure 28. Note that each report output from the Infutest will
include blanks at the bottom for the technician's name and signature.

p. 01

INFUTEST 2000-E
Datrend Systems Inc.

TEST SUMMARY REPORT

Start of Test - Date: Aug 01 2005

- Time: 09:38

Infusion Device Information:

Manufacturer: _______________ Model: ___________________

Serial No.: _________________ Control No.: ECN1234567

Department: _________________ Location: ________________

Set Rate(s): ____________ml/h VTBI: __________________ml

Infutest ID: EDC05080651

Channel: A

SINGLE RATE TEST

Infusion Time: hh:mm:ss
Volume Infused: VVVVV ml
Average Rate: RRRRR ml/h
Back Pressure: PPP mmHg

Tech: _________________ Signature: ________________________

Figure 28 - Format of Summary Report printout .

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4.9 Alarms
On power up, Infutest may detect an alarm condition which may or may not indicate the
need for service. The alarm message screen will appear following the self test screen.
Most FAULT conditions will require factory service, while WARNING conditions will
require a user action, but should not prevent the use of the instrument.

4.9.1 Nonrecoverable Alarms

The following FAULT conditions will require the unit to be returned to the factory
or authorized service center for service:

FAULT: TCO SCI Serial Communications Error

FAULT: TCO RAM Memory Error - RAM
FAULT: TCO ROM Memory Error - ROM
FAULT: TCO EPM Memory Error - EEPROM

4.9.2 Recoverable Alarms

The following WARNING and FAULT conditions will require user action before
proceeding, but should not prevent the use of the instrument for testing:

WARNING: UNIT UNPRIMED

Both flow sensors are completely dry and MUST be primed with water
before a test can be initiated. This will normally only appear after
extended periods of storage with no fluid in the sensors (i.e. after delivery
of unit from dealer).

WARNING: NVRAM ERROR

The data and clock backup battery on the unit may be too low to retain
data on power down, or the clock may be incorrect. The instrument will
operate correctly, however, the data in the Data Log may be corrupted
when the power is turned off, or the time and date in the tests may be
incorrect. The battery should be replaced at the earliest opportunity.

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FAULT: Pressure/Vacuum Applied to unit

When the power was applied, the pressure at the input (or output) was
either too high or too low to be zeroed out by the internal pressure zero
circuitry.

This could be caused by incorrect positioning of the collection container

or by a pump running at the input while the output is blocked.

Remove the cause of the pressure or vacuum and re-power the unit.

If the Infutest is left in a partially primed state (e.g. the glass and tubing
are filled with sections of air and small columns of water) simply
connecting then disconnecting a collection vessel to the O/P may result
in enough pressure being applied then stored in the system to cause a
fault when the unit is powered on and the self test is performed.

There are two methods for clearing the fault and removing the pressure.

One method is to release the pressure by opening the I/P shutoff valve.
This can be accomplished by connecting the appropriate coupling to the
I/P shut off valve thus releasing the pressure. The applied coupling may
not be connected to an Infusion pump or any other device, it must be
open to atmosphere.

The second method is to prime the unit and then remove any
connections to the I/P and O/P couplings.

In either case, re-power the unit.

FAULT: TCO/SCI Serial Communications Error

When unit power is rapidly cycled on and off this message may be
displayed on some units. Shut the unit off for a minimum of 30 seconds
before attempting to power up the unit. If the error persists, contact
Datrend Customer Service with the unit serial number for further
instructions.

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4.10 AutoSequences
To assist in standardizing test protocols, the Infutest provides nine (9) user
programmable autosequences. An AutoSequence defines a series of steps that the user
would normally perform on a given make of infusion pump. The steps consist of a
timed flow rate test [single rate, dual rate or PCA], a timed occlusion pressure test and an
automatic output to either the serial or printer port. Six pump test protocols have been
preprogrammed as examples of how the AutoSequence testing is setup. These tests may
be overwritten or modified based on the user’s needs. Any changes made to the
autosequences are retained in nonvolatile memory for future use.

To enter the AutoSequence Editor, select EDIT SEQ from either the power up screen,
following the system self test, or the START screen during normal operation. The
sequence editing screen is shown in Figure 29 and provides access to all of the test
parameters that make up a test sequence. The arrow (<- or ->) points to the
parameter to be modified or edited, and may be moved using the SELECT key.

AutoSequence 1

ENABLED: No <- RATE TEST: Single

MFR: ABBOTT INF TIMER: 90 sec
MOD: PLUM XL OCCL TEST: Off
REMARK: AUTO-OUTPUT: Summary
Set pmp rate OUTPUT PORT: Printer
EXIT AUTOSEQ+ MODIFY SELECT

Figure 29 - AutoSequence editing screen.

The definition of the prompts displayed on the screen are:

ENABLED:

Determines if the test sequence will be available in the series of tests selectable
for each channel. The factory default setting is ‘No’, which disables the
autosequences. Press the MODIFY key to change the setting.

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MFR:

The pump manufacturer’s name may be keyed into this space (or any other
prompt you wish). The MFR parameter is seven characters long and may be
changed by pressing the MODIFY key when the arrow (<-) points to the MFR
line. On entering the text editor, the display of Figure 30 will appear, with the
first character of the text highlighted. To change the highlighted character,
press SET+ or SET- to scroll through the available character set. If the key
remains pressed, the scroll will be continuous until it is released. When the
correct character is found, press SELECT to move to the next character.
When all the characters have been selected, press ENTER to return to the main
sequence editing screen.

MOD:

The model of the pump may be optionally inserted or edited when the arrow
points to this parameter. The MOD parameter is seven characters long and is
edited as described in the MFR section.

AutoSequence 1

ENABLED: Yes RATE TEST: Single

MFR: ABBOTT <- INF TIMER: 90 sec
MOD: PLUM XL OCCL TEST: Off
REMARK: AUTO-OUTPUT: Summary
Set pmp rate OUTPUT PORT: Printer
ENTER SET- SET+ SELECT

Figure 30 - Text editing screen.

REMARK:

The remark entry consists of 24 characters and is generally a user prompt

which will appear on the test START screen. It is intended as a reminder to
the user to set the pump to a specific rate, VTBI, etc. before the test is begun.
The REMARK is presented as two lines of twelve characters in the sequence
editor, in order to fit on the screen. Each of the two - 12 character segments
will flash alternately on the screen until the text editor is chosen. When editing
the remark, the first twelve character segment will be displayed, with the first
character highlighted. As described under MFR, each highlighted character
may be changed with the SET+ or SET- keys, and the character to change is
chosen with the SELECT key. When the last character of the twelve character
segment is highlighted and the SELECT key is pressed, the second twelve

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character remark segment will be presented for editing. When the remark is
complete, press ENTER to accept the new text.

RATE TEST:

The rate test parameter has four preset options: Single, Dual, PCA and None.
With the arrow (->) pointing at RATE TEST, press MODIFY to change the
type of flow rate test desired. The ‘None’ option allows the selection of an
occlusion test alone, if desired. Depending on the RATE TEST selected,
other parameters may change for consistency in the logic. (ie. ‘None’ will turn
the timer ‘Off’)

INF TIMER:

The infusion timer parameter sets the time limit for the rate test, and should be
calculated based on the desired rate and volume to be infused for the pump
test protocol. For instance, if the protocol recommends setting the pump to
400 ml/hr and the volume to be infused to 10 ml, the test time would be ((10
ml/400 ml/hr) * 3600) = 90 sec. The infusion time may be changed by
pressing the MODIFY key. The timer edit screen works the same as the text
edit screen, except the available characters are limited to the numerical values
0-9. The maximum time selectable is 9999 sec (167 min).

OCCL TEST:

The occlusion test parameter has ten preset options: 0.5 min, 1 min, 2 min, 3
min, 5 min, 10 min, 20 min, 30 min, 50 min, and Off) The time required for
an occlusion test will depend on the flow rate and the occlusion pressure limit
set on the pump. Some experimentation may be required in setting up this
parameter. For each of the factory preset sequences, the occlusion test has
been turned off.

AUTO-OUTPUT:

The test results may optionally be automatically output to the printer or the
serial port at the end of the test. There are three preset options: Summary, Log
and Off. If a test finishes while another channel is outputting data to the
selected port, the test results will be placed in the output queue, as described in
section 4.8 Output of Summary and Data Logs .

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OUTPUT PORT:

As described above, the test results may optionally be automatically output to

the printer or the serial port at the end of the test. If an automatic output has
been enabled, the output port may be selected from either the ‘Printer’ or
the ‘Serial’ port. If the automatic output has been turned off, the output
port will indicate ‘None’, and cannot be modified.

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Test Usage
This chapter discusses the basic guidelines that should be followed to
ensure good test results. Also discussed are the test methods to follow for
each of the test types, and typical usage criteria.

5. TEST USAGE GUIDELINES

5.1 General Rules

5.1.1 Test Fluids

Infutest must be used with the right test fluid to ensure accuracy of the
measurements displayed and to promote longevity of the internal valves and flow
sensors. Here are some recommendations regarding the use of various fluids in the
Infutest.

a. Use distilled water

Distilled water may be obtained in bags or bottles from several areas in your
hospital (e.g. pharmacy, stores). If your hospital does not stock plain distilled
or "sterile" water in a convenient container, you may buy a gallon jug which
may provide enough distilled water to supply several months of PM testing.

The advantage of using distilled water is you may keep your Infutest set up and
primed all the time without damaging the internal valves or flow sensors.
Outgassing is less likely to occur with room temperature distilled water than
with cold water drawn directly from the tap.

Infutest is calibrated using distilled water as the test fluid. For this reason, you
should also use distilled water as the test fluid if you want to get maximum
accuracy from your Infutest.

Distilled water may be left in the Infutest for months (or even years) without
damaging the internal sensors or causing rusting of the valves.

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b. Use tap water with caution

Water drawn from the cold faucet is an acceptable test fluid provided it is
"soft" (low mineral content), clean and perfectly clear. Do not use water from
the hot tap as foreign material from your building's water heater may damage
the Infutest's flow sensors.

Tap water that's been left open to air may collect dust and dirt, and may even
grow algae if exposed to sunlight. To maintain cleanliness, tap water should be
kept in an enclosed vessel and should be replaced daily.

If you use water from the tap, collect the (cold) water in a clean container and
leave it for a few hours to de-gas and warm up to room temperature. It is also
good practice to pass tap water through a domestic water filter before use (for
example, a Brita filter).

c. DON’T use coloured water

The Infutest's flow sensors incorporate optoelectronics which are calibrated to
detect transparent (i.e. distilled) water. Using water mixed with food dye or
other colouring may cause Infutest to display erroneous flow and volume
measurements. Dyes may also stain the tubing and fittings of Infutest's internal
fluid system, which will void the warranty.

d. DON’T use saline

You may use normal saline (e.g. 0.9% Sodium Chloride Injection USP) if you
must, but you may damage the Infutest if you don't flush out the fluid channel
thoroughly with distilled water immediately after testing the pump.

Never use saline to test a pump and then leave the saline in the instrument, or
simply drain the Infutest and store the instrument away on the shelf. Since
Infutest's occluder valves are made of magnetic stainless steel, exposure to
both salt water droplets and oxygen will eventually cause the valves to rust. At
this point you will find you can't prime the Infutest, or you can't perform the
Occlusion Pressure Test.

Damage to the Infutest's valves from use of saline as a test fluid is not
covered under warranty.

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e. DON’T use D5W, D25W, or D50W

The Infutest's flow sensors are designed and calibrated to work with distilled
water. D5W, D25W and similar dextrose solutions, in addition to being too
viscous, leave a sticky residue in the glass tubes of the flow sensors which
prevents proper operation.

Never allow dextrose or TPN solution to get into the Infutest. If you do,
Infutest will probably display erratic and/or erroneously low measurements.
You will then have to clean the sticky material out of the Infutest's flow
sensors (see Section 5.1.3).

Contamination of Infutest's fluid system from use of dextrose, TPN or

other similar solutions is not covered under warranty.

5.1.2 Pump IV Sets and Syringes

The condition of the IV set or syringe you install in the device under test
will largely determine the quality, validity and accuracy of your test results.

You should obtain a new IV set for each make of pump you will be testing. Use
the IV set only with distilled water or clean tap water. After testing the pump,
drain the IV set and store it in an air-tight bag or container until another pump of
the same type needs testing. Do not store the set in a pump or use the set's
roller clamp or pinch clamps to keep the set primed. Doing so will quickly
degrade the IV set and will likely influence the set's accuracy.

"Test IV sets" may remain usable up to several weeks if you treat them carefully as
described above. However, accuracy of IV sets is usually not guaranteed by the
manufacturer over such long intervals. Ideally, IV sets should be replaced in
accordance with manufacturer's recommendations (e.g. every 48 hours of testing)
so that test results reflect clinical usage of the infusion device.

Always install a new disposable syringe before testing a syringe pump. The
lubrication in disposable syringes tends to wear off after a few uses, causing the
syringe plunger to stick in the barrel. A syringe pump equipped with an old, worn-
out syringe will deliver erratically and inaccurately, and this will be evident as
"spikes" appearing on Infutest's flow graph display.

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If somebody gives you a pump to test, and that pump has a used set or syringe in
it, take the set out of the pump and throw it away. A set which has been used on
a patient may contain saline, dextrose or other solutions which may potentially
damage the Infutest.

If you must re-use an IV set for an incident investigation, first rinse the IV set
with distilled water and flush the Infutest thoroughly after the tests have been
completed.

5.1.3 Cleaning

NOTE: The cleaning procedure for the Infutest Series E is different

from previous series of Infutest. Improper cleaning of the unit
may result in damage which is not covered under warranty.

The following cleaning procedure should be performed on the Infutest once per
month if the instrument is used with tap water, or once every three months if the
Infutest is used exclusively with distilled water. These recommendations apply to
instruments which remain set up and primed at all times. If the Infutest spends
most of its time dry and in storage, cleaning should be conducted more frequently,
ideally when the dry instrument is first primed during setup. Cleaning after a
period of dry storage is the preferred method of "wetting" the fluid system prior to
use (see Section 3.2, Priming).

In the event of accidental contamination with dextrose or TPN solution, the

following procedure should be adequate provided cleaning is performed
immediately following contamination. If cleaning does not appear to improve test
results (i.e. flow measurements are persistently erratic, low or nonexistent), contact
your dealer and/or Datrend Customer Service.

a. Make up about 200 ml of cleaning solution by mixing 100 ml of distilled

water with 100 ml of "Sudsy Ammonia" household cleaner (e.g. AMEX
brand by Colgate-Palmolive Inc.). If “Sudsy Ammonia” is not available in
your area, add one-half teaspoon of liquid dish detergent to the 200 ml of
ammonia and water solution.

b. Fill a disposable 60 ml syringe with the cleaning solution and discharge the
syringe quickly into CHANNEL A at about 2 ml per second. Don't use
the same syringe you use to prime the Infutest because the cleaning
solution will remove the syringe's lubricant. Refill the syringe and inject
CHANNEL B with the cleaning solution in the same manner.

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c. Fill the syringe with 20 ml of cleaning solution and connect the syringe to
CHANNEL A. Inject about 10 ml into the channel. Under no
circumstances should you quickly draw solution back into the
syringe as the excessive suction may damage the pressure sensors.

d. Repeat (c) for CHANNEL B.

e. Let the cleaning solution sit in the Infutest for about 10 to 15 minutes.
DO NOT leave the cleaning solution in the Infutest any longer than 15
minutes as prolonged exposure to the solution may damage the neoprene
seals of the internal valves.

f. Rinse the fluid channel thoroughly with distilled water to remove all
ammonia from the fluid system.

g. If the fluid system has been contaminated with a sticky liquid (e.g. D5W,
D25W, TPN solution, etc.), you may need to perform this procedure
using undiluted Sudsy Ammonia to clean the flow sensors. In this case,
DO NOT leave ammonia in the Infutest for more than 10 minutes, and
be sure to thoroughly flush the instrument with distilled water afterwards.

5.1.4 Input and Output Connections

The input tubing sets supplied with your Infutest incorporate a calibrated flow
restriction so as to be in conformance with IEC recommendations, simulating
viscous fluids (IEC 601-2-24 Pt. 2). Always connect the device under test
(DUT) to the flow restriction, not the prime/flush port of the input
stopcock (see Figure 4). Do not attempt to bypass or remove the flow restriction.
Accuracy of the Infutest is specified only with the IEC flow restriction in line.

When using only one Infutest channel to test a single infusion device, do
not leave the unused channel's input open to air. Ensure that the stopcock of
the unused channel is rotated to the CHANNEL OFF position to block off the
unused input (see Figure 6). If the unused input is not blocked, Infutest's internal
fluid system will fill up and will eventually drain out the open input. Although this
will cause no damage to the Infutest, the resulting drainage may adversely affect
nearby electronic equipment.

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Do not extend the length of the supplied A&B Output tubing set by more
than 12" (30 cm). Do not restrict the output tubing set or extend it with narrow-
gauge IV tubing. Follow the instructions in Appendix A when applying a back
pressure to the A&B Output.

Do not attempt to verify calibration of the Infutest by connecting the A&B

Output to a burette or other volumetric or gravimetric measuring device.
The output of Infutest's two flow channels are combined in an internal reservoir
or "collection tank" before draining via the A&B Output port (see Appendix B,
Operational Overview). The tank is filled mostly with air when the pressure applied to
the A&B Output is near zero. Therefore, the flow of test fluid into the Infutest
and the exit of test fluid from the A&B Output are poorly related except in a gross
sense.

You should ensure no fluid pressure is applied to the Infutest's inputs or

output when you first turn the instrument on. This is important because
Infutest attempts to zero the offset of its pressure transducers as part of an
internal self-test.

Remember if you allow gravity free-flow through a pump from an IV bag to the
Infutest, you will be applying a pressure to the Infutest by virtue of the head
created by elevation of the IV bag. Install the set into the pump to stop the
free-flow and eliminate the pressure head before turning on the power to the
Infutest. Otherwise, Infutest may display a "pressure zero alarm" at the end of its
self-test (see Section 3.2, Priming).

5.1.5 Flushing Prior to Test Startup

Before starting a Single Rate Test (or any AutoSequence incorporating a

Single Rate Test), the channels should be flushed to purge extraneous air
bubbles from the channel’s flow sensor. This is always the safest way to
avoid potential problems.

Do not forcefully inject large volumes of water into the channel when flushing.
Such action will generate troublesome air bubbles rather than purge them.
To minimize bubbles generated by turbulence, gradually inject about 5cc from the
priming syringe over a few seconds.

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You may also use the device under test (DUT) to purge the fluid channel if you
wish. If the DUT is pumping at 100 ml/hr prior to test startup, it will take the
DUT at least 90 seconds to infuse the minimum amount required for purging. If
the DUT is set to a lower rate, a proportionally longer time must be allowed.

In the process of measuring flow and volume, Infutest deliberately introduces air
bubbles into the test fluid as flow "markers" (see Appendix B, Operational Overview).
If air bubbles are present in the channel before a Single Rate Test is started, such
extraneous bubbles may cause the flow and volume displayed to be multiplied by
a factor of two or more. If, for example, you are testing a pump set to 400 ml/hr
and Infutest consistently reads around 800 ml/hr or higher, the error may be
because the fluid channel was not flushed before the Single Rate Test was started.
This is the primary risk of not flushing the channel before test startup. If the
device under test is known to produce continuous flow, and the device is being
tested at rates below 170 ml/hr, this multiplication error maynot occur and so
flushing prior to starting the Single Rate Test is optional.

The Infutest incorporates software algorithms to reject most air bubbles in the
test fluid which arise from outgassing, and which may accidentally drift into the
fluid channel while running a test. The Infutest will also reject some air bubbles in
the fluid channel which it detects at test startup.

Infutest's "bubble rejection software" is highly effective in the Dual-Rate and PCA
Pump Tests, which operate over a restricted range of flow rates (up to 170 ml/hr).
Flushing the fluid channel prior to starting a Dual-Rate, PCA Pump or Occlusion
Pressure Test is rarely necessary, unless the channel is completely dry.

However, the bubble rejection software of the Infutest is somewhat less effective
in the Single Rate Test than the other tests due to the extended range of flows
which may be measured (up to 1200 ml/hr). It is always best to flush the channel
before running a Single Rate Test.

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5.2 Single Rate Test

5.2.1 Test Description

The Single Rate Test is the test you will select in most cases to verify flow
and volumetric accuracy on all types of infusion devices - ranging from
acute care to home care pumps, and including syringe pumps, linear
peristaltic pumps, cassette pumps, ambulatory pumps, and enteral feeding
and TPN/TNA pumps.

The Single Rate Test measures flow over two ranges - LOW and HIGH. The
LOW range is used for measuring flow below 170 ml/hr, and the HIGH range
above 170 ml/hr, up to 1200 ml/hr. Transparent to the user, the Infutest selects
the most appropriate flow range automatically at the beginning of the Single Rate
Test through execution of both range selection and flow pattern recognition
software algorithms.

These algorithms will select the HIGH range if pulsatile or erratic flow is detected
at the start of the test. For pulsatile flow patterns, a greater degree of volumetric
averaging is applied to increase the accuracy of the flow measurement, however,
measurement time may be substantially increased. For pulsatile flow with an
average rate of 5 ml/hr, a single measurement will require nearly 14 minutes to
complete, as opposed to a nominal 11 seconds for 5 ml/hr continuous flow. The
type of flow detected will be displayed in the flow status indicator, which appears
in the upper right hand corner of the test measurement screen. The flow status
indicator may show LOW or HI if the flow pattern is relatively smooth and
continuous, PUL if moderately pulsatile flow is detected (pulses having volume
0.035 to 0.070 ml - typical of Abbott Lifecare 4P and similar pumps), or VPF if
very pulsatile flow is detected (pulses having volume over 0.070 ml - typical of
enteral feeding ("Kangaroo") pumps).

Infutest will always assume LOW flow at the start of the test, and will, if necessary,
make a change after 0.2 to 1.2 ml has been delivered. In some instances, the flow
status indicator may intermittently read IFL ("interrupted flow") when running a
LOW flow test. This is an indication that the pump under test has generally
continuous flow, with intermittent pauses in flow. This is typical of some linear
peristaltic pumps which have a pause in their flow pattern when the pump
mechanism reaches the bottom of its travel and recycles to the top (e.g. Baxter
FloGard 6201, Sigma 6000).

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The Single Rate Test also incorporates a software algorithm called SynchroStart.
When you start the Single Rate Test, SynchroStart places Infutest on "standby"
until fluid flow is actually detected from the device under test (DUT). As flow
from the DUT is detected, SynchroStart automatically initializes the flow and
volume measurements. In an AutoSequence, SynchroStart also prevents the INF
TIMER ("infusion timer") from running until flow from the DUT detected.
Synchronizing the startup of the Single Rate Test to the flow produced by the
DUT is important for accurately measuring the cyclic fluid delivery produced by
pulsatile infusion devices, and also for measuring the actual volume delivered by a
DUT in a preset VTBI ("Volume-to-Be-Infused") or "DOSE".

The table below lists nominal times required for the Infutest to obtain
measurements at selected flow rates. The theoretical values listed are approximate
and assume continuous flow conditions.

FLOW RATE MEASUREMENT TIME

(ml/hr)
15 to 20 minutes, first measurement,
0.1
10 minutes, subsequent measurements
1.5 to 2 minutes, first measurement
1
1 minute, subsequent measurements
6 to 170 10 to 15 seconds
Switch to HIGH range above 170 ml/hr...
200 20 seconds
500 10 seconds
999 4 seconds

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5.2.2 Test Usage

The most basic use of the Single Rate Test is to verify rate accuracy of an infusion
device. To verify rate accuracy, program the device with the desired test Rate and
disable the "Volume-to-Be-Infused" (VTBI) or "Dose Limit" function on the
device. Alternatively, you may set the VTBI or Dose on the device under test
(DUT) to an arbitrarily large value (e.g. 9999 ml). Connect the DUT to Infutest,
flush the channel, start the test on the Infutest (press GO) and then run the DUT.
The length of time you choose to run the Single Rate Test will depend on the type
of pump you are testing (see Section 5.7, Understanding Your Test Results). Refer to
the manufacturer's recommendations with respect to volumetric accuracy testing,
which should be included in the manufacturer's Service Manual for the DUT.

If the DUT produces continuous flow (e.g. syringe pump), you may start the
Single Rate Test either before or after starting the DUT if you are simply checking
for basic rate accuracy. If the DUT is pulsatile, and especially if the DUT is used
in enteral feeding or TPN applications (e.g. "Kangaroo pump"), you should
start the Infutest first, and then start the DUT running after Infutest switches
from the START to TEST display. This will activate Infutest's SynchroStart
feature so that the Single Rate Test is synchronized with the delivery cycle of the
DUT.

Flow pattern recognition is ongoing throughout the Single Rate Test. At the start
of the test, the flow pattern recognition may select PUL or VPF measurement
algorithms based on a startup surge or other flow anomaly that the DUT produces
when it first starts running. If you wish to avoid this, start the Single Rate Test
after letting the DUT run and stabilize for a few minutes.

In addition to rate accuracy testing, you may also use the Single Rate Test to verify
accuracy of the DUT in delivering a preset Volume-to-Be-Infused (VTBI) or
Dose.

Program the DUT with the desired Rate and VTBI/Dose. Suitable Rate and VTBI
settings for this type of test will usually appear in the Service Manual of the DUT,
under a "flow accuracy" or volumetric test procedure. Prior to starting the test,
clear or reset the Total Volume Infused on the DUT. Most infusion devices
provide a separate button for clearing the Total Volume Infused.

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When testing a pump for VTBI or Dose delivery accuracy, Infutest should always
be started first, and the DUT started afterwards. If the DUT is started before the
Single Rate Test, you will defeat Infutest's SynchroStart feature and the infused
volume as measured by Infutest may be erroneously LOW. If the test is not
SynchroStarted, it is likely that the volume dispensed from the DUT at the
beginning of the infusion will be missed.

The DUT will typically produce an audio-visual alarm (the "End-Of-Infusion"

alarm) when it completes delivery of the VTBI or Dose. Infutest's STOP key
should be depressed the instant this alarm is produced to obtain an accurate
measure of the actual volume delivered by the DUT. Pressing the STOP key will
activate Infutest's End-Infusion-Analysis (EIA) feature. EIA calculates the total
volume infused by the DUT using the measured Average Flow and the elapsed
time at which the test was STOPped. The EIA will be accurate provided the
pump is running or just coming to a stop at the time the STOP key is
pressed.

If the STOP key is depressed substantially after the DUT ends the VTBI delivery,
you will introduce an error in the elapsed time of the test and the infused volume
as displayed by Infutest may be erroneously HIGH. The "Volume
Infused" displayed on Infutest's SUMMARY screen will flash to indicate this
potential uncertainty in the End Infusion Analysis.

When testing a pump for VTBI or Dose delivery accuracy, stopping the test at
the appropriate time is important to obtaining an accurate measure of the Volume
Infused. Infutest's programmable AutoSequences provide an infusion timer (INF
TIMER) which may reduce this uncertainty in a VTBI or Dose delivery test. Refer
to the programming instructions in Section 4.10, AutoSequences.

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5.3 Dual-Rate Test

5.3.1 Testing Piggyback Operation

"Piggybacking" is the clinical term most often used to describe delivery of

a "Secondary" Volume-to-Be-Infused (VTBI) or Dose at a first rate,
followed by delivery of a "Primary" VTBI or Dose at a second and often
lower flow rate. Use the Dual-Rate Test to evaluate Primary-Secondary
delivery or delivery "piggybacking" on continuous-flow infusion devices
which provide this feature.

Restrictions which apply to the Dual-Rate Test are:

i. continuous flow conditions only (non-pulsatile)
ii. maximum flow rate is 170 ml/hr average, 200 ml/hr peak
iii. at least 1.0 ml of fluid must be delivered at the Secondary rate (Infutest
RATE #1)
iv. to detect the switch from Secondary delivery to Primary delivery,
the Secondary flow rate setting on the pump must be at least five
times higher than the Primary rate setting.

For example, an infusion device capable of piggyback operation might be

programmed with the delivery schedule listed below, and the actual delivered
volumes and rates could be verified using the Dual-Rate Test. In a "piggybacked"
infusion, the Secondary medication is delivered first. Infutest will display the
Secondary delivery as RATE #1 and the Primary delivery as RATE #2.

Delivery Flow Rate VTBI or "Dose" Infusion

Setting Time
Secondary (RATE #1) 100 ml/hr 5.0 ml 3.0 min
Primary (RATE #2) 20 ml/hr 2.0 ml 6.0 min

Once the above rates and volumes have been programmed into the device under
test (DUT), the Total Volume Infused on the DUT must be cleared or reset
before starting the test. Most infusion devices provide a separate button for
clearing the Total Volume Infused.

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In a "Piggyback" test, Infutest should always be started first, and the DUT started
afterwards. If the DUT is started before the Dual-Rate Test, you will defeat
Infutest's SynchroStart feature and the Secondary volume as measured by Infutest
may be erroneously LOW (see Section 5.2.2, Test Usage Single Rate).

The DUT will typically produce an audio-visual alarm (the "End-Of-Infusion"

alarm) when it completes delivery of the Primary VTBI or Dose. Infutest's STOP
key should be depressed the instant this alarm is produced to obtain an accurate
measure of the Primary volume delivered by the DUT. If the STOP key is
depressed after the DUT produces the alarm, you will disrupt Infutest's End-
Infusion-Analysis feature and the Primary volume as measured by Infutest may be
erroneously HIGH (see Section 5.2.2, Test Usage Single Rate). The "Volume
Infused" displayed on Infutest's SUMMARY screen will flash to indicate this
uncertainty in the End Infusion Analysis.

Some DUT's produce a brief audio-visual indication at the end of the Secondary
delivery. Do not confuse this indication with the DUT's End-Of-Infusion alarm.
Audio tones produced at the conclusion of the Secondary delivery are usually not
persistent, whereas an End-Of-Infusion alarm will persist until the "ALARM
SILENCE" or equivalent button on the DUT is pressed.

Stopping the Dual-Rate Test at the appropriate time is important to obtaining an

accurate measure of the Primary infused volume. Infutest's programmable
AutoSequences provide an infusion timer (INF TIMER) which may reduce
uncertainty in the timing aspect of the Dual-Rate Test. Refer to the programming
instructions in Section 4.10, AutoSequences. Note that for a Dual-Rate Test you will
program the INF TIMER based on the expected durations of the Secondary
delivery plus the Primary delivery, as follows:

INF TIMER = (Secondary VTBI (ml) / Secondary Rate (ml/h)) * 3600 +

(Primary VTBI (ml) / Primary Rate (ml/h)) * 3600

5.3.2 Testing Titrated Rates

Some infusion devices, although unable to switch flow rate automatically, allow
the user to change the rate while the device is pumping. This feature is sometimes
referred to as titration. Provided the flow rate can be reduced quickly enough, the
Dual-Rate Test may be used to evaluate a titratable infusion device at two different
rates without stopping the test. Although using the Dual-Rate Test may be
quicker than conducting two Single Rate Tests in succession, the restrictions
described in the previous section must be observed.

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5.3.3 Testing KVO Operation

Most infusion devices incorporate a Keep-Vein-Open (KVO) function. Such

pumps will automatically switch to the KVO Rate after delivery of a preset
Volume-to-Be-Infused (VTBI) or Dose. The KVO Rate depends on the make
and model of the infusion device being tested, although most pumps have a preset
KVO Rate in the range 1 to 5 ml/hr. Some infusion devices (e.g. MedFusion
2001) allow the KVO Rate to be programmed over a restricted range.

The Dual-Rate Test may be used to check the KVO function of an infusion device
even though the device may not be capable of "piggybacked" deliveries. In
accordance with the Dual-Rate Test restrictions, ensure the primary delivery rate is
at least fives times the KVO Rate of the pump for the switch to KVO operation
to be detected.

For example, you could program an infusion device with the following rate
schedule and check the device's switch to KVO mode using the Dual-Rate Test.
Infutest will indicate the KVO delivery as RATE #2.

Delivery Flow Rate VTBI or Infusion "Dose" Time

RATE #1 50 ml/hr 5.0 ml 6.0 min
KVO (RATE #2) 5 ml/hr N/A As desired

Remember to start the Dual-Rate Test first, and then the infusion device so that
the actual volume infused at RATE #1 is measured accurately. After the infusion
device switches to KVO operation, allow the test to continue for at least few
minutes so that an accurate measure of the average KVO Rate is obtained. (The
DUT’s KVO alarm indicator will usually continue to sound and must be ignored
for the duration of the KVO rate measurement).

5.3.4 Testing Bolus-Plus-Basal Mode Operation

Some Patient-Controlled Analgesia (PCA) pumps are capable of infusing a preset

Bolus volume while simultaneously delivering medication at a background Basal
flow rate. The Dual-Rate Test may be used to evaluate this feature. Refer to the
PCA pump manufacturer's manuals regarding Basal delivery.

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Set the Basal Rate equal to or less than one-fifth the Bolus delivery rate of the
PCA pump. If the Bolus delivery rate of the pump is unknown, try a Basal Rate of
10 ml/hr. Program the pump to deliver a suitable Bolus Volume (e.g. 2 ml) and
start the device pumping at the Basal rate.

Set up the Infutest for a Dual-Rate Test. Start the Dual-Rate Test, then at the
same time trigger the PCA Pump manually with the patient's medication delivery
switch. After Bolus delivery, leave the pump running at the Basal rate for a few
minutes. The Dual-Rate Test will measure the volume of the Bolus delivered, the
rate at which it was delivered (RATE #1), and the background Basal flow rate
(RATE #2).

5.3.5 Dual-Rate “PULSATILE” Warning

The Dual-Rate Test is suitable for use only with continuous-flow infusion
devices. If Infutest detects that the infusion device produces pulsatile flow, a
WARNING! message will be displayed on the test measurement screen and the
flow status indicator will flash "PUL". In this case, changes in flow rate will not be
detected and Infutest will remain measuring RATE #1 indefinitely. Flow and
volume measurements displayed on screen may also be erroneously LOW if
the pulsatile warning message is posted during the Dual-Rate Test.

Pulsatile infusion devices should be evaluated using the Single Rate Test (see
Section 5.2).

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5.4 PCA Pump Test

5.4.1 Test Description

Use the PCA Pump Test to determine volumetric accuracy and verify
lockout operation of continuous-flow, patient-controlled infusion devices.
The volume of each Bolus delivered is precisely measured using the LOW
range of the flow sensor, and lockout time is determined to the nearest
second, based on observation of flow onset and cessation.

Restrictions which apply to the PCA Pump Test are:

i. continuous flow conditions only (non-pulsatile)
ii. maximum flow rate is 170 ml/hr average, 200 ml/hr peak
iii. bolus volume must be at least 0.5 ml
iv. flow must be zero during the lockout period

The PCA Pump Test requires a cable to connect a trigger output on the Infutest
rear panel (Figure 3) to the patient control switch input on the PCA pump. A
pair of unterminated cables with two insulated conductors plus braided shield is
available as an accessory from Datrend Systems (PCA-1). A schematic of the
unterminated cable is shown in Figure 31.

The Infutest PCA trigger incorporates both normally-open or normally-closed

relay contacts which are activated during the PCA Pump Test to simulate the
patient actuating the medication delivery switch. Connection of the Infutest to the
PCA Pump is dependent on the make and model of the pump; refer to the
manufacturer's technical service manual when preparing a PCA trigger cable.

When the PCA Pump Test is started, the Infutest will activate the trigger relay
until flow from the pump is detected. Flow and cumulative volume measurements
are obtained until the programmed bolus is delivered and flow falls to zero. The
Infutest detects this condition and begins to time the lockout period,
simultaneously attempting to trigger the pump to deliver another bolus via its
internal trigger relay.

During the lockout period, a timer posted in the upper right corner of the test
measurement screen keeps track of the elapsed time of the lockout. When flow is
detected, the trigger relay is stopped and the delivery/lockout measurement
process is repeated. The number of boluses delivered, the average bolus volume,
average lockout time and average bolus flow rate is provided in the channel
Summary. Full details of each bolus delivered is available in the channel Data Log.

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Figure 31 - Schematic of unterminated PCA trigger cable (PCA-1), available from Datrend Systems.
The trigger output is provided by floating relay contacts; normally-open contacts are available
between ring and shield; normally-closed contacts are available between tip and shield.

5.4.2 Test Usage

Connect the trigger cable to the trigger output of the Infutest, and select the PCA
Pump Test via the START screen. Program the pump to deliver several boluses;
the test algorithm works well with bolus volumes of approximately 1.0 to 2.5 ml.
Programming the lockout time to the minimum setting available on the pump
(typically 1 to 5 minutes) will shorten total testing time while providing adequate
verification of lockout operation. If the bolus delivery rate is also programmable,
set it between 25 and 100 ml/hr.

If the PCA pump is capable of producing a "Basal Flow", ensure the Basal
rate is set to zero or that Basal delivery is disabled. To test Bolus-Plus-
Basal mode delivery, use the Dual-Rate Test as described in Section 5.3.4.

Some PCA Pumps do not provide an electrical trigger input suitable for
connection to Infutest's PCA trigger output. Ambulatory PCA Pumps may have
only a front panel push button which is pressed to deliver a bolus. Other PCA
Pumps may have a pneumatically-based trigger switch. Such PCA pumps may be
tested manually, using the real-time display of the lockout posted on the test
measurement screen as a "prompt".

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For manual PCA Pump testing, the lockout interval of the pump is presumed to
be preset to an integer number of minutes (e.g. 5.0 minutes). During the lockout
period, Infutest will produce an audio alert tone every time the seconds indicator
of the lockout time display passes 45 seconds. The audio alert is meant to signal
the user to manually activate the trigger button on the PCA pump as the end of
the preset lockout approaches. The PCA Pump should be repeatedly triggered
about once per second after Infutest produces an alert tone which is close to the
preset lockout time, until the pump actually begins to deliver a bolus. At the start
of a bolus delivery, the Infutest trigger relay will stop and the state of the test
measurement screen will change.

5.4.3 PCA Pump “PULSATILE” Warning

The PCA Pump Test is suitable for use only with continuous-flow infusion
devices. If Infutest detects that the infusion device produces pulsatile flow, a
WARNING! message will be displayed on the test measurement screen and the
flow status indicator will flash "PUL". The PCA Pump Test will still detect bolus
deliveries and lockout intervals even if the WARNING! message is activated.
However, flow and volume measurements displayed on screen may be
erroneously LOW.

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5.5 Occlusion Pressure Test

5.5.1 Measuring Occlusion Pressure

Use the Occlusion Pressure Test to determine the maximum pressure

generated by an infusion device when its output is occluded.

Set the infusion device to produce a suitable flow rate (e.g. 50 to 100 ml/hr) and
start the device pumping. Starting the Occlusion Pressure Test will cause the
channel to be occluded by an internal valve, and the pressure at the input to be
sampled and displayed once every two seconds.

If the infusion device is operating properly, the displayed pressure will increase
until the device detects the occlusion, stops pumping, and produces an alarm.
After this point, the displayed pressure will remain approximately constant or may
decrease slightly. The pressure at which the device produces the alarm is the
occlusion pressure. If the test is terminated by the test timer or terminated with
the STOP key, the Summary will report the maximum pressure reading from the
test. If the Nurse Call is activated during the occlusion pressure test, the Summary
will report the pressure reading when the Nurse Call signal occurred. This will
normally coincide with the pump’s occlusion alarm.

If the measured pressure exceeds 2586 mmHg (50psi) during the test, the internal
occluding valve will be automatically opened, the test will be stopped, and the
Summary will indicate an Over Pressure Reading.

It is important to note that most pumps sample their internal pressure signal at a
relatively slow rate. If the pump is tested at too high a rate, it is quite likely
that the actual occlusion pressure will be higher than the maximum
specified by the manufacturer. In many cases, Infutest will measure and report
the actual pressure, which may seem high. If this occurs, rerun the test at a lower
rate (try 50 ml/hr) and see if the occlusion pressure seems more reasonable.

5.5.2 Checking the Nurse Call Alarm

The Occlusion Pressure Test may also be used to check the operation of the
Nurse Call Alarm output on an infusion device which incorporates this feature.
The test requires a cable with two insulated conductors plus braided shield to
connect the Nurse Call input on the Infutest rear panel (Figure 3) to the Nurse
Call output of the infusion device. A pair of unterminated cables for this purpose
is available as an accessory from Datrend Systems (NCA-1). A schematic of the
unterminated cable is shown in Figure 32.

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The Nurse Call Alarm produced by the infusion device may be any one of the
following signals:
i. normally-open or normally-closed relay contacts;
ii. open collector output;
iii. TTL output;
iv. RS-232 level; or
v. 20 mA current loop.

Refer to the manufacturer's technical service manual for the infusion device being
tested when preparing a Nurse Call cable for connection with the Infutest.

Figure 32 - Schematic of unterminated Nurse Call cable (NCA-1), available from Datrend
Systems. For voltage-output Nurse Call, connect the higher potential to ring, and the
lower potential or pump ground to tip. For current loop Nurse Call, connect so that
current flows in direction of the arrows as shown above. For relay-output Nurse Call,
the polarity of the connection is arbitrary. In all cases, the shield of the Nurse Call cable
must not be connected to the pump.

During the Occlusion Pressure Test, the Nurse Call Alarm signal is sampled once
every 200 msec and may be in either logical state at the start of the test. A change
in the state of the Nurse Call signal will cause the pressure to be sampled
immediately and stored in the Data Log with a "NRS CALL" message. The
Occlusion Pressure Test is then automatically stopped. If the Occlusion Pressure
Test is part of an AutoSequence, detection of a Nurse Call alarm will cause the
AutoSequence to stop the occlusion test and begin the automatic report printout
or download (if enabled).

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5.6 AutoSequences

5.6.1 Running Default Test Sequences

Infutest is supplied to you with 9 automatic test sequences in battery-backed

memory. These "AutoSequences" may be viewed, enabled and edited by powering
up the instrument and pressing the EDIT SEQ key following the self-test.

The first six default AutoSequences are programmed as defined in the following
table. The sequences include a timed Single Rate Test, with the duration of the test
being set by the INF TIMER, followed by automatic output of the Test Summary
Report to the printer.

TABLE I

Sequence Parameter Factory Default Setting

ENABLED NO
MFR, MOD, REMARK Depends on pump
make/model
RATE TEST Single Rate
INF TIMER Depends on manufacturer's
test protocol
OCCL TEST Off
AUTO-OUTPUT Test Summary Report
OUTPUT TO Printer port

Default AutoSequences 7, 8 and 9 are almost identical. ENABLED, RATE TEST,

AUTO-OUTPUT and OUTPUT TO for these sequences are the same as shown
above. For default AutoSequences 7, 8 and 9, INF TIMER is set to 180 sec and
OCCL TEST is set to 1 min. MFR, MOD and REMARK are left blank.

The EDIT SEQ screen may be used to edit the above settings as desired. Refer to
Section 4.10, AutoSequences. An AutoSequence must have "ENABLED" set to
"Yes", otherwise the sequence cannot be selected via Infutest's START
screen.

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The default INF TIMER settings are derived from Service Manual test protocols
published by the manufacturers of Infutest's default infusion devices. These test
protocols typically require the user to program the device under test (DUT) with a
RATE and a "Volume-to-Be-Infused" (VTBI) or "Dose". Refer to the
manufacturer's service manual of the DUT to review the relevant test procedure
(usually referred to as a "flow accuracy" or volumetric test), setup of the DUT, and
performance specifications or ranges of acceptance for device performance in
these tests.

In accordance with the manufacturer's recommended test protocols, the Infutest's

default infusion devices should be programmed as defined in the table below,
prior to running the AutoSequence.

TABLE II

AUTOSEQUENCE MANUFACTURER FLOW RATE VTBI or

AND MODEL NO. SETTING "DOSE"
(ml/hr) SETTING
(ml)
#1 ABBOTT PLUM "XL" 400 10
or PLUM 5000
#2 AVI/3M model 3000 999 49
#3 BAXTER FloGard 200 35
model 6201
#4 IMED Gemini 125 5
#5 IVAC model 570 800 40
#6 McGAW Horizon 120 10

Before running a default AutoSequence, the device under test (DUT) should be
set up, primed, and connected to Infutest. A printer should be connected to
Infutest's printer port and should be ON LINE prior to starting the sequence.
Default AutoSequences automatically output the Test Summary Report, which
consists of a single printed page.

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If the OUTPUT TO port of a default AutoSequence is changed to "Serial", the

Infutest should be connected to a COM port on the receiving device (i.e. the PC)
prior to starting the sequence. The PC should be running a terminal emulation
program (e.g. Windows Hyperterminal, or Datrend’s DTP software) which will
save the down loaded test report to disk when the report is transmitted from
Infutest at the end of the AutoSequence. Refer to Section 3.3 for the necessary
interface connections.

Verify the Rate and VTBI/dose settings for the DUT are programmed as defined
in TABLE II. Before running the DUT, clear the DUT's "Total Volume
Infused" display. Most infusion devices provide a separate button on the front
panel which will reset the Total Volume Infused.

Flush the Infutest. Start the selected AutoSequence first, and then start the pump.
This will activate Infutest's SynchroStart feature so the actual volume infused by
the DUT is measured by the end of the rate test, which may then be compared to
the acceptance range for delivered volume published in the manufacturer's Service
Manual for the DUT.

5.6.2 Reloading Default Test Sequences

If you make changes to the factory default AutoSequences and wish to restore the
original settings, power up the Infutest while holding down the front panel key
second from the left. Infutest will prompt you to reprogram the AutoSequences
with factory default settings. All 9 AutoSequences will be reprogrammed with
factory defaults if you enter "YES".

5.6.3 Adding the Occlusion Test to Sequences

Most pumps sample their internal pressure signal at a relatively slow rate. If the
Occlusion Pressure Test is run with the pump set at too high a rate, it is quite
likely that the actual occlusion pressure will be higher than the maximum specified
by the manufacturer. Because of this pump limitation, Occlusion Pressure Tests
are best conducted with the pump rate set between 50 and 100 ml/hr (see Section
5.5, Occlusion Pressure Test).

The manufacturer-specified test flow rates may be too high to conduct an

Occlusion Pressure Test. However, the Occlusion Pressure Test may be added to
the default AutoSequences if the pumps are programmed to decrease the flow rate
at the onset of the pressure test. This may be accomplished by programming the
pump with a "piggyback" delivery.

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Follow these instructions to add an occlusion test to an AutoSequence, and then

run the sequence:

a. Run a manual Occlusion Pressure Test with the pump set to 50 ml/hr to
determine the nominal time required for the device to produce an occlusion
alarm. For the devices listed in the preceding table the required time is
expected to be less than 2 minutes.

b. Use the EDIT SEQ screen to program the desired AutoSequence with an
appropriate OCCL TEST time, based on the findings of your experiment in
step (a). Choices available for the OCCL TEST include 0.5 min; 1 min; 2 min;
3 min and so on. Refer to Section 4.10, AutoSequences for programming
instructions.

c. Leave RATE TEST set to "Single". Ensure that the desired AutoSequence has
ENABLED set to "Yes". Exiting the AutoSequence screen will save the
changes you made.

d. Set up and prime the pump. Program the pump's SECONDARY RATE and
VTBI or "Dose" with the settings listed in the previous table. Set the pump's
PRIMARY RATE to 50 ml/hr and VTBI or "Dose" to 100 ml. Clear the
"Total Volume Infused" display on the pump.

e. On Infutest's START screen, select the desired AutoSequence. Flush the fluid
channel and press the GO key.

f. After starting the Infutest, start the SECONDARY infusion on the pump. At
completion of the Secondary delivery, the pump rate should switch to 50
ml/hr and about two seconds later Infutest should begin the pressure test (the
primary rate will not actually be tested, the switch is intended only to set the
rate to a suitable value for occlusion pressure testing). Automatic report
printout or download, if enabled, will follow the end of the timed pressure test.

g. The next time you choose to run this AutoSequence, an occlusion test will be
performed along with the timed rate test and automatic report output. Follow
instructions (d) - (f) each time you run the sequence.

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5.7 Understanding Your Test Results

Infutest measures Instantaneous Flow, Average Flow, and Infused Volume. Of these,
Average Flow and Infused Volume are the most important because it is these
measures which the pump manufacturers use in specifying the accuracy of their
products. At this time, manufacturers do not specify pump performance in terms of
instantaneous flow. However, Infutest's ability to measure instantaneous flow (and
Infutest's FLOW graph display) may be useful in comparing the quality of fluid delivery
of pumps of differing makes and models.

Infutest measures instantaneous flow by observing the volume delivered from a pump
over relatively short time intervals. These time intervals nominally range from 4 to 20
seconds, the exact interval depending on the rate. The majority of medical infusion
devices do not produce "steady flow" when the volume delivered is measured
over such short time intervals. This fact has been previously described in the scientific
literature. For example, refer to the test results and graphs in:

Stull et al. "Flow rate variability from electronic infusion devices", Crit. Care
Medicine, vol.16, pp. 888-891, 1988.

Farrington "Flow rate variability from selected syringe and mobile infusion pumps",
Drug Intellegence and Clin. Pharm., Vol. 22, pp. 687-690, Sept. 1988.

Leff et al. "Accuracy, continuity, and pattern of flow from five macrorate infusion
devices", Am. J. Hosp. Pharm., vol. 45, pp. 361-5, Feb. 1988.

Auty, B. "Equipment for intravenous infusion - some aspects of performance",

Agressologie, vol. 29, 12: 824-828, 1988.

Tam, Y. "Automated performance checking of infusion equipment", Clin. Phys.

and Physiol. Meas., vol.10, pp. 311-318, 1989.

Infutest's Average Flow is a cumulative measurement of the total volume delivered from
the pump divided by the total time taken to deliver it. All medical infusion devices will
produce a stable Average Flow reading (i.e. a horizontal line on Infutest's AVG. graph) if
given enough time. Infutest's instantaneous flow reading and FLOW graph, however, will
be highly dependent on the functional type, manufacturer and model of pump being
tested.

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Syringe pumps (e.g. AutoSyringe AS20S, Bard 150 XL, MedFusion 2001) may exhibit a
"startup characteristic" in which flow is initially low, and then gradually increases to the
set rate as slack in the lead screw mechanism is taken up. Syringe pumps may also
produce erratic flow if the syringe has been re-used so often that its internal lubricant has
worn off. Such anomalies may be avoided, however, by installing a new syringe and
allowing the pump to run for several minutes before testing.

Linear peristaltic pumps (e.g. Baxter 6200, Sigma 6000) tend to be more erratic in their
instantaneous flow at lower rates - you will normally see large peaks and valleys in
Infutest's FLOW graph when testing many linear peristaltic pumps at rates below 50
ml/hr. Such instantaneous variations are related to the design and precision of the finger
mechanism which squeezes the tubing, and to the quality and compliance of the tubing
section being squeezed.

The opposite is true of many cassette pumps (e.g. IMED 960, IVAC MedSystem 3,
McGaw Horizon, Siemens MiniMed III). These pumps often produce more erratic
instantaneous flow at higher rates as the pump compensates between delivering the
required volume and refilling its cassette on alternating cycles. Infutest's FLOW graph
will normally show large peaks and valleys when testing many cassette pumps at rates
over 500 ml/hr. Depending on the cassette pump, large dips in the FLOW graph may
appear at periodic intervals.

Caution should be exercised when testing some cassette pumps. When set to high
delivery rates, such pumps may produce brief bursts of flow which are beyond Infutest's
ability to measure (peak flow exceeding 1700 ml/hr). In this case, Infutest will appear to
"lock up", failing to begin a measurement or halting a measurement in progress. For
example, the IMED model 960 pump should not be tested at rates over 700 ml/hr. If
set to 800 ml/hr, the IMED 960 will produce a very high flow (exceeding 1800 ml/hr)
immediately following the cassette refill cycle.

Enteral feeding and TPN pumps (e.g. Abbott Provider, Sherwood Kangaroo 324),
inventoried by many Home Care providers, may produce the most non-steady flow of
the devices mentioned so far. Such pumps often deliver fluid by alternately turning on
and off the motor of a rotary peristaltic mechanism. Since the motor runs at one speed,
the duration of the motor's "on-cycle" and the interval between on-cycles determines the
flow rate. The bolus delivered in each on-cycle may range from 0.2 ml to 2 ml, with the
zero-flow interval between bolus deliveries ranging from a few seconds to several
minutes. Infutest's status indicator will show "VPF" when testing such devices, and the
FLOW graph may show large, periodic rises and falls at rates over 100 ml/hr.

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Because of these differences in short-term delivery characteristics, pump manufacturers

choose to specify the accuracy of their products based on Average Flow, or the total
volume delivered in a test divided by the total time. For most pumps operating at 50 to
500 ml/hr, Infutest's AVG. graph will stabilize to a straight, horizontal line after running
the Single Rate Test for 5 to 10 minutes. At this point, most of the pumps described
above will have produced a stable enough reading to verify the pump's accuracy. Note
this limit on the minimum test time is due to the quality and design of the pump being
tested, not the Infutest.

You should find a "flow accuracy" or volumetric test procedure in the Service Manuals
of the infusion devices you will be testing. These procedures will define the
manufacturers' recommendations for pump settings, minimum test time and/or
collected volume. The pump Service Manuals will include specifications for device
performance or an acceptance range based on the volumetric test results. Always refer to
the manufacturer's procedures and recommendations before using Infutest to test your
pumps.

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Remote Control
This chapter describes the Infutest serial communications features and
explains the use of the commands used to request information from the
Infutest, or to remotely control its operation.

6. REMOTE CONTROL

6.1 Overview
Infutest Remote Control (IRC) is the interactive software communications protocol
command structure which allows Infutest to communicate with an external controller,
such as a personal computer or other device, via RS-232. Using these communications
protocols, Infutest may receive and respond to commands to start tests, stop tests, and
transmit measurement data through the serial communications port.

IRC’s comprehensive and flexible set of commands allows the creation of simple
programs on a personal computer to automatically perform and document any pump
test to any desired protocol. IRC is also compatible with other manufacturer’s
automated test instrumentation. However, not all IRC commands are compatible with all
systems. Refer to the operator’s manual for your instrument, especially with regard to
serial port settings, serial cable wiring, data transmission format and data packet length.

This section of the manual describes the IRC commands and provides command
examples.

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6.2 Connections
a. Connect Infutest’s serial port to your controller’s serial port using an RS-232
extension cable with a DB-25 female connector at the Infutest end. If your
controller is a personal computer, use an RS-232 cable with a DB-25 or DB-9
female connector for the computer end and connect to COM1 or COM2 of
the computer (an accessory RS-232 cable for use with the Infutest is available
from Datrend Systems (SSC-1)).

b. Each pin on the Infutest serial port connects to the same pin on your
controller’s serial port; do NOT use a null modem cable or null modem
adapter. However, use of a commonly available RS-232 computer-to-modem
cable with a gender changer is acceptable.

c. Set the serial port on your controller as follows : 9600 baud, NO parity, 8 data
bits, 1 stop bit

d. Refer to Section 3.3 for complete serial interfacing details.

6.3 Command Syntax

All IRC commands follow the following, very simple format:

COMMAND[chan][parameter]

where the COMMAND consists of two UPPER CASE letters, [chan] is the channel of
interest (also UPPER CASE), and [parameter] is an additional numerical function
parameter, if required. The complete command totals four (4) ASCII characters
terminated by a carriage return (OD hex) and/or a line feed (OA hex). For the basic
Infutest, the channel may be either A or B. If a Remote Sensor Module (RSM) has been
connected, channel may also include C or D.

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6.4 Command Types and Return Values

Test Control Commands are used to start or stop tests and AutoSequences. If a Test
Control command is received, Infutest will return one of the following:

* Acknowledged, test may be started/stopped

? Syntax error
e Error, test already running on channel
n Channel specified does not exist

Report Output Control Commands are used to put Summary or Data Logs for a completed
test into the output queue. Infutest will return one of the following:

* Acknowledged, output job has been queued

? Syntax error
n Channel specified does not exist

Get Data Commands are used to obtain specific data from Infutest’s memory either during
or after a test. If a Get Data Command is received, Infutest returns the requested data as
a string of up to 34 ASCII characters, or one of the following error codes:

? Syntax error
e Test/AutoSeq not stopped if summary data requested
Test/AutoSeq not started if real-time data requested
x No new data available if real-time data requested
n Channel specified does not exist

All data returned from Infutest to the controller, including the error codes, are
terminated with a carriage return (CR) character.

In some cases, Infutest will not transmit a response to a command. For example,
Infutest may be busy sending measurement data to the controller and still receive
additional commands from the controller. These commands will not be acknowledged,
to prevent interference with the data transmission already in progress.

Infutest requires at least 50 milliseconds to interpret and begin executing a command

once it has been received. You must ensure that your computer programs do not
transmit commands to Infutest faster than one command every 50 milliseconds.

To prevent overloading Infutest with commands, it would be easiest to program your

system to wait for a response from Infutest before proceeding to the next command.

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6.5 Command List

Test Control commands:

RT Run Test
RS Run Sequence
ST Stop Test/Sequence

Report Output commands:

PR Place Data to Print (parallel) in Output Queue

DL Place Data to Download (serial) in Output Queue

Get Data commands:

GS Get Test Summary Data (up to 34 characters)

GR Get Real-time Data during test (up to 34
characters)

6.6 Command Descriptions

This section presents the IRC commands, with detailed descriptions of each command.
Examples of each command show exactly how the command should be typed, and the
typical data Infutest would return to the controller.

6.6.1 Test Control Commands - RUN TEST

Starts a test running on a channel.

Format:
RT[chan][parm] chan = A, B, C, or D
parm = 1 for single rate (SR)
2 for dual rate (DR)
3 for PCA
4 for occlusion (OP)
Examples:

RTA1 - run SR test on channel A

RTC3 - run PCA test on channel C (RSM only)

Returns:

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* Acknowledged, test may be started/stopped

? Syntax error
e Error, test already running on channel
n Channel specified does not exist

6.6.2 Test Control Commands - RUN AUTOSEQUENCE

Starts a preset AutoSequence running on a channel.

Format:
RS[chan][parm] chan = A, B, C, or D
parm = 1 for AutoSeq #1
2 for AutoSeq #2
Etc.
9 for AutoSeq #9
Examples:

RSA1 - run AutoSequence #1 on channel A

RSD5 - run AutoSequence #5 on channel D (RSM only)

Returns:
* Acknowledged, test may be started
? Syntax error
e Error, test already running on channel
n Channel specified does not exist

Note that the controlling device must be ready to receive serial data transfer of
up to 60,000 characters if AutoSequence AUTO-OUTPUT is set to Summary or
DataLog, and if OUTPUT TO is set to SERIAL.

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6.6.3 Test Control Commands - STOP TEST/ABORT

AUTOSEQUENCE

Stops a running test or aborts an AutoSequence in progress on the specified

channel.

Format:
ST[chan] chan = A, B, C, or D
Examples:
STA - stop test/AutoSequence on channel A
STC - stop test/AutoSequence on channel C (RSM Only)

Returns:
* Acknowledged, test may be stopped
? Syntax error
e Error, no test currently running on channel
n Channel specified does not exist

6.6.4 Report Output Control - PRINT REPORT

Places a print job in the report output queue.

Format:
PR[chan][parm] chan = A, B, C, or D
parm = 1 for Summary Report
2 for Data Log Report
Examples:

PRA1 - put channel A Summary report in output queue

[print]
PRD2 - put channel D Data Log in output queue [print]
(RSM only)
Returns:
* Acknowledged, job placed in queue
? Syntax error
n Channel specified does not exist

6.6.5 Report Output Control - DOWNLOAD REPORT

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Places a serial download job in the report output queue.

Format:
DL[chan][parm] chan = A, B, C, D
parm = 1 for Summary Report
2 for Data Log Report
Examples:
DLA1 - put channel A Summary report in output queue
[serial]
DLD1 - put channel D Summary report in output queue
[serial](RSM only)
Returns:
? Syntax error
n Channel specified does not exist

Otherwise, Summary or Data Log report (up to 60,000 bytes)

6.6.6 Get Data Commands - GET TEST SUMMARY

Returns summarized test results as a string of up to 34 ASCII characters,

terminated by a carriage return, after a test has been stopped or a preset
AutoSequence has completed.

Format:
GS[chan][parm] chan = A, B, C, or D
parm = 1 for SR Summary
or, for DR Summary RATE#1
2 for DR Summary RATE#2
3 for PCA Summary
4 for OP Summary
Examples:
GSA1 - Get SR test Summary for channel A
GSB3 - Get DR test Summary for RATE #2 from channel B
GSD5 - Get OP test Summary from channel D (RSM only)

Returns:
For [parm] = 1 or 2

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hh:mm:ss VVVVV ml AAAAA ml/h

Where
hh:mm:ss = infusion time (hrs:min:sec)
VVVVV = infused volume
AAAAA = average infusion rate
For [parm] = 3
VVVVV ml AAAAA ml/h mm:ss
or,
VVVVV ml? AAAAA ml/h mm:ss?
Where

VVVVV = average bolus volume

AAAAA = average bolus delivery rate
mm:ss = average lockout time between
deliveries (min:sec)
? = uncertainty indicator for
volume or time
(See Section 4.6.3)
For [parm] = 4
<type> PP.P psi pppp mmHg at mm:ss
Where
<type> = OVR for overpressure data
= MAX for maximum pressure data
= NRS for nurse call pressure data
PP.P = occlusion pressure, in psi
pppp = occlusion pressure, in mmHg
mm:ss = elapsed time to indicated pressure
(min:sec)
Error Codes Returned:
? Syntax error
e Test/AutoSequence not stopped
(Summary not available)
n Channel specified does not exist

6.6.7 Get Data Commands - GET REAL-TIME DATA

Retrieves data in real-time as displayed on the LCD during test execution.

Useful for logging data from extremely long pump tests or to run multiple tests,
or to create Visual Basic/Visual C++ data acquisition programs. Data is

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returned as a comma delimited string of up to 34 ASCII characters, terminated

by a carriage return. Data must be retrieved from the LCD before it changes, or
that particular data is lost.

Format:
GR[chan] chan = A, B, C, or D
Examples:
GRA - Get displayed data from channel A
GRD - Get displayed data from channel D (RSM only)

Returns:
For SR, DR and PCA test data:

<type>,hh,mm,ss,FFFFF,AAAAA,VVVVV,ppp
Where:
<type> = A - SR low range flow (LOW)
B - SR high flow range (HI)
C - SR pulsatile flow (PUL)
D - SR very pulsatile flow (VPF)
E - SR interrupted flow (IFL)
F - DR rate #1 data
G - DR rate #2 data
H - PCA bolus flow data
I - DR/PCA pulsatile warning data
J - DR/PCA end of delivery data
K - SR or DR end of infusion data
L - PCA end of test averages
hh = Elapsed time, hours
mm = Elapsed time, minutes
ss = Elapsed time, seconds
FFFFF = Instantaneous flow rate, ml/h
AAAAA = Average flow rate, ml/h
VVVVV = Effused volume, ml
ppp = Back Pressure, mmHg
Additional DR test data:
M = indicates start of rate #1
N = indicates start of rate #2
Additional PCA test data:
O,NNN = start of PCA bolus delivery #NNN
Q,mm,ss = lockout time between bolus delivery

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NNN and NNN+1; mm = minutes, ss =

seconds

Occlusion Pressure test data:

R,mm,ss,PP.P,pppp
Where
R = occlusion pressure data indicator
mm = elapsed time, minutes
ss = elapsed time, seconds
PP.P = pressure, psi
pppp = pressure, mmHg
End of Occlusion test data:
<type>,mm,ss,PP.P,pppp
Where
<type>= S for maximum pressure data
= T for nurse call alarm data
= U for overpressure data (exceeded 50
psi)
mm = elapsed time, minutes
ss = elapsed time, seconds
PP.P = pressure, psi
pppp = pressure, mmHg
Error Codes Returned:
x No new data available from LCD since last GR
command received (No Data Ready)
? Syntax error
e Test/AutoSequence not running
n Channel specified does not exist
6.7 Programming Examples

6.7.1 QBasic Programming

This section provides some examples of BASIC programs for controlling

Infutest. MS-DOS1 version 5.0 and 6.0 owners will be able to use Microsoft's
QBasic1 program.

The examples provided in this chapter were written for QBasic version 1.02 and
assume some familiarity with BASIC or other programming languages. The
examples include comments to explain what each program and each line does.

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Editing the programs to perform alternate tasks, or translation of the programs

to Visual Basic or other compilable languages should be straightforward.

Assuming your PC is equipped with DOS 5 or a later version, power up your PC

and then type:
qbasic

at the DOS command prompt. QBasic should boot, showing the "Welcome"
screen. Press ^ to clear the screen, or press f to view the QBasic HELP index.

When typing in the programs, be sure to include all punctuation marks which
appear in the programs. These punctuation marks ( " , ; ! % $ and so on) are
critical to proper functioning of the programs. However, you may delete the
remark lines from the programs if you wish. In QBasic, remark lines begin with
the quote character ( ' ).

Each program example must be typed in and then saved as a separate .BAS file.
After you have finished entering one of the following example programs, save it
by typing aF , followed by S. To run the example, connect Infutest to COM1, set
up the pump and then type aR followed by S. To quit QBasic, type aF followed
by X. You can access QBasic's HELP system by typing aH. If you need help on
a QBasic keyword, move the cursor to the first letter of the keyword and then
press F1.

1: The inclusion of this information with this manual should not be considered in any way to be an endorsement of a
Microsoft product.

2: The INPUT statement of QBasic version 1.1 (supplied with MS-DOS version 6.0) may sometimes produce anomalous
results on a high-speed computer when reading data from Infutest. No such problems have been detected with QBasic
version 1.0, supplied as part of MS-DOS version 5.0.

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Example #1: Serial Connection Diagnostic

' [Link]
' Serial Connection Test: Infutest-to-PC
' (c) Datrend Systems Inc. 2005
'
' This diagnostic tests the serial connection between Infutest and the PC
' by sending a single character out COM1. If Infutest is powered and
' properly connected to the PC, Infutest should respond by sending back a
' "?" character. If the response returned is not "?", 'ERROR' is displayed
' on the PC screen. If there is a fault in the connection itself (e.g. bad
' cable, wrong or defective COM port), the PC displays 'TIMEOUT'.
' The OPEN COM statement may be edited to set the port to COM2 if desired.
' However, don't change any of the other parameters in the statement.
'
' This is a good program to try first.
Main:
CLS
PRINT "SERIAL CONNECTION TEST: INFUTEST-TO-PC"
PRINT
' Initialize COM1 for communication with Infutest.
OPEN "COM1:96ØØ,N,8,1,CDØ,CS1ØØØ,DSØ,OPØ,RB2Ø48,TB32" FOR RANDOM AS #1
' Display TIMEOUT error message if no CTS on COM1 within 1 second
ON ERROR GOTO CommTimeOut
DO
' Read character from keyboard
DO
C$ = INKEY$
LOOP WHILE C$ = ""
' Send test character to Infutest via COM1
PRINT #1, C$
' Read response from Infutest via COM1. If response takes more than
' 1 second, device timeout error is generated
INPUT #1, IFTdata$
' Expected response is "?"
IF IFTdata$ = "?" THEN
PRINT "O.K."
ELSE
PRINT "ERROR"
END IF
ReadKey:
LOOP UNTIL C$ = "x"
' Turn off COM port
CLOSE
END
CommTimeOut:
' Error interrupt handler.
' If no response from Infutest after 1 second, display timeout error
PRINT "TIMEOUT"
RESUME ReadKey

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Example #2: Single Rate With Occlusion Test

' SROP_TST.BAS
' Single Rate Plus Occlusion Pressure Test
' (c) Datrend Systems Inc. 2005
'
' This QBasic program illustrates how to use the Infutest Remote Control
' commands to run a Single Rate Test followed by an Occlusion Pressure Test.
' After you input how long you want each test to run, the program starts
' the Single Rate Test, waits until the user-input time has elapsed, and then
' stops the test. The program then gets and displays the Single Rate test
' summary.
' An Occlusion Pressure Test is then started. After this test is stopped,
' the program gets and displays the peak pressure measured during the test.
' When both test results have been displayed, the program produces a
' "bee-bop" from the speaker to remind the tech that coffee is over!
' If you want to bypass either the Single Rate or Occlusion Pressure Tests,
' enter zero (0) for the test duration when prompted.
' If during either the Single Rate or Occlusion Pressure Test you want to
' skip the time remaining in the test, press the <ESC> key.
'
DECLARE SUB Delay (seconds%)
Main:
' Initialize COM1 for communication with Infutest.
OPEN "COM1:96ØØ,N,8,1,CDØ,CSØ,DSØ,OPØ,RB2Ø48,TB32" FOR RANDOM AS #1
' Clear the PC's screen
CLS
' Display some reminders on the screen
PRINT "Flush Channel A and start device pumping."
PRINT
' Input testing times for Single Rate and Occlusion Pressure portions
' of the program.
INPUT "Enter duration of Single Rate Test (sec): ", SRtestTime%
INPUT "Enter duration of Occlusion Pressure Test (sec): ", OPtestTime%
' Conduct a Single Rate Test, if test time was not set to zero...
IF SRtestTime% <> 0 THEN
PRINT
PRINT "Executing Single Rate Test..."
PRINT #1, "RTA1" ' Send START command to Infutest,
' Chan A, SR Test
INPUT #1, IFTdata$ ' Get Infutest's "*" acknowledge response
Delay (SRtestTime%) ' Delay the desired number of seconds
PRINT #1, "STA" ' Send STOP command to Infutest
INPUT #1, IFTdata$ ' Get Infutest's "*" response

' Display the test results on the screen

PRINT : PRINT : PRINT "TEST RESULTS:"
PRINT #1, "GSA1" ' GET Summary - up to 34 ASCII characters
INPUT #1, IFTdata$ ' Get and display data from Infutest

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Example #2: Single Rate With Occlusion Test (cont’d)

PRINT " Time Volume Average Flow"

PRINT IFTdata$
PRINT
END IF
' Conduct an Occlusion Pressure Test, if test time was not set to zero...
IF OPtestTime% <> 0 THEN
PRINT
PRINT "Executing Occlusion Pressure Test..."
PRINT #1, "RTA4" ' Send START command to Infutest,
' Chan A, OP Test
INPUT #1, IFTdata$ ' Get Infutest's "*" response
Delay (OPtestTime%) ' Delay the desired number of seconds
PRINT #1, "STA" ' Send STOP command to Infutest
INPUT #1, IFTdata$ ' Get Infutest's "*" response
' Display the test results on the screen
PRINT : PRINT : PRINT "TEST RESULTS:"
PRINT #1, "GSA4" ' GET OCCL PR results command
INPUT #1, IFTdata$ ' Get data from Infutest and display
PRINT " Occlusion pressure: "
PRINT IFTdata$
PRINT
END IF
' Output "I'm finished" sound
PLAY "O3L8EC"
' Turn off the COM port
CLOSE
END
'Delay (seconds)
'This SUBroutine is called to produce a delay of 'seconds' allowing Infutest
'some time to collect measurement data after a test has been started. The
'time remaining in the delay is continuously posted on the screen.
'The time remaining can be skipped by pressing the ESC key on the keyboard.
'
SUB Delay (seconds%)
row% = CSRLIN
PRINT "Time remaining in test: "; seconds%; "sec"
PRINT "Press <ESC> key to stop test"
DO WHILE seconds% > 0 AND INKEY$ <> CHR$(27)
' Wait here for 1.0 seconds
Tzero! = TIMER
DO WHILE TIMER - Tzero! < 1!: LOOP
' 1 second elapsed - decrement seconds counter
seconds% = seconds% - 1
' Update time posted on screen
LOCATE row%, 25
PRINT seconds%
LOOP
END SUB

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Example #3: Serial download from AutoSequence

' [Link]
' AutoSequenced Test with Data Saved to File
' (c) Datrend Systems Inc. 2005
'
' This QBasic program illustrates how to use Remote Control commands to run
' an Infutest AutoSequence, and have the report automatically output by the
' AutoSequence saved in a disk file on your computer.
' The program first asks you to input a name for the file to save the data
' output at the end of the AutoSequence. The program starts AutoSequence #1
' running on Channel A after you input the file name, and then asks you to
' run the pump. AutoSequence #1 should be programmed with AUTO-OUTPUT
' set to "Summary" or "Log", and OUTPUT TO set to "Serial". You can set the
' other parameters of AutoSequence #1 to whatever you wish.
' The part of the program that does the downloading is fairly simple and
' can be easily transplanted to other programs which run just a Single
' Rate,Dual Rate etc test as opposed to a complete AutoSequence.
' [Link] relies on the fact that all test reports sent from Infutest
' via the serial port are terminated with the BELL character (CHR$(7)) as
' an end-of-file indicator. This tells [Link] that all the test data
' has been downloaded and the disk file can be closed.
' [Link] creates a new file for your test data, or overwrites existing
' files. If you want the test data appended onto a file which already
' exists in the current working directory, use 'APPEND' instead of 'OUTPUT'
' as the file mode in the OPEN statement for device #2.
'
Main:
' Initialize COM1 for communication with Infutest.
OPEN "COM1:96ØØ,N,8,1,CDØ,CSØ,DSØ,OPØ,RB2Ø48,TB32" FOR RANDOM AS #1
' Clear the PC's screen
CLS
' Display some reminders on the screen
PRINT "AUTOSEQUENCE DOWNLOADER"
PRINT
PRINT "Flush Infutest Channel A."
PRINT "Press any key to proceed or <ESC> to abort now: ";
' Wait here for user to press a key
DO
C$ = INKEY$
LOOP WHILE C$ = ""
IF C$ <> CHR$(27) THEN
PRINT
INPUT "Enter file name for storage of test report: ", filename$
PRINT
PRINT #1, "RSA1" ' Send START command to Infutest,
' Chan A, AutoSequence #1
INPUT #1, IFTdata$ ' Get Infutest's "*" response
PRINT "AutoSequence #1 started."
PRINT "Start infusion pump running anytime..."

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Example #3: Serial download from AutoSequence (cont’d)

' ------------------ SERIAL DATA DOWNLOAD --------------------

'
' Open the file for the test report.
' Substitute 'APPEND' for 'OUTPUT' if you want the data appended
' to the end of an existing file.
OPEN filename$ FOR OUTPUT AS #2
' If you are not interested in AutoSequences, you can use a loop
' like this to download test data collected during ordinary Single
' Rate, Dual Rate, PCA Pump or Occlusion Pressure tests. Just
' precede this DO loop by the statement PRINT #1, "DLA1" for the
' summary, or PRINT #1, "DLA2" for the data log.
DO
IFTdata$ = INPUT$(1, #1) ' Wait here for a character
' from Infutest
PRINT #2, IFTdata$; ' Print character to file

' Echo character to screen.

' When printing to the screen, Qbasic translates "newline" to
' "carriage return" and blanks the screen for "formfeed" characters.
' This IF statement prevents this from happening.
IF IFTdata$ <> CHR$(10) AND IFTdata$ <> CHR$(12) THEN
PRINT IFTdata$;
END IF
' Continue downloading until Infutest sends BELL character.
LOOP UNTIL IFTdata$ = CHR$(7)
PRINT
' Output "I'm finished" sound
PLAY "O3L8EC"
END IF
' Close the data file and turn off COM port
CLOSE
END

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Example #4: Hard Disk Data Logger

' [Link]
' Log Infutest Data to Disk
' (c) Datrend Systems Inc. 2005
'
' Infutest's data log memory is limited to a maximum of 900 measurements
' per channel, or about 2 hours of testing at 100 ml/hr. This QBasic
' program shows you how to convert your PC into a data logger with
' capacity limited only by the size of your hard disk.
' The program runs a Single Rate Test on Infutest Channel A and uses the
' Get Real-Time commands to retrieve test data from Infutest as it is
' measured. The Single Rate Test is run until the user hits the ESC key.
' [Link] is a simple program which is ideal for saving the large
' amount of data produced during overnight tests.
' [Link] begins with some input prompts allowing the user to enter
' the pump make/model, ECN and so on. More INPUT statements can be added
' here to input other info (Department, Location, etc.
' [Link] creates a new file for your test data, or overwrites existing
' files. If you want the test data appended onto a file which already exists
' in the current working directory, use 'APPEND' instead of 'OUTPUT' as the
' file mode in the OPEN statement for device #2.
'
Main:
' Initialize COM1 for communication with Infutest.
OPEN "COM1:96ØØ,N,8,1,CDØ,CSØ,DSØ,OPØ,RB2Ø48,TB32" FOR RANDOM AS #1
' Clear the PC's screen and prompt user to input pump info
CLS
PRINT "HARD DISK DATA LOGGER"
PRINT
INPUT "Enter file name for storage of test data: ", filename$
PRINT
INPUT "Enter pump make and model number: ", Pump$
PRINT
INPUT "Enter pump equipment control no.: ", ECN$
PRINT
INPUT "Enter test rate (ml/hr): ", TestRate$
PRINT
PRINT "Flush Channel A, then start device pumping."
PRINT
PRINT "Press any key to proceed or <ESC> to abort now: ";
' Wait here for user to press a key
DO
C$ = INKEY$
LOOP WHILE C$ = ""
IF C$ <> CHR$(27) THEN
' Open data file and print header info.
' Substitute 'APPEND' for 'OUTPUT' if you want the data appended
' to the end of an existing file.
OPEN filename$ FOR OUTPUT AS #2
PRINT #2, " DATA LOG”

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Example #4: Hard Disk Data Logger (cont’d)

PRINT #2, " TEST DATA FILE: "; filename$

PRINT #2, " TEST DATE/TIME: "; DATE$; " "; TIME$
PRINT #2, " PUMP MAKE/MODEL: "; Pump$
PRINT #2, " CONTROL NUMBER: "; ECN$
PRINT #2, " TEST FLOW RATE: "; TestRate$; " ml/hr"
PRINT #2, " SINGLE RATE TEST”
PRINT #2, ""
PRINT #2, " Elapsed Flow Avg Flow Volume [Link]"
PRINT #2, " Time (ml/h) (ml/h) (ml) (mmHg)"
' Clear PC screen and display data table headings
CLS
PRINT "Press <ESC> to stop test anytime."
PRINT
PRINT "Elapsed Flow Avg Flow Volume [Link]"
PRINT " Time (ml/h) (ml/h) (ml) (mmHg)"
VIEW PRINT 5 TO 25
PRINT #1, "RTA1" ' Send START command to Infutest,
' Chan A, SR Test
INPUT #1, IFTdata$ ' Get Infutest's "*" response
'----------------- DATA LOGGING LOOP ------------------
DO
' Delay 1 second
' Tzero! = TIMER
' DO WHILE TIMER - Tzero! < 1!: LOOP
SLEEP 1
' SLEEP 60 or 300 will pause for 60 or 300 seconds and reduce the
' number of data points saved, but not ALL instantaneous points
' will be collected
' Get real-time data from Infutest chan A
PRINT #1, "GRA"
INPUT #1, DataType$
' If data is not "x" (NO DATA READY), echo data
' to screen and save in file
IF DataType$ <> "x" THEN
INPUT #1, Hr$, Min$, Sec$, Flow$, Avg$, Vol$, BPr$

PRINT Hr$; ":"; Min$; ":"; Sec$; " ";

PRINT Flow$; " "; Avg$; " "; Vol$; " "; BPr$
PRINT #2, " "; Hr$; ":"; Min$; ":"; Sec$; " ";
PRINT #2, Flow$; " "; Avg$; " "; Vol$; " "; BPr$
END IF
C$ = INKEY$ ' Loop until user hits ESCape key
LOOP UNTIL C$ = CHR$(27)
PRINT #1, "STA" ' Send STOP command to Infutest
INPUT #1, IFTdata$ ' Get Infutest's "*" response
END IF
PRINT #2, " END OF DATA”
' Close the data log file and turn off COM port
CLOSE

END

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6.7.2 medTester Programming

The Infutest is fully compatible with the DNI Nevada medTester 5000B and the
Fluke Biomedical medTester 5000C. Using the medTester, you may control the
Infutest to automatically start and stop tests, and download test results into the
medTester via the serial communications interface.

If you wish to interface the Infutest with a medTester, please contact Datrend
Systems for further information.

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APPENDIX A. BACK PRESSURE TESTING

A back pressure may be applied by the user to the infusion device under test (DUT) to
oppose the flow from the device. Back pressures up to 300 mmHg may be applied
during the Single Rate, Dual-Rate and PCA Pump Tests at the A&B Output of the
Infutest. The Infutest will measure and display the back pressure during each of these
tests.

This appendix describes apparatus and provides instructions for testing an infusion
device with a pneumatically-applied back pressure. The test apparatus and method
discussed are similar to those recommended by the Association for the Advancement
of Medical Instrumentation (AAMI) in their proposed standard for infusion devices.

Connect the apparatus shown in Figure 33 to the A&B Output of the Infutest as
illustrated. The flask should have a large internal volume (1 to 2 litres) so that the fluid
level within the flask does not change substantially during the test. The components and
all seals should be capable of withstanding the maximum pressure applied to the system.

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Figure 33 - Apparatus for applying Back Pressure

Alternatively, a syringe bulb may be used to pressurize the flask instead of the
compressed air source and regulator valve shown in Figure 33. This approach, although
simple, has the disadvantage in that the back pressure is unregulated. If air leaks are
present within the system, or if the water level within the flask changes substantially, the
back pressure will be affected and the test results may be invalid.

To perform a Single Rate, Dual-Rate, or PCA Pump Test with an applied back pressure:

a. Power up the Infutest with NO PRESSURE applied to the A&B

Output. During its power-on self-test, the Infutest will auto-zero the
internal pressure sensor.

b. If a back pressure is detected at the time of power-up, the Infutest will

produce an alarm via the SELF-TEST screen. Refer to Section 4.9, Alarms.

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c. After the START screen has been selected, the fluid system of Figure 33
may be primed with water (see Section 3.2, Priming) and the flask
pressurized up to a maximum of 300 mmHg before starting the test.

Under no circumstances should a vacuum be applied to the A&B

Output as this may damage the internal pressure sensor.

d. Water may be pumped out of the flask into the Infutest’s A&B Output
during pressurization of the apparatus. If this happens, reprime the
Infutest once the apparatus has been pressurized so that the tubing
connecting the A&B Output to the flask is completely filled with water.

e. Prepare the DUT, then set up and start a Single Rate, Dual-Rate, or PCA
Pump Test (see Sections 4.2, 4.3). The back pressure applied to the DUT
will be measured, displayed on the TEST screen, and stored in the Data
and Summary logs along with the measured flow and volume data.

f. The back pressure should not be allowed to change for the duration of the
test. IV tubing is compliant, and an increase in back pressure may cause a
drop in measured flow and volume simply because the IV tubing is being
stretched by the increased pressure in the system. Variations in device
performance may therefore be more an effect of the tubing than of the
device itself.

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APPENDIX B. OPERATIONAL OVERVIEW

B.1 General Description
Figure 34 is a block diagram showing the major assemblies of the Infutest. Test fluid
flows from the Channel A and B inputs to the Sensor Chassis where the flow sensing
system, comprising two flow sensors and a number of solenoid valves, is located.
Channel pressure is measured via a transducer connected at each input via a tee. Fluid
exiting the flow sensor on the Sensor Chassis is combined in a collection tank which
drains out the A&B Output. Analog signals from the flow and pressure sensors are A-D
converted and analyzed by the Test Controller (TCO), which also outputs valve control
signals to the Sensor Chassis.

16-bit CPU of the TCO interacts with the sensors and valves, executing software
algorithms (SynchroStart, flow pattern analysis, Single Rate Test, etc.) which perform
the actual measurements. Calibration data for the flow and pressure sensors are stored in
a 512-byte EEPROM located on the TCO. Calibration of the Infutest is completely
software based - there are no manual adjustments or controls inside the unit.

Measurement data obtained by the TCO is serially transmitted to the Display Unit for
display to the user. The Display Unit is based on an 8-bit CPU which operates the LCD,
keypad, printer, serial and AUX interface ports. The Display Unit includes a real-time
clock and a 32K RAM where measurement data from the TCO are stored (the "data
log"). Contents of the 32K RAM are preserved by a 3 V lithium battery in the Display
Unit when the Infutest is powered down.

After powering up the Infutest, the LCD will display two software version numbers
following a successful self-test. The versions are displayed as "IFT / TCO", where "IFT"
is the software version of the Display Unit (ie. 3.7/3.2).

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Figure 34 - Infutest Block Diagram

B.2 Flow Measurement System

Figure 35 is a schematic diagram of the patented Infutest flow sensor. Pressure
developed by an air pump is released through an injector valve, introducing an air bubble
into the flowing fluid via a needle located at the sensor input. Fluid entering the flow
sensor pushes the injected bubble through a glass capillary tube having an end-to-end
volume of approximately 1.2 ml. Bubble position is tracked continuously using an array
of 16 optical sensors located along the glass tube as shown in Figure 35.

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Figure 35 - Flow Sensor schematic diagram.

The first 15 optosensors are used to measure flow over the low range (0.1 - 170 ml/hr).
For high range flow (170 - 1200 ml/hr), optosensor #3 and the output optosensor, #16,
are used. Continuous flow measurement is performed by injecting a new bubble every
time the preceding bubble passes the fifteenth (low range) or sixteenth (high range)
optosensor.

Volume of the glass capillary tube between adjacent optosensors is calibrated at the
factory to within +/- 0.0000052 ml using a precision microsyringe dispensing system.
These volume calibrations along with other flow sensor and pressure sensor calibrations
are programmed into the TCO EEPROM.

Flow measurement is accomplished based on a transit time principle. As described,

volume of the glass tube between optosensors is known precisely. Flow is derived by
measuring the time required for the bubble to cross these calibrated volumes. Volume is
derived by summing up the calibrated volumes incrementally as the bubble crosses them.
Signals from the optosensors are continuously analyzed and dynamic corrections may be
applied by the software algorithms depending on rate and the fluid delivery pattern of
the device under test (flow pattern analysis).

Figure 36 illustrates how each flow sensor is incorporated into the patented Infutest
flow sensing system. After the test fluid passes through the flow sensors, the fluid is
collected in a large tank inside the Infutest before draining out the A&B Output.
Pneumatic feedback from the tank to the air pump ensures the injected bubble size

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remains independent of pressures or moderate vacuums applied at the A&B Output.

As shown in Figure 36, the collection tank of the pneumatic feedback system is mostly
filled with air. Because of this, fluid draining from the Output is poorly correlated with
flow entering the input.

B.3 Pressure Measurement System

Figure 34 shows a pressure transducer located at each channel’s input. During Single
Rate, Dual-Rate and PCA Pump Tests, the transducer is used to measure pressure in the
channel, which is displayed as Back Pressure.

During the Occlusion Pressure Test, a solenoid valve on the Sensor Chassis is activated
which blocks fluid flow downstream of the pressure transducer. Pressure developed by
the infusion device against the blockage is sensed by the transducer and displayed.

Figure 36 - Flow Sensing System

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APPENDIX C. CALIBRATION
C.1 Annual Calibration
Calibration of Infutest by a Datrend Authorized Service facility is recommended on an
annual basis, and is required to extend the product warranty. The basic one (1) year
warranty can be extended to a maximum of five (5) years provided that calibration is
performed by a Datrend Authorized Service Center on an annual basis.

The Infutest can only be CALIBRATED with specialized equipment and software
found at Datrend authorized service facilities. This equipment allows proper adjustment
of the internal electronics of the instrument.

Independent service providers may be able to perform a performance

VERIFICATION; however, they will NOT be able to perform repairs or adjustments
to your Infutest. Use of an unauthorized facility for service and/or calibration will void
your warranty.

When calibration is due, contact Datrend Customer Service to determine the authorized
service facility nearest your location and to obtain an RMA number. In North America:
1-800-667-6557; Outside North America: (604) 291-7747;
e-Mail: customerservice@[Link]

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C.2 Calibration Verification

C.2.1 Pressure Accuracy Verification - Field Test

Calibration of Infutest's pressure measurement system may be verified in the field by

running an Occlusion Pressure Test with an external pressure gauge connected via a
tee to the input. Validity of the pressure calibration verification will be dependant on
the accuracy and traceability of the external gauge used.

C.2.2 Flow Accuracy Verification - Field Test

Calibration of the flow measurement system CANNOT be verified in the field

using infusion devices intended for medical applications. Such devices lack
the stability and repeatability required for checking calibration.

Calibration of the flow measurement system CANNOT be verified in the field

using measuring devices connected to the A&B Output (see Appendix B).

Calibration of the flow measuring system may be checked using a precision syringe
pump of laboratory grade which has itself been calibrated using a gravimetric test
protocol and apparatus similar to that defined in IEC 601-2-24 Part 2, or
equivalently, ANSI Standard ID-26. We recommend Harvard Apparatus model 22 or
model 44 with a precision-ground glass syringe or glass microsyringe having the
minimum volume necessary for the verification, depending on the verification rates
of interest (Harvard Apparatus USA, Holliston MASS, (800)-272-2775; ENGLAND
Edenbridge, Kent, 44-1732-864001; [Link]). For verification
rates in the range 50 to 200 ml/hr, B-D Yale #2313 (precision 20 cc) is
recommended.

If the test pump is a Harvard model 22 equipped with B-D Yale #2313, the test
pump should be tested gravimetrically at 50 ml/hr and 200 ml/hr prior to each
verification run on the Infutest. The pump should be allowed to dispense 1 ml at the
selected rate before any test measurement is started. Use an analytical balance to
measure the mass of distilled water effused from the test pump over 10 minutes at
50 ml/hr and over 4 minutes at 200 ml/hr. Calculate the average rate in ml/hr by
dividing the mass by the specific gravity (0.9973 gm/ml at 24O C), and then by the
test time. Compare this result to Infutest's Average Flow from a Single Rate Test of
10 minute (50 ml/hr) or 4 minute (200 ml/hr) duration. Three runs, consisting of a
gravimetric measurement followed by the Infutest Single Rate Test, should be
conducted to obtain repeatability of both the standard (gravimetric) and the Infutest.

Appendix C # Page 110