Fresenius Pilote A2 - User Manual
Fresenius Pilote A2 - User Manual
Syringe pump
3,/27$
Introduction
The Pilot A2 has been designed and manufactured with the greatest care. It introduces a new concept of control with easy reading of alarms and safety features. The configuration flexibility of the Pilot A2 provides overall improvement in the working conditions of medical teams, thus increasing patient safety. A choice of easily accessible configurations ensures optimum use of functions according to the needs of each department.
Table of contents Operations for use ...................................................... 2 Internal safety features ............................................... 3 Performances............................................................... 5 Technical characteristics ........................................... 6 Configuration ............................................................... 8 Operating precautions ................................................ 9 Maintenance............................................................... 10 External power source.............................................. 12 Operation with the internal battery.......................... 12 Accessories................................................................ 13
The use of this material requires great care. The user must be able to handle the instrument properly and must know how to fully operate. Please read the operators guide carefully before putting the device into use.
Infused volume
Consulting the infused volume: Erasing the infused volume:
(continuous press)
Volume limit
Programming a volume limit (ml):
10 1 0.1
Syringe installation
1. Connect the extension set to the syringe according to proper practices. 2. Place syringe in its cradle, the flanges correctly in the provided slot. 3. Turn the syringe barrel clasp into the closed position and move the syringe drive forward the syringe plunger head. Erasing programmed volume limit: Programmed volume limit recall:
(double press)
(double press)
(continuous press)
Bolus function
Administering a bolus (ml):
EROX
(continuous press)
(continuous press)
Stop (sound warning after one minute): To resume infusion: Pause duration selection, from 1 min to 9 hrs 59 min:
(double press)
Drug name selection: (according to device configuration: 3$U&) 2. Prime the line:
(e.g.: ADRENALIN)
$GUH
3XU*
(continuous nd press)
3. 4.
Connect infusion set to patient and check general installation. Flowrate setting (ml/h):
10 1 0.1
5.
Lower limit
Middle limit
Upper limit
Important: flow rate may be programmed during infusion and must be confirmed within 15 seconds following the change. Proceed as described above to change the syringe.
OFF
To turn off the Pilot :
(press for more than 2 seconds)
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Infusion
NO
YES
YES
YES
Alarm + end of infusion indicators Note: to use Empty syringe mode press CONFIRM key.
YES NO
YES YES
Total syringe empty 5 minutes before the volume limit alarm or 10% of syringe capacity.
Alarm Pressure Syringe installed Occlusion alarm Syringe barrel clasp Syringe flanges insertion Plunger head position Anti-siphon systems Disengaged mechanism
YES (2 min) Volume limit reached YES (2 min) Programmed limit reached YES (2 min) Syringe incorrectly positioned
YES
YES
YES
YES
Others alarms
---
NO
YES
YES
no syringe selection > 1 min q Flashing confirm signal + flashing capacity and brand syringe indicators Pressing an unauthorised key Programmed end of pause Audible signal only Alternating displays of flow rate value and 6W23
Key disabled
NO
NO
YES
NO
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Checks
Silence alarm
Activation
Message
YES
YES
YES
(U--
Error message + technical malfunction + alarm indicators Press STOP to resume the device normal operation
Error messages : (U ; ; ; ; ; ; ; ; , Error message : (U Error messages : (U ; ; ;
YES
YES
(U-Error message + technical malfunction + alarm indicators (U-Error message + technical malfunction + alarm indicators
YES
NO
Keyboard anomaly
YES
YES
1 ml deviation/ volume to be (U-Error message + technical infused malfunction + alarm indicators Date of maintenance reached (3$UE)
NO
---
Note: in case of malfunction alarm, note the error message ((U) and stop the device by pressing the OFF key (5 - 10 seconds can be necessary). If the alarm persists when the device is switched on again, without use on patient, contact the qualified technicians in your establishment or our AfterSales Department. The sound level can be set by rotating the shutter placed underneath the device .
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Performances
Flow rates
The values given in the table below correspond to device configuration. Syringes 50/60 ml Infusion flow rate (ml/h) Bolus rate (ml/h) Prime rate (ml/h)
0.1 ml/h increments.
Pressure limit
Pilot A2 proposes a choice of 3 occlusion alarm thresholds. Syringes 50/60 ml Threshold value lower z middle zz upper zzz 300 500 900 20 ml 600 1000 1700
Volume limit
Volume limit (ml) from 1 to 99.9 ml, 0.1 ml increment from 100 to 999 ml, 1 ml increment KVO rate (Keep Vein Open): 1 ml/h or flow rate originally selected if this is less than 1 ml/h.
(mmHg)
Values given for B-D Plastipak Luer Lok syringes. Note : 1 bar = 750 mmHg = 1000 hPa.
Accuracy
Flow rate accuracy Device accuracy Syringe accuracy 3 % with pre-programmed syringes 1% 2%
Pause duration
From 1 minute to 9 hours 59 minutes, 1 min. increments.
zzz
120 20 50
Syringe used: B-D Plastipak Luer Lok (B-D Plastipak and Luer Lok are registered trademarks of Becton Dickinson).
T T T T T T
T T T
20 ml syringe
Different syringe lists are available. For further information, please contact our Customer Service.
Note: wait until the Alarm + occlusion + flashing indicators turns on, indicating the bolus has been reduced.
Fresenius Vial cannot accept any responsibility for errors in flow due to modifications of the specifications of the syringes introduced by the manufacturer.
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Technical characteristics
Mains supply
Mains supply Maxi. consumption Maxi. power consumption Internal protective fuse 230 V ~ - 50-60 Hz (110V on request) 100mA 23 VA T 100 mA 250V IEC 127 Confirm signal Infusion in progress Prealarm External supply 12 to 15 Volts - Continuous voltage Power > 15 Watts Alarm KVO flashing green flashing green flashing orange flashing red
Indicators lights
Mains power operation Battery power operation constant yellow
constant green
External supply
Battery
Characteristics Autonomy Battery recharging 6 V 1,1/1,3 Ah - Sealed lead rechargeable min. 7 h av. at 5 ml/hr Partial (70% of capacity): 8 hours Total (100% of capacity): 16 hours On hold duration Programmed volume limit or infused volume Flow rate
KVO ml
ml/h min
constant or flashing green constant or flashing green 3 green digits (tens, units) 1 orange digit (decimals) capacity (ml): constant or flashing green brand and type: constant or flashing green flashing red flashing red
Compliance
Compliance with EN 60 601-1 and EN 60 601-2-24. CE0454 IP34 CE 0459 marking in compliance with EEC 93/42 Medical Device Directive Protection against ingress of liquid Protection against leakage current: Type CF equipment Protection against electrical shocks: Class II equipment
Display
Device materials
Casing/ Drive/ Syringe barrel clasp Programming keyboard / labels Polycarbonate/ Polyester alloy / shock resistant Polyester
Plunger head position anti- siphon system Disengaged mechanism End of infusion
flashing red
flashing red
flashing orange
Dimensions - Weight
Height / Width / Depth Weight 120 x 330 x 155 mm approx. 2.2 Kg
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Trumpet curves
Trumpet curves demonstrate the evolution of the minimum and maximum variance of the Syringe/Syringe-Pump combination. The test protocol used to obtain these results is described in the EN 60 601-2-24. For further information, please refer to this publication. This graph is therefore representative of syringes used during trials and serve as an indication only of the pumps overall performance. Please contact our After-Sales Department for the others curves.
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Configuration
Fresenius Vial recommends the presence of its qualified personnel or of a member of the Technical Department of your establishment to help you implement the configuration procedures you wish to choose.
Moving to configuration of the various parameters mode, press within 2 seconds to confirm start of configuration. Note: press
Press
, then simultaneously
3$U: flow rate memorizing 3$U: syringe selection type 3$U: max. flow rate selectable
T T T T T T
last selection in ml/hr default value 00.0 ml/hr automatic confirmation manual scrolling for 50 ml syringe types for 20 ml syringe types
T T
syringe list given as an example
6(/ QR6( 3XU* QR3X .92 QR.9 68,G QR68 ex : 1230 h GU8* QRGU $,/( QR$, 0(0 QR0(
from 50 to maxi to accede to the to next name, or change the name ($=) from 1 to 9999
3$U: confirming compulsory 3$U: KVO rate 3$U$: empty syringe mode
T T T T T T T T T T T T T T
priming compulsory priming not compulsory KVO rate no KVO rate empty syringe mode no empty syringe mode from 1 to 9999 hours of continuous use drug name selection no selection syringe flanges detection no detection last selection in ml/h default value in ml/h
st
3$UE: frequency of maintenance 3$U&: drug name 3$UG: syringe flanges 3$U): bolus rate memorizing 3$U*: drug name entry
$GUH e.g.:
ADRENALIN,
name
or free
T T T
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Operating precautions
The symbol visible on the condensed instruction guide of the device, recommends this Operator Guide should be completely read, in accordance with the EN 60 601-1 Standard. Standard precaution should be taken to prevent contamination or injuries while discarding the associate disposable (e.g. syringes, extension sets, needles, etc.). The device is designed to infuse any medical substance that can be injected. The physiological effects of medicine can be influenced by the characteristics of the device and disposable syringe. Check that they are compatible with prescriptions, the characteristics of trumpet curves and occlusion alarm setting times in relation to the programmed flow rate. While in use, negative pressure variation may occur in the syringe, by the relative height from the device to the injection site or by combined infusion devices such as blood pump, alternative clamp, etc. When the device is placed higher than the injection site, please pay attention to correctly secure the syringe and manipulate the syringe only when the extension set is clamped or disconnected from patient side. High depression may create syringe siphoning. In this situation, you must check the integrity if the syringe used (possible leakage), and if necessary insert anti-siphon valves. Pressure variation may generate flow discontinuity mainly noticeable at low flow rates and depending of the infusion system characteristics such as friction force, stickiness, compliance of syringes and mechanical back lash. Anti-siphon valves will also eliminate any risk of free flow during syringe changes. An air leakage in a syringe with a line not equipped with an anti-siphon valve may generate an uncontrolled flow delivery. Do not use in conjunction with positive pressure infusion devices that could generate back pressure higher than 2 000 Hpa susceptible to damage infusion disposable and the device.
Fresenius Vial will not be liable for any damages or claims, medical or otherwise, of any nature whatsoever, whether direct or consequential, caused by improper use of this device.
Special attention must be paid to the stability of the Pilot. Use the device in horizontal position, on a table or with the I.V. pole accessories. We recommend you partially or completely recharge the battery when you receive the device or in the case of prolonged storage so as to prevent all risk of premature discharge. The device must not be used in the presence of inflammable anaesthetic agents due to the risk of explosion. It should always be used away from all risk areas. The recommended temperature for normal use of the device is between +10 and +40C. The device may only be connected to the mains with the power cord supplied by the manufacturer. Check that the supply voltage corresponds with the value indicated on the label placed underneath the device. Fuses should be replaced by equivalent parts. Refer to the part list of the technical manual for full specification. Do not exceed the permitted voltage whether the supply is from the mains, an external source or via the different external connections. DC adapter should not be used. Only external battery like vehicle battery can be attached to drive the pump from external power. Fresenius Vial recommend the used of the external power source cable for Pilot. To preserve the environment, remove the battery from the device prior to destruction or at the end of the device life and as during normal maintenance replacement, return it to a competent recycling organisation. Proceed in the same way for the device itself (electronic boards, plastics). Avoid short circuit and excessive temperature. This device can be disturbed by a large electromagnetic fields, external electrical influences and electrostatic discharges above the limits stipulated by EN 60 601-1-2 and EN 60 601-2-24. It can also be disturbed by pressure or pressure variations, mechanical shocks, heat ignition sources, etc. If you wish to use the device in special conditions, please contact our After-Sales Department. Only use Luer Lock three-part syringes from the list of pre-programmed brands. If a syringe is used which does not correspond to the syringe list on the device, the specified precision level cannot be guaranteed. Use only sterile catheter extensions which can resist pressures of up to 2000 HPa. The use of unscrewable extension lines or syringes may result in spillage if infusions are carried out at high flow rates and/or high pressure. Infusion line set up must be done in accordance with local standard operating procedures and good clinical practice. Fresenius Vial recommends the use of the Luer Lock type infusion lines proposed in page 13.
Fresenius Vial recommends the use of one way valves or positive pressure infusion devices for multi-line infusions. If there is no one way valve on a gravity infusion line during a multi-line infusion, this will make it impossible to detect occlusions on the patient side, and could result in accumulation of the drug being infused in the gravity line, which could later be infused in an uncontrolled manner when the occlusion is released. Place the connection between the feeder line and the syringe-driver line as near to the start of the catheter as possible in order to minimise the dead space and consequently the impact of any change in flow rate on the feeder line.
Do not use this assembly Preferred assembly
Non-reflux valve
Opening the pump or the battery cover must only be carried out by the qualified personnel in your establishment, and taking all the necessary technical precautions. Non-respect of these procedures is dangerous to the personnel and may damage the syringe pump. We recommend you follow the maintenance procedures defined in the technical maintenance manual. To obtain a copy of the technical maintenance manual, please contact our After-Sales Department or our Commercial Department specifying the identification number of the device.
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Maintenance
Cleaning and disinfection
The Pilot is part of the patients immediate environment. It is advisable to clean and disinfect the devices external surfaces on a daily basis in order to protect patient and staff.
Servicing
To ensure normal performance of the device, it is recommended to replace the internal battery each 3 years. This should be done by a qualified technician.
T T T T
Disconnect the device from its mains supply before starting to clean.
The qualified technicians in your establishment or our After-Sales Service Do not place in an AUTOCLAVE nor IMMERSE the device. Do not let should be informed if the device is dropped or if any of malfunction occurs. liquids enter the devices casing. In this case, the device must not be used. If the device is placed in a high contamination risk unit, it is advisable For further information concerning the pump servicing or its use, please to leave it in the room during aerial disinfection, after having contact our After-Sales Service or our Customer service. disinfected it with a moist cloth. Use a cloth soaked in DETERGENT-DISINFECTANT, previously diluted with water if required, to destroy micro-organisms. Avoid abrasive scrubbing which could scratch the casing. Do not rinse or wipe surfaces. Do not use: TRICHLOROETHYLENE-DICHLOROETHYLENE AMMONIA - AMMONIUM CHLORIDE - CHLORINE and AROMATIC HYDROCARBON - ETHYLENE DICHLORIDE-METHYLENE CHLORIDE - CETONE. These aggressive agents could damage the plastic parts and cause device malfunction. If the device has to be returned to our After-Sales Department, proceed to its cleaning and desinfection. Then , pack it very carefully, if possible in its original packaging, before sending it.
Fresenius Vial is not liable for loss or damage to the device during transport to our After-Sales Department.
Take care also with ALCOHOL BASED SPRAYS (20% - 40% alcohol). They lead to tarnishing of and small cracks in the plastic, and do not provide the necessary cleaning prior to disinfection. Using disinfecting applies by SPRAYS may be done, in accordance with the In order to check that the device is functioning optimally, regular manufacturer recommendations, from a distance of 30 cm of the inspections are recommended every 12 months. device, avoid the accumulation of the product in liquid form. A regular control check consists of various inspection operations listed in Please contact the appropriate service, handling suitable cleaning and the Technical manual. These control checks must be performed by an disinfection products, in your establishment for further details. experienced technician and are not covered by any contract or agreement provided by Fresenius Vial.
Regular inspections
Storage
The device should be stored in a dry, cool place. In case of prolonged storage, the battery should be disconnected via the battery access flap situated underneath the device. This should be done by a qualified technician.
Note: the pump must be checked, serviced and repaired only by Fresenius Vial or by a qualified technician. Failure to comply with these maintenance procedures can damage the device and lead to a functional failure.
T T
Storage temperature: -10C + 60C. Permissive relative humidity: maxi 85%, no condensation.
- 10 -
Department: ........................
Name: .............................
1. Check the state of the device : absence of impact marks and noises (turn upside down the device), presence of all labels as well as their legibility. 2. Press ON (power supply lead not connected): the indicator illuminates. indicator illuminates. YES V NO V
3. Check the condition of the power lead and connect the device to the mains source : the mains 4. Install a syringe.
and
keys.
&75
1. Press
&75
1. Press
2. The DISENGAGED MECHANISM and ANTI-SIPHON indicators flash. Disengage pusher block: constant indicators light up. The confirm signal flashes: press .
3. The SYRINGE BARREL CLASP and +,*+ flash. Position the syringe barrel clasp on upper position: constant indicator and +,*+ light up. The confirm signal flashes: press .
4. The flashing display indicates &&. Turn the syringe barrel clasp into the closed position and check the detected capacity by the device. The confirm signal flashes: press . YES V NO V
5. The SYRINGE BARREL CLASP and /28 flash. Remove the syringe and position the syringe barrel clasp on lower position: constant indicator and /28 light up. The confirm signal flashes: press 6. Select 2.$< or &WU (return) by pressing and confirm . .
&75
1. Press
2. Install a 50 or 20 ml syringe filled at 7 cc. and start the test : UXQ appears on displays. The end of the test is signalled by : message 2.$< and 3. Select syringe FF (volume infused) for 50 and 20 ml syringe (check the advance of syringe plunger: 5 cc 0.5 cc). 4. Select 2.$< ; QR or &WU (return) by pressing and confirm .
5. After the validation of 2.$<, the message (QG indicates the end of the auto control test. 6. Press Visa : to restart device on normal mode. All control result comply: YES V NO V YES NO
- 11 -
E$W K
autonomy in h/min
Note: use charging mode for a complete battery life indicator when device is turned off.
Charging mode
It includes total duration of charging battery when device is not used. 1. Remove syringe and press 2. Charging mode activation: .
&+$U
(continuous press)
(continuous press)
- 12 -
Accessories
Fresenius Vial recommends the use of Pilot range accessories.
Transfix cat # 073416 Composed of transport handle (cat # 073419) and the multi-purpose clamp (cat # 073418), this system enables rapid fixation to a horizontal rail or vertical support, decreases loss of space and provides perfect stability. Transport Handle cat # 073419
Disposable
SE 2400Y - 2 channel - Sterile catheter extension set in PVC.
Injectomat Line PE 200 orange - Opaque extension line for infusion of light sensitive drugs or for drugs not compatible with PVC.
SE 1500 AR - 1 channel - Sterile catheter extension set in PVC with Y connector equipped with one way valve.
RS 232 cord Cat. # 073413 (9m/9f) Cat. # 073414 (9m/25) Battery supply cable cat # 073415
SE 1600 AR AS - 1 channel - Sterile catheter extension set in PVC with anti-siphon valve and Y connector equipped with one way valve.
Power Fix 2 - cat # : 073428. Power Fix 4 - cat # : 073429. 1 power cord only to connect 2 or 4 Pilot to mains. Power Fix 2 and 4 : includes mounting clamps for I.V. pole. CE marking - complies with EN 60-601.1. 230 V ~ - 50/60 Hz (110 V on request).
Note that the expiry date is written on the packaging (set can be used for 5 years from the manufacturing date also written on the peel-open pouch). All sets are designed and controlled by Fresenius in order to guarantee the performances and the safety features of our pumps. The manufacturing is done by Fresenius (CE0123, CE0459) or by its qualified subcontractors (CE0123, CE0318) for and on behalf of Fresenius in exclusive distribution. The CE certificates are available on request.
Power Link - cat # : 073430. To connect a POWER FIX 2 to a POWER FIX 2 or 4 together.
Installation with 2 POWER FIX 2, 1 POWER LINK ; 1 ROLLING STAND 180 (cat # 073070)
- 13 -
Conditions of guarantee
Fresenius Vial guarantee that this product is free from defects in materials and workmanship (excluding batteries and accessories) for a period of one year from the date of invoice. If you comply to benefit from the materials and workmanship guarantee from our After-Sales Service or an agent authorised by Fresenius Vial, the following conditions must be respected:
T T T T
The device must have been used according to the instructions in this Operators Guide. The device must not have been damaged when in storage, at the time of repair, or show signs of improper handling. The device must not have been altered or repaired by non-qualified personnel. The serial number (ID/N) must not have been altered, changed, or erased.
In case of non-respect of these conditions, Fresenius Vial will prepare an estimate for repair covering the parts and labour required. Where return and repair of a device is necessary, please contact Fresenius Vial Customer or After-Sales Department.
- 14 -
Notes
- 15 -
Useful addresses
All requests for information or documentation (technical files, tubing sets catalogue or brochures) must be sent to:
Fresenius Vial Le Grand Chemin F-38590 BREZINS (France) Tel: +33 (0)4 76 67 10 10 Fax: +33 (0)4 76 67 11 34
This Operators Guide may contain inaccuracies or typographical errors. Modifications may thus be made and will be included in later editions. As standards and equipment change from time to time, the features shown and described in this document must be confirmed by our departments. This Operators Guide may not be reproduced in whole or in part without the written consent of Fresenius Vial. Fresenius Vial - sige social : Le Grand Chemin - F-38590 BREZINS (FRANCE).