SECTION 5
CALIBRATION PROCEDURES
The purpose of these procedures is to provide instructions and
acceptance/rejection criteria to calibrate the e360 Ventilator.
This section describes how to use the e360 Ventilator’s Diagnostic
Mode to calibrate the e360 ventilator. The Diagnostic Mode can
also be used for troubleshooting (see Section 3 for more
information on troubleshooting).
WARNING An authorized Newport Medical Instruments factory-
trained service technician must perform all service and repairs
on the e360 Ventilator.
WARNING Hazardous voltages are present inside the e360
ventilator. Disconnect electrical power, air, and oxygen sources
before attempting any disassembly. Failure to do so could
result in injury to service personnel or damage to equipment.
NOTE: To prevent damage from ESD and possible failure of the
e360 ventilator, ALWAYS use standard anti-static practices when
working inside the e360 ventilator, handling circuit boards or
handling any other electronic components.
Calibration Equipment
Verify that all test equipment is in current calibration status. To
calibrate the e360 Ventilator you will need the following:
• NMI Reusable Breathing Circuit (PBC340A) or equivalent
• Cap to plug the end of the breathing circuit (CAP100P) or
equivalent
• Clean, dry regulated medical air and oxygen supplies at 50
±2 psig.
NOTE: To perform the calibration procedures correctly, the gas
supply pressure must be regulated to 50 ±2 psig. The gas supplies
can support a minimum constant flow of 180L/min.
• Power Source of 100 – 240VAC, 50/60 Hz.
• High Pressure Gauge for reading from 0 – 60 psig, or
equivalent.
• Low Pressure Gauge for reading from 0 – 200 cmH2O, or
equivalent.
• Calibrated pressure syringe; NMI tool (TOL1952P) or
equivalent.
SER360 A1106 5-1
CALIBRATION PROCEDURES
• 1/4 inch Open-ended Wrench
• 5/16 inch Open-ended Wrench
• Medium size flat head screw driver
Caution The accuracy of all test equipment (electronic or
pneumatic) used for verification or calibration procedures
should be certified annually by a testing laboratory before
use.
SETUP Oxygen Supply
Air Supply
Figure 5-1 e360 Ventilator Connected to Gas Sources
1 Visually inspect the e360 ventilator for cosmetic defects,
damage or missing items.
2 Before removing the Top Cover, unplug the e360 ventilator
from the AC power and gas sources.
3 Remove the 6 screws on the Back Panel that secures the Top
Cover to the e360 ventilator. Remove the Top Cover, see
Section 4, “Removal of Top Cover”.
4 Reconnect the AC power to the e360 ventilator.
5 Connect both air and oxygen supply gas sources to the e360
ventilator, verify supply gas sources are at 50 ±2 psig.
6 Prior to starting the calibration procedure, verify that all test
equipment is in current calibration status.
5-2 SER360 A1106
SECTION 5
Diagnostic Mode
Most of the calibrations on the e360 ventilator are performed in the
Diagnostic Mode. The Diagnostic Mode enables you to perform
Servo Valve Calibration, Exhalation Valve Calibration, and
Regulator Calibration.
Table 5-1 Diagnostic Mode
Diagnostic Mode Calibration
D0 N/A
D1 Air Servo Valve Calibration
D2 Oxygen Servo Valve Calibration
D3 Manual Flow Adjustment
D4 Exhalation Servo Valve Calibration
D5 Analog PCB Calibration
D6 N/A
D7 N/A
D8 N/A
D9 Exhalation Flow Sensor Calibration
Entering Diagnostic Mode
To enter Diagnostic Mode use the following instructions:
1 Confirm the e360 ventilator is OFF and connected to AC power.
2 Press and hold the “Accept” button and turn ON the power.
3 Release the “Accept” button when NMI Logo Screen is displayed.
4 Wait for few minutes until the Software Download/Diagnostics
Mode Screen is displayed, see Figure 2-11.
5 Press “Start Diagnostics” on the LCD touch screen, see
Figure 2-11. After short beeps, Diagnostic Data Screen will be
displayed.
PROCEDURES .
Most calibrations rely on the Analog PCB being accurately
calibrated first. The Analog PCB has five (5) Transducers and
each one must be calibrated according to the procedure in this
Section. After the Analog PCB has been properly calibrated,
proceed with the rest of the calibrations.
To perform the calibrations successfully, it is very important that
the air and oxygen gas supply are regulated to 50 ±2 psig and that
SER360 A1106 5-3
CALIBRATION PROCEDURES
the supply is capable of supporting a minimum of 180 L/min of
constant flow.
Attach the patient circuit to the e360 ventilator.
NOTE: Observe ESD precautions throughout the following
procedures for Analog PCB and Pneumatics Calibrations:
Analog PCB Calibration: d5
To locate the transducers on the Analog PCB, see Figure 5-2, below.
1
Panel and “0” will be displayed in the “Flow/t Insp” window
“d0” will be displayed in the “Trig” window on the Control
when the e360 ventilator enters into the Diagnostics Mode.
2 Press the button below the “Trig” window, then the display
will start blinking.
3 While the display is blinking, turn the Adjustment Knob to
change the setting from “d0” to “d5”. Then press the
“Accept” button to acknowledge.
NOTE: Steps 4 to 14 are to calibrate zero pressure offset of
the Exhalation drive pressure transducer XD107.
4 Remove the ORANGE tubing from transducer XD107 on the
Analog PCB.
5 Press the “Manual Inflation” button to start the offset
calibration. The Message ID will change to “25”. Refer to
Table 5-5 for the descriptions of all message ID’s.
6 Verify the setting of “t Insp” is “0”. If not, press the button below
“Flow / t Insp” window, then the display will start blinking.
7
adjust the setting of “t Insp” to “0”, and then press the
While the display is blinking, turn the Adjustment Knob to
“Accept” button to acknowledge.
8 Press the button below “Resp Rate” window, then the display
will start blinking.
9 While the display is blinking, turn the Adjustment Knob to
change the setting to any value, and then press the “Accept”
button to acknowledge.
10 After the “Accept” button is pressed, the value of “Drive
Pressure” displayed on the LCD touch Screen will change.
5-4 SER360 A1106
SECTION 5
11 As the setting of “Resp Rate” increases, the value of “Drive
Pressure” will decrease after the “Accept” button is pressed.
12 As the setting of “Resp Rate” decreases, the value of “Drive
Pressure” will increase after the “Accept” button is pressed.
13 When the setting of “Resp Rate” is “0”, which cannot be
further decreased, consequently the value of “Drive Pressure”
“Resp Rate” to a high value and then decrease it. Always
cannot be increased. In this case, first increase the setting of
press “Accept” button when the adjustment of the “Resp Rate”
setting is made.
14 Repeat steps 8 to 13 to obtain drive pressure of 3.00 cmH2O
± 0.05cmH2O, then press “Manual Inflation” button to
acknowledge. The Message ID will change to “26”.
NOTE: Steps 15 to 25 are to calibrate the gain of the
Exhalation drive pressure transducer XD107.
15 Press the button below “Flow / t Insp” window, then the
display will start blinking.
16 While the display is blinking, turn the Adjustment Knob to set
the value of “t Insp” to “1”, and then press the “Accept”
button to acknowledge.
17 Use a pressure syringe to apply a pressure of 110 ± 1 cmH2O
to the bottom port of transducer XD107. (Tee in a pressure
gauge 0 to 200 cmH2O to insure accurate pressure delivery).
18 Press the “Manual Inflation” button to start the gain
calibration. The Message ID will change to “25”.
19 Press the button below the “Resp Rate” window, then the
display will start blinking.
20 While the display is blinking, turn the Adjustment Knob to change
the setting to any value, then press the “Accept” button.
21 After the “Accept” button is pressed, the value of “Drive
Pressure” displayed on the LCD touch Screen will change.
22 As the setting of “Resp Rate” increases, the value of “Drive
Pressure” will increase after the “Accept” button is pressed.
23 As the setting of “Resp Rate” decreases, the value of “Drive
Pressure” will decrease after the “Accept” button is pressed.
24 Repeat steps 19 to 23 to obtain drive pressure of 110.0
cmH2O ± 1.0 cmH2O, then press “Manual Inflation” button
to acknowledge. The Message ID will change to “26”.
SER360 A1106 5-5
CALIBRATION PROCEDURES
25 Remove the pressure and then connect the ORANGE tubing
back to the bottom port of transducer XD107.
26 To calibrate the zero pressure offset of Machine 2 pressure
transducer XD106, repeat steps 4 to 14, except for the
following difference.
a. In step 4, remove GREEN tubing from transducer
XD106.
b. In step 7, adjust the setting of “t Insp” to “2”.
c. In step 14, calibrate the value of “Machine 2” to 0.00 ±
0.05 cmH2O.
27 To calibrate the gain of Machine 2 pressure transducer
XD106, repeat steps 15 to 25, except for the following
difference.
a. In step 16, adjust the setting of “t Insp” to “3”.
bottom port of transducer XD106.
b. In step 17, apply a pressure of 110 ± 1 cmH2O to the
c. In step 25, connect GREEN tubing back to the bottom
port of transducer XD106.
28 To calibrate the zero pressure offset of Machine 1 pressure
transducer XD105, repeat steps 4 to 14, except for the
following difference.
a. In step 4, remove CLEAR tubing from transducer
XD105.
b. In step 7, adjust the setting of “t Insp” to “4”.
c. In step 14, calibrate the value of “Machine 1” to 0.00
± 0.05 cmH2O.
29 To calibrate the gain of Machine 1 pressure transducer
XD105, repeat steps 15 to 25, except for the following
difference.
a. In step 16, adjust the setting of “t Insp” to “5”.
the top port of transducer XD105 and the bottom port
b. In step 17, apply a pressure of 110 ± 1 cmH2O to both
of transducer XD106.
c. In step 25, connect CLEAR tubing back to the top port
of transducer XD105 and connect GREEN tubing back
to the bottom port of transducer XD106.
5-6 SER360 A1106
SECTION 5
Note: If pressure is only applied to transducer XD105 during this
calibration, Device Alert will occur when the pressure to XD105 is
20cmH2O higher than the pressure to XD106. Device Alert can be
only cleared by turning OFF and ON the e360 ventilator.
30
pressure transducer XD102, repeat steps 4 to 14, except
To calibrate the zero pressure offset of Air Gas Supply
for the following difference.
a. In step 4, remove YELLOW tubing from transducer
XD102.
b. In step 7, adjust the setting of “t Insp” to “6”.
c. In step 14, calibrate the value of “Air Gas Supply” to
0.0 + 0.1 psig.
31 To calibrate the gain of Air Gas Supply pressure transducer
XD102, repeat steps 15 to 25, except for the following
difference.
a. In step 16, adjust the setting of “t Insp” to “7”.
of transducer XD102.
b. In step 17, apply a pressure of 25psig to the top port
c. In step 24, calibrate the value of “Air Gas Supply” to
25.0 ± 0.1 psig.
d. In step 25, connect YELLOW tubing back to the top
port of transducer XD102.
32 To calibrate the zero pressure offset of Oxygen Gas Supply
pressure transducer XD103, repeat steps 4 to 14, except for
the following difference.
a. In step 4, remove BLUE tubing from transducer XD103.
b. In step 7, adjust the setting of “t Insp” to “8”.
c. In step 14, calibrate the value of “Oxygen Gas
Supply” to 0.0 + 0.1 psig.
33 To calibrate the gain of Oxygen Gas Supply pressure
transducer XD103, repeat steps 15 to 25, except for the
following difference.
a. In step 16, adjust the setting of “t Insp” to “9”.
of transducer XD101.
b. In step 17, apply a pressure of 25psig to the top port
SER360 A1106 5-7
CALIBRATION PROCEDURES
c. In step 24, calibrate the value of “Oxygen Gas
Supply” to 25.0 ± 0.1 psig.
d. In step 25, connect BLUE tubing back to the top port
of transducer XD103.
34 Turn OFF the power, and then disconnect the Air and O2 gas
supplies and AC power.
Figure 5-2 Analog PCB
5-8 SER360 A1106
SECTION 5
Table 5-2 Zero Offset Calibration
ZERO SETTING
TRANSDUCER LCD t Insp PRESSURE TOLERANCE TUBE COLOR
ID DISPLAY
XD107 Drive 0 3.00 cmH2O ±0.05 Orange
Pressure
XD106 Machine 2 2 0.00 cmH2O ±0.05 Green
XD105 Machine 1 4 0.00 cmH2O ±0.05 Clear
XD102 Air Gas 6 0.0 psig ±0.1 Yellow
Supply
XD103 O2 Gas 8 0.0 psig ±0.1 Blue
Supply
Table 5-3 Gain Calibration
GAIN SETTING
TRANSDUCER LCD t Insp PRESSURE TOLERANCE DESIGN TUBE
ID DISPLAY ATION COLOR
XD107 Drive 1 110 cmH2O ±1.0 Bottom Orange
Pressure Port
XD106 Machine 2 3 110 cmH2O ±1.0 Bottom Green
Port
XD105 Machine 1 5 110 cmH2O ±1.0 Top Port Clear
XD102 Air Gas 7 25 psig ±0.1 Top Port Yellow
Supply
XD103 O2 Gas 9 25 psig ±0.1 Top Port Blue
Supply
Pneumatics Calibration
NOTE: Before proceeding with the pneumatics calibration, the
Analog PCB in the e360 ventilator must be previously calibrated.
NOTE: To calibrate Air/Oxygen Inlet Regulators, and Safety
Regulator, use Diagnostic Mode “d3”: Manual Flow Adjustment.
Air Inlet Regulator
1 Connect the Air and Oxygen gas supplies and AC power to
the e360 ventilator.
2 Turn ON the power to the e360 ventilator.
3 Enter the Diagnostics Mode following the procedure “Entering
Diagnostics Mode” in this Section.
SER360 A1106 5-9
CALIBRATION PROCEDURES
4 Press the button below the “Trig” window then the display will
start blinking.
5 While the display is blinking, turn the Adjustment Knob to
change the setting from “d0” to “d3”. Then press the “Accept”
button to acknowledge. The Message ID will change to “11”.
6 Press the button “Select” above the “Flow/t Insp” window
and press the “Accept” button to select Flow.
7 Press the “Manual Inflation” button to enable manual flow
adjustment. The message ID will change to “12”.
8 Press the button below the “Flow / t Inst” window then the
display will start blinking.
9 While the display is blinking, turn the Adjustment Knob to
change the setting from “0” to “3”. Then press the “Accept”
button to acknowledge. This is to obtain a flow of 3 L/min.
10 Verify the value of “Air Gas Supply” is 15.5 ±0.5 psig. Adjust
the Air Inlet Pressure Regulator if not within specification.
11 To adjust the Air Inlet Pressure Regulator, use a 5/16” open-
ended wrench to loosen the bottom lock nut (see Figure 5-3).
Using a 1/4” open-ended wrench, rotate the top adjustment
bolt to adjust the pressure. Rotate the bolt clockwise to
increase the pressure and counter clockwise to decrease the
pressure. When the value of “Air Gas Supply” is 15.0 ±0.5
psig, secure the bottom lock nut.
Lock nut
Adjustment bolt
Figure 5-3 Air/Oxygen Pressure Regulators Adjustment
12 Adjust Flow as shown below and verify that the expected
regulated pressure for each flow setting is within tolerance.
5-10 SER360 A1106
SECTION 5
Table 5-4 Air Flow and Pressure Settings
Flow Setting Air Inlet Pressure
3 L/min 15.0 to 16.0 psig
100 L/min 12.0 to 14.5 psig
180 L/min > 9.5 psig
Oxygen Inlet Regulator
1 While still in Diagnostic Mode “d3”, adjust FIO2 to 100%
oxygen and adjust Flow to 3 L/min.
2 Adjust the oxygen inlet regulator pressure to 15.5 ±0.5 psig.
3 To adjust the Oxygen Inlet Pressure Regulator, refer to the
above “Air Inlet Regulator”, step 9.
4 Adjust Flow as shown below and verify that the expected
regulated pressure for each flow setting is within tolerance.
Table-5-5 Oxygen Flow and Pressure Settings
Flow Setting Oxygen Inlet Pressure
3 L/min 15.0 to 16.0 psig
100 L/min 12.0 to 14.5 psig
180 L/min > 9.5 psig
5 Adjust Flow to 0 L/min and FIO2 to 21% after the calibration is
completed.
Exhalation Servo Regulator
1 Take the ORANGE tubing from the Exhalation Servo Valve
port “IN” and connect to a high pressure gauge, see Figure
5-4.
2 Use a flat head screw driver to adjust the Exhalation Servo
Regulator, which is located near the Exhalation Servo Valve,
between 15.0 and 15.5 psig.
3 Reconnect the ORANGE tubing to the Exhalation Servo Valve
port “IN”.
SER360 A1106 5-11
CALIBRATION PROCEDURES
Orange
Tubing to
Exh. Servo
Val. Port “IN”
Exh. Servo Val.
Exh. Servo
Regulator
Safety
Regulator
Figure 5-4 Exhalation Servo / Safety Regulators
Safety Regulator
1 While still in Diagnostics Mode “d3”, adjust Flow to 3 L/min.
2 Connect a patient circuit to the e360 ventilator as shown in
Figure 6-1. (Test lung is not needed)
3 Disconnect the patient circuit from the Exhalation Valve, and
connect it to the Y-piece of the patient circuit, which is to form
a close loop.
4 Tee in a low pressure gauge in the patient circuit.
5
see Figure 5-4, to obtain 140 ± 5 cm2HO of “Machine 1”
Use a flat head screw driver to adjust the Safety Regulator,
pressure displayed on LCD touch screen.
6
the value of “Machine 1” pressure.
Verify the reading of the pressure gauge is within 2 cmH2O of
7
press “Manual Inflation” button to disable manual flow
Adjust Flow to 0 L/min after the calibration is completed. Then
adjustment. The “Message ID” will change to “13”.
Air Servo Valve: d1
Caution: Do not attempt to perform Air Servo Valve calibration
unless instructed by NMI Representative or for one of the
following conditions:
•Replacement or readjustment of Air Inlet Regulator
•Replacement of Air Servo Valve
•Replacement of Analog PCB
•Replacement of Main PCB
5-12 SER360 A1106
SECTION 5
Caution: Do not attempt to perform Air Servo Valve calibration
unless the air gas supply is regulated to 50 ± 2 psig and capable
of supporting a minimum of 180 L/min of constant flow.
1 Set the e360 ventilator to Diagnostics Mode “d1”.
2 Disconnect the patient circuit from the e360 ventilator.
3 Press the “Manual Inflation” button to initiate Air Servo Valve
calibration. The e360 ventilator will go through a calibration
maneuver that slowly increases and then decreases flow twice.
4 The value of “TSI Air Flow” displayed on LCD touch screen
will slowly change as the delivered flow changes.
5
“Message ID” changes to “6”.
Wait for several minutes to complete the calibration until the
Note: If the “Message ID” shows “7” during this calibration, the Air
Servo Valve needs to be replaced.
Oxygen Servo Valve: d2
Caution: Do not attempt to perform Oxygen Servo Valve
calibration unless instructed by a NMI Representative or for one
of the following conditions:
•Replacement or readjustment of Oxygen Inlet Regulator
•Replacement of Oxygen Servo Valve
•Replacement of Analog PCB
•Replacement of Main PCB
Caution: Do not attempt to perform Oxygen Servo Valve
calibration unless the oxygen gas supply is regulated to 50 ± 2
psig and capable of supporting a minimum of 180 L/min of
constant flow.
1 Set the e360 ventilator to Diagnostics Mode “d2”.
2 Disconnect the patient circuit from the e360 ventilator.
3 Press the “Manual Inflation” button to initiate Oxygen Servo
Valve calibration. The e360 ventilator will go through a
calibration maneuver that slowly increases and then
decreases flow twice.
4 The value of “TSI O2 Flow” displayed on LCD touch screen
will slowly change as the delivered flow changes.
5
“Message ID” changes to “10”.
Wait for several minutes to complete the calibration until the
Note: If the “Message ID” shows “7” during this calibration, the
Oxygen Servo Valve needs to be replaced.
SER360 A1106 5-13
CALIBRATION PROCEDURES
Exhalation Flow Sensor: d9
1 Turn OFF the e360 ventilator.
2
Standby” screen is displayed.
Turn ON the e360 ventilator and wait until the “Ventilation
3 Connect the patient circuit to the e360 ventilator as shown in
Figure 6-1.
4 Occlude the patient circuit at the Y-piece using a cap. A filter
and test lung is not required for this calibration.
5 Press “CIRCUIT CHECK” on LCD touch screen to perform
the circuit check. Confirm that the circuit check passes.
6
Sensor” to start Exhalation Flow Sensor calibration. It may
Press “SENSORS” on LCD touch screen, and press “Flow
require performing several times in order to pass the
Exhalation Flow Sensor calibration.
7 Turn OFF the e360 ventilator and turn ON while pressing and
holding “Accept” button to enter Diagnostics Mode.
8 Set the e360 ventilator to Diagnostics Mode “d9”.
9 With patient circuit occluded, press “Manual Inflation” button
to start Exhalation Flow Sensor calibration in Diagnostics Mode.
The Message ID will change to “63”.
10 Wait for several minutes to complete the calibration until the
“Message ID” changes to “41”.
Exhalation Servo Valve: d4
1 Set the e360 ventilator to Diagnostics Mode “d4”.
2 With patient circuit occluded, press the “Manual Inflation”
button once. The “Message ID” will change to “35”.
3
calibration, now the “Message ID” will change to “15”.
Press the “Manual Inflation” button again to start the
4 Wait for several minutes to complete the calibration until the
“Message ID” changes to “20”.
5-14 SER360 A1106
SECTION 5
Table 5-6 Descriptions of Message ID
D1: Air Servo Valve Calibration
ID Meaning
4 Hit Manual Inflation Button to Start Air Servo Valve Calibration
5 Calibrating Air Servo Valve
6 Air Servo Valve Calibration Completed
7 Calibration Failed: Valve Leaks more than 50 cc
D2: Oxygen Servo Valve Calibration
ID Meaning
8 Hit Manual Inflation Button to Start Oxygen Servo Valve Calibration
9 Calibrating Oxygen Servo Valve
10 Oxygen Servo Valve Calibration Completed
7 Calibration Failed: Valve Leaks more than 50 cc
D3: Manual Flow Adjustment
ID Meaning
11 Hit Manual Inflation Button to Enable Manual Flow Adjustment
12 Adjust Flow Setting
13 Manual Flow Adjustment Disabled
D4: Exhalation Valve Calibration
ID Meaning
14 Hit Manual Inflation Button to Enable Exhalation Valve Calibration
35 Occlude the Patient Circuit and Hit Manual Inflation Button Again to Start Exhalation Valve
Calibration
15 Calibrating Exhalation Valve
20 Exhalation Valve Calibration Completed
16 Exhalation Valve Calibration Failed: Proximal Pressure Less than 1cmH2O when Exhalation
Valve Closed
17 Exhalation Valve Calibration Failed: Proximal Pressure High than 1cmH2O when Exhalation
Valve Opened
18 Exhalation Valve Calibration Failed: Proximal Pressure Low than Target Pressure
19 Exhalation Valve Calibration Failed: Test Flow Less than 1L/min
D5: Analog Board Calibration
ID Meaning
21 Hit Manual Inflation Button to Start Analog Board Calibration
25 Analog Board Calibration Enabled
26 Analog Board Calibration Disabled
SER360 A1106 5-15
CALIBRATION PROCEDURES
D9: Exhalation Flow Sensor Calibration
ID Meaning
2 Occlude the Patient Circuit and Hit Manual Inflation Button to Start Exhalation Flow Sensor
Calibration
63 Calibration Exhalation Flow Sensor
41 Exhalation Flow Sensor Calibration Completed
59 Exhalation Flow Sensor Failed: Sensor Bad
60 Exhalation Flow Sensor Calibration Failed: No Flow Detected
Note: Proximal pressure is the average pressure of Machine 1 and Machine 2 pressure
5-16 SER360 A1106