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Electrical safety test: If required by Customer record measured values additional to the PMS
Checklist in the following form "Electrical Safety Test Form Babylog 8000".
Caution: Service, Inspection and Calibration are to be performed by Drger trained and authorized
Service Personnel only!
Note: Test Equipment for this procedure is listed in the document "Test equipment for CCS devices".
DO NOT USE any test equipment having an expired calibration date.
Warning: During Service and Inspection some systems may be disconnected. Ensure these systems
are reconnected, test equipment is removed and all covers are replaced after testing!
Note: If only expiratory valves are to be tested perform test item 1.4, 2.1.1, 2.1.2, 5.6.1, 5.6.2, 6.1
and 6.3.
Contents:
1.1 Labeling
Note: If only expiratory valves are to be tested perform in addition test item 2.1.1, 2.1.2,
5.6.1, 5.6.2, 6.1 and 6.3.
1.7.2 New trolley P/N 84 18 097 as of 1999 with 4 castors (if available)
Check for damage
Check casters: 2 castors are lockable, casters not damaged and dirty,
check tightness of screw connections with 25 Nm (18.4 lb-ft)
Check humidifier holder P/N 84 11 956
Babylog is secured with 2 fixing screws P/N 2M 17 338
Kit PMS 6 month - Babylog 8000 with 2 Expiration Valves, P/N 41 14 763
1 x Filter 83 05 367
2 x Diaphragm 84 09 184
Kit PMS 24 month - Babylog 8000 with 2 Expiration Valves, P/N 41 14 764
1 x Kit PMS 6 month 41 14 763
2 x Filter 84 08 208
1 x Flat packing gasket 84 08 204
3 x Lip seals 84 08 442
1 x Battery 83 01 856
6 x O-Ring R 50 121
Kit PMS 72 month - Babylog 8000 with 2 Expiration Valves, P/N 41 14 765
1 x Kit PMS 24 month 41 14 764
1 x Diaphragm 84 03 352
1 x Diaphragm 84 10 181
1 x Seal disc 84 09 823
1 x Pneumatic micro switch 84 07 265
2 x Pressure regulator 84 09 199
2 x O-Ring D 19 080
2 x O-Ring M 23 154
When What
1/2 , 1, 1.5 years P/N 41 14 763
2 years P/N 41 14 764
2.5, 3, 3.5 years P/N 41 14 763
4 years P/N 41 14 764 and P/N 18 28 142 (TK-RAM)
4.5, 5, 5.5 years P/N 41 14 763
6 years P/N 41 14 765
6.5, 7, 7.5 years P/N 41 14 763
8 years P/N 41 14 764 and P/N 18 28 142 (TK-RAM)
8.5, 9, 9.5 years P/N 41 14 763
10 years P/N 41 14 764
10.5, 11, 11.5 years P/N 41 14 763
12 years P/N 41 14 765 and P/N 18 28 142 (TK-RAM)
2.2.1 Battery
Replace battery P/N 83 01 856 behind fan cover on the back of the Babylog every 2 years.
Note: Electrostatically sensitive component! Use proper ESD controls!
2.2.2 Time-Keeper-RAM
Replace Time-Keeper-RAM P/N 18 28 142 on the PCB CPU every 4 years.
Note: Electrostatically sensitive component! Use proper ESD controls!
Read out the following data in the operating mode before replacing T-K-RAM:
Operating hours
Interface configuration (if option is installed)
Flow sensor settings (SW 5.0 only):
Y or ISO and NTPD or BTPS
After replacing the T-K-Ram re-enter the following data in the operating mode:
Note: Testing the opening pressure of emergency breathing valve D3.1 with filter F3.1 at a
negative flow of 1 L/min. There are two different valves installed for units with HFV
(2 to 4 cmH2O) or without HFV (0 to 4 cmH2O) option. The HFV option is only available in
Canada.
Switch on Babylog and read out if the HFV option (as of SW 4.n, for Canada only) is
installed.
Inspiratory Unit
F3.1
D3.1
Using the syringe in the test set-up, draw a volume of 50 mL within 3 1 seconds out of the
inspiratory nozzle.
Test values
Note: Testing the opening pressure (0 to 10 cmH2O) of safety valve Y3.3 at a flow of 1 L/min
during emergency phase or power off.
0 mbar /
c mH2 O
Y3 . 3
I ns pi r a t o r y Uni t
Pump a volume of 50 mL into the inspiration nozzle within 3 1 seconds using the syringe.
Note: If the displayed value is too high refer to TSB Babylog 8000 # 1.
Note: Testing the opening pressure (0 to 10 cmH2O) of safety valve Y3.3 at a flow of 1 L/min
simulated for operation. The valve Y3.3 is triggered by pressure relief valve D4.1 and should
be supplied with 21.75 psi.
1 . 5 ba r / 100 mbar /
2 1 . 8 ps i 102 cmH2 O
Y3 . 3
D4 . 1
I ns pi r a t o r y Uni t
Pump a volume of 50 mL into the inspiration nozzle within 3 1 seconds using the syringe.
Test value displayed on reference pressure gauge: 92 to 112 cmH2O (90 to 110 mbar).
Note: If the displayed value is too high refer to TSB Babylog 8000 # 1.
Remove test equipment, reconnect the original hose at the pressure relief valve and re-
assemble side cover.
Assemble device ready for operation including patient circuit system and test lung
P/N 84 09 742 (Bellows K, complete) but without humidifier.
Software version
Operating hours
Option Communication
Option PSV/VG (as of SW 5)
Option LFT (as of SW 5)
Option HFV (as of SW 4, for Canada only)
Note for SW 5.0 only: For best flow measurement accuracy select type of flow sensor to be
calibrated (Y or ISO) and reference conditions (NTPD or BTPS) before and then calibrate
flow measurement.
Y: Flow sensor integrated into Y-piece
ISO: ISO flow sensor connected between Y-piece and ET-tube connector
NTPD: Temperature at 20C, barometric pressure at 760 mmHg, dry air
BTPS: Body temperature, barometric pressure at 767 mmHg, saturated air
Note: Testing all LEDs and audible alarm sound generator for power failure.
All LEDs and the audible back-up horn are actuated after 2 seconds.
Note: Using the service mode allows individual settings to be made, test routines to be
started, and all sensor values to be displayed.
Do not connect any patient circuit system to the insp. and exp. nozzles during call up of
diagnosis mode.
Operation in the service mode with SW 2, 3, and 4 is to be confirmed in each case within 2
minutes using the key "Alarm silence", otherwise restart with error message "823".
The errors "002", "800", "801", "804" "805" or "823" can be ignored in the service mode.
Note: In the language setting "American" pressure readings in the diagnosis mode are listed
in psi and cmH2O, in other languages they are listed in bar and mbar. Both versions are used
for displayed values and test equipment in this document.
Babylog is in the service mode, press softkeys "Electronics" and then "User interface".
The key pressed (except right return softkey) is shown on the display.
Note for SW 2, 3, and 4: Press key "Alarm silence" twice or system will reset to normal
operation.
Note: Testing LCD/ELD for proper function, all displayed data are visible. Only single pixel
faults are allowed if they do not effect the displayed data.
Note: The potentiometers are read out from the master and the monitoring CPU system.
Both values are tested in 3 different settings of all 6 potentiometers. The values must be in
the permissible deviation.
Babylog is in the service mode, press softkeys "Electronics", "User interface" and then
"3 Potentiometer".
Test values:
Note: Check for proper configuration in line with installed software version, for software
version 3.n and 4.n also in line with present scaling of PEEP/CPAP potentiometer.
Babylog is in the service mode, press softkeys "Electronics", "User interface" and then
"4 Option switches".
All versions 84 10 280 (see rating plate under Typ) with software version 5.0:
All versions 84 11 111 (see rating plate under Typ) with software version 5.0:
Bit 0 = fitted
Bit X = Option switch 2, jumper fitted or not fitted depending on scaling of
PEEP/CPAP potentiometer:
Bit 0 = fitted
Bit X = Option switches 2 and 3, jumper fitted or not fitted depending on scaling of
PEEP/CPAP potentiometer:
If there is a deviation please refer to TSB Babylog 8000 # 15 (SW5.0) or Repair Instructions
section Frontcontroller/Front PCB.
5.2 Pressure regulators and supply pressure sensors for Air and O2
Note: The supply pressure sensors for Air and O2 are absolute pressure sensors:
(displayed value = current ambient pressure + supply pressure).
With disconnected pressure supply the values must be at ambient pressure and the values
must be in the permissible deviation.
Test set-up:
Babylog is in the service mode, press softkeys "Pneumatics" and then "Meas.".
Read out values PAir and PO2 from the supply pressure sensors at ambient pressure:
Note: If the displayed values PAir or PO2 are higher than the current ambient pressure it is
necessary to disconnect the hoses between the valve bank to the supply pressure sensors at
the valve bank. To do so open the pneumatics for this test, refer to "Opening the Babylog
8000" in the Repair Instructions Babylog 8000.
Test values:
Permissible difference between PAir and PO2 max. 1.4 psi (0.1 bar).
Permissible deviation between PAir and PO2 to a barometer max. 1.4 psi (0.1 bar),
or
Note down displayed values PAir and PO2 (current ambient pressure) for next tests.
Note: Testing of Air supply pressure sensor and Air pressure regulator with different settings
of flow. The displayed values are compared with a reference pressure gauge. This test set-
up can be used for adjusting the Air pressure regulator.
Note: The supply pressure sensor for Air is an absolute pressure sensor:
(displayed value = current ambient pressure + supply pressure).
With connected pressure supply the values must be at ambient pressure plus outlet pressure
of pressure regulator. The values must be in the permissible deviation.
Test set-up:
Connect pressure gauge (expected max. pressure 0 to 29 psi / 0 to 2 bar) to center lip seal
(outlet 5a).
DR1.2
O2
Y1.1
Y1.2
Y1.4
5a
P
O2-conc. = 21
Insp. Flow = 1
Pinsp = 80
Do not preset pressure set values with softkeys " " and " " (Pref = 0).
Test values:
Measured value of the reference pressure gauge: 23.20 to 24.65 psi (1.6 to 1.7 bar)
O2-conc. = 21
Insp. Flow = 30
Pinsp = 80
Do not preset pressure set values with softkeys " " and " " (Pref = 0).
Test value:
Measured value of the reference pressure gauge > 18.85 psi (> 1.3 bar)
Note: Testing of O2supply pressure sensor and O2 pressure regulator with different settings
of flow. The displayed values are compared with a reference pressure gauge. This test set-
up can be used for adjusting the O2 pressure regulator.
Note: The supply pressure sensor for O2 is an absolute pressure sensor:
(displayed value = current ambient pressure + supply pressure).
With connected pressure supply the values must be at ambient pressure plus outlet pressure
of pressure regulator. The values must be in the permissible deviation.
Connect pressure gauge (expected max. pressure 0 to 29 psi / 0 to 2 bar) to center lip seal
(outlet 5a).
DR1.2
O2
Y1.1
Y1.2
Y1.4
5a
P
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 1".
O2-conc. = 100
Insp. Flow = 1
Pinsp = 80
Do not preset pressure set values with softkeys " " and " " (Pref = 0).
Test values:
Measured value of the reference pressure gauge: 23.20 to 24.65 psi (1.6 to 1.7 bar)
O2-conc. = 100
Insp. Flow = 30
Pinsp = 80
Do not preset pressure set values with softkeys " " and " " (Pref = 0).
Test value:
Measured value of the reference pressure gauge > 18.85 psi ( > 1.3 bar)
Note: Testing outlet pressure of pressure regulators with no outlet flow. The maximum
pressure must not exceed the calculated limit.
Note: The supply pressure sensors for O2 and Air are absolute pressure sensors:
(displayed value = current ambient pressure + supply pressure).
Babylog is in the service mode, press softkeys "Electronics" and then "PC boards" and
then "9 PCB I/O".
Wait until the displayed values Control Press. Air and Control Press. O2 have reached
their maximum values.
Test values:
Displayed Control Press. Air (ambient pressure) + 30.5 psi (2.1 bar)
Note: Testing negative pressure of PEEP/PIP valve not electrical triggered. The negative
pressure is generated by the ejector in the PEEP/PIP valve and is depending on the value of
the supply pressure.
Test set-up:
Remove expiratory valve and measure pressure at the right lip seal (expected max. pressure
100 cmH2O).
s e c r et i on s i g ht
g l a ss 2 M0 75 8 2
O2-conc. = 21
Insp. Flow = 10
Pinsp = 80
Set unit of Pref to decimal values (dec.) by pressing the key "Cal. Config." (SW 5) or
"Monitoring" (SW 3 or 4).
Important: When performing this test PEEP/PIP valve must be in normal installation
position; Babylog is therefore not to be tilted!
Seal off center lip seal with finger (outlet 5a to the injector, see arrow) when performing next
measurements and settings.
Set displayed value of Pref to 0 with softkeys " " and " ".
Read out value PAir in the menu "Meas." and calculate relative supply pressure to PEEP/PIP
valve:
The reference pressure gauge must indicate the following test value depending on the
calculated supply pressure to the PEEP/PIP valve:
Note: Testing is performed for all metering valves on O2 and Air end by way of O2
concentration measurements in the service mode. The O2 concentration is measured with
the O2 sensor of the Babylog. The O2 measurement was calibrated in a previous test.
The set value is calculated in each case from the valve bank setting and supply pressure and
is displayed in the menu "Set. 2".
Valve bank
Y2.1 Y2.2 Y2.3 Y2.4 Y2.5 Y2.6 Y2.7 Y2.8 Y2.9 Y2.10
E
O2
Air
O2
Y2.11 Y2.12 Y2.13 Y2.14 Y2.15 Y2.16 Y2.17 Y2.18 Y2.19 Y2.20
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 2"
In the following tests switch on metering valve pairs with the same nominal value, all other
valves of the valve bank are switched off.
Note: The measured value from internal O2 measurement is displayed in "O2 = XXX.X%",
the calculated set value is displayed in "O2set = XX.X".
Note: When exceeding tolerances in the following 10 tests of valve pairs refer to
TSB Babylog 8000 # 5B and measure the outlet flow at the inspiratory nozzle.
Test values with Babylog 8000 switched off:
With connected compressed O2 only: max. flow = 10 mL/min
With connected compressed Air only: max. flow = 10 mL/min
Test value:
Test value:
O2 measured value = set value 3 % by Vol.
Test value:
O2 measured value = set value 3 % by Vol.
Test value:
O2 measured value = set value 3 % by Vol.
Test value:
O2 measured value = set value 3 % by Vol.
Test value:
O2 measured value = set value 4 % by Vol.
Test value:
O2 measured value = set value 5 % by Vol.
Test value:
O2 measured value = set value 10 % by Vol.
Test value:
O2 measured value = set value 20 % by Vol.
Note: The airway pressure sensors Pinsp. and Pexp. are relative pressure sensors
(displayed value = supply pressure).
5.5.1 Testing airway pressure sensors at ambient pressure and Bias voltages
Note: The bias voltages of the sensors Pinsp. and Pexp. are stored during self-test after
power on without pressure at the sensors and are used for the zero calibration of the airway
pressure sensors. This allows an accurate airway pressure measurement of the Babylog.
The bias voltages must be within the test values listed below.
Test set-up:
Babylog is in the service mode, press softkeys "Pneumatics" and then "Meas.".
Test values:
Test values:
Note: Testing linearity of airway pressure sensors Pinsp. and Pexp. in combination with
PEEP/PIP valve and expiratory valve with 3 different settings at a flow of 5 L/min. The values
are compared to a reference gauge.
Settings are carried out in menu "Set. 1" and measurements in menu "Meas.".The set value
to be adjusted is the value indicated on the reference pressure gauge and is set in menu
"Set. 1" with softkeys " " and " ".
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
Connect reference pressure gauge (expected max. pressure 100 cmH2O) between
inspiratory and expiratory nozzle. Use short ventilation hoses or hoses 7x2.5, 200 mm
between nozzles and Y piece:
5 L/ mi n
PI
E
P
E
PE
Set wi t h soft keys
PEEP/PIP- Pref
valve
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 1".
Adjust set value on reference pressure gauge to 20.0 cmH2O (19.6 mbar)
with softkeys " " and " ".
Test values:
Adjust set value on reference pressure gauge to 40.0 cmH2O (39.2 mbar)
with softkeys " " and " ".
Test values:
Adjust set value on reference pressure gauge to 80.0 cmH2O (78.4 mbar)
with softkeys " " and " ".
Test values:
Test set-up 1:
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
Remove expiratory valve. Connect pressure gauge to the right lip seal (expected max.
pressure 100 cmH2O).
s e c r e t i o n s i g ht
g l a ss 2 M 0 75 8 2
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 1".
O2-conc. = 21
Insp. Flow = 4
Pinsp = 80
Close center lip seal with finger (outlet 5a to the ejector, depressurized on reaching the
following setting).
Adjust value on reference gauge with softkeys " " and " " to 5.1 cmH2O (5 mbar).
V a lv e ba nk I n s p i r a t o ry b l o c k
4 L/ m in
E
PE
S e t w i t h s of t k ey s
P r ef
P E E P/ PI P
v a lv e
E x p i r a t o r y v a lv e
Test value:
Note: If the test value is out of tolerance, the crater in the expiratory valve must be adjusted
(use crater tool P/N 79 01 627):
Turn to the left increase PE
Turn to the right decrease PE
Turn by 90 PE of 2 to 3 cmH2O
Note: Test is performed by actuating the ejector and measuring the resultant vacuum with
expiration nozzle occluded.
Test set-up:
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
1.5bar/21.8psi
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 2".
Only switch on safety control valve Y1.2 (SaVal) and ejector control valve Y1.4 (Eject).
Test value:
5.7 O2 sensor
Note: Testing O2 sensor voltages. If the O2 sensor voltages are less than 10 mV, is it
advisable to replace the O2 sensor as the minimum sensor voltage of 9.2 mV at 21 % by Vol.
will soon be reached.
Test set-up:
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
Babylog is in the service mode, press softkeys "Pneumatics" and then "Set. 1".
O2-conc. = 21
Insp. Flow = 5
Pinsp = 80
Test value:
Babylog is in the service mode, press softkey "Electronics", "PCBs" and then
"10 PCB Comm".
Test set-up:
1
Short circuit Pin 2 and 3 of RS232 socket on back of
device with test connector RS232 P/N 79 01 885.
Test value:
Remove test connector and press softkey "Return " three times
Note: The "vector" information as well as the "Msn" menu is used by R&D only.
Assemble Babylog with patient system, flow sensor with flow sensor cable, and test lung
84 09 742 (bellows K) ready for operation.
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
O2-conc. = 21
Insp. Flow = 10
Tin = 0.4
Tex = 0.6
Pinsp = 20
PEEP/CPAP = 10
After power up, perform flow calibration and set the following MV (VE) alarm limits (note old
values and reset afterwards):
Note: Testing airway pressure build up and flow measurement in the mode CMV.
PEEP/CPAP = 0
Ventilate as set:
PEEP/CPAP = 10
6.2 Alarms
Note: Testing alarms by simulation. The displayed text messages may differ slightly
depending on the installed software version and the used language setting during this test.
Test values:
Switch on CMV.
Test values:
Test values:
O2-conc. = 60
Test values:
Reconnect O2 connector.
Reconnect O2 connector.
Insp. Flow = 2
Pinsp = 80
PEEP/CPAP = 0
Confirm setting.
Switch on CPAP
Keep "man. Insp." pressed. A pressure build-up takes place which is limited to 5 seconds.
Test value:
Within this period the pressure at the bar graph must reach 78 to 82 cmH2O.
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
Note: Testing tightness of one way check valve Y1.6 (nebulizer outlet) and resistance R1.1.
Test values:
Tightness of output
Testing: After 30 minutes the temperature of the patient section with the expiratory valve
must be higher than the room temperature (check by hand).
Note: Testing audible alarm and data back up in the TK-RAM on the CPU PCB.
Test value:
Continuous audible alarm should sound and remains at a constant volume for about 30
seconds.
Test value:
Call up volume adjustment via the menu, the function "alarm silence" must not be activated.
Test value:
In lowest volume setting the alarm tone must be perceptible at low background noise level.
Test set-up:
Short-circuit insp. and exp. nozzle with a ventilation hose or hose 7 x 2.5 (P/N 11 98 343 by
meter) 24 to 40 inch (0.6 to 1.0 m).
Connect O2 and Air pressure supply to Babylog 8000 (40 to 87 psi / 3 to 6 bar).
Frequ. = 20 Hz
Ampl. = 100 %
O2-conc. = 21
PEEP/CPAP = 3.0 (Check setting via menu "list" and "set 1")
Pinsp = 80
Test value:
Within 60 s the displayed P (Mean) pressure shall be 3.0 0.2 cmH2O
Test value:
Within 60 s the displayed P (Mean) pressure shall be 16 1 cmH2O
Test set-up:
Short-circuit insp. and exp. nozzle with a ventilation hose or hose 7 x 2.5 (P/N 11 98 343 by
meter) 24 to 40 inch (0.6 to 1.0 m).
Frequ. = 20 Hz
Ampl. = 100 %
O2-conc. = 21
PEEP/CPAP = 25
Pinsp = 80
Test value:
PIP (Peak) 40 cmH2O
Frequ. = 10 Hz
Test value:
PIP (Peak) 60 cmH2O
Note: A detailed instruction for electrical safety testing is given in the following documents:
"Babylog 8000, Electrical Safety Test in the USA and Canada according to UL2601-1
with Biotek Model 501 Pro "
"Babylog 8000, Electrical Safety Test in the USA and Canada according to UL2601-1
with DNI Nevada Model -Test 2000"
Select "Chassis resistance measurement" on the tester. Follow operating instructions of your
tester.
Perform 4 tests with the probe attached to the following test items of the Babylog 8000:
3) Fastening screw gas inlet block or bottom plate, back side of Babylog
4) Attach probe with an alligator clip to the potential ground stud of the power pack on the
back side of Babylog.
This is a measurement of the leakage current from the Chassis to earth ground.
Attach probe of the tester with an alligator clip to the potential ground stud of the power pack
on the back side of Babylog.
Switch on Babylog 8000 and allow the unit to complete the self-test.
This is a measurement of the leakage current flowing through the ground wire of the power
cord.
Select "Earth Leakage current measurement" on the tester. Follow operating instructions of
your tester.
Select "Patient Leakage current measurement" on the tester. Follow operating instructions of
your tester.
Short all pins of the flow sensor cable using the shorting plug P/N 79 01 772.
Plug the other end of the shorting plug into the tester.
Switch on Babylog.
Completely fill in the header information of the document PMS Checklist Babylog 8000.
If the Babylog 8000 passed all tests above in this document, fill out the
"PM CERTIFICATION" label (P/N S010006 with "Call 1-800-543-5047 for service" /
P/N S010007 w/o service number). Check box "Certified" and write the month and year,
(six month from date of PM Certification) next to "NEXT VISIT DUE".
Any Babylog 8000 not receiving a "PM CERTIFICATION" label shall receive a
"WARNING NOT CERTIFIED" label (P/N 4114857). This label shall be placed at a
prominent location after the previous "PM CERTIFICATION" label has been removed.
Have the Customer sign each PMS Checklist form and review the equipment conditions
with the Customer.
Return the top copy to Drger Medical, Inc Service Department, keep the middle copy for
service organization records, and give bottom copy to customer.