Recall Incubator 8000 series in the USA and Canada
Conversion Instructions Analog PCB for Field Service
and Feedback Form
Dear Customer,
You have received a repair kit for your Incubator 8000 series. Please read all
Conversion Instructions before you start the modification and use the Feedback Form
on page 6 to inform us about the device you have upgraded.
As a medical device manufacturer we are required to report the results of the corrective
action to the FDA and Health Canada, therefore a feedback form must be completed
for each Incubator modified. If you have any questions, please feel free to call Dräger
Medical, Inc. at 1 800 4 DRAGER and ask for Service.
Sincerely,
Andreas Lenke
Technical Product Manager
DrägerService
1Action to be taken:
• Installation of a modified Analog PCB.
• Installation of a new Software Version on units delivered prior to 1999.
• Follow up validation of replacement of CPU Incubator PCB according to
TSB Incubator 8000 IC/SC/NC # 12.
• Disconnection of the auxiliary fan on the Power Pack PCB according to
TSB Incubator 8000 IC/SC/NC # 17.
• Retrofitting of 2 warning labels according to TSB Incubator 8000 IC/SC/NC # 19.
Incubator 8000 seriesConversion Instructions Analog PCBNovember 7, 20001/6
for Field Service and Feedback Form
Dräger Medical, Inc.
2Parts needed for Conversion in the USA and Canada
2.1For Incubator 8000 IC with ThermoMonitoring and SW 21.n:
On units with ThermoMonitoring the sockets for the two skin temperature sensors are
located on the left side of the blue housing of the Incubator.
P/N 4116706-001, Contents of delivery:
• 1 piece Analog PCB P/N 2M 22 404, P/N 2M 22 405, P/N 2M 22 406,
P/N 2M 22 407, P/N SE 2M 22 404, P/N SE 2M 22 405, P/N SE 2M 22 406,
SE 2M 22 407, or 2M 22 382, or SE 2M 22 382
- Incubator 8000 IC/SC/NC, Electrical Safety Test in the USA and Canada
according to CAN/CSA - 22.2 No. 601.1 - M90
4Conversion Instructions for Units in the USA and Canada
4.1 Please fill out the feedback form during the modification. Some of the data is on
the parts that will be installed.
4.2 Observe ESD precautions
Electrostatic discharge may damage electrostatic sensitive devices. When
handling electrostatic sensitive devices, use always a static-dissipative mat
and a static-dissipative wrist wrap.
4.3If you modify an Incubator with a yellow skin-temperature socket on the left side
of the Incubator housing:
Please verify the correct setting of the skin temperature deviation alarm on the
received Analog PCB (P/N 2M 22 404, P/N 2M 22 405, P/N 2M 22 406,
P/N 2M 22 407, or 2M 22 382) according to the steps below (section 4.3.1 or
4.3.2).
4.3.1 For Incubator 8000 IC with ThermoMonitoring only (units with SW 21.n)
Set jumper configuration for X5 on the Analog PCB to:
1
8
1.0 °C
Incubator 8000 seriesConversion Instructions Analog PCBNovember 7, 20004/6
for Field Service and Feedback Form
Dräger Medical, Inc.
4.3.2 For Incubator 8000 SC/NC without ThermoMonitoring but with one socket for a
skin-temperature sensor on the left side of the Incubator housing:
Set jumper configuration for X5 on the Analog PCB to:
1
8
0.5 °C
Note: If necessary please take a jumper from the removed PCB Analog.
4.4For the installation of the Analog PCB and the EPROM use the attached
Please check before closing the Incubator's cover plate below the Control Unit:
- CPU PCB in the Control Module according to
TSB Incubator 8000 IC/SC/NC # 12.
- Disconnect the auxiliary fan (if available) on the Power Pack PCB in the
Control Module according to TSB Incubator 8000 IC/SC/NC # 17.
Please note: This is the only fan in the Control Unit.
4.5For testing electrical safety use the attached instructions "Incubator
8000 IC/SC/NC, Electrical Safety Test in the USA and Canada according to
CAN/CSA - 22.2 No. 601.1 - M90".
4.6Adhere 2 warning labels according to the enclosed instructions "Adhesive
statement 2M22363".
4.7Fill out feedback form and send it back by fax. Please send the original feedback
form back with the replaced parts.
5Address for sending back replaced parts
Please send back all replaced parts with RMA number as soon as possible to:
Dräger Service
3124 Commerce Drive
Trelford, PA 18969
Note: If no RMA # is available please call Customer Service at 1 800 4 DRAGER.
End of Conversion
Incubator 8000 seriesConversion Instructions Analog PCBNovember 7, 20005/6
for Field Service and Feedback Form
Dräger Medical, Inc.
Feedback Form Incubator 8000 series / Field Conversion
DrägerService
Andreas Lenke
3122 Commerce Drive
Telford, PA 18969
1-215-721-5789
Hospital name and address:
Name:
Department:
Street:
City:
Tel.:
Fax.:
Name of device:
❑
Incubator 8000 IC
❑
Incubator 8000 SC
❑
Incubator 8000 NC
This is to confirm the following conversion of the Incubator:
❑
The following updated PCB Analog has been installed:
• Perform the "skin-temperature measurement" conversion only if the
Incubator8000IC/SC/NC is equipped with a skin-temperature module.
1.1.1Incubator8000 IC/SC/NCwithskin-temperature control
Function: Skin-temperaturecontrol
>37 °C
Control
Control
>37 ˚C
Check
Alarm Inop.
°C LUFT/AIR
°C
±1,5 °C
Sensor
°C
Reset
% FEUCHTE/HUMID.
%
%
H O
2
Sensor
Control
Control
VOL.%O
Vol.%
O
± 5 Vol.%Sensor
Skin-temperaturemodule
2
2
Vol.%O
ControlCal.>40%
2
>40%
Cal.
Control
21%
C HAUT/SKIN/PEAU/PIEL
°C
°C
± 0,5 °C
Check36 °C
Sensor
Control
Control
±0,1
Fig.1:Frontview of the Incubator's controlunit withskin-temperature control
U-Inkubator8000IC-SC-NC.fm 17.08.00
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page1 of 17
Dräger Medizintechnik
1.2Conversion Procedure
1.Move electrical height adjustment (optional) of the Incubator 8000 IC/SC/NC to the
highest position.
2.Switch off the Incubator 8000 IC/SC/NC using the ON/OFF switch.
3.Unplug the power plug of the Incubator 8000 IC/SC/NC from the mains socket-outlet.
Electrostatic discharge may damage electrostatic sensitive devices.
When handling electrostatic sensitive devices, use a static-dissipative
mat and a static dissipative wrist strap.
4.Observe ESD precautions.
5.Support the Incubator's cover plate with one hand and turn catches (a) 90° counterclockwise.
U-Inkubator8000IC-SC-NC.fm 17.08.00
a
Fig.3: Left and right side view of the Incubator 8000 IC/SC/NC
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page2 of 17
Dräger Medizintechnik
6.Unlock latches (b) of the electronic module and fold down the electronic unit.
Inkubator 8000
D
b
b
Fig.4: View of the Incubator 8000 IC/SC/NC
Risk of damage to equipment. The electronic unit is connected with the
Incubator's cables which might be damaged during disassembly. To
avoid damage to these cables, carefully remove the electronic unit as
shown in the following step.
7.Remove the following cable connectors from the electronic unit:
- Disconnect cable connectors of the protective conductors (c) from the housing frame
of the electronic unit.
- Take the cable connector (d) by the connector and disconnect it from the Analog PCB.
- Take the cable connector (e), if present, by the connector and disconnect it from the
Analog PCB.
U-Inkubator8000IC-SC-NC.fm 17.08.00
c
d
e
Fig.5: Cable connections of the electronic unit
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page3 of 17
Dräger Medizintechnik
8.Carefully remove the electronic unit and disconnect the cable connector of the auxiliary
fan (f) (Note: The cable connector of the auxiliary fan is located on the left side of the
Motherboard PCB).
f
Fig.6: Detail of the Motherboard PCB
9.Disconnect cable connector (g) from the Motherboard PCB; to do so press both latches
of the cable connectors sideways at the same time.
g
U-Inkubator8000IC-SC-NC.fm 17.08.00
Fig.7: Right side view of the electronic unit
10. Place the electronic unit on a stable surface.
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page4 of 17
Dräger Medizintechnik
11. Unscrew screws (h) and remove board securing clamps.
Board securing
clamps
h
Fig.8: Removing the board securing clamps
12. Pull the Analog PCB out of the Motherboard PCB.
Analog PCB
h
U-Inkubator8000IC-SC-NC.fm 17.08.00
Fig.9: Removing the Analog PCB
13. Place the Analog PCB aside.
14. Take the modified Analog PCB from the conversion kit.
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page5 of 17
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