Drager 8000 User manual
Field
Service
Instruction
Part Number: 4116708
Date: 17 August 2000
Rev: -
Installation Instructions:
Incubator 8000 Control Unit
Dräger Medical, Inc.
Recall Incubator 8000 series in the USA and Canada
Installation Instructions for Control Unit and
Feedback Form
Dear Customer,
You have received a modified Control Unit with some additional parts for your
Incubator 8000 series. Please read all Instructions before you start the installation and
use the feedback form on page 3 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 Service Manager
DrägerService
1 Action to be taken:
• Installation of modified Control Unit.
• Retrofitting 2 warning labels according to TSB Incubator 8000 IC/SC/NC # 19.
2 Parts needed for conversion:
• Modified Control Unit
• 2 pieces label P/N 2M22351
• Conversion Instructions (see list of documents in section 3)
Recall Incubator 8000 Installation Instructions for Control August 18, 2000 1/3
Unit and Feedback Form
Dräger Medical, Inc.
3 Attached documents for conversion:
- Skin-Temperature Measurement Conversion Instructions
(Incubator 8000 IC/SC/NC)
- TSB Incubator 8000 IC/SC/NC # 19
- Adhesive statement 2M22363 (according to
TSB Incubator 8000 IC/SC/NC # 19)
- Incubator 8000 IC/SC/NC, Electrical Safety Test in the USA and Canada
according to CAN/CSA - 22.2 No. 601.1 - M90
4 Installation Instructions for Units in the USA and Canada
4.1 Please fill out the feedback form during the installation. 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 staticdissipative mat and a static-dissipative wrist wrap.
4.3 For the installation of the Control Unit use the attached instructions "SkinTemperature Measurement Conversion Instructions (Incubator 8000 IC/SC/NC)"
and begin with step 31.
Note: Install the upgraded Control Unit in the original Incubator only.
4.4 For 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".
4.5 Retrofit 2 warning labels according to the attached instructions "Adhesive
statement 2M22363".
4.6 Fill out feedback form and send it back by fax.
Recall Incubator 8000 Installation Instructions for Control August 18, 2000 2/3
Unit and Feedback Form
Dräger Medical, Inc.
Feedback Form Incubator 8000 series / Installation
Control Unit
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 Control Unit has been installed:
P/N: S/N: A R __ __ - __ __ __ __
❑
2 warning labels according to TSB # 19 are placed on the device
Your Name
___________________________________________________
___________________________________________________
___________________________________________________
___________________ State: _____ Zip: _________
___________________________________________________
___________________________________________________
(number on
:
Serial No. Incu.
rating plate under "Fabr. Nr.")
__ __ - __ __ __ __
A R
(please print)
Part No. Inc.
rating plate under "Typ")
: Title: Date: Signature:
(number on
:
Recall Incubator 8000 Installation Instructions for Control August 18, 2000 3/3
Unit and Feedback Form
Dräger Medizintechnik
Please note: For removal of control unit see step 1 - 10, for installation see step 31 - 47.
1 Skin-Temperature Measurement Conversion Instructions
(Incubator 8000 IC/SC/NC)
1.1 General Information
• Perform the "skin-temperature measurement" conversion only if the
Incubator 8000 IC/SC/NC is equipped with a skin-temperature module, see the
following Figure.
1.1.1 Incubator 8000 IC/SC/NC with skin-temperature control
Function: Skin-temperature control
>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-temperature module
2
2
Vol.%O
Control
Cal.
>40%
2
>40%
Cal.
Control
21%
C HAUT/SKIN/PEAU/PIEL
°C
°C
± 0,5 °C
Check
36 °C
Sensor
Control
Control
±0,1
Fig. 1: Front view of the Incubator's control unit with skin-temperature control
For internal use only. Copyright reserved.
U-Inkubator8000IC-SC-NC.fm 17.08.00
6141.2XX Incubator 8000IC/SC/NC 08/2000 Conversion Instructions Page 1 of 20
Dräger Medizintechnik
The Incubator 8000 IC/SC/NC is equipped with different Analog PCBs:
8200920-00
8200920-01
8200922-13
8200922-16
or
8290678-01
8290678-02
8290678-03
8290680-04
Analog PCB, part numbers
8200920-00
8200920-01
8200922-13
8200922-16
can be identified by the following characteristics:
The skin-temperature sensor socket is either fitted on the environmental
sensor or on the rear panel of the Incubator.
Analog PCB, part numbers
8290678-01
8290678-02
8290678-03
8290680-04
can be identified by the following characteristics:
A yellow skin-temperature sensor socket is fitted on the left side of the
Incubator.
U-Inkubator8000IC-SC-NC.fm 17.08.00
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC 08/2000 Conversion Instructions Page 2 of 20
Dräger Medizintechnik
Parts included in the conversion kit
• Conversion kit for Incubator 8000 IC/SC/NC with a yellow skin-temperature sensor
socket on the left side of the Incubator:
Part Number
Conversion Instructions
Adhesive label 2M22384
EPROM Software version 11.02
(Incubator 8000 NC/SC)
EPROM Software version 21.02
(Incubator 8000 IC)
Analog PCB 2M22404-00
or
Analog PCB 2M22405-00
or
Analog PCB 2M22406-00
or
Analog PCB 2M22407-00
• Conversion kit for Incubator 8000 IC/SC/NC with the skin-temperature sensor socket
fitted either on the environmental sensor or on the rear panel of the Incubator:
Conversion Instructions
2M22332
2M22331
Part Number
U-Inkubator8000IC-SC-NC.fm 17.08.00
Adhesive label 2M22384
EPROM Software version 10.05
(Incubator 8000 NC/SC)
EPROM Software version 20.04
(Incubator 8000 IC)
Analog PCB 2M22400-00
or
Analog PCB 2M22401-00
or
Analog PCB 2M22402-00
or
Analog PCB 2M22403-00
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC 08/2000 Conversion Instructions Page 3 of 20
2M22326
2M22327
Dräger Medizintechnik
• If all items are included, proceed to conversion procedure, step 1.
1.1.2 Incubator 8000 IC/SC/NC with thermomonitoring
Function: Thermomonitoring
°C LUFT/AIR
°C
°C
±1,5 °C
Sensor
Reset
Control
>37 ˚C
>37 °C
Control
Check
Alarm
Inop.
% FEUCHTE/HUMID.
%
%
H O
2
Sensor
Control
Control
VOL.%O
Vol.%
O
± 5 Vol.%
Sensor
Skin-temperature module
>40%
Control
Control
Cal.
>40%
C HAUT/SKIN/PEAU/PIEL
°C
°C
± 0,5 °C
Check
36 °C
±0,1
Sensor
Control
Control
2
2
Vol.%O
2
Cal.
21%
Fig. 2: Front view of the Incubator's control unit with thermomonitoring
Parts included in the conversion kit
• Before starting the conversion, check that all items listed below are included in the
conversion kit:
Part Number
Conversion Instructions
Adhesive label 2M22384
EPROM Software version 11.02
2M22332
(Incubator 8000 NC/SC)
EPROM Software version 21.02
2M22331
(Incubator 8000 IC)
Analog PCB 2M22404-00
or
Analog PCB 2M22405-00
or
Analog PCB 2M22406-00
or
Analog PCB 2M22407-00
• If all items are included, proceed to conversion procedure, step 1.
U-Inkubator8000IC-SC-NC.fm 17.08.00
For internal use only. Copyright reserved.
6141.2XX Incubator 8000IC/SC/NC 08/2000 Conversion Instructions Page 4 of 20
Dräger Medizintechnik
1.2 Conversion 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/NC 08/2000 Conversion Instructions Page 5 of 20
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/NC 08/2000 Conversion Instructions Page 6 of 20
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