Drager 8000 Analog PCB User manual

Field

Service

Instruction

Part Number: 4116707

Date:7November 2000

Rev:A

Conversion Instructions:

Incubator 8000 Analog PCB

Dräger Medical, Inc.

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

1 Action 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 series Conversion Instructions Analog PCB November 7, 2000 1/6

for Field Service and Feedback Form

Dräger Medical, Inc.

2 Parts needed for Conversion in the USA and Canada

2.1 For 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

• 1 piece EPROM Software version 21.02, P/N 2M 22 331

• 1 piece Label P/N 2M 22 384

• 2 pieces label P/N 2M 22 351

• Conversion Instructions (see list of documents in section 3)

2.2 For Incubator 8000 IC without ThermoMonitoring and SW 20.n

On these units the socket for the skin temperature sensor is connected in the sensor module.

P/N 4116706-002, Contents of delivery:

• 1 piece Analog PCB P/N 2M 22 400, P/N 2M 22 401, P/N 2M 22 402, P/N 2M 22 403, PCB P/N SE 2M 22 400, P/N SE 2M 22 401, P/N SE 2M 22 402, P/N SE 2M 22 403, 2M 22 381, or SE 2M 22 381

• 1 piece EPROM, Version 20.04, P/N 2M 22 327

• 1 piece Label P/N 2M 22 384

• 2 pieces label P/N 2M 22 351

• Conversion Instructions (see list of documents in section 3)

Incubator 8000 series Conversion Instructions Analog PCB November 7, 2000 2/6

for Field Service and Feedback Form

Dräger Medical, Inc.

2.3 For Incubator 8000 NC/SC without ThermoMonitoring and SW 10.n

On these units the socket for the skin temperature sensor is connected on the backside of the Incubator.

P/N 4116706-003, Contents of delivery:

• 1 piece Analog PCB P/N 2M 22 400, P/N 2M 22 401, P/N 2M 22 402, P/N 2M 22 403, PCB P/N SE 2M 22 400, P/N SE 2M 22 401, P/N SE 2M 22 402, P/N SE 2M 22 403, 2M 22 381, or SE 2M 22 381

• 1 piece EPROM, Version 10.05, P/N 2M 22 326,

• 1 piece Label P/N 2M 22 384

• 2 pieces label P/N 2M 22 351

• Conversion Instructions (see list of documents in section 3)

2.4 For Incubator 8000 SC without ThemoMonitoring and SW 11.n:

On units with SW 11.n the socket for one skin temperature sensor is located on the left side of the blue housing of the Incubator.

P/N 4116706-004, 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

• 1 piece EPROM, Software version 11.02, P/N 2M 22 332

• 1 piece Label P/N 2M 22 384

• 2 pieces label P/N 2M 22 351

• Conversion Instructions (see list of documents in section 3)

Incubator 8000 series Conversion Instructions Analog PCB November 7, 2000 3/6

for Field Service and Feedback Form

3 Attached documents for conversion:

Dräger Medical, Inc.

Skin-Temperature Measurement Conversion Instructions (Incubator 8000 IC/SC/NC)"

TSB Incubator 8000 IC/SC/NC # 12

TSB Incubator 8000 IC/SC/NC # 17

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 Conversion 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.

4.3 If 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:

1.0 °C

Incubator 8000 series Conversion Instructions Analog PCB November 7, 2000 4/6

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:

0.5 °C

Note: If necessary please take a jumper from the removed PCB Analog.

4.4 For the installation of the Analog PCB and the EPROM use the attached

instructions "Skin-Temperature Measurement Conversion Instructions (Incubator 8000 IC/SC/NC)".

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.

4.5 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".

4.6 Adhere 2 warning labels according to the enclosed instructions "Adhesive statement 2M22363".

4.7 Fill out feedback form and send it back by fax. Please send the original feedback form back with the replaced parts.

5 Address 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 series Conversion Instructions Analog PCB November 7, 2000 5/6

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:

P/N: S/N: A R __ __ - __ __ __ __

___________________________________________________

___________________ State: _____ Zip: _________

___________________________________________________

Part No. Incu.

rating plate under "Typ")

(number on

Serial No. Incu.

rating plate under "Fabr. Nr.")

A R

(number on

__ __ - __ __ __ __

(if available

)

❑

Correct EPROM (Software) has been installed:

SW version: S/N: A R __ __ - __ __ __ __

❑

Correct CPU PCB according to Follow Up TSB # 12 has been installed

❑

Fan on the Power PCB has been disconnected according to TSB # 17

❑

2 warning labels according to TSB # 19 are placed on the device

Your Name

Incubator 8000 series Conversion Instructions Analog PCB November 7, 2000 6/6

(please print)

: Title: Date: Signature:

for Field Service and Feedback Form

Dräger Medizintechnik

1 Skin-Temperature Measurement Conversion Instructions

(Incubator 8000 IC/SC/NC)

1.1 General Information

• Perform the "skin-temperature measurement" conversion only if the Incubator8000IC/SC/NC is equipped with a skin-temperature module.

1.1.1 Incubator 8000 IC/SC/NC with skin-temperature control



Function: Skin-temperature control

>37 °C

Control

>37 ˚C

Check

Alarm Inop.

°C LUFT/AIR

°C

±1,5 °C

Sensor

°C

Reset

% FEUCHTE/HUMID.

H O

Sensor

Control

VOL.%O

Vol.%

± 5 Vol.% Sensor

Skin-temperature module

Vol.%O

Control Cal. >40%

>40%

Cal.

Control

21%

C HAUT/SKIN/PEAU/PIEL

°C

± 0,5 °C

Check 36 °C

Sensor

Control

±0,1

Fig. 1: Front view of the Incubator's control unit with skin-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 Page 1 of 17

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

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 Page 2 of 17

Dräger Medizintechnik

6. Unlock latches (b) of the electronic module and fold down the electronic unit.

Inkubator 8000



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

Fig. 5: Cable connections of the electronic unit

For internal use only. Copyright reserved.

6141.2XX Incubator 8000IC/SC/NC11/2000 Conversion Instructions Page 3 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).



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.

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 Page 4 of 17

Dräger Medizintechnik

11. Unscrew screws (h) and remove board securing clamps.



Board securing

clamps

Fig. 8: Removing the board securing clamps

12. Pull the Analog PCB out of the Motherboard PCB.

Analog PCB

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 Page 5 of 17

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