5900 Optical Ct, San Jose, CA 95138

APPROVALS DATE TITLE

DRAW N
C. PRECIADO
4/11/2003 40L INSUFFLATOR REPAIR PROCEDURE
ORIGINATOR

S. LIN 4/11/2003
DOC. CONTROL

WENDY HU 4/11/2003
SIZE DOCUMENT NO. SHEET OF
A MAP-0289 1 13
REVISIONS REVISIONS
LTR ECN NO. DATE APPROVED LTR ECN NO. DATE APPROVED
A 20998 9/19/2001 S/P. MERCER

B 24931 4/11/2003 S/S. LIN

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INSUFFLATOR REPAIR PROCEDURE
1. PURPOSE

1.1. To provide the Imaging Repair Team with instructions regarding the analysis and repair of 40L
Insufflator.

2. SCOPE

2.1 This procedure affects all 40L Insufflators repaired by the Imaging Unit Repair Team.

3. REFERENCE

3.0 40L Service Manual

3.1 QIP 196 – Insufflator Inspection Procedure
3.2 SOP 0051 – Decontamination of Returned Products
3.3 40L Operations Manual

4. GENERAL:

4.1 Documents will be completed in accordance with Good Documentation Practices.

4.2 Repairs will be performed in accordance with this document and supplemented by the 40L
Insufflator Service Manual.
4.3 Prior to release products will be inspected in accordance with QIP 0196.

5. UPGRADES:

5.1 See Addendum B and C

6. ANALYSIS:

6.1 Review the Device History Record associated with the unit that needs repair.
6.1.1 Review the customer’s comments.
6.1.2 Review the unit’s repair history.
6.1.3 If the unit has been in for repairs 3 times or more within the last year, consult with
the Production Supervisor to determine if the unit will be replaced.
6.1.4 If the unit is under repair warranty, inform the Production Supervisor.
6.1.5 If the unit is associated with an official customer complaint, inform the Quality
Engineer.
6.2 Perform a visual inspection, checking for dents and blemishes or damaged components externally.
6.3 Remove cover and inspect unit internally:
6.3.1 Check the ribbon cable to the USB port on the rear panel so it is not tucked underneath
the power supply cover and also does not rub against screws. Rearrange as needed.
6.3.2 Disconnect tube connector elbow (contamination sensor) from front panel and inspect for
debris. Clean as needed. Reattach elbow connector.
6.3.3 Check DB10 Ribbon Cable connector on Display PC Board that it is held in place with a
dab of silicone.

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6.3.3.1 If not, make sure that the Heater Board Ribbon Cable is not placed between the
DB10 Ribbon Cable and the Display PC Board
6.3.3.2 Reroute if needed.
6.3.3.3 Lock the DB10 connector into place by applying a dab of sealant across the sides
of it and the socket.
6.3.4 Curl in the Ribbon-Bus-Connector where it extends from the video or Hermes board,
toward the side of the top-cover (to prevent accidental shorts).

7. FUNCTION TEST:

7.1 Perform the function test according to Section 11-2 through 11-7 of the Operation manual.

8. REPAIR:

8.1 Repair or replace any defective or faulty components that were discovered during the visual
analysis or functional test.
8.2 NOTE: Front panel, LPU, and PC Board replacement requires software reload and calibration
(except Heater & Power Button Boards).
8.3 Always upgrade software to latest revision level according to Addendum B.

9. CALIBRATION

9.1 Perform calibration according to Addendum A.

10. FINAL TEST:

10.1. Verify calibration by performing step 7.
10.2. If additional problems are noted, return to step 8.

11. DISPOSITION:
11.1. Forward the unit to QC for the final disposition.

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ENDOSCOPY, SAN JOSE, CALIFORNIA. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED,
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Addendum A
40 Liter Insufflator Calibration Procedure

Materials
Full CO2 canister
High pressure hose and yoke
Fitting wrenches
Flathead screw driver
Power cord
High pressure gauge for up 100 bars (app. 1450 psi)
Flow meter gauge for up to 40L
Low pressure manometer which is good for up to 60 mmHg
Heating board tester
Note: If a calibration step is not successful the first time you should always try it again.
A single calibration step might fail just because of an incomplete data transfer
-----------------------------------------------------------------------------------------------------------

General Setup
1. Connect the high pressure gauge and gas canister to the 40L
2. Open gas canister
3. Turn the unit on
4. Wait for the successful self check “device OK”
5. Press menu button
6. Press the t(for the preset flow) button 1 time

Service Code Set-up

1. You should read: service menu
2. Press the menu bottom for OK
3. Service code menu is now displayed
4. Press 1 time the t(for the preset flow) button to obtain digit 1 for the service code
5. Press the OK button 4 times to obtain the code “1000”

ALL Offset
1. You should now read: All offset
2. Close the canister and release the pressure from the high pressure hose
3. Make sure that the patient connector has nothing attached to it

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4. Press the menu button for OK
5. Wait until the unit has set all off sets
6. You should read on the display: calibration success
7. Press menu button for OK
8. To go up into the next calibration level press the t (Preset flow) button
9. Connect the canister again and open it

Low Pressure Calibration

1. You should now read: LOW-pressure Calibration
2. Connect the low pressure manometer to the patient connector
3. Press the menu button for OK
4. The insufflator automatically calibrates a pressure ramp
5. Wait until display reads: adjust pressure
6. Look at you pressure manometer and adjust the DEF value with the ut buttons. The DEF value has to match
with the pressure at your external manometer and must be between the displayed MIN/MAX values
Note: To avoid a time out error the adjustment should be done in app. 1 min
7. If done, press the menu button for OK
8. You should read: Calibration success
9. Press the menu button for OK
10. Remove the low pressure manometer from the patient connector
11. To go up into the next calibration level press the t button

High Pressure Calibration

1. You should read: HIGH-pressure Calibration
2. Make sure that the high pressure gauge is attached and the canister is open
3. Press the menu button for OK
4. Below ACT you can read the canister pressure measured by the unit, on the high pressure gauge you can read
the real canister pressure
5. The pressure measured by the unit and measured pressure by the high pressure gauge should be approx. the
same (plus minus 5 bars)
6. Now adjust the DEF value at the unit with the ut buttons. The DEF value has to match with the pressure at
your external high pressure gauge and must be between the displayed MIN/MAX values
Note: To avoid a time out error the adjustment should be done in app. 1 min.
7. If done press the menu button for OK
8. You should now read: Calibration success
9. Press the menu button for OK
10. To go up into the next calibration level press the t button

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ENDOSCOPY, SAN JOSE, CALIFORNIA. NEITHER THIS DOCUMENT NOR THE INFORMATION HEREIN MAY BE REPRODUCED,
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--------------------------------------------------------------------------------------------------------

LPR- Adjust
1. You should now read: LPR-Adjust
Low Pressure Reducer, the one, which is next to the display)
2. Press the menu bottom for OK
3. The unit automatically puts pressure on the reducer several times and releases it.
4. Below ACT you can read the actual outgoing pressure from the reducer. Adjust the actual pressure by turning the
screw (top of the reducer) until it matches the value, which is written below DEF
Note: To avoid a time out error the adjustment should be done in app. 1 min.
5. The ACT value can be vary from the DEF value but must be between MIN and MAX
6. If done press the menu bottom for OK
7. You should read now: Calibration success
8. Press the menu bottom for OK
9. Add a dab of paint to the screw
10. To go up into the next calibration level press the t bottom

Flow Calibration
1. You should read now: Flow Calibration
2. Attach the flow meter via a tube to the patient connector
3. Press the menu bottom for OK
4. The unit starts insufflating, wait until the flow meter reaches a stable point and until you can read on the display:
adjust flow
5. Now adjust the DEF value at the unit with the ut buttons. The DEF value has to match with the flow at your
external flow meter and must be between the displayed MIN/MAX values
Note: To avoid a time out error the adjustment should be done in app. 1 min.
6. If done press the menu button for OK
7. The insufflator automatically calibrates a flow ramp
8. Wait unit you can read: Calibration success
9. Press the menu button for OK
10. Detach the flow meter
11. To go up into the next calibration level press the t button

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LSV-Adjust
1. You should now read: LSV-Adjust
Low pressure Safety Valve, the one, which is closer to the power board
2. Close the patient connector (with the thumb, this is easiest)
3. Press the menu bottom for OK and keep the patient connector close until you can read a stable value below ACT
on the display
4. The unit automatically puts pressure on the safety valve.
5. Now open and close the patient connector at least 3 times until the display always shows the same pressure
below ACT, which is the actual relief opening pressure from the valve.
6. Adjust the actual relief opening pressure by turning the screw (top of the valve) until the ACT value matches with
the value below DEF. During the adjustment the patient connector must be closed.
Note: To avoid a time out error the adjustment should be done in app. 1 min.
7. If done press the menu button for OK
8. You should now read: Calibration success
9. Press the menu button for OK
10. Add a dab of paint to the screw (keeps it from turning)
11. To go up into the next calibration level press the t button

Heater Calibration
1. You should now read Heater Calibration
2. Insert test device into front panel heater connector and press menu
3. Follow instructions on LCD display
4. At end of test you should read: Calibration Success
5. Press menu once and reset twice to return to main menu

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Addendum B
40 Liter Insufflator Software Upgrade/Reload Procedure

Materials
PC with CD-Reader
A/C Cord
RS232/DB9 Cable for COM1 to Insufflator Connection
-----------------------------------------------------------------------------------------------------------

Setup
1. Connect PC-COM1 to DB9 on 40L unit back panel
2. Do not insert A/C cord into 40L unit at this time!
3. Check back panel of 40L unit for Hermes or video connection
4. Insert proper software CD (Hermes or video) into PC
5. On PC desktop right click “my computer” and select explore
6. When “my computer” window opens, expand CD drive with software CD inserted and double click on folder
shown

Download
1. Double click on “G20000Pro” icon. 2 windows will open.
nd
2. When 2 window opens and prompts for “Power On,” insert A/C cord on 40 liter unit
3. Unit now starts download showing progression on different windows
4. Wait for window prompting for “Power Off-On”
5. Press power button (green) on 40 liter unit front panel and keep depressed until unit powers off (approx. 2-3
seconds)
6. Push power button again to power up unit again. Software download will continue.
7. NOTE: If waiting too long with power on/off (steps 5-6) download window will post a baud rate problem and
download will stop. Close download windows, remove A/C cord from 40 liter unit and restart at step 1.
8. Do not interfere with process until all windows are closed again.
9. Return to repair procedure.

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Addendum C
Hermes Upgrade Procedure

Materials
Hermes Upgrade Kit (240-020-309)
WOM-Adhesive Metal Strip
Fitting wrenches
Flathead screw driver
Power cord
-----------------------------------------------------------------------------------------------------------

General Procedure
1. Power off and disconnect the 40L unit
2. Remove top cover
3. Remove video card (leftmost PC-Board connected to adapter board on back panel via ribbon cable)
4. Remove interface adapter board from back panel
5. Cover empty video I/F openings on back panel with WOM-adhesive metal strip
6. Remove black plastic cover from USB-port opening on back panel
7. Install Hermes Board into empty board slot
8. Install USB Connector supplied with upgrade kit into back panel
9. Connect ground wire of USB Connector to power supply cover stud screw
10. Connect USB Connector to Hermes Board
11. Reinstall device cover and power on unit
12. Reload firmware into 40 liter unit according to Appendix B using Hermes Software
13. Verify Hermes unit with 40L -- Insufflator driver detects unit after connecting Hermes & 40L USB-ports with USB-
cable

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Addendum D
40 Liter Insufflator Decontamination

Materials
40L Service Manual
Phillips screwdriver
Set of socket drivers
Gloves
-----------------------------------------------------------------------------------------------------------

General Procedure
1. Place unit in decontamination facility
2. Upon repair approval by customer, proceed as follows
3. Remove top cover and PUT ON GLOVES
4. Remove LPU according to service manual, step 4-3
5. Remove tube connector according to service manual, step 4-10
6. Dispose of PLU, tube connector and gloves in accordance with hazardous waste regulations
7. Cover unit with top, remove from decontamination facility and proceed with repair at workbench
8. Install new tube connector according to service manual, step 4-10
9. Install new LPU according to service manual, step 4-3
10. Reload firmware (video or Hermes), see Appendix B
11. Recalibrate unit, see service manual, step 3-2
12. Perform full functional test, see operations manual, section 11-2

STRYKER CONFIDENTIAL - THIS DOCUMENT CONTAINS CONFIDENTIAL AND PROPRIETARY INFORMATION OF STRYKER
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Addendum E
Failure and Repair Codes

Failure Codes Repair Codes

BCH Bent/Damaged Chassis RDC Replaced/Repaired Chassis
BLM Blemished Cosmetically TUP Touched Up Cosmetically
CDC Could Not Duplicate Comment PFT Performed Full Functional Test
DM1 Upgrade Required
DM2 Upgrade Required
DM3 Upgrade Required
LCO Loose Connection TCO Tightened Loose Connection
NPF No Problem Found NRN No Repair Needed
SWU Software upgrade required USW Upgraded software
UNR Unit Not Repairable SBU Send Back Unrepaired
SRU Shipped a replacement unit
110 Low pressure safety calibration error RLU Replace Low Pressure Unit
111 Adjustment - Low pressure safety not in range CTS Calibrated to Current Specs
130 Flow RLU Replace Low Pressure Unit
131 Flow Resistance too high RLU Replace Low Pressure Unit
133 Flow intake value too low RLU Replace Low Pressure Unit
134 Flow intake value too high RLU Replace Low Pressure Unit
135 Flow sensor value changed RLU Replace Low Pressure Unit
136 Amplification - Flow sensor too low RLU Replace Low Pressure Unit
137 Amplification - Flow sensor too high RLU Replace Low Pressure Unit
138 Offset proportional value too low RLU Replace Low Pressure Unit
139 Offset proportional value too high RLU Replace Low Pressure Unit
140 Offset proportional valve too low RLU Replace Low Pressure Unit
141 Offset proportional valve too high RLU Replace Low Pressure Unit
142 Amplification - proportional valve too low RLU Replace Low Pressure Unit
143 Amplification - proportional valve too high RLU Replace Low Pressure Unit
144 Sticky proportional valve RLU Replace Low Pressure Unit
CAL Unit Needs Calibration CTS Calibrated to Current Specs
CBE Calibration error CTS Calibrated unit
CGU Central Gas Software Upgrade Required SF2 Software Upgrade for Central Gas
CNT Contaminated unit DCO Decontaminated
DBB Defective basic board module BBR Repalced basic board module
DCC Damaged Case cover RCV Repalced Case Cover
DFP Damaged front panel RFP Replaced Front Panel
DFS Defective fluid sensor RFS Replaced fluid sensor
DHB Defective Gas Heating board RGH Replaced Gas Heating Board
DHI Defective Hermes Interface RHI Replaced Hermes Interface
DHU Defective High Pressure Unit RHU Replaced High pressure unit
DIO Defective input/output Board module RIO Replaced Input output Board
DIS New Diss Inlet Connector Required NDC New DISS Connector Installed

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DIT Defective/damaged insufflator tube connection RIT Replaced Insufflator tube connection
DLD Damaged LCD board or Display RDD Replaced LCD Board or Display
DNP Defective Non-heating device plug RNP Replaced non-heating device plug
DPE Damaged Potential Equalization Plug RPE Replaced potetial equalization plug
DPK Defective Power Pack Supply RPK Replaced Power Supply
DPL Defective Panel Board PBR Panel Board Replaced
DVB Defective Video Board RVB Replaced Video Board
EDE Electronic Defect Error REL Replaced electronic component
HBU Heater board upgrade UHB Upgraded heater board
RPR Residual pressure OCB Offset calibration
SDE Sensor Defect Error RLU Replace Low Pressure Unit
VCK Valve check RLU Replace Low Pressure Unit
X00 General Error RLU Replace Low Pressure Unit
X01 Timeout RLU Replace Low Pressure Unit
X02 General software error RLU Replace Low Pressure Unit
X03 EEPROM write error RLU Replace Low Pressure Unit
X10 General offset calibration error RLU Replace Low Pressure Unit
X11 offset low pressure regulator too low RLU Replace Low Pressure Unit
X12 Offset low pressure sensor too low RLU Replace Low Pressure Unit
X13 Offset safety pressure sensor too low RLU Replace Low Pressure Unit
X14 offset differential pressure sensor too low RLU Replace Low Pressure Unit
X15 Offset high pressure sensor too low RLU Replace Low Pressure Unit
X16 Offset Temperature sensor too low RLU Replace Low Pressure Unit
Offset current monitoring of high pressure gas
X17 heater too low RLU Replace Low Pressure Unit
X18 Offset gas heater too low RLU Replace Low Pressure Unit
X19 Offset low pressure regulator RLU Replace Low Pressure Unit
X20 Offset low pressure sensor too high RLU Replace Low Pressure Unit
X21 Offset safety pressure sensor too high RLU Replace Low Pressure Unit
X22 Offset diferrential pressure sensor too high RLU Replace Low Pressure Unit
X23 offset high pressure sensor too high RLU Replace Low Pressure Unit
X24 Offset Temperature sensor too hight RLU Replace Low Pressure Unit
Offset current monitoring of high pressure gas
X25 heater too high RLU Replace Low Pressure Unit
X26 Offset gas heater too high RLU Replace Low Pressure Unit
X50 General low pressure calibration error
X51 Low pressure - large leak
X52 Low pressure - small leak
X53 Low pressure intake value too low
X54 low pressure intake value too high
X55 Amplification I - Low pressure RLU Replace Low Pressure Unit
X56 Amplification I - Low pressure sensor too high RLU Replace Low Pressure Unit
X57 Amplification II - Low pressure sensor too low RLU Replace Low Pressure Unit
X58 Amplification II - Low pressure sensor too high RLU Replace Low Pressure Unit
X59 Amplification - Safety pressure sensor too low RLU Replace Low Pressure Unit
Low pressure amplification - Safety pressure
X60 sensor too high RLU Replace Low Pressure Unit

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X70 General High pressure calibration error RHU Replace High Pressure Unit
X73 High pressure intake value too low
X74 high pressure intake value too high
X75 High pressure sensor value too high
X76 High pressure sensor amplification too low RHU Replace High Pressure Unit
X77 High pressure sensor amplificaiton too high RHU Replace High Pressure Unit
X90 General low pressure regulator not in range RLU Replace Low Pressure Unit
X91 Adjustment - low pressure regulator not in range CAL Calibration
Software Upgrade BAM7, PCU8, IOM6,
SF1 VIM4

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