Service Manual
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F105 Insufflator for Laparoscopy
SERVICE MANUAL
F105/200-6031-0/1201/AMA
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This manual contains information that is subject to copyright. All rights reserved. This manual should not be photocopied, duplicated on microfilm or otherwise copied or distributed, completely or in part, without the approval of the manufacturer. Some of the parts and equipment referred to in this manual bear registered trademarks but are not identified as such. It should therefore not be assumed that the absence of the trademark indicates that any given designation is not subject to trademark protection. Also, it is not evident whether patents or copyrights exist. Users of ours products should not hesitate to point out to us any errors or unclarities in this manual. Copyright © STRYKER ENDOSCOPY
Manufacturer STRYKER ENDOSCOPY 2590 Walsh Avenue Santa Clara, CA. 95051 USA Tel.: 408 567 9100 Fax: 408 567 2505
US-2
Safety Instructions
Contents 1
2
3
4
Introduction/Basics ... 4 1-1 Functional Diagram F105 ... 4 1-2 Explosion Diagram ... 5 1-3 Cable Layout Plan ... 6 1-4 Testing Tools and Resources ... 7 1-5 Front of the Device ... 7 1-6 Rear of the Device ... 8 1-7 Opening the Device ... 8 Function Test ... 9 2-1 Safety Test ... 9 2-2 Damages Caused by Disinfectants, UV Rays, etc. ... 9 2-3 Testing the High Pressure Unit (HPU) ... 9 2-4 Testing the Low Pressure Controller LPC ... 10 2-5 Low Pressure Safety Valve LSV ... 10 2-6 Testing Low Pressure Unit for Leaks ... 10 2-7 Testing Flow Volume ... 10 2-8 Testing Overpressure Alarm ... 11 2-9 Testing Blockage Alarm ... 11 2-10 Testing Gas Heater ... 11 Service Menu ... 12 3-1 Opening the Service Menu ... 12 3-2 Calibration ... 13 3-2-1 Offset Calibration ... 14 3-2-2 Low Pressure Calibration ... 15 3-2-3 HIGH Pressure Calibration ... 17 3-2-4 LPR Calibration ... 18 3-2-5 Flow Calibration ... 19 3-2-6 LSV-Calibration ... 21 3-2-7 Heater Calibration ... 22 3-2-8 12h Test ... 23 3-2-9 Factory Default ... 24 Replacing Components ... 25 4-1 High Pressure Unit HPU ... 25 4-2 Gas Connection ... 26 4-3 Low Pressure Unit LPU ... 26 4-4 Power Pack ... 27 4-5 Non-Heating Device Plug ... 27 4-6 Panel Board (ON/OFF Key) ... 28 4-7 Modules/Boards ... 29 4-8 Video Board/LCD ... 29 4-9 Heater Board HB ... 30 4-10 Insufflation Tube Connection (Gas Outlet) ... 30 4-11 Fluid Sensor ... 30 4-12 Front Panel ... 31
5
Spare Parts List ... 32
6
Calibration Error Messages ... 33
7
Technical Data ... 35
8
Glossary
... 36
9
Index
... 37
Liability
Device and additional equipment have been carefully and thoroughly tested at the factory before shipping. The manufacturer is only responsible for the safety and reliability as well as performance of the product if all tests and repairs are carried out by qualified and authorized personnel and the device and all additional equipment is employed according to its proper and intended use. WARNING Maintenance, repair, or modifications may be carried out only by personnel authorized by the manufacturer. The electrical installation of the power supply has to comply with DIN/IEC rules and regulations. An authorized service technician has to inspect and service the device every two years to ensure the safety and functionality of the unit. If the service interval is not adhered to, the manufacturer does not assume any liability for the functional safety of the device. Service technicians are to be trained and certified only by the manufacturer. The manufacturer is not liable for direct or consequential damages; the warranty is null and void if
the device or any additional equipment is used improperly.. instructions and rules of the manual are not observed. the device or any additional equipment is used, prepared, or maintained/repaired improperly. non-authorized personnel carries out repairs, adjustments, or modifications on the device or any additional equipment. the prescribed inspection and maintenance intervals are exceeded. Receiving technical documents does not constitute authorization to repair, adjust, or modify the device or any additional equipment. Proper care and maintenance of the device and any additional equipment is required to ensure safe operation. Function and operational of the device and additional equipment thus have to be checked after each maintenance session to protect patient and operator. New factory supplied and repaired products have to be prepared before first use (see manual).
Protection from Germs
Devices, instruments, and any additional equipment returned for repairs have to be prepared before shipping according to the manual to protect the service personnel and ensure safety during transport. If this is not possible,
the contaminated product has to be clearly marked referencing the type of contamination and has to be shrink-wrapped in two layers of safety foil.
10 Maintenance- and Checklist ... 38
Test Record
... 39
Return form
... 41
Certificate
The device or instrument operator has to be provided with a certificate about the scope and extent of the performed services/repairs. This certificate has to list the date of the service as well as the company together with a signature. Please use the maintenance and checklist included in the back of the service manual.
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1
Introduction/Basics
1-1
Functional Diagram F105
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1
Introduction/Basics
1-2
Explosion Diagram
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1
Introduction/Basics
1-3
US-6
Cable Layout Plan
1
Introduction/Basics
This device has to be serviced every two years. The chapter Function Test describes this routine inspection.
1
Introduction/Basics
1-5
Front of the Device
Please use the maintenance and checklist included in the back of the service manual to document the bi-annual inspection.
1-4
Testing Tools and Resources
The following tools and resources are required to perform the maintenance and service tasks described in this manual. Please make sure that all tools and resources are calibrated and in perfect working order before commencing any service or maintenance tasks.
Manometer
Range 0-70 mm Hg, Test Class 1.0 Manometer Range 0-7 bar, Test Class 1.6 Manometer Range 0-100 bar, Test Class 1.6 Silicone Tube 8x2 mm PVC Tube 6x4 mm, 1 m T Connector 8-8-8 mm Flow Column Range 0-20 l/min CO2 Max. Pressure Drop at 9 l/min < 10 mbar Flow Column Range 0-40 l/min CO2 Max. Pressure Drop at 9 l/min < 10 mbar Veress Hollow Needle Length 100 mm, Opening Diameter 1.4 mm, Inner Diameter 1.6 mm Heater Calibration Box T100/T101 Universal Multimeter
Fig. 1-5: : F105 Front Control and Display Elements
1 Start/Stop Key 2 Display 3 Gas Heater Connection 4 Insufflation Tube Connection 5 Nominal Gas Flow + 6 Nominal Gas Flow 7 Gas Consumption Reset Key 8 Menu Key 9 Nominal Pressure bl Nominal Pressure + bm Line Voltage LED bn ON/OFF Key
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Introduction/Basics
1
1-6
Rear of the Device
1-7 1.
DE
2.
Introduction/Basics Opening the Device
You will need a recessed head screwdriver (Phillips) size 2 to open the device. (See Fig. 1-6) Remove four screws from top and two screws from . each side Lift the case cover panel towards the top and remove.
1
9
3.
Fig. 1-6: Connection Elements, Rear of the Device
1 Recessed Head Screw to Fasten Case 2 Case Cover 3 Recessed Head Screw to Fasten Case 4 Blank Cover HERMES (Optional) 5 Service Interface 6 Potential Equalization Plug 7 Video Output RGB/FBAS 8 Video Output SVHS 9 Recessed Head Screw to Fasten Case bl Video Input SVHS bm Video Input RGB/FBAS bn Power Pack Plug bo Fuse Holder bp Gas Connection
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2
2
Function Test
2
2-1
Safety Test
Testing High Pressure Unit for Leaks 1. Connect manometer (0-70 bar) to gas bottle connection. 2. Remove tube (press plastic ring and pull out tube) from HPU output and connect a 0-7 bar manometer. 3. Connect gas supply. 4. Briefly open the gas supply and reconnect. 5. Wait 10 min. Pressure at 70-bar manometer may not have dropped more than 5 bar.
Trained personnel has to perform a safety test as part of the annual system inspection. 1.
Perform a visual inspection. Make sure that the fuse corresponds with the specifications indicated by the manufacturer labels and stickers on device are legible the mechanical condition of the unit allows for safe operation the device is clean 2. Measure leakage currents according to DIN EN 60601-1/ IEC 601-1. 3. Measure protective conductor resistance according to DIN EN 60601-1/IEC 601-1. The protective conductor resistance is measured while device is connected to the power supply. The maximum value is 0.2 W. 4. Measure the insulation resistance with 500-700 V DC. The min. value is 50 MW. The electric strength with high voltage cannot be measured. As an alternative, perform safety test according to DIN VDE 0751 Section 1.
2-2
Function Test
2
Adjustment Check gas connection Replace high-pressure unit HPU High Pressure Valve HPV 1. Open the gas supply line. 2. Use a felt marker to mark the position of the adjustment screw of the high-pressure controller (Fig. 2-3-1).
1
Damages Caused by Disinfectants, UV Rays, etc.
The surfaces of the device components can be changed and/or damaged by disinfectants used in the operating room or the ozone released during the use of UV emitters. This requires the following inspections: Cabling The cables are to be checked for proper fit and condition. Any cables suspected of being damaged or flawed in any way (e.g., insufficient insulation, breaks, malfunctioning contacts, etc.) are to be replaced. Electronic Boards If the boards show signs of corrosion or other damage to the contacts or soldering joints, they are to be replaced to ensure the safety of the device/system. Front Panel and Case Front panel and case are to be checked for damage. Check for safety-and function-relevant damages. The proper function of the control panel and displays is to be checked.
Fig. 2-3-1: Position of High Pressure Unit HPU
Tubing Fluid can enter the device via the insufflation tube connection. This is detectable through the residue visible in the transparent tube in the area of the tube nozzle. If this is the case, please replace the entire pneumatics block.
4.
2-3
Adjustment Use the adjustment screw for any adjustments.
Testing the High Pressure Unit (HPU)
The high-pressure unit consists of the following:
Gas Intake Filter GIF High Pressure Sensor HPS High Pressure Controller HPC High Pressure Heater HPH High Pressure Valve HPV
3.
at high-pressure controller to Turn adjustment screw increase pressure until triggering of the high-pressure valve can be clearly heard (hissing sound). Reverse screw until you can no longer hear any hissing sound. The then reached pressure has to be above 4 bar. Reset the adjustment screw to the marked position.
1
3
5.
1
3 of the high-pressure valve
High Pressure Controller HPC NOTE The output value drops with rising temperature (e.g., long operating hours). 1. 2.
Relieve pressure of tube at magnetic valve (briefly remove and reconnect tube) until a stable final value of 3.2 bar is reached (±0.6). Remove manometer and reconnect tube.
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2
Function Test
2
Adjustment
Use the adjustment screw of the high-pressure controller for any adjustments.
1. 2.
Open the gas supply line. In the service menu, open the LPC Adjust menu option and check the settings. (Adjust with adjustment screw, Fig. 2-4-1)
1
DE 2-4 Testing the Low Pressure Controller LPC
Function Test
2 Syringe 3 T Connector 1. Attach manometer 1, air-filled syringe 2, tube, and Tconnector 3to the insufflation tube connection. 2 3.
Use the syringe to generate a pressure of at least 50 mm Hg. Clamp tube at 50 mm Hg. Wait 30 seconds. Pressure at manometer may not have dropped more than max. 2 mm Hg.
Adjustment Check fluid sensor and low-pressure unit tube(and replace if necessary).
2-7
Testing Flow Volume
Fig. 2-4-1: F105 Low Pressure Controller Settings
2-5
Low Pressure Safety Valve LSV
Close device exit using a tube clamp (Fig. 2-6-1 ,
4).
In the service menu, open the LSV Adjust menu option and check the settings. Adjustment Use the adjustment screw of the low-pressure safety valve for a slight adjustments.
2-6
Testing Low Pressure Unit for Leaks
Fig. 2-7-1: Test Layout: Flow Volume
1 Tube Connection 2 Flow Column (40 l/min) 1. 2. 3. 4. 5.
6. 7.
Attach a tube and a flow column to insufflation tube connection (Fig. 2-6-1). Turn on device. Set a nominal pressure of 15 mm Hg. Press the Start/Stop key. Check flow volume of device in gas flow levels 2 and 3. The value of the nominal flow indicator may not exceed a tolerance of ±2,0 l/min. The flow column value is not to be considered until after gas flow fluctuations have stabilized. Press the Start/Stop key to end test. Remove all measuring tools and resources.
Adjustment Service menu option Flow Calibration.
Fig. 2-6-1: Test Layout: Low Pressure Unit Leakage Test
1 Manometer (0-70 mm Hg) US-10
2
2-8 1. 2. 3. 4. 5. 6. 7. 8.
Function Test
Testing Overpressure Alarm
Attach a tube and an air-filled syringe to insufflation tube connection (Fig. 2-5-1). Use the syringe to slowly generate a pressure of 15 mm Hg. Slowly increase pressure to 21 mm Hg and press the Start/ Stop key. An alarm is sounded after approx. 5 seconds and Overpressure is displayed. Select gas flow level 2. The bleeder (relief) system is activated after approx. 5 seconds (time and pressure value can be changed in the user menu). The bleeder system relieves the pressure; alarm and Overpressure warning symbol are turned off. Press the Start/Stop key and remove test tools and resources.
Adjustment Replace low-pressure unit.
2-9 1. 2. 3. 4. 5.
Testing Blockage Alarm
Connect insufflation tube and close off the end of the tube. Press the Start/Stop key. An alarm is sounded after approx. 5 seconds and Blockage is displayed. The acoustic warning signal can be deactivated in the user menu. Open the insufflation tube connection; the alarm is turned off. Press the Start/Stop key.
Adjustment Return device to factory.
2-10 Testing Gas Heater 1. 2. 3. 4. 5.
Connect a heater tube to insufflation tube and gas heater connection. The display depicts HEATING. The tube is being prewarmed. Unplug the gas heater. The display HEATING disappears. Remove heater tube. Turn off device.
Adjustment Replace HPL board or cable to HPL.
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3 3-1
Service Menu Opening the Service Menu
Device parameters are displayed and changed in the service menu. Menu options are to be carried out in sequence to avoid malfunctions. Use the keys below the display for input. The function of each key is displayed above. Confirm input (Enter) with the (MENU) key. Use the (RESET) key to exit current menu level (Esc) or (VOLUME) to return to the previous level.
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Service Menu
3-2
Calibration
The following chart provides an overview over the necessary calibrations.
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Service Menu
3-2-1 Offset Calibration
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Service Menu
3-2-2 LOW Pressure Calibration Fig. 3-2-2: Test Layout: Low Pressure Calibration
1Manometer (0-70 mm Hg) 2Device Output/Tube Connection
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3-2-4 LPR Calibration
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3-2-5 Flow Calibration Fig. 3-2-5: Test Layout: Flow Calibration
1Device Output/Tube Connection 2Flow Column (40 l/min)
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