Ethicon Womens Health & Urology
GYNECARE VERSAPOINT System
VERSAPOINT II Troubleshooting Quick Reference Guide
Quick Reference Guide
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Troubleshooting Guide:
Gynecare Versapoint™ II Bipolar Electrosurgery System VersaPoint II works ONLY when all the following conditions are met: • The fluid media used during the procedure must be Saline. • The generator must be exposed to temperatures >20° C for >2 hours. • The connector cable is entirely dried after the autoclaving process. • The product is assembled properly per the Gynecare VersaPoint II User Manual and IFUs
• The 4mm loop (code # 01942) is ONLY compatible with the NEW: a. GYNECARE VERSAPOINT™ II Generator (code # 00465) b. GYNECARE VERSAPOINT™ II Connector Cable (part # 00463) • The 4mm loop (code # 01942) WILL NOT WORK with the old: a. GYNECARE VERSAPOINT™ Generator (code # 00482) b. GYNECARE VERSAPOINT™ Connector Cable (part # 00480)
ERROR CODE DISPLAYED Refer to the reverse side of this card for further troubleshooting instructions If problem is not resolved, restart the generator by pressing the MODE button. If the error still occurs or the generator doesn’t restart by pressing the MODE button, then turn the generator off using the ON/OFF switch. After approximately 10 seconds, turn it back on. If the error is not resolved, switch the generator off using the ON/OFF switch, then disconnect the cable, footswitch and electrode accessories from the generator. Turn the generator on using the ON/OFFswitch. If the error IS NOT resolved, then there is a malfunction with the generator.
If the error IS cleared, determine which accessory is malfunctioning by turning the generator off using the ON/OFF switch and connecting the accessories, one at a time, restarting the generator between each device. When the malfunctioning device is connected, the error code should displayed. Whichever device caused the error to be displayed is malfunctioning and should be replaced.
• Doing procedures with cold saline requires a lot of power to form the vapor pocket and it is . therefore recommended to use saline that is approximately 35¡ C (body temperature) during the procedure to improve vapor pocket formation.
• High Saline flow rates can effect vapor pocket formation and if this occurs reduce your saline. flow rate to improve vapor pocket formation. DO NOT operate with flow rates that are lower than indicated in the IFU or that compromise visibility.
• After autoclaving the connector cable it should be thoroughly dried to prevent moisture build up. Before connecting the electrode. Verify that the cable is dry – if it is not it may cause an error code 200.
• The system should only be used with Saline. Do not attempt to use non-electrolyte solutions such as Glycine, Sorbitol etc.
FOR INTERNAL USE ONLY: NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION
Troubleshooting Guide:
Gynecare Versapoint™ II Bipolar Electrosurgery System ERROR CODE
POSSIBLE REASON
ACTION
HOW TO AVOID
100: REF 10-28 200: REF 10-27
Generator Internal Hardware or Software malfunction
Disconnect all the accessories from the generator and recycle the power by unplugging the generator from the wall outlet and plugging it back to the outlet. Send generator back if the error is not resolved.
These errors were most likely introduced during the manufacturing process and cannot be avoided by the user.
200: REF 28
Generator has been exposed to low temperatures <15° C for a long time.
Expose generator for ~10minutes to temperatures >20° C and turn it ON. If the error still occurs keep repeating the step above until it is removed.
Expose generator to >20° C for at least 1 hour prior to the procedure.
200: REF 33-37
Generator Internal Hardware or Software malfunction
Disconnect all the accessories from the generator and recycle the power by unplugging the generator from the wall outlet and plugging it back to the outlet. Send generator back if the error is not resolved.
These errors were most likely introduced during the manufacturing process and cannot be avoided by the user.
200: REF 39
The power supplied to the generator through the wall outlet is outside the acceptable range by the generator.
Use power conditioner.
Do not use the generator when there is insufficient power on the Operating Room or Office settings.
200: REF 42-92
Generator Internal Hardware or Software malfunction
Disconnect all the accessories from the generator and recycle the power by unplugging the generator from the wall outlet and plugging it back to the outlet. Send generator back if the error is not resolved.
These errors were most likely introduced during the manufacturing process and cannot be avoided by the user.
200: REF 93-94
Generator Internal Software malfunction
Disconnect all the accessories from the generator and recycle the power by unplugging the generator from the wall outlet and plugging it back to the outlet. Contact Service Center how to upgrade software.
These errors were most likely introduced during the manufacturing process and cannot be avoided by the user.
300: REF 10-12
Generator internal overheating
Shut down the generator for a couple of minutes and turn it back on. If time permits allow 30 minutes before the generator is used again.
Keep Operating Room or Office environment temperature between 20-25° C.
300: REF 14-21
Shorted output. Active and Passive electrodes cross each other without any insulation. Low impedance due to cold or high flow rate of saline. Moisture build up on the connector cable due to autoclaving.
Replace the electrode and if the error is still present then replace connector cable or thoroughly dry out the connector cable currently being used.
Warm saline is recommended operating under low flow rates as long as vision is not compromised. Dry cables thoroughly after autoclaving process.
400: REF 10-14
Generator Internal Hardware or Software malfunction.
Disconnect all the accessories from the generator and recycle the power by unplugging the generator from the wall outlet and plugging it back to the outlet. Send generator back if the error is not resolved.
These errors were most likely introduced during the manufacturing process and cannot be avoided by the user.
400: REF 15-30 600: REF 20-22
One of the footswitch or generator buttons is pressed.
Make sure that nothing is being pressed. If the error still occurs disconnect the footswitch and wait a few seconds until the generator restarts. If it doesn’t then contact Service Center.
Do not press any of the buttons while the generator is starting.
FOR INTERNAL USE ONLY: NOT FOR USE WITH ANY CUSTOMERS OR FOR DISTRIBUTION
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