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00732467 Rev. D

Page

110

Definitions

APC

Argon Plasma Coagulation

CQM

Contact Quality Monitoring

ESA

Electrical Safety Analyzer

ESU

Electrosurgical Unit

IFU

Instructions For Use

LCD

Liquid Crystal Display

LED

Light Emitting Diode

Low Frequency

Magnetic Resonance

POST

Power On Self-Test

PSS

Pad Safe System

Radiofrequency

Содержание G1110001

Страница 1: ...gi4000 Electrosurgical Unit Reference Reorder No G1110001 User and Maintenance Manual ...

Страница 2: ... this date and product use please contact STERIS Endoscopy to determine if additional information is available Unless otherwise indicated all marks denoted with or are registered with the U S Patent and Trademark Office or trademarks owned by STERIS Corporation US Endoscopy is a wholly owned subsidiary of STERIS Corporation Serious incidents that have occurred in relation to this medical device sh...

Страница 3: ...dicator Lights 25 7 1 3 Pad Safe System PSS 26 7 1 4 Touchscreen 28 7 1 5 Standby Mode 29 7 1 6 Argon Gas System 30 7 1 7 Footswitch 31 7 1 8 Back Panel 32 7 1 9 Bottom Panel 33 7 2 GoCart Mobile Cart 34 8 0 Technical Specifications 35 8 1 General 35 8 2 Classifications 35 8 3 Dimensions and Weight 36 8 4 Environmental Operating Parameters 36 8 5 Environmental Transport and Storage Parameters 36 8...

Страница 4: ...4 9 2 Installation gi4000 ESU 54 9 3 Installation GoCart Mobile Cart 56 9 4 Setup Argon Gas System 57 9 4 1 Argon Gas Bottle Indicator Icons 57 9 4 2 Installing Argon Gas Bottle 58 9 4 3 Replacing Empty Argon Gas Bottle 59 9 5 Setup Lavage Pump 60 10 0 Using the gi4000 62 10 1 Pre Procedural Setup 62 10 1 1 Power ON Self Test POST 62 10 1 2 Lavage Function 64 10 2 Procedural Use 66 10 2 1 Power Se...

Страница 5: ...2 Troubleshooting 81 13 0 Maintenance and Repair 83 13 1 Periodic Inspection 84 13 2 Preventative Maintenance Testing 84 13 2 1 Device Inspection Procedure 85 13 2 2 Electrical Safety Test Procedure 86 13 2 3 RF Output Test Procedure 99 13 2 4 Internal Argon Gas Filter Replacement 104 13 3 Service Menu 106 13 3 1 Accessing Service Menu 106 13 3 2 Factory Default Power Settings 107 13 4 Pump Head R...

Страница 6: ... This page is intentionally left blank ...

Страница 7: ...puts to perform cutting and or coagulation and coagulation with or without delivery of argon gas in flexible endoscopic applications The integrated lavage pump is intended to wash tissue or mucosa within the gut when used in conjunction with washing catheters or bipolar endoscopic probes endoscope water jet channels or endoscope working channels The ArConnect argon probe connector is intended for ...

Страница 8: ...ion CQM Contact Quality Monitoring ESA Electrical Safety Analyzer ESU Electrosurgical Unit IFU Instructions For Use LCD Liquid Crystal Display LED Light Emitting Diode LF Low Frequency MR Magnetic Resonance POST Power On Self Test PSS Pad Safe System RF Radiofrequency ...

Страница 9: ...n the European Community 5 1 3 Date of Manufacture Indicates the date when the medical device was manufactured 5 1 4 Use By Indicates the date after which the medical device is not to be used 5 1 5 Batch Code Indicates the manufacturer s batch code 5 1 6 Catalog Number Indicates the manufacturer s catalogue number 5 1 7 Serial Number Indicates the manufacturer s serial number 5 2 7 Non Sterile Ind...

Страница 10: ...overy Recyclable Indicates that the marked item is part of a recovery or recycling process ISO 7010 Graphical Symbols Safety Colours and Safety Signs Registered Safety Signs M002 Follow Instructions for Use Refer to instruction manual booklet W012 Warning Electricity Use caution to avoid coming into contact with electricity when working with high voltage terminals IEC 60417 Graphical Symbols for U...

Страница 11: ...fibrillation proof type CF applied part complying with IEC 60601 1 All HF receptacles and the PSS receptacle applied parts meet Type CF requirements and are protected against the effects of defibrillator discharge IEC 60601 2 2 Medical Electrical Equipment Part 2 2 Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgica...

Страница 12: ... equipment N A N A Monopolar Receptacle Indicates the receptacle by means of which an 8 mm monopolar active cord is connected to the equipment N A N A Bipolar Receptacle Indicates the receptacle by means of which a bipolar device with a co axial style plug is connected to the equipment N A N A Decrease Water Flow Indicates the switch by means of which the water flow rate output of the irrigation p...

Страница 13: ...ated N A N A Irrigation Pedal Indicates the pedal by means of which the irrigation pump output is activated N A N A Note Indicates an operating tip or general information useful for operating or servicing the equipment N A N A Standards Compliance This certification symbol on the gi4000 ESU indicates it is listed by Intertek Testing Services as meeting the requirements of AAMI ES IEC 60601 1 IEC 6...

Страница 14: ...oper maintenance methods which may damage the equipment or render it unsafe It is important to understand that these warnings and precautions are not exhaustive customers are encouraged to develop their own safety policies and procedures to enhance and complement these warnings and precautions DANGER Indicates an imminently hazardous situation which if not avoided could result in death or serious ...

Страница 15: ...endoscopic procedure WARNING A thorough understanding of the technical principles of endoscopic electrosurgery is necessary before using these devices WARNING Hazardous Electrical Output DO NOT use electrosurgical equipment unless trained to use it properly in accordance with this Manual Use of this equipment without such training can result in serious patient injury or death or damage to equipmen...

Страница 16: ...r devices can be determined by turning this equipment ON and OFF When doing so observe the equipment in the installation area for abnormal behavior Try to correct the interference using one or more of the following Reorient or relocate the receiving device Increase the separation between the gi4000 ESU and other electrical equipment Connect the gi4000 ESU to a receptacle on a different circuit fro...

Страница 17: ...ock and damage to property the gi4000 ESU power cord must ONLY be connected to a properly grounded power supply mains receptacle with a protective earth Use ONLY the STERIS Endoscopy power cord with the gi4000 ESU STERIS Endoscopy recommends connecting the power plug of the power cord directly to a hospital grade grounded wall outlet green dot or to a multiple power socket outlet equipped with an ...

Страница 18: ... be sure they are properly attached Be sure that the attachment clip covers the gel free connecting lugs or tabs so that they do not contact the patient s skin Ensure the patient dispersive electrode makes complete contact with the patient s skin The user should continuously check the patient dispersive electrode throughout the procedure and during the procedure if the patient is repositioned is i...

Страница 19: ...h the patient or other leads is avoided because the capacitance between the electrode cable and the patient may result in some local high current densities causing thermal burns to the patient Needle monitoring electrodes are not recommended as their small surfaces allow for high current density Keep the active electrode at least 15 cm 6 inches away from any monitoring electrode DO NOT place the a...

Страница 20: ...ly activated when not in Standby Mode DO NOT activate the gi4000 ESU in open circuit conditions Activate ONLY when the active accessory is in view and near or touching target tissue DO NOT use worn or ill fitting active cords dispersive electrode cables or connector adapters as shock or burn can occur DO NOT leave the active accessory in the patient when not in use WARNING Burn Hazard The user sho...

Страница 21: ...lower than 40 inspired oxygen fraction to prevent acceleration of combustion is recommended If used in the GI tract CO2 insufflation is recommended in place ambient air insufflation To avoid the risk of bowel explosion an adequate bowel preparation is required DO NOT point probe at or near flammable materials WARNING Gas Embolism and Intraluminal Gas Pressure Hazard The argon gas flow rate should ...

Страница 22: ...us and in body cavities Any fluid pooled in these areas should be removed before activating the gi4000 ESU WARNING Burn Hazard If the gi4000 ESU is activated and activation DOES NOT stop when the footswitch is released DO NOT remove the active accessory or endoscope from the patient as this may result in serious injury to the patient and or user and or damage to property and equipment If this were...

Страница 23: ... disposable or single use only as it may result in patient or user injury or equipment damage WARNING Fire Hazard It is recommended that the gi4000 ESU and GoCart Mobile Cart not be cleaned with flammable detergents and disinfectants as they may cause a risk of fire resulting in serious injury to the patient and or user or equipment and or property damage Reference section 13 0 Maintenance and Rep...

Страница 24: ...ed on a periodic basis Failure to perform these inspections may result in compromised safety unit malfunction injury to the user and or patient or costly damage to the unit and or other equipment DANGER Equipment Damage Hazard Blown line fuses may ONLY be replaced by fuses which have the same rating as the one specified on the rear panel of the gi4000 ESU Use of incorrect line fuses may result in ...

Страница 25: ... or failure Reference section 8 5 Technical Specifications Environmental Transport and Storage Parameters for manufacturer recommended Transport and Storage parameters If the equipment was transported or stored below or above the recommended temperature pressure and humidity levels the equipment will require a certain acclimation time at a specified temperature range Insufficient acclimatization t...

Страница 26: ... electrosurgical accessories that can withstand the maximum output voltage for each output mode listed in section 8 8 Technical Specifications Output Power Use of an accessory which is rated lower than the listed maximum output voltage may result in injury to the patient or user or damage to equipment or property Reference Instructions for Use provided by the accessory manufacturer for information...

Страница 27: ...incompatibility CAUTION MRI Compatibility Hazard Do not use the gi4000 in an environment where it could be exposed to MRI systems This device has not been tested for Magnetic Resonance compatibility CAUTION Personal Injury and Equipment Damage Hazard DO NOT spray any cleaning product directly onto the system components Dampen a soft cloth with the cleaning solution and wring out the excess moistur...

Страница 28: ...to activate both energy delivery Monopolar or Bipolar AND lavage concurrently NOTE When a Fault displays on the screen reset the gi4000 ESU by turning the power ON OFF switch OFF and back ON If the Fault clears the screen the gi4000 ESU can be put back into service If the Fault does not clear from the screen contact STERIS Customer Service at 1 800 769 8226 or your local STERIS Endoscopy Electrosu...

Страница 29: ... adjustable via the touchscreen display located on the front of the unit The gi4000 ESU irrigation pump allows for the delivery of a variable pressurized lavage to improve visualization during endoscopic procedures The gi4000 ESU is equipped with the Pad Safe System PSS assuring adequate contact between the patient and the dispersive electrode This system constantly monitors patient pad contact wh...

Страница 30: ...Lights 6 Lavage Pump ON Light 7 Argon Gas Bottle with Grip 8 Pump Head Lid 9 Sterile Water Bottle Holder 10 Pump Head 11 Pump Head Tubing Adjustments 12 Bipolar Receptacle 13 Information Tray 14 Monopolar Receptacle 15 ArConnect Argon Probe Receptacle 16 PSS Return Receptacle for dispersive electrode 17 PSS Indicator Light 1 16 15 14 12 11 3 4 5 6 7 9 2 17 10 8 13 Figure 7 1 ...

Страница 31: ...ains power supply source and the power ON OFF switch is in the ON position denoted by an I the lavage pump is active The pump activates at a default flow rate Setting 3 and can be adjusted by pressing the UP and DOWN arrows located to the LEFT of the LED indicators The number of GREEN LED lights illuminated indicates the flow rate setting increasing the number of LED lights increases the lavage fl...

Страница 32: ... is both attached to the generator and to the patient but an unsafe situation is detected OR a dispersive electrode fault unsafe situation is detected with either type of pad while energy is being delivered OR a Sensing Split dispersive electrode was attached to the patient while the generator was in STANDBY Mode Dispersive Electrode Type Possible Notification Action Any WARNING No Pad Detected Co...

Страница 33: ...em PSS will function with contact quality monitoring CQM Sensing Split dispersive electrodes or Non Sensing Non Split dispersive electrodes Other dispersive electrode products may result in patient or user injury and or product damage In order for all safety aspects of the gi4000 Pad Safe System PSS to operate Sensing Split dispersive electrodes must be used Non Sensing Non Split dispersive electr...

Страница 34: ... the Argon Method is selected the user can change the power the rate of argon gas flow and monitor the volume of gas remaining in the disposable argon gas bottle Optionally the user can see and use alternative default power settings for an accessory type represented by the pictogram by engaging the Tap a Tool software feature To do so the user simply taps the picture of the accessory of choice The...

Страница 35: ...d either by the standby button on the gi4000 ESU footswitch or the standby icon on the upper left hand side of the touchscreen display The standby icon is visible in all methods modes When Standby Mode is activated a standby screen will appear on the touchscreen display To exit Standby Mode you can either touch anywhere on the touchscreen display or press the standby button on the footswitch Figur...

Страница 36: ... is to be discarded along with the argon bottle when empty The integrated argon system is designed for use with STERIS Endoscopy ArConnect argon probe connector The single use ArConnect argon probe connector has a standard argon plasma coagulation APC probe connector fitting which is compatible with many APC probes on the market Attach disposable argon probes to the gi4000 ESU using the single use...

Страница 37: ...OT be active at the same time Standby Mode is activated and released by the black circular button located between the pedals The gi4000 footswitch is waterproof and fully submersible for cleaning EXCEPT for the footswitch connector Reference section 10 3 2 Care Cleaning and Storage for detailed cleaning instructions Figure 7 12 1 Carry Handles x2 2 Footswitch Cable 3 Standby Button 4 Power ON OFF ...

Страница 38: ...67 Rev D Page 32 of 110 7 1 8 Back Panel 1 Vent Ports 2 Footswitch Receptacle 3 Equipotential Grounding Terminal 4 AC Mains Connector with Integrated Fuses and Cord Lock 5 Speaker Ports 1 2 4 3 5 Figure 7 13 ...

Страница 39: ...00732467 Rev D Page 33 of 110 7 1 9 Bottom Panel 1 Non Slip Rubber Feet x4 2 Information Tray 3 Vent Ports 1 2 1 3 Figure 7 14 ...

Страница 40: ...sembly Instructions provided with cart for proper assembly prior to installation of the gi4000 ESU In this manual see section 8 0 Technical Specifications for cart specifications and section 9 3 Installation GoCart Mobile Cart for installation and use 1 Front and Rear Handles 2 gi4000 Specific Mounting Plate 3 Accessory Baskets 4 Front Locking Casters NOTE The GoCart Mobile Cart is sold separately...

Страница 41: ...EC 60601 1 requirements 8 2 Classifications Type of Protection Against Electrical Shock Class I IEC 60601 1 Degree of Protection Against Electrical Shock Type CF Equipment IEC 60601 1 Defibrillation Proof Applied Parts Applied parts are the electrosurgical accessories connected to the output receptacles of the unit including but not limited to dispersive electrodes ArConnect argon probe connector ...

Страница 42: ...0 to 1060 hPa 8 5 Environmental Transport and Storage Parameters Temperature 40 to 158 F 40 to 70 C Humidity 10 to 95 non condensing Atmospheric Pressure 14 8 to 31 3 in Hg 500 to 1060 hPa Acclimation If the gi4000 ESU has been stored or transported at temperatures below 50 to 104 F 10 to 40 C the unit will require approximately three 3 hours to acclimate at room temperature 59 to 77 F 15 to 25 C ...

Страница 43: ...ually decreasing from 784 Hz to 262 Hz All Warnings repeating pattern from 784 Hz and 494 Hz 8 7 Input Power General Input Characteristics Input Mains Voltage Full Regulation 100 240 V Mains Line Frequency Range Nominal 50 60 Hz Input Mains Current 100 V 5 0A 120 V 4 0A 240 V 2 0A Power Cord ONLY use STERIS Endoscopy provided Power Cords Nominal Input Current Characteristics gi4000 ESU 120V 50 60 ...

Страница 44: ...ts Rated Load ohms Voltage Open Circuit Max VPeak Operating Frequency Typical kHz Duty Cycle On time Off time Typical Crest Factor at Rated Load MONOPOLAR CUT CUT 200 500 900 350 100 1 4 PULSE CUT 120 300 1300 350 100 Pulsed ON 50ms OFF 700 ms 1 4 BLEND CUT 200 500 1950 350 50 2 7 PULSE BLEND CUT 120 500 4400 350 50 Pulsed ON 50ms OFF 700 ms 2 7 MONOPOLAR COAG BLEND COAG 120 500 2700 350 12 6 3 CO...

Страница 45: ...ral All RF Active and Patient Plate Line Polarity to Nominal Ground Open 10 A Line Polarity Reversed Ground Open 150 A Radio Frequency RF Leakage Current Monopolar Method All Modes at Maximum Power Setting Patient Plate to Ground 150 A Active to Ground 150 A Bipolar Method Maximum Power Setting Each Lead to Ground 54 A 8 11 Output Power vs Resistance Graphs The below graphs show characteristics fo...

Страница 46: ...0 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance CUT Mode Power vs Load Resistance CUT200 CUT100 CUT Default35 0 20 40 60 80 100 120 140 160 180 200 0 20 40 60 80 100 120 140 160 180 200 Output Power Power Setting CUT Mode Output Power vs Power Setting into 500 ohm Load Figure 8 2 ...

Страница 47: ... 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance Pulse CUT Mode Power vs Load Resistance Pulse CUT 120 Pulse CUT 60 Pulse CUT Default35 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting Pulse CUT Mode Output Power vs Power Setting into 300 ohm Load ...

Страница 48: ...600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance Blend CUT Mode Power vs Load Resistance Blend CUT 200 Blend CUT 100 Blend CUT Default35 0 20 40 60 80 100 120 140 160 180 200 0 20 40 60 80 100 120 140 160 180 200 Output Power Power Setting Blend CUT Mode Output Power vs Power Setting into 500 ohm Load ...

Страница 49: ...1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance Pulse Blend CUT Mode Power vs Load Resistance Pulse Blend CUT120 Pulse Blend CUT60 Pulse Blend CUTDefault 35 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting Pulse Blend CUT Mode Output Power vs Power Setting into 500 ohm Load ...

Страница 50: ... 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance Blend COAG Mode Power vs Load Resistance Blend COAG 120 Blend COAG 60 Blend COAG Default20 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting Blend COAG Mode Output Power vs Power Setting into 500 ohm Load ...

Страница 51: ... 500 600 700 800 900 1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance COAG Mode Power vs Load Resistance COAG 120 COAG 60 COAG Default20 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting COAG Mode Output Power vs Power Setting into 500 ohm Load ...

Страница 52: ...00 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance TouchSoft Mode Power vs Load Resistance SoftCOAG 120 SoftCOAG 60 SoftCOAG Default50 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting TouchSoft Mode Output Power vs Power Setting into 100 ohm Load Figure 8 20 Figure 8 21 ...

Страница 53: ...1000 1100 1200 1300 1400 1500 1600 1700 1800 1900 2000 Output Power Load Resistance ARGON Mode Power vs Load Resistance ARGON 120 ARGON Default60 0 10 20 30 40 50 60 70 80 90 100 110 120 0 10 20 30 40 50 60 70 80 90 100 110 120 Output Power Power Setting ARGON Mode Output Power vs Power Setting into 500 ohm Load Figure 8 23 Figure 8 24 ...

Страница 54: ...00732467 Rev D Page 48 of 110 8 11 9 Bipolar Method Figure 8 25 Figure 8 26 Figure 8 27 ...

Страница 55: ...ic Environment Guidance RF emissions CISPR 11 Group 1 The gi4000 ESU intentionally emits RF energy at 350 kHz and 460 kHz as this is the therapy being delivered It must comply with Group 1 emissions when switched on with the RF output not energized RF emissions CISPR 11 Class A The gi4000 ESU is suitable for use in all commercial establishments other than domestic and those directly connected to t...

Страница 56: ... line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70...

Страница 57: ...absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should...

Страница 58: ...0 MHZ TO 800 MHZ P d 3 5 3 800 MHZ TO 2 5 GHZ P d 3 7 0 01 W 0 12 m 0 12 m 0 23 m 0 1 W 0 37 m 0 37 m 0 74 m 1 W 1 17 m 1 17 m 2 33 m 10 W 3 69 m 3 69 m 7 38 m 100 W 11 67 m 11 67 m 23 33 m For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is...

Страница 59: ...ng power settings and surgical energies when the operator has activated the desired clinical characteristics at the lowest setting and shortest activation time to achieve desired clinical effect providing safe and efficacious surgical effects when the generator is placed into and setup properly for flexible endoscopic surgical procedures providing safe and efficacious surgical effects only when ac...

Страница 60: ...The gi4000 ESU should be placed on a stable horizontal surface If a mobile cart is to be used be certain that it provides adequate stability and strength to support the electrosurgical unit and accessories Users may choose to use the optional GoCart Mobile Cart If using the GoCart Mobile Cart reference section 9 3 System Installation and Setup Installation GoCart Mobile Cart 5 Prior to connecting ...

Страница 61: ...On Self Test POST is not successful an alarm will sound and a FAULT message will be displayed on the touchscreen All system output will be disabled Reference section 12 0 Troubleshooting for actions to correct the error or contact STERIS Customer Service or your local STERIS Endoscopy Electrosurgery Specialist 11 An on screen prompt for factory default settings will appear press OK on the touchscr...

Страница 62: ...5 System accessories can be placed in the lower and upper baskets on the GoCart Mobile Cart for easy access WARNING Pinch Point Hazard When installing the gi4000 ESU on the GoCart Mobile Cart pinch points are created underneath the gi4000 ESU Watch hands and fingers when placing the gi4000 ESU on the mobile cart plate WARNING Personal Injury and or Equipment Malfunction DO NOT wrap accessory cords...

Страница 63: ...le is not detected The Argon Gas Bottle is detected and full The Argon Gas Bottle is about half consumed Be sure that backup stock is available The Argon Gas Bottle is nearly empty The Argon Gas Bottle is empty RED outline is blinking The following message will appear Finish case then vent and replace Prepare to vent discard and replace the bottle RED outline is no longer blinking The bottle has s...

Страница 64: ...other than the gi4000 argon gas bottle or to attach argon probe accessories to the gi4000 ESU in any way other than by the use of the ArConnect argon probe connector may pose a serious hazard to patients and users NOTE It is recommended that the water bottle holder be removed during installation and removal of the argon gas bottle for easier access to the argon port NOTE Continue turning clockwise...

Страница 65: ... either the trash or the recycling according to your facility standards WARNING Venting and Discarding Argon Gas Bottles ALWAYS remove the argon coagulation accessory device from the patient in the event that the argon gas bottle becomes empty and needs to be replaced Disconnect the ArConnect probe connector from the gi4000 ArConnect probe connector receptacle Reconnect all accessories ONLY after ...

Страница 66: ...market You can use a number of irrigation tubing sets from different manufacturers with the gi4000 ESU STERIS Endoscopy recommends the use of Torrent irrigation tubing Table 9 1 Product Number Tubing Inner Diameter Tubing Wall Thickness 00711561 3 2 mm setting 1 6 mm setting 1 Ensure power to the gi4000 ESU is OFF 2 Lift up on the pump head lid until it is in the OPEN position WARNING Pinch points...

Страница 67: ...3 To adjust the pump head to accommodate a different irrigation tubing size move the dials on BOTH sides of the pump head until the 1 6 pointer indicates the size of tubing that is desired Figure 9 6 Tubing Wall Thickness Tubing Inner Diameter ...

Страница 68: ...wer cord for cuts fraying or insulation damage Visually inspect the power cord lock and power cord receptacle The power cord lock should be secure and the receptacle should have the fuse box fully installed Verify the power cord fits securely in the power cord receptacle Visually inspect the water bottle holder The bracket should be secured tightly to the holder Visually inspect the argon bottle p...

Страница 69: ...screen function by pressing each method and mode of operation on the LCD Verify the functionality of Standby Mode by pressing the standby icon on the touchscreen display To exit Standby Mode press anywhere on the LCD To verify footswitch functionality complete the following i Ensure there is no patient dispersive electrode attached to the PSS receptacle Press the power pedal A notification should ...

Страница 70: ...he positional markers on the irrigation tubing and insert into the pump head between the positional markers 7 While placing the irrigation tubing into the pump head grasp the tubing together and gently pull upward as shown in Figure 10 1 This will ensure that the irrigation tubing is centered and aligned properly in the Pump Head to avoid kinking tearing or disruption of water flow 8 Ensure the ir...

Страница 71: ...uring device setup replacement of water bottles and between patient uses WARNING Biohazard Exposure to bodily fluids may occur during the connection or disconnection of the irrigation tubing The user is responsible for adhering to Body Substance Isolation protocols NOTE The ultimate water flow rate will be defined by the smallest size lumen used with any tubing or accessory attached The pump activ...

Страница 72: ... DEFAULT SETTINGS All power defaults listed in Table 10 1 are suggested ranges for typical use denoted in watts W The final power output chosen must always be the decision of the physician Good electrosurgery practice recommends using the lowest power possible for effective completion of the therapy Table 10 1 Method Mode Output Power Range Default Power Tap a Tool Alternate Default Power Argon 0 ...

Страница 73: ...es used in flexible endoscopic procedures with electrosurgery generators The pictograms do not indicate any specific brand of such accessories Double Tapping Double tapping touching quickly twice the active Argon or Bipolar Method buttons will revert Argon or Bipolar Method s to their default power settings Double tapping the active Monopolar Method button will Revert the screen to Monopolar Coag ...

Страница 74: ...the user via the touchscreen display There are three 3 user selectable electrosurgical output methods Monopolar Bipolar and Argon The Monopolar Method has seven 7 subset Modes TouchSoft Coag Blend Coag Pulse Blend Cut Blend Cut Pulse Cut and Cut When a Method Mode has been selected a default power setting is displayed that is an appropriate power suggestion for any and all of the accessories pictu...

Страница 75: ...uring use or if impedance conditions change to a level outside the unit s acceptable level during the procedure the unit is designed to sound an alarm notify the user via a message and prevent the system from outputting energy The dispersive electrode warning must be corrected for operation to resume In order for all safety aspects of the gi4000 Pad Safe System PSS to operate sensing or split mode...

Страница 76: ...in electrosurgical burns at the patient dispersive electrode site DO NOT cut a patient dispersive electrode to reduce its size as this may result in patient burns due to high current density in the smaller patient dispersive electrode Place dispersive electrodes in the most suitable position that is closest to the operating site Choose a site that is muscular and well vascularized Never attach the...

Страница 77: ...n on the gi4000 footswitch 8 Confirm settings on touchscreen before proceeding with procedure 9 Deliver power by engaging the power pedal on the footswitch 10 2 6 Argon Method 1 Select Argon Method 2 Check the amount of argon gas in the argon gas bottle Verify the status of the argon gas bottle icon on the touchscreen display If the argon bottle is red or flashing vent the tank to empty and replac...

Страница 78: ...the argon system has been primed the gi4000 will continue to purge the argon line every 30 seconds in all methods modes The gi4000 will continue to auto purge until the system power is cycled OFF ON or argon coagulation has not been activated for 30 minutes An audible click can be heard each time the auto purge activates 11 When not in use the ArConnect argon probe connector should be removed from...

Страница 79: ...ect the footswitch connector from the footswitch receptacle Loosely coil the footswitch cable to avoid kinking and store 9 Disconnect the power cord from the wall outlet by pulling on the plug DO NOT pull the power cord by the cable section Loosely coil the power cord and secure in the gi4000 accessory cord clip 10 3 2 Care Cleaning and Storage Care and Cleaning WARNING Personal Injury and or Equi...

Страница 80: ...al damage The storage area should have temperature humidity and pressure characteristics as described in section 8 5 Technical Specifications Environmental Transport and Storage Parameters and be free of any risk of water leakage or splashes Storage It is recommended that the gi4000 ESU be thoroughly checked by a qualified biomedical engineer if it has been stored for longer than one 1 year Allow ...

Страница 81: ...with the gi4000 ESU 11 2 Neutral Electrodes The gi4000 Pad Safe System PSS is designed to be used with non sensing non split and sensing split neutral electrodes Before use verify gi4000 ESU compatibility with the neutral electrode manufacturer STERIS Endoscopy recommends the use of sensing split neutral electrodes with the gi4000 ESU For additional information regarding the Pad Safe System see se...

Страница 82: ...pts to various sizes of irrigation tubing currently available to the flexible endoscopy market You can use a number of irrigation tubing sets from different manufacturers with the gi4000 ESU STERIS Endoscopy recommends the use of Torrent irrigation tubing Product Number Tubing Inner Diameter Tubing Wall Thickness 00711561 3 2 mm setting 1 6 mm setting 11 6 Footswitch The gi4000 ESU is only compati...

Страница 83: ...place the Argon Gas Bottle See section 9 4 3 System Installation and Setup Replacing Empty Argon Gas Bottle WARNING Power Supply Calibration Required Medium Priority Finish procedure then Contact STERIS Customer Service for equipment service WARNING Main Calibration Required Medium Priority Finish case then Contact STERIS Customer Service for equipment service WARNING No Pad Detected Medium Priori...

Страница 84: ...um Priority Continue turning clockwise firmly until the bottle is fully engaged This can be anywhere from to 2 full turns tighter even after seeing the GREEN Argon Gas Bottle icon appear Do not stop turning until the bottle is fully seated and cannot be turned any tighter to prevent argon from leaking at the bottle If the GREEN Argon Gas Bottle icon does not appear remove the bottle by turning cou...

Страница 85: ...ces High Priority Remove and re install the Argon Gas Bottle See section 9 4 2 System Installation and Setup Installing Argon Gas Bottle Cycle unit power If POST is successful go to Argon Method and push PURGE If the fault does not reappear the gi4000 is OK to use If POST is not successful or if purging triggers the fault screen contact STERIS Customer Service for equipment service FAULT FPGA argo...

Страница 86: ...fault screen returns then Contact STERIS Customer Service FAULT SLCD macro file version failure Contact Technical Services High Priority Contact STERIS Customer Service FAULT SLCD communications failure Contact Technical Services High Priority Contact STERIS Customer Service FAULT Disconnect Stuck Footswitch High Priority Footswitch may be sticky or dirty Soak and clean Do NOT submerse Footswitch ...

Страница 87: ...Power Line Cord to the AC Mains Connector on the rear panel of the unit and snap the Cord Lock into place Connect the Power Line Cord into the wall outlet Check both fuses in the AC Mains Connector on the rear of the gi4000 Check ON OFF switch Touchscreen does not illuminate Confirm that the gi4000 will Power ON see above Touchscreen is illuminated but unresponsive Touchscreen calibration required...

Страница 88: ...ighter even after seeing the GREEN Argon Gas Bottle icon appear Do not stop turning until the bottle is fully seated and cannot be turned any tighter to prevent argon from leaking at the bottle Backflow into the ArConnect Receptacle Do not disconnect ArConnect argon probe or argon probe from the gi4000 until the procedure is complete The positive pressure system will constantly flow argon through ...

Страница 89: ...ssor power cords If necessary work with your endoscope manufacturer to purchase shielded video cables or auxiliary endoscope grounding cables 13 0 Maintenance and Repair The maintenance and repair procedures recommended by STERIS Endoscopy are described in this section of the manual Only these recommended maintenance procedures should be followed A listing of the safety precautions to be observed ...

Страница 90: ...i4000 ESU should undergo preventive maintenance testing annually NOTE When performing electrical testing which requires the use of test leads test leads should be fully stretched out and not touching each other or any conductive surfaces including the floor A thorough preventative maintenance program is essential to safe and proper equipment operation Comprehensive instructions for annual preventa...

Страница 91: ...ctor and fuse box for looseness signs of damage 5 Inspect fuses for damage 6 Inspect the vent ports for any dust or debris Clean by wiping with cloth or spray with air vacuum if necessary 7 Inspect the speaker ports for any dust or debris Clean by wiping with cloth or spray with air vacuum if necessary Bottom Panel Inspection 1 Inspect the bottom panel of the gi4000 for major scratches indentation...

Страница 92: ...Reference Figure 13 1 below 2 Connect the ESA power cord to a grounded AC mains outlet with appropriate voltage current rating 3 Connect the gi4000 power cord to the Equipment DUT Outlet on the ESA 4 Power ON the ESA 5 Using test leads connect the gi4000 equipotential ground connector on the rear panel of the gi4000 ESU to the input receptacle on the front panel of the ESA 6 Record the measured va...

Страница 93: ...cle on the front panel of the ESA 4 Measure the earth leakage in the following three 3 test conditions Normal Condition NORMAL POLARITY CLOSED NEUTRAL CLOSED EARTH Single Fault Condition No 1 REVERSE POLARITY OPEN NEUTRAL CLOSED EARTH Single Fault Condition No 2 NORMAL POLARITY OPEN NEUTRAL CLOSED EARTH 5 Record the measured value from the ESA on the 00732974 Preventative Maintenance Test Data Sum...

Страница 94: ... of the gi4000 ESU to the input receptacle on the front panel of the ESA 5 Measure low frequency LF leakage current between the chassis of the gi4000 ESU and the ESA in the following two 2 test conditions Normal Condition NORMAL POLARITY CLOSED NEUTRAL OPEN EARTH Single Fault Condition REVERSE POLARITY CLOSED NEUTRAL OPEN EARTH 6 Record the measured value from the ESA on the 00732974 Preventative ...

Страница 95: ...ESA 5 Measure low frequency LF leakage current between the active portion of the argon receptacle on the gi4000 ESU and the ESA in the following two 2 test conditions Normal Condition Test NORMAL POLARITY CLOSED NEUTRAL OPEN EARTH Single Fault Condition Test REVERSE POLARITY CLOSED NEUTRAL OPEN EARTH 6 Record the measured value from the ESA on the 00732974 Preventative Maintenance Test Data Summar...

Страница 96: ...low frequency LF leakage current between the Monopolar Receptacle on the gi4000 ESU and the ESA in the following two 2 test conditions Normal Condition Test NORMAL POLARITY CLOSED NEUTRAL OPEN EARTH Single Fault Condition Test REVERSE POLARITY CLOSED NEUTRAL OPEN EARTH 6 Record the measured value from the ESA on the 00732974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU 7 Unplug the ...

Страница 97: ...e current between the Bipolar Receptacle on the gi4000 ESU and the ESA in the following two 2 test conditions Normal Condition Test NORMAL POLARITY CLOSED NEUTRAL OPEN EARTH Single Fault Condition Test REVERSE POLARITY CLOSED NEUTRAL OPEN EARTH 6 Record the measured value from the ESA on the 00732974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU 7 Disconnect the test leads from the p...

Страница 98: ...n the PSS Receptacle on the gi4000 ESU and the ESA in the following two 2 test conditions Normal Condition Test NORMAL POLARITY CLOSED NEUTRAL OPEN EARTH Single Fault Condition Test REVERSE POLARITY CLOSED NEUTRAL OPEN EARTH 5 Record the measured value from the ESA on the 00732974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU 6 Disconnect the test leads from the PPS Receptacle on the...

Страница 99: ...for RF output testing 4 Connect the opposite end of the test lead to the active receptacle on the ESU Analyzer as shown in Figure 13 10 below 5 Connect the ground lead to the earth connector on the ESU Analyzer and the ground terminal on the rear panel of the gi4000 6 Connect a dummy dispersive electrode test lead to the PSS Receptacle on the gi4000 ESU to receive yellow indicator as shown in Figu...

Страница 100: ...00732467 Rev D Page 94 of 110 Figure 13 10 RF Leakage Measurement Test Diagram Argon Active and Dispersive Figure 13 11 RF Leakage Measurement Test Diagram Dispersive Electrode ...

Страница 101: ... 6 Reference Figure 13 13 below 7 Connect the earth ground test lead to the ground terminal on the rear panel of the gi4000 ESU 8 Connect the earth ground lead to the earth ground input receptacle on the ESU Analyzer 9 Connect a dummy dispersive electrode test lead to the PSS Receptacle on the gi4000 ESU to receive yellow indicator as shown in Figure 13 12 below 10 Measure the RF leakage current f...

Страница 102: ...he bipolar test lead 6 Record the measured value from the ESU Analyzer on the 00732974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU 7 Disconnect the active test lead from the active input on the ESU Analyzer 8 Reference Figure 13 15 below 9 Connect the other bipolar test lead dispersive to the active input receptacle on the ESU Analyzer 10 Adjust the power setting on the gi4000 ESU ...

Страница 103: ...00732467 Rev D Page 97 of 110 Figure 13 14 RF Leakage Measurement Test Diagram Bipolar Active Figure 13 15 RF Leakage Measurement Test Diagram Bipolar Dispersive ...

Страница 104: ...2974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU Dispersive Electrode Configuration CQM Test Part 2 Sensing Mode 1 Reference Figure 13 16 below 2 Disconnect one 1 of the dispersive electrode test leads from the resistance decade box or ESU Analyzer 3 Set the resistance on the measuring device to 100 Ω 4 Reconnect the dispersive electrode test lead to the resistance decade box or ES...

Страница 105: ...e on the rear panel of the gi4000 ESU 2 Connect the power cord to the power cord receptacle on the rear panel of the gi4000 ESU Then plug the gi4000 power cord into a grounded AC mains outlet with appropriate input ratings as listed in section 8 7 Input Power of this manual 3 Power on the gi4000 ESU 4 Set up your ESU Analyzer per the instructions provided by the ESU Analyzer manufacturer 5 Select ...

Страница 106: ...e PSS receptacle on the front panel of the gi4000 ESU 11 Connect the neutral electrode leads to the ESU analyzer 12 For this test the following monopolar output mode s shall be measured a TouchSoft COAG b COAG c BLEND COAG d BLEND CUT e CUT 13 Reference 00732974 Preventative Maintenance Test Data Summary Sheet gi4000 ESU for applicable test settings for each monopolar mode 14 Record the measured v...

Страница 107: ... below 4 Connect the Bipolar Test Adaptor to the Bipolar Receptacle on the front panel of the gi4000 ESU 5 Connect the BLACK dispersive electrode lead of the Bipolar Test Adaptor into the DISPERSIVE RECEPTACLE on the ESU Analyzer 6 Connect the RED active electrode lead of the Bipolar Test Adaptor into the ACTIVE RECEPTACLE on the ESU Analyzer 7 Reference 00732974 Preventative Maintenance Test Data...

Страница 108: ...ct Receptacle as shown in Figure 13 20 below the left port can be ignored for RF output testing 5 Reference Figure 13 21 below 6 Connect the opposite end of the test lead to the active receptacle on the ESU Analyzer 7 Connect the neutral electrode leads to the PSS Receptacle on the front panel of the gi4000 8 Connect the neutral electrode leads to the ESU analyzer 9 Reference 00732974 Preventative...

Страница 109: ...00732467 Rev D Page 103 of 110 Figure 13 21 Argon RF Output Test Diagram ...

Страница 110: ...d is disconnected from the wall outlet and the power cord receptacle on the rear panel of the unit 2 Remove all cover screws a Five 5 on back panel b One 1 on left side panel as viewed from front c One 1 on right side panel as viewed from front 3 Remove two 2 screws and gas bottle tube cap as shown in Figure 13 23 below Figure 13 23 4 Remove the gi4000 cover by sliding it backwards and lifting up ...

Страница 111: ...ckwise 7 Install new filter by threading luer fittings into filter ends and secure by turning clockwise Ensure that the molded text on the filter is facing the IN label on the argon tubing as shown in Figure 13 25 Figure 13 25 8 Dispose of used filter in accordance with your facility procedures and policies ...

Страница 112: ...aintenance information is available to be viewed on the touchscreen display when this area is accessed 13 3 1 Accessing Service Menu To access the service information menu 1 Go to the Bipolar Method screen 2 TOUCH and HOLD the top right corner of the Power Bar for four to five seconds 3 Release when the Service Menu appears Figure 13 26 ...

Страница 113: ...s using the UP DOWN arrow keys on the Power Bar Access limited settings parameters are listed in Table 13 1 below First values are for the overall Method Mode default others are for the individual Tap a Tool default parameters All numbers are in watts Table 13 1 MONOPOLAR METHOD LOW HIGH TouchSoft Overall 10 80 TouchSoft Coagulator 10 80 Forceps 10 80 COAG Overall 10 50 Snare 10 50 Forceps 10 30 B...

Страница 114: ... counter clockwise to align the keyed slot on the back of the pump head with the drive shaft on the pump head mounting plate Once aligned rotate the pump head 45 clockwise until it locks into position see Figure 13 30 and Figure 13 31 6 Visually verify the pump head and the pump head mounting plate are aligned 7 Open and close the pump head lid visually verify it opens and closes completely 8 Reco...

Страница 115: ... unit to remove the fuse holder from the power cord receptacle see Figure 13 32 4 Replace the fuses as marked on the rear panel of the unit see Figure 13 33 5 Holding the unit in place reinstall the fuse holder into the power cord receptacle The fuse holder will click into place 6 Reconnect the power cord to the rear panel of the unit and the wall outlet 7 Switch the power ON OFF switch to the ON ...

Страница 116: ... regulated waste in compliance with federal state and local regulations Please contact STERIS Endoscopy Customer Service at 1 800 769 8226 or your local STERIS Endoscopy Electrosurgery Specialist for assistance in decommissioning equipment Argon Gas Bottle Disposal regulations require that argon gas bottles be empty before being discarded or recycled The gi4000 ESU venting cycle is designed to ven...

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