GS1000 Insufflator Instruction Manual Rev AB Oct 2010

Proprietary Information This manual contains information deemed proprietary to Linvatec Corporation. The information contained herein, including all of the designs and related materials, is the sole property of ConMed Linvatec and/or its licensors. ConMed Linvatec and/or its licensors reserve all patent, copyright and other proprietary rights to this document, including all design, manufacturing methodology and reproduction. This document, and any related materials, is confidential and is protected by copyright laws and shall not be duplicated, transmitted, transcribed, stored in a retrieval system, or translated into any human or computer language in any form or by any means, electronic, mechanical, magnetic, manual or otherwise, or disclosed to third parties, in whole or in part, without the prior express written consent of ConMed Linvatec. ConMed Linvatec reserves the right to revise this publication and to make changes from time to time in the contents hereof without obligation to notify any person of such revision or changes, unless otherwise required by law. Linvatec, Hall, and CPS are trademarks or registered trademarks of Linvatec Corporation. Manufactured for Linvatec Corporation EC Representative: ConMed Linvatec Biomaterials Ltd. Hermiankatu 6-8L 33720 Tampere FINLAND

© Linvatec Corporation 2009, 2010. All Rights Reserved. Printed in USA

Record the Model and Serial Numbers of the Insufflator(s), and Gas Warmer(s) and the date received. Retain for future reference. Insufflator Model No. Insufflator Model No. Insufflator Model No. Gas Warmer Model No. Gas Warmer Model No. Gas Warmer Model No. Gas Warmer Model No.

Serial No Serial No Serial No Serial No Serial No Serial No Serial No

Date Date Date Date Date Date Date

Table of Contents

1.0

2.0

Page

INTRODUCTION 1.1

Intended Use... 1

1.2

Contraindications... 1

1.3

Safety Features... 1

1.4

Warnings and Precautions... 2 1.4.1

Warnings... 2

1.4.2

Precautions... 4

1.5

Symbol Definitions... 5

1.6

Environmental Directives... 7

1.7

Unpacking and General Inspection... 8

1.8

Front Panel Controls... 9

1.9

Rear Panel Controls... 11

INSTALLATION AND OPERATION 2.1

2.2

Assembly Prior to Surgery... 12 2.1.1

Insufflator Preparation... 12

2.1.2

Electrical Connections... 12

2.1.3

CO2 Hose Connections... 13

2.1.4

Insufflation Tubing Connection... 13

2.1.5

GS1013 CPS Tubing Connections... 13

2.1.6

Gas Warmer Connections (GS1012)... 14

Procedural Setup... 15 2.2.1

CO2 Gas Supply... 15

2.2.2

Power On... 16

2.2.3

Preparation Test... 16

2.2.4

Gas Warmer... 16

2.2.5

Setting Flow Rate... 17

2.2.6

Initial Insufflation with Verres Needles... 17 i

Table of Contents

Page

2.2.7

Initial Insufflation with Hasson Cannulae... 18

2.2.8

Setting Patient Pressure... 18

2.2.9

Monitoring Patient Pressure without CPS feature... 18

2.2.10 Monitoring Patient Pressure with CPS feature... 19 2.3

3.0

4.0

2.2.11 CO2 Volume Display... 19 Shut-Down Procedure... 19

MAINTENANCE 3.1

Troubleshooting Guide... 20

3.2

Cleaning and Sterilization Precautions... 23

3.3

Cleaning, Sterilization and Storage... 24 3.3.1

Insufflator Cleaning and Storage... 24

3.3.2

Gas Warmer (GS1012) Cleaning... 24

3.3.3

Gas Warmer (GS1012) Autoclave Sterilization... 25

3.3.4

Gas Warmer (GS1012) 100% EO Sterilization... 25

3.4

Repair... 26

3.5

Ordering Information... 27

3.6

Equipment Specifications... 28

CUSTOMER SERVICE 4.1

Assistance and Repair... 35

ii

1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize the ConMed Linvatec GS1000 Series of Insufflators and Gas Warmers. The safe and effective use of this equipment requires the understanding of and compliance with all warnings, precautionary notices, and instructions marked on the product, and included in this manual.

1.1 Intended Use The GS1000 Series of Insufflators shall be used for gas distension of the abdomen for diagnostic and/or operative laparoscopy. They should be used only when laparoscopic procedures are called for, and should therefore not be used for any other treatments. They are designed to function with specific laparoscopic instruments that provide passage of gas to the intra-abdominal cavity and should only be used with instruments specifically designed for that purpose. They should only be used under the direct guidance of a skilled laparoscopic surgeon.

1.2 Contraindications Use of this device for intra-abdominal distension is contraindicated whenever laparoscopy is contraindicated. See operators manual of your laparoscope for absolute and relative contraindications. These devices are contraindicated for hysteroscopic insufflation, i.e., it must not be used for intrauterine distension.

1.3 Safety Features The following features help to ensure safe operation of the unit: • Gas flow can be stopped at any time by pressing the flow RUN/STOP button. • Upon turning power on, gas flow is not initiated until the flow RUN/STOP button is pressed. • The Output Gas Ports will not allow gas to flow unless a tubing set is properly connected. • If the preset pressure is exceeded, a valve will start to relieve pressure until the preset pressure is re-attained. • The pressure cannot be set above 15 mmHg without holding down the increment button until the display flashes, giving a warning that higher pressure may now be set. • A fixed pressure relief occurs at 50 mmHg. • An audible alarm will sound if the pressure exceeds the pre-set pressure by 5 mmHg for 2-1/2 seconds or when the gas bottle pressure is low. • An audible alarm is heard if the abdomen pressure reaches 20 mmHg or higher. If the 5 mmHg alarm is active, the alarm will be continuous and will not beep. • The CPS™ feature measures the pressure through the CPS tubing set, negating the need for the Insufflation Tubing Set to act as a pressure monitoring line. This provides the patient with an uninterrupted flow of gas through the insufflation tubing set. • If either a Gas Warmer or drive circuit is defective, or the gas temperature exceeds specification, the TEMP ALARM indicator will turn on and the audible alarm will sound. 1

1.4 Warnings and Precautions The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be read carefully. WARNING: The safety and/or health of the patient, user, or a third party is at risk. Comply with this warning to avoid injury to the patient, user, or third party. PRECAUTION: This contains information concerning the intended use of the device or accessory. Damage to the equipment is possible if these instructions are not followed. NOTE: A note is added to provide additional, focused, information. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Prior to using the device, read and follow all warning and precautionary notices and instructions marked on the product and included in this manual. 1.4.1 Warnings 1. This device should be operated only by or under the direct supervision of a physician experienced in laparoscopic surgical procedures. The user should be thoroughly familiar with the operation of this device prior to use. 2. Never attempt to service the device. The cabinet should not be opened except by a qualified service person. Hazardous voltages inside the device can cause severe electrical shock. Tampering by unqualified persons can cause personal injury and can also damage the unit. Refer servicing to a qualified ConMed Linvatec service facility. 3. The Insufflation and CPS Tubing Sets are packaged sterile. Do not use if packaging is damaged. 4. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. 5. To avoid the risk of electrical shock, connect the power cord to a properly wired grounding receptacle only. 6. As with any precision instrument, periodic calibration of the unit is recommended on an annual basis or on a more frequent basis if conditions require. 7. Take precautions for EMC safety. The GS1000 Series Insufflators have been tested to CISPR 11 and EN55011 GROUP 1 and IEC60601-1-2:2001 emissions standards, however: • The GS1000 Series Insufflators have the potential to interfere with the operations of surrounding electronic equipment. • This interference can cause such equipment to operate unpredictably. • Electromagnetic interference can be reduced by increasing the distance from the GS1000 Series Insufflators and the gas warming cables to the electronic equipment of interest. • Connect only to UL 1950/IEC 60950 or other applicable IEC or harmonized UL standard compliant device. 2

8. A ≤0.2 micron hydrophobic filter must be used in the tubing set to prevent unit contamination and patient cross contamination. 9. This device is designed to function with specific laparoscopic instruments which provide passage of gas to the intra-abdominal cavity and should be used only with instruments specifically designed for that purpose. 10. Use of insufflation tubing not manufactured by ConMed Linvatec may result in flow rates that are inadequate to achieve or maintain pneumoperitoneum (abdominal distention). 11. Verify proper connection of tubing before using the unit. 12. Ensure that all high-pressure gas line connections are secure before opening the gas source(s). Loose connections could separate unexpectedly with great force, causing personal injury. 13. Operative procedures should only be performed with insufflators capable of flow rates of at least 4-10 LPM. Insufflators with lower maximum flow rates should only be used for diagnostic procedures. 14. Prolonged intra-abdominal pressures greater than 20 mmHg should be avoided. This can cause any of the following: • Metabolic Acidosis with resultant cardiac irregularity • Compromised diaphragmatic excursions resulting in decreased respiration • Decreased venous return • Decreased cardiac output 15. Excessive absorption of CO2 results from either excessive flow rate and/or excessive pressure. The abdomen can be adequately distended by pressure in the range of 15-20 mmHg. Use of pressure < 20 mmHg will dramatically reduce the likelihood of intravasation of CO2 gas into open vascular channels. Also, adequate respiration helps avoid problems related to CO2. 16. In the event of a catastrophic failure of the unit, the Gas Warmer could reach a temperature high enough to lead to hyperthermia; and direct physical contact of the Gas Warmer could cause burns to the skin. 17. Infusion of CO2 gas can result in hypothermia. Therefore, CO2 gas warming is recommended. Use a ConMed Linvatec CO2 Gas Warmer, GS1012 or equivalent. 18. Infusion of CO2 can result in embolization and carbonic acid irritation of the diaphragm. 19. Air Embolism Hazard: Purge air from tubing sets and instruments with CO2 before delivering gas to the patient. Allow 0.1 Liter volume for each 6 feet (2 m) of tubing. 20. Idiosyncratic reactions: In patients with sickle cell disease or pulmonary insufficiency use of these devices may pose increased risks of metabolic imbalance related to excessive CO2 absorption. 21. Disconnect all adapters from the gas output port in-between uses. Adapters installed in either gas output port will allow gas to flow without an insufflation tubing set connected to the unit. This may allow CO2 to flow into the atmosphere when the RUN/STOP button is pressed, causing drowsiness and headache. 22. Use of CO2 supply hoses not manufactured by ConMed Linvatec, or use of CO2 supply hoses that are manufactured with Hytrel®, may result in flow rates that are inadequate to achieve or maintain pneumoperitoneum (abdominal distention). 3

1.4.2 Precautions 1. United States Federal law restricts sale of this device to or on the order of a physician. 2. Do not allow fluids to enter the device. Damage can result.

Rx ONLY

3. The warranty becomes void and the manufacturer is not liable for direct or resulting damage if: • The device or the accessories are improperly used, prepared or maintained; • The instructions in the manual are not adhered to; • Non-authorized persons perform repairs, adjustments or alterations to the device or accessories. 4. This device should only be used in compliance with its intended use. 5. After each use, thoroughly clean equipment (See ““3.3 Cleaning, Sterilization and Storage” on page 24”). 6. The Insufflator and tubing sets contain the phthalate plasticizer DEHP, which may leach into the patient during administration of irrigant. Animal studies have shown that high-level exposure to DEHP may affect male fertility and reproductive development; these findings have not been confirmed in clinical studies. In determining use of this device in a child, or a pregnant or nursing female, the clinical benefits should outweigh any potential risk to the infant. NOTES: • Observe all national waste management regulations. • Do not dispose of WEEE as unsorted municipal waste.

4

1.5 Symbol Definitions The following list contains abbreviations and symbols for commonly used terms throughout this manual: CPS™:

Continuous Pressure Sensing. Method for monitoring patient abdomen pressure

Gas Warmer: Gas Warmer System L

Liter (or Liters)

LPM

Liter Per Minute or Liters Per Minute

mmHg

Millimeters of mercury

Gas

CO2

PSI

Pounds per Square inch Follow instructions for use. Precaution or warning notice. Power ON. Power OFF. Type B equipment (Insufflator): equipment providing a particular degree of protection against electric shock, particularly regarding allowable leakage current and reliability of the protective earth connection. Type BF equipment (Gas Warmer). Electrical Shock Hazard. Dangerous Voltage. Non-Sterile. Flammable Anesthetic - Danger, risk of explosion if used in the presence of flammable anesthetics. Equipotentiality - Interconnection to ensure all equipment is at the same potential or earth ground.

Rx ONLY

Caution: Federal Law restricts this device to sale by or on the order of a physician.

5

Waste Electronics and Electrical Equipment (WEEE) Symbol. Regarding European Union end-of-life of product. GAS BOTTLE STATUS - Indicates status of Input CO2 source. ALARM RESET - Momentarily silences Insufflator Alarms. VOLUME - Display indicates volume of gas used during the procedure. VOLUME RESET - Resets the VOLUME LITERS display. FLOW RATE - Display shows flow rate in LITERS/MIN. VIDEO DISPLAY - Activates the video display. NETWORK - Bi-directional RS-232 connection. RESTRICTION - Indicates restriction in the gas path. Run/Stop Button - Starts or stops gas flow. Run Indicator - Indicates when gas flow is active. INPUT - CO2 Gas Input. FLOW PRESET - Increases gas flow rate in preset increments. WARMER READY - Indicates the Gas Warmer is at normal operating temperature. ALARM - Indicates unit is not functioning correctly. INCREMENT - Increases Pressure or Flow Rate. DECREMENT - Decreases Pressure or Flow Rate.

6

PRESSURE - Displays show SET and ACTUAL Abdominal Pressure in millimeters of mercury (mmHg). OVER PRESSURE - Indicates pressure exceeds preset by 5 mmHg. CPS™ - Lit when the CPS™ Tubing Set is in use to measure intra-abdominal pressure.

1

PRIMARY OUTPUT - CO2 Gas Output to the patient.

2

SECONDARY OUTPUT - CO2 Gas Output to the patient. DEHP Symbol.

1.6 Environmental Directives WEEE Directive [2002/96/EC] on Waste Electrical and Electronic Equipment. This statement only applies to European countries with regard to the Waste Electrical and Electric Equipment (WEEE) European Directive. The WEEE symbol on the product or its packaging indicates that this product must not be disposed of with other waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of Waste Electrical and Electronic Equipment. The separate collection and recycling of your waste equipment at the time of disposal will help conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your medical equipment at the end of its useful life for recycling, please contact ConMed Linvatec.

7

1.7 Unpacking and General Inspection Proper care and maintenance are critical for safe operation of sophisticated medical equipment. We recommend careful inspection of all equipment upon receipt and prior to each use as a safeguard against possible injury to patient or operator. To avoid inadvertent damage study this manual thoroughly before handling, assembling, testing, using or cleaning a GS1000 Series Insufflator. Examine the shipping carton and instrument for signs of damage. Any breakage or other apparent damage should be noted, the evidence retained, and the carrier or shipping agency notified. Verify that the shipping carton contains the items listed below: • GS1000 Series Insufflator • Operator’s Manual • High Pressure Hose & CO2 Yoke Gas Warmers (GS1012) and power cords are sold and shipped separately. Notify ConMed Linvatec Customer Service at 1-800-325-5900 immediately if any damage or discrepancies are noted.

8

1.8 Front Panel Controls 1. POWER Switch - Turns the power to the unit on and off. 2. Set Pressure Display - Displays the SET pressure in mmHg. 3. Pressure Decrement Button - Decreases the SET pressure. 4. Pressure Increment Button - Increases the SET pressure. Pressure higher than 15 mmHg may be attained by pressing and holding this button until the display flashes. 5. Over Pressure Indicator - This red indicator lights anytime the pressure exceeds the preselected pressure setting. 6. Actual Pressure Display - Displays the ACTUAL abdominal pressure in mmHg. 7. Run / Stop Button - Starts or stops the flow of gas. 8. Run Indicator - This indicator lights when the gas is flowing. 9. Flow Preset - Increases the SET flow rate by preset increments: • GS1000 presets: 3, 14, 25, 35 LPM • GS1002 presets: 3, 14, 25, 40 LPM 10. Set Flow Rate Display - Displays the SET flow rate in liters/minute. 11. Flow Rate Decrement Button - Decreases the SET flow rate. 12. Flow Rate Increment Button - Increases the SET flow rate. 13. Restriction Indicator - This yellow indicator lights when the unit senses a high restriction in the gas path. 9

14. Actual Flow Rate Display - Displays the ACTUAL flow rate in liters/minute. 15. Volume Reset Button - Clears the volume display to zero. 16. Gas Supply Indicators - Three colors of LED to indicate the amount of gas available. NOTE: Do not start a procedure with less than 125 PSI tank pressure, or less than 40 PSI central supply pressure. 17. Volume Display - Indicates the total amount of gas used. 18. Alarm Reset Button - Momentarily silences the insufflator audible alarm. 19. Alarm Indicator - An audio alarm sounds and the ALARM indicator lights when the abdominal pressure remains 5 mmHg above the preset pressure for more than 2.5 seconds or, if the gas supply pressure is critically low. 20. Video Display Button (GS1002 Only) - The display appears on the video screen when the button is activated. Each successive button push moves the display to the adjacent corner of the screen. The display disappears on the fifth button push. 21. Warmer #1 Ready Indicator (GS1002 Only) - This green indicator blinks while the Gas Warmer is warming up, then turns on continuously when the gas reaches the specified temperature. NOTE: At flow rates approaching 20 LPM this indicator may blink randomly as the unit attempts to reach a stable temperature. 22. Temp Alarm Indicator #1 (GS1002 Only) - This red indicator flashes when there is an open heater element or a shorted sensor and is accompanied by an audio alarm. The LED will be continuously on when there is an open sensor, an over-temperature condition or a shorted drive circuit and will be accompanied by a continuous audible alarm. 23. Warmer #1 Connector (GS1002 Only) - Connector for the Primary Channel Gas Warmer and temperature sensors. 24. Gas Output #1 to Patient (GS1002 Only) - Connector for primary insufflation tubing set. 25. CPS Indicator (GS1002 Only) - This green indicator lights anytime the CPS line is connected and verifies that a proper path for abdominal pressure measurement exists. 26. CPS Connector (GS1002 Only) - Connector for CPS tubing set. 27. Warmer #2 Ready Indicator - This green indicator blinks while the Gas Warmer is warming up, then turns on continuously when the gas reaches the specified temperature. NOTE: At flow rates approaching 20 LPM this indicator may blink randomly as the unit attempts to reach a stable temperature. 28. Temp Alarm Indicator #2 - This red indicator flashes when there is an open heater element or a shorted sensor and is accompanied by an audio alarm. The indicator will be on continuously when there is an open sensor, an over-temperature condition or a shorted drive circuit and will be accompanied by a continuous audible alarm. 29. Warmer #2 Connector - Connector for the Gas Warmer and temperature sensors (Secondary Channel for GS1002). 30. Gas Output #2 to Patient - Connector for the insufflation tubing set (Secondary Channel for GS1002).

10

CO 2 INPUT

VIDEO DISPLAY S-VIDEO

NETWORK

1 4

6

INPUT

2200 PSI/150 Bar maximum pressure Use only pre-filtered medical grade gas Utiliser exclusivement du gas medical pre-filtre a une pression maximum de 150 bar (2200 PSI)

2200 psi/150 bar Maximaldruck Nur vorgefiltertes Gas f¸r medizinische Anwendungen verwenden

Replace with Time Delay fuse as marked 100 - 240 V

5

T

OUTPUT

2A 250V

100W 50/60 Hz

Utiliser un fusible de rechange du meme type

Wie markiert gegen tr‰ge Sicherung auswechseln

3

ED

CL

2 S AS IFI

C U L US Æ

7N70

MEDICAL EQUIPMENT WITH RESPECT TO ELECTRIC SHOCK, FIRE, MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH UL2601-1 AND CAN/CSA C22.2 NO. 601.1

DANGER

53-56000-1 REV. B

1.9 Rear Panel Controls 1. Gas Inlet Port - For connecting an e-cylinder using a high pressure hose and yoke assembly, or a high pressure hose to an appropriate central supply connector. 2. AC Power Connection - Universal AC line input device – nominal AC line voltage 100 to 240 VAC, frequency 50 Hz to 60 Hz. The AC line voltage should not drop below 90 VAC or exceed 264 VAC. There are no switches or other AC line configuration requirements. AC input is with a standard hospital grade power cord. 3. Potential Compensator Plug - Connection used to interconnect other instruments to ensure that they are at the same potential or earth ground. 4. Video Input Connector (GS1002 Only) - S-Video Input (4 pin mini DIN). Connect the laparoscopic video camera output here. NOTE: Use only shielded cable Acoustic Research part number AP022 or equivalent. 5. Video Output Connector (GS1002 Only) - S-Video Output (4 pin mini DIN). Connect the video monitor here. NOTE: Use only shielded cable Acoustic Research part number AP022 or equivalent. 6. Communication Port (GS1002 Only) - Communication port (DB-9 female) allows remote operation of insufflator functions via external computer. NOTES: • Cable must be shielded for EMI/RFI compliance. • Connect only to UL 1950/IEC 60950 or other applicable IEC or harmonized UL standard compliant device.

11

2.0 INSTALLATION AND OPERATION 2.1 Assembly Prior to Surgery PRECAUTION: If at any time the unit performs abnormally, remove the unit from service and have it repaired. The insufflator should be inspected upon receipt and before each use. Damaged equipment should be removed from service and returned to ConMed Linvatec for repair or replacement. Before each use, perform the following procedures or inspections. The Insufflator and tubing sets contain the phthalate plasticizer DEHP, which may leach into the patient during administration of irrigant. Animal studies have shown that high-level exposure to DEHP may affect male fertility and reproductive development; these findings have not been confirmed in clinical studies. In determining use of this device in a child, or a pregnant or nursing female, the clinical benefits should outweigh any potential risk to the infant. 2.1.1 Insufflator Preparation 1. Install the insufflator on a flat surface away from potential sources of spraying or leaking liquids. 2. Visually inspect the insufflator for outward signs of damage. Damaged equipment should be removed from service and returned to ConMed Linvatec for repair or replacement. 2.1.2 Electrical Connections 1. Connect the Power Cord to the AC Input Connection on the back of the insufflator. 2. Inspect the electrical connections. Do not use if inspection reveals any damage. 3. When connecting the power cord to the wall outlet, make sure that the main power switch is off and that the voltage is correct. The GS1000 Series Insufflators are universal AC line input devices. The nominal AC line voltage is 100 to 240 VAC and the AC line frequency is 50 Hz to 60 Hz. The AC line voltage should not drop below 90 VAC or exceed 264 VAC. There are no switches or other AC line configuration requirements.

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2.1.3 CO2 Hose Connections WARNING: Use of CO2 supply hoses not manufactured by ConMed Linvatec, or use of CO2 supply hoses that are manufactured with Hytrel®, may result in flow rates that are inadequate to achieve or maintain pneumoperitoneum (abdominal distention).

1. Attach the CO2 Yoke of the CO2 High Pressure Hose to the CO2 Supply Tank. Tighten with the Yoke Attachment Screw. 2. Remove cap from the CO2 High Pressure Hose Threaded End and from the CO2 Inlet on the back of the insufflator. Attach the threaded end of the CO2 high-pressure Hose to the CO2 Inlet. Carefully tighten the hose connection with a wrench. 3. For central supply, remove the CO2 yoke from the high pressure hose, and attach the appropriate central supply connector. 2.1.4 Insufflation Tubing Connection 1. Attach a tubing set to the GS1000 gas output. For GS1002 use either of the gas outputs. This will supply all the flow that is needed most of the time. NOTE: It is important to use only high flow tubing with a ≤0.2 micron hydrophobic filter to prevent cross contamination of the patient or insufflator. ConMed Linvatec produces special tubing and filters designed to provide optimum insufflator performance. We recommend the GS1016 Tubing Set be used. WARNING: Use of insufflation tubing not manufactured by ConMed Linvatec may result in flow rates that are inadequate to achieve or maintain pneumoperitoneum (abdominal distention). 2. The second tubing set need not be attached to a GS1002 at this time. The unit will be able to sense the presence of the secondary tubing set and will not supply gas unless a tubing set is properly installed. Thus, if the user does not consider that more than 20 LPM of insufflation will be required for a procedure, only one tubing set need be installed. If it becomes apparent during the procedure that more gas flow is necessary, the second tubing set may be installed at any time, allowing additional flow, up to a maximum of 40 LPM. 2.1.5 GS1013 CPS Tubing Connections The CPS Tubing Set, with an in line 0.2 micron hydrophobic filter, should be connected only after initial insufflation has been achieved. Then connect the end of the tubing set nearest to the filter to the CPS connector on the front panel of the unit, and the other end of the tubing set to a spare port on the trocar or cannula.

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2.1.6 Gas Warmer Connections (GS1012) WARNINGS: 1. Air Embolism Hazard: Before delivering gas to the operative site, be sure to purge air from the insufflation tubing and Gas Warmer by priming with CO2. 2. The Gas Warmer is shipped non-sterile. It must be sterilized before the first use and every subsequent use. Reference the associated instructions supplied with the Gas Warmer for sterilization information. 3. To avoid risk of burn, do not plug the Gas Warmer cable into the insufflator before attaching the end cap. 4. In the event of catastrophic failure of the unit, the Gas Warmer could reach a high enough temperature to cause hyperthermia in the patient and to burn skin. PRECAUTIONS: • The Gas Warmer is supplied as a re-usable accessory. Examine the device carefully for any damage before every use. Do not use if there is any physical degradation of the Warmer, or fraying or other damage to the cable or connector. • Before use, allow the Heater Assembly of the Gas Warmer to cool down after autoclaving or a false over-temperature alarm condition will be registered and the warmer will not operate. 1. Using sterile technique, place the Gas Warmer, with pre-attached power cable, in the sterile field. Assemble the Gas Warmer by screwing the end cap onto the Gas Warmer body. 2. Connect the metal connector end of the power cable into the front panel receptacle marked WARMER/HUMIDIFIER. Verify that the plug is securely locked once it is connected. The warmer circuit will automatically activate provided the insufflator is turned on. NOTE: If required, unplug the Gas Warmer to cease warming of the CO2 gas. 3. In the sterile field, cut the insufflation tubing set approximately three (3) inches from the distal end (near the trocar). Cutting the tubing this close to the distal end will help to ensure the warming effect of the delivered gas. 4. Attach both ends of the cut insufflation tubing to each of the barbed fittings of the Gas Warmer. The Gas Warmer is Bi-Directional, so the tubing may be connected to either end. 5. Connect the long section of the insufflator tubing set to a Gas Output on the insufflator front panel. 6. Connect the distal end of the insufflation tubing, with the attached Gas Warmer, to a verres needle or luer fitting of a trocar. 7. If a second tubing set is to be used with the GS1002 Insufflator, repeat steps 1 through 6 connecting the high flow connector to the other Gas Output on the insufflator front panel. 8. Secure each Gas Warmer to the sterile drape using towel clips as required. Gas Warmer - Used to warm CO2 gas during laparoscopic insufflation

14

2.2 Procedural Setup After insuring that the tubing set and cables are properly installed, plug the unit into a properly grounded AC outlet. WARNING: Air Embolism Hazard: Prime the tubing set with CO2 to displace all the air. Purge air from tubing sets and instruments with CO2 before delivering gas to the patient. Allow 0.1 Liter volume for each 6 feet (2 m) of tubing. 2.2.1 CO2 Gas Supply The GS1000 Series Insufflator automatically adjusts for an E-cylinder or a central supply gas source. NOTES: • If the gas supply is interrupted during operation, the gas flow will need to be restarted when the supply is restored (e.g. when changing E-tanks). • When in Central Supply mode, the Gas Supply Display will indicate a relatively low pressure (red-yellow with or without green LED's lit). It will also flash to indicate the central supply condition. Gas Supply Display The CO2 Gas Supply Indicator should read like a red-yellow-green bar graph. NOTE: If supply pressure is < 30 psi (red) flow will be inhibited. E-Cylinder: The color coding in the bar graph is a guide to determine whether there is sufficient gas in an E-cylinder to finish a procedure as indicated below. Do not start a procedure with less than 125 psi tank pressure to prevent running out of gas during a case, or causing the pressure display to assume central supply mode. Gas Supply Display Color

Available CO2 Gas

Red-Yellow-Green

Tank Pressure > 175psi

Red-Yellow

Tank Pressure 75-175psi

Red

Tank Pressure < 75psi. Change Tank

Central Supply: Gas Supply Display Color

Available CO2 Gas

Red-Yellow-Green

Pressure > 75psi

Red-Yellow

Pressure 35-75psi

Red

Pressure < 35psi.

NOTE: In Central Supply mode, gas supply display will flash to indicate that a low pressure gas supply is connected. The display will typically show only red and yellow LED’s illuminated. 15

2.2.2 Power On Open the CO2 valve approximately 1 turn. Turn on the Power Switch. Upon turn on, all lights and indicators will be illuminated for a brief period. 2.2.3 Preparation Test There is always the possibility that delicate equipment can be damaged in transportation or storage. Therefore, it is important to verify proper operation of the unit before surgery. 1. After power is applied to the unit, verify that the front panel lights are enabled. When the unit is turned on, but the RUN/STOP button has not been pressed, the unit will display the SET FLOW and PRESSURE values, allowing the operator to verify the settings prior to initiating gas flow. After the RUN/STOP button has been pressed, the ACTUAL FLOW and PRESSURE displays will indicate the actual flow and abdominal pressure. 2. To verify proper flow control, depress the RUN/STOP button and verify that the green START symbol is illuminated. 3. To verify proper Pressure Control and Display function, press the PRESSURE INCREMENT button repeatedly to raise the pressure through the range of 0-25 mmHg. Then press the PRESSURE DECREMENT button repeatedly to bring the set pressure back down to zero. Verify that the SET PRESURE display shows all the numbers from 0-25. NOTE: After the set pressure has dropped below 15 mmHg, the procedure of holding down the PRESSURE INCREMENT button must be repeated to again achieve pressures above 15 mmHg. 4. If the unit does not perform accordingly, do not use in surgery, return to ConMed Linvatec for service. 2.2.4 Gas Warmer To verify proper Gas Warmer function: 1. Turn on the Power Switch, located on the front panel of the unit. 2. Verify that the gas warmer is connected to the insufflator front panel and the TEMP ALARM indicator is not lit. 3. The green Warmer READY indicator will flash during warm-up. Allow the indicator to become continuously lit prior to abdominal insufflation. This will assure the delivery of body temperature gas. The Warmer may take several minutes to fully warm the insufflation gas to body temperature. 4. Wait until the green “READY” symbol stops flashing and remains illuminated before proceeding with gas insufflation to the abdomen. This will assure the delivery of body-temperature gas. WARNING: Air Embolism Hazard: Purge air from tubing sets and instruments with CO2 before delivering gas to the patient. Allow 0.1 Liter volume for each 6 feet (2 m) of tubing.

16