GS1000 Insufflator Instruction Manual Rev B Aug 2005

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: Linvatec Europe B1070 Brussels, Belgium The following U.S. patent applies: 6,299,592 © Linvatec Corporation 2005. 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. Warmer/Humidifier Model No. Warmer/Humidifier Model No.

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

Date Date Date Date Date Date Date

Page

Table of Contents

1.0

2.0

INTRODUCTION 1.1

Intended Use... 1

1.2

Contraindications... 1

1.3

Safety Features... 1

1.4

General Warnings and Cautions... 2

1.5

Symbol Definitions... 4

1.6

Unpacking and General Inspection... 5

1.7

Front Panel Controls... 6

1.8

Rear Panel Controls... 9

INSTALLATION and OPERATION 2.1

Assembly Prior to Surgery... 10 2.1.1

Insufflator Preparation... 10

2.1.2

Electrical Connections... 10

2.1.3

CO2 Hose Connections... 10

2.1.4

Insufflation Tubing Connection... 11

2.1.5

GS1013 CPS Tubing Connections... 11

2.1.6

Gas Warmer Connections (GS1012)... 11

2.1.7

Gas Warmer-Humidifier Connections... 12 2.1.7.1 Gas Warmer-Humidifier Heater Assembly (GS1014)... 12 2.1.7.2

Sheath Assembly & Tubing Set (GS1015)... 12

2.1.7.3 Gas Warmer-Humidifier Assembly... 13 2.2

Procedural Setup... 13 2.2.1

CO2 Gas Supply... 13 2.2.1.1 Gas Supply Display... 14

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Page

Table of Contents

2.0

INSTALLATION and OPERATION (Continued) 2.2.2

Power On... 14 2.2.2.1 Preparation Test... 14 2.2.2.2 Gas Warmer/Humidifier... 15 2.2.2.3 Setting Flow Rate... 16 2.2.2.4

Initial Insufflation with Verres Needles... 16

2.2.2.5 Initial Insufflation with Hasson Cannulae... 16 2.2.2.6 Setting Patient Pressure... 17 2.2.2.7 Monitoring Patient Pressure without CPS feature... 17 2.2.2.8 Monitoring Patient Pressure with CPS feature... 18 2.2.2.9 CO2 Volume Display... 18 2.2.3

3.0

Shut-Down Procedure... 18

MAINTENANCE 3.1

Troubleshooting Guide... 19

3.2

Cleaning and Sterilization Precautions... 24

3.3

Cleaning, Sterilization and Storage... 24 3.3.1

Insufflator Cleaning and Storage... 24

3.3.2

Gas Warmer Cleaning and Sterilization (GS1012):... 25 3.3.2.1 Cleaning:... 25 3.3.2.2 Autoclave Sterilization... 26 3.3.2.3 100% EO Sterilization... 26

3.3.3

Gas Warmer/Humidifier Cleaning and Sterilization (GS1014)... 27

3.4

Repair... 27

3.5

Ordering Information... 28

3.6

Equipment Specifications... 29

ii

1.0 INTRODUCTION

1.3

Safety Features

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

The following features help to ensure safe operation of the unit:

1.1

• If the preset pressure is exceeded, a valve will start to relieve pressure until the preset pressure is re-attained.

I

• Gas flow can be stopped at any time by pressing the flow START/STOP button. • Upon turning power on, gas flow is not initiated until the flow START/STOP button is pressed. • The Output Gas Ports will not allow gas to flow unless a tubing set is properly connected.

Intended Use

he 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.

T

1.2

• 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.

Contraindications

• 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.

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.

• If either a Gas Warmer/Humidifier 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

5.

1.4

General Warnings and Cautions

1.

This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Read and follow all warning and cautionary notices and instructions marked on the product and included in this manual.

2.

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.

3.

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.

4.

Take precautions for EMC safety. The Linvatec GS1000 Series Insufflators have been tested to CISPR 11 and EN55011 GROUP 1 and IEC60601-1-2:2001 emissions standards, however:

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

• The Linvatec 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 Linvatec GS1000 Series Insufflators and the gas warming cables to the electronic equipment of interest.

6.

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.

7.

Infusion of CO2 gas can result in hypothermia. Therefore, CO2 gas warming is recommended. Use a Linvatec CO2 Gas Warmer, GS1012 or equivalent.

8.

Infusion of CO2 gas can result in tissue dehydration. Tissue dehydration may be alleviated by the use of humidification. Use a Linvatec Gas Warmer/Humidifier, GS1014 or equivalent.

9.

Infusion of CO2 can result in embolization and carbonic acid irritation of the diaphragm.

10. 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.

• Connect only to UL 1950/IEC 60950 or other applicable IEC or harmonized UL standard compliant device.

2

11. 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.

19. 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.

12. 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.

20. In the event of a catastrophic failure of the unit, the Gas Warmer or Gas Warmer/ Humidifier could reach a temperature high enough to lead to hyperthermia; and direct physical contact of the Gas Warmer or Gas Warmer/Humidifier could cause burns to the skin.

13. Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide.

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 START/STOP button is pressed, causing drowsiness and headache.

14. To avoid the risk of electrical shock, connect the power cord to a properly wired grounding receptacle only. 15. The Insufflation and CPS Tubing Sets are packaged sterile. Do not use if packaging is damaged.

22. Federal law restricts this device to sale by or on the order of a physician.

16. This device contains both active and passive pressure relief mechanisms. A ≤0.2 micron hydrophobic filter must be used in the tubing set to prevent unit contamination and patient cross contamination.

23. Do not allow fluids to enter the device. Damage can result. 24. Verify proper connection of tubing before using the unit.

17. 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.

25. After each use, thoroughly clean equipment (See “3.3 Cleaning, Sterilization and Storage” on page 25).

18. 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.

3

1.5

Equipotentiality Interconnection to ensure all equipment is at the same potential or earth ground.

Symbol Definitions

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

Rx ONLY

Continuous Pressure Sensing. Method for monitoring patient abdomen pressure

GAS BOTTLE STATUS Indicates status of Input CO2 source.

Gas Warmer: Gas Warmer/Humidifier System L

Liter (or Liters)

LPM

Liter Per Minute or Liters Per Minute

mmHg

Millimeters of mercury

Gas

CO2

PSI

Pounds per Square inch

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

ALARM RESET Momentarily silences Insufflator Alarms. VOLUME - Display indicates volume of gas used during the procedure.

Attention, consult accompanying documents.

VOLUME RESET - Resets the VOLUME LITERS display.

Power ON. FLOW RATE - Display shows flow rate in LITERS/MIN Power OFF. VIDEO DISPLAY - Activates the video display. Type B equipment (Insufflator) NETWORK - Bi-directional RS-232 connection. Type BF equipment (Gas Warmer).

RESTRICTION - Indicates restriction in the gas path.

Flammable Anesthetic Danger, risk of explosion if used in the presence of flammable anesthetics.

START/STOP - Starts or stops Gas Flow. INPUT - CO2 Gas Input

Electrical Shock Hazard. Dangerous Voltage.

4

FLOW PRESET - Increases gas flow rate in preset increments.

1.6

WARMER READY - Indicates the Gas Warmer is at normal operating temperature.

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.

ALARM - Indicates unit is not functioning correctly.

Unpacking and General Inspection

INCREMENT - Increases Pressure or Flow Rate.

To avoid inadvertent damage study this manual thoroughly before handling, assembling, testing, using or cleaning a GS1000 Series Insufflator.

DECREMENT - Decreases Pressure or Flow Rate.

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.

PRESSURE - Displays show SET and ACTUAL Abdominal Pressure in millimeters of mercury (mmHg).

Verify that the shipping carton contains the items listed below: • Linvatec GS1000 Series Insufflator

OVER PRESSURE - Indicates pressure exceeds preset by 5 mmHg

• Operator’s Manual • High Pressure Hose & CO2 Yoke

CPS™ - Lit when the CPS™ Tubing Set is in use to measure intra-abdominal pressure.

Gas Warmers (GS1012), Warmer/Humidifiers (GS1014/GS1015), and power cords are sold and shipped separately.

PRIMARY OUTPUT - CO2 Gas Output to the patient.

Notify ConMed Linvatec Customer Service at 1-800-325-5900 immediately if any damage or discrepancies are noted.

SECONDARY OUTPUT CO2 Gas Output to the patient.

5

1.7

8) Start Indicator - This green indicator lights when the gas is flowing.

Front Panel Controls

9) Flow Preset - Increases the SET flow rate by preset increments:

1) Power Switch - Turns the power to the unit on and off.

• GS1000 presets: 3, 14, 25, 35 LPM

2) Set Pressure Display - Displays the SET pressure in mmHg.

• GS1002 presets: 3, 14, 25, 40 LPM

3) Pressure Decrement Button - Decreases the SET pressure.

10) Set Flow Rate Display - Displays the SET flow rate in liters/minute.

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.

11) Flow Rate Decrement Button - Decreases the SET flow rate.

5) Over Pressure Indicator - This red indicator lights anytime the pressure exceeds the preselected pressure setting.

13) Restriction Indicator - This yellow indicator lights when the unit senses a high restriction in the gas path.

6) Actual Pressure Display - Displays the ACTUAL abdominal pressure in mmHg.

14) Actual Flow Rate Display - Displays the ACTUAL flow rate in liters/minute.

7) Start / Stop Button - Starts or stops the flow of gas.

15) Volume Reset Button - Clears the volume display to zero.

12) Flow Rate Increment Button - Increases the SET flow rate.

6

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.

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.

23) Warmer/Humidifier #1 Connector (GS1002 Only) - Connector for the Primary Channel Gas Warmer or Warmer/ Humidifier and temperature sensors.

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.

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.

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.

26) CPS Connector (GS1002 Only) - Connector for CPS tubing set.

21) Warmer #1 Ready Indicator (GS1002 Only) - This green indicator blinks while the Gas Warmer or Warmer/Humidifier is warming up, then turns on continuously when the gas reaches the specified temperature.

27) Warmer #2 Ready Indicator - This green indicator blinks while the Gas Warmer or Warmer/Humidifier 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.

NOTE: At flow rates approaching 20 LPM this indicator may blink randomly as the unit attempts to reach a stable temperature.

7

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.

Gas Warmer/Humidifier Heater Assembly Used with a Sheath and Tubing Set to provide warmed and humidified CO2 gas during laparoscopic insufflation TO INSUFFLATOR

TUBING SET (PART OF SHEATH & TUBING SET ASSEMBLY).

HEATER CORE

29) Warmer/Humidifier #2 Connector - Connector for the Gas Warmer or Warmer/ Humidifier and temperature sensors (Secondary Channel for GS1002).

METAL CONNECTOR PLUG

HEATER ASSEMBLY

30) Gas Output #2 to Patient - Connector for the insufflation tubing set (Secondary Channel for GS1002). Gas Warmer - Used to warm CO2 gas during laparoscopic insufflation PLUG INTO WARMER CONNECTOR 23

TO TROCAR

TUBING TO INSUFFLATOR

APPROXIMATELY 3" PIECE OF TUBING

Gas Warmer/Humidifier Sheath and Tubing Set Used with a Heater Assembly to provide warmed and humidified CO2 gas during laparoscopic insufflation TO VERRES NEEDLE OR TROCAR INJECTION PORT

TO INSUFFLATOR

SHEATH & TUBING ASSEMBLY

8

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

C

ED

CL

2 S AS IFI

U L US Æ

7N70

1.8

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

4) Video Input Connector (GS1002 Only) S-Video Input (4 pin mini DIN). Connect the laparoscopic video camera output here.

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.

NOTE: Use only shielded cable Acoustic Research part number AP022 or equivalent.

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.

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.

6) Communication Port (GS1002 Only) - Communication port (DB-9 female) allows remote operation of insufflator functions via external computer.

AC input is with a standard hospital grade power cord.

NOTE: Cable must be shielded for EMI/RFI compliance.

3) Potential Compensator Plug - Connection used to interconnect other instruments to ensure that they are at the same potential or earth ground.

NOTE: Connect only to UL 1950/IEC 60950 or other applicable IEC or harmonized UL standard compliant device.

9

2.0

2.1

INSTALLATION and OPERATION

2.1.2

Assembly Prior to Surgery

CAUTION: If at any time the unit performs abnormally, remove the unit from service and have it repaired.

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.

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:

2.1.1 1.

2.

Electrical Connections

Insufflator Preparation 2.1.3

Install the insufflator on a flat surface away from potential sources of spraying or leaking liquids. 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.

10

CO2 Hose Connections

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 1.

Insufflation Tubing Connection

2.1.6

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.

WARNINGS:

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 this tubing be used. 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

Gas Warmer Connections (GS1012)

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.

CAUTIONS: 1.

The Gas Warmer is supplied as a reusable 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.

2.

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.

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.

11

1.

2.

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.

2.1.7

Gas Warmer-Humidifier Connections

The Gas Warmer-Humidifier is shipped in two separate sections; the Warmer Humidifier and the Sheath Tubing Set.

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.

2.1.7.1 Gas Warmer-Humidifier Heater Assembly (GS1014) The Heater Assembly is supplied as a re-usable accessory

NOTE: If required, unplug the Gas Warmer to cease warming of the CO2 gas.

WARNING: The Heater Assembly is shipped NON-STERILE. It must be sterilized before using and before every subsequent use. Reference the associated instructions supplied with the Heater Assembly for sterilization information.

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.

2.1.7.2

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.

WARNING: The Sheath Assembly & Tubing Set are supplied as a disposable assembly, packaged sterile. Do not use if the packaging has been damaged. Do not attempt to re-use.

8.

Secure each Gas Warmer to the sterile drape using towel clips as required.

NOTE: The Heater Assembly 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-Humidifier, if the heater core is loose or there is any fraying or other damage to the cable or connector.

12

Sheath Assembly & Tubing Set (GS1015)

2.2

2.1.7.3 Gas Warmer-Humidifier Assembly

After insuring that the tubing set and cables are properly installed, plug the unit into a properly grounded AC outlet.

NOTE: Before use, allow the Heater Assembly to cool after autoclave sterilization or a false over-temperature alarm condition will be registered and the warmer will not operate. 1.

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.

Using sterile technique, place the Heater Assembly and Sheath Assembly in the sterile field. Assemble the two parts by sliding the Heater into the center of the Sheath and screwing the Sheath onto the base of the Heater Assembly.

2.2.1

WARNING: To avoid risk of burn, do not plug the Heater Assembly cable into insufflator without a Sheath Assembly attached. 2.

Connect the metal connector end of the power cable into the front panel receptacle marked WARMER/HUMIDIFIER.

3.

Inject 15 cc of sterile solution into the injection port on the Warmer-Humidifier Sheath.

Procedural Setup

CO2 Gas Supply

The Linvatec GS1000 Series Insufflator automatically adjusts for an E-cylinder or a central supply gas source. NOTE: 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).

NOTE: If more than 200 liters of gas are used, additional fluid injections may be required. If an additional tubing set is to be used with a GS1002 insufflator, repeat steps 1 through 3 connecting the high flow connector to the other Gas Output on the insufflator front panel.

13

2.2.1.1 Gas Supply Display

2.2.2

The CO2 Gas Supply Indicator should read like a red-yellow-green bar graph.

1.

NOTE: If supply pressure is <30 psi (red) flow will be inhibited.

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.

E-Cylinder:

2.2.2.1 Preparation Test

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.

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 START/ 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 START/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 START/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 0-15 mmHg. To achieve pressure greater than 15 mmHg, press and hold the PRESSURE INCREMENT button until the display flashes. Release the button and then press repeatedly until 25 mmHg is displayed. 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.

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 > 175psi

Red-Yellow

Pressure 35-75psi

Red

Pressure < 35psi.

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NOTES:

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.

1.

The Gas Warmer may initially take several minutes to reach body temperature. If the green symbol does not stop flashing for several minutes after the Gas Warmer has been connected, replace the Gas Warmer. If replacing the Gas Warmer does not remedy the flashing green symbol, return the insufflator with warming feature to ConMed Linvatec for service.

2.

A steadily illuminated red symbol marked “TEMP ALARM” on the insufflator control panel indicates an alarm condition such that, although the gas continues to flow, it is not being warmed, a control unit fault, an over-temperature condition, or a temperature sensor fault exists. An audible alarm will accompany the illuminated symbol. Disconnect and replace the Gas Warmer. If replacing the Gas Warmer does not remedy the red “TEMP ALARM” condition, return the insufflator with warming feature to ConMed Linvatec for service.

3.

At flow rates approaching 20 LPM this indicator may blink randomly as the unit attempts to reach a stable temperature.

If the unit does not perform accordingly, do not use in surgery, return to ConMed Linvatec for service.

2.2.2.2 Gas Warmer/Humidifier To verify proper Gas Warmer or Warmer/ Humidifier 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/Humidifier 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.

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2.2.2.3 Setting Flow Rate 1.

To set the flow rate, press the FLOW INCREMENT button. Each press will increase the SET flow rate by one (1) LPM. Similarly, to decrease the SET flow rate, press the FLOW DECREMENT button once for each LPM reduction required. The set flow rate will be indicated on the SET FLOW display in liters per minute.

2.

Alternately, the FLOW PRESET button may be used to jump directly to preset flow rates of 3, 14, 25, and 35 LPM (GS1000) or 3, 14, 25, and 40 LPM (GS1002).

3.

When the START/STOP button is pressed, the actual flow rate will be indicated by the ACTUAL FLOW display in liters per minute.

4.

2.2.2.4

1.

Initial Insufflation with Verres Needles

When the power is turned on the unit will automatically set the SET pressure to 12 mmHg, the SET flow to 3 LPM, and FLOW stopped. Additionally, this unit is designed to measure negative patient pressure should the surgeon desire to “tent” the abdomen to test for accurate Verres needle insertion.

2.2.2.5 Initial Insufflation with Hasson Cannulae For initial insufflation through a Hasson type cannula the SET FLOW rate can be set to 35 LPM (GS1000) or 20 LPM from one of the Gas Output Ports (GS1002).

The Linvatec GS1000 Insufflators will produce a flow rate, unobstructed on the front panel, of 35 LPM (GS1000) or a combined flow rate at the two (2) output connectors of 40 LPM (GS1002). Due to the restrictions in various instruments and tubing sets, the actual flow rate may never reach the SET flow rate. For optimum performance use 11mm cannulae for the gas flow to the patient.

NOTE: If Supply Pressure is <30 PSI, flow cannot be initiated.

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