24k Irrigation System Instruction Manual Rev AB March 2014

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, 10k and 24k are trademarks or registered trademarks of ConMed Linvatec.

 Linvatec Corporation 2012, 2014. All Rights Reserved.

Record the Model and Serial Numbers of the Pump and date received. Retain for future reference. Pump Model No.

Serial No

Date

Table of Contents

1.0

INTRODUCTION 1.1

Operating Principle... 1

1.2

Indications for Use... 2

1.3

Intended Use... 2

1.4

Contraindications... 2

1.5

Warnings and Precautions... 2 1.5.1

Warnings... 3

1.5.2

Precautions... 7

1.6

Environmental Directives... 8

1.7

Product Photographs and Drawings... 8

1.8

Symbol Definitions... 9

1.9

2.0

Page

1.8.1

Product Symbols... 9

1.8.2

Warnings and Information Symbols... 10

Safety Information... 12

SYSTEM INSTALLATION AND OPERATION 2.1

2.2

Product Description... 14 2.1.1

24k Irrigation System Front Panel... 14

2.1.2

24k Irrigation System Back Panel... 17

Assembly/Installation Instructions... 18 2.2.1

24k Irrigation System Setup... 18

2.2.2

Installing the 10k Arthroscopy Tubing Set on the 24k Irrigation System . . . 23

2.2.3

Priming the 10k Tubing Sets... 24

2.2.4

Installing the 24k100 Arthroscopy Outflow/Suction Tubing Set... 25

2.2.5

Installing the True Intra-articular Pressure Sensing Tubing Set (24kTIPS) . 26

2.2.6

Performing a Patency Test on TIPS Tubing Set... 27

2.2.7

Patency Test Passes... 28

2.2.8

Collapsed Balloon Detected... 28

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Table of Contents

Page

2.2.9

To Reinflate the Balloon... 29

2.2.10 Installing the 24k Shaver Sensor (24k900) and Extension Cable (24k191) . 29 2.2.11 Hand Held Remote Installation and Operation... 30 2.3

2.4

3.0

2.3.1

24k Irrigation System Operation... 33

2.3.2

Disconnecting the System... 35

Preoperative Functional Test... 36

MAINTENANCE 3.1

3.2

4.0

Operating Instructions... 33

Cleaning Information... 37 3.1.1

Warnings, Precautions and Notes... 37

3.1.2

Manual Cleaning Instructions... 37

3.1.3

Remote Cleaning Instructions... 38

3.1.4

Irrigation Tubing Set Cleaning Instructions... 38

3.1.5

Shaver Sensor and Extension Cable Cleaning Instructions... 38

Sterilization Information... 38 3.2.1

Warnings, Precautions and Notes... 38

3.2.2

Sterilization Instructions... 39

3.2.3

Remote Sterilization Instructions... 39

3.2.4

Irrigation Tubing Set Sterilization Instructions... 39

3.2.5

Shaver Sensor and Extension Cable Sterilization Instructions... 39

3.3

Troubleshooting... 40

3.4

Maintenance Schedule... 41

3.5

Fuse Replacement... 42

TECHNICAL SPECIFICATIONS 4.1

Product Technical Specifications... 43 4.1.1

Technical Specifications... 43

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Table of Contents

Page

4.1.2

Power Cord Requirements... 44

4.1.3

Tubing Set Technical Specification... 44

4.1.4

Remote Technical Specification... 44

4.1.5

Shaver Sensor Specification... 44

4.2

4.3

5.0

Product Environmental Requirements... 45 4.2.1

Environmental Technical Specifications... 45

4.2.2

Electromagnetic Requirements... 45

Accessories... 49

CUSTOMER SERVICE 5.1

Assistance and Repair... 50

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Table of Contents

Page

iv

1.0 INTRODUCTION It is recommended that personnel study this manual before attempting to operate, clean, or sterilize this or associated equipment. 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. This equipment is designed for use by medical professionals completely familiar with the required techniques and instructions for use of the equipment. Service intervals, as listed in Section “3.4 Maintenance Schedule”, are required to keep the equipment at its optimum operating performance.

1.1 Operating Principle The 24k Irrigation System is located in the surgical suite next to, but not in the sterile field. Other accessories may or may not enter the sterile field as needed in their application. This system should be used by individuals and staff who are knowledgeable and trained in the art and techniques of arthroscopic and laparoscopic surgery. The 24k Irrigation System consists of a console with two peristaltic pumps and a control valve. It uses several types of disposable tubing sets for arthroscopic or laparoscopic surgery. When a tubing set is installed, the equipment automatically identifies which type is installed. Once the Run/Stop button is depressed, the system will provide sterile fluid to the surgical site and monitor the pressure via the pressure sensor window per the user selected set pressure or a applied 24kTIPS tube set. The set pressure or measured pressure is displayed on the equipment depending on the mode chosen (i.e. “set point or “pressure feedback”). Arthroscopic mode This mode allows the surgeon to maintain a clear field and remove debris from the surgical site during surgery. The circulator loads an arthroscopic tubing set on the front of the unit and the surgeon sets the desired pressure (10 - 150 mmHg). The pump's control loop will monitor the pressure in the tubing set and adjust the speed of the motor to maintain the operator's chosen set pressure. When the pressure falls below the set point, the pump will speed up to deliver more fluid to maintain the pressure. As the pressure nears the set point, the pump will slow down until the set pressure is met. This control loop will respond to maintain pressures as various out flow devices are opened or closed in the system. An outflow tubing set can be loaded on the outflow peristaltic pump and will control the outflow using a control valve as a function of the shaver activity. Laparoscopic mode This mode allows the surgeon to wash the surgical site. The circulator loads a laparoscopic tubing set on the front of the unit and the surgeon sets the speed/flow (10-100%). Once the Run/Stop button is pressed, the system will run to pressurize the tubing set. After this priming step, the tubing is ready to irrigate the surgical site upon depression of the appropriate valve button on the tubing set. Once the tubing valve button is depressed, the equipment will turn on at the set speed and deliver fluid until the valve button is released. SAFETY: This references critical information for the safe operation of this system. It is highly recommended that the surgeon read section “1.9 Safety Information” to help the surgical team ensure safe and efficient use of the 24k Irrigation System prior to its operation.

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1.2 Indications for Use The ConMed Linvatec 24k Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid irrigation during laparoscopic procedures.

1.3 Intended Use Same as Indication for Use.

1.4 Contraindications 1. The ConMed Linvatec 24k Irrigation System is not intended for hysteroscopic procedures. 2. The ConMed Linvatec 24k Irrigation System is not intended for use in acute arthroscopic or hysteroscopic procedures, or in instances where capsular integrity is suspect, TMJ endoscopy, or other non-arthroscopic or non-laparoscopic procedures.

1.5 Warnings and Precautions

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Do not bypass this section. It contains warnings and precautions that must be thoroughly understood before operating any of the equipment. Lack of understanding or adherence to these warnings and precautions may result in injury or even death to the patient. The words WARNING, PRECAUTION, and NOTE carry special meanings and they must be read carefully. WARNING: A warning contains critical information regarding serious adverse reactions and potential safety hazards that can occur in proper use or misuse of the equipment. Failure to observe the information or procedures presented in a warning may result in injury, death or other serious adverse reactions to the patient and/or surgical staff.

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PRECAUTION: A precaution contains instructions for any special care to be exercised by the practitioner for the safe and effective use of the equipment. Failure to observe the information or procedures presented in a Precaution may result in damage to the equipment.

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NOTE: A note is added to provide additional focused information. This information has no critical effect on the patient or equipment. SAFETY: This references critical information for the safe operation of this system. It is highly recommended that the surgeon read section “1.9 Safety Information” to help the surgical team ensure safe and efficient use of the 24k Irrigation System prior to its operation. The color of the logo is blue.

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1.5.1 Warnings

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WARNINGS: Console 1. Eye protection is recommended when operating equipment. Eye injury may result. 2. It is the surgeon's responsibility to be familiar with the appropriate surgical techniques prior to use of the equipment and its associated accessories. 3. Do not use equipment if, upon receipt, package is opened, damaged, or shows any signs of tampering.

4. Do not use equipment in the presence of flammable anesthetics, gases, disinfecting agents, cleaning solutions, or any material susceptible to ignition due to electrical sparking. 5. To avoid the risk of electric shock, this equipment must be connected to a supply mains with protective earth. The voltage and frequency characteristics must be compatible with those listed on the unit or in this manual. Do not use plug adapters or extension cords; such devices may defeat the safety ground and could result in injury. 6. Do not excessively bend or kink the power cord or accessory cords. Always inspect cords for signs of excessive wear or damage. If any wear or damage are found, discontinue use and replace handpiece immediately. Using a damaged power cord could possibly cause injury. 7. Do not allow this device to run unattended. Patient safety requires that the equipment be continuously monitored during operation. 8. Do not use the 24k Irrigation System with a gas distention medium. Use only with sterile, Normal Saline, Lactated Ringer's or Sorbitol solution for distention of the surgical site. 9. Do not insert foreign objects or fingers into the pump or pump rollers. This constitutes a safety hazard and can cause extensive damage or injury. 10. Do not place any adhesive labels on the front of the console. Pressure sensor readings can be blocked. 11. The front panel power switch removes power from console. Also, to remove mains power, disconnect the power cord. Position the console with easy access to the power cord. 12. Do not simultaneously contact the console and patient. This may contaminate the sterile field and create an unsafe electrical condition. 13. This system may cause radio interference or may disrupt the operation of nearby equipment. Avoid stacking equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the 24k Irrigation System or shielding the location. 14. Do not place the remote on or near a magnetic device. A magnetic field can activate a remote. Failure to comply may cause injury to the patient or operating room personnel.

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WARNINGS: Tubing Sets

1. Carefully read the ConMed Tube Sets Instruction Manuals for detailed instructions regarding the proper use and set-up of the Irrigation System console, Irrigation System tubing and Irrigation System accessories before using the ConMed Linvatec 10k Irrigation System. 2. The disposable irrigation tubing sets are single-use only. Do not clean, disinfect, resterilize or reuse; dispose of properly. Tubing sets can be used only if the original packaging and labeling are intact. If packaging is opened or altered, Do Not Use. Sterility may be compromised. 3. The ability to effectively clean and re-sterilize this single use device has not been established and subsequent re-use may adversely affect the performance, safety and/or sterility of the device.

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2

STERILIZE

2

STERILIZE

4. This device contains 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. 5. Do not crimp, kink, puncture or roll over tubing set with carts or other equipment. Incorrect readings may result, possibly causing injury and/or extravasation to the patient. 6. Do not use tubing sets for pumping air or any other gas. 7. Do not attempt to attach or remove a tubing set, remote, shaver sensor or cables while the console is operational. Damage or injury could occur. 8. For optimal performance in TIPS mode a ConMed Linvatec Pressure Sensing Scope Sheath Cannula must be used to function correctly and provide optimal flow to the surgical site 9. All tubing sets are latex free.

LATEX

10. For optimal performance in Inline mode and in IPS mode a ConMed Linvatec Quick Latch Cannula must be used to function correctly and provide optimal flow to the surgical site 11. Do not use sterile equipment beyond the expiration date listed on the label. Sterility of the product cannot be assured beyond the expiration date.

4

WARNINGS: Pressure Sensing Scope Sheath (PSSS) 1. Reference the associated IFU for care, cleaning and sterilization information. 2. Assemble the Pressure Sensing Scope Sheath (PSSS) system before surgery. Ensure the PSSS is not damaged and all parts fit together. Lack of a round arthroscopic view on the monitor indicates an incorrectly assembled system. Fluid leakage and incorrect pressure readings may result. 3. After every use, thoroughly clean all PSSS ports. Improper cleaning may lead to erratic pressure readings and extravasation. 4. The 70° Wolf and Dyonics scopes are longer than the ConMed Linvatec PSSS. When these scopes are used, ensure the tip of the outer cannula is inside the joint cavity to avoid pumping fluid outside the joint capsule. 5. The diameter of the PSSS system outer cannula is slightly larger than a standard scope sheath. If the joint space cannot accommodate the outer cannula during the initial diagnosis, a standard scope sheath is recommended for use during the rest of the procedure. Surgeons who use this device for these joint conditions must exercise caution using the PSSS cannulas to avoid damaging the osteochondral cartilage and other anatomical structures. 6. Carefully inspect all parts of the cannula system for damage before each use. Do not use if the O-ring is missing or the system starts to leak. A loose fitting system can compromise the pressure sensing system. Discontinue use and return for repair. 7. Do not use the PSSS system as an outflow/pressure sensing sheath only. This can compromise the patency of the pressure sensing channel and the ability to accurately monitor pressure and may lead to extravasation.

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WARNINGS: True Intra-Articular Pressure Sensing (TIPS) Tubing Set 1. Do not use the 24k Irrigation System in TIPS pressure sensing mode in a three portal knee technique where the TIPS pressure sensing line is connected to an outflow cannula and placed in the suprapatellar pouch. The equipment may not regulate pressure correctly possibly causing injury and/or extravasation to the patient.

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2. Extravasation may occur if the pressure sensing system does not function properly. ALWAYS perform a patency test on the TIPS Tubing Set prior to each procedure. (Refer to section “2.2.6 Performing a Patency Test on TIPS Tubing Set”.) 3. Avoid abrupt changes in joint position. This may result in high intra-articular pressure spikes and/or extravasation. 4. Periodically examine the distal location of the inflow cannula or sheath to ensure it is in the joint capsule. Extravasation may occur due to improper cannula or sheath placement or excessive intra-articular joint pressure. 5. For true intra-articular pressure to work, pressure sensing should occur in the joint space close to the surgical site. Failure to do so may result in increased risk of extravasation. 6. Do not disconnect TIPS tubing during operation. This may result in increased risk of extravasation. 7. To avoid inconsistent and inaccurate pressure readings, do not squeeze the balloon chamber of the TIPS tubing while the device is in use. 8. Failure to tighten the TIPS tubing set luer connector to the TIPS connector on the 24k Irrigation System could result in a slow air leak. This may lead to a collapsed balloon, which over a lengthy case could increase the possibility of extravasation. Periodically check the TIPS balloon to verify inflation. (Refer to section “2.2.5 Installing the True Intra-articular Pressure Sensing Tubing Set (24kTIPS)”) for an explanation on correcting this condition. WARNINGS: Hand Held Remote 1. Prior to installing the remote, ensure the contact surfaces of the connector are dry. Moisture in the connector can cause system malfunctions.

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2. Prior to using the remote, ensure it is cool when touched. A hot remote can cause system malfunctions and may lead to patient injury. 3. Do not excessively bend or kink the power cord or accessory cord. Always inspect cords for signs of excessive wear or damage, or bent, broken or missing pins within the connector(s). If any wear or damage are found, discontinue use and replace handpiece immediately. Using a damaged power cord could possibly cause injury. 4. Refer also to appropriate Remote Instruction for Use.

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1.5.2 Precautions 1. United States Federal law restricts sale of this device to or on the order of a physician.

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2. This device should only be used in compliance with its intended use. 3. Handle all equipment carefully. If any equipment is dropped or damaged in any way, return it immediately for service. 4. Use only ConMed Linvatec approved equipment, attachments and accessories. They have been tested and certified to specific medical standards. Using unapproved accessories may result in improper operation, may negatively affect EMC performance and may result in non-compliance to medical standards. 5. 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. 6. There are no user-serviceable parts inside. No modification of this equipment is allowed. Removing the cover may introduce an electrical shock hazard by exposing you to dangerously high voltages or other risks. 7. Prior to each use, perform the following: • Ensure all accessories are correctly and completely attached. (Refer to section “2.2 Assembly/Installation Instructions”). • Perform the required Preoperative Functional Tests for the equipment and accessories. (Refer to section “2.4 Preoperative Functional Test”). 8. Clean and sterilize all equipment and associated accessories according to instructions for use. (Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”). 9. Do not use any instrumentation, especially sharp objects, to make selections on the front panel. Damage may result. 10. Do not handle the console, remote, or shaver sensor by the cord. Do not pull on the cord to remove it from console. Grasp the strain relief of the cable. 11. Only connect IEC 60950 and IEC 60601 series complaint devices to signal input and output devices. Precautions: 24k Shaver Sensor and Extension Cable ! 1. The shaver sensor and extension cable are not for use in the sterile field. 2. When both LEDs are not illuminated after connection to the pump and the shaver cable, recheck and verify connections. If both LEDs are still not illuminated, discontinue use and replace. 3. Do not immerse shaver sensor or extension cable in fluids. Damage occurs. 4. Do not autoclave shaver sensor or extension cable. Damage occurs. 5. Refer also to appropriate Instruction for Use.

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Precautions: Hand Held Remote 1. Do not allow any sharp instruments to come in contact with the remote buttons. Damage may occur.

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2. Refer also to appropriate Remote Instruction for Use.

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 Electronic 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.

1.7 Product Photographs and Drawings The pictures in this manual are for reference only. Items shown may not represent the actual product. However, procedural steps are identical, unless otherwise specified. When necessary, the actual pictures will be represented.

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1.8 Symbol Definitions 1.8.1 Product Symbols Console Standby

Remote Control

Increase

Decrease

Run/Stop

TIPS Trademark Symbol

Presets button (Front Panel). Used to select between preset settings for knee, shoulder, small joint, and hip surgeries.

Clear Field

Outflow. Used to select outflow settings between OFF, LOW, MEDIUM and HIGH.

Suction. Used to select suction settings between OFF, LOW, MEDIUM and HIGH. No Shaver Sensor Icon. Displays when the shaver sensor is not connected.

Cassette Load Icons. Displays when no tubing set is loaded. Drain

Declog

Shoulder Surgery Icon

Knee Surgery Icon

Small Joint Surgery Icon

Hip Surgery Icon

W A V

Proprietary ConMed Communication Ports. Use only ConMed approved equipment.

???

E

Displays when there is a fault/failure with the pump console. All buttons and motor movement are locked. This can only be cleared when the condition that caused the failure is cleared (i.e., multiple buttons pressed simultaneously).

+ Run

9

Stop

WAVE Icon. Displays when Knee Surgery option is selected. Provides pulsating inflow and outflow of fluid through the joint space. System Alarm Icon. Displays when there is a fault/failure with the pump console. All buttons and motor movement are locked. This is cleared by pressing the Run/Stop or POWER button. If this icon still displays, the pump cannot be used and must be returned for service.

Remote Run/Stop

Decrease Pressure

Clear Field

Increase Pressure

Drain

Declog

Outflow. Used to select outflow settings between OFF, LOW, MEDIUM and HIGH.

Suction. Used to select suction settings between OFF, LOW, MEDIUM and HIGH.

1.8.2 Warnings and Information Symbols Catalog Number

REF

! EC REP

Manufacturer

Date of Manufacture

Consult Instructions for Use

Refer to Instruction Manual/Booklet (for critical safety instruction) The color of the logo is blue.

Caution

DEHP Symbol

Authorized Representative in the European Community

CE Mark of Conformity

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

No User Service Recommended. Refer servicing to qualified ConMed Linvatec service personnel

Non Sterile STERILE

2

STERILIZE

EO

Serial Number

SN

Sterile - Sterilized Using EO

STERILE STERILE

R

Sterile Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize

Do Not Sterilize

Do Not Resterilize

Do Not Reuse (for Single Use Only)

10

Do Not Use Oil

Do Not Use for Plunge Cutting

Eye Protection Required

Biohazard Risk

Do Not Immerse

~

QTY

Quantity

Type B Applied Part

Type BF Applied Part

UL Classification Mark

UL Recognized Components

Rating Fuse

Fuse Location

Alternating Current

Protective Earth Ground

Equipotentiality (Equipment Potential)

Non-Ionizing Electromagnetic Radiation (RF Symbol)

Temperature Limitation

Humidity Limitation

Atmospheric Pressure Limitation

Use by Date

Fragile

This Side Up

Do Not Use if Package is Damaged

Keep Dry

Warning: Corrosive Substance

Warning: Electrical Hazard/High Voltage

Waste Electrical and Electronic Equipment (WEEE) Symbol. Regarding European Union end-of-life of product, indicating separate collection for electrical and electronic equipment Recycle. Batteries contain materials which must be recycled or disposed of properly. The disposal of batteries as municipal waste is prohibited. Dispose or recycle in accordance with your local, state and governmental regulations. In the U.S. call 1-800-237-0169, or outside the U.S. contact your local ConMed Linvatec representative for additional information on battery disposal or recycling. 11

1.9 Safety Information Extravasation Management Arthroscopically induced compartment syndrome is a potential patient complication caused by several means, whether inflow is by gravity or a mechanized fluid infusion system. The surgical team should understand how to prevent and treat arthroscopic fluid induced compartment syndrome. 1. Closely monitor the patient during and after the surgical procedure for signs of complications resulting from excess fluid absorption. 2. Accurate cannula placement is essential to avoid extravasation of fluids. Placement of the cannula should be verified to ensure the distal end is within the joint capsule. 3. Excessive intra-articular pressure or improper inflow cannula placement may result in extravasation. 4. Visually inspect, examine and palpate the patient’s joint periodically to check for proper distention. 5. An established outflow is recommended during arthroscopic surgery. 6. The volume of distention fluid instilled and drained should be monitored throughout the procedure. The amount of fluid collected from the outflow device, combined with the amount of fluid on the floor, should be approximately equal to the amount of instilled fluid. 7. Periodically examine the distal location of any inflow, outflow, sheath or pressure sensing sheath or cannula to ensure that the sheath or cannula is within the joint capsule. Extravasation may occur as a result of improper sheath or cannula placement or excessive intra-articular joint pressure. 8. Monitor fluid intake carefully in cases of known joint trauma with possible capsular defects to avoid excessive effusion. 9. Avoid abrupt changes in joint position which may result in high intra-articular pressure spikes. 10. Synovial injury may warrant lower intra-articular pressure and distention and more frequent visual examination. 11. Extravasation can occur more rapidly when using a mechanized fluid infusion system than when using a gravity system. Carefully palpate and visually inspect the extremity and surgical site frequently throughout the procedure for possible signs of extravasation. 12. Extravasation may occur when passing the arthroscope in or out of the surgical site if fluid flow is not stopped. Be sure to temporarily stop fluid flow whenever the scope is removed from the surgical site. 13. Avoid Arthroscopic procedures in patients whose capsular integrity is suspect. Treatment Swelling of an extremity due to fluid extravasation into soft tissue can occur during any arthroscopic surgical procedure. Arthroscopic fluid induced compartment syndrome is caused by a non-crystalline substance (e.g., normal saline) that does not localize or clot. Once infusion of fluids is stopped, excess fluid is rapidly reabsorbed and passed as waste, reducing elevated compartment pressures to near normal levels within 30-60 minutes. There may however, be clinical signs of swelling present for a longer period of time. What this suggests is that arthroscopically induced compartment syndrome can be initially treated conservatively for the first hour. If conservative treatment fails to lower intra-muscular compartment pressures to below threshold levels, a fasciotomy may be necessary. Orthopedic literature supports management of extravasation by time, elevation and serial compression wrapping. Fasciotomy is rarely indicated. 12

Bibliography The following literature supports management of extravasation by time, elevation, and serial compression wrapping. Fasciotomy is rarely indicated. Bomberg, C., Hurley, P., Clark, C., McLauglin, C., Complications Associated with the Use of an Infusion Pump During Knee Arthroscopy. Arthroscopy: The Journal of Arthroscopic and Related Surgery. 1992; 8(2): 224-228. Johnson, L., Arthroscopy Surgery: Principles and Practice. 3rd ed., St. Louis, MO: C. V. Mosby Company; 1986. Lee, Y., Cohn, L., Tooke, S. M. Intramuscular Deltoid Pressure During Shoulder Arthroscopy. Journal of Arthroscopic and Related Surgery. 1989; 5(3): 209-212. Noyes, F., Spievack, E., Extra articular Fluid Dissection in Tissues During Arthroscopy. American Journal of Sports Medicine. 1982; 10(6). Parisien, J., Arthroscopic Surgery. New York, NY: McGraw-Hill; 1988; 224-225. Sprague III, N., Complications in Arthroscopic Surgery. New York, NY: Raven Press; 1989. Peek, R., Hayes, D., Compartment Syndrome as a Complication of Arthroscopy. American Journal of Sports Medicine. 1984; 12(6). Bergstrom, R., Gillquist, J., The Use of an Infusion Pump in Arthroscopy. Journal of Arthroscopic and Related Surgery. 1986; 2(1): 41-45. Oretop, N., and Elmersson, S., Arthroscopy and Irrigation Control. Journal of Arthroscopic and Related Surgery. 1986; 2(1): 46-50.

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2.0 SYSTEM INSTALLATION AND OPERATION 2.1 Product Description 2.1.1 24k Irrigation System Front Panel

10

11

e.

8

7

d. c.

12

9

f.

1

b.

2

a.

3

5

4

6

With the 24k Irrigation System, pressure can be set between 10 mmHg and 150 mmHg in 5 mmHg increments. The 24k Irrigation System maintains a selected outflow without affecting the pressure. Flow rate settings are OFF, LOW (low - 50ml/min), MED (medium - 150ml/min) and HIGH (high - 300ml/min). At any time during a procedure, the surgeon can adjust the flow rate manually to change surgical conditions. NOTE: When the outflow cassette of the 24k tubing set is not connected or only a 10k tubing set is connected, outflow functions are not enabled (suction, outflow, drain or declog). Button/ Number Function

Description

1.

Standby Power Button - Press this button to toggle the console between on and stand-by. While on, the LED illuminates green. To set the equipment to stand-by mode press this button again. The LED illuminates amber.

2.

Remote Control Connector - Insert the connector of the C8115 Remote Control here.

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