ConMed Linvatec 10k® Irrigation

System Instruction Manual

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 10k are trademarks or registered trademarks of Linvatec Corporation.

 Linvatec Corporation 2012, 2014. All Rights Reserved.

Record the Model and Serial Numbers of all attachments, and date received. Retain for future reference.
Pump Model No. Serial No Date
Table of Contents Page

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
1.6 Environmental Directives . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.7 Product Photographs and Drawings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
1.8 Symbol Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.8.1 Product Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.8.2 Warnings and Information Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
1.9 Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

2.0 SYSTEM INSTALLATION AND OPERATION

2.1 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.1 10k Irrigation System Front Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
2.1.2 10k Irrigation System Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.2 Assembly/Installation Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.1 10k Irrigation System Surface Installation . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.2.2 Pole Mount Installation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.3 Hand Held Remote Installation and Operation . . . . . . . . . . . . . . . . . . . . . . . 14
2.2.4 Setting up the 10k Console Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
2.2.5 Irrigation Tubing Set Installation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
2.3 Operating Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.1 10k Irrigation System Operations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2.3.2 Shutdown and Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2.4 Preoperative Functional Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

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Table of Contents Page

3.0 MAINTENANCE
3.1 Cleaning Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.1 Warnings, Precautions and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.2 Manual Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.3 Remote Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.1.4 Irrigation Tubing Set Cleaning Instructions . . . . . . . . . . . . . . . . . . . . . . . . . 21
3.2 Sterilization Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.1 Warnings, Precautions and Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.2 Sterilization Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.3 Remote Sterilization Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
3.2.4 Irrigation Tubing Set Sterilization Instructions. . . . . . . . . . . . . . . . . . . . . . . 22
3.3 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.4 Maintenance Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
3.5 Fuse Replacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3.6 Pressure Sense Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

4.0 TECHNICAL SPECIFICATIONS

4.1 Product Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
4.1.1 10k Irrigation System Technical Specifications . . . . . . . . . . . . . . . . . . . . . . 26
4.1.2 Power Cord Requirements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1.3 Tubing Set Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.1.4 Remote Technical Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
4.2 Product Environmental Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2.1 Environmental Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.2.2 Electromagnetic Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
4.3 Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.0 CUSTOMER SERVICE

5.1 Assistance and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

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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 10k 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 knowable and trained in the art and techniques
of arthroscopic and laparoscopic surgery.
The 10k Irrigation System consists of a peristaltic Irrigation System console and several types of disposable
tubing sets for arthroscopic or laparoscopic surgery. When a tubing set is installed, the Irrigation System
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. The set pressure or measured pressure is displayed on the irrigation system 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 surgeon loads an arthroscopic tubing set on the front of the unit and sets the desired pressure
(30 - 150 mmHg). The Irrigation System'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 irrigation system will speed up to deliver more fluid to maintain the pressure. As the pressure
nears the set point, the irrigation system 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.
Laparoscopic mode
This mode allows the surgeon to wash the surgical site. The surgeon loads a laparoscopic tubing set on the
front of the unit and 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
irrigation system 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 10k Irrigation System prior to its operation.

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1.2 Indications for Use

The ConMed Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the
operative site during arthroscopic procedures and irrigation during laparoscopic procedures.

1.3 Intended Use

Same as Indications for Use.

1.4 Contraindications

1. The ConMed Linvatec 10k Irrigation System is not intended for hysteroscopic procedures.
2. The ConMed Linvatec 10k 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

!
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.
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.
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 10k Irrigation System prior to its operation. The color of the logo
is blue.

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1.5.1 Warnings
!
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 cord. 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 Irrigation System be
continuously monitored during operation.
8. Do not use the 10k 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 irrigation system or irrigation system 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
10k 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.
15. Do not use equipment in acute arthroscopic procedures or in instances where capsular integrity is suspect.

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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 portion of the 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 2
STERILIZE

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 resterilize the single use devices have not been
established and subsequent re-use may adversely affect the performance, safety and/or 2
STERILIZE

sterility of the device. Do not clean, disinfect, resterilize or reuse, dispose of properly.
4. This device contains the phthalate plasticizer DEHP, which may leach into the patient during
administration of irrigate. 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 Irrigation Systeming air or any other gas.
7. Do not attempt to attach or remove a tubing set or remote cables while the console is operational.
Damage or injury could occur.
8. For optimal performance a ConMed Linvatec Quick Latch cannula must be used to function correctly and
provide optimal flow to the surgical site.
9. All tubing sets are latex free.
LATEX
10. 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.
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.
Warnings: Handheld Remote
!
1. The remote is provided non-sterile, reusable and must be cleaned and sterilized before the first
use and after every use. Refer to section “3.1 Cleaning Information” and section
“3.2 Sterilization Information”
2. Prior to installing the remote, ensure the contact surfaces of the connector are dry. Moisture in the
connector can cause system malfunctions.
3. Prior to using the remote, ensure it is cool when touched. A hot remote can cause system malfunctions and
may lead to patient 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.
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 the equipment and associated accessories according to instructions for use.
(Refer to section “3.1 Cleaning Information” and section “3.2 Sterilization Information”.
9. Equipment is factory sealed. Do not disassemble or lubricate, as this may void the warranty.
10. Do not use any instrumentation, especially sharp objects, to make selections on the front panel.
Damage may result.
11. 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.
12. Keep the pressure sensor window area clean. Do not allow sharp objects to come in contact with this area.
13. Do not transport the infusion pole with saline bag(s), tube sets, or Irrigation System attached. Remove
bag(s), tube sets, and Irrigation System from infusion pole prior to transporting.
14. When moving adjusting location of the Irrigation System and pole, grasp the pole, do not pull using the
Irrigation System.
15. Only connect IEC60950 or IEC60601 series compliant devices to signal input or output ports.

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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.

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 Increase

Remote Control Decrease

Run Stop
Run/Stop

Remote

Run/Stop (On/Off). Increase

Tamponade Assist Decrease

1.8.2 Warnings and Information Symbols

REF Catalog Number SN Serial Number

Manufacturer Date of Manufacture

Refer to Instruction Manual/Booklet (for

Consult Instructions for Use
critical safety instruction). The color is blue.

! Caution DEHP Symbol

Authorized Representative in the

EC REP CE Mark of Conformity
European Community
Prescription Only: Federal Law No User Service Recommended. Refer
restricts this device to sale by or on servicing to qualified ConMed Linvatec
the order of a physician service personnel

Non Sterile STERILE Sterile

STERILE EO Sterile - Sterilized Using EO STERILE R Sterile - Sterilized Using Irradiation

Do Not Steam Sterilize Do Not Sterilize

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 2
STERILIZE Do Not Resterilize Do Not Reuse (for Single Use Only)

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

Equipotentiality (Equipment
Protective Earth Ground

Non-Ionizing Electromagnetic Radiation

Potential) (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.

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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.
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.

9
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
Athroscopic and Related Surgery. 1989; 5(3): 209-212.
Noyes, F., Spievack, E., Extraarticular 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 10k Irrigation System Front Panel

6
2
3 7

4
5 8

1. Irrigation System Rotor — Contains the Irrigation System rollers that the tubing set loop mounts over.
Rollers rotate to assist fluid flow.
2. Run/Stop LED — Illuminated LED indicates when the Irrigation System is in “RUN” mode. Note: Rotor
may stop while Irrigation System is in RUN mode if set pressure is achieved.
3. Run/Stop Button — Press to start the Irrigation System. Press again to stop the Irrigation System.
4. Illuminated Display — Displays pressure, in mmHg, for arthroscopic procedures, or percentage of
fluid flow (%) for laparoscopic procedures. The designated indicator will illuminate. Also displays
any user information codes or special instructions.
5. Standby Power Switch — To activate the Irrigation System, place this switch in the “ON” position.
To set the Irrigation System to stand-by mode, place this switch to the “OFF” position.
6. Pressure Increase Button — Press to increase pressure.
7. Pressure Decrease Button — Press to decrease pressure.
8. Hand Held Remote Control Receptacle — Accepts the connector of the C7115 Remote Control.
9. Pressure Sensor Window — Contains pressure sensors that detect the pressure flowing through the
attached tubing set.

11
2.1.2 10k Irrigation System Back Panel

1. Pole Mounting Bracket — An integrated clamp used to mount the Irrigation System to an infusion pole.
2. Fuse Module — Houses the fuses. (Refer to section “3.5 Fuse Replacement”, and section
“4.0 TECHNICAL SPECIFICATIONS”) for more information.
3. Mains Receptacle — Accepts the supplied power cable to provide AC power.

12
2.2 Assembly/Installation Instructions

2.2.1 10k Irrigation System Surface Installation

To fasten the Irrigation System to a surface, perform the following (the Irrigation System mounting kit,
Catalog number 10k009, is recommended for mounting the Irrigation System to a flat surface):
1. Wipe the contact areas of the surface and the underside of the Irrigation System with alcohol wipes.
2. Remove the protective liner from one side of the Dual-Lock Fastener and adhere to the bottom of the
Irrigation System, as shown. Apply firm, uniform pressure to ensure contact with the Irrigation System
surface. Repeat with second fastener (Figure 1).

3. Press each mating piece of the Dual-Lock Fasteners to the previously mounted strips on the bottom of the
Irrigation System (Figure 2).

4. Remove the protective liner from each piece and position the Irrigation System into its desired position on
the surface. Apply firm, uniform pressure to the Irrigation System to ensure good adhesive contact with the
surface.
NOTE: After installation of the Dual-Lock Fasteners and Irrigation System, do not remove from surface
for 72 hours for maximum bond strength.
5. The Irrigation System may be removed by lifting from front to back.

13
2.2.2 Pole Mount Installation
1. To install the Irrigation System onto the infusion pole, support the Irrigation System in one hand and
insert the infusion pole into the integrated pole mounting bracket on the back of the Irrigation System.
2. Position the Irrigation System at approximately the same height as the inflow portal and securely tighten
the clamping knob.

NOTES:
• When removing the Irrigation System from the pole, always support the unit by placing your hand
underneath the Irrigation System prior to loosening the clamping knob.
• The base of the infusion pole in use must be at least 21.5 inches (54.5 cm) in diameter.
• The pole in use must have a base of six wheels that are at least 3 inches (10.2 cm).
• Do not mount the Irrigation System higher than 49 inches (1.25 m) from the floor or Irrigation System
and pole may tip.
• The bag hanger should be no more than 32 inches (81.25 cm) above the Irrigation System with the
height of the top of the bag not exceeding 76 inches (1.9 m) from the floor.
• It is recommended that no more than two 1 liter bags should be used on the bag hanger of the pole to
avoid instability issues.

2.2.3 Hand Held Remote Installation and Operation

The Hand Held Remote Control allows the operator full functionality of the 10k Irrigation System from
within the sterile field.
Use surgical aseptic technique to connect the remote to the Irrigation System.
1. Hold the sterilization container in the vicinity of the Scrub.
2. Remove the remote from the sterilization container and place it in the sterile field.
3. Hand the connector body to the Circulator. The remainder of the remote and cord stays in the sterile field.
4. Line up the alignment marks on the connector body and remote receptacle on the Irrigation System, and
insert the connector completely.
5. To start the Irrigation System roller when the Standby switch is in the “ON” position, press the Run/Stop
button. Press again to deactivate Run mode.
NOTE: The Irrigation System rotor may not begin spinning, if the in-joint pressure is equal to the set
pressure. The rotor will remain stationary until the in-joint pressure decreases below the set pressure by
allowing outflow.

14
C7115 Remote Control

1 2

4 5

The Hand Held Remote Control allows the operator full functionality of the 10k Irrigation System
from within the sterile field.
1. Decrease Flow Button — Press to set the Irrigation System to the preset Low flow rate (1000 ml/min.).
NOTE: This button has no functionality when the laparoscopic tubing set is in use.
2. Increase Flow Button — Press to set the Irrigation System to the preset High (2000 ml/min.) flow
rate.
NOTE: This button has no functionality when the laparoscopic tubing set is in use.
3. Tamponade Assist Button — When the Irrigation System is running, press this button for a 20
mmHg increase in set pressure. After two minutes, set pressure automatically returns to the original
set point. Each consecutive press of the button results in another 20 mmHg increase. Pressing any
other button returns the Irrigation System to the original set point.
NOTE: This button has no functionality when the Laparoscopic Tubing Set is in use.
4. Decrease Pressure Button — Press to decrease set pressure.
5. Increase Pressure Button — Press to increase set pressure.
6. Run/Stop Button — Press to start the Irrigation System roller when the Standby switch is in the
“ON” position. Press again to stop the Irrigation System roller.
7. Refer also to appropriate Remote Instruction for Use.

15
2.2.4 Setting up the 10k Console Display
The 10k Console is capable of two display modes: “Set Point” and “Pressure Feedback”. The console is
shipped from the factory in the “Set Point” mode.
If the “Pressure Feedback” mode is preferred, first ensure that there is not a tubing set loaded. Ensure the
power is off and perform the following steps:
1. Press and hold the Pressure Decrease, Pressure Increase, and Run/Stop buttons simultaneously
while turning the console power on. Release all buttons once the display indicates “d1”.
2. Place a finger on the face of the Irrigation System to the right of the standby power switch, and to
the left of the pressure sensor window. While applying slight pressure, slide your finger toward the
pressure sensor window until the display indicates “Pr”.
Run Stop

Cycle the power off and then back on. The console will now be in “Pressure Feedback” mode. The display
will now indicate a representation of in-joint pressure once a tubing set has been loaded.
3. To display the pressure set-point, press the Pressure Increase to Decrease buttons once. The display
will indicate the current set pressure for approximately three (3) seconds and then revert back to a
representation of in-joint pressure.

This procedure need only be performed once, as the console retains this mode in memory, even if
power is turned off or interrupted.
To change the display to the “Set Point” mode, first ensure that there is not a tubing set loaded. Ensure the
power is off and perform the following steps:

1. Press and hold the Pressure Decrease, Pressure Increase, and “Run/Stop” buttons simultaneously
while turning the console power on. Release all buttons once the display indicates “d 1”.

Run Stop

16
2. Place a finger on the face of the Irrigation System to the left of the remote control receptacle, and to the
right of the pressure sensor window. While applying slight pressure, slide your finger toward the pressure
sensor window until the display indicates “Poi”.

3. Cycle the power off and then back on. The console will now be in “Set Point” mode.

2.2.5 Irrigation Tubing Set Installation

1. Install the appropriate tubing set using aseptic technique:
2. If an Arthroscopic tubing set is being used, the display will indicate the SET pressure (mmHg) once the
Tubing Set is connected.
3. If a Laparoscopic tubing set is being used, the display will indicate “LAP”, then toggle to the set percentage
(%) once the tubing set is connected.
a. Open the tubing set package. Present the package contents to the Scrub.
b. Remove the tubing set from its sterile package and pass the cassette and bag spike line out of the
sterile field.
c. Position the tubing loop over the Irrigation System rotor with the Linvatec name on the cassette
facing upward (Figure 1).

Figure 1 Figure 2

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 d. Pull the cassette down and stretch the tubing over the Irrigation System display. Position the cassette
under the Irrigation System display and allow the cassette to snap into place (Figure 2).
e. Close the bag clamps.
f. Hang the fluid bag(s) on the infusion pole, so that the bottom of the bag(s) is at a minimum of 12
inches (30cm) from the top of the Irrigation System, and spike the bag(s).

2.3 Operating Instructions

2.3.1 10k Irrigation System Operations

1. Plug the power cord into the Irrigation System receptacle and a properly earthed mains supply outlet
(i.e., receptacle marked “Hospital Grade” or “Hospital Only”).
2. Press the Standby Power switch on the front of the Irrigation System to the “ON” position.
3. The Irrigation System will perform a self-diagnostic check. Settings default to last used settings.
NOTE: If no tubing set is connected, the display will indicate “CAS”. Refer to 2.2.5 Irrigation
Tubing Set Installation.
4. Prime the tubing set:
Using the 10k100 and 10k100D
a. Ensure the inflow clamp is open. Hold the patient end of the tubing over a basin.
b. Open the bag clamps.
c. Press the Run/Stop button on the Irrigation System or the remote control. Run Stop

d. After all air is purged from the tubing, close the patient inflow clamp.
e. Attach the lure fitting on the tubing set to the inflow device.
Using the 10k150
a. Ensure the inflow clamp is open. Hold the patient end of the tubing over a basin.
b. Open the bag clamps.
c. Press the “Run/Stop” button on the Irrigation System or the remote control. Run Stop

d. After all air is purged from the tubing, close the patient inflow clamp.
e. Attach the lure fitting on the Tubing Set to the inflow device.
f. Separate the outflow line from the inflow line, as needed, by pulling the two lines apart.
Connect the outflow tubing line to the outflow device or shaver.
g. Connect the suction/gravity tubing line to the appropriate hospital collection mechanism.
Using the 10k600 and 10k605
a. Ensure the inflow clamp is open. Hold the patient end of the tubing over a basin.
b. Open the bag clamps.
c. Press the Run/Stop button on the irrigation system or the remote control.
Run Stop

d. After all air is purged from the tubing, close the patient inflow clamp.
e. Attach the lure fitting on the tubing set to the inflow device.
f. At end of the case, stop the irrigation system and close the bag clamps.

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 g. Remove the single patient use inflow tubing set section of the tube set and discard.
h. Cap the tube set with the supplied cap.
i. When setting up for the next case, remove the cap and install the next 10k605 tube set.
j. Ensure the inflow clamps are open. Hold the patient end of the tubing over a basin.
k. Open the bag clamps.
l. Press the ‘Run/Stop” button on the Irrigation System or the remote control.
m.After all air is purged from the tubing, close the patient inflow clamp.
n. Attach the lure fitting on the Tubing Set to the inflow device.
o. Repeat per case.
Using the 10k500 and 10k505
a. Direct the distal tip of the cannula towards a basin.
b. Open the bag clamps.
c. Press the “Run/Stop” button on the Irrigation System or the remote control. Run Stop

d. After all air is purged from the tubing, release the blue inflow button.
e. Connect the suction/gravity tubing line to the appropriate hospital collection mechanism.
5. The Irrigation System is now ready for use.
6. To adjust irrigation pressure:
a. Press the appropriate button to increase or decrease the amount of pressure.
b. To continuously adjust the irrigation pressure, press and hold the appropriate button.
The pressure will increase in increments of 5 for three (3) seconds, then accelerate to
increments of 15.
c. To quickly adjust the pressure, press and release the appropriate button. The pressure
increases or decreases as fast as the button is pressed and released, in increments of 5.
7. To begin fluid flow, open the inflow clamp.
NOTE: If using the Laparoscopy Tubing Set (10k500 and 10k505), press the blue inflow button. Run Stop

8. To stop fluid flow, press the “Run/Stop” button again, either on the Irrigation System or the remote
control, or close the inflow clamp.
9. When the procedure is complete, remove the Tubing Set by pulling down on the cassette and
removing the tubing loop from around the Irrigation System rotor. Dispose of Tubing Set properly.

2.3.2 Shutdown and Disposal

1. When the procedure is complete, stop the Irrigation System by pressing the Run/Stop button. Press the
Power stand-by button. The indicator light is yellow.
2. Unplug remote C7115 (if present) and prepare for sterilization per section “3.2 Sterilization Information”.
3. Disconnect the tubing sets from all connections (cannula, shaver endpiece and drain connections).
4. Remove the tubing set from Irrigation System. Pull the cassette down and away from the console to remove
the tubing loop from the Irrigation System head.
5. Dispose of tubing sets properly. Do not resterilize or reuse.
2
6. Unplug 10k console and prepare for sterilization. STERILIZE

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2.4 Preoperative Functional Test

1. Press the “Run/Stop” button on the Irrigation System or the remote control.
2. After all air is purged from the tubing, close the patient inflow clamp.
3. Verify that no error codes should be displayed. The Irrigation System is ready for operation.

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3.0 MAINTENANCE

3.1 Cleaning Information

3.1.1 Warnings, Precautions and Notes

1. Follow universal precautions for protective apparel when handling and cleaning contaminated
!
instruments.
2. Clean instruments within 30 minutes after use to minimize the potential of blood and debris drying.
3. Never clean equipment in an ultrasonic cleaner.
4. Always detach accessories from equipment prior to cleaning.
5. Never clean equipment with bleach, chlorine-based detergents, liquid or chemical disinfectants, or any
products containing sodium hydroxide (such as, INSTRU-KLENZ or Bell Cleaner). These products
degrade the anodized aluminum coating and may result in reduced equipment reliability.
6. For aluminum surfaces, a neutral-pH agent should be used. To prevent corrosion, avoid contact with strong
alkaline solutions (pH over 10.5) or agents containing iodine or chlorine.
Refer also to Section “1.5 Warnings and Precautions”.

3.1.2 Manual Cleaning Instructions

1. Turn the equipment power off. Disconnect the equipment from the electrical power source.
2. Remove any accessories from the equipment that may be attached.
3. Wipe the equipment with a clean, soft cloth dampened with a mild, pH-balanced detergent of your
choosing. Ensure you follow the manufacturer's instructions for the cleaning product that you select that it
is approved for use on plastics. Failure to follow these guidelines may cause damage to the equipment.
Repeat cleaning if necessary until clean.
4. Ensure equipment is free of all debris.
5. After disinfecting the equipment, wipe it again with distilled or sterilized water.
6. Dry all areas thoroughly with a clean, soft cloth.
7. Perform functional checks according to Section “2.4 Preoperative Functional Test”. Check mating
accessories closely for proper assembly.
8. Remove and repair any damaged equipment. Repeat Manual Cleaning Instructions as necessary.

3.1.3 Remote Cleaning Instructions

Refer to appropriate Remote Instruction for Use.

3.1.4 Irrigation Tubing Set Cleaning Instructions

Refer to appropriate Irrigation Tubing Set Instruction for Use.

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3.2 Sterilization Information

3.2.1 Warnings, Precautions and Notes

1. The use of disinfecting solutions for an exterior instrument wipe will not sterilize the equipment
!
and is not recommended.
2. Do not sterilize equipment or accessories using Ethylene Oxide (EtO).
3. Do not sterilize equipment or accessories using a STERIS system or by comparable sterilization methods.
4. Do not sterilize equipment or accessories in cold sterilants like CIDEX.
5. Always detach accessories from equipment prior to sterilization.
6. Do not sterilize console. Damage would occur.
Refer also to Section “1.5 Warnings and Precautions”

3.2.2 Sterilization Instructions

There are no sterilization instructions for the Irrigation System since it is used outside of the sterile field.

3.2.3 Remote Sterilization Instructions

Refer to appropriate Remote Instruction for Use.

3.2.4 Irrigation Tubing Set Sterilization Instructions

The disposable irrigation tubing sets are single-use only. Do not clean, disinfect, resterilize or reuse; dispose
of properly.
Refer to appropriate Irrigation Tubing Set Instruction for Use.

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3.3 Troubleshooting

Table 1: Troubleshooting Guide

Symptom Possible Cause Corrective Action

Irrigation System does not • Power cord is unplugged. • Plug power cord into the Irrigation System
power up when the stand- and/or a properly grounded receptacle.
by power switch is turned
on. • Suspect power cord. • Replace power cord.
• Blown fuse(s). • Check fuses. Replace.
No fluid flowing through • Fluid bag is empty. • Replace fluid bag.
tubing.
• Tubing line is severely bent or • Remove all severe bends and/or kinks. If
kinked. tubing is damaged, replace tubing set.
• Clamps not open. • Open clamps.
Fluid flow rate is not • Fluid bag is empty. • Replace fluid bag.
consistent.
• Tubing line is severely bent or • Remove all severe bends and/or kinks. If
kinked. tubing is damaged, replace tubing set.
• Clamps not open. • Open clamps.
User Information Code • Ensure no buttons are being depressed on the
consistently displayed. Irrigation System or remote. Verify the
cassette is seated properly or completely
removed. Cycle power off, wait at least five
seconds, then cycle back on to clear the code.
If code is still present, or returns, return
Irrigation System to ConMed Linvatec for
service.

3.4 Maintenance Schedule

Regular and proper maintenance of your equipment is the best way to protect your investment. It is essential
that you have your equipment serviced as scheduled in order to retain its optimum performance and
reliability, which will reward you with safer, less problematic product performance over time.
The equipment is not field repairable. Your ConMed Linvatec authorized service department is the most
knowledgeable about this equipment and its accessories and will provide competent and efficient services.
Service at ConMed Linvatec at the recommended service interval is mandatory to keep your product warranties
in effect. Any services and/or repairs done by any unauthorized repair facility may result in reduced
performance of the equipment or equipment failure. (Refer to section “5.0 CUSTOMER SERVICE”).
The 10k Irrigation System console and accessories shall be returned every 12 months for servicing.

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3.5 Fuse Replacement

1. Turn the equipment power off and disconnect the mains power cord.
2. Using a flat blade tool, remove the fuse holder.

3. Replace the fuses with the correct value, as stated on the equipment or in the “4.0 TECHNICAL
SPECIFICATIONS” section of this manual.

4. Replace the fuse holder.

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3.6 Pressure Sense Test

The Pressure Sense Test is recommended do be done at the recommended service interval
of the Irrigation System, which is once a year, or as needed.
Required items:
• 10k Irrigation System
• Bag of fluid – one liter minimum
• Tube set; 10k100, 10k100D or 10k150
• bag hanger
1. Program the Irrigation System to “Pressure Feedback” mode.
2. Set up the console, tube set, and fluid bag.
3. When bubbles no longer exit the tube, place the Irrigation System in stop mode by pressing the
Run/Stop button. Run Stop

4. Lift the patient luer fitting so that it is 3 feet (89 cm) above the base of the Irrigation System.
5. If the display is below 53 mmHg or above 81 mmHg, the Irrigation System console should be returned to
ConMed Linvatec for service.

3 feet
(89 cm)

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4.0 TECHNICAL SPECIFICATIONS

Medical electrical equipment complies with and was tested with respect to electric shock, fire,
electromagnetic compatibility, mechanical and other specified hazards only, in accordance with
UL60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC60601-1:1988 +A1:1991 +A2:1995,

ES60601-1:2005 +A1: 2009 +A2: 2010, CAN/CSA C22.2 No.60601-1-1-08 and IEC60601-1:2005 +C1:2006
+C2:2009.
Tested to IEC60601-1-2:2007 and Part 15 of the FCC Rules as follows: 1) The system may not cause
harmful interference: 2) The system will accept interference, including interference that might cause
undesired operation. If interference occurs, separate the instruments. For more information, contact
customer service.

4.1 Product Technical Specifications

4.1.1 10k Irrigation System Technical Specifications

Classification: Class1, Type BF applied parts

Protection Ingress of IPX0, Ordinary, no protection
Fluids:
Mode of Operation: Continuous operation, with intermittent loading
Input Voltage: 100 - 240 VAC
Frequency: 50-60 Hz
Line (Touch) Leakage: < 100 μa, normal condition
< 300 μa, single fault condition, balanced input voltage
< 500 μa, single fault condition, unbalanced input voltage
Power Consumption: 65VA
Fuses: T1AL, 250 V
Fluid Pressure Range: 30 - 150 mmHg (± 20 mmHg) (Factory default at 30 mmHg)
Irrigation System Flow 0 - 2500 (± 10%) mL/minute
Rate:
Laparoscopy: Set point range 10-100% (0-1800 ml/min. Factory default 100%)
Fluid flow range is 0 to 1800 ml/min ±20%
Dimensions: 7.75 in. (W) 6.5 in.(H) 8.0 in.(D)
19.7 cm (W) 16.5 cm (H) 20.3 cm (D)
Weight: 7.0 lbs. (3.15kg)

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4.1.2 Power Cord Requirements

North American Mains UL and CSA Certified.

Cord Specifications: Male Plug: NEMA 5-15P Hospital Grade with Green Dot, 15A/125V
Cord: UL style SJT, 18AWG X 3 conductor, color coding black, white, green.
Cord Length: 10 ft. max.
Female Plug: IEC320/C13 EN60320, 10A/125V
International Mains Cord Country/Region Certified
Specifications: Male Plug: 10A/250V
Cord: H05VV-F3G1.0 or country/region recognized equivalent,
1mm2 X 3 conductor, color coding brown, light blue, green/yellow stripe or
country/region requirement.
Cord Length: 3.6m max.
Female Plug: IEC320/C13 EN60320, 10A/250V

4.1.3 Tubing Set Technical Specifications

Material: PVC, ABS, Polycarbonate, Silicone, Acrylic

These tubing sets are latex-free products.
Overall Dimensions: Approximately 14.0 feet (4.2m)
Weight: Approximately 1.1 lbs. (.50kg)

4.1.4 Remote Technical Specifications

Material: Silicone
This remote is latex-free products.
LATEX

Overall Dimensions: 2.19 inches wide, 5.1 inches length, 0.78 inches depth, 11 feet cable length
5.56 cm wide, 13.97 cm length, 1.98 cm depth, 3.35 meter cable length
Weight Approximately.78 lbs. (.35kg)

27
4.2 Product Environmental Requirements

4.2.1 Environmental Technical Specifications

Environmental Conditions Operating Storage and Transport

Temperature:

75% 93%

Relative Humidity:
30% Non-Condensing 10% Non-Condensing

Atmospheric Pressure:

4.2.2 Electromagnetic Requirements

Table 2: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions

The ConMed Linvatec 10k Irrigation System is intended for use in the electromagnetic
environment specified below. The customer or the user of the 10k Irrigation System should assure it
is used in such an environment.

Emissions Test Compliance Electromagnetic environment - guidance

RF Emissions Group 1 The 10k Irrigation System uses RF energy only for its internal
CISPR 11 function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

RF Emissions
Class B
CISPR 11
The 10k Irrigation System is suitable for use in all establishments,
Harmonic Emissions including domestic establishments and those directly connected
Class A
IEC 61000-3-2
to the public low-voltage power supply network that supplies
Voltage fluctuations/ buildings used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

28
 Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity

The ConMed Linvatec 10K Irrigation System is intended for use in the electromagnetic
environment specified below. The customer or the user of this 10K Irrigation System should assure
that it is used in such an environment.

IEC 60601 Electromagnetic Environment

Immunity Test Test Level Compliance Level Guidance

Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete or

discharge (ESD) ceramic tile. If floors are covered
IEC 61000-4-2 ± 8 kV air ± 8 kV air with synthetic material, the relative
humidity should be at least 30%.

Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be that
transients/bursts supply lines supply lines of a typical commercial or hospital
IEC 61000-4-4 environment.
± 1 kV for input/ ± 1 kV for input/output
output lines lines

Surge ± 1 kV line to line ± 1 kV line to line Mains power quality should be that
IEC 61000-4-5 of a typical commercial or hospital
± 2 kV lines to earth ± 2 kV lines to earth environment.

Power frequency 3 A/m 3 A/m Power frequency magnetic fields

(50/60 Hz) should be at levels characteristic of
magnetic field a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.

Voltage dips, short <5% Ut (>95% dip in <5% Ut (>95% dip in

interruptions and Ut) Ut) Mains power quality should be that
voltage variations for 0.5 cycle for 0.5 cycle of a typical commercial or hospital
on power supply environment. If the user of the 10k
input lines 40% Ut (60% dip in 40% Ut (60% dip in Irrigation System requires
IEC 61000-4-11 Ut) Ut) continued operation during power
for 5 cycles for 5 cycles mains interruptions, it is
recommended that the 10k
70% Ut (30% dip in 70% Ut (30% dip in Irrigation System be powered from
Ut) Ut) an uninterruptable power supply or
for 25 cycles for 25 cycles battery.

<5% Ut (>95% dip in <5% Ut (>95% dip in

Ut) Ut)
for 5 seconds for 5 seconds

NOTE: Ut is the a.c. mains voltage prior to application of the test level.

29
 Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic
Immunity (Continued)

The ConMed Linvatec 10K Irrigation System is intended for use in the electromagnetic
environment specified below. The customer or the user of this 10K Irrigation System should assure
that it is used in such an environment.
Portable and mobile RF communications equipment should be no closer to any part of the 10k Irrigation System,
including cables, than the recommended separation distance calculated from the equation applicable to the frequency
of the transmitter.

IEC 60601 Electromagnetic Environment

Immunity Test Compliance Level
Test Level Guidance
Recommended Separation Distance
Conducted RF
150 kHz to 80 MHz 3 Vrms d = 1.2 √ P
IEC 61000-4-6
Radiated RF d = 1.2 √ P 80 MHz to 800 MHz
80 MHz to 2.5 GHz 3 V/m
IEC 61000-4-3 d = 2.3 √ P 800 MHz to 2.5 GHz
Where P is the maximum output where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be
less than the compliance level in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and/or people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
10k Irrigation System is used exceeds the applicable RF compliance level above, the 10k Irrigation System
should be observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as re-orienting or relocating the 10k Irrigation System.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

30
 Table 4: Recommended Separation Distances Between Portable and Mobile RF Communications
Equipment and the 10k Irrigation System

The ConMed Linvatec 10k Irrigation System is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The customer or the user of the 10k Irrigation
System can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the 10k Irrigation System
as recommended below, according to the maximum output power of the communications
equipment.

Separation Distance According to Frequency of Transmitter

Rated Maximum m
Output Power of
Transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

W d = 1.2 √P d = 1.2 √P d = 2.3 √P

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distances d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

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4.3 Accessories

REF Description

Miscellaneous
10k009 10k Irrigation Console Mounting Kit

Remote
C7115 Hand Held Remote

Tubing Sets
10k100 10k Arthroscopy Tubing Set
10k100D 10k Arthroscopy Tubing Set for Dyonics Inflow Scope Sheath with Colder
Adapter
10k150 10k Arthroscopy Tubing Set with Outflow Line
10k500 10k Laparoscopy Suction/Irrigation Tubing Set
10k505 10k Laparoscopy Suction/Irrigation Tubing Set with 5mm Cannula
10k600 Eco-Flow™ 10k®/24k® Arthroscopy Day Use Pump Inflow Tubing Set
10k605 Eco-Flow 10k/24k Arthroscopy Single use Patient Inflow Tubing Set

32
5.0 CUSTOMER SERVICE

5.1 Assistance and Repair

If you need technical assistance regarding the use or application of this product, or you encounter a problem
that requires servicing or repair, contact ConMed Linvatec Customer Service at 1-800-237-0169 or your
ConMed Linvatec Sales Representative. Outside the U.S. contact your local ConMed Linvatec
Representative.
Report any events involving injuries or malfunctions to the ConMed Linvatec Regulatory Product Support.
Returning products for any reason requires an authorized Service Request (S.R.) number prominently
displayed on the box and included on all paperwork. Refer to this number if making inquiries about the
repair status. Please call ConMed Linvatec Customer Service and provide the following information to
obtain an S.R. number prior to returning any product for repair:
• Product Number
• Serial/Lot Number
• Reason for Return
• Original Invoice Number
• Date of Purchase
• Detailed description of the problem

ConMed Linvatec
Attn.: Customer Service Dept.
11311 Concept Boulevard
Largo, Florida 33773-4908 USA
Customer Service
(within U.S.) Phone: 1-800-237-0169
FAX: (727)-399-5256
(outside U.S.) Phone: +1 (727)-392-6464
FAX: +1 (727)-397-4540
ConMed Linvatec Regulatory Product Support
(within U.S.) Phone: 1-800-325-5900
(outside U.S.) Phone: +1 (727)-392-6464

33
34
 525 French Road
Utica, NY 13502-5994 USA
(727) 392-6464
EC REP
Customer Service: 1-800-237-0169
MDSS GmbH FAX: (727) 399-5256
Schiffgraben 41 International FAX: +1 (727) 397-4540
D-30175 Hannover, Germany
email: customer_service@conmed.com
www.conmed.com

All rights reserved. W41-242-004 Rev.AB 03/2014