POWER PACK Instructions for Use Rev D July 2010

English

POWER PACK INSTRUCTIONS FOR USE

Rx ONLY

Introduction

• The reason for repair request - problem or complaint. Please describe in writing the damage or apparent trouble. Indicate the name of the person we may contact to discuss the problem and the complete address of the facility. Then, please carefully repackage and return the product to the facility

Use of This Documentation This manual provides operation and maintenance instructions for Irrigation Aspiration System. Users should be thoroughly trained in its use and applicable medical procedures. Instruction manuals should be made available to the users during the procedure. Follow all instructions contained in the manual pertaining to the devices used in the procedure, with particular attention given to the warnings and cautions.

Warnings and Cautions Warnings and caution statements are placed throughout the text referring to procedures, practices, or conditions essential to the safety of personnel and patients and/or equipment and property. All warnings and cautions should be reviewed prior to the use of this equipment during a procedure. Operational Safety A thorough review of this entire manual is essential before using. CONMED Corporation has taken great care to ensure the safety of the patient and the operating room staff. However, many useful features may not be readily discernible without reviewing this documentation. Use of the equipment should therefore not be undertaken until the user is fully familiarized with the instructions for assembly and operation. If you have any questions, please contact your distributor or CONMED Corporation. Modifications The Power Pack system is a precision crafted device manufactured from quality components to ensure a long product life. Modifications of any kind are not recommended and will void warranties. Modifications may also pose significant possible hazards and/or impair the continuous safe operation of the device. Inspection upon receipt Thoroughly inspect shipment immediately upon arrival. Merchandise is carefully packed to prevent damage in transit. Our responsibility, however, ends with the delivery of the shipment in good condition to the transport company. Examine all shipments promptly upon receipt.

RETURN PROCEDURE

Authorization must be obtained from your distributor prior to returning any merchandise. When requesting a Return Goods Authorization (RGA) number, please provide the Customer Service Representative with: • Your facility name as it appears on the invoice. • Your telephone number and the name of the person to contact. • Your purchase order number and invoice number. • The catalog number(s) of the merchandise. • The Lot number of the device. • The reason for return - problem or complaint. When returning merchandise, please include a copy of the original invoice or the original invoice or packing slip to ensure prompt issuing of credit. Write the RGA number on all paperwork and mark it clearly on the box you are returning. Credit will only be issued if the merchandise is in a saleable condition. If the product(s) have been used in surgery, the product must be CLEANSED and STERILIZED and a written statement confirming such must accompany the product(s). Full credit will be issued for items returned within 30 days of invoice date, if in resalable condition and in the original packaging. No cash refunds after 30 days. Items returned after 30 days from date of invoice will be subject to the following restocking fee:

30 days or less

0

31-60 Days

10%-25% (Depending on packaging)

60-90 Days

25%

If no return goods authorization number, 10% or product will be returned to origination facility. If the product is returned more than 30 days after a return goods authorization is issued, a restocking fee will be charged. A credit memo based on the dollar amount will be issued to the account. No credit will be issued on any item returned after 90 days.

Repair Program

If repairs are necessary due to damage other than that incurred during initial shipment (see section labeled INSPECTION UPON RECEIPT), call to alert us of this return of your unit. Authorization must be obtained from your distributors or CONMED Customer Service Department prior to returning any merchandise. When requesting a Return Goods Authorization (RGA), please provide the Customer  Service Representative with: • Your name or customer number as it appears on the invoice. • Your telephone number and the name of the person to contact. • Your application P.O. number and invoice number. • The catalog number(s) of the merchandise. • The serial number(s) of the merchandise.

(315) 797-8375 • FAX (315) 797-0321 Customer Service (USA) 1-800-448-6506 e-mail: [email protected] © CONMED Corporation, Printed in USA

from which you purchased the device. Warranty All products are manufactured for use only by qualified medical personnel who are trained in their use. The equipment carries a limited lifetime warranty against defects in workmanship and materials. Any product with such defects returned to your distributor will be promptly repaired or replaced at no charge to the customer. The warranty does not apply to damages caused by misuse, mishandling, improper operation and/or abuse of the product. Repairs or modifications performed other than by an authorized repair facility will void this warranty. For further details and warranty information, call your distributor or CONMED Corporation.

OPERATION

The Power Pack has been specifically designed to provide the delivery of pressurized air to the irrigation devices used in elective procedures. The Power Pack utilizes a compressor and accumulator to supply compressed air at 725mmHg. Overview of Power Pack The Power Pack is electrically powered (110V 60Hz). An indicator lamp on top of the unit shows that power is supplied to the unit when lit. Output air pressure is supplied at 725mmHg when unit is in operation.

Warning: DO NOT use for infusion of blood or IV’s or for Hysteroscopy.

Description of Power pack components: 1. Power Pack 5. Pole mounting brackets 2. Power Cord 6. Fuse 3. Indicator light 7. ON/OFF switch 4. Output air connection Assembly Instruction Power Pack 1. Securely attach Power Pack to pole. Unit is mounted with indicator lamp at top. Pole diameter should be between 3/4” and 1 1/2” with a minimum 25” diameter, 5 point base. The bottom of the unit should be no more than 26” from floor. 2. Fasten clamps at the back of Power Pack around the pole and tighten knob screws until unit is stable. 3. Attach Power cord to a grounded 110V 60Hz power supply. Operating Instructions 1. Turn unit on. Wait 60 seconds before using. 2. To attach irrigation device to output connector: Depress quick connect on end of tubing into output air connection on top unit. 3. To Disconnect: Press lever on side of output air connection to release.

Precaution: Follow all instructions and observe all warnings before irrigation device is used in procedure.

Post Surgical Procedure 1. Turn unit off. 2. Disconnect power cord from power supply. Cleaning Instructions The exterior of the unit should be wiped with a damp cloth and germicide. No cleaning is required inside the unit. DO NOT immerse unit in liquids. DO NOT use solvents to clean. For service and technical support, contact your distributor. System Storage The Power Pack should be covered and stored off the floor in a dry location. Care should be taken not to drop or jar unit.

For international orders or inquiries, Please contact CONMED International Sales +1 (315) 797-8375 • FAX +1 (315) 735-6235 www.conmed.com P/N 480023 REV D 07/10