Medtronic Xomed NIM-Response 2.0 User manual

NIM-Response® 2.0

Patient Simulator

USER’S GUIDE

NIM Help line

1-800-874-5797

For Questions and Service

Copyright (c) 2003 Medtronic Xomed, Inc.

All Rights Reserved

Made in U.S.A.

MEDTRONIC XOMED, Inc.

6743 Southpoint Drive North

Jacksonville, FL 32216-0980 USA

www.xomed.com

O

MDD 93/42/EEC

Authorized Representative (for EC regulatory matters)

Medtronic B.V.

Earl Bakkenstraat 10

6422 PJ Heerlen
The Netherlands

Tel.: [phone]

Fax: [phone]

A CAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner.

™ are trademarks and ® are registered marks of Medtronic Xomed, Inc.

2 15

T ABLE OF CONTENTS

LIMITED WARRANTY ............................................................................................4

CUSTOMER SERVICE ............................................................................................ 5

SYMBOLS ................................................................................................................ 5

INTRODUCTION ..................................................................................................... 6

INTENDED USE ...................................................................................................... 6

INDICATIONS .......................................................................................................... 6

CONTRAINDICATIONS .......................................................................................... 6

SYSTEM DESCRIPTION ......................................................................................... 7

NIM-Response® 2.0 PATIENT SIMULATOR ........................................................... 7

NIM-Response® 2.0 PATIENT INTERFACE CONNECTION ..................................7

SYSTEM SETUP ......................................................................................................8

SIMULATOR SETUP ............................................................................................... 8

CONNECTING TO THE NIM-Response® 2.0 ......................................................... 9

SYSTEM ASSESSMENT ......................................................................................... 10

CONFIRMING ELECTRODES ................................................................................ 10

ELECTRODE LEAD OFF ........................................................................................ 11

STIMULATION .........................................................................................................12

MECHANICAL STIMULATION .............................................................................. 12

EMG STIMULATING AND TONES ........................................................................13

BASELINE TEST ...................................................................................................... 13

CLEANING ............................................................................................................... 14

TROUBLESHOOTING ............................................................................................. 14

Page #

314

t

d

LIMITED WARRANTY

t

d

A. This LIMITED WARRANTY provides assurance for the customer who purchases a NIM-Response® 2.0

Patient Simulator (hereinafter the “Product”) that should the Product fail to function to Medtronic
Xomed’s published specifications during the term of this LIMITED WARRANTY (one year from the date
of shipment), Medtronic Xomed will either replace, repair, or issue a credit (adjusted to reflect the age of
the Product) for the Product or any portion thereof. This LIMITED WARRANTY is extended only to the
buyer purchasing the Product directly from Medtronic Xomed or from its affiliate or its authorized
distributor or representative.

B. To qualify for this LIMITED WARRANTY, the following conditions must be met:

(1) The Product must be used on or before its “Use By” or “Use Before” date, if applicable.
(2) The Product must be used in accordance with its labeling and may not be altered or subjected to

misuse, abuse, accident or improper handling.

(3) Medtronic Xomed must be notified in writing within thirty (30) days following discovery of a

defect.

(4) The Product must be returned to Medtronic Xomed within thirty (30) days of Medtronic Xomed

receiving notice as provided for in (3) above.

(5) Upon examination of the Product by Medtronic Xomed, Medtronic Xomed shall have determined

that: (i) the Product was not repaired or altered by anyone other than Medtronic Xomed or its
authorized representative, (ii) the Product was not operated under conditions other than normal use,
and (iii) the prescribed periodic maintenance and services have been performed on the Product.

C. This LIMITED WARRANTY is limited to its express terms. THIS LIMITED WARRANTY IS IN LIEU

OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR
OTHERWISE, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. In no event shall Medtronic Xomed be liable for any consequential,
incidental, prospective or other similar damage resulting from a defect, failure, or malfunction of the
Product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

D. The exclusions and limitations set out above are not intended to, and should not be construed so as to,

contravene mandatory provisions of applicable law. Users may benefit from statutory warranty rights
under legislation governing the sale of consumer goods. If any part or term of this LIMITED
WARRANTY is held by any court of competent jurisdiction to be illegal, unenforceable, or in conflict
with applicable law, the validity of the remaining portion of the LIMITED WARRANTY shall not be
affected, and all rights and obligations shall be construed and enforced as if this LIMITED WARRANTY
did not contain the particular part or term held to be invalid.

CAUTION

Applicable law may restrict the sale, distribution or use of this device to, by or on the order of a licensed
medical practitioner.

RETURNS AND/OR REPAIRS

Medtronic Xomed Customer Service
800-872-9877
904-296-6448 (FAX)
Monday – Friday
8:00 AM – 5:00 PM E.S.T.
www.xomed.com

Note: When contacting our Customer Service and Technical Support, please have:

• Product Number

• Product Serial Number

• Date of Purchase

• Nature of Inquiry Available.

A PRECAUTIONS

To avoid cross contamination and ensure aseptic technique, use of the Patient Simulator is not recommended
for use in a clinical setting.

4 13

CUSTOMER SERVICE

U.S. CUSTOMER SERVICE

General customer service and technical support are available toll-free:
800-874-5797 or 904-296-9600
Monday-Friday 8:00 AM – 6:00 PM E.S.T.
www.xomed.com

MICROELECTRONICS REPAIR

Technical Support:
800-872-9877 904-296-6448 (FAX)
Monday – Friday 8:00 AM – 5:00 PM E.S.T.
www.xomed.com

Return Address:

Medtronic Xomed, Inc.
6743 Southpoint Drive North
Jacksonville, FL 32216-0980 USA
Attn.: Repair Department

INTERNATIONAL SER VICE

International customers should contact their local Medtronic Xomed office:
AUSTRALIA: 61-2-9879-5999
CANADA: 905-826-6020
FRANCE : 33-4-7067-9800
U.K.: 44-1454-619555
GERMANY: 49-89-32140060
THE NETHERLANDS: 31-40-2333888
BELGIUM: 32-2-4560900
or their local distributor.

THE NIM-Response® 2.0 HELPLINE

Should you need immediate help with a technical question or guidance through the appropriate protocol, just
call the NIM-Response® 2.0 Help Line at 1-800-874-5797.

NOTE:

When contacting our Customer Service and Technical Support, please have the appropriate product number,
product serial number, date of purchase, and nature of inquiry available.

Product Number

Serial Number

Date of Purchase

SYMBOLS

A Attention, See Instructions For Use

C Catalog Number

N Serial Number

D Date Of Manufacture

B Lot Number

O CE Mark

512