MaxTech MAXO2 operating instructions Declaration of Conformity, Preface, Thank You

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DECLARATION OF CONFORMITY

Manufacturer's Name:	Maxtec®, Inc.
Manufacturer's Address:	Maxtec®, Inc.
	6526 South Cottonwood Street
	Salt Lake City, Utah 84107
	USA
European Representative:	Bio MS (Airox)
	L'Echangeur, Parc d'activite Pau-Pyrenees
	64000 Pau, France
Product:	Oxygen Analyzer
Model(s):	MAXO2®+ A, MAXO2®+ AE
Classification:	IIa
Classification criteria:	Clause 3.2 Rule 10 of Annex IX of MDD

We herewith declare that the above mentioned products meet the provisions of the following EC Council Directives and Standards. All supporting documents are retained under the premises of the manufactur- er and the notified body.

Directives:	General application directives: Medical Device Directive,
	COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning
	medical devices (MDD 93/42/EEC)
Standards:	EN/IEC 601-1 1988, Amendment I 1991, Amendment II 1995
	IEC 60601-1-2: 2001
	EN 1041
	IEC 878
	EN 980
	ISO 7767; 1997
	EN 60601-1-4: 2000-04
Notified Body:	TUV Product Service
	RIDLERSTRASSE 65, D-80339 MUNICH, Germany
EC Certificate No.:	G1 01 12 45041 001
Date CE mark was affixed:	June 21, 2004
Name:	Gordon R. Roth
Position:	Manager, Quality System/ISO Representative
	Maxtec®, Inc.
	6526 South Cottonwood Street
	Salt Lake City, UT 84107 U.S.A.
General Telephone:	801-266-5300
Toll Free U.S.A.:	800-748-5355
FAX:	801-270-5590
Web Site:	www.maxtecinc.com
E-mai:	info@maxtecinc.com

PREFACE

This manual describes the function, operation and maintenance of the MAXO2® + hand-held oxygen analyzer. A member of Maxtec®'s MAXO2® analyzer line of oxygen analyzers and monitors, the MAXO2® + utilizes the MAX-250+ oxygen sen- sor and is engineered for long life, maximum reliability and stable performance. The MAXO2® + is intended as a tool for use by qualified personnel to spot-check or measure oxygen concentration of a delivered air /oxygen mixture. The MAXO2® + is not intended for use in continuous monitoring of oxygen delivery to a patient.

NOTE: In order to obtain optimum performance from your MAXO2®+ analyzer, all operation and maintenance must be performed in accordance with this manual. Please read the manual thoroughly before using the analyzer and do not attempt any repair or procedure that is not described herein. Maxtec® cannot warrant any damage resulting from misuse, unauthorized repair or improper maintenance of the instrument.

Thank You

Thank you for your purchase of a Maxtec® MAXO2® + oxygen analyzer. We appreci- ate the time and energy you invest in selecting the equipment best suited to your needs. In exchange, we are supplying you with a reliable, high-quality instrument that, with proper care and operation, will provide you with years of exceptional service. We also encourage your comments or suggestions as to how our equip- ment, in any way, can better serve your needs. Please feel free to write, FAX or e- mail us at the address on page ii of this manual c/o the Maxtec® Marketing Department. Please visit our website www.maxtecinc.com for more information on our products and services.

WARNING:

Never install the sensor in a location that will expose the sensor to patient’s exhaled breath or secretions, unless you intend to dispose of the sensor, flow diverter and tee adapter.

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

CAUTION: NOT for use with inhalation agents. Operating the device in flammable or explosive atmospheres may result in fire or explosion.

NOTE: Not for use in a MRI environment.

NOTE: Device specified for dry gas only.

NOTE: This product is latex free.

Never allow an excess length of tubing, lanyard or sensor cable near the patient’s head or neck, which may result in strangulation.

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