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manual abstract
Maxtec®, Inc. 6526 South Cottonwood Street Salt Lake City, Utah 84107 USA DECLARATION OF CONFORMITY Manufacturer's Name: Manufacturer's Address: medicalManual.RevD.qxd 9/9/04 4:18 PM Page 2 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 manufacturer 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: E-mai: info@maxtecinc.com ii 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 sensor 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 appreciate 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 equipment, 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 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. WWW.MAXTECINC.COM iii Before use, all individuals who will be using the MAXO2®+ must become thoroughly familiar with the information contained in this Operation Manual. Strict adherence to the operating instructions is necessary for safe, effective product performance. This product will perform only as designed if installed and operated in accordance with the manufacturer’s operating instructions. medicalManual.RevD.qxd 9/9/04 4:18 PM Page 4 Before use, all individuals who will be using the MAXO2®+ must become thoroughly familiar with the information contained in this Operation Manual. Strict adherence to the operating instructions is necessary for safe, effective product performance. This product will perform only as designed if installed and operated in accordance with the manufacturer’s operating instructions. medicalManual.RevD.qxd 9/9/04 4:18 PM Page 4 Use only genuine Maxtec® accessories and replacement parts. Failure to do so may seriously impair the analyzer’s performance. Repair or alteration of the MAXO2® + beyond the scope of the maintenance instructions, or by anyone other than an authorized Maxtec® service person, could cause the product to fail to perform as designed. Calibrate the MAXO2® + weekly when in operation, or if environmental conditions change s...