Maxtec MAXO2+A, MAXO2+AE Instructions Manual

MAXO
2
®
+
A /AE USER’S GUIDE & OPERATING INSTRUCTIONS
BAT
CAL
2
®
+
A
2
®
+
AE
R217M40 Rev.D
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PREFACE
This manual describes the function, operation and maintenance of the MAXO
2
®
+
hand-held oxygen analyzer. A member of Maxtec®'s MAXO
2
®
analyzer line of
oxygen analyzers and monitors, the MAXO
2
®
+
utilizes the MAX-250+ oxygen sen-
sor and is engineered for long life, maximum reliability and stable performance. The MAXO
2
®
+
is intended as a tool for use by qualified personnel to spot-check or
measure oxygen concentration of a delivered air /oxygen mixture. The
MAXO
2
®
+
is
not intended for use in continuous monitoring of oxygen delivery to a patient.
NOTE: In order to obtain optimum performance from your MAXO
2
®
+ 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®MAXO
2
®
+
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 e­mail 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.
ii iii
WWW.MAXTECINC.COM
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): MAXO
2
®+ 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: www.maxtecinc.com
E-mai: info@maxtecinc.com
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Classification
Protection against electric shock: Internally powered equipment. Protection against water: IPX1 Mode of Operation: Continuous Sterilization: See section 7.0
Safety Labeling
The following symbols and safety labels are found on the MAXO
2
®
+
:
Attention, Consult ACCOMPANYING DOCUMENTS
Off/On
Calibration
Found to meet the requirements of U.S. and Canadian nationally recognized codes and standards listed or classified by ETL.
v
WWW.MAXTECINC.COM
iv
MANUFACTURED BY MAXTEC, INC.
Before use, all individuals who will be using the MAXO
2
®
+
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.
Use only genuine Maxtec
®
accessories and replacement parts. Failure to do so
may seriously impair the analyzer’s performance. Repair or alteration of the
MAXO
2
®
+
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
MAXO
2
®
+
weekly when in operation, or if environmental conditions change significantly. (ie, Elevation, Temperature, Pressure, Humidity — refer to Section 3.0 of this manual).
Use of the
MAXO
2
®
+
near devices that generate electrical fields may cause erratic
readings.
If the
MAXO
2
®
+
is ever exposed to liquids (from spills or immersion) or to any other physical abuse, turn the instrument OFF and then ON. This will allow the unit to go through its self test to assure everything is operating correctly.
Never autoclave, immerse or expose the
MAXO
2
®
+
(including sensor) to high temperatures (>70°C). Never expose the device to pressure, irradiation vacuum, steam, or chemicals.
NOTE: Replace the batteries with recongnized high quality AA Alkaline or Lithium batteries.
NOTE: If the unit is going to be stored (not in use for 1 month), we recommend that you remove the batteries to protect the unit from potential battery leakage.
FAILURE TO COMPLY WITH THESE WARNINGS AND CAUTIONS COULD RESULT IN INSTRUMENT DAMAGE AND POSSIBLY JEOPARDIZE THE WELL BEING OF THE PATIENT AND/OR HEALTH CARE PROFESSIONAL.
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1.0 SYSTEM OVERVIEW
1.1 Base Unit Description
The MAXO
2
®
+
analyzer provides unparalleled performance and reliability due to an advanced design that includes the following features and operational benefits.
• Extra-life oxygen sensor of approximately 900,000 O
2 percent hours
(2-year warranty)
• Durable, compact design that permits comfortable, hand-held operation
and easy to clean.
• Operation using only two AA Alkaline batteries (2 x 1.5 Volts) for approxi-
mately 5000 hours of performance with continuous use. For extra extend­ed long life, two AA Lithium batteries may be used.
• Oxygen-specific, galvanic sensor that achieves 90% of final value in
approximately 15 seconds at room temperature.
• Large, easy-to-read, 3 1/2-digit LCD display for readings in the 0-100%
range.
• Simple operation and easy one-key calibration.
• Self-diagnostic check of analog and microprocessor circuitry.
• Low battery indication.
• Calibration reminder timer that alerts the operator, using a calibration icon
on the LCD display, to perform a unit calibration.
1
WWW.MAXTECINC.COM
vi
MANUFACTURED BY MAXTEC, INC.
TABLE OF CONTENTS
1.0 SYSTEM OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.1
Base Unit Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
1.2
Component Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.3 Component Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
1.4 MAX-250+ Oxygen Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.0
OPERATING INSTRUCTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1.1
Protect Tape . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1.2 Remove the Battery Ribbon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
2.1.3 Automatic Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.2
Calibrating the MAXO
2
®
+
Oxygen Analyzer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
2.2.1
In Line Calibration (Flow Diverter - Tee Adapter) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
2.2.2 Direct Flow Calibration (Barb) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
3.0 FACTORS INFLUENCING ACCURATE READINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.1
Elevation Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.2 Temperature Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.3 Pressure Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
3.4
Humidity Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
4.0 CALIBRATION ERRORS AND ERROR CODES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7
5.0 CHANGING THE BATTERIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
6.0
CHANGING THE OXYGEN SENSOR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
6.1 MAXO
2
®
+
A Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9
6.2 MAXO
2
®
+
AE Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
7.0 CLEANING AND MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
8.0
SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
8.1
Base Unit Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
8.2
Sensor Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
9.0 MAXO
2
®
+
SPARE PARTS AND ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
9.1
Included With Your Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .12
9.2 Standard Replacement Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
9.3 Optional Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
9.3.1
Optional Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
9.3.2 Mounting Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
9.3.3 Carrying Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
10.0
WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
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