Maxtec Handi+, R218P12 Instructions Manual

®
Handi+
OPERATING MANUAL &
INSTRUCTIONS FOR USE
R218P12
R218M12 Rev. D
Authorized Representative:
EC REP
QNET BV Hommerterweg 286 6436 AM Amstenrade The Netherlands
CLASSIFICATION
Classi¿cation: .............................................Class II medical device.
Protection against electric shock:........................ Internally powered equipment.
Protection against water: ...................................................IPX1
Mode of Operation:.................................................. Continuous
Sterilization: ....................................................See section 6.0
Flammable anesthetic mixture: .....................Not suitable for use in presence of a
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash disposal. Return sensor to Maxtec for proper disposal or dispose according to local guidelines. Follow local guidelines for disposal of other components.
WARRANTY
Maxtec®, Inc., warrants the Handi®+ to be free from defects of workmanship or materials for a period of two-(2) years from the date of shipment from Maxtec®, under normal operating conditions and provided that the Handi®+ is properly operated and maintained in accordance with Maxtec®'s operating instructions. Should Handi®+ fail prematurely, the replacement
®
Handi
+ is warranted for the remainder of the original analyzer warranty period. Based on Maxtec®'s product evaluation, Maxtec®'s sole obligation under the foregoing warranty is limited to making replacements, repairs or issuing credit for equipment found to be defective. This warranty extends only to the buyer purchasing the equipment directly from Maxtec®, Inc. or through Maxtec®'s designated distributors and/or agents as new equipment. Routine maintenance items are excluded from this warranty. Maxtec to the purchaser or other persons for incidental or consequential damages or equipment that has been subject to abuse, misuse, misapplication, alteration, negligence or accident. THESE WARRANTIES ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
Àammable anesthetic mixture
®
, Inc. shall not be liable
866.4.Maxtec www.maxtecinc.com I
WARNINGS
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
»
Before use, all individuals who will be using this product must become thoroughly
familiar with the information contained in this Operation Manual. Strict adherence to the operating instructions is necessary for safe and effective product performance. This product will perform only as designed and only if installed and operated in accordance with the manufacturer's operating instructions.
»
Although the sensor of this device has been tested with various anesthesia gases including
nitrous oxide, Halothane, IsoÀurane, EnÀurane, SevoÀurane and DesÀurane and found to have acceptably low interference, the device in entirety (including electronics) is not suitable for use in the presence of a Àammable anesthetic mixture with air or with oxygen or nitrous oxide. Only the threaded sensor face, Àow diverter, and ³T´ adapter may be allowed to contact such a gas mixture.
»
This device does not contain automatic barometric pressure compensation.
» Do not use near any type of flame or flammable/explosive substances, vapors or
atmosphere.
»
Not for use in an MRI environment.
» Improper use of this device can cause inaccurate oxygen readings which can lead to improper
treatment, hypoxia or hyperoxia. Follow the procedures outlined in this user manual.
CAUTION:
Indicates a potentially hazardous situation, if not avoided, could result in minor or moderate injury and property damage.
»
The Maxtec MAX-250 oxygen sensor is a sealed device containing a weak acid electrolyte,
lead (Pb), and lead acetate. Lead and lead acetate are hazardous waste constituents and should be disposed of properly, or returned to Maxtec for proper disposal or recovery.
» The
Handi autoclave or expose the sensor to high temperatures. Do not immerse the analyzer in any cleaning solution.
»
The Àow diverter provided with the Handi
the diverter when performing static sampling (e.g., in incubators, oxygen tents, oxygen hoods).
»
Do not attempt any repairs or procedures, which are not described in this Operation Manual.
Maxtec cannot warrant this product from damage resulting from misuse, unauthorized repair or improper maintenance of this product.
» The Federal (USA) law restricts this device to sale by or on the order of a physician.
»
There are no internal user-serviceable parts.
»
Never install the sensor in a location that will expose the sensor to patient’s exhaled breath
or secretions.
®
is not intended for steam, ethylene oxide or radiation sterilization. Do not
+
®
+ is for use with Àowing gases only. Do not use
Handi
®
oxygen
+
866.4.Maxtec www.maxtecinc.comII
TABLE OF CONTENTS
Classi¿cation....................................................... I
Warranty.......................................................... I
Warnings..........................................................II
1.0 INTRODUCTION ................................................1
1.1 Component Identi¿cation.........................................1
1.2 Symbol Guide .................................................2
1.3 Description ...................................................2
2.0 CALIBRATING THE HANDI+ .......................................2
2.1 Before you begin ...............................................2
2.2 Calibrating the HANDI
2.3 In-Line Calibration (Con¿guration A)................................3
2.4 Direct Flow Calibration (Con¿guration B) ............................3
3.0 OPERATING THE HANDI
4.0 FACTORS INFLUENCING ACCURATE READINGS .....................5
4.1 Elevation Changes .............................................5
4.2 Temperature Effects ............................................5
4.3 Pressure Effect ................................................5
4.4 Humidity Effect ................................................6
5.0 CALIBRATION ERRORS AND ERROR CODES ........................6
6.0 CLEANING AND MAINTENANCE ...................................7
7.0 SPECIFICATIONS ...............................................7
7.1 Analyzer Speci¿cations ..........................................7
7.2 Effect of Interferent Gases and Vapors ..............................8
®
+ Oxygen Analyzer...........................2
®
+........................................4
8.0 HANDI+ SPARE PARTS AND ACCESSORIES .........................8
8.1 Standard Replacement Parts and Accessories........................8
9.0 FREQUENTLY ASKED QUESTIONS .................................9
866.4.Maxtec www.maxtecinc.com III
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