Maxtec Handi+ Instructions Manual

H

Handi+

OPERATING MANUAL &

INSTRUCTIONS FOR USE

R218P12

R218M12 Rev. J

®

CAL

866.4.Maxtec www.maxtec.com I

Maxtec TEL [phone]
2305 South 1070 West FAX [phone]

Salt Lake City, Utah 84119 www.maxtec.com

USA

Authorized Representative:

QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands

CLASSIFICATION

Classification:...............................................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

flammable anesthetic mixture

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, 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 or through Maxtec's designated distributors and/or
agents as new equipment. Routine maintenance items are excluded from
this warranty. Maxtec shall not be liable 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.

EC REP

866.4.Maxtec www.maxtec.comII

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, Isoflurane, Enflurane, Sevoflurane and Desflurane
and found to have acceptably low interference, the device in entirety (including
electronics) is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide. Only the threaded sensor face, flow diverter,
and “T” 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+ is not intended for steam, ethylene oxide or radiation sterilization.

DO NOT autoclave or expose the sensor to high temperatures.
DO NOT immerse the Handi+ oxygen analyzer in any cleaning solution.

» The flow diverter provided with the Handi+ is for use with flowing gases only.

DO NOT use 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.

866.4.Maxtec www.maxtec.com III

TABLE OF CONTENTS

CLASSIFICATION, WARRANTY ..................................... I

WARNINGS, CAUTION ...........................................II

1.0 INTRODUCTION.............................................1

1.1 Component Identification .........................................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+ Oxygen Analyzer .............................3

2.3 In-Line Calibration (Configuration A) .................................3

2.4 Direct Flow Calibration (Configuration B) ..............................4

3.0 OPERATING THE HANDI+ .....................................4

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 Specifications ...........................................7

7.2 Effect of Interferent Gases and Vapors................................8

8.0 HANDI+ SPARE PARTS AND ACCESSORIES ........................8

8.1 Standard Replacement Parts and Accessories..........................8

9.0 FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9