Product Disposal Instructions; Symbol Guide - Maxtec Handi+ Instrucciones De Uso

Maxtec
2305 South 1070 West
Salt Lake City, Utah 84119
USA
NOTE: The latest edition of this operating manual can be downloaded from our website at www.maxtec.com
CLASSIFICATION
Classification ....................................................................................................Class II medical device
Protection against electric shock .................................................... Internally powered equipment
Protection against water ...............................................................................................................IPX4
Mode of Operation .............................................................................................................Continuous
Sterilization .................................................................................................................. See section 6.0
Flammable anesthetic mixture .....................................................Not suitable for use in presence

Product Disposal Instructions:

The sensor, batteries, and circuit board are not suitable for regular trash dis-
posal. 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 evalua-
tion, 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, misapplica-
tion, 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.
WARNING
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 operat-
ing 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 manu-
facturer'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 suit-
able 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.
ENGLISH
phone: (800) 748.5355
fax: (801) 973.6090
email: sales@maxtec.com
web: www.maxtec.com
of a flammable mixture
AUTHORIZED REPRESENTATIVE:
QNET BV
Kantstraat 19, NL-5076 NP Haaren
The Netherlands
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, unau-
thorized 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.

SYMBOL GUIDE

The following symbols and safety labels are found on the Handi+:
Follow instructions for use
Warning
Meets ETL standards
Do Not
Contains acid
Catalog Number
Lot code/Batch code
Federal law (USA) restricts
this device to sale by or
on order of a physician
50°C
(122°F)
Storage Temperature Range
-15°C
(5°F)
2
Conforms to:
AAMI STD ES60601-1, ISO STD
80601-2-55, IEC STDS 60601-
1-6, 60601-1-8 & 62366
Certified to:
CSA STD C22.2 No. 60601-1
On/Off Button
Calibration Button
Do not throw away.
Follow local guidelines
for disposal
Manufacturer
Caution
Serial Number
Ingress Protection
Rating
Authorized
Representative
in the European
Community
WWW .MAXTEC .COM • (800) 748-5355