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ENGLISH
2
WWW.MAXTEC.COM • (800) 748-5355
AUTHORIZED REPRESENTATIVE:
QNET BV
Kantstraat 19, NL-5076 NP Haaren
The Netherlands
Read this entire manual before attempting to operate or service the MaxBlend 2. Attempting
to operate the MaxBlend 2 without fully understanding its features and functions may result
in unsafe operating conditions.
CLASSIFICATION
Protection class ..................................................................................................................... II, Type B
Protection against water ............................................................................................................... IPX1
Mode of operation .............................................................................................................Continuous
Safety of application in the presence of a flammable anesthetic mixture ...........See section 9.4
Power specification .............................................................7.5V(MAX)
1.9W/250mA(MAX)
CAUTION:
Federal law restricts this device to sale by, or on the order of, a medical
professional.
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
The MaxBlend 2 is designed for air/oxygen delivery. Under normal operating conditions,
Maxtec warrants the MaxBlend 2 to be free from defects of workmanship or materials for a
period of three years from the date of receipt from Maxtec, provided that the unit is prop-
erly operated and maintained in accordance with Maxtec’s operating instructions. Based on
Maxtec’s product evaluation, Maxtec’s sole obligation under the foregoing warranty is limited
to making repairs, or issuing credit, or replacement for equipment found to be defective. This
warranty extends only to buyers purchasing new equipment directly from Maxtec, or through
Maxtec’s designated distributors and agents. Maxtec warrants the MAX-550E oxygen sensor
in the MaxBlend 2 to be free from defects in material and workmanship for a period of two
years from Maxtec’s date of shipment in a MaxBlend 2 unit. Should a sensor fail prematurely,
the replacement sensor is warranted for the remainder of the original sensor warranty period.
Routine maintenance items, such as batteries, are excluded from warranty. Maxtec, and any
other subsidiaries, shall not be liable to the purchaser or other persons for incidental or con-
sequential damages to 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.
NOTE:
In order to obtain optimum performance from your MaxBlend 2, all operation and
maintenance must be performed in accordance with this manual. Please read the manual
thoroughly before using the MaxBlend 2, and do not attempt any repair or procedure that is
not described herein. Maxtec cannot warranty any damage resulting from misuse, unauthor-
ized repair, or improper maintenance of the instrument.
EMC Notice
This equipment uses, generates, and can radiate radio frequency energy. If not installed
and used in accordance with the instructions in this manual, electromagnetic interference
may result. The equipment has been tested and found to comply with the limits set forth
in IEC 60601-1-2 for medical products. These limits provide reasonable protection against
electromagnetic interference when operated in the intended use environments described in
this manual.
MRI Notice
This equipment contains electronic and ferrous components, whose operation can be affected
by intense electromagnetic fields. Do not operate the MaxBlend 2 in an MRI environment
or in the vicinity of high-frequency surgical diathermy equipment, defibrillators, or short-
wave therapy equipment. Electromagnetic interference could disrupt the operation of the
MaxBlend 2.
WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in death or seri-
ous injury.
The following warnings apply any time you operate
or service the MaxBlend 2:
◆
Always confirm prescribed flow before administering to patient and monitor flow on a
frequent basis.
◆
Always follow ANSI and CGA standards for medical gas products, flowmeters, and oxygen
handling.
DO NOT
operate the MaxBlend 2 unless qualified personnel are in attendance to promptly
respond to alarms, inoperative conditions, or sudden malfunctions.
◆
Patients on life-support equipment should be visually monitored at all times.
DO NOT
ignore audible alarms of the MaxBlend 2. Alarms indicate conditions that require
your immediate attention.
DO NOT
use parts, accessories, or options that have not been authorized for use with
the MaxBlend 2. Using unauthorized parts, accessories, or options may be harmful to the
patient or damage the MaxBlend 2.
◆
Check all audible and visual alarms periodically to ensure they are operating properly. If
an alarm fails to activate, contact your Maxtec Certified Service Technician.
DO NOT
operate the MaxBlend 2 with the monitor powered off or without setting the
adjustable alarms. All adjustable alarms must be set to ensure safe operation.
DO NOT
steam autoclave or otherwise subject the MaxBlend 2 to temperatures above
122°F (50°C).
◆
If either the air or oxygen source pressure is reduced or increased sufficiently to create a
pressure differential of 20 PSI or more, an audible alarm will sound. This condition may
significantly alter the FiO2 and flow output from the MaxBlend 2.
DO NOT
tape, obstruct, or remove the alarm during clinical use.
DO NOT
occlude the sensor port on the side of the MaxBlend 2.
◆
An air inlet/water filter is recommended for use with the MaxBlend 2. See section 6.1.
DO NOT
use lubricants on the MaxBlend 2.
DO NOT
use the MaxBlend 2 until correct performance has been verified. See section 3.0.
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
NOTE:
The latest edition of this operating manual can be downloaded from our website at
www.maxtec.com
Maxtec
2305 South 1070 West
Salt Lake City, Utah 84119
USA
phone: (800) 748.5355
fax: (801) 973.6090
email: [email protected]
web: www.maxtec.com
EN
Instructions for Use