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Maxtec
2305 South 1070 West
Salt Lake City, Utah 84119
USA
The latest edition of this operating manual can be downloaded from our website at: www.maxtec.com
NOTE: The UltraMax O2 is for use only by trained personnel. Before use, all individuals using the
UltraMax O2 should become familiar with the information contained in this Operation Manual.
Adherence to these instructions is necessary for safe, effective product performance. Thoroughly
read all instructions and labeling provided with this device and any other equipment that will
be used.
CLASSIFICATION
Protection against electric shock .......................................................Internally Powered Equipment
Protection against water ................................................................................................................ IP22
Mode of operation .............................................................................................................. Continuous
Sterilization ...................................................................................................................... See section 6
Flammable anesthetic mixture ........... Not for use in presence of flammable anesthetic mixtures
Applied Parts .................................................................................................................................... N/A
CAUTION: Federal law restricts this device to sale by or on the order of a physician or other
licensed healthcare practitioner.
Product Disposal Instructions:
The UltraMaxO2 and batteries are not suitable for regular trash disposal. Dispose
of device and batteries according to local guidelines.
WARRANTY
Under normal operating conditions, Maxtec warrants the UltraMax O2 to be free from defects of
workmanship or materials for a period of Three (3) years from the date of shipment from Maxtec, provided
that the unit is properly operated and maintained in accordance with Maxtec's operating instructions.
Based on Maxtec 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 agents as new equipment.
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 consequential damages
or equipment that has been subject to abuse, misuse, mis-application, 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.
PRINCIPLE OF OPERATION
The UltraMax O2 Oxygen Analyzer measures oxygen concentration and flow using ultrasound technology
and measures pressure using a piezoresistive silicon pressure sensor.
WARNINGS
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
NOT FOR USE in an MRI environment.
◆
Improper use of the UltraMaxO2 can cause inaccurate oxygen readings leading to improper
treatment and/or patient harm. Follow the procedures outlined in this user manual.
◆
The UltraMaxO2 is for checking oxygen concentrators only.
DO NOT use the UltraMaxO2 for continuous oxygen monitoring.
DO NOT use the UltraMaxO2 to measure the oxygen concentration of a concentrator when flowing at
rates lower than its optimal performance as specified by the concentrator manufacturer; generally 4
LPM or less on concentrators that have a maximum flow of 10 LPM, and 1 LPM or less on concentrators
that have a maximum flow of 5 LPM.
◆
Not for use in anesthesia applications or for measuring oxygen concentration from any sources other
than conventional oxygen concentrators.
◆
Not for use with inhalation agents. Operating the UltraMax O2 in flammable or explosive
environments may result in fire or explosion.
NOT SUITABLE for use in the presence of flammable anesthetic mixtures.
◆
Oxygen rapidly accelerates combustion.
WWW.MAXTEC.COM • (800) 748-5355
phone: (800) 748.5355
fax: (801) 973.6090
email: sales@maxtec.com
web: www.maxtec.com
EMERGO EUROPE
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
DO NOT smoke while using the UltraMax O2 for checking oxygen concentrators.
◆
Users must become thoroughly familiar with the information contained in this Operation Manual
before use. Strict adherence to the operating instructions is necessary for safe, effective product
performance. This product will perform only as designed if operated in accordance with the
manufacturer's operating instructions.
◆
Use only genuine Maxtec accessories. Failure to do so may seriously impair the performance of the
UltraMax O2. Repair or alteration of the UltraMax O2 by anyone other than an authorized Maxtec
service representative could cause the product to fail to perform as designed.
◆
Use of the UltraMax O2 near devices that generate electrical fields may cause erratic readings.
◆
If the UltraMax O2 is ever exposed to liquids from spills or immersion, immediately remove the
batteries and let the device dry completely. When dry, replace the batteries and check for proper
operation.
DO NOT autoclave or expose the UltraMaxO2 to high temperatures (>60°C).
DO NOT use ethylene oxide sterilization.
DO NOT expose the UltraMaxO2 to irradiation, vacuum, steam, or harsh chemicals.
DO NOT expose the UltraMaxO2 to pressure greater than 50 psi. Exposure to pressure above 50 psi
could cause leaks in the device which may adversely affect performance in flow and pressure
readings.
CAUTIONS
Indicates a potentially hazardous situation, if not avoided, could result in minor or moderate injury and
property damage.
◆
Replace the batteries with high Quality AA Alkaline batteries.
DO NOT use rechargeable batteries.
◆
When not in use for periods greater than 30 days remove the batteries to protect the UltraMax O2
from potential battery leakage.
◆
Avoid dropping the UltraMax O2 to prevent damage which may adversely affect its performance. If
damage to the device is suspected, perform the calibration verification procedure in Section 2.3 of
this operating manual.
◆
Avoid foreign matter entry into the UltraMax O2.
DO NOT use the UltraMaxO2 to check a concentrator with a humidifier in place. Humidity from a
humidifier could damage the device.
DO NOT check a concentrator while holding the mode button or the reading will be inaccurate.
◆
Following storage in extremely hot or cold conditions, allow the gas to flow through the analyzer
long enough for the internal sensors to reach the gas stream temperature, or wait for the analyzer
to equilibrate to room temperature before use.
◆
Product is not made with natural rubber.
NOTE: SERIOUS incident(s) that occur in relation to the device should be reported to Maxtec and the
competent authority of the Member State in which the user and/or patient is established. Serious
incident(s) is defined as directly or indirectly le, might have led, or might lead to the death of a patient,
user, or other person: the temporary or permanent serious deterioration of a patient's, user's or other
person's state of health; or a serious public health threat.
3
Conforms to:
ANSI/AAMI STD ES60601-1
IEC STDS 60601-1-6 &
60601-1-11
Certified to:
CSA STD C22.2 No. 60601-1
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