Maxtec MaxO2+ Bedienungsanleitung Seite 3

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
This manual describes the function, operation and maintenance of the Maxtec Model MaxO2+ A
and AE oxygen analyzer. The MaxO2+ family of Oxygen Analyzers utilizes the Maxtec Max-250
oxygen sensor and is engineered for fast response, maximum reliability and stable
performance. The MaxO2+ is designed as a tool for use by qualified personnel to spot-check or
measure oxygen concentration of delivered air/oxygen mixtures. The MaxO2+ A and AE
Analyzers are not intended for use in continuous monitoring of oxygen delivery to a patient.
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.
CLASSIFICATION
Protection against electric shock .......................................................Internally Powered Equipment
Protection against water ................................................................................................................ IP33
Mode of operation .............................................................................................................. Continuous
Sterilization ...................................................................................................................... See section 7
Needs Applied Parts ........................................................................................ Type BF (entire device)
Flammable anesthetic mixture ....................................................... Not suitable for use in presence
There are no specific diseases or conditions this device directly helps to screen, monitor, treat,
diagnose, or prevent.
For purposes of emergency medical services (EMS) this device is transportable in a road
ambulance and is considered hand-held. It may also be pole-mounted using the optional
dovetail adapter.
WARRANTY
The MaxO2+ Analyzer is designed for medical oxygen delivery equipment and systems. Under normal
operating conditions, Maxtec warrants the MaxO2+ Analyzer to be free from defects of workmanship or
materials for a period of 2-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.
Maxtec warrants Max-250 oxygen sensor in the MaxO2+ Analyzer to be free from defects in material and
workmanship for a period of 2-years from Maxtec's date of shipment in a MaxO2+ 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 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.
WARNINGS
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
◆
Never install the sensor in a location that will expose the sensor to patient's exhaled breath or
secretions, unless you intend to dispose of the sensor, flow diverter and tee adapter.
◆
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.
◆
NOT FOR USE in an MRI environment.
◆
Device specified for dry gas only.
◆
Never allow an excess length of tubing, lanyard or sensor cable near the patient's head or neck, which
may result in strangulation.
◆
Before use, all individuals who will be using the MaxO2+ must become thoroughly familiar with the
information contained in this Operation Manual. Strict adherence to the operating instructions is
necessary for safe, effective product performance.
WWW.MAXTEC.COM • (800) 748-5355
phone: (800) 748.5355
fax: (801) 973.6090
email: sales@maxtec.com
web: www.maxtec.com
of a flammable anesthetic mixture
EMERGO EUROPE
Westervoortsedijk 60,
6827 AT Arnhem
The Netherlands
◆
This product will perform only as designed if installed and operated in accordance with the
manufacturer's operating instructions.
◆
Use only genuine Maxtec accessories and replacement parts. Failure to do so may seriously impair
the analyzer's performance. Repair or alteration of the MaxO2+ beyond the scope of the maintenance
instructions or by anyone other than an authorized Matec service person could cause the product to
fail to perform as designed. No modification of this equipment allowed.
◆
Calibrate the MaxO2+ weekly when in operation, or if environmental conditions change significantly.
(i.e., Elevation, Temperature, Pressure, Humidity — refer to Section 3 of this manual).
◆
Use of the MaxO2+ near devices that generate electrical fields may cause erratic readings.
◆
If the MaxO2+ is ever exposed to liquids (from spills or immersion) or to any other physical abuse,
turn the instrument OFF and then ON. This will allow the unit to go through its self-test to assure
everything is operating correctly.
◆
Never autoclave, immerse or expose the MaxO2+ (including sensor) to high temperatures (>70°C).
Never expose the device to pressure, irradiation vacuum, steam, or chemicals.
◆
This device does not contain automatic barometric pressure compensation.
◆
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.
NOT FOR USE with inhalation agents. Operating the device in flammable or explosive
◆
atmospheres may result in fire or explosion.
◆
This product is not intended as a life-sustaining or life-supporting device.
◆
Medical oxygen should meet the requirements of USP.
◆
The MaxO2+ and sensor are non-sterile devices.
◆
In the event of exposure to an ELECTROMAGNETIC DISTURBANCE the analyzer may display an E06 or
E02 error message. If this occurs, turn the instrument OFF, remove the batteries and wait 30 seconds.
Then, re-load the batteries and allow the unit to go through its self-test diagnostics to make sure
everything is functioning correctly.
◆
Gas leaks that cause room air to mix with the gas sample may cause inaccurate oxygen readings.
Ensure the O-rings on the sensor and flow diverter are in place and intact prior to use.
◆
Use of the oxygen sensor beyond the expected service life may result in degraded performance or
reduced accuracy of the oxygen sensor. Refer to section 6 for replacement of the oxygen sensor.
CAUTIONS
Indicates a potentially hazardous situation, if not avoided, could result in minor or moderate injury and
property damage.
◆
Federal Law (USA) restricts this device to sale by or on the order of a physician.
◆
Replace the batteries with recognized high-quality AA Alkaline or Lithium batteries.
DO NOT use RECHARGEABLE BATTERIES.
◆
If the unit is going to be stored (not in use for 1 month), we recommend that you remove the batteries
to protect the unit from potential battery leakage.
◆
The Maxtec Max-250 oxygen sensor is a sealed device containing a mild 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.
DO NOT use ethylene oxide sterilization
DO NOT immerse the sensor in any cleaning solution, autoclave or expose the sensor to high
temperatures.
◆ Dropping sensor can adversely affect its performance.
◆
The device will assume a percent oxygen concentration when calibrating. Be sure to apply 100%
oxygen, or ambient air concentration to the device during calibration or the device will not calibrate
correctly.
NOTE: Product is not made with natural rubber latex
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 led, might have led, or might lead to the death of a patient,
user, or other person; the temporary or permanent serious deterioration of the patient's user's or other
person's state of health; of serious public health threat.
3
Conforms to:
ANSI/AAMI STD ES60601-1
IEC STDS 60601-1-6, 60601-
1-11, 60601-1-12
Certified to:
CSA STD C22.2 No. 60601-1
ENGLISH