SONOTRAX Series Ultrasonic Pocket Doppler User Manual
WARNING
: The stretching length of probe cable should be less than 2m in
order to avoid the cable breaking away from the probe socket.
CAUTION
: Federal law restricts this device to be used by or on the order of a
physician.
CAUTION
: Refer servicing to qualified personnel.
CAUTION
: The main unit of the SONOTRAX Series is designed for continuous
operation and is 'ordinary'. Do not immerse in any liquid (i.e. not
drip or splash-proof).
CAUTION
: Keep the device clean. Avoid vibration.
CAUTION
: Do not use high temperature sterilizing process and E-beam or
gamma radiation sterilization.
CAUTION
: Electromagnetic Interference-Ensure that the environment in
which the device is operated is not subject to any source of strong
electromagnetic interference, such as radio transmitters, mobile
telephones, etc. Keep them far away.
CAUTION
: The user must check that the equipment does not have visible
evidence of damage that may affect personnel's safety or
monitoring capability before use. The recommended inspection
interval is once per month or less. If damage is evident,
replacement is recommended before use.
CAUTION
: The following safety checks should be performed once every two
years or as specified in the institution's test and inspection protocol
by a qualified person who has adequate training, knowledge, and
practical experience to perform these tests.
Z Inspect the equipment for mechanical and functional damage.
Z Inspect the safety relevant labels for legibility.
Z Verify that the device functions properly as described in the
instructions for use.
Z Test the the pregnant woman's leakage current according to
IEC 60601-1/1988: Limit: 100 uA (B).
The leakage current should never exceed the limit. The data should
be recorded in an equipment log. If the device is not functioning
properly or fails any of the above tests, the device has to be
repaired.
CAUTION
: If the rechargeable buttony battery is used, please charge it fully
before use in order to protect its performance and life. Under
normal temperature, the battery should be charged for 14 hours
continuously at standard charge circuit.
CAUTION
: The battery must be taken out from the battery compartment if the
device will not be used for a long time.
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SONOTRAX Series Ultrasonic Pocket Doppler User Manual
CAUTION
: The device shall only be used if the battery cover is closed.
CAUTION
: The battery must be proper disposed according to local regulation
after their use.
CAUTION
: The device could be sent back to the manufacturer for recycling or
proper disposal after their useful lives.
1.2 Symbols
This item is compliant with Medical Device Directive 93/42/EEC of 14 June 1993, a directive
of the European Economic Community.
: Attention. Refer to accompanying documents.
This symbol consisting of two parts, see below.
It indicates that the equipment should be sent to the special agencies according to local
regulation for separate collection after its useful life.
It indicates that the equipment is put on the market after 13 August 2005.
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