zebris ARCUSdigma 3, Руководство пользователя

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2.2.5. Safety information on heart pacemakers/defibrillators
• The magnetic coupling for attaching the lower jaw sensor to the lower jaw attachment
contains strong permanent magnets (neodymium magnets) such as those that are
used on headphones on MP3 players. Electronic implants such as e.g. Pacemakers or ICD’s can
switch to a maintenance mode when the magnetic field is strong. To exclude potential risks,
patients with electronic implants should keep the lower jaw sensor at a minimum distance of
10 cm from the patient’s chest and record with an upper body. Also, the lower jaw sensor should
not be placed on thepatient’s upper body in patients with.
• The ARCUSdigma 3 can be operated wireless via WiFi as an interface to the evaluation PC.
Although there are no indications of possible interference with electronic implants by WiFi
transmitters, it is recommended for patients with electronic implants to keep the face bow of the
ARCUSdigma 3 at least 15 cm away from the patient’s thorax.
2.2.6. Prohibited use
• Improper and/or prohibited use of the measurement system is not permitted an
express warning is herewith provided of such.
• Do not under any circumstances attempt to maintain or prepare the measurement
system in any way other than as described in the operating instructions. This could cause the
high sensitivity sensor technology to be in impaired terms of its measurement accuracy.
• In the case of malfunctions and/or defects being suspected and / or ascertained, the device has
to be taken out of use immediately, labeled as ”Out of Use” , and secured to prevent use, with
the on / off switch being covered and secured with adhesive tape. Please contact your dealer
before further use.
• Changing or modifying the measurement system or its accessory parts without the written
permission of zebris Medical GmbH is not allowed. If the device is changed without permission,
the operator is obliged to carry out suitable examinations and inspections in order to guarantee
the secure use.
• It is not permitted to operate the systems under conditions different from those lined out in
chapter: 2.2.1. Environmental Conditions, p. 8 .
• Do not attempt to reprocess the disposable accessories. In addition to an infection risk associated
with reprocessing, it can not be guaranteed that equivalent measuring accuracy will be obtained
by using reprocessed components. Thus, the reprocessing eliminates the manufacturer’s warranty
for the disposable product.
• Parallel/simultaneous operation of other programs (SOUP) and ARCUSdigma 3 on the same PC
system is not permitted and is not provided for purpose. The manufacturer assumes no liability
for hazards that occur in this context.