Synthes MAXFRAME AUTOSTRUT, Руководство пользователя

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4 Physician User Manual • MAXFRAME AUTOSTRUT™ System
2.5 General Warnings
• MAXFRAME AUTOSTRUT System hardware and
software must only be used with the MAXFRAME
System hardware and software.
• MAXFRAME AUTOSTRUT is not to be used for
diagnosis.
• The patient and/or post operative care team must be
capable of understanding the system operation,
indications (lights/sounds) made throughout the
treatment, and provide timely communications back to
their surgeon.
• MAXFRAME AUTOSTRUT Control System is powered
by batteries. In the case that the battery power goes
below ~30% capacity, LED lights indicating LOW BAT
will illuminate (see example “System Indicators” in
Section 3). The system will continue to work according
to plan until the battery is fully empty.
• Care should be taken during product unpacking to
ensure the product is not damaged.
• Electromagnetic compatibility (EMC):
• Electric medical units are subject to special
precautionary measures with regard to EMC and
may only be installed and put into operation in
compliance with the EMC information and safety
instructions specified in this document, and
exclusively for intended purposes.
• Accuracy of positioning is essential for safe use of
the MAXFRAME AUTOSTRUT System. Use of
MAXFRAME AUTOSTRUT System in environment
with EM disturbances beyond specified in CL. 7.4
can lead to degradation of accuracy and lead to
hazardous situation.
• Exposure to electromagnetic disturbances may cause
damage to the control unit requiring replacement.
o
Airport metal detectors emit electromagnetic
energy. If the patient plan to travel on an
airplane, the security metal detector will alarm
and may interfere with the MAXFRAME
AUTOSTRUT System functionality. Patient
should request a hand-pat search and avoid
the metal detector. Additionally, patient may
get asked by airport security about the device
and if it has batteries. The device contains
two 9-volt lithium batteries and meets the
criteria for air travel per regulation 49 CFR
175.10.
• Use of this equipment adjacent to or stacked with
other equipment should be avoided because it could
result in improper operation. If such use is necessary,
this equipment and the other equipment should be
observed to verify that they are operating normally.
• Use of accessories, transducers and cables other
than those specified or provided by the manu-
facturer of this equipment could result in increased
electromagnetic emissions or decreased electro-
magnetic immunity of this equipment and result in
improper operation.
• Portable RF communications equipment (including
peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm
(12 inches) to any part of the MAXFRAME
AUTOSTRUT system, including cables specified by
the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
• Electric medical units are subject to special
precautionary measures with regard to EMC and
may only be installed and put into operation in
compliance with the EMC information contained in
this document.
• Portable and mobile radiofrequency communication
devices can influence electric medical devices.
• Patient should take care to avoid impact to the
MAXFRAME AUTOSTRUT System (e.g., hitting
against or colliding with other objects) as such
activity can result in detached and/or damaged
components (i.e., cables, cable splitters, motors etc.).
2. Introduction