About This Manual; General Warnings And Cautions - Synthes MAXFRAME AUTOSTRUT Patient User Manual

Welcome

1. About this Manual

This User's Manual is intended for use by the patient.
It familiarizes you with MAXFRAME AUTOSTRUT™
Multi-Axial Correction System (MAXFRAME
AUTOSTRUT™ System, or just "System" for short) and
will help you to understand the elements and operation
of the system.
It is important to carefully read the instructions detailed
in this manual.
This Patient User Manual is intended only as an instruc-
tional guide. For additional information and questions,
please contact your physician.
■ Note:
The following terms all refer to the MAXFRAME
AUTOSTRUT™ System:
• MAXFRAME AUTOSTRUT
• OrthoSpin AutoStrut
• AutoStrut G2
1.1 Notes Statements
Notes statements are used throughout this manual to
provide additional information and emphasize important
information. You should read these statements to ensure
your safety and allow for effective use of the device.

1.2 General Warnings and Cautions

• Exposure to electromagnetic disturbances may affect
the system and cause delayed treatment.
• Airport metal detectors emit electromagnetic
energy. If you plan to travel on an airplane, the
security metal detector will alarm and may interfere
with the MAXFRAME AUTOSTRUT System
functionality. You should request a hand-pat search
and avoid the metal detector. Additionally, you may
get asked by airport security about your device and
if it has batteries. Your device contains two 9-volt
lithium batteries and meets the criteria for air travel
per regulation 49 CFR 175.10.
• Do not disassemble the control box, attempt to
replace/recharge or sterilize the batteries.
• Devices that emit RF (radiofrequency) energy should
be used no closer than 30 cm (12 inches) to any part of
the MAXFRAME AUTOSTRUT System. Otherwise,
degradation of the performance of the System could
result.
• Care should be taken to prevent 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.). In case of
detachment of components, the dislodgement of
motors, or damage to any component, please contact
your physician as soon as possible.
• WARNING: Choking Hazard – contains small parts.
■ Note:
As with any prescription medical device, failure to follow
product instructions which includes tampering with the
device or changing settings may lead to improper prod-
uct performance and the potential for serious injury. Do
not tamper with the device.
MAXFRAME AUTOSTRUT™ System • Patient User Manual 1