BIOMET EBI Bone Healing System, Руководство для врачей и инструкция по применению

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Important Safeguards and Contents
Read All Instructions Before Using
When using electrical products, basic safety
precautions should always be observed:
! WARNING: To reduce the risk of electric shock,
fire or potential injuries please adhere to the
following:
1. Do not use your bone healing system while
bathing.
2. Do not place or store your bone healing
system where it can fall or be pulled into a
tub, sink or any pool of liquid.
3. Do not immerse or drop your bone healing
system’s control unit, treatment coil, AC
Wall Adapter, in any liquid.
4. Do not reach for your bone healing system
that has fallen into a liquid. Unplug from
the wall outlet immediately.
5. Do not permit the AC Wall Adapter to be
connected when wet.
6. Never touch the AC Wall Adapter contacts
when the AC Wall Adapter is plugged into
an AC Wall outlet.
7. Do not place the AC Wall Adapter in the
bed with you if you are treating while you
are sleeping.
8. Never operate your bone healing system if
it has a damaged link cable, cord or plug,
if it is not working properly, if it has been
dropped and damaged, or immersed into
any liquid. Contact Biomet immediately for
a replacement part(s).
9. Keep all electrical cords and cables away
from heated surfaces.
10. Keep all electrical cords and cables away
from children.
11. Never insert any object into any opening of
your bone healing system.
12. Do not place your bone healing system’s
control unit in prolonged heat or direct
sunlight. (Normal operating temperature
range is 5°C to 38°C,[41°F to 100°F],
20-80% RH non-condensing, normal
storage/transport temperature is -15°C to
60°C [5°F to 140°F].)
13. Use your bone healing system only for its
intended use as prescribed by your
physician and described in this manual.
14. No modification to this device is allowed for
any reason whatsoever.
15. Routine use of bone healing systems for
over 30 years has demonstrated that any
known hazard associated with their use
does not present an unreasonable risk of
illness or injury when compared to the
benefit of their use.
16. Use of your bone healing system for the
spine and skull has not been evaluated or
approved.
*NOTE: Please contact the Biomet Patient
Support Department in Parsippany, New Jersey
between the hours of 8:30 a.m. and 5:30 p.m.
Eastern Time at 1.973.299.9300 with any
questions or problems.
SAVE THESE INSTRUCTIONS
Contents – Biomet
®
EBI Bone Healing System
Control unit/Controller
Connector cables (0" and 28")
Belt
Clip Holder
AC Wall Adapter
User Manual and Package Insert
Carrying case
CAUTION: Rx Only Federal Law (U.S.A.) restricts
this device to sale by or on the order of a
physician. For Prescription Use Only. Single
prescription. Single patient use. Not for re-sale.
Please note: This system does not contain a
treatment coil. Please contact your Biomet/
EBI representative for the specific anatomically
correct treatment coil.
*NOTE: The Control Unit must not be worn on
the coil.