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

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6
General Treatment Instructions
Recommended Usage
The recommended daily treatment dosage is
normally 10 hours per day.
Although the device was shown to be effective at
treatment times between 3 to 10 hours per day, a
review of the clinical data has shown that healing
may occur earlier when treatment is achieved at
the recommended 10 hours per day.
Compliance with the recommended ten
(
10)
hours per day treatment is very important. A
review of the clinical data demonstrates that
less than the recommended use of this device
possibly results in an increase in the time to
heal your fracture. If you are unable to treat for
ten continuous hours, it is recommended that
you break up the total treatment time into more
than one session. Please refer to the following
General Treatment Instructions.
General Treatment Instructions
Treatment should not be suspended until
healing occurs or until such time as the
prescribing physician recommends
discontinuation of the device.
The Biomet
®
EBI Bone Healing System is
programmed to deliver a maximum of 270
therapeutic treatment periods. Biomet
recommends a therapeutic treatment period
of 10 hours per day. A therapeutic treatment
period is defined as a 10 hour treatment
session accomplished either continuously or
discontinuously in segments totaling 10 hours.
• Unsegmented Continuous Treatment Period:
Patient wears the device with coil in place for
10 consecutive hours without interruption
• Segmented Discontinuous Treatment Period
(Example): Patient treats with coil in place for
four hours, turns the device off and does not
push the RESET button. Patient then turns the
device on within the next 12 hours and only
completes the remaining six hours of treatment
for that therapeutic treatment period.
• Shortened Segmented:
A treatment period of less than 10 hours may
be achieved by pushing the reset button prior
to the completion of the 10-hour period.
Once the device has been reset, the system
software will reset the controller to start a
new treatment period.
• Shortened Segment Treatment Period
(Example): Patient completes eight hours of
treatment with coil in place and then turns
device off. Less than 12 hours later, the patient
turns device on and pushes RESET button.
Patient received eight hours of treatment and
controller is set to treat for a full 10 hours.
Patient compliance usage log is credited with
eight hours.
All hours treated will be electronically recorded
and stored within the controller. Patients unable
to treat on consecutive days will be able to treat
non-consecutively within 400 days after the
first one-hour treatment period. If the device
is not used for a 12 hour period, the treatment
clock will automatically reset and be ready to
deliver the next 10 hour therapeutic treatment
period when next turned on.
• Non-consecutive treatment period
(Example): On Monday, the patient treats for
seven hours and turns the device off. Patient
does not treat on Tuesday. Wednesday, patient
turns controller on. System will be ready to
treat for a full 10 hours, not the remaining three
from Monday’s period. Device usage log will
record a seven hour treatment and a day of no
treatment.
The maximum recommended therapeutic
treatment period is nine months (approximately
270 days).