Melmak Patient User Manual

Melmak Patient User Manual
Instructions For Use
PATIENT MANUAL
BTT01-044-00
Rev1-01/2012
i
BTT Melmak Development & Production GmbH
Gewerbegebiet 16
82399 Raisting
Germany
Tel. +49 (0)8807 923922
Fax +49 (0)8807 8806
Email: [email protected]
www.melmak.com
MANUFACTURED FOR:
Biomedical Tissue Technologies Pty Ltd (BTT)
342 Chisholm Road
Auburn NSW 2144
Tel.: +61 2 8717 7940
Fax: +61 2 8717 7999
www.biottech.com
(All enquiries regarding the Melmak device and support should be first directed to your local Melmak Distributor.)
ii
Symbols
Manufacturer
BTT Melmak Development & Production GmbH
Gewerbegebiet 16, D-82399 Raisting, Germany
Order Number
0483
The CE mark indicates conformity with
European Council of directive concerning
Medical Devices (93/42/EEC)
Serial Number
Keep dry
Batch Number of the Product
Follow Manual
Type BF
Protection Class II
HF-Transmitter
Non Sterile
EU: Not for general Waste
For details of how to dispose these items
please contact your local waste agency or your
local Melmak Distributor
C-Tick
Service Sticker
Connector with Electrostatic discharge (ESD)
– Attention: follow manual
iii
Table of Contents
1 INTRODUCTION... . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . . .
1.1 Indications and Intended Use . . . . . . . . . .
1
1.2 Use with Internal Fixation . . . . . . . . . . . .
1
1.3 Contra-indications . . . . . . . . . . . . . . .
1
1.4 Complications . . . . . . . . . . . . . . . . .
1
1.5 Warnings . . . . . . . . . . . . . . . . . . .
1.5(i) Non-union . . . . . . . . . . . . . . .
1.5(ii) Fresh Fracture . . . . . . . . . . . . .
1
1
1
1.6 Precautions . . . . . . . . . . . . . . . . . .
1.6(i) Non-union . . . . . . . . . . . . . . .
1.6(ii) Fresh Fracture . . . . . . . . . . . . .
2
2
2
1.7 General Precautions . . . . . . . . . . . . . .
2
1.8 Safety Instructions . . . . . . . . . . . . . . .
3
2 MELMAK.DEVICE.(LIPUS) . ... ... ... ... ... ... ... ... ... .. . .
2.1 Components . . . . . . . . . . . . . . . . . .
2.1(i) Control Unit & Transducer . . . . . . . .
2.1(ii) Accessories . . . . . . . . . . . . . . .
4
4
4
5
3 OPERATING.GUIDE. ... ... ... ... ... ... ... ... ... ... ... ... .. . .
3.1 Before Treatment. . . . . . . . . . . . . . . .
3.1(i) Rechargeable Battery & USB connection. .
3.1(ii) Audio Feedback. . . . . . . . . . . . .
3.1(iii) LCD Screen . . . . . . . . . . . . . . .
3.1(iv) Error Symbols & Message Displayed on LCD
Screen . . . . . . . . . . . . . . . . .
3.1(v) ON/OFF Push Button . . . . . . . . . .
3.1(vi) Display Statistics Push Button . . . . . .
3.1(vii) Transducer Monitoring . . . . . . . . .
1
6
6
6
6
7
7
8
8
6
iv
INTRODUCTION
4 USE.INSTRUCTIONS .... .... .... .... .... .... .... .... .... .... .... .... .. . .
10
4.1 Non-Cast Use Instructions . . . . . . . . . . . . 10
4.2 Use Instructions When Using Strap Attachment
Over Cast . . . . . . . . . . . . . . . . . . . 11
4.3 Use Instructions When Transducer Holder is
Incorporated Into Cast . . . . . . . . . . . . . 12
5 CARE.AND.MAINTENANCE ... . .. . .. . .. . .. . .. . .. . .. . .. . . .
14
5.1 Care and Cleaning of the Melmak Device . . . . . 14
5.2 Disposal of Melmak Device . . . . . . . . . . . 15
5.3 Warranty and Statutory Rights . . . . . . . . . 15
5.4 Enquiries . . . . . . . . . . . . . . . . . . . 15
5.5 Servicing . . . . . . . . . . . . . . . . . . . 15
5.6 Melmak Service and Support Centres . . . . . . 15
5.6(i) European Authorised Representative . . . 15
5.6(ii) Australian Representative . . . . . . . . 15
6 TECHNICAL.INFORMATION... . .. . .. . .. . .. . .. . .. . .. . .. . . .
6.1 Control Unit Specification . . . . . . . . . . . . 16
6.2 Battery Charger Specification . . . . . . . . . . 16
6.3 Information about Electro-Magnetic-Compatibility
(EMC) . . . . . . . . . . . . . . . . . . . . . 17
6.3(i) Guidelines and Manufacturer’s Declaration Electro-Magnetic Emission . . . . . . . 17
6.3(ii) Guidelines and Manufacturer’s Declaration Electro-Magnetic Stability . . . . . . . . 18
6.3(iii) Declaration Conformity . . . . . . . . . 21
16
INTRODUCTION
1
Introduction
The Melmak Device is a Low Intensity Pulsed
Ultrasound Device (LIPUS). LIPUS devices have
been clinically found to support and accelerate the
healing process of fresh fractures and non-unions.
The Melmak Device is intended for non-invasive
use only, and should only be used as prescribed by
1.4
Complications
There have been no known adverse reactions or
medical complications related to the use of the
Melmak Device.
Warnings
a Physician or other Health Professional for its
intended use.
1.5
Treatment is carried out for 20 minutes, once a day.
Patients should treat themselves at approximately
the same time each day.
benefit, evidence of safety and effectiveness has not
been established in the following:
1.1
Indications and Intended Use
The Melmak Device is indicated for the treatment
of fresh bone-fractures and established non-unions
excluding treatment of the skull and the vertebral
column. The location and type of fracture will
influence results.
This non-invasive treatment can only be prescribed
by a Physician or other Health Professional.
1.2
Use with Internal Fixation
The Melmak Device can be used in the presence
of metal screws and plates.
1.3
Contra-indications
There are no known Contra-indications to the use of
the Melmak Device.
Whilst use of the Melmak Device may be of clinical
1.5(i)
Non-union
♦ For the treatment of fractures of the vertebrae or
skull
♦ In the skeletally immature
1.5(ii)
Fresh Fracture
♦ For the treatment of fractures of the vertebrae or
skull
♦ All fracture types
♦ In the skeletally immature
♦ Reduced fractures which remain substantially
displaced
♦ For pregnant and breast feeding women
♦ For use in pathological fractures due to bone
pathology or malignancy
♦ For complex fractures requiring surgical
intervention to reduce and stabilise
01
02
INTRODUCTION
♦ For use in patients with vascular disease or
somatosensory dysfunction
♦ For use in patients with any neurological
disorders which may affect the general wellbeing
of the person, including any condition leading to
nutritional deficiency
♦ For use in patients taking various medications
including phosphonate therapy, steroids and
cardiac medication
♦ If using for greater than the recommended
20 minutes per day
♦ For use outside the recommended clinical
parameters, including prolonged use beyond
prescribed guidelines
1.6
Precautions
Whilst use of the Melmak Device may be of clinical
benefit, evidence of safety and effectiveness has not
been established in the following:
1.6(i)
Non-Union
♦ Reduced fractures which remain substantially
displaced. The Melmak Device will not correct
any displacement.
♦ For pregnant and breast feeding women
♦ For complex fractures requiring surgical
intervention to reduce and stabilise
1.6(ii)
Fresh Fracture
♦ Reduced fractures which remain substantially
displaced. The Melmak Device will not correct
any displacement.
♦ For pregnant and breast feeding women
♦ For complex fractures requiring surgical
intervention to reduce and stabilise
♦ If using for greater than the recommended
20 minutes per day
♦ For use outside the recommended clinical
parameters, including prolonged use beyond
prescribed guidelines
1.7
General Precautions
Mobile phones may cause interference. Please keep
mobile phones at a safe distance from the Melmak
Device during a treatment.
The Melmak Device is a medical electrical device and
needs special precautions regarding electromagnetic
compatibility (EMC) and must be installed
according to EMC information.
People with cardiac pacemakers should get clearance
from their physician prior to use.
Some individuals may be susceptible to the following:
♦ a potential allergic reaction to the coupling gel
♦ If using for greater than the recommended
♦ mild swelling
♦ For use outside the recommended clinical
♦ pain
20 minutes per day
parameters, including prolonged use beyond
prescribed guidelines
♦ muscle spasm at treatment site
♦ mild erythema
INTRODUCTION
If any of these occur the individual should cease use
of the Melmak Device and seek medical attention
immediately.
1.8
Safety Instructions
The Melmak Device is intended for non-invasive
use only, and should only be used as prescribed
by a Physician or other Health Professional for it’s
intended use.
The Operating Guide must be followed accurately.
The Melmak Device is to be used only with
Melmak specified and supplied equipment
and not in combination with other devices.
For external use only.
The Melmak Device is to be operated and stored
under dry conditions.
For any queries please contact your local Melmak
Distributor.
02
04
INTRODUCTION
2
2.1
Melmak Device (LIPUS)
Components
The following components are part of your
Melmak Device shipment.
2.1(i)
Control Unit and Transducer
Tested and validated for 1500 treatments. This model Transducer transmits a low intensity, high frequency pulsed
ultrasound signal through the patient’s skin to the fracture site to be treated.
MINI USB CONNECTOR
for battery charging
LCD SCREEN
ON / OFF
Push button
DISPLAY STATISTICS
Push button
ULTRASOUND
TRANSDUCER
LENGTH 1.5m
MELMAK DEVICE
2.1(ii)
Accessories
ULTRASOUND GEL
250 gram bottle. Gel must be applied to
Transducer head prior to all treatment
to enable ultrasound signal to pass from
Transducer through skin to the fracture
site. Only use Gel supplied by your
local Melmak Distributor.
ASSEMBLED TRANSDUCER
HOLDER & STRAP
Used to position ultrasound Transducer
over fracture site
FELT
For cast application
BATTERY CHARGER
(including adaptors)
USB Cable is used for charging the internal
non-replaceable battery of the Melmak
Device. Length 1.8m. For international
use multiple adaptors are supplied.
INSTRUCTIONS FOR USE
MANUAL
Operation instructions
05
INTRODUCTION
06
3
3.1
Operating Guide
Millennium Electronics Pty. Ltd.
Before a Treatment
The Melmak Device is a battery operated
4.
2100-0148
23 July
FUNCTIONAL SPECIFICATION
the charging
process,
thewhich
Melmak
Device
The ECU features aDuring
backlit Liquid
Crystal Display
(LCD)
provides
the patient with
information on the remaining treatment time, number of treatments left to be completed. In
cannot
be
operated.
addition, the ECU has two (2) tactile push buttons that enables the patient to start and stop the
treatment
device,
it and to display the status of the treatment.
In summary, the ECU provides the following features:
will need to be charged prior to use using a country
3.1(ii) Audio Feedback
 Liquid Crystal Display (LCD) with green backlight
specific adaptor.
 On/Off Push Button
A high
frequency audible sound is generated to give
 Display Statistics
Button
3.1(i)
Rechargeable Battery and
USB connection



Rechargeable
Lithium-Ion
Battery
feedback
when:
Audio Feedback
USB Connection
for charging
connection to a Personal Computer (PC) for set up
♦ Pressing
anyand
button
and data logging.
If gelDisplay
is required, 3 short beeps, repeated
4.1.
The Melmak Device Control Unit is powered by
a Liquid♦Crystal
approximately
every 3 seconds
non-replaceable, rechargeable Lithium-Ion (Li-On)
The Liquid Crystal Display (LCD) has the following specification:
(Wthe
x H):
63.2 mm x38.5
battery pack. A medical grade battery charger with Display♦sizeAt
completion
of mm
a treatment, alarm will sound
 Viewing area size (W x H): 59.9 mm x 30.5 mm
inbuilt USB connector is used to charge the internal
6
short
beeps
 Driving Condition : 1/3 Duty (i.e. 3 Back Planes) , 1/3 Bias, 3V Operate,
battery. Country specific adaptor must be used.  LCD Type : TN Type
♦ Low battery level is detected
The USB mini connector on the top edge of the
Melmak Device is used for charging.
Viewing Angle: 6 O'clock
Polarizer Type & Mode: Transflective
Connector Type : Pins
3.1(iii)
Operating Temp: 10°C ~ 50°C
Storage Temp : 0°C – 65°C





LCD Screen
All functions of the Melmak Device will be disabled
The design of the LCD is as follows:
Treatment time remaining in minutes
and seconds. Maximum time 20:00.
if the device is not charged. The voltage level of the
battery pack is constantly monitored by the Control
Unit while operating and the voltage level is displayed
on the LCD.
Millennium Electronics Pty. Ltd.
Millennium Electronics Pty. Ltd.
2100-0148-01C
23 July 2010
When the battery voltage falls below 3.55 Volt during a treatment cycle, in addition to the
flashing “ 2100-0148-01C
” symbol at 1 Hertz, i.e. 500 ms on and 500 ms off, the LCD will also
2010
show “Lo Bat”23asJuly
follows:
When the battery voltage falls below the critical
battery level during a treatment session, in addition
” signal.
to flashing, the LCD will also show “
When the “
” signal is present, the current
When the battery voltage falls below 3.55 Volt during a treatment cycle, in addition to the
flashing “
” symbol at 1 Hertz, i.e. 500 ms on and 500 ms off, the LCD will also
show “Lo Bat” as follows:
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
Figure 16 – Example of the display on LCD when low battery level is detected.
Once the treatment is completed, the ECU will not allow further treatment to commence
until the battery is recharged. Pressing and releasing the ON/OFF Push Button when the
battery voltage is below 3.55 Volt cannot initiate a new treatment cycle. The LCD will
light and display the following for 5 seconds and then switch off.
Once the treatment is completed, the ECU will not allow further treatment to commence
until the battery is recharged. Pressing and releasing the ON/OFF Push Button when the
battery voltage is below 3.55 Volt cannot initiate a new treatment cycle. The LCD will
light and display the following for 5 seconds and then switch off.
treatment will be completed but further treatments
will not be possible until the Melmak Device is
recharged.
Figure 16 – Example of the display on LCD when low battery level is detected.
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
Battery
Number of
Total Number
Figure 2 - BTT
Unit Display showing
all available segments
status
treatments
of available
indicator
completed
treatments
During the charging process, the LCD will show
the letter “P” and the animated battery symbol
Copyright Millennium Electronics Pty. Ltd
Figure 1: Display showing all symbols
will be displayed.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
4.6.
Add gel
indicator
Audio Feedback
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
A high frequency audible sound is generated (1.7kHz approx.), to give an audible
4.6.
Audio Feedback
feedback for the following operations:

Pressing any button will sound for 200mS approximately.
A high frequency audible sound is generated (1.7kHz approx.), to give an Ifaudible
gel is required, an audible alarm will also be sounded, 3 short beeps, repeated
feedback for the following operations:
approximately every 3 seconds.
4.7.

Pressing any button will sound for 200mS approximately.

If gel is required, an audible alarm will also be sounded, 3 short beeps,
 repeated
Low battery level is detected.
approximately every 3 seconds.

At the completion of a treatment the audible alarm will also sound 6 short beeps.

At the completion of a treatment the audible alarm will also sound4.7.
6 short USB
beeps.and External Battery Charger Connector

Low battery level is detected.
USB and External Battery Charger Connector
The USB mini connector on the top edge of the BTT unit, is used for communications to
a PC, and for charging the internal Lithium Ion battery.
A Power Pack with inbuilt USB mini B connector can be used to charge the internal
battery.
The USB mini connector on the top edge of the BTT unit, is used for communications
to
a PC, and for charging the internal Lithium Ion battery.
Millennium
A Power Pack with inbuilt USB mini B connector can be used toCopyright
charge the
internal Electronics Pty. Ltd
battery.
Page 14 of 16
Page 7 of
OPERATING GUIDE
3.1(iv)
Error Symbols and Message
Displayed on LCD Screen
“
The Control Unit monitors the Transducer status and
gel level continuously during the 20 minute treatment
cycle. The treatment will be interrupted if an error
mode occurs. In this case the error message will be
07
”. This message will be displayed for
1 minute and then the device will switch off.
If an error message is displayed please contact your
local Melmak Distributor.
♦ NO ALLOCATED TREATMENTS
REMAINING “
”
Once all treatments allocated to the Control
displayed as follows:
Unit are used the following error message will be
♦ INSUFFICIENT GEL “ ”
If insufficient gel is detected before or during a
treatment cycle, the Control Unit will suspend the
displayed “
”. If above error is displayed
please contact your local Melmak Distributor.
treatment cycle unit until sufficient gel is applied.
3.1(v) ON/OFF Push Button
The Control Unit will generate three audible beeps
The ON/OFF Push Button on the Control Unit
every 3 seconds and will display a flashing drop
Millennium Electronics
2
allowsPty.
theLtd.patient to start and terminate a treatment
symbol “ ” in the lower right corner of the display.
cycle.
If sufficient gel is not applied within 2 minutes
The information provided by the LCD includes:
after error symbol is displayed the device will
Remaining time of the 20 minutes treatment cycle in minutes and seconds
STARTING A TREATMENT SESSION
The number of programmed treatments and completed treatments, e.g. 34/150
automatically switch off.
(Gellevel
mustand
becharge
placedstatus
on theindicator
ultrasound head to enable
Battery
“Add
Gel” symbolof ultrasound signal from the ultrasound
♦ LOW BATTERY “
”
transmission
Once the Control Unit detects a low battery level
Transducer
4.2.
ON/OFF
Push across
Buttonthe skin to the fracture site)
this will be displayed with the following message:
The ON/OFF Push Button on the ECU allows the patient to start and terminate
♦ Pressing and releasing the ON/OFF Push
“
” and the flashing battery symbol “ treatment
”
cycle.
Button an
willaudible
start abeep
20 minute
treatment
session.
and switch
on the LCD
backlight for 5 seco
displayed in the lower left corner of the display,The ECU will generate
when the ON/OFF
Push
ButtonUnit
is pressed.
The
Control
will
generate
a
short
beep
indicating battery needs to be charged. The low
and athe
LCD will
be lit for 5 seconds. The
4.2.1. Starting
Treatment
Cycle
battery status allows you to finish the current
If the treatmentminute
cycle has
not been
started,
and releasing the ON/OFF P
count
down
timerpressing
will commence
treatment but will not allow for further treatmentsButton will20start
the treatment cycle. The ECU will generate a short beep
counting
the push down.
button is pressed and the LCD and its backlight will be lit f
to be performed until the battery is recharged. acknowledge
Millennium Electronics Pty. Ltd.
2100-0148-01C
23 July 2010
When the battery voltage falls below 3.55 Volt during a treatment cycle, in addition to the
flashing “
” symbol at 1 Hertz, i.e. 500 ms on and 500 ms off, the LCD will also
show “Lo Bat” as follows:
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
lennium Electronics Pty. Ltd.
2100-0148-01C
23 July 2010
When the battery voltage falls below 3.55 Volt during a treatment cycle, in addition to the
flashing “
” symbol at 1 Hertz, i.e. 500 ms on and 500 ms off, the LCD will also
show “Lo Bat” as follows:
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted:
English
Do
Figure 16 – Example of the display
on LCD
when(U.S.),
low battery
level is detected.
not check spelling or grammar
Once the treatment is completed, the ECU will not allow further treatment to commence
until the battery is recharged. Pressing and releasing the ON/OFF Push Button when the
battery voltage is below 3.55 Volt cannot initiate a new treatment cycle. The LCD will
light and display the following for 5 seconds and then switch off.
Formatted: English (U.S.), Do
not check spelling or grammar
Figure 16 – Example of the display on LCD when low battery level is detected.
Once the treatment is completed, the ECU will not allow further treatment to commence
until the battery is recharged. Pressing and releasing the ON/OFF Push Button when the
battery voltage is below 3.55 Volt cannot initiate a new treatment cycle. The LCD will
light and display the following for 5 seconds and then switch off.
Formatted:
English
(U.S.),
Do
Figure 17 – Example of the display
on LCD
when
low battery
level is detected at
the start of the treatment cycle not check spelling or grammar
4.6.
Audio Feedback
A high frequency audible sound is generated (1.7kHz approx.), to give an audible
feedback for the following operations:

Pressing any button will sound for 200mS approximately.

If gel is required, an audible alarm will also be sounded, 3 short beeps, repeated
approximately every 3 seconds.

At the completion of a treatment the audible alarm will also sound 6 short beeps.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
 Low battery level is detected.
4.6.
Audio Feedback
Pressing and releasing the ON/OFF button will
light the display for 5 seconds and then switch off
the device.
4.7.
seconds as illustrated in Figure 3
USB and External Battery Charger Connector
A high frequency audible sound is generated (1.7kHz
give an on
audible
Theapprox.),
USB minitoconnector
the top edge of the BTT unit, is used for communications to
feedback for the following operations:
a PC, and for charging the internal Lithium Ion battery.

Pressing any button will sound for 200mS approximately.
A Power Pack with inbuilt USB mini B connector can be used to charge the internal
battery.
If gel is required, an audible alarm will also be sounded, 3 short beeps, repeated
approximately every 3 seconds.

Millennium
Electronics
Pty. Ltd
At the completion of a treatment the audibleCopyright
alarm will
also sound
6 short beeps.

Low battery level is detected.

4.7.
Page 14 of 16
USB and External Battery Charger Connector
♦ TRANSDUCER FAULT “
”
If the Control Unit detects a Transducer fault,
the treatment cycle will be interrupted until
the Transducer fault is rectified. The following
error message will be displayed:
The USB mini connector on the top edge of the BTT unit, is used for communications to
a PC, and for charging the internal Lithium Ion battery.
A Power Pack with inbuilt USB mini B connector can be used to charge the internal
battery.
pyright Millennium Electronics Pty. Ltd
Page 14 of 16
Figure 3 – Example of display on the LCD at the start of a treatment cycle
Figure 2: Example of display on the LCD at the start of a treatment session
The ECU will commence the treatment cycle and the 20 minute treatment count do
timer will commence counting. An example of the information being displayed on
LCD 5 seconds into the 20 minutes treatment cycle is as follows:
23 July 2010
Formatted: Complex Script
Font: 11 pt, English (U.S.), Do
not check spelling or grammar
08
INTRODUCTION
END OF A TREATMENT SESSION
and the total number of programmed treatments
Figure 10 – Example of display on LCD when the Display Statistics Push B
pressed
Figure 5 – Example of display on LCD showing 7 minutes and 10 isseconds
150. and released once.
remaining
thecountdown
treatment cycle
♦
Whenonthe
timer reaches zero, the
treatment
is completed
4.2.3.
End
of a Treatment
Cycle and a short audible beep
When the 20
treatment
count will
down
timer
zero, the treatment is
willminutes
be heard.
The LCD
show
thereaches
following
completed and the ECU will generate a short audible beep and the LCD will show the
for
20
seconds
and
then
switch
off.
following for 20 seconds and then switch off.
Formatted: English (U.S.), Do
not check spelling or grammar
Figure
11 – Example
of theondisplay
thethe
LCD
when
the Display
Figure
4: Example
of the display
the LCDon
when
Display
Statistics
Push Statistic
Button
pressed
released
second
timethe
while
the backlight
Button isispressed
andand
released
second
time while
backlight
is enabled is enabled.
3.1(vii)
3: ExampleofofLCD
LCD atatthe
of of
a 20the
minute
treatment
FigureFigure
6 – Example
theend
end
20 minutes
treatment cycle
Transducer Monitoring
The Control Unit will monitor the Transducer status
4.2.4.
Terminating a Treatment Cycle
gela level continuously throughout the 20 minutes
PressingTERMINATING
and holding the ON/OFF
Push Button for 4 seconds or longer and
during
A TREATMENT
treatment cycle, the ECU will stop and terminate the treatment cycle.
treatment session.
If the treatment
cycle and
has gone
over the
sixteen
(16) minutes
the 20 minutes treatment
♦ Pressing
holding
ON/OFF
PushofButton
cycle, the ECU will registered the treatment cycle as a valid cycle and the LCD
will
TRANSDUCER
FAULT
forFigure
4 seconds
longer
a treatment
stop4.2.3 above,
display as in
7. Theor
ECU
will during
behave as
outlined in will
Section
i.e.
Figure 12 – Example of the display on the LCD five (5) seconds after the D
the ECU will
generate
a
short
audible
beep
and
the
display
will
continue
to
show
the treatment session.
Button is pressed and released the second time.
♦Statistics
If the Push
Control
Unit detects a Transducer fault,
“End” for 20 seconds and then switch off.
♦ The Control Unit will generate a short audible 4.4.
Formatted: English (U.S.), Do
Transducer
Monitoring
the Control
Unit
suspend
the treatment
not
checkwill
spelling
or grammar
the Transducer
fault
rectified.
The througho
beep and the display will continue to show “End”
The ECU will session
monitor until
the Transducer
status and
GelisLevel
continuously
20 minutes treatment
cycle.
Melmak
Device may need to be returned to your
for 20 seconds and then switch off.
The following local
table Melmak
tabulates the
conditionsfor
in which
the ECU
the sta
Distributor
diagnostic
testsdetermines
and
the Transducer and Gel level
potential repair.
3.1(vi) Display Statistics Push Button
Gel Sense Voltage
Condition
Notes
♦ Voltage
The LCD
will display following
signal Error Condition
Gel Sense
≤ 500mV
Short errorCircuited
The Display Statistics Push Button is only operational
Sensor
“
when a treatment is in progress.
The Statistics-button enables the patient to:
ght Millennium Electronics Pty. Ltd
♦ Pressing and releasing the ON/OFF Push Button
Copyright Millennium
Electronics
Ltd Control
will
switch Pty.
of the
Page 9 of 16
♦ Switch on the back light by pushing and releasing
the button once
♦ Receive information about the number of
” for 1 minute and then switch off.
treatments completed and the programmed
number of treatments by pushing and releasing the
button a second time. This will be displayed by the
following message in the lower right corner of the
display
, indicating 34 completed treatments
Unit immediately.
INSUFFICIENT GEL
♦ If insufficient gel is detected during the treatment
cycle, the Control Unit will suspend the treatment
until sufficient gel is applied to Transducer head.
♦ The Control Unit will generate 3 audible beeps
every 3 seconds and will display a flashing “ ”
symbol.
Figure 13 – Example of the display on LCD when a Transducer fault is detected.
Pressing and releasing the ON/OFF Push Button will switch off the ECU
immediately.
4.4.2.
Insufficient Gel
If insufficient gel is detected during the treatment cycle, the ECU will suspend the
treatment cycle until sufficient gel is applied.
The ECU will generate three (3) audible beeps every 3 seconds and will display the
“
” symbol will flash at 1 Hertz, i.e. 500ms on and 500 ms off:
OPERATING GUIDE
Formatted: Complex Script
Font: 11 pt, English (U.S.), Do
not check spelling or grammar
Formatted: Complex Script
Font: 11 pt, English (U.S.), Do
not check spelling or grammar
Figure 5:
of theofdisplay
on LCD when
insufficient
gel is detectedgel is detected
Figure
14Example
– Example
the display
on LCD
when insufficient
The ECU will apply the gel sensing signal for 2 minute at a rate of 100 ms every
♦ The
Unitgelwill
apply the
gel sensing
500ms and
if theControl
insufficient
condition
persists
at the endsignal
of the 2 minutes time
period, the ECU will reset the 20 minutes treatment cycle timer and will not register
for 2 minutes. If the insufficient gel condition
the treatment as a valid treatment.
persists at the end of the 2 minute time period, the
Unit
right MillenniumControl
Electronics
Pty. will
Ltd
reset the 20 minute treatment
session timer and will not register the treatment as
a valid treatment.
♦ If the insufficient gel condition is not rectified for
another minute, i.e. 3 minutes after the low gel
condition is detected, the Control Unit will switch
off.
♦ Pressing and releasing the ON/OFF Push
Button or the Display Statistics Push Button has
no effect while “ ” is being displayed.
Page 12 of 16
09
10
INTRODUCTION
4
4.1
Use Instructions
Non-Cast Use Instructions
1. Before starting, Physician will mark an “X”
over fracture site, to ensure accurate placement of
Transducer holder for every treatment. You will
4. Hold Transducer and place a small amount
of ultrasound gel on the Transducer face,
approximately 1.5cm diameter.
need to ensure this point is reproducible for each
treatment. An indelible marker may assist.
Place ultrasound Transducer through Transducer
holder. Ensure cable is routed through cut out
on cap and secure by closing cap.
2. Place strap with Transducer holder over fracture
site and stabilise securely using the Hook and
Loop fasteners. It is vital that Transducer holder
be held securely over site to be treated, to ensure
Transducer is accurately positioned.
3. Open Transducer holder by pushing two
turquoise tabs on either side of Transducer
holder towards centre.
The spring mechanism on the cap provides light
pressure to the Transducer. It ensures good
contact to the gel and skin over the treatment
area for ultrasound transmission.
USE INSTRUCTIONS
5. Press ON/OFF button to start treatment. Timer
will illuminate and count down from 20 minutes
and then turn off automatically.
3. Hold Transducer and place a small amount
AFTER TREATMENT HAS COMPLETED
of Transducer gel on the Transducer face.
Approximately 1.5cm diameter.
6. Undo strap and remove Transducer head from
treatment site. Clean gel from Transducer head,
strap and skin with soft cloth. Pack Melmak
device into carry case for safe keeping.
4.2
Use Instructions When Using Strap
Attachment Over Cast
1. Strap with Transducer holder to be secured
over your fracture site and stabilised securely
using the Hook and Loop fasteners.
2. Open Transducer holder by pushing two
turquoise tabs on either side of Transducer
holder towards centre.
4. Position the Transducer in the window of the
cast directly over the fracture site. Ultrasound gel
must be touching the skin. Close cap to secure.
11
12
INTRODUCTION
5. Press ON/OFF button once to begin treatment.
2. Hold Transducer and place a small amount
6. Remove Transducer head from treatment site.
3. Place ultrasound Transducer through
Timer will illuminate and count down from 20
minutes and then turn off automatically.
Clean gel from Transducer head, strap and skin
with a soft cloth.
7. Place the round felt plug into the cast window
and close cap to secure.
4.3
of Transducer gel on the Transducer face.
Approximately 1.5cm diameter.
Transducer holder. Ensure cable is routed
through cut out on cap and secure by closing cap.
Ultrasound gel must be touching the skin. Close
cap to secure.
Use Instructions When Transducer
Holder is Incorporated into Cast
1. Open Transducer holder by pushing two
turquoise tabs on either side of Transducer holder
towards centre.
4. Press ON/OFF button once to begin
treatment. Timer will illuminate and count
down from 20 minutes and then turn off
automatically.
USE INSTRUCTIONS
5. Remove Transducer head from treatment site.
Clean gel from Transducer head, strap and skin
with a soft cloth.
6. Place the round felt plug into the cast window
and close cap to secure.
13
14
INTRODUCTION
5
5.1
Care and Maintenance
Care and Cleaning of the
Melmak Device
The Melmak Device must be used according to the
following instructions:
♦ The Melmak Device is only to be used according
to the intended use mentioned in this manual.
♦ Please read this manual very carefully and only
operate and handle the Melmak Device according
to these instructions.
♦ The Melmak Device must only be used with
Melmak supplied and specified equipment. The
Melmak Device must not be used in combination
with other devices.
Warning: Using other than Melmak specified
cables and accessories may negatively affect
electromagnetic compatibility performance.
♦ Never use cleaning agents or solvents to clean
device, its components or accessories. For
cleaning use only a soft moist cloth or soft
paper towel or tissue.
♦ The Melmak Device must be operated under
dry conditions. The Melmak Control unit must
never be exposed to liquid.
♦ Please check the Melmak Device and its
components after each treatment for any
damage. Never use a damaged or broken device
or component. In case of damage contact your
local Melmak Distributor.
♦ Do not open and do not try to repair or modify
the Melmak Device.
♦ Warning: Do not touch Connector pins marked
”. Connections
with the following symbol “
between these pins must not be conducted
without using specified Electrostatic Discharge
(ESD) Safety precautions.
-> Using procedures to avoid electrostatic
charging (e.g. conducting flooring,
non-synthetic clothing)
-> Discharging of the own body to
ground or large metallic items
-> Connection to ground by wristband
♦ Warning: The Melmak Device is not to be stored
or located close to other electrical equipment.
♦ Use only the charger and the accessories supplied
by your local Melmak Distributor to avoid any
increase in emissions or interference resistance by
the Melmak device.
♦ All staff including e.g. medical engineers and
nursing staff are recommended to receive
explanation and training in ESD procedures.
♦ The minimum specifications of ESD precautionary
procedure training are:
-> Introduction into physical basics of electrical
charging and the danger of destroying
electrical functionality of devices.
-> Methods to avoid electrical charging and
explanation for necessity of grounding.
♦ Please contact your local Melmak Distributor
in case of any questions or concerns.
CARE AND MAINTENANCE
5.2
Disposal of Melmak Device
Disposal of electrical waste is an important
environmental issue. Disposal of this device should
not be treated like household waste.
Please contact your local Melmak Distributor for
On the rear of the Melmak Control Unit you find
the following service sticker “
mandatory date for next service.
5.6
” indicating the
Melmak Service and Support
Centres
information on correct disposal of your Melmak
Device.
5.6(i)
To minimise environmental impact, components of
BTT MELMAK DEVELOPMENT &
this device will be recycled where possible.
5.3
Warranty and Statutory Rights
The Melmak product is covered by a 2 year limited
warranty. Please contact your local Melmak
Distributor for full warranty terms. In addition,
the Melmak product may be covered by specific
statutory rights in your jurisdiction. To find out
details of any statutory rights you may have (for e.g.
under any consumer guarantees) please contact your
local Melmak Distributor.
Do not try to repair or modify your Melmak
Device. This will void your warranty.
5.4
Enquiries
For any questions, concerns or assistance please
contact your local Melmak Distributor.
5.5
Servicing
Return your Melmak Device to your local Melmak
Distributor for a technical service once a year in order
to ensure optimum performance of the device and the
intended therapeutic response.
European Authorised Representative
PRODUCTION GMBH
Gewerbegebiet 16
82399 Raisting
Germany
Phone:
+49 (0)8807/ 92 39 22
Fax:
+49 (0)8807/ 88 06
www.melmak.com
5.6(ii)
Australian Representative
BIOMEDICAL TISSUE TECHNOLOGY
PTY LTD (BTT)
342 Chisholm Road
Auburn NSW 2144
Phone:
+61 (0)2 8717 7940
Fax:
+61 (0)2 8717 7999
www.biotech.com
15
16
INTRODUCTION
6
6.1
Technical Information
Control Unit Specification
6.2
Battery Charger Specification
♦ Ultrasound Frequency f: 1.5 + 5% MHz
♦ Input Voltage: 100 - 240 VAC
♦ Modulating Burst Width tp: 200 + 10% μs
♦ Input Current: <0.5 A RMS Max
♦ Repetition Rate REF: 1.0 + 10% KHz
♦ Input Frequency: 47 - 63 Hz
♦ Acoustic Power P1: 116mW
♦ Output Voltage: 5.0 V, No Load to Full Load,
♦ Spatial Average - Temporal Average (SATA)
Ie: 30 + 30% mW/cm
2
♦ Spatial Average - Temporal Maximum (SATM)
Im: 116 + 30% mW/cm2
♦ Power Supply - Lithium Ion Rechargeable
Battery: 3.7 DCV nominal
♦ Power Input Pin: 1.1 + 0.6 W
♦ Beam Non-Uniform Ratio RBN: <6
♦ Waveform: Pulsed
♦ Effective Acoustic Radiating Area Aer: 3.88cm2
♦ Duty Factor DF: 5
♦ Time Average Intensity: 6
♦ Weight (Control Unit including Transducer):
approximately 285 g
No Minimum Load Required
♦ Output Current: 1.0 A
♦ Output Power (Rated): 5 W Max
TECHNICAL INFORMATION
6.3
Information about Electro-Magnetic-Compatibility (EMC)
6.3(i)
Guidelines and Manufacturer’s Declaration - Electro-Magnetic Emission
The Melmak Device is destined for the use under the circumstances listed below. The customer and
the user of the Melmak device may ensure that the device will be operated in such a surrounding.
Transient emissions measuring
Correlations
HF emission according to CISPR 11
Group 1
HF emission according to CISPR 11
Class B
Emission of harmonic according to
IEC 61000-3-2
Class A
Emission of voltage variation / Flicker
according to IEC 61000-3-3
Agreed
Electro-Magnetic
Environment – Guideline
The Melmak Device applies HF-Energy for
internal function only. Therefore the HFEmission is very low and it’s unlikely, that it will
interfere with other electronic devices nearby.
The Melmak Device is a Device which is for the
use in every facility including residential areas
and those connected to the public power supply,
supplying buildings made for living.
17
18
INTRODUCTION
6.3(ii)
Guidelines and Manufacturer’s Declaration - Electro-Magnetic Stability
The Melmak device is destined for the use under the circumstances listed below. The customer and
the user of the Melmak device may ensure, that the device will be operated in such a surrounding.
Stability Tests
IEC 60601-Test Level
Correlations Level
Electro-Magnetic
Environment - Guidelines
+ 6 kV Contact discharge + 6 kV Contact discharge Floors may consist of wood or
concrete or ceramic tile. If the
+ 8 kV Air discharge
+ 8 kV Air discharge
floor consists of synthetic material,
the relative humidity has to be at
least 30%.
+ 2 kV for power line
+ 2 kV for power line
The quality of the supply voltage
Fast transients / Bursts
should be up to the standard of
according to IEC 61000-4-4
+ 1 kV for input- and
+ 1 kV for input- and
a typical business- or hospitaloutput-lines (not applicable) output-lines (not applicable) environment.
Discharge static electricity
(ESD) according to
IEC 61000-4-2
+ 1 kV push-pull voltage
Surge Voltages (Surges)
according to IEC 61000-4-5
+ 2 kV common-mode
voltage (not applicable)
Voltage drops, short time
< 5% U T
interruption and variations of (> 95% voltage drop of UT)
for ½ of Period
supply voltage according to
IEC 61000-4-11
40% U T
(60% voltage drop of UT)
for 5 Periods
+ 1 kV push-pull voltage
+ 2 kV common-mode
voltage (not applicable)
< 5% U T
(> 95% voltage drop of UT)
for ½ of Period
40% U T
(60% voltage drop of UT)
for 5 Periods
70% U T
70% U T
for 25 Periods
for 25 Periods
(30% voltage drop of UT)
(30% voltage drop of UT)
< 5% U T
< 5% U T
for 5 s
for 5 s
(> 95% voltage drop of UT)
Magnetic Field at supply
3 A/m
frequency (50/60 Hz)
according to IEC 61000-4-8
Note: U T = alternating voltage before application of test levels
The quality of the supply voltage
should be up to the standard of
a typical business- or hospitalenvironment.
The quality of the supply voltage
should be up to the standard of
a typical business- or hospitalenvironment. If the user of
the Melmak Device requires
continuous function even at
interruptions of the power
supply, it’s recommended to
operate the Melmak Device
with an independent power
supply or a battery.
(> 95% voltage drop of UT)
3 A/m
Magnetic fields of the supply
frequency should be up to the
standard of a typical businessor hospital-environment.
TECHNICAL INFORMATION
6.3(ii)
Guidelines and Manufacturer’s Declaration - Electro-Magnetic Stability (continued)
The Melmak device is destined for the use under the circumstances listed below. The customer and
the user of the Melmak device may ensure, that the device will be operated in such a surrounding.
Stability Tests
IEC 60601-Test Level
Correlations Level
Electro-Magnetic
Environment - Guidelines
Portable and mobile walkie-talkies
may not be operated in a lower
distance to the Ultrasound-Therapy
device, including the wires, than
according to the recommended
security distance, determined by
the following equation:
Recommended Security Distance:
conducted HF-transient
3 Veff
according to IEC 61000-4-6 150 kHz to 80 MHz
3 Veff
d = 1,16 * P
3 V/m
radiated HF- transient
according to IEC 61000-4-3 80 MHz to 2,5 GHz
3 V/m
d = 1,16 * P for 80 MHz to 800 MHz
d = 2,33 * P for 800 MHz to 2,5 GHz
P = actual power output of sender
(S) expressed as in Watt (W)
according to the information of
the sender manufacturer
d = recommended security distance
expressed as in Meter (m)
The field intensity of static
transmitter may be for all
frequencies according to an
investigation on sitea lower than
the correlations levelb.
In the vicinity of device labelled
with the following sign,
interferences are possible.
Note 1
Note 2
a
b
At frequencies of 80 MHz and 800 MHz the higher frequency range is valid
These guidelines may not be applicable in all cases. The electromagnetic parameter propagation will be influenced by absorption and
reflection of buildings, subjects or people.
The wave band of static senders, e.g. the base station of a Mobile Telephone and mobile walkie-talkies, amateur radio operation devices,
AM- and FM- Radio- and TV-Stations can in theory not be determined in advance. In order to investigate the electro-magnetic environment
concerning static senders, a survey of the site has to be considered. If the determined field intensity on site, where the Melmak device will be
operated, exceeds the above mentioned correlations level, the Melmak device has to be monitored, in order to verify the designated function. If
unusual characteristics will be determined, additional action may be required, e.g. a different orientation or a different location of the Melmak
device.
For frequency range from 150kHz to 80MHz the field intensity may be lower than 10V/m.
19
20
INTRODUCTION
6.3(ii)
Guidelines and Manufacturer’s Declaration - Electro-Magnetic Stability (continued)
The Melmak device is destined for the use in an electro-magnetic environment, where the HF-transient
is controlled. The customer or user of the Melmak device can help to avoid electro-magnetic inferences by
keeping the minimum distance (see below) between portable and mobile HF-Telecommunication Devices
(Senders) and the Melmak device – dependent on the output power of the communication device:
Actual Power Output of
Sender (W)
Security Distance dependent on Transmitter Frequency (m)
150 kHz to 80 MHz
d = 1,16 * P
80 MHz to 800 MHz
d = 1,16 * P
800 MHz to 2,5 GHz
d = 2,33 * P
0,01
0,116
0,116
0,23
0,1
0,366
0,366
0,73
1
1,16
1,16
2,33
10
3,66
3,66
7,36
100
11,6
11,6
23,3
For transmitter, who’s actual power output is not mentioned in the chart above, the recommended security distance d (m)
can be determined by using the equation belonging to the corresponding column.
P = actual power output of sender (S) expressed as in Watt (W) according to the information of the sender manufacturer.
Note 1
Note 2
At frequencies of 80 MHz and 800 MHz the higher frequency range is valid
These guidelines may not be applicable in all cases. The electromagnetic parameter propagation
will be influenced by absorption and reflection of buildings, subjects or people.
TECHNICAL INFORMATION
6.3(iii)
Declaration of Conformity
21
If you have further questions or require additional information,
please contact your local Melmak Distributor:
Local Distributor Label Here
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