BTT Melmak User manual

Instruc ons For Use
PATIENT MANUAL

Activate the service label on the backside of the
device before rst use.
Please mark month and next year. The device has
to be returned to service at this date.
Year
Month

BTT Health GmbH
Billerberg 7
82266 Inning am Ammersee
Germany
Tel. [phone]
Fax [phone]
[email protected]
www.btt-health.com
(All enquiries regarding the Melmak device and support should be  rst directed to your local Melmak Distributor.)
i

Symbols
Manufacturer
BTT Health GmbH
Billerberg 7, D-82266 Inning, Germany
Order Number
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
ii
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
Keep away from sunlight!
Handle with care!
Control Unit: protection against entry of solid foreign
bodies ≥12.5mm ø and protection against dripping
water when housing is tilted up to 15°
Transducer: Dust proof and protection against the
e ects of temporary immersion
IP22
IP67

Table of Contents
1INTRODUCTION . . . . . . . . . . . . . 1
1.1 Indications and Intended Use . . . . . . . . . . . . . 1
1.2 Use with Internal Fixation . . . . . . . . . . . . . . . 1
1.3 Contraindications . . . . . . . . . . . . . . . . . . 1
1.4 Complications . . . . . . . . . . . . . . . . . . . 2
1.5 Warnings . . . . . . . . . . . . . . . . . . . . . 2
1.5(i) Non-union. . . . . . . . . . . . . . . . . . 2
1.5(ii) Fresh Fracture . . . . . . . . . . . . . . . . 2
1.6 Precautions . . . . . . . . . . . . . . . . . . . . 2
1.6(i) Non-union. . . . . . . . . . . . . . . . . . 3
1.6(ii) Fresh Fracture . . . . . . . . . . . . . . . . 3
1.7 General Precautions . . . . . . . . . . . . . . . . . 3
1.8 Safety Instructions. . . . . . . . . . . . . . . . . . 3
2MELMAK DEVICE (LIPUS) . . . . . . . . . . 4
2.1 Components . . . . . . . . . . . . . . . . . . . . 4
2.1(i) Control Unit & Transducer . . . . . . . . . . . . 5
2.1(ii) Accessories . . . . . . . . . . . . . . . . . 5
3OPERATING GUIDE . . . . . . . . . . . . 6
3.1 Before a Treatment . . . . . . . . . . . . . . . . . 6
3.1(i) Rechargeable Battery & USB connection . . . . . . 6
3.1(ii) Audio Feedback . . . . . . . . . . . . . . . 6
3.1(iii) LCD Screen . . . . . . . . . . . . . . . . . 6
3.1(iv) Error Symbols & Message Displayed on LCD Screen . 7
3.1(v) ON/OFF Push Button . . . . . . . . . . . . . 7
3.1(vi) Display Statistics Push Button . . . . . . . . . . 8
3.1(vii) Transducer Monitoring . . . . . . . . . . . . . 8
iii

iv
4USE 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
5CARE AND MAINTENANCE . . . . . . . . . 14
5.1 Care and Cleaning of the Melmak Device . . . . . . . . . 14
5.2 Disposal of Melmak Device . . . . . . . . . . . . . . 15
5.3 Warranty and Statuatory Rights . . . . . . . . . . . . 15
5.4 Enquiries . . . . . . . . . . . . . . . . . . . . . 15
5.5 Servicing . . . . . . . . . . . . . . . . . . . . . 15
6TECHNICAL INFORMATION . . . . . . . . . 16
6.1 Control Unit Speci cation . . . . . . . . . . . . . . . 16
6.2 Battery Charger Speci cation . . . . . . . . . . . . . 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 of Conformity . . . . . . . . . . . . 21
Table of Contents (continued)

1Introduction
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
a physician or other health professional for its intended use.
Treatment is carried out for 20 minutes, once a day. Patients should treat themselves at approxi-
mately the same time each day.
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 loca-
tion and type of fracture will inuence 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 Contraindications
There are no known contraindications to the use of the
Melmak Device.
01
INTRODUCTION

1.4 Complications
There have been no known adverse reactions or
medical complications related to the use of the Melmak
Device.
1.5 Warnings
Whilst use of the Melmak Device may be of clinical
bene t, evidence of safety and e ectiveness has not been
established in the following:
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
•For use in patients with vascular disease or soma-
tosensory dysfunction
•For use in patients with any neurological disorders
which may a ect the general wellbeing of the person,
including any condition leading to nutritional
de ciency
•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 bene t,
evidence of safety and e ectiveness has not been estab-
lished 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
02

•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(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.
03INTRODUCTION
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
•mild swelling
•muscle spasm at treatment site
•pain
•mild erythema
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 specied
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 Distribu-
tor.

MINI USB CONNECTOR
for battery charging
ON / OFF
Push button
ULTRASOUND
TRANSDUCER
LARGE
ULTRASOUND
TRANSDUCER
SMALL
DISPLAY STATISTICS
Push button
LCD SCREEN
CABLE LENGTH 1.5m
2Melmak Device (LIPUS)
2.1 Components
The following components are part of your Melmak Device shipment.
2.1(i) Control Unit and Transducer
The device is available with a Transducer in small or large housing
and is tested and validated for max. 1500 treatments. This model
Transducer transmits a low intensity, high frequency pulsed ultra-
sound signal through the patient’s skin to the fracture site to be
treated.
04

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 LARGE
Used to position ultrasound Transducer
over fracture site
ASSEMBLED TRANSDUCER
HOLDER & STRAP SMALL
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
05MELMAK DEVICE

3Operating Guide
3.1 Before a Treatment
The Melmak Device is a battery operated device, it will
need to be charged at least for 12 hours prior to  rst use
using a country speci c adaptor.
3.1(i) Rechargeable Battery and USB connection
The Melmak Device Control Unit is powered by a non-
replaceable, rechargeable Lithium-Ion (Li-On) battery pack.
A medical grade battery charger with inbuilt USB connec-
tor is used to charge the internal battery. Country speci c
adaptor must be used.
The USB mini connector on the top edge of the Melmak
Device is used for charging. Please do not connect any
unspeci c device to the USB. IF a PC is to be connected
to the USB of the device the PC has to be approved
according to IEC 60950.
All functions of the Melmak Device will be disabled 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.
When the battery voltage falls below the critical battery
level during a treatment session in addition to  ashing, the
LCD will also show “
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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:
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.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
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.
 Low battery level is detected.
4.7. 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.
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
” signal. When the “
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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:
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.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
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.
 Low battery level is detected.
4.7. 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.
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
”
signal is present, the current treatment will be completed
but further treatments will not be possible until the Melmak
Device is recharged.
During the charging process, the LCD will show the letter
“P” and the animated battery symbol will be displayed.
During the charging process, the Melmak Device cannot be
operated.
3.1(ii) Audio Feedback
A high frequency audible sound is generated to give feed-
back when:
•Pressing any button
•If gel is required, 3 short beeps, repeated
approximately every 3 seconds
•At the completion of a treatment, alarm will sound 6
short beeps
•Low battery level is detected
3.1(iii) LCD Screen
Figure 1: Display showing all symbols
06
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4. FUNCTIONAL SPECIFICATION
The ECU features a backlit Liquid Crystal Display (LCD) which provides the patient with
information on the remaining treatment time, number of treatments left to be completed. In
addition, the ECU has two (2) tactile push buttons that enables the patient to start and stop the
treatment and to display the status of the treatment.
In summary, the ECU provides the following features:
 Liquid Crystal Display (LCD) with green backlight
 On/Off Push Button
 Display Statistics Button
 Rechargeable Lithium-Ion Battery
 Audio Feedback
 USB Connection for charging and connection to a Personal Computer (PC) for set up
and data logging.
4.1. Liquid Crystal Display
The Liquid Crystal Display (LCD) has the following specification:
 Display size (W x H): 63.2 mm x38.5 mm
 Viewing area size (W x H): 59.9 mm x 30.5 mm
 Driving Condition : 1/3 Duty (i.e. 3 Back Planes) , 1/3 Bias, 3V Operate,
 LCD Type : TN Type
 Viewing Angle: 6 O'clock
 Polarizer Type & Mode: Transflective
 Connector Type : Pins
 Operating Temp: 10°C ~ 50°C
 Storage Temp : 0°C – 65°C
The design of the LCD is as follows:
Figure 2 - BTT Unit Display showing all available segments
Formatted: Font color: Black
Battery
status
indicator
Number of
treatments
completed
Total Number
of available
treatments Add gel
indicator
Treatment time remaining in minutes
and seconds. Maximum time 20:00.

“ ”. This message will be displayed for 1 minute and
then the device will switch o. If an error message is dis-
played please contact your local Melmak Distributor.
•NO ALLOCATED TREATMENTS REMAINING “”
Once all treatments allocated to the Control Unit are
used the following error message will be displayed
“”. If above error is displayed please contact
your local Melmak Distributor.
3.1(v) ON/OFF Push Button
The ON/OFF Push Button on the Control Unit allows the
patient to start and terminate a treatment cycle.
•STARTING A TREATMENT SESSION
(Gel must be placed on the ultrasound head to enable
transmission of ultrasound signal from the ultrasound
Transducer across the skin to the fracture site)
•Pressing and releasing the ON/OFF Push Button will
start a 20 minute treatment session. The Control Unit
will generate a short beep and the LCD will be lit for 5
seconds. The 20 minute count down timer will com-
mence counting down.
Figure 2: Example of display on the LCD at the start of a treatment session
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The information provided by the LCD includes:
Remaining time of the 20 minutes treatment cycle in minutes and seconds
The number of programmed treatments and completed treatments, e.g. 34/150
Battery level and charge status indicator
 “Add Gel” symbol
4.2. ON/OFF Push Button
The ON/OFF Push Button on the ECU allows the patient to start and terminate the
treatment cycle.
The ECU will generate an audible beep and switch on the LCD backlight for 5 seconds
when the ON/OFF Push Button is pressed.
4.2.1. Starting a Treatment Cycle
If the treatment cycle has not been started, pressing and releasing the ON/OFF Push
Button will start the treatment cycle. The ECU will generate a short beep to
acknowledge the push button is pressed and the LCD and its backlight will be lit for 5
seconds as illustrated in Figure 3
Figure 3 – Example of display on the LCD at the start of a treatment cycle
The ECU will commence the treatment cycle and the 20 minute treatment count down
timer will commence counting. An example of the information being displayed on the
LCD 5 seconds into the 20 minutes treatment cycle is as follows:
Figure 4 – Example of display on LCD 5 seconds after the treatment cycle has
commenced.
4.2.2. Viewing Remaining Time of the Treatment Cycle
Pressing and releasing the ON/OFF Push Button during a treatment cycle will switch
on the backlight of the LCD for 5 seconds.
Formatted: English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
not check spelling or grammar
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 displayed as follows:
•INSUFFICIENT GEL “ ”
If insucient gel is detected before or during a treatment
cycle, the Control Unit will suspend the treatment cycle unit
until sucient gel is applied. The Control Unit will generate
three audible beeps every 3 seconds and will display a
ashing drop symbol “ ” in the lower right corner of the
display. If sucient gel is not applied within 2 minutes after
error symbol is displayed the device will automatically
switch o.
•LOW BATTERY “
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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:
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.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
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.
 Low battery level is detected.
4.7. 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.
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
”
Once the Control Unit detects a low battery level this will be
displayed with the following message: “
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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:
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.
Figure 17 – Example of the display on LCD when low battery level is detected at
the start of the treatment cycle
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.
 Low battery level is detected.
4.7. 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.
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
” and the
ashing battery symbol “ ” displayed in the lower left cor-
ner of the display, indicating battery needs to be charged. The
low battery status allows you to nish the current treatment
but will not allow for further treatments to be performed until
the battery is recharged. Pressing and releasing the ON/OFF
button will light the display for 5 seconds and then switch o
the device.
•TRANSDUCER FAULT “ ”
If the Control Unit detects a Transducer fault, the treatment
cycle will be interrupted until the Transducer fault is recti-
ed. The following error message will be displayed:
07OPERATING GUIDE

END OF A TREATMENT SESSION
•When the countdown timer reaches zero, the treatment
is completed and a short audible beep will be heard. The
LCD will show the following for 20 seconds and then
switch o .
Figure 3: Example of LCD at the end of a 20 minute treatment
TERMINATING A TREATMENT
•Pressing and holding the ON/OFF Push Button for
4 seconds or longer during a treatment will stop the
treatment session.
•The Control Unit will generate a short audible beep and
the display will continue to show “End” for 20 seconds
and then switch o .
3.1(vi) Display Statistics Push Button
The Display Statistics Push Button is only operational
when a treatment is in progress.
The Statistics Button enables the patient to:
•Switch on the back light by pushing and releasing the
button once
•Receive information about the number of treatments com-
pleted 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 treat-
ments and the total number of programmed treatments
150.
Figure 4: Example of the display on the LCD when the Display Statistics Push
Button is pressed and released second time while the backlight is enabled
3.1(vii) Transducer Monitoring
The Control Unit will monitor the Transducer status and
gel level continuously throughout the 20 minutes treatment
session.
TRANSDUCER FAULT
•If the Control Unit detects a Transducer fault, the Con-
trol Unit will suspend the treatment session until the
Transducer fault is recti ed. The Melmak Device may
need to be returned to your local Melmak Distributor
for diagnostic tests and potential repair.
•The LCD will display following error signal “ ” for 1
minute and then switch o .
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Figure 10 – Example of display on LCD when the Display Statistics Push Button
is pressed and released once.
Figure 11 – Example of the display on the LCD when the Display Statistics Push
Button is pressed and released second time while the backlight is enabled.
Figure 12 – Example of the display on the LCD five (5) seconds after the Display
Statistics Push Button is pressed and released the second time.
4.4. Transducer Monitoring
The ECU will monitor the Transducer status and Gel Level continuously throughout the
20 minutes treatment cycle.
The following table tabulates the conditions in which the ECU determines the status of
the Transducer and Gel level
Gel Sense Voltage Condition Notes
Gel Sense Voltage ≤ 500mV Short Circuited
Sensor
Error Condition
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
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Figure 5 – Example of display on LCD showing 7 minutes and 10 seconds
remaining on the treatment cycle
4.2.3. End of a Treatment Cycle
When the 20 minutes treatment count down timer reaches zero, the treatment is
completed and the ECU will generate a short audible beep and the LCD will show the
following for 20 seconds and then switch off.
Figure 6 – Example of LCD at the end of the 20 minutes treatment cycle
4.2.4. Terminating a Treatment Cycle
Pressing and holding the ON/OFF Push Button for 4 seconds or longer during a
treatment cycle, the ECU will stop and terminate the treatment cycle.
If the treatment cycle has gone over sixteen (16) minutes of the 20 minutes treatment
cycle, the ECU will registered the treatment cycle as a valid cycle and the LCD will
display as in Figure 7. The ECU will behave as outlined in Section 4.2.3 above, i.e.
the ECU will generate a short audible beep and the display will continue to show
“End” for 20 seconds and then switch off.
Formatted: Complex Script
Font: 11 pt, English (U.S.), Do
not check spelling or grammar
Formatted: English (U.S.), Do
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Formatted: English (U.S.), Do
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08

•Pressing and releasing the ON/OFF Push Button will switch of the Control
Unit immediately.
INSUFFICIENT GEL
•If insucient gel is detected during the treatment cycle, the Control Unit will
suspend the treatment until sucient gel is applied to Transducer head.
•The Control Unit will generate 3 audible beeps every 3 seconds and will
display a ashing “ ” symbol.
Figure 5: Example of the display on LCD when insucient gel is detected
•The Control Unit will apply the gel sensing signal for 2 minutes. If the insuf-
cient gel condition persists at the end of the 2 minute time period, the
Control Unit will reset the 20 minute treatment session timer and will not
register the treatment as a valid treatment.
•If the insucient gel condition is not rectied for another minute, i.e. 3 min-
utes after the low gel condition is detected, the Control Unit will switch o.
•Pressing and releasing the ON/OFF Push Button or the Display Statistics
Push Button has no eect while “ ” is being displayed.
Millennium Electronics Pty. Ltd. 2100-0148-01C
23 July 2010
Copyright Millennium Electronics Pty. Ltd Page 12 of 16
Gel Sense Voltage Condition Notes
500 mV < Gel Sense Voltage ≤ 1.8 V Gel Sense OK, No
Fault
1.8 V < Gel Sense Voltage ≤ 2.8V Insufficient Gel Insufficient Gel
Warning
Gel Sense Voltage ≥ 3V Open Circuit Sensor Error Condition
4.4.1. Transducer Fault
If the ECU detects the Transducer fault condition, the ECU will suspend the
treatment cycle until the transducer fault is rectified.
The LCD will display “Err” as in Figure 13 for 1 minute and then switches off.
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:
Figure 14 – Example of the display on LCD when insufficient gel is detected
The ECU will apply the gel sensing signal for 2 minute at a rate of 100 ms every
500ms and if the insufficient gel condition persists at the end of the 2 minutes time
period, the ECU will reset the 20 minutes treatment cycle timer and will not register
the treatment as a valid treatment.
Formatted: Complex Script
Font: 11 pt, English (U.S.), Do
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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
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09OPERATING GUIDE

4Use Instructions
Depending on the size of the housing of the Transducer a
small or large Transducer holder will be supplied.
The following descriptions apply for both sizes.
4.1 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 need to ensure this
point is reproducible for each treatment. An indelible
marker may assist.
2. Place strap with Transducer holder over fracture site
and stabilise securely using the Hook and Loop fasten-
ers. It is vital that Transducer holder be held securely
over site to be treated, to ensure Transducer is ac-
curately positioned.
3. Open Transducer holder by pushing two turquoise tabs
on either side of Transducer holder towards centre.
4. Hold Transducer and place a small amount of ultra-
sound gel on the Transducer face, approximately
1.5cm diameter.
Place ultrasound Transducer through Transducer
holder. Ensure cable is routed through cut out on cap and
secure by closing cap.
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The spring mechanism on the cap provides light pres-
sure to the Transducer. It ensures good contact to the
gel and skin over the treatment area for ultrasound
transmission.
5. Press ON/OFF button to start treatment. Timer will
illuminate and count down from 20 minutes and then
turn o automatically.
AFTER TREATMENT HAS COMPLETED
6. Undo strap and remove Transducer head from treat-
ment 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.
3. Hold Transducer and place a small amount of Transducer gel
on the Transducer face. Approximately 1.5cm diameter.
11USE INSTRUCTIONS

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.
5. Press ON/OFF button once to begin treatment. Timer
will illuminate and count down from 20 minutes and
then turn o automatically.
6. Remove Transducer head from treatment site. 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 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.
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2. Hold Transducer and place a small amount of Transducer
gel on the Transducer face. Approximately 1.5cm diameter.
3. Place ultrasound Transducer through 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.
4. Press ON/OFF button once to begin treatment. Timer will
illuminate and count down from 20 minutes and then turn
o automatically.
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.
13USE INSTRUCTIONS

5Care and Maintenance
5.1 Care and Cleaning of the
Melmak Device
The Melmak Device must be used according to the follow-
ing 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 sup-
plied and speci ed equipment. The Melmak Device must
not be used in combination with other devices.
Warning: Using other than Melmak speci ed cables and
accessories may negatively a ect electromagnetic com-
patibility performance.
•Never use cleaning agents or solvents to clean device,
its components or accessories. For leaning use only a
soft moist cloth or soft paper towel or tissue.
- For multiple patient use please contact your sales
representative or physician for reprocessing and
cleaning instructions
•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 with the
following symbol “ ”. Connections between these pins
must not be conducted without using speci ed Electro-
static Discharge (ESD) Safety precautions.
-> Using procedures to avoid electrostatic charging
(e.g. conducting  ooring, 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 sta including e.g. medical engineers and nursing
sta are recommended to receive explanation and
training in ESD procedures.
•The minimum speci cations 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.
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