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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

Electro-Magnetic                                                              

Environment – Guideline 

HF emission according to CISPR 11

Group 1

The Melmak device applies HF-Energy for internal func-
tion only. Therefore the HF-Emission is very low and it’s 
unlikely, that it will interfere with other electronic devices 
nearby.

HF emission according to CISPR 11

Class B

The Melmak device is a device which is for the use in 
every facility including residential areas and those con-
nected to the public power supply, supplying buildings 
made for living.

Emission of harmonic according to  
IEC 61000-3-2

Class A

Emission of voltage variation / Flicker  
according to IEC 61000-3-3

Agreed

17

TECHNICAL INFORMATION

Содержание Melmak

Страница 1: ...Instructions For Use PATIENT MANUAL ...

Страница 2: ...Activate the service label on the backside of the device before first use Please mark month and next year The device has to be returned to service at this date Year Month ...

Страница 3: ...82266 Inning am Ammersee Germany Tel 49 0 8143 99241 20 Fax 49 0 8143 99241 29 info btt health com www btt health com All enquiries regarding the Melmak device and support should be first directed to your local Melmak Distributor i ...

Страница 4: ...rile 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 ...

Страница 5: ...sh Fracture 3 1 7 General Precautions 3 1 8 Safety Instructions 3 2 MELMAK DEVICE LIPUS 4 2 1 Components 4 2 1 i Control Unit Transducer 5 2 1 ii Accessories 5 3 OPERATING 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 Statistic...

Страница 6: ...osal of Melmak Device 15 5 3 Warranty and Statuatory Rights 15 5 4 Enquiries 15 5 5 Servicing 15 6 TECHNICAL INFORMATION 16 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 St...

Страница 7: ...ts 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 influence results This non invasive treatment can only be prescribed by a physician or other health p...

Страница 8: ...duce and stabilise For use in patients with vascular disease or soma tosensory 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 recomme...

Страница 9: ...recautions regarding electromagnetic compatibility EMC and must be installed according to EMC information 03 INTRODUCTION 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...

Страница 10: ...LIPUS 2 1 Components The following components are part of your Melmak Device shipment 2 1 i Control Unit andTransducer 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 ...

Страница 11: ...ANSDUCER 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 I...

Страница 12: ...nce 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 ...

Страница 13: ...e 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 ...

Страница 14: ... Pty Ltd Page 11 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...

Страница 15: ...n 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...

Страница 16: ...ndelible 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 ...

Страница 17: ...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 T...

Страница 18: ...count down from 20 minutes and then turn off 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 holde...

Страница 19: ...nd 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 off 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 1...

Страница 20: ...ents 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 specified Electro static Discharge ESD Safety precau...

Страница 21: ...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 consum er 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 co...

Страница 22: ...e Battery 3 7 DCV nominal Beam Non Uniform Ratio RBN 6 Waveform Pulsed Effective Acoustic Radiating Area Aer 3 88cm2 1 Duty Factor DF 20 Weight Control Unit including Transducer approximately 285 g 6 2 Battery Charger Specification Input Voltage 100 240 VAC Input Current 0 5 A RMS Max Input Frequency 47 63 Hz Output Voltage 5 0 V No Load to Full Load No Minimum Load Required Output Current 1 0 A Ou...

Страница 23: ...line HF emission according to CISPR 11 Group 1 The Melmak device applies HF Energy for internal func tion only Therefore the HF Emission is very low and it s unlikely that it will interfere with other electronic devices nearby HF emission according to CISPR 11 Class B The Melmak device is a device which is for the use in every facility including residential areas and those con nected to the public...

Страница 24: ...voltage 2 kV common mode voltage not applicable 1 kV push pull voltage 2 kV common mode voltage not applicable The quality of the supply voltage should be up to the standard of a typical busi ness or hospital environment Voltage drops short time inter ruption and variations of supply voltage according to IEC 61000 4 11 5 UT 95 voltage drop of UT for of Period 40 UT 60 voltage drop of UT for 5 Peri...

Страница 25: ...ter 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 At frequencies of 80 MHz and 800 MHz the higher frequency range is valid Note 2 These guidelines may not be applicable in all cases The electromagnetic parameter propagation will be influenced by absorp...

Страница 26: ...uency 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 outp...

Страница 27: ...l classe et MDD règlement class and MDD rule classificatione e MDD regola Melmak Ultraschallgerät Melmak n a Klasse IIa Regel 9 allen Anforderungen der Medizinprodukte Richtlinie 93 42 EWG und 2007 47 EG entspricht remplit toutes les exigences de la directive sur les dispositifs médicaux 93 42 CEE qui le concernait meets all the provisions of the Directive93 42 EEC which apply to him addempie a tu...

Страница 28: ...If you have further questions or require additional information please contact your local Melmak Distributor BTT01 044 00 V 3 09 2016 32 Local Distributor Label Here ...

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