Melmak Patient User Manual
Contents
1. symbol OPERATING GUIDE 09 Figure 5 Example of the display on LCD when insufficient gel is detected 4 The Control Unit will apply the gel sensing signal for 2 minutes If the insufficient 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 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 fp is being displayed MOWmak Faster Fracture Healing 4 Use Instructions 4 1 Non Cast Use Instructions E 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 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 Open Transducer holder by pushing two turquoise tabs on either side of Transducer holder towards centre Hold Transducer and place a small amount of ultrasound gel o2. 16 6 2 Battery Charger Specification 16 6 3 Information about Electro Magnetic Compatibility EMC EEN 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 ii Declaration Conformity 21 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 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 approximately 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 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 INTRODUCTION 01 1 4 Compli
3. btt Faster Fracture Healing PATIENT MANUAL BTT01 044 00 Rev1 01 2012 ec BTT Melmak Development amp Production GmbH Gewerbegebiet 16 82399 Raisting Germany Tel 49 0 8807 923922 Fax 49 0 8807 8806 Email info melmak com 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 Faster Fracture Healing All enquiries regarding the Melmak device and support should be first directed to your local Melmak Distributor Melwak Faster Fracture Healing Symbols 8 E o 00 oO ole ES El Q gt p D AUT Ex Manufacturer BIT Melmak Development amp Production GmbH Gewerbegebiet 16 D 82399 Raisting 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 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 Table of Contents 14 ompliatins 1 LS Wald we a S Z dba OE SX Rem 1 15 Non unon 1 15
4. 20 minutes and then turn off automatically Remove Transducer head from treatment site Clean gel from Transducer head strap and skin with a soft cloth 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 Open Transducer holder by pushing two turquoise tabs on either side of Transducer holder towards centre Hold Transducer and place a small amount of Transducer gel on the Transducer face Approximately 1 5cm diameter E 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 Press ON OFF button once to begin treatment Timer will illuminate and count down from 20 minutes and then turn off automatically Bu 6 Remove Transducer head from treatment site Clean gel from Transducer head strap and skin with a soft cloth Place the round felt plug into the cast window and close cap to secure USE INSTRUCTIONS 13 14 Faster Fracture Healing 5 Care anq Maintenance 5 1 Care and leaning of the Melmak Device The Melmak Device must be used according to the following instructions 4 The Melmak Device is only to be used according to the intended use mentioned in this manual Please read this manual very carefully
5. actual power output of sender S expressed as in Watt W according to the information of the sender manufacturer 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 absorption and reflection of buildings subjects or people TECHNICAL INFORMATION 21 6 3 ii Declaration of Conformity KONFORMITATSERKLARUNG DECLARATION DE CONFORMITE DECLARATION OF CONFORMITY DICLARATIONE DE CONFORMITA Wir Nous We Noi Name Adresse der Firma BTT Melmak Development amp Production GmbH Nom adresse de l entreprise Gewerbegebiet 16 Name address of manufactuer Nome indorizzo della ditta D 82399 Raisting Germany erkl ren in alleiniger Verantwortung dass d clarons sous notre propre ea que declare on our own responsibility tha dichiariamo sotto propria enee D Che das Medizinprodukt pana nom name nome Melmak Ultraschallger t mod ltype or model le dispositif m dical I PA eas f o de i seran ou de Melmak the medical device serie lot or serial number no lot campioane o il dispositivo medico ggf Herkunft St ckzahl source et nombre pora qr ie sources and numbers of items fonte e numero Klasse und MDD Regel ckasse et MDO lla Regel 9 gemens ces sed MOD nis visione a e MDD allen Anforderungen der Medizinprodukte Richtlinie 93 42 EWG u
6. 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 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 information on correct disposal of your Melmak Device To minimise environmental impact components of 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
7. in addition to flashing the LCD will also show Lo bgt signal When the Lo dat 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 i Audio Feedback A high frequency audible sound is generated to give feedback 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 Treatment time remaining in minutes and seconds Maximum time 20 00 Battery Number of Total Number Add gel status treatments of available indicator indicator completed treatments Figure 1 Display showing all symbols 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 Wi If insufficient gel is detected before or during a treatment cycle the Control Unit will suspend the treatment cycle unit until sufficient gel is applied The Con
8. 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 amp 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 Melwak Faster Fracture Healing 3 Operating Guide 3 1 Before a Treatment The Melmak Device is a battery operated device it will need to be charged prior to use using a country specific 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 connector is used to charge the internal battery Country specific adaptor must be used The USB mini connector on the top edge of the Melmak Device is used for charging 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
9. 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 CARE AND MAINTENANCE 15 On the rear of the Melmak Control Unit you find c ES the following service sticker T indicating the mandatory date for next service 5 6 Melmak Service and Support Centres 5 6 i European Authorised Representative BTT MELMAK DEVELOPMENT amp 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 16 Faster Fracture Healing 6 Technical Information 6 1 Control Unit Specification o 9 9 o 9 9 gt gt Ultrasound Frequency f 1 5 5 MHz Modulating Burst Width tp 200 10 us Repetition Rate REF 1 0 10 KHz Acoustic Power P4 116mW Spatial Average Temporal Average SATA Ie 30 30 mW cm Spatial Average Temporal Maximum SAT M Im 116 30 mW cm Power Supply Lithium lon Rechargea
10. 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 with the following symbol s Connections between these pins must not be conducted without using specified Electrostatic Discharge ESD Safety precautions gt 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
11. applicable voltage not applicable environment Voltage drops short time lt 5 U lt 5 U The quality of the supply voltage interruption and variations of gt 95 voltage drop of UT gt 95 voltage drop of UT should be up to the standard of supply voltage according to for of Period for 1 2 of Period a typical business or hospital IEC 61000 4 11 environment If the user of 40 U 40 U the Melmak Device requires 60 voltage drop of U T 6096 voltage drop of UT continuous function even at for 5 Periods for 5 Periods interruptions of the power supply it s recommended to 70 U 70 U operate the Melmak Device 30 voltage drop of U T 3096 voltage drop of UT with an independent power for 25 Periods for 25 Periods supply or a battery 5 U lt 5 U gt 95 voltage drop of UT gt 95 voltage drop of UT for 5 s for 5 s Magnetic Field at supply Magnetic fields of the supply frequency 50 60 Hz frequency should be up to the according to IEC 61000 4 8 standard of a typical business or hospital environment Note U alternating voltage before application of test levels TECHNICAL INFORMATION 19 6 3 i 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 Tes
12. ble Battery 3 7 DCV nominal Power Input Pin 1 1 0 6 W Beam Non Uniform Ratio Ry lt 6 Waveform Pulsed Effective Acoustic Radiating Area Aer 3 88cm Duty Factor DF 5 Time Average Intensity 6 Weight Control Unit including Transducer approximately 285 g 6 2 Battery Charger Specification Input Voltage 100 240 VAC Input Current lt 0 5 A RMS Max Input Frequency 47 63 Hz Output Voltage 5 0 V No Load to Full Load No Minimum Load Required 4 4 4 4 Output Current 1 0 A Output Power Rated 5 W Max TECHNICAL INFORMATION 17 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 i Electro Magnetic Transient emissions measuring Correlations MER Environment Guideline HF emission according to CISPR 11 HF emission HF emission according to CISPR11 to CISPR 11 CasB B Emission of harmonic See to Class A IEC 61000 3 2 Emission of voltage variation Flicker Agreed according to IEC 61000 3 3 The Melmak Device applies HF Energy for internal function only Therefore the HF Emission is very low and it s unlikely that it will interfere with other electronic devices nearby M Melmak Dev
13. cations 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 benefit evidence of safety and effectiveness has not been established in the following 1 5 i Non union For the treatment of fractures of the vertebrae or skull 4 In the skeletally immature 1 5 i Fresh Fracture For the treatment of fractures of the vertebrae or skull All fracture types 4 In the skeletally immature Reduced fractures which remain substantially displaced Y For pregnant and breast feeding women For use in pathological fractures due to bone pathology or malignancy Y For complex fractures requiring surgical intervention to reduce and stabilise Melwak Faster Fracture Healing 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 safe
14. e 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 Melwak Faster Fracture Healing 6 3 i 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 Ihe 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 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz d 1 16 P d 1 16 P d 2 33 P 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
15. he back light by pushing and releasing the button once Receive information about the number of 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 34 158 indicating 34 completed treatments 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 Control Unit will suspend the treatment session until the Transducer fault is rectified 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 E for 1 minute and then switch off 4 Pressing and releasing the ON OFF Push Button will switch of the Control Unit immediately INSUFFICIENT GEL 4 If insufficient gel is detected during the treatment cycle the Control Unit will suspend the treatment until sufficient gel is applied to Transducer head 4 The Control Unit will generate 3 audible beeps every 3 seconds and will display a flashing
16. i Fresh Fracture 2 1 16 Precautions 0004 2 1 6 i Non union 7 1 6 1i Fresh Fracture 2 1 7 General Precautions 2 18 Safetylnstrutins 3 Sch Components sc cs sreo a sss aoe N 4 2 1 i Control Unit 8 Transducer 4 2 1 1i Accessories 5 3 1 Before Treatment 6 3 1 i Rechargeable Battery amp USB connection 6 3 1 1i AudioFeedback 6 31i LCD Screen 6 3 1 iv Error Symbols amp Message Displayed on LCD o RIN 7 3 1 v ON OFF Push Button 7 3 1 vi Display Statistics Push Button 8 3 1 vii Transducer Monitoring 8 memak Faster Fracture Healing 41 Non CastUselnstructions 10 4 2 Use Instructions When Using Strap Attachment Over Cast cuu dk poe RR RACER 11 4 3 Use Instructions When Transducer Holder is Incorporated Into Cast 12 5 LAKE 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 54 Enquiries 15 55 Serving 15 5 6 Melmak Service and Support Centres 15 5 6 i European Authorised Representative 15 5 6 i Australian Representative 15 6 TECHNICAL INFORMATION 16 6 1 Control Unit Specification
17. ice 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 Melwak Faster Fracture Healing 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 Discharge static electricity 6 kV Contact discharge 6 kV Contact discharge Floors may consist of wood or ESD according to concrete or ceramic tile If the IEC 61000 4 2 8 kV Air discharge 8 kV Air discharge floor consists of synthetic material the relative humidity has to be at least 30 Fast transients Bursts 2 kV for power line 2 kV for power line The quality of the supply voltage according to IEC 61000 4 4 should be up to the standard of kV for input and kV for input and a typical business or hospital output lines not applicable output lines not applicable environment Surge Voltages Surges 1 kV push pull voltage 1 kV push pull voltage The quality of the supply voltage according to IEC 61000 4 5 should be up to the standard of 2kV common mode 2kV common mode a typical business or hospital voltage not
18. lmak 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 tbe ultrasound Transducer across tbe skin to tbe 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 commence counting down Figure 2 Example of display on the LCD at the start of a treatment session Melwak Faster Fracture Healing END OF A TREATMENT SESSION When the countdown timer reaches zero the treatment is completed and a short audible beep will be heard Ihe LCD will show the following for 20 seconds and then switch off 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 off 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 t
19. n the Transducer face approximately 1 5cm diameter zu Place ultrasound Transducer through Transducer holder Ensure cable is routed through cut out on cap and secure by closing cap 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 5 Press ON OFF button to start treatment Timer will illuminate and count down from 20 minutes and then turn off automatically AFTER TREATMENT HAS COMPLETED 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 Da USEINSTRUCTIONS 1 Hold Transducer and place a small amount of Transducer gel on the Transducer face Approximately 1 5cm diameter 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 2 Open Transducer holder by pushing two turquoise tabs on either side of Transducer holder towards centre m Faster Fracture Healing Press ON OFF button once to begin treatment Timer will illuminate and count down from
20. nd 2007 47 EG entspricht remplit toutes les exigences de la directive sur les dispositifs m dicaux 93 42 CEE ou 90 385 CEE qui le concernait meets all the provisions of the Directive93 42 EEC or 90 385 EEC which apply to him addempie a tutte le exigenze della Direttiva 93 42 CEE opure 90 385 CEE che lo riguardano Angewandte harmonisierte Normen EN 980 EN 1041 EN ISO 10993 1 EN ISO 10993 3 EN ISO 10993 10 EN ISO 10993 11 EN ISO 10993 18 EN ISO edel deen 13485 EN ISO 14155 1 2 ISO TR 14969 DIN EN ISO Norme armonizzate applicate 14971 ISO 15223 DIN EN ISO 17050 EN 60601 1 1 6 2 5 Angewandte nationale Normen n a Normes nationales appliqu es Applied harmonized standards Norme nazionali applicate Andere normative Dokumente n a Autres documents normatifs Other normative documents Altri documenti normativi Benannte Stelle falls zutreffend mdc medical device certification GmbH Organisme notifi le cas ch ant Registration 0483 Notified body if applicable Kriegerstrasse 6 D 70191 Stuttgart Germany Organo notificato se il caso Konformit tsbewertungsverfahren Anhang V Abschnitt 3 Proc dure d valuation de la conformit Conformity assessment procedure Procedimento d evaluazione della conformita Laufzeit der Konformit tserkl rung 01 01 2011 01 08 2016 Dur e de la declaration de conformit n YET Ort Datum l place date luogo eng If you have fu
21. rther questions or require additional information please contact your local Melmak Distributor
22. 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 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 INTRODUCTION 02 04 Faster Fracture Healing 2 Melmak Device LIPUS 2 1 Components The following components are part of your Melmak Device shipment 2 1 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 05 2 1 ii Accessories ULTRASOUND GEL 250 gram bottle Gel must be applied to Transducer head prior to all treatment
23. trol Unit will generate three audible beeps every 3 seconds and will display a flashing drop symbol fp in the lower right corner of the display If sufficient gel is not applied within 2 minutes after error symbol is displayed the device will automatically switch off LOW BATTERY Lo bdt E Once the Control Unit detects a low battery level this will be displayed with the following message Lo bgt and the flashing battery symbol 1 A displayed in the lower left corner of the display indicating battery needs to be charged The low battery status allows you to finish 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 off the device TRANSDUCER FAULT rr 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 OPERATING GUIDE 07 een 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 77 7 7 1587 150 Once all treatments allocated to the Control Unit are used the following error message will be displayed If above error is displayed sg sg please contact your local Me
24. ts 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 Iherapy device including the wires than according to the recommended security distance determined by the following equation Recommended Security Distance conducted HF transient 3 Veg d 116 P according to IEC 61000 4 6 150 kHz to 80 MHz radiated HF transient 3 V m d 1 16 P for 80 MHz to 800 MHz according to IEC 61000 4 3 80 MHz to 2 5 GHz 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 site lower than the correlations level In the vicinity of device labelled with the following sign interferences are possible Dech 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 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 b
25. ty and effectiveness has not been established in the following 1 6 4 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 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 i 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 4 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
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