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Related Manuals for BTT Melmak
Summary of Contents for BTT Melmak
- Page 1 Instructi ons For Use PATIENT MANUAL...
- Page 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. Month Year...
- Page 3 BTT Health GmbH Billerberg 7 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 fi rst directed to your local Melmak Distributor.)
- Page 4 EU: Not for general Waste BTT Health GmbH For details of how to dispose these items Billerberg 7, D-82266 Inning, Germany please contact your local waste agency or your local Melmak Distributor Order Number C-Tick The CE mark indicates conformity with Service Sticker...
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Page 5: Table Of Contents
1.8 Safety Instructions....MELMAK DEVICE (LIPUS) 2.1 Components .... - Page 6 5.1 Care and Cleaning of the Melmak Device ..5.2 Disposal of Melmak Device ....5.3 Warranty and Statuatory Rights .
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Page 7: Introduction
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. -
Page 8: Complications
In the skeletally immature • 1.6 Precautions 1.5(ii) Fresh Fracture Whilst use of the Melmak Device may be of clinical benefi t, evidence of safety and eff ectiveness has not been estab- For the treatment of fractures of the vertebrae or skull •... -
Page 9: Ii) Fresh Fracture
For use outside the recommended clinical parameters, • including prolonged use beyond prescribed guidelines The Operating Guide must be followed accurately. The Melmak Device is to be used only with Melmak specified 1.7 General Precautions and supplied equipment and not in combination with other devices. -
Page 10: Melmak Device (Lipus)
Melmak Device (LIPUS) Components The following components are part of your Melmak Device shipment. Control Unit and Transducer 2.1(i) 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... -
Page 11: Ii) Accessories
Used to position ultrasound Transducer over fracture site over fracture site BATTERY CHARGER (including adaptors) INSTRUCTIONS FOR USE USB Cable is used for charging the internal MANUAL non-replaceable battery of the Melmak Operation instructions Device. Length 1.8m. For international use multiple adaptors are supplied. -
Page 12: Operating Guide
USB and External Battery Charger Connector The USB mini connector on the top edge of the BTT unit, is used for communications to 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. -
Page 13: Iv) Error Symbols & Message Displayed On Lcd Screen
Pressing any button will sound for 200mS approximately. The USB mini connector on the top edge of the BTT unit, is used for communications to If gel is required, an audible alarm will also be sounded, 3 short beeps, repeated a PC, and for charging the internal Lithium Ion battery. -
Page 14: Vi) Display Statistics Push Button
3.1(vi) 4.4. Transducer Monitoring Transducer fault is rectifi ed. The Melmak Device may The ECU will monitor the Transducer status and Gel Level continuously throughout the need to be returned to your local Melmak Distributor The Display Statistics Push Button is only operational 20 minutes treatment cycle. - Page 15 1.8 V < Gel Sense Voltage ≤ 2.8V Insufficient Gel Insufficient Warning Gel Sense Voltage ≥ 3V Open Circuit Sensor Error Condition OPERATING GUIDE 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.
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Page 16: Use Instructions
Use Instructions Depending on the size of the housing of the Transducer a 3. Open Transducer holder by pushing two turquoise tabs small or large Transducer holder will be supplied. on either side of Transducer holder towards centre. The following descriptions apply for both sizes. 4. -
Page 17: Use Instructions When Using Strap Attachment Over Cast
Transducer face. Approximately 1.5cm diameter. 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. -
Page 18: Use Instructions When Transducer Holder Is Incorporated Into Cast
4. Position the Transducer in the window of the cast 6. Remove Transducer head from treatment site. Clean directly over the fracture site. Ultrasound gel must be gel from Transducer head, strap and skin with a soft touching the skin. Close cap to secure. cloth. - Page 19 USE INSTRUCTIONS 2. Hold Transducer and place a small amount of Transducer gel on the Transducer face. Approximately 1.5cm diameter. 5. Remove Transducer head from treatment site. Clean gel from Transducer head, strap and skin with a soft cloth. 3. Place ultrasound Transducer through Transducer holder. Ensure cable is routed through cut out on cap and secure by closing cap.
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Page 20: Care And Maintenance
Melmak Device. ing instructions: Warning: Do not touch Connector pins marked with the • The Melmak Device is only to be used according to the • following symbol “ ”. Connections between these pins intended use mentioned in this manual. -
Page 21: Disposal Of Melmak Device
Melmak Device. response. To minimise environmental impact, components of this On the rear of the Melmak Control Unit you find the following device will be recycled where possible. service sticker “ ” indicating the mandatory date for next service. -
Page 22: Technical Information
Technical Information Control Unit Specifi cation Battery Charger Specifi cation Acoustic Working Frequency f : 1.5 + 5% MHz Input Voltage: 100 - 240 VAC • • Pulse Duration t : 200 + 10% μs Input Current: <0.5 A RMS Max •... -
Page 23: Information About Electro-Magnetic-Compatibility (Emc)
Guidelines and Manufacturer’s Declaration – Electro-Magnetic Emission 6.3(i) 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. Electro-Magnetic Transient emissions measuring Correlations Environment –... -
Page 24: Ii) Guidelines And Manufacturer's Declaration - Electro-Magnetic Stability
Guidelines and Manufacturer’s Declaration – Electro-Magnetic Stability 6.3(ii) 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. Electro-Magnetic Stability Tests... - Page 25 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 moni tored, in order to verify the designated function.
- Page 26 (continued) The Melmak device is destined for the use in an electro-magnetic environment, where the HF-tran- sient is controlled. The customer or user of the Melmak device can help to avoid electro-magnetic infer- ences by keeping the minimum distance (see below) between portable and mobile HF-Telecommunication Devices (Senders) and the Melmak device –...
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Page 27: Iii) Declaration Of Conformity
......CEO ..Ort, Datum / Name und Funktion / lieu, date nom et fonction place, date / luogo, data name and function / nome e funzione Declaration of Conformity-Melmak-until 03-07-2019; Vers.2 2016-08-16... - Page 28 If you have further questions or require additional information, please contact your local Melmak Distributor: Local Distributor Label Here BTT01-044-00, V.3/09.2016...
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