HLD LymphaTouch F02 User Manual Download | Manualshive

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USER MANUAL

Ver. A02 SW rev 2.0x

The manual contains instructions for use, maintenance and handling of the device,
as well as safety precautions and warnings. Read through carefully before using
the device, to ensure safety and efficiency for you and your patient. Keep for future
reference.

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Summary of Contents for LymphaTouch F02

Page 1: ...l contains instructions for use maintenance and handling of the device as well as safety precautions and warnings Read through carefully before using the device to ensure safety and efficiency for you and your patient Keep for future reference ...

Page 2: ...2 ...

Page 3: ...ion 9 4 Connectors 10 5 Symbols and product markings 11 6 Installation 12 7 Using the PhysioTouch LymphaTouch device 16 8 Treatment settings 20 9 Maintenance and cleaning 27 10 Troubleshooting 28 11 Service 30 12 Software upgrade 31 13 Disposal 33 14 Technical data 34 15 EMC 36 ...

Page 4: ... Healthy Life Devices Ltd FDA device class I Quality ISO9001 2008 13485 2003 Manufacturer HLD Healthy Life Devices Ltd Kuortaneenkatu 2 00510 Helsinki Finland www physiotouch com www lymphatouch com Safety and EMC certificate HLD PhysioTouch LymphaTouch A02 conforms with Medical Device Directive 93 42 EEC and medical electrical equipment electromagnetic compatibility IEC 60601 1 2 0537 710359 ...

Page 5: ...g to use the device Caution potentially hazardous situation which if not avoided may cause minor to moderate injuries or damage to the device Warning potentially hazardous situation which can cause injuries or damage the device if instructions are not followed Danger potentially hazardous situation which can result in serious injury or death if instructions are not followed 1 Safety ...

Page 6: ... object Inspect the device and the related accessories for cracks or other signs of overuse and replace accessories as required Make sure the filter in the treatment cup is in place before attaching it to the Treatment Head to avoid dust and debris from being sucked into the device Never use the unit for purposes other than those recommended by HLD Healthy Life Devices Ltd HLD Healthy Life Devices...

Page 7: ...nant patient without prior consultation with the attending doctor Do not use on a patient with cancer during active treatment period or without prior consultation with the attending doctor Do not use on acute infection Be very careful when applying on fragile skin and on the throat area Do not use on a patient with a diagnosed current venous thrombosis Do not use on a patient suffering from protei...

Page 8: ... effects of negative pressure in tissues Negative pressure created by the treatment device stretches the skin and the tissue underneath pulling on anchoring filaments to dilate the endothelial openings of lymph vessels Vertical stretching of the fascial connective tissue structures is accomplished at the same time expanding the space for circulation of blood and lymph Lymph and the metabolic waste...

Page 9: ...n Off switch 4 Touch screen 5 Treatment Head 6 Cable 7 Different sizes of treatment cups for the Treatment Head 8 Soft covers for the treatment cups detachable on the larger treatment cups 9 Treatment cup filter 10 DC power country adapter included ...

Page 10: ...le treating patient or let the patient touch the USB while being treated Do not use USB or LAN connectors while treatment in progress 1 Device s serial number 2 Integrated air hose and cable connector 3 Mains power 4 LAN for future use 5 USB 5 2 1 4 3 ...

Page 11: ...as Class BF according to the standard IEC 60601 The device has double insulation connection to mains does not require a grounding pin Special instructions are needed to dispose device properly Lithium ion battery must be disposed properly The carton package of the device can be recycled This side up Weights less than 5 51 lbs Do not use sharp instrument to open the package Fragile Handle with care...

Page 12: ...send the device for service it is most safely transported in the box it was originally shipped in 6 2 Internal Battery PhysioTouch LymphaTouch has internal battery which is advised to charge full before first usage During battery recharge amber light blinks in the power button When battery is fully charged amber light is on constantly When device is used via battery and the device is on the light ...

Page 13: ...ed but do not use excessive force or rotate connector To disconnect pull the connector straight 6 4 Connecting and disconnecting the Treatment Head Attach the integrated air hose and cable to the round connector on the end of the Treatment Head Make sure the cable is tightly connected but do not use excessive force or rotate connector To disconnect pull the connector straight ...

Page 14: ...reatment cup Connect the treatment cup to the Treatment Head as indicated in the figure Caution Make sure the treatment cup is connected in right orientation as indicated by the guiding rails 6 6 Connecting removable soft part to the treatment cup 60mm and 80mm treatment cups have separate soft parts Connect the treatment cup soft part to treatment cup as indicated in the figure ...

Page 15: ...ents provided or recommended by HLD Healthy Life Devices Ltd to mount the device If the device is not attached properly it may fall and cause injury or damage to the equipment Caution HLD0901 Roll stand is designed solely to be used with PhysioTouch LymphaTouch device Do not connect other devices or equipment to the Roll stand Basket of the roll stand is designed to withstand the weight of 4 treat...

Page 16: ...rner Device starts in 35 seconds To turn off the device press the on off switch The device will also shut down automatically after an hour of inactivity while on battery power The display will shut down and the device will enter a power saving mode when the device has not been used for 30 minutes Reactivate the unit by pressing the on off switch or by touching the screen ...

Page 17: ...smoothly on the skin Avoid excessive use of oil or massage cream If the patient s skin is very dry and producing dandruff the filter in the treatment cup may get clogged faster than normal This will result in difficulty achieving the set pressure Replace the treatment cup in order to continue an efficient treatment The error message below is displayed if filter is clogged Do not use talcum powder ...

Page 18: ...dance while using your own clinical judgment as to what is an appropriate size for each situation Treatment cup Size Removable rubber ring Body areas HLD0335 35 mm Local scars Small joints Face Head and neck HLD0350 2 50 mm Local scars Joint areas Face Head and neck Palm area HLD0360 60 mm X Whole body HLD0380 80 mm X Torso Upper and lower limbs ...

Page 19: ... Treatment cup 35mm 20pcs HLD1020 50 Treatment cup 50mm 20pcs HLD1020 60 Treatment cup 60mm 20pcs HLD1020 80 Treatment cup 80mm 20pcs HLD0122 Treatment Cable HLD1601 PhysioTouch LymphaTouch carrying bag 7 5 Accessories Use these codes to order accessories from the nearest distributor ...

Page 20: ... a wedge During treatment a blue wedge appears which indicates the current vacuum in the treatment cup 2 The vacuum is adjusted with the touch screen by moving the slider at the desired location If the desired vacuum is not achieved make sure that the treatment cup selected is suitable to the affected area of the body If necessary replace the treatment cup with a more appropriate size or repositio...

Page 21: ...nnected to the mains the top of the battery icon is a power plug icon and when the battery is charging a flash icon 3 During treatment it is possible to choose either pulsating or continuous treatment The pulsation button at the bottom right is green with bristles when pulsation is activated Button is green and continuous when continuous treatment is selected To modify the pulsation setting touch ...

Page 22: ...he top of the screen between 30 90 2 Set pulse length by sliding the arrow or by pressing the desired location on the axis on the lower part of the screen 3 Constant negative pressure Return to main screen and deactivate pulsation 4 Return to main screen and keep the pulsation on ...

Page 23: ...rom the timer display Press the treatment button to open a display where you can select the desired duration of treatment Remaining duration of treatment is shown on the main display See the picture below When treatment time ends PhysioTouch LymphaTouch will notify with treatment head valve ending ...

Page 24: ...ncy screen by pressing the high frequency button on the main screen On the High frequency screen there are two buttons the left one is for turning the high frequency treatment off and the right one is for high frequency treatment Initial settings are the high frequency treatment mode off and the pulsation treatment mode activated ...

Page 25: ...et on by deactivating pulsation treatment mode and activating the high frequency treatment mode By activating both the high frequency vibration and the pulsation treatment mode combination treatment can be started Treatment mode is now vibrating pulsation treatment ...

Page 26: ...26 8 4 Numeric keypad Numeric keypad button can be found from timer setting screen Numeric keypad screen is used mainly in service purposes ...

Page 27: ... treatment cup is a small white filter that prevents dust and debris from entering the device When cleaning the treatment cup be careful not to touch the filter as the detergent may also cause clogging of the filter Manufacturer recommends that mouthpieces are replaced with new ones when there is visible wear and tear or when the cups have been used longer than three months 9 2 Cleaning main unit ...

Page 28: ...r immediately There may be an internal error which has caused the system to halt Press the on off switch for 10 seconds to reset the device Problem Treatment cable disconnected Verify that the cable is properly connected both to the device and to the Treatment Head Contact service if necessary Problem Suction will not start when the Treatment Head is brought to the patient s skin If the treatment ...

Page 29: ...u are attempting to treat Try to find a location where you can achieve an airtight connection or replace treatment cup with the size that fits better The filter in the treatment cup may be clogged Replace the treatment cup Verify that the treatment cup is properly connected to the Treatment Head Verify that the soft treatment cup cover is properly connected to the treatment cup and intact Wear and...

Page 30: ... reappears contact the reseller and inform the error code displayed on the lower right corner Warning Danger Only persons certified by HLD Healthy Life Devices Ltd are authorized to perform servicing of the device Opening the device or servicing the device without authorization will result in voiding the warranty and may lead to serious injury or damage to the equipment ...

Page 31: ...tions on performing the software upgrade and detailed description of the new software features will be included with each software upgrade If you have received a software zip file upgrade via email or downloaded it from the www physiotouch com Web site unzip the file to the USB memory stick root folder There should be the following two files on the memory stick when the upgrade process is initiate...

Page 32: ...ions on the screen Do not disconnect the memory stick until instructed to do so The device will restart and update the device s main board and Treatment Head if necessary If the Treatment Head is not connected at the time it will be updated the next time it is connected Upgrading is complete and the device is ready for use If you have several PhysioTouch LymphaTouch treatment devices in use it is ...

Page 33: ...nal power source Do not throw away the device with normal household waste at the end of its life Consider the environment deliver the device for recycling at an official collection point for electronic devices Check with the appropriate recycling organization for local disposal information ...

Page 34: ...attery Type HLD 2200 Lithium Ion 10 8V 5 2Ah 56Wh Replacement interval 3 years Duration time in use 8 hours Duration time in stand by 18 hours Charging while in use 8 hours Charging while in stand by 5 hours Estimated time Time can vary due to the ambient and or device temperature Note Designed lifetime for the adapter is two years ...

Page 35: ... altitude 0 3000 m Classification Medical device CE MDD class 2a Conformity to standards ISO 13485 2003 IEC 60601 1 IEC 60601 1 11 Performance specifications Negative pressure adjustment Range 0 250 mmHg Accuracy 10 10 mmHg Pulsation adjustment Range 0 5 5 s Accuracy 10 0 05s Vibration adjustment Range 20 90 Hz Accuracy 10 Designed lifetime 5 years ...

Page 36: ...cers and cables other than those specified with the exception of transducers and cables sold by HLD Healthy Life Devices as replacement parts for internal components may result in increased electromagnetic emissions or decreased immunity of the device to such emissions Warning PhysioTouch LymphaTouch should not be used adjacent to or stacked with other equipment If adjacent or stacked use is neces...

Page 37: ...ry low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The PhysioTouch LymphaTouch is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic emissions IEC 61000 3 2 Not Applicable low inpu...

Page 38: ...can affect this equipment and should be kept at least a distance d see tables on pages 40 41 away from the any part of the PhysioTouch LymphaTouch including cables Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Floors should be wood concrete or ceramic tile If floors are ...

Page 39: ...s 5 UT 95 dip in UT for 5 s 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 s Mains power quality should be that of a typical commercial or hospital environment If the user of the PhysioTouch LymphaTouch requires continued operation during power mains interruptions it is recommended that device is installed with battery optio...

Page 40: ...ch frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Radiated RF IEC 61000 4 3 3 V m 80 MHz 2 5 GHz 3 V m NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths...

Page 41: ...utput power of transmitter W Separation distance according to frequency of transmitter m 150kHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 2 5GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 2 1 2 2 3 10 3 7 3 7 7 4 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to ...

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Page 44: ...00510 Helsinki Tel 358 0 10 423 7300 Fax 358 0 10 423 7309 contact physiotouch com contact lymphatouch com www physiotouch com www lymphatouch com ISO 9001 2008 13485 2003 Certified company Copyright 10 2016 v8 0 HLDID 30 1238 EN Directive 93 42 EEC 0537 ...

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