LifeWave BST User Manual - E-QURE
Contents
1. 10 Treatment Session Notes m If the blue AUDIO button middle button is pressed on a beep will be heard every 10 seconds during treatment indicating that the LifeWave BST is operating properly m If the device identifies a problem e g disconnection of electrodes a beep will be heard every 2 seconds In such an event recheck whether all cables are connected properly and electrodes are at tached to the skin To disable the alarm signal at session s completion press the blue AUDIO button middle button to switch it off When the sound is disabled you will receive only visual notification when the treat ment has been completed To pause a session at any time press the red STOP button right button once Press the green START button left button to continue the session from the point it was paused To stop the session at any time press the red STOP button right button twice End of Treatment Session 1 Once the treatment session has been completed turn off the BST device s power switch 2 Disconnect the electrodes lead from the connector cable Keep the electrodes on your skin 3 If this is the last usage session of the pair of electrodes the elec trodes duration use is indicated on the electrode s labels remove the electrodes by holding their edge and peeling them carefully away from the skin towards the wound Do not pull the electrode lead to remove the electrodes All R2. Contents Each LifeWave BST package contains the following 1 BST Device Fig 1 2 Power Cable Fig 2 3 Connector Cable Fig 3 4 LifeWave BST disposable Electrodes and their lead Fig 4 Please check that you have all the components before starting treatment Power Connection 1 Place the BST device Fig 1 on a clean flat surface and connect the power cable Fig 2 to the BST device 2 Plug the power cable Fig 2 into a wall socket and turn on the BST device using the power switch Fig 5 3 The LifeWave BST logo appears on screen indicating that the system is ready Note To adjust the display contrast turn the knob Fig 6 located on the right side of the BST device If the timer from a previous treatment is displayed switch the power switch Fig 5 off and turn on again to reset Electrode Connections Clean and dry the skin around the wound according to your physician s instruc tions Cleaning is necessary to ensure that the skin is free of any dirt or ointments and that it is dry enough to enable the attachment of the electrodes 1 Connect the connector cable Fig 3 to the BST device Fig 7 2 Open the electrodes packet 3 Separate and remove the outer lining from the electrodes to expose the electrode s sticky surface and try not to touch the sticky surface 4 Place the electrodes firmly on the healthy skin on opposite sides of the wound Each electrode s concave
3. LifeWave BST User Manual a J Da F P J i s LifeWave Bol TIRA EEEN OMN Care www life wave com Table of Content Introduction Indications for Use 0 eerren General Device Description Contraindications 0000000000 eeeeceeeecceeeeeeennees SIde ENES 2 ee Warnings 22 ee eee Precautions 4 4 ees ee r Before You Begin ernieren Treatment Session l l CEH ee E 10 Gi CA 12 CEJ 14 cE 16 16 Cleaning and Disinfecting Ce o Storage and Environmental 12 Maintenance and Replacement Parts a 12 Troubleshooting n 13 Technical Specifications cece Definition Of Symbols n LES Warranty EE EEEE n Copyright EMC Parameters Electro Magnetic Compatibility QZ Ce oocooooooooooooooooooooooooooooooooooooooooooo o oooooooooooooooooooooooHo All Right Reserved LifeWave Ltd 2010 Introduction LifeWave BST Bioelectrical Signal Therapy a proprietary to Live Wave device indicated for the treatment of chronic ulcers The de vice emits a specific electrical signal across the wound to stimulate the natural wound healing process of the human body This sig nal was identified on humans during the healing process of acute healing wounds and found to be associated with the nerves action during the healing process The transmission of this signal to non healing chronic wound imitates and creates the electrical field of the normal wound healing process
4. On LL Pycckn Espa ol Portugu s Italiano Deutsch NNAY 11 Storage and Environmental Store LifeWave BST in a dry place at room temperature Environmental Allowed Conditions Operating temperature range 5 C to 40 C 41 F to 104 F Storage temperature range 10 C to 50 C 50 F to 122 F Operating humidity 5 to max 95 RH relative humidity non condensing Storage humidity 30 max 85 RH non condensing Maintenance and Replacement Parts If your BST device needs repair or a replacement part please contact your physician or distributor 12 All Right Reserved LifeWave Ltd 2010 Troubleshooting The following table summarizes possible malfunctions and actions to be taken in response Actions to take Screen shows nothing after turning on the LifeWave BST Timer stopped in the middle of a session the Y Y icon appears Timer stopped in the middle of a session the _ 9 icon appears 1 No power to Life Wave 1 Check the power cable BST 2 The contrast knob is either in the MIN or MAX position The red STOP button right button was inad vertently pressed The electrical circuit between the BST device and electrodes is broken connections wall socket BST device and or make sure that the power switch is switched on 2 Turn the display contrast knob and look for a change in display contrast Press the green START button
5. left button again and note that the counter continues from the time it was stopped 1 Make sure that the electrodes are firmly attached to your skin If the problem still persists 2 Make sure the connec tor cable is firmly con nected to the electrode s lead and the BST device If the problem persists 3 Contact the physician or distributor All Right Reserved LifeWave Ltd 2010 Yn On be LL Pycckn Espa ol Portugu s Italiano Deutsch NNAY Technical Specifications LifeWave BST Height 130mm 5 11 Length 256mm 10 07 Width 220mm 8 66 Weight Electrical Characteristics Maximum output current 6 5 MA rm s on 500 Ohm The complete output provides net zero DC Power source 120V 60Hz 0 2A or 230V 50Hz 0 1A model dependent Output waveform Symmetrical biphasic waveform com posed of 1 A rectangular pulse train rate 4pps pulse width 4mSec interspaced with 2 A stochastic random signal frequency spectrum from 0 to 3000 Hz 80 of power from 0 to 1300 Hz Classification Safety Class II Type BF EN60601 1 IEC 60601 1 90 A1 93 A2 95 CSA C22 2 No 60 1 1 Electrodes Physical Characteristics L x W cm in 7 5cm x 4 5cm 2 96 x 1 72 Cable length cm in 66cm 26 All Right Reserved LifeWave Ltd 2010 Symbol Description Class Il equipment Caution consult accompanying documents Type BF applied equipment according t
6. 40 UT hospital environment 60 dip in UT 60 dip in UT If the user of the LifeWave BST requires continued for 5 cycles for 5 cycles operation during power gt IEC 61000 4 11 lt 5 UT lt 5 UT mains Merrupuons tt is recommended that LifeWave BST be powered Ta 70 UT 70 UT from an uninterruptible ta power supply or battery s 30 dip in UT 30 dip in UT K for 25 cycles for 25 cycles lt 5 UT lt 5 UT S S Sa lt 5 UT lt 5 UT O gt 95 dip in UT gt 95 dip in UT an for 5s for 5s Power frequency Power frequency magnetic A fields should be at levels ra 50 60 Hz magnetic field IEC 61000 4 8 characteristic of a typical public low voltage power supply network that supplies buildings used for domestic purposes commercial or hospital environment NOTE UT is the a c main voltage prior to application of the test level All Right Reserved LifeWave Ltd 2010 i ae d M Table 4 Guidance and manufacturer s declaration electromagnetic immunity LifeWave BST The LifeWave BST is intended for use in the electromagnetic environment specified below the customer or the user of the LifeWave BST should assure that it is used in such an environment IEC 60601 Immunity Compliance toSt Test level level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the LifeWave BST including cables than th
7. The BST signal is applied to the wound by a single channel Bioelectrical generator to a pair of surface electrodes BST electrodes that are attached to the healthy skin around the wound The use of each pair of electrodes is according to the duration marked on the electrodes package LifeWave BST is a user friendly easy to operate medical device Indications for Use LifeWave BST is indicated for the treatment of chronic ulcers i e hard to heal wounds General Device Description LifeWave BST is comprised of the following components 1 BST device Bioelectrical generator a computerized system based on specially designed software which generates the treat ment signal 2 LifeWave BST electrodes Pair of disposable electrodes that deliver Bioelectrical current to the skin surrounding the wound The duration of usage of the electrodes is indicated on the elec trode s labels All Right Reserved LifeWave Ltd 2010 a2 On L Pycckn Espa ol Portugu s Italiano Deutsch nnay Aspe Contraindications Do not use LifeWave BST if You are below 18 years old You have an active pacemaker or defibrillator or any other implanted electrical device You are pregnant or nursing You have wounds on the chest or epigastric region i e middle or upper abdomen You are being treated with metal ion containing wound care products such as silver dressings There is prese
8. edge should be 1 5 2 cm away from the edge of the wound 5 Connect the electrode s connector to the connector cable Fig 8 All Right Reserved LifeWave Ltd 2010 a 5 o LS aS es Ss i i g Se m me Treatment Session The duration of the programmed treatment session is 30 minutes two to three sessions per day per wound Your physician may instruct you to perform additional sessions per wound Each session should be no more than 30 minutes with a minimum of 5 hours between sessions on the same wound Important Note For achieving best results it is important to follow the treatment regimen as instructed by your physician Start Treatment Ensure that the electrodes are firmly attached to the surrounding skin throughout treatment BST operating buttons 1 Press the green START button left button 2 Two check marks Vv will be displayed indicating that the LifeWave BST is properly connected and ready for use vv on screen indicates LifeWave BST is ready for use 3 Press the green START button left button again A 30 minute timer will appear and a countdown will begin 4 After 30 minutes the bioelectrical signal is automatically shut off and a sound beep is heard indicating the end of the session All Right Reserved LifeWave Ltd 2010 B i ee o ae OO ee lIl a oe A U m a al a On LL Pycckun Espanol Portugu s Italiano Deutsch nnay
9. e recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 17 P d 1 17 P 80MHzto 800 MHz IEC 61000 4 6 150 k Hz d 2 34 P 800 MHzto 2 5 GHz to 80 MHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Radiated RF 3 V m IEC 61000 4 3 80 MHZ to 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol n 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 from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the LifeWave BST is used exceeds the applicabl
10. e RF compliance level above the LifeWave BST should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the LifeWave BST b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 148 All Right Reserved LifeWave Ltd 2010 Ba 2 oo H h a a ad Table 6 Recommended separation distances between portable and mobile RF communications equipment and the LifeWave BST The LifeWave BST is intended for use in an electromagnetic environment in which radiated RF S disturbances are controlled The customer or the user of the LifeWave BST can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile i RF communications equipment transmitters and the LifeWave BST as recommended below according to the maximum output power of the communications equipment a O Separation distance according to frequency of transmitter z eb Rated maximum Meters m A output power of transmitter 150kHz to 80MHz to 800MHz to 2 5GHz 80MHz 800MHz oO Watts W 5 d 1 17 P d 1 17VP d 2 34 P clad N lt O O S Cc O A For transmitters rated at a maximum output power not listed above the recommended separation distance din meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating
11. he connector cable electrodes or the BST device Do not expose LifeWave BST to water You cannot use another manufacturer s cables or electrodes Do not apply LifeWave BST electrodes directly on the wound itself or to its boundaries see Paragraph Electrode connection Do not attach LifeWave BST electrodes to each other Do not fold or bend the LifeWave BST electrodes Carefully position all cables so you do not become entangled in them Ensure that you do not lie down or sit on any LifeWave BST components during treatment Operate LifeWave BST according to the conditions specified in the EMC Parameters section of this manual Do not sterilize any part of the LifeWave BST electrodes LifeWave BST connector cable or BST device damage or destruction may result Refer all service calls to your physician or distributor All Right Reserved LifeWave Ltd 2010 a2 On i LL Pycckn Espa ol Portugu s Italiano Deutsch NNAY Precautions m LifeWave BST Electrodes are disposable and intended for a single wound Each wound requires a new pair of electrodes m Inspect the wound frequently following the procedure recommend ed by your physician Contact your physician if deterioration oc curs or if you suspect a worsening of the wound condition If the wound seems to be worsening or changes colors including black yellow or green stop using the LifeWave BST and consult your p
12. hysician lf the wound is infected treat the wound according to your physician s instructions E f you have an excessive growth of scar tissue or if you are prone to form excessive growth of scar tissue at the wound area consult your physician before using the device lf you have advanced heart cardiac disease uncontrolled bleeding disorders or if you have a metallic implant consult your physician before using the device aln case of a malignancy cancer any signs of deterioration occurring faster than expected should be followed up with your physician Ensure that the BST device and connector cables underwent a Cleaning and disinfection process as described in the clean ing and disinfection section before transferring them from one wound to another if applicable LifeWave BST needs to be operated according to the EMC parameters listed in Tables 1 2 4 and 6 at the end of this manual All Right Reserved LifeWave Ltd 2010 Sa a er F a a Fig 1 BST device Fig 2 Power cable Fig 3 Connector cable Fig 4 LifeWave BST disposable electrodes and their lead Fig 7 Connection of the connector cable to the BST device Fig 8 Connection of the electrode s connector to the connector cable All Right Reserved LifeWave Ltd 2010 ee a ma ae C mm d ke _ On LL Pycckn Espa ol Portugu s Italiano Deutsch nnay
13. ight Reserved LifeWave Ltd 2010 Cleaning and Disinfecting Clean and disinfect the BST device and cables before starting the use and at completion of treatment period If you have more than one wound that needs to be treated clean and disinfect the device between sessions with separate wounds Use the following procedure to clean and disinfect the BST device and cables 1 Switch off the BST device using the power switch Fig 5 2 Disconnect the power cable Fig 2 from the wall socket and from the BST device 3 Disconnect the electrode s lead from the connector cable Fig 7 Only if this is the last session of treatment with the current electrodes the electrodes duration use is indicated on the elec trode s labels discard the electrodes with their lead 4 Use a damp soft fiber free fabric moistened with clean water to remove dirt and debris from the surface of the BST device and ca bles Do not use any plastic organic solvents nor abrasive clean ers Use with care in order to prevent water from entering the BST device 5 Dry with a separate soft cloth 6 Wipe down all surfaces of the BST device and cables with a fib er free fabric dampened with 70 alcohol or with a commercially available disinfectant wipe 7 Moisten another fiber free fabric with clean water Wipe down all surfaces and cables 8 Dry with a separate dry fiber free fabric All Right Reserved LifeWave Ltd 2010 a
14. nce of a malignancy cancer less than 10 cm distance from your wound You were diagnosed with Epilepsy or suffer from other neuroexcitatory conditions related to the nervous system f there is presence of over granulation rough tissue discontinue treatment immediately Do not use LifeWave BST on metal implant in direct proximity to the wound Side Effects In addition to LifeWave BST s therapeutic effect some side effects may occur during treatment such as light itching tingling redness or discomfort in areas where the electrodes were placed If these side effects bother you and persist for more than a few days or even if the side effects cease spontaneously or with local treatment please contact your physician Some side effects requiring medical attention may include signs of allergic reaction such as a skin rash severe itching skin blisters swelling or consistant redness If any of these reactions or side ef fects occur please contact your physician immediately All Right Reserved LifeWave Ltd 2010 Avoid cellular phones or any communications equipment when operating LifeWave BST Do not operate LifeWave BST near shortwave or microwave therapy equipment Do not simultaneously connect LifeWave BST and any other high frequency equipment to yourself Do not open the BST device an electrical shock hazard exists Do not use LifeWave BST if there are any visible signs of damage to t
15. o EN IEC A 60601 1 C CE Marking in accordance with the Medical Device 0473 Directive 93 42 EEC G CSA mark in accordance with Canadian Standards As m sociation CSA C22 2 No 607 Date of manufacture E ECZ Serial Number Authorized representative in the European Union Waste Electrical and Electronic Equipment WEEE com pliance symbol w F Catalog number Da Temperature limits r Batch number All Right Reserved LifeWave Ltd 2010 he m e w k Yn On i LL Pycckn Espa ol Portugu s Italiano Deutsch NNAY 16 LifeWave Ltd LifeWave the manufacturer of the LifeWave BST guarantees LifeWave BST Bioelectrical Signal Therapy LifeWave BST or device throughout its local distribution against defects in materials and workmanship under normal use for a period of one year from the date of purchase start of use In case of any complaint please contact your local distributor whose de tails are attached on the opposite page Copyright Copyright 2010 by LifeWave Ltd LifeWave Ltd reserves the right to make changes to its products or specifications to improve performance reliability or manufacturability Information furnished by LifeWave Ltd is believed to be accurate and reliable However LifeWave Ltd assumes no responsibility for its use All rights reserved No part of this publication may be reproduced transmitted transcribed stored in a retrieval sys
16. of the transmitter in watts W according e to the transmitter manufacturer s N LUI NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected S by absorption and reflection from structures objects and people O A A fal r Aw All Right Reserved LifeWave Ltd 2010 149 a D u Presure Ulcers Die betic Ulcers Vascular Ulcers Contact us LifeWave Ltd 9 Hashiloach Street Petach Tiqwa 49514 Israel Phone 972 3 609 5630 Fax 972 3 609 5640 support life wave com www life wave com g X Local Distributor Authorised European Repres tative Medes Ltd A 5 Beaumont gate Shenley Hill f 4 Radlett Hertfordshire WD7 7AR United Kingdom Phone 44 0 1923 859810 Fax 44 0 1245 225121 medes arazygroup com IRAN Ae LI Medical Devices P N M 0031 0 Rev 1 JUNE 2010 All Right Reserved LifeWave Ltd 2010
17. r use in the electromagnetic environment specified below the customer or the user of the LifeWave BST should assure that it is used in such an environment Immunity IEC 60601 Compliance Electromagnetic environment guidance test Test level level Electrostatic discharge ESD IEC 61000 4 2 146 6 kV 6 kV contact contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 8 kV air 8 kV air All Right Reserved LifeWave Ltd 2010 Electrical fast i a ee Table 2 Cont 2 kV for power 2 kV for power Main power quality should be that of a typical public transient burst supply lines supply lines low voltage power supply network that supplies eee buildings used for domestic n _ 1 kV for input output Not Applicable AoE T rian hl zi lines 1 kV differential 1 kV differential Main power quality should Bucs be that of a typical public c urg mode mode low voltage power supply O network that supplies nd IEC 61000 4 5 buildings used for domestic T ial 2 kV common mode 2 kV common aL E T RS a N mode Voltage dips short lt 5 UT lt 5 UT Main power quality should 2 a interruptions and gt 95 dip in UT gt 95 dip in UT ee ete na voltage variations for 0 5 cycle for 0 5 cycle network that supplies buildings used for domestic on power supply purposes commercial or a input lines 40 UT
18. tem or translated into any language or computer language in any form or by any means electronic mechanical or otherwise without prior written permission of LifeWave Ltd All Right Reserved LifeWave Ltd 2010 a EMC Parameters Guidance and manufacturer s declaration for electromagnetic compatibility EMC for the LifeWave BST according to EN 60601 1 2 2007 Guidance and Table 1 manufacturer s declaration electromagnetic emissions LifeWave BST The LifeWave BST is intended for use in the electromagnetic environment specified below the customer or the user of the LifeWave BST should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations flicker emissions IEC 61000 3 3 The LifeWave BST uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class B The LifeWave BST is suitable for use in all establishments Class A including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Complies Table 2 Guidance and manufacturer s declaration electromagnetic immunity LifeWave BST The LifeWave BST is intended fo
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