User manual EN - The Medcom Group, Ltd.
Contents
1. Check if the remote control is well connected Replace the fuse s 36 of the connector with fuses of the same type and calibre 2 fuses T 750 mA 250V 6 3 x 32 KINETEC order 4610007434 If the display still does not indicate any information contact your nearest KINETEC technician e Your device KINETEC Breva does not work and the display indicates 0 STOP 25 25 press START again If your KINETEC machine still does not work contact your nearest KINETEC technician e Your device KINETEC Breva does not work and the display indicates SERVICE D1 angle measurement function failure or SERVICE D2 no movement or SERVICE D3 abnormal electrical consumption by motor or PUSH STOP START power failure or disconnected motor switch the machine off then on contact your nearest KINETEC technician if the same message is displayed 14 3 Cleaning Before carrying out any cleaning operation SWITCH OFF the unit and disconnect the power supply In order to ensure optimal hygiene you are advised to clean the machine for each new patient Cleaning should be carried out in the environmental conditions specified in the Technical Specifications section below Use a DISINFECTANT product alcohol free or lt 5 alcohol solution in spray In order to ensure optimal hygiene you are advised to clean the covers for each new patient All the consumables enable hazard free disposal 14 4 Disposal and recycling a Packaging2. Unpacking and packing Unpacking When you unpack the machine don t forget that you may need to pack it up again We recommend that you keep the packaging materials boxes and plastic bags Recommendations for plastic bags do not put them over the head as there is a risk of suffocation and keep them out of the reach of children Be careful with small sized pieces they could be swallowed by a child Be careful with cables and wires risk of strangulation Your machine is ready to be connected to the power supply See page 4 Packing To prevent any problems when the machine is transported only pack it using its original packaging Stop the motor at 0 Remove all accessories from the machine Set the leg extension to its minimum length Fold up the central bar and tighten the fastening knob Place the machine s base in the bottom box step 5 Place the straps in the free space step 4 Place the second box containing the unit s other accessories 8 Installing the device The device KINETEC Breva machine is designed to be used in hospitals clinics doctors offices or in private homes rental The Breva machine can be used with a physiotherapy table a healthcare bed a bed or a chair The machine must be installed on a flat surface that is wide enough to accommodate the entire device plus the other leg If a chair is used we recommend checking whether the floor is slippery in order to e
3. only be modified while the unit is stopped Pauses and ByPass mode are not available during warm up cycles The Warm Up cycles are only performed when the movement is first started To start a new Warm Up session press the Warm Up key twice The calculation mode used enables the pre set ROM to be reached in approximately seven full cycles Example For a Warm Up treatment with a pre set ROM from 40 to 30 The first cycle starts at 32 plantar to 22 dorsal increasing 5 of the range each cycle 30 A on Oo oO E E g pe D aS 3 8 3s 3s oe a te te te z N ce S LS LS LS E a ad 4 4 L S 5 N oO le gt oo a u Lo 3 S S S S ra E gt gt gt gt gt gt g o oO O 6 O oO 6 2 3 2 E 40 Breva ES 12 20 11 13 To define the patient tolerance At the start of a session E Mod This function MODULATION MODE allows the maximum limits that a patient can tolerate to be defined and recorded at the beginning of a session Set up the patient and proceed as below KINETEC BREVA V01 0 PL FLEX DOR FLEX Please wait PL FLEX DOR FLEX 20 STOP 18 20 EV RIGHT INV Beginning Switch the unit ON To select the desired movement ire LORS RIRE Rae Ue aa lt a PL FLEX DOR FLEX i PLIDOR 20
4. 20 PL 5 O PL FLEX PL FLEX 20 DOR 5 0 PL FLEX DOR FLEX 20 DOR 5 15 The value blinks The new value blinks To confirm the new value press another key PL FLEX DOR FLEX SPEED 2 or wait more than 3 seconds for automatic confirmation PL FLEX DOR FLEX FORCE ___ PL FLEX DOR FLEX Timer disable key to change if necessary While the value blinks press the or Or To display the pause at the movement s upper or lower limit PL FLEX DOR FLEX PAUSE DOR OS PL FLEX DOR FLEX PAUSE PL OS or lower limit Successive presses on this key selects the pause at the movement s upper To change the pause if necessary PL FLEX DOR FLEX PAUSE PL 15S The new pause value blinks To confirm the new value press another key or wait more than 3 seconds The display shows the selected mode PL FLEX PL FLEX 20 STOP 5 15 The unit is ready to start with the new parameters Comments The values in the display column are given as an example Breva 8 20 11 9 PROGRAM MODE To enter a program Program EE To switch off the unit Press the 2 keys at the same time and switch the unit ON Then KINETEC BREVA V01 0 Program 1 EMPTY Welcome text displayed for 3 seconds The program number blinks To change the program if necessary Program 10 EMPTY The new program number blinks To choose the movement RIGHT PROG No 10 10 INV EVE 10 LEFT PRO
5. Before using this machine always check that the machine is not damaged in particular the protective housings In case of electromagnetic interference with other devices move the device Please do not touch the fixed or moving parts while the unit is running pinching or crushing risk Keep children and pets away from the machine Modifying the machine in any way is strictly forbidden Always check the motion parameters displayed on the hand control before starting the device Only the accessories spare parts and supplies described in this manual should be used with this machine Do not connect the device to other devices not described in this manual If unforeseen events or malfunctions occur please contact your KINETEC distributor Wireless communications devices such as domestic wireless devices in networks mobile phones wireless telephones and their base stations and walkie talkies may affect the machine You are recommended to keep at least a distance d between these devices and the machine See the table on page 20 The device KINETEC Breva complies with the standards of Directive 93 42 EEC and bears the EC mark The device KINETEC Breva complies with the standards in force IEC 60601 1 2 concerning the electromagnetic compatibility of medical devices and IEC 60601 1 concerning electrical safety The device KINETEC Breva meets the requirements of the Machinery Directive No 2006 42 EC Breva ES 3 20 7
6. Breva Before use please read this document EN User manual Kinetec reserves the right to effect technical modifications S rie 1 2 3 467896290 07 2014 C Notice Originale 0459 Distributed by Manufactured by kinet kinet A Kinetec SAS Kinetec USA us Zone Industrielle de Tournes W225N16708 Cedar Park Ct Rue Maurice P rin Jackson WI 53037 F 08090 Tournes USA France 262 677 1248 33 0 3 24 29 85 05 262 677 1314 33 0 3 24 33 51 05 2 contact kinetecusa com Pas contact kinetec fr www kinetecusa com www kinetec fr Contents Page 1 Definition shine M nt ERA nr de et sde ee Ted ee 2 2 UOC OI EEEE EEE E E EE EE EE EEE 2 3 fiae BE NEERA AREE N T ATE E AE AEE RA 2 4 EAEE NE EETA EE 2 5 Warming and safety INSUTI reena E EE 3 6 COMPIIARER Er eee eee 3 rA Unbpacking and B kKINdi snai hierbei rends Ah Re dl dde red h bete P ads de 4 8 Eee The CEVIC Cacia cette RAM A NN ane 4 9 De SCIIDNON nies cane daeadengdadsdada dada dedadadedodadadedadadadedaahdadodadadad 5 10 EIEEINGAlCONNESCHONZSCFETY frs tisse ini init un 6 Tle JUSInO Te AGM COMMON ses RE ARR ER ARR ee ere ee eee Geena ee ne 6 AS STGMTIMGOSTAS WIT s Mas na een tent a st en 6 11 2 Changing the display lOnGuage n scancaceuacadasanacadasacacanacan 6 11 3 START STOP REVERSE TUNGO Moaea a E R 7 11 4 Procedure to stop the machine 7 11 5 Locking Unlocking the hand control setting 7 11 6 Possible values f
7. EN 7 20 11 7 Quick Start Set up the patient and proceed as below a PL FLEX DOR FLEX Switch the unit ON 20 STOP O 20 The display indicates the last movement selected Eversion Inversion To select the Inversion Eversion movement INVERSION EVERS RIGHT LEFT EV RIGHT INV 10 STOP O 10 INV LEFT EV 10 STOP O 10 The display shows the movement selected and then the key to select the foot for right or for left To select the Plantar Flexion Dorsiflexion movement To start the session with the original parameters for the movement default setting To stop the unit PL FLEX PL FLEX 20 STOP O O0 PL FLEX PL FLEX 20 RUN 3 0 PL FLEX PL FLEX 20 STOP 5 0 The display shows the movement selected with the default settings locked See page 7 The angle display changes with the current movement Check that the hand control is not Eversion Inversion To select the Inversion Eversion movement INVERSION EVERS RIGHT LEFT EV RIGHT INV 10 STOP 5 10 INV LEFT EV 10 STOP 5 10 the foot for right or for left The display shows the movement selected and then the key to select To select the Plantar Flexion Dorsiflexion movement PL FLEX PL FLEX 20 STOP 5 0 The display shows the movement selected with the default settings To display the limit for the movement To change the limit if necessary PL FLEX PL FLEX
8. G WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING The machine must be installed and commissioned according to the information provided in this manual If you need any assistance in the assembly use or maintenance of the device please contact your Kinetec distributor The practitioner determines the protocol and ensures its proper implementation settings session duration and frequency of use Run a cycle with the device unloaded before installing the patient on the machine For optimum safety always give the hand control to the patient before starting the system The patient must know the start stop reverse function on the hand control see page 7 To avoid the parameters being changed lock the machine s hand control before giving it to the patient see page 7 Danger risk of explosion Do not use the machine with anaesthetic gas or in an environment that is rich in oxygen For Type B Class devices and to avoid all risks of electric shock the machine should only be connected to a power supply that has protective earthing see page Before using this machine always check that the electrical socket is in good condition and is suitable for the splint power supply cord Only use the original cable supplied with the machine Check that the cables remain free around the device so that they do not get damaged
9. G No 10 10 INV EVE 10 Program 10 20 PL DOR 0 The display indicates the movement After selecting the movement press the Warm Up key to confirm Warm Up To display the extension or flexion limit of the movement Program 10 20 PL DOR 0 Program 10 20 PL DOR 0 The value blinks To change the limit if necessary To confirm the new value press another key or wait more than 3 seconds Program 10 20 PL DOR 20 Program 10 Speed 1 Program 10 Force Program 10 Timer disable Program 10 Pause PL Os The new value blinks While the value blinks press the or key to change if necessary To record program 10 program Program 10 Save clear A Program 10 Program 10 has been recorded and Then Saving the display indicates the next P 11 program so you can change another rogram program EMPTY Program 10 OR CLEARING Program 10 has been removed and To cancel the program Z Program 11 EMPTY the display indicates the next program so you can change another program To exit program mode switch the unit OFF and switch back ON KINETEC BREVA VO1 0 To use the modified program see page 10 Comments The values in the display column are given as an example Breva 9 20 PROGRAM Comments EMPTY e When a program has been deleted the display shows Program table Jowl JOWI sned ywl 19m0 JO SNOd s
10. Indications Passive mobilization of the following fractures after osteosynthesis Malleolar fractures Tibial pilon fractures Talar fractures Calcaneal fractures Mobilisation of the joints of the foot after operative or other treatment of lesions of the Achilles tendon Lateral collateral ligament Medial collateral ligament Surgical lengthening of the Achilles tendon for post traumatic stiffness 3 Clinical Benefits Effectively breaks the vicious circle of trauma gt immobility gt effusion gt atrophy Improves the nutrition of joint surfaces Speeds the recovery of post operative range of motion Stimulates the venous circulation of the lower leg Speedy recovery of the motor pattern for the limb operated on Promotes joint cartilage healing Prevents venous thrombosis Provides immediate post operative continuous passive motion Reduces hospitalization time Reduces the need for pain medication Visual feedback for users Realization of postures resting stretching muscles 4 Contraindications Rheumatoid arthritis in the inflammatory phase algodystrophy in the inflammatory phase hyper painful para osteo arthroplasty unhealed infected wounds bone cancer infectious arthritis deformed joint surfaces paralysed limbs atonic or spastic non stabilised fractures Breva EN 2 20 5 Warning and safety instructions BE 6 Compliance WARNING WARNING WARNING WARNIN
11. N OFF switch 11 see page 6 11 5 Locking Unlocking the hand control setting The hand control allows the patient to control the machine as appropriate Simultaneously press the A and Z keys to lock the hand control The display reads LOCK you cannot change the parameters if you try the message LOCK will be displayed To unlock the hand control simultaneously press the A and Z keys the display reads UNLOCK We recommend that you lock the hand control when you give it to the patient Note hand control locking is preserved when you switch the unit ON OFF 11 6 Possible values for each parameter Possible values Default setting Plantar Flexion Dorsiflexion Inversion Eversion Plantar Flexion Dorsiflexion Inversion Eversion 25 inversion to 20 eversion right foot Plantar Flexion 40 10 Inversion or Eversion e i j ji rower innit Dorsiflexion 25 25 eversion to Flanigenaxien 20 depending on the foot 20 inversion left foot 20 inversion to Upper limit Plantar Flexion 35 25 eversion right foot Dorsiflexion 0 10 Eversion or Inversion PP Dorsiflexion 30 20 eversion to depending on the foot 25 inversion left foot Speed 1 to 5 from 50 to 150 per minute 2 e Force 1 to e Extension pause 0 to 900 seconds 15 minutes e Flexion pause 0 to 900 seconds 15 minutes e Timer No timer 00H00 to 24H00 Breva
12. RVICE TIME Mx when the system is switched on Despite this indication you can continue to use your machine by pressing START but you should contact your nearest KINETEC technician to have the maintenance operations carried out as soon as possible An after sales service inspection sheet and the technical catalogue are available on request from your KINETEC distributor WARNING Before using this machine always check that the electrical socket is in good condition and is suitable for the splint power supply cord Only use the original cable supplied with the machine Check that the cables remain free around the device so that they do not get damaged WARNING Before using this machine always check that the machine is not damaged in particular the protective housings When the machine is no longer in working condition please return it to us together with its accessories for destruction A motor running time counter is available by simultaneously pressing keys and limit limit the displays shows RESET TIME 215H this is an example This counter can be reset by pressing the key r 14 2 Troubleshooting guide A spare parts list and technical catalogue are available on request from your KINETEC distributor If after connecting the power supply cable to the power supply and switching on the machine e The display does not indicate any information Check that the electrical socket is live using another device or voltmeter
13. STOP 18 20 o select use or he display indicates the keys used to MODULATION MODE 20 STOP 18 20 Plett o message is Mod Ao Z MODUL use or he unit begins to move as selected 20 MANUAL 28 28 he settings are controlled by you o select the pain level key for flexion key for extension Continuous press OR MODUL use or he new limit of the movement is limit 20 MANUAL 28 28 recorded o set the pain level when reached limit o start the session with the new movement start PL FLEX DO R FLEX he angle display changes with the imits 20 RUN 15 28 current movement Note when the movement s max limit is reached the max angle is automatically recorded and the function is exited 11 14 To define the patient tolerance During the session R O M By Pass This function BYPASS MODE allows the maximum limits that a patient can tolerate to be defined and recorded which allows you to work on increasing amplitude IMPORTANT this function can be only used when the machine is running but not during Warm Up cycles a PL FLEX DOR FLEX Check that the hand control is not he unit is running 20 RUN 15 28 locked See page 7 EN BYPASS USE or he display indicates the keys used to n run the machine This message is BYPASS MODE RIM 20 RUN 20 28 displayed 3 seconas 6 select ine NEW Dan level Ao Z BYPASS USE or he unit begins to move as selected Pp 20BYPASS 30 28 he settings are controll
14. The packaging must be separated into plastic and paper cardboard components and taken to special recycling sites b Kinetec patient pad kit Clean with a disinfectant product then take it to special recycling sites c Unit It contains electronic components cables aluminium steel and plastic parts When the machine is no longer operational disassemble it separate it into different types of material and take these to authorised recycling centres or return the machine to Kinetec for destruction Or contact the local authorities to determine the appropriate method of disposal for parts and accessories that are potentially hazardous to the environment Breva EN 17 20 14 5 Technical specifications Product Lifespan of the machine 12 years Weight 10 9 kg 24 pounds Splint dimensions 56cm 22in x 37cm 14 5in x 45cm 17in Angular limits see page 7 Speeds from 50 to 150 per minute Foot sizes from 19cm 7 5in to 29cm 11 4in Maximum weight of the user 135 kg 297 pounds Acoustic pressure lt 70dB Electricity Power supply 100 240V Frequency 50 60 Hz Power consumption 50 VA Class Device of Type BF Class Il or Type B Class Protection classification IP 20 Protected against solid objects greater than 12 5mm but not protected against liquids Fuse T 750mA 250V 6 3 x 32mm Kinetec order 4610007434 Environment Storage transport conditions Temperature 25 to 70 C 13 to 158 F Rela
15. alf support position 1 with the knobs 2 and 4 The calf support slope is free The knob 31 allows the depth of the foot to be adjusted e Select the Extension Flexion movement or select a program see page 11 Breva EN 15 20 13 2 Eversion Inversion Eversion Inversion The device KINETEC Breva provides movements from 25 of abduction to 25 of adduction with a Valgus Varus component G Loosen the button 4 Position the Extension Flexion footplate as shown A label Position the motor as shown above indicates which footplate is to be used Tighten the button 4 The green indicator 32 shows when it is in the correct position Position the synchronization bar 33 in its guide 34 and tighten the knob 35 Setting up the patient Adjust the slope of the splint with the button 7 in either the sitting or lying down position Adjust the calf support position 1 with the knobs 2 and 4 The calf support slope is free Select the Eversion Inversion movement Press and set the movement parameters see page 8 Inversion or select a program see page 11 Breva EN 16 20 14 Product information 14 1 Maintenance After 2 000 hours of operation or once a year the device KINETEC Breva requires lubrication and maintenance operations lubrication of the joints and pointer stops The need for maintenance is indicated by display of the message SE
16. an environment The device KINETEC Breva 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 The device KINETEC Breva 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 ESD Immunity test vies Compliance level Electromagnetic environment Guidance 2 kV 4 kV 6 kV 2 KV 4 kV 6 kV Electrostatic discharge contact contact Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity 0 5 KV 1 kV 2 kV between line and earth between line and earth IEC 61000 4 2 2 kV 4 kV 8 kV 2 KV 4 kV 8 kV should be at least 30 air air nee fast transient 2 kV 2 kV Mains power quality should be that of a typical IEC 61000 4 4 for power supply lines for power supply lines commercial or hospital environment 0 5 KV 1 kV He ETEY Benween lines between lines Surge Mains power quality should be that of a typical IEC 61000 4 5 0 5 kV 1 kV 2KkV commercial or hospital environment Voltage interruptions lt 5 Ur gt 95 dip in Ur lt 5 Ur gt 95 dip in Ur When the interruption occurs the device KINETEC Breva for 25 cycles for 25 cycles IEC 61000 4 11 forb se
17. conds for sseconds is reset After turning on push START to begin the session lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur ee FOEYES Mains power quality should be that of a typical 40 Ur 40 Ur commercial or hospital environment If the user of the Voltage dips 60 dip in Ur 60 dip in Ur device KINETEC Breva requires continued operation IEC 61000 4 11 for 5 cycles for 5 cycles during power supply interruptions we recommend powering the device KINETEC Breva using an 70 Ur 70 Ur uninterruptible power supply or a battery 30 dip in Ur 30 dip in Ur Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the AC mains voltage prior to application of the test level Breva 19 20 Guidance and manufacturer s declaration Electromagnetic immunity The device KINETEC Breva is intended for use in the electromagnetic environment specified below The customer or the user of the Immunity test device KINETEC Breva should ensure that i Test level according to Compliance is used in such an environment Electromagnetic environment IEC 60601 level Guidance Mobile and portable RF communication devices should not be used closer to any part of the device KINETEC Breva machine including its cables than th
18. ction by structures objects and people tted power is not given above the recommended separation distance d in metres m can e to the emitter frequency where P is the emitter s maximum emission power characteristic in At 80 and 800 MHz the separation distance for the highest frequency range is applicable These directives cannot be applied in every situation Electromagnetic propagation is affected by absorption and Breva 20 20 Distributed by kinetec USA Kinetec USA W225N16708 Cedar Park Ct Jackson WI 53037 USA N 262 677 1248 L 262 677 1314 Z contact kinetecusa com www kinetecusa com Manufactured by kinetec Kinetec SAS Zone Industrielle de Tournes Rue Maurice P rin F 08090 Tournes France 33 0 3 24 29 85 05 33 0 3 24 33 51 05 Z contact kinetec fr www kinetec fr
19. d value D Displays the speed value After 5 seconds or after pressing on another PL FLEX PL FLEX key 20 STOP 10 0 PL FLEX PL FLEX The current parameters are those To exit and confirm the selected program 20 STOP 10 0 recorded in program 10 To start ne uni o B lll Comments e The values shown in the Display column are examples They actually depend on the stored programs The current movement parameters can be changed while using that program but no data will be stored in the original program See programming mode page 9 to modify programs Breva EN 11 20 11 12 Touse the WARM UP key Wam Up EE PL FLEX DOR FLEX Check that the hand control is not To stop the unit 20 STOP 10 5 locked See page 7 To select the PL FLEX DOR FLEX Plantar Flexion Dorsiflexion movement 20 STOP 10 5 PL DOR FLX W UP 20 STOP 10 5 To select Warm Up mode OR To select the INVERSION EVERS To set movement values see page 8 Inversion Eversion movement Eversion RIGHT LEFT Inversion EV Right INV 10 STOP 10 10 To select the right or left foot To select Warm Up mode EV WUP RIGHT INV 10 STOP 10 10 EV WUP RIGHT INV The angle display changes with the 10 RUN 10 10 current movement To start the movement Warm Up rules The device KINETEC Breva starts at 70 of the full ROM increasing 5 of the range each full cycle until the pre set ROM is reached Note The parameters should
20. display shows in succession KETEL Ey LZ FLEX DOR FLEX PLZ FLEX DORZ FLEX BREVA Vo LD PLEASE WAIT eG STOR 5 20 Your device KINETEC Breva is ready to be used Note The parameters from the last session are retained when the machine is switched on off except Timer and Warm Up mode Warning Always check the motion parameters displayed on the hand control before starting the device 11 2 Changing the display language E KINETEC Check that the hand control is not Switch the unit ON 40 STOP 50 110 locked See page 7 Press simultaneously on the 2 keys speed force LANGUAGE he display indicates the language ENGLISH selected he French language is selected To change the language A LANGUAGE Available languages English French Or FRENCH Germon Italian and Spanish OK o exit and confirm the new SWITCH ON OFF anguage switch OFF and Switch ON he unit To confirm the new language Breva EJ 6 20 11 3 START STOP REVERSE function As with all KINETEC systems the device KINETEC Breva is equipped with a START STOP REVERSE function Press the key of the hand control The movement stops Press the start key of the hand control The movement starts in the opposite direction CAUTION For optimum safety always give the hand control to the patient before starting the system 11 4 Procedure to stop the machine To stop the machine s movement press the key To switch the unit off press the O
21. e date of purchase by the consumer KINETEC is the only organization able to assess the application of the warranty to its systems The warranty will be considered null and void if the device has been used abnormally or under conditions of use other than those indicated in the user s manual The warranty will also be considered null and void in the event of deterioration or an accident due to negligence inappropriate surveillance or inappropriate maintenance or due to transformation of the equipment or an attempt to repair the equipment Breva EN 18 20 14 8 Guidance and manufacturer s declaration Electromagnetic emissions Guidance and manufacturer s declaration The device KINETEC Breva is intended for use in the electromagnetic environment specified below The customer or the user of the device KINETEC Breva should ensure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Radio frequency emissions CISPR 11 Group 1 61000 3 3 Radio frequency emissions CISPR 11 Class B Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations Flicker emissions IEC Complies purposes Guidance and manufacturer s declaration Electromagnetic immunity The device KINETEC Breva is intended for use in the electromagnetic environment specified below The customer or the user of the device KINETEC Breva should ensure that it is used in such
22. e recommended separation distance calculated based on the equation applicable to the emitter s frequency Recommended separation distance Conducted RF interference iori R 80 MHz SN d 1 24P IEC 61000 4 6 3 V m 3 V m d 1 24 P from 80 MHz to 800 MHz Radiated RF interference IEC 61000 4 3 from 80 MHz to 2 5 GHz d 2 34VP from 800 MHz to 2 5 GHz where P is the emitter s maximum output power characteristic in watts W according to the emitter s manufacturer and d is the recommended separation distance in metres m The field intensities of fixed RF emitters determined by an on site electromagnetic investigations should be below the compliance level in each frequency ranger There may be interference near appliances bearing the following symbol A NOTE 1 NOTE 2 by structures objects and people At 80 and 800 MHz the highest frequency range is applicable These directives cannot be applied in every situation Electromagnetic propagation is affected by absorption and reflection a The field intensity of fixed emitters such as base stations for radio telephones cellular cordless and land mobile radios amateur radio AM FM radio broadcasts and TV broadcasts cannot be predicted exactly in theory To evaluate the electromagnetic environment due to fixed RF emitters an on site electromagnetic investigation should be considered If the field intensity measured where the device KINETEC Breva machine is u
23. ed by you continuously press o set the new pain level when reached OR BYPASS USE or he mewlimitor he MovSMeEntIs 30BYPASS 30 28 recorded limit limit Continue the session with the new movement PL FLEX DO R FLEX he angle display changes with the imits 30 RUN 17 28 current movement Note when the movement s max limit is reached the max angle is automatically recorded and the function is exited Breva EN 13 20 12 Using the device KINETEC Patient Pad kit The device KINETEC Patient Pad Kit is designed for rapid fitting optimal hygiene and maximum patient comfort Please refer to the instructions below for using and positioning the straps FOR OPTIMAL HYGIENE A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT CLEANING Disinfecting the straps Wash at 30 C using a disinfectant solution during the rinse cycle Example of product that can be used Solution Bac linge at 0 125 or Souplanios at 0 125 from ANIOS Laboratories A complete list of distributors in your country is available on request Adult slipper Paediatrics slipper Breva EN 14 20 13 Possible movements Loosen the button 4 Position the Extension Flexion footplate Position the motor as shown above as shown A label indicates which Tighten the button 4 footplate is to be used Setting up the patient Adjust the slope of the splint with the button 7 in either the sitting or lying down position Adjust the c
24. ned yui 4addn jo SNDOd 99104 posds pwi 18ddn uwun HU J9MO7 ws PEE amp B edd JUSUISAOW 9L SL vi el cL LL OL Wwe 5oid Jequunu WIDIBOldg 10 20 Breva 11 10 Using Programs program The device KINETEC Breva allows you to store up to 16 programs numbered 1 to 16 including the type of movement ROM speed force pauses and timer The original parameter values of the program are empty These values can be modified and saved at any time see To enter a program page 9 T PL FLEX DOR FLEX Check that the hand control is not To stop the unit 20 STOP 5 20 locked See page 7 To access program mode program es 1 he program number blinks To change the program if necessary A or Z RE Be he new program number blinks PL FLEX PL FLEX he current parameters are those To exit and confirm the selected program start 20 STOP 5 0 recorded in program 10 a confirming the selected tee cere ee Back to the starting parameters PL FLEX PL FLEX The angle display changes with the 20 STOP 10 O current movement To start the unit 11 11 Reading the values of a program e g SPEED a PL FLEX PL FLEX Check that the hand control is not TSSOP MEU 20 STOP 10 O locked See page 7 To access program mode program res 1 The program number blinks To change the program if necessary Messner X The new program number blinks To read the spee
25. nsure that the machine does not move during the session We do not recommend using the machine with a bench We do not recommend the use of an air mattress Breva EN 4 20 9 Description The device KINETEC Breva is a portable one piece device It consists of the following components 14 Liquid crystal display 2 lines of 16 characters 15 BYPASS mode key 16 MODULATION key 17 e WARM UP key 18 Eversion Inversion key 19 e Plantar flexion dorsiflexion key 20 Upper limits setting 21 Lower limits setting 22 Increase decrease keys 23 START key 24 e STOP key 25 FORCE key 26 SPEED key 27 PAUSE key 28 TIMER key 29 e PROGRAM access key Display Details Ae 16 character line used to display various messages when starting up the machine then the type of movement during operation Be 16 character line used to display various messages when starting up the machine then it displays the operational parameters C 3 character area showing the lower limit De 4 character area showing various messages RUN STOP EXT FLEX Ee 3 character area showing the real time angle of the knee this value changes with the current movement Fe 3 character area showing the upper limit Breva 1 Calf support 2 e Calf support setting lock 3 Lower limb setting lock 4 Motor position setting lock 5 Motor 6 Foot support 7 Bed or chair position setting lock 8 Po
26. or each parameter 7 TIZ QuickSTartsrssessineninanimenenanennnenannnonetennhanniinananenene 8 11 8 To adjust the basic parameters of the movement ss 8 11 9 PROGRAM MODE To enter a Program inner 9 LIAO USNO Progra N 6m nentn ca tatatatntatotnnntatans 11 11 11 Reading the values of a program e g SPEED ee eesessesesseeteeseeeeseeseeeeeneenees 11 2 Touse the WARM UP Key iii 12 11 13 To define the patient tolerance At the start of A session 13 4 To define the patient tolerance During the SESSION es eeeeeceeeeeeseeseeeeeneeeee 13 12 Using the device KINETEC Patient Pad Kibisssmnimenaananananenannnenanedene 14 1 3 CPOSSIDIGMOVENNCIMS isa sense en O ie ce en Et 15 IS Extension Fl XOns ne Re ee ne ne ns 15 1952 1 EV SIOn INVerSION ren red Re 16 14 tProduefinormationis ssintinnan nanh dnhs hf n e did de detente 17 L413 MOINT NAONC SR AAT 17 14 2 Troubleshooting Quid c wisdededade dodadase dude dodadsdedsesdudads 17 14 3 Clg E E nn A A A 17 14 4 Disposal endrecyclIN eA AAA E AEE 17 14 5 Technical specifications iii 18 14 6 SYMbBols Used ansasinen iniii i EAEE a 18 14573 Warana aeaa ne baud ir ee a tenues 18 148 Guidance and manufacturer s declaration ss 19 Breva ET 1 20 1 Definition The device KINETEC Breva is a PASSIVE mobilisation device for the rear foot and allows the following movements Plantar Flexion Dorsiflexion Eversion Inversion 2
27. sed exceeds the aforementioned applicable RF compliance level the device KINETEC Breva machine should be monitored to check that it is working normally If abnormal results are observed additional measures may be necessary such as reorienting or repositioning the device KINETEC Breva b Over the frequency range 150 kHz to 80MHZ field intensities should be less than 3V m Recommended separation distances between mobile and portable RF communication devices and the device KINETEC Breva machine The device KINETEC Breva machine is designed to be used in an electromagnetic environment in which radiated RF interference is controlled The customer or user of the device KINETEC Breva machine can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communication devices emitters and the device KINETEC Breva machine as recommended below according to the communication device s maximum output power Maximum assigned output power for the emitter Separation distance according to the emitter s frequency m from 150 kHz to 80 MHz 80 MHz to 800 MHz from 800 MHz to 2 5 GHz di d 12VP d 12VP d 23VP 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For emitters whose assigned maximum emi be estimated using the equation applicab watts W according to the latter s manufacturer NOTE 1 NOTE 2 refle
28. sition handle 9 e Transport handle 10 e Hand control 11 ON OFF switch 12 e Motor connector 13 Hand control connector L FUEX DOR FUEX 0 RUES o 25 PUDOR Inversion FLEX Up By Pass 5 20 10 Electrical connection safety first 2 versions of electrical protection are available for the device KINETECS Breva E machine The identification label shows which version a machine is equipped With Type BF Class II devices gt for home use bear the following symbols ol Type B class devices A for use in a professional environment bear the following symbol VN See page 18 for the meaning of the symbols Before connecting the device to the power supply check that the mains voltage matches that shown on the identification plate 100 240 V 50 60Hz 11 Connect the hand control 13 and the motor 12 Connect the power supply cable 30 IMPORTANT For Type B Class devices and to avoid all risks of electric shock the machine should only be connected to a power supply that has protective earthing To connect the power supply only use the original cable supplied with the machine Check that the cables remain free around the device so that they do not get damaged Check that the machine is not damaged in particular the protective housings 11 Using the hand control 11 1 Starting the unit Press the ON OFF switch 11 The display comes on the machine carries out a self test and the
29. tive humidity up to 93 without condensation Operating conditions Temperature 5 to 40 C 41 to 104 F Relative humidity 15 to 93 without condensation Atmospheric pressure 700 hPa to 1060 hPa 14 6 Symbols used ICAUTION consult the accompanying speed Speed Flexion limit documentation O ISTOP power off timer Timer limit ih Warm up Warm Up ION power on force Force Modulation Mod Start Start movement pause Pause ByPass R O M By Pass ncrease WU Key for Plantar Flexion Dorsiflexion movement stop Stop movement program Program access D Right way up when box is stored Contains electric and electronic components do not throw away with 70 C U ac be D Decrease Eversion Inversion movement Extension limit Alternating current Fragile sa a Keep dry during storage or transport Follow the instructions for use s Follow the instructions for use household refuse Temperature Limit during storage or 2 transport HD D e TYPE BF device IRE papucs Class Il device A protection against protection against electric shocks electric shocks 14 7 Warranty The device KINETEC warranty is strictly limited to the replacement free of charge or to factory repairs of part s recognised as defective KINETEC guarantees its continuous passive motion systems for 2 years against all defects of manufacture from th
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