User manual - Rehabmart.com
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1. 0 Stop the Unit PI flex pl flex 20 stop 10 O Check if the hand control is not locked See page 5 o access the program mode program PROGRAM 1 empty The program number blinks o change the program if necessary AT PROGRAM 10 20 PL dor O To change the program if necessary To read the speed value After 5 seconds or after pressing on another key speed PROGRAM 10 Speed 1 PI flex pl flex 20 stop 10 O Displays the speed value To exit and validate the selected program PI flex pl flex 20 stop 10 O The current parameters have been recorded in program 3 Start the unit Comments PI flex pl flex 20 stop 10 O The value change atthe speed of the movement The values shown in the Display column are examples They actually depend on the stored programs e The current movement parameters can be changed while using that program but no data will be stored in the original program See the programming mode p 8 to modify programs Use of the hand control E How to use the WARM UP key wae PI fl ex DOR fl ex Check ifthe hand control is not locked 20 stop 10 5 See page 5 o stop the unit PI fl ex DOF fl ex 20 stop 10 5 o select the Extension F lexion movement PI DOR FLX WUP 20 STOP 10 5 To select the Warm Up mode Or INVERSION evers To change the movement value if To select the Inversion E version movement Right l2. 20 STOP 5 O default settings PL FLEX pl FLEX 20 PL 5 O To display the upper or lower limit of the movement The value blinks PL FLEX pl FLEX 20 Dor 5 O PL FLEX DOR FLEX To change the limit if necessary 20 Dor 5 15 The new value blinks PL FLEX DOR FLEX SPEED 2 To validate the new value press another key PL FLEX DOR FLEX While the value blinks press the or or wait more than 3 seconds Load key to change if necessary PL FLEX DOR FLEX Timer disable PL FLEX DOR FLEX Or PAUSE DOR OS Or to display pause in extension or flexion limit Successive presses on this key selects the pause at the extension or flexion limit PL FLEX DOR FLEX PAUSE PL OS PL FLEX DOR FLEX To change the pause if necessary PAUSE PL 15S The new pause value blinks To validate the new value press another key or wait more than 3 seconds The display shows the selected mode PL FLEX pl FLEX The unit is ready to start with the new 20 stop 5 15 parameters Comments The values shown in the Display column are examples Use of the hand control How to modify programs PROGRAM MODE To switch off the unit Press the two keys at the same time and switch the unit ON AT KINETEC BREVA V01 0 Welcome text during 3 seconds Then Program 1 EM PTY The program number blinks To change the program if necessary AV Program 10 EM PTY The new p
3. If floors are covered with synthetic material the relative humidity should be at least 30 IEC 61000 4 4 1 kV for input output lines 1 kV for input output lines air air 2 kV for power supply 2 kV for power supply Electrical fast transient burst lines lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 0 5 KV 1 kV differential mode 0 5 KV 1 kV 2 kV common mode 0 5 kV 1 kV differential mode 0 5 kV 1 kV 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage interruptions CEI 61000 4 11 lt 5 UT gt 95 dip in Ur for 5 seconds lt 5 UT gt 95 dip in Ur for 5 seconds At the interruption there is a reset of the KINETEC Breva After turning on check up the operating parameters then push START to begin the session Voltage dips and voltage variations on power supply input lines CEI 61000 4 11 lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ut 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ut 30 dip in Ut for 25 cycles Mains power quality should be that of a typical commercial or hospital environment Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3A m 3A m Power frequency magne
4. hand control Comments Program 11 When a program has been deleted the display shows EM PTY Program table Tiner timer Pause on lower limit pause Pause on upper limit pause Speed speed Upper limit limit Lower limit limit Moverrent type PUDOR on El Warm Up Aininilst nlotTnjoloal Q yjqgIqginils 1 4918 Progam number program Use of the hand control Using Programs program The KINETEC Breva allows you to store up to 16 programs including the type of movement ROM speed load pauses and timer The original parameter values of the program are empty These values can be modified and recorded at any time see How to enter a program page 8 0 Stop the Unit PL FLEX dor FLEX 20 STOP 5 20 Check if the hand control is not locked See page 5 0 access the program mode program PROGRAM 1 empty The program number blinks To change the program if necessary AT PROGRAM 10 20 PL dor O The new program number blinks To exit and validate the selected program start PI flex pl flex 20 stop 5 O The current parameters have been recorded in program 3 o exit without validation of selected program Start the unit Reading the values of a program example SPEED start PL FLEX dor FLEX 20 STCP 5 20 PI flex pl flex 20 stop 10 O Back to the starting parameters The value change atthe speed of the movement
5. program program see page 10 Product information Maintenance After 2 000 hours of operation KINETEC Breva requires a few lubrication and maintenance operations lubrication of the joints pointer stops and ball screws The need for maintenance is indicated by display of the message SERV MOTOR when the system is switched on Despite that warning you can continue to use your KINETEC Breva by pressing START but you should contact your nearest KINETEC technician to have the maintenance operations conducted as soon as possible A motor running time counter is available Simultaneously press keys and the displays shows RESET TIME 924H imit limit Reset imit I ow _ this counter can be resetting by pressing the key limit Cleaning Before conducting any cleaning operation SWITCH the unit OFF and disconnect the power supply Use a DISINFECTANT PROPANOL ISOPROPANOL or ALDEHYDE based solution Spray the disinfectant on the SURFACES plastic shells and metal components In order to ensure optimal hygiene you are advised to clean the covers for each new patient All the consumables enable hazard free disposal Technical specifications Product Electrical Environment ro Weight 12 5kg 27 5 Ib Power suppi 100 240 V Storage transport conditions Unitdimensions Frequency 50 60 Hz aad aie 40 to 160 F 40 to 70 C Length 56cm 22 in Power consumption 50 VA Relative hamai up to 90 width 37cm 15 5 in Device of typ
6. Before use please read this document User manual Kinetec reserves the right to effect technical modifications Cas 467896290 07 2004 Tne Your contact Page e Definition 3 Cece Me ics Melati tion d ti Bo BGA he ho Seale cate abet aA gle 2s 2 e Description tas tact weaned hence Nee Ane cee oe oe te ee ae 3 MSIE ty a es eh ta Sta centa Bie ne Bie aa meee tee Tes See 4 Electrical connection 2 8 2a 2 ey 4 tee se ee Fee ee aE tah eM ho ee Oh 4 Use of the hand control Select your language eee 5 Locking the hand control setting ____ 22222 5 START STOP REVERSE function 22 5 Quick Start U 6 Possible values for each parameter ___ 222222 6 How to adjust the basic parameters of the movement ____ 22222222L 7 How to modify programs PROGRAM MODE ____ 22 8 9 Using Programs 5 oe coc ae ee ee ee es mo 10 Reading the values of a program eee 10 How to use the WARM UP key 22 11 How to use the MOD key 22 12 How to use the R O M ByPass 2 22222 12 Use of the Kinetec Patient Pad Kit _ 222222222 13 Possible movements Extension Flexion 14 Eversion Inversion ____ 222 15 Product information Maintenance 9 ye 16 Cleaning tere ca hea Pas let Ore Ow ep de Bee rd Sete ae dana Be 16 Technical specifications ee 16 Troubleshooting 222 16 Symbols used 17 sWanantye e e eta a a e Da e E et a Pa ee E 17 Guidance and manufacturer s declaration ______ 2 222222 18 Maintenancesheet eee 19 SAFETY RECOMMENDATIONS e The ph
7. chilles tendon for post traumatic stiffness e Clinical Benefits Breaks the cycle of trauma inflammation and the loss of range of motion Prevents joint stiffness Speeds the recovery of post operative range of motion Stimulation of the venous circulation of the lower leg Maintains the quality of the joint surface Reduces pain and edema Promotes joint cartilage healing Reduces hospitalization time Reduces the need for pain medication Provides immediate post operative continuous passive motion Digital ROM readout on the patient hand control for positive reinforcement Maintains desired positions for stretching and muscular rest e Contraindications Bone Cancer Warped joint surfaces Spastic paralyses Unstable fractures Uncontrolled infection The KINETEC Breva is a portable machine single unit device that can be used in a chair or in a bed It consists of the following components 1 Calf support 2 Calf support setting lock 3 Lower limb setting lock 4 Motor position setting lock 5 e Motor 6 Foot support 7 Bed or chair position setting lock 8 Position handle 9 e Transport handle 10 Hand control 11 ON OFF switch 12 Motor connector 13 Hand control connector 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 Extension Flexion key 20 Upper limits s
8. e B class Operating conditions CE ri 17 7 in IP 20 Room temperature 50 to 105 F 10 to 40 C Angular limits see page 6 Fuse T 750mA 250V 6 3x32mm Relative humidity up to 80 Speed from 50 to 150 min KINETEC order 4610007434 Foot sizing from 19cm 7 5in to 29cm 11 4in Troubleshooting A spare parts list and technical catalog are available to you on request from your KINETEC distributor If after connecting the power supply cable to the power supply and switching on KINETEC Breva The display does not indicate any information lt a Check that the electrical socket is live using another device Check if the remote control is well connected Replace the fuse s 36 of the connector with fuses of the same type and caliber 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 Your KINETEC Breva does not work and the display indicates 50 STOP 25 115 Press START again Your KINETEC Breva still does not function Contact your nearest KINETEC technician YourKINETEC Breva does not function and the display indicates SERVICE D1 angle measurement function failure or SERVICE D2 no movement or SERVICE D3 abnormal consumption or SERVICE D4 motor connection failure Contact your nearest KINETEC technician if the same message is displayed after having witched the device off then on and started it by pr
9. eft necessary see page 7 Ev right inv To select the right or left foot y 10 stop 10 10 Ev wup right inv T tthe Warm Up mod o select the Warm Up mode 10 stop 10 10 The value change atthe speed of the Ev wup right inv 10 RUN 10 10 _ j mvement Start the movement Warm Up rules The Kinetec Breva starts at 70 of the full ROM increasing 5 of the range every other cycle until the pre set ROM is reached Comments The parameters modification should always be done while the unit is sopped Pauses and By Pass mode are not available during warm up cycles The Warm Up cycles are only working when the movementis firstly run To start new Warm Up sessions press twice the Warm Up key The calculation mode used enables reaching the pre set ROM in approximately seven full cycles Example For a Warm Up treatment with a pre set ROM from 40 to 30 The first cycle starts from 32 to 22 and increase 5 each cycle 30 S a G Ge L L x e xL axl S te te te 5 8 828 e ca 5 ru oj el Mme ory Cy 3 amp amp 2 L 2 o fe S S S S oO S re oO gt gt gt gt gt gt 2 a O O O O O O 40 Use of the hand control How to define the patient tolerance At the start of a session Mod This function MODULATION Mode is a way to set within the to
10. essing START Product information Symbols used TYPE B device PEN R protection against electric speed Speed Upper limit shocks limit Caution 3 AN consult the accompanying timer Timer Warm up documents io O STOP power off force Force t Modulation Mod ON power on pause Pause tt ByPass By Pass start Start movement A Increase Extension Flexion movement PHR Stop movement N7 Decrease Eversion Inversion movement Eversion Inversion progam Program access Lower limit m Alternative current limit Warranty The KINETEC warranty is strictly limited to the replacement free of charge or repair in the plant of the component or components found to be defective KINETEC guarantees its continuous passive motion systems for 2 years against all defects of manufacture from the 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 Product information Guidance and manufacturer s declara
11. eters of the 20 RUN lt 350 Bod movement default setting Possible values for each parameter Y Eversion Inversion He Extension Flexion Plantar Flexion 40 The value change at the speed of the movement Inversion E version Right Foot 25 to 20 daaa Dorsiflexion 25 Left Foot 25 to 20 eer pce a Speed 1 to 5 from 50 to 150 per minute Load 1 to 6 Upper Pause 0 to 900 seconds 15 minutes Lower Pause 0 to 900 seconds 15 minutes Timer No timer 00H00 to 24H00 Default setting values for each parameter Eversion Inversion Flex Extension Flexion 10 of Inversion or Eversion Inversion E version e Lower limit Plantar flexion 20 according the foot Upper limit Dorsiflexion 0 igs Raine Speed e Load e Upper Pause e Lower Pause Timer No timer 00H00 Use of the hand control How to adjust the basic parameters of the movement PL FLEX PL FLEX Check if the hand control is not locked To stop the unit 20 STO 5 O See page 5 Inver sion Evers Right Left Eversion Inversion EV RIGHT INV The display shows the movement selected and then to choose the foot side for right To select the Inversion E version movement 10 stop 5 10 or for left INV LEFT EV 10 stop 5 10 PL FLEX pl FLEX The display shows the movement with the To select the Extension Flexion movement
12. etting 21 Lower limits setting 22 Increase decrease keys 23 START key 24 STOP key 25 e FORCE key 26 SPEED key 27 PAUSE key 28 TIMER key 29 e PROGRAM access key The physician defines the protocol and ensures that it is correctly implemented adjustments session duration and frequency of use The first cycle of the movement need to be done without the patient The patient must know the start stop reverse function on the control handle Hand control must be accessible to patient at all times See page 5 KINETEC Breva complies with Directive 93 42 CEE EXPLOSION HAZARD KINETEC Breva is not designed for use in the presence of flammable anesthetics In case of electromagnetic interference with other devices move the device KINETEC Breva is in compliance with standards in force IEC 60601 1 2 2001 electromagnetic compatibility standard for medical devices Please do not touch the moving parts while the unit is running pinching risk Electrical Connection KINETEC Breva is a type B class device K Before connecting the device to the power supply check that the x mains voltage matches that shown on the identification plate 100 240 V 50 60H2 Connect the hand control 13 and the motor 12 Connect the power supply cable 30 IMPORTANT Check that the electrical socket is in good condition and is Suitable for the splint power supply cord The latter complies with current standards a
13. heck if the hand control is not blocked See page 7 To select the BYPASS mode Mod BYPASS USE or 20 RUN 20 28 The display indicates the keys used to run the machine This message is displayed 3 seconds Ao V7 To select the new discomfort level Continuous press BYPASS USE or ZOBYPASS 30 28 The unit is moving to the selected way Itis waiting for you to select new limits Or To select the new discomfort level when reached immediately press limit BYPASS USE or 3OBYPASS 30 28 The new limit of the movementis recorded Continue the session with the new movement limits PL FLEX DOR FLEX 30 RUN 17 28 The angle display changes with current movement Comment arrived at the limit max of the movement the angle max is automatically recorded and exit of the function Use of the Kinetec Patient Pad Kit The KINETEC Patient Pad Kit is designed for rapid fitting optimal hygiene and maximum patient comfort FOR OPTIMAL HYGIENE A NEW SET OF PADS SHOULD BE USED FOR EACH PATIENT CLEANING Disinfecting of the pads Washing at 30 C with use of a disinfecting solution during the rising cycle Adult slipper Pediatrics slipper Possible movements nn Extension Flexion eS PL DOR FLEX The KINETEC Breva provides a motion from 40 of plantar flexion to 30 of dorsiflexion Loosen the button 4 Position the Extension Flexion footplate as shown Position
14. lerance of a patient at the beginning of a session Setup the patient and proceed as below Switch the unit ON KINETEC BREVA V0O1 0 PL FLEX DOR FLEX PI ease wait PL FLEX DOR FLEX 20 STOP 18 20 To choose the movement EV RIGHT INV 10 SIOP 18 18 PL FLEX DOR FLEX 20 STOP 18 20 The display shows the new movement selected To select the MODULATION Mode MODUL use or 20 STOP 18 20 The display indicates the keys to be used to drive the machine this message is displayed 3 seconds o select the pain level key for flexion Key for extension Continuous press MODUL use or 20 manual 28 28 The unit is moving to the selected way Itis waiting for you to select new limits To set the pain level when reached immediately press Or limit limit MODUL use or 20 manual 28 28 The new limit of the movementis recorded To start the session with the new movement limits start PL FLEX DOR FLEX 20 RUN 15 28 The angle display changes with current movement Comment arrived at the limit max of the movement the angle max is automatically recorded and exit of the function How to define the patient tolerance During the session R O M By Pass This function The BY PASS MODE is a way to address the pain threshold of a patient during a session IMPORTANT Can be used only when the machine RUN The unit is running PL FLEX DOR FLEX 20 RUN 15 28 C
15. nd has a grounding socket The plug may be connected to any standard socket The socket must however have a grounded pin 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 Starting the unit Switch on 11 While the unit begins an auto diagnostic the display shows the following KINETEC E PL f ex dor fl ex PL f ex dor fl ex Br eva VO1 0 PI ease wait 20 STOP O 20 Your KINETEC Breva is ready to be used Comment The values of the movements are record when the machine is switched on off except Timer and Warm Up mode Use of the hand control Select your language Beginning Keys to press Display Remarks KINETEC BREVA V0O1 0 Switch the unit ON PL FLEX DOR FLEX PI ease wait PL FLEX DOR FLEX 20 STOP O 20 Press the 2 keys in the same time speed force Language The display indicate the language selected engl ish The English language is selected English To change the language A or VS Tees Ae To validate the new language To exit and confirm the new language Sw itch on of f switch OFF and Switch ON the unit limit Locking the hand control setting The hand control allows the patient to control the machine as appropriate f Simultaneously press the AAN nS keys to lock the hand control The display reads LOCK you can not change the parameters if you try
16. rogram number blinks 0 6 RIGHT PROG NR10 7 10 INV eve 1 Inversion 9 pees The display shows the new movement selected To choose the movement Y eft PROG NR1O eyed 10 INV eve 10 After the selection of the movement press the Warm Up key to validate it Program 10 PUDOR 20 pl dor O FLEX To display the extension or flexion limit of the movement limit limit Program 10 20 pl dor oO Program 10 20 pl dor oO The value blinks To change the limit of movement if necessary A J speed Program 10 20 pl dor 20 Program 10 The new value blinks Speed 1 Po Program 10 To validate the new value press another key EO gC mien While the value blinks press the or or wait more than 3 seconds key to change if necessary gt Program 10 H Timer disabl e pause Program 10 Pause pl Os To record the program 10 program Preeren a Save clear A Pr ogr am 10 Saving The program 10 has been recorded and the Then display indicates the next program so you Program 11 can change another program EM PTY V Program 10 OR C_EARING The program 10 has been cancelled and To cancel the program Program 11 the display indicates the next program so you can change another program EM PTY eae mode switch OFF and switch ON O j TE o To use the modified program see page 10 Comments e The values shown in the Display column are examples Use of the
17. the display reads LOCK To unlock the hand control simultaneously press the A nZ keys the display reads UNLOCK We recommend that you lock the hand control when you give it to the patient Comment The hand control is unlocked when you switch the unit ON OFF START STOP REVERSE function As with all KINETEC systems KINETEC Breva is equipped with a START STOP REVERSE function When the unit is running the display reads RUN Press the key of the hand control The movement stops The display reads STOP Press the key of the hand control The movement starts in the opposite direction and the display reads RUN start Caution For optimum safety always give the hand control to the patient before starting the system Use of the hand control Quick Start Setup the patient and proceed as below KINETEC BREVA V0O1 0 PL FLEX DOR FLEX PI ease wait Switch the unit ON PL FLEX DOR FLEX 20 STOP O 20 Inver sion Evers Right Left The display indicates the last movement selected EV RIGHT INV 10 stop O 10 To select the Inversion Eversion movement INV LEFT EV 10 stop O 10 PL FLEX pl FLEX To select the Extension Flexion movement 20 STCP Oo oO The display shows the movement selected and then to choose the foot side for right or for left The display shows the movement with the default settings PL FLEX RLA HEX Start the session with the original param
18. the motor as shown above The Extension F lexion Icon label indicates the correct one Tighten the button 4 Setting up the patient Adjust the slope of the splint with the button 7 choose the right position on the bed or on the chair Adjust the calf support position 1 with the Knobs 2 and 4 The calf support slope is free The knob 31 allows the adjustment of the depth of the foot eChoice of the Extension Flexion movement Press and adjust your parameters see page 7 Cw PUDOR FLEX Or selecta program program see page 10 Possible movements Eversion Inversion The KINETEC Breva provides a motion from 25 of Eversion to 25 of Inversion Loosen the button 4 Position the Eversion Inversion footplate as shown Position the motor as shown above The Eversion Inversion Icon label indicates the correct one Tighten the button 4 The correct position is indicated by the green indicator 32 Position the synchronization bar 33 in its guide 34 and tighten the knob 35 into the threaded hole on the Shaft Setting up the patient Adjust the slope of the splint with the button 7 choose the right position on the bed or on the chair Adjust the calf support position 1 with the knobs 2 and 4 The calf support slope is free eChoice of the Eversion Inversion movement x j Press and adjust your parameters see page 7 version E Inversion Or select a
19. tic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment NOTE Uris the a c mains voltage prior to application of the test level Product information Maintenance sheet Serial number Purchasing date Running time see page 16 Exchange parts Running time see page 16 Exchange parts Running time see page 16 Exchange parts
20. tion Electromagnetic emissions The KINETEC Breva is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Breva should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance Radio Frequency emissions The KINETEC Breva uses RF energy only for its internal function Therefore its CISPR 11 Group 1 RF emissions are very low and are not likely to cause any interference in nearby electronic equipment a emissions Class B p armonic emesan The KINETEC Breva is suitable for use in all establishments including domestic IEC 61000 3 2 Class A and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Voltage fluctuations Flicker emissions Complies IEC 61000 3 3 p Electromagnetic immunity The KINETEC Breva is intended for use in the electromagnetic environment specified below The customer or the user of the KINETEC Breva should assure that itis used in such an environment Immunity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 2 KV 4 KV 6 kV contact 2 KV 4 KV 8 kV 2 kV 4 kV 6 kV contact 2 KV 4 KV 8 kV Floors should be wood concrete or ceramic tile
21. ysician defines the protocol and ensures that it is correctly implemented adjustments session time and frequency of use e We recommend that you lock the hand control when you give it to the patient e For optimum safety always give the hand control to the patient before starting the system e Explosion hazard KINETEC Breva is not designed for use in the presence of flammable anesthetics e Check that the electrical socket is in good condition and is suitable for the splint power supply cord The latter complies with current standards and has a grounding socket The plug may be connected to any standard socket The socket must however have a grounded pin 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 Manuel N 467896290 Update 13 12 05 The KINETEC Breva is used in a chair or in a bed for passive mobilization of the ankle and rear foot and allows the following movements Plantar Flexion Dorsiflexion Eversion Inversion Indications Passive mobilization of the following fractures after internal fixation malleolar fractures tibial pilon fractures talar fractures calcaneal fractures Mobilisation of the joints of the foot after operative or conservative treatment of lesions of the Achilles tendon lateral collateral ligament medial collateral ligament Surgical lengthening of the A
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