Manual THERA-Trainer balo
Contents
1. Applying the patient belt The patient belt with leg straps and bottom enlarged is available in 4 different Note Sizes Select patient belt size to fit the user s abdominal girth Bend the upper body of the user forward in his wheelchair Place base 1 bottom edge of patient belt safely between buttocks and wheelchair seat Lean the user back and close abdominal belt Make sure that user is sitting on base 1 bottom edge of patient belt If necessary put both leg straps around the user s legs and fix them on the patient belt with velcro straps Vvvv www Art no A002 565 25 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL Controlling the electric lift via control unit To lift the user P Press button Arrow down on control unit Belts move down Pull down right and left belt Close patient belt by putting buckle tongues into buckles Make sure that buckle tongues audibly click into place Make sure that base of patient belt is under the user s buttocks Press button Arrow up on control unit The electric lift slowly lifts the user To lower the user P Press button Arrow down on control unit The electric lift slowly lowers the user gt Open patient belt by pulling buckle tongues out of belt buckles gt X Press button Arrow up on control unit Belts move up gt Remove patient belt from user Controlling the electric lift via sip and puff control Pl2. Make sure that cable and circular connectors are dry for the installation Short circuit due to incorrect installation i gt Observe colour code of circular connectors Caution Installing the electric lift 12 3 3 2 Al 4 Components LJ Motor unit with belt straps LJ Main cable Q Control unit with connecting cable LJ Sip and puff hose Q SAFETY STOP button with connecting cable Installation Remove safety screws 2 Put electric lift 1 onto forearms Pull out safety catches 4 Slide electric lift the right way around onto fixture pipes 3 Make sure that safety catch audibly clicks into place Tighten safety screws is possible to adjust the height of the electric lift nn Art no A002 565 11 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL Connecting cables Material damage due to incorrect installation Make sure that circular connector is plugged in correctly when connecting cables Observe position of plug Caution P Make sure that circular connectors are secured O Oo Plug power supply cord into port 1 on motor housing Plug helix cable of control unit into yellow port on motor housing 3 and use the screw to secure it observe position of plug 5 Plug cable of SAFETY STOP button into red port on motor housing 4 and use the screw to secure it observe position of plug 5 Put the SAFETY STOP button in a place where the user
3. gt Before starting the training session make sure that transport castors with brake are locked P Observe the enclosed user manual Adjusting the table holder Note Table holder is suitable for control and display unit with 10 4 colour screen P Settable holder individually to correct tilt gt Before every training session make sure that metal support foot is in optimal training position gt Observe the enclosed user manual 23 Art no 002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL TRAINER Setting the software package Balancing individual therapy Line left right w Un General mobilisation combination l Task Collect fruits with help of weight shift Weight shift forward backward combi Starting position Parallel standing position or step position Level of difficulty can be varied with help of Line left right track width j j Begin of training In th t Line diagonal right egin of training in the center Training time 15 minutes Line diagonal left Line forward backward i gt a Jg dd X Functions Q itis possible to choose between several therapy sessions biofeedback illus trations quick start with 2 buttons is possible up to 5 training parameters per training session can be set e g coordination training time etc It is also possible to configure one s own individual training sessions from pre set modules Observe the encl
4. Before starting the training session make sure that transport castors with brake are locked Move user directly behind THERA Trainer balo in a wheelchair Secure wheelchair to prevent it from moving Put the user s feet on tread of THERA Trainer balo and secure them see 8 1 Preparation for training Position Knees in knee supports Lift the user and stand him into the training position Apply pelvic support and secure the user see 8 1 Preparation for training Vvvv www vv To lower the user Move wheelchair directly behind THERA Trainer balo P Remove pelvic support set from user gt Seat user in wheelchair Remove the user s feet from the tread of THERA Trainer balo Art no A002 565 27 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 9 4 Starting up the control and display unit The control and display unit supports goal oriented training with biofeedback illus trations Note Use control and display unit with 10 4 or 23 colour screen exclusively with soft ware package Balancing individual therapy position sensor and holder gt Switch on control and display unit gt Operate control and display unit via touch soft keys P Observe the enclosed user manual Adjusting the mobile holder Note Mobile holder is suitable for control and display unit with 23 colour screen Setmobile holder individually to correct height correct tilt correct distance
5. P Before every training make sure that safety equipment is work ing correctly gt Incase of any malfunction have the unit repaired by a trained Warning dealer SAFETY STOP button After pressing SAFETY STOP button 1 LI Electric lift of THERA Trainer balo stops To continue lifting or lowering the user P Check or eliminate danger P Unlock SAFETY STOP button P Press arrow buttons on control unit of electric lift to continue lifting or lowering the user gt Blow air into sip and puff hose of sip and puff system to continue lowering the user to a sitting position P Suck air out of sip and puff hose of sip and puff system to continue lifting the user Thermal circuit breaker Function Q protects electric lift from excess load overheating Q stops electric lift when it is constantly moving up and down When the thermal circuit breaker has tripped LJ LED on electric lift lights up red LJ The only possible action is to lower the electric lift once Q Lifting is only possible after the electric lift has cooled down approx 10 min and the LED on electric lift lights up green Art no A002 565 23 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 9 CONTROL 9 1 Control elements 1 2 1 Button Arrow up 2 Button Arrow down Note While in operation always hold the control element as shown in the picture Functions of control elements Button Arrow up _ Pre
6. Art no A002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL TRAINER 1 4 Symbols on the product User manual Observe the user manual Manufacturer Date of manufacture Market launch according to directive 93 42 EEC for medical devices Serial number Type BF medical device Disposal Do not dispose of product with the regu lar household waste Dispose of product in accordance with local regulations Protect product from humidity Maximum body weight Art no A002 565 5 Version 04 2013 THERA TRAINER V WV vvvvv V VVVVVVVVY VV v v THERA TRAINER BALO USER MANUAL SAFETY AND DANGERS Observe the user manual Use THERA Trainer balo exclusively in good and functional condition Regularly check tightness of screws Prior to the initial start up have your trained dealer doctor or therapist show you how to use the product Put THERA Trainer balo on even and slip proof floor Keep sufficient distance between THERA Trainer balo and any walls and obstacles Always wear closed shoes when training both user and assistant Always use THERA Trainer balo with knee support set and pelvic support set Before getting in make sure that all transport castors with brake are blocked Block balance function before getting in Exercise exclusively under supervision of a trained assistant Do not use THERA Trainer balo in wet humid or hot environments Have excl
7. 15 4 Electromagnetic emission Directives and manufacturer s declaration Electromagnetic emissions The electric lift is designed for operation in an electromagnetic environment as described below The customer or the user of the electric lift should make sure that the unit is used in such an environment Emission measurement Compliance Directive for electromagnetic environment HF emissions according to CISPR 11 The electric lift uses HF energy exclusively for internal functions This incurs very low HF emis sions 5 it is unlikely to interfere with any nearby electronic devices HF emissions according to CISPR 11 The electric lift is designed for use in various faci Harmonics according to IEC 61000 3 2 lities including Voltage fluctuation flicker according to Dae connected IEC 61000 3 3 to a public mains supply which also supplies residential buildings Art no A002 565 33 Version 04 2013 THERA TRAINER BALO USER MANUAL THERA TRAINER 15 5 Immunity Directives and manufacturer s declaration Immunity to electromagnetic disturbance The electric lift is designed for operation in an electromagnetic environment as described below The customer or the user of the electric lift should make sure that the unit is used in such an environment Immunity test EC 60601 test level Level of conformity Directive for electromagnetic en vironment Static discharge ESD 6 kV contact discharge 6 kV con
8. 555 WOU DDODDUOL 4 2 users weighing more than 140 kg users shorter than 120 cm with balance unit short users taller than 160 cm with balance unit short users shorter than 150 cm with balance unit long for users taller than 200 cm with balance unit long users with serious contractures users with ulcers or raw skin that would touch the unit if in doubt seek medical advice users with extreme osteoporosis users with imperfect osteogenesis Osteogenesis imperfecta users with unstable circulation e g due to being bedridden users with limited exercise tolerance of their lower extremities outdoor exercise transport e g of the user unsupervised training Misuse Do not use THERA Trainer balo in n n Q combination with other products emitting ionising radiation e g radiation therapy nuclear medicine etc rooms containing explosive substances oxygenated air the presence of flammable anaesthetics volatile solvents Art no A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER 5 SCOPE OF DELIVERY AND DESCRIPTION OF DE LIVERED EQUIPMENT The THERA Trainer balo comes with individual options This user manual describes all options available for the THERA Trainer balo Depending on the model the user manual may include options not featured by the THER A Trainer balo If the THERA Trainer balo features options not described in the user ma
9. EMISSION sa uomen dou Emm dep SORE D AEE ve RE qx E 4 RR YE dem ruEoPop vewee sede un 34 15 5 Immunity llle eee eer hes 35 15 6 Recommended protective distances between portable and mobile HF telecommunication devices and THERA Trainer balo gec24 44 4020 9n9a REETTSOITLO TUO TOL TITTTTTLTITTTTTPTTSTIT 37 16 MARRANTYSS 1 se e cees oe eee UNA eee ce 37 Art no A002 565 3 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 1 USER GUIDE User manual and product are labelled with symbols The symbols and their functions make it easier to use the product safely and efficiently 1 1 Warning notices Classification of warning notices There are different types of warning notices indicated by the following signal words depending on the type of danger Q Caution warns about the risk of material damage Q Warning warns about the risk of physical injury Q Danger warns about the risk of fatal injury Structure of warning notices Type and source of danger gt Action to avoid the danger Signal words 1 2 Notes Note Information on the efficient use of the product 1 3 Symbols in the user manual Instructions Structure of instructions gt Instruction to do something Result of the action if necessary Lists Structure of bulleted lists n List level 1 List level 2 Structure of numbered lists 1 List level 1 2 List level 1 2 1 Listlevel 2 2 2 List level 2 4
10. using a non interruptible l power system or a battery to supply 99 9u5Ip gt 95 dip the electric lift Magnetic field at sup ply frequency 50 60 Hz according to IEC 61000 4 8 34 Magnetic fields at mains frequency should correspond to the typical values for business and hospital environments NOTE Uy is the supply AC voltage before the test level is applied Art no A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER Directives and manufacturer s declaration Immunity to electromagnetic disturbance The electric lift is designed for operation in an electromagnetic environment as described below The customer or the user of the electric lift should make sure that the unit is used in such an environment Immunity test EC 60601 test level Level of conformity Directive for electromagnetic en vironment Conducted HF emissi 3 Vas Portable and mobile radio equipment ons according to 150 kHz to 80 MHz should not be used closer to the IEC 61000 4 6 electric lift including line as the pro tective distance recommended The Radiated HF emissi 3 V m equation for the transmission fre ons according to 80 MHz to 2 5 GHz quency in question is used to calcu IEC 61000 4 3 late it Recommended protective dis tance d 8 5 3 VP 1 17 NP d 8 5 3 NP 1 17 NP for 80 MHz to 800 MHz d 7 0 3 VP 2 33 NP for 800 MHz to 2 5 GHz with P as the transmitter s power rat
11. THERA TRAINER THERA TRAINER BALO 2 USER MANUAL CEN English translation of original user manual MADE IN GERMANY THERA a THERA TRAINER BALO TRAINER USER MANUAL Congratulations Opting for a THERA Trainer was a great choice This innovative movement exerciser offers top perfor mance Made in Germany This user manual will help you get to know your THERA Trainer better It will safely guide you through all functions and control options and provide you with tips and information on how to use your new exerciser best Before starting the unit for the first time please read and observe chapter 2 Safety and dangers Should you have any questions or suggestions your local specialist dealer will be happy to help Have fun and get moving with your THERA Trainer 2 Art no A002 565 Version 04 2013 THERA TRAINER THERAW USER MANUAL TRAINER 1 USER GUIDE rerin k iea ea eee eee ee ee we dac ee acd ae ee der as uw ib dee ae 4 1 1 Warning notices anaana aaae eee eee eens 4 EE c P L r R 4 1 3 Symbols in the user 0 0 0 0 hrs 4 1 4 Symbols on the product 5 Z SAFETY AND DANGERS 663 606 13978 be eee enh eee eee ween He
12. can reach it e g on the table and fasten it with velcro straps If necessary connect sip and puff hose of sip and puff control to connection nipples on motor housing 2 V Ww Ww Connecting the position sensor Material damage due to incorrect installation gt Make sure that USB cable is correctly plugged in Caution Plug USB cable of position sensor into USB interface 1 of control and display unit The USB interfaces are located on rear side or top of the control and display unit Observe the enclosed user manual gt gt gt 12 Art no A002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL TRAINER 7 3 Transport of THERA Trainer balo Risk of injury due to incorrect transport Do not use THERA Trainer balo for training in transport con dition gt Never use THERA Trainer balo to transport users Warning P Use exclusively transport castors with brake for moving the THERA Trainer balo P Before any transport make sure that THERA Trainer balo is standing on transport castors with brake balance function is locked 8 OPERATION 8 1 Preparation for training Risk of injury due to insufficient preparation Before starting any exercise make sure that balance unit is intact and working correctly gt Make sure that patient belt with leg straps and bottom enlarged is Warning intact e g no defective seams gt Make sure that patient belt wit
13. ctly secured Www v v Adjusting the quick securing system for heels gt Position the user s feet on the tread of THERA Trainer balo Adjusting the quick securing system for heels P Push down winged screw 1 on both quick securing systems for heels and turn them by 90 Remove quick securing systems for heels 2 and position them individually in the holes 3 gt P Press down winged screw in holes and turn it by 90 Before every training session check if quick securing systems for heels are correctly secured Art no A002 565 Version 04 2013 TRAINER 17 THERA Note 18 TRAINER THERA TRAINER BALO USER MANUAL Adjusting the pelvic support set Danger of injury due to faulty fuse i gt Make sure that the ball catch pin goes completely through both holes when applying the pelvic support set Warning Use THERA Trainer balo exclusively with pelvic support set The pelvic support set safely supports the user s pelvis on the sides and in the back 12 1 3 4 5 4 gt Apply the pelvic support set exclusively with the help of an assistant who is familiar with the process Applying the pelvic support set The pelvic support set is pre installed on the left hand handrail Bring the user into training position Slide pelvic support set on right hand handrail Push pelvic support set onto the user s buttocks Slide retaining ring 3 onto right hand handrail until it
14. e user s build Loosen four retaining screws 3 Allen key 5 mm on underside of table unit Keep table from dropping with the help of a second person Position table unit as required Tighten four retaining screws Vvvvv Adjusting the handrails P Make sure that handrails are easily accessible during the training session 1 2 7 Adjusting the handrails Loosen winged screw 1 on first vertical pipe Set height using marks 2 Tighten winged screw on vertical pipe Set height on second vertical pipe Make sure that height settings of left and right vertical pipe are the same Vvvvv 14 Art 002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER Adjusting the knee support set Risk of injury due to incorrectly adapted knee support Prior to every training session adapt knee support to the user s individual needs l P Adjust knee support so as to prevent overextension of joints and Warning damage to muscles tendons or ligaments Use THERA Trainer balo exclusively with knee support set Note The knee support set safely supports the user when rising standing and sitting down Adjusting the knee support set does not require any tools 12 2 1 3 4 5 3 4 5 COT L gt Position user in wheelchair in front of THERA Trainer balo Select knee support size small normal wide to fit knee width Setting the height Loosen star shaped handle 1 on fi
15. fety catch audibly clicks into place Vvvvv Applying the upper body support Straighten the user into an upright position Make sure that pelvic support set and the four retaining rings fastened tightly and without slack Secure user with upper body support Adjust cushions of upper body support with safety catches 5 6 to fit the user s needs Adapt chest belt to the user s chest circumference Secure user completely with upper body support Www vv vv Positioning arm support cushions gt If necessary put an arm support cushion for the paretic arm on the table unit P If necessary clean and disinfect arm support cushion Installing the tread extension 1 1 2 b P Hook tread extension 2 into screws 1 It is not possible to transport the THERA Trainer balo once the tread extension is installed P Transport THERA Trainer balo exclusively without tread extension Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER Installing the tread enhancement 1 2 2 1 3 3 Turn safety catch 3 to the front and pull it out Put bolts 1 of tread enhancement into holes on tread 1 Release safety catch Adapt tread enhancement e g foot fixing to fit the user s needs Observe enclosed service instructions vvYvVYY Setting balance function Before every training session gt Lift THERA Trainer balo by table unit on left and right side If itis possible t
16. h leg straps and bottom enlarged is correctly positioned and and safely connected to the buckles gt Make sure that pelvic support set is correctly fastened Disinfect THERA Trainer balo before every training see 10 Cleaning and disinfection Height markings on table unit knee supports and handrails make it easy to change Note horizontal settings Before every training session adjust settings of THERA Trainer balo to match the user s individual needs Locking transport castors with brake Prevent THERA Trainer balo from moving as follows gt X Before every training session lock all four transport castors with brake P Push down locking lever on transport castors with brake Releasing transport castors with brake To transport THERA Trainer balo Release locking lever on transport castors with brake Art no A002 565 13 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL Adjusting the table unit Note A pneumatic spring supports the height adjustment 1 2 3 Setting the height of the table unit Loosen winged screw 1 on first vertical pipe Set height using marks 2 Tighten winged screw on vertical pipe Set height on second vertical pipe Make sure that height settings of left and right vertical pipe of table unit are the same VvvvvV Setting the horizontal position of the table unit There are three possible pre set positions Set horizontal position of table unit to suit th
17. ing in Watts W according to the indications of the transmitter manuf acturer and d as the recommended protective distance in metres m An on site test should show that the field intensity of stationary radio transmitters are below the compli ance level with all frequencies Disturbances are possible in the vici nity of equipment labelled as follows e i NOTE 1 For 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not be applicable in every case Buildings objects and persons influence the propagation of electromagnetic waves by absorption and reflection An exact technical estimate of the field intensity of stationary transmitters such as base stations of mobile phones and land mobile radio devices amateur radio stat ions AM and FM radio broadcast and television stations is not possible In order to determine the electromagnetic environment with regard to stationary transmitters one should consider a survey of the location If the field intensity measured at the location where the electric lift will be used exceeds the conformity levels listed above one should observe the electric lift in order to check if it is working correctly and as intended Should any performance irregularities occur it might be neces sary to take additional measures such as modifications to the THERA Trainer balo or a change of locations In the frequency range between 150 kHz and 80 MHz the field intensity
18. it short 120 to 160 cm suitable for users with body weight L with balance unit long up to 140 kg 1 with balance unit short up to 140 kg Materials used steel stainless steel aluminium rubber plastics POM PA6 ABS PE wood 13 STANDARDS AND LAWS The THERA Trainer balo conforms to the following standards MDD 93 42 EEC Machinery directive 2006 42 EC DIN EN 60601 1 DIN EN 60601 2 DIN EN 12182 DIN EN ISO 13485 14 DISPOSAL To dispose of the THERA Trainer balo Observe country specific regulations and specifications P Dispose of metal parts as scrap metal gt Dispose of plastic parts as prescribed depending on the type of material Dispose of electric and electronic components as electronic scrap LDDCDDLDLC Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER 15 NOTES ON ELECTROMAGNETIC COMPATIBILITY 15 1 Lines line lengths and accessories The electric lift of the THERA Trainer balo is to be exclusively used with the origin al supply cable 15 2 Warning notice regarding installation The electric lift is not to be used in the immediate vicinity of or stacked with other devices If it is necessary that the device or system be used next to or in a stack with other devices one should observe the electric lift to check if the arrangement permits it to work as intended 15 3 Level of conformity The immunity level requirements of IEC 60601 are met
19. lder Replace defective fuse with new fuse siehe 12 Technical data Push fuse holder into fuse slot Close fuse slot 1 11 4 Further use The THERA Trainer balo is suitable for further use by a different customer Before every further use of the THERA Trainer balo Clean and disinfect thoroughly see 10 Cleaning and disinfection Replace all cushions velcro straps and the patient belt with leg straps and bottom enlarged Make sure that all accessories and options are at hand see delivery note Perform a safety inspection by way of a visual check or a functional check Ask the manufacturer for the service instructions for safety control Www vv Art no A002 565 31 Version 04 2013 THERA 32 TRAINER THERA TRAINER BALO USER MANUAL 12 TECHNICAL DATA THERA Trainer balo Dimensions Ixwxh Q with balance unit long 118 cm x 78 cm x 95 125 cm LJ with balance unit short 118 cm x 78 cm x 77 98 cm Weight 1 with balance unit long 77 kg 101 5 kg 1 with balance unit short 75 kg 99 5 kg Power supply for electric lift 230 V 50 60 Hz Medicaldevice ass H LY THERA Trainer balo Sound emission BEA Ambient conditions for use 5 C to 40 C 5 to 93 Rh 700 to 1 060 hPa Ambient conditions for 25 C to 70 C Transport delivery 5 to 93 Rh 700 to 1 060 hPa suitable for users with body size Q with balance unit long 150 cm to 200 cm L with balance un
20. ndicated in technical data use exclusively with accessory patient belt with leg straps and bottom enlarged use exclusively with pelvic support set Before using the electric lift check if patient belt with leg straps and bottom enlarged is correctly fastened Before using the THERA Trainer balo check if pelvic support set and knee support set are correctly fastened Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER Before every training make sure that safety equipment is working correctly Before every training make sure that balance unit is working correctly Keep animals and playing children away from THERA Trainer balo Set spring resistance of THERA Trainer balo to fit the user s activity body size and body weight 3 INTENDED USE The THERA Trainer balo is an indoor therapy device for supervised indoor use only Vwww The THERA Trainer balo helps the user to stand dynamically or maintain a vertical or nearly vertical position by Verticalisation Tone regulation Improving balance with fall prophylaxis Maintaining or prolonging the supporting leg phase Preventing muscular atrophy Strengthening existing musculature Stabilising the hip joint Improving upper body stability Activating or stabilising the circulation Activating or stabilising the metabolism Contracture prophylaxis DDD U DU DU OU DDD UC The THERA Trainer balo is a medical device The i
21. ntended use includes the treat Note ment as a medical device 3 1 Indications The THERA Trainer balo is suitable for users with congenital or acquired restric tions or loss of their ability to stand e g for stroke patients elderly patients or per sons with multiple sclerosis Parkinson s disease muscular diseases or paraplegia The THERA Trainer balo enables users to get out of their wheelchairs safely with or without help depending on the user s condition The THERA Trainer balo is suitable for users with balance or coordination pro blems while standing Minimum requirement Q the user s lower extremities are able to support his full weight To stand in the THERA Trainer balo without assistance Q The user is able to actively straighten his upper body If the user is able to control the THERA Trainer balo without assistance Q Make sure that a trained assistant supervises the training 3 2 Biocompatibility All components and options of the THERA Trainer balo the user will touch when using the unit as intended are designed to meet the biocompatibility requirements of the applicable standards P For any questions contact a trained dealer Art no A002 565 7 Version 04 2013 THERA TRAINER 4 THERA TRAINER BALO USER MANUAL FORESEEABLE MISUSE The THERA Trainer balo is not suitable for n n n 4 1 Diagnosis Monitoring Measuring Contraindications Do not use THERA Trainer balo for
22. nual an appendix will be included 5 1 Scope of delivery The delivery note contains all necessary information on the scope of delivery 5 2 Basic equipment Q Base unit Powder coated metal pipe frame Transport castors with brake blockable LJ Tread unit Metal tread with holes for variable positioning of foot fixing Wear resistant anti slip mat Forefoot securing system Balance unit Knee support set in different sizes Pelvic support set Hand arm fixing Handrail adjustable in height Table unit User manual THERA Trainer balo 5 3 Options Available options Tread extension Tread enhancement Forefoot quick securing system Quick securing system for heels Knee support lowering Knee support set in different sizes small knee width up to approx 10 cm normal knee width up to approx 12 cm wide knee width up to approx 14 cm Center cushion for pelvic support set Electric lift Main cable SAFETY STOP button Q Patient belt with leg straps and bottom enlarged in different sizes size S abdominal girth 85 106 cm size M abdominal girth 91 114 cm size L abdominal girth 104 130 cm size XL abdominal girth 117 146 cm Cushion for arm rest Upper body support Center cushion Control and display unit with 23 colour screen incl touch function in combi nation with Mobile holder for control and display unit Control and display unit with 10 4 c
23. o remove the vertical pipe from the balance unit then training with the THERA Trainer balo is not allowed gt Contact a trained dealer 1 2 3 4 5 gt Unlock release lever 1 by pulling locking ring 2 gt Set release lever to 0 1 or 2 Position O T balance function disabled 3 Position 1 T balance function enabled with limited range of movement up to 6 4 Position 2 T balance function enabled with full range of movement up to 11 5 Release locking ring gt Make sure that locking ring latches on Art no A002 565 21 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL Spring resistance settings Risk of injury due to tipping over P Set spring resistance to fit the user s activity body size and body weight Warning 3 e Unlock release lever 1 by pulling up locking ring 2 Set release lever to O 4 Release locking ring Make sure that locking ring latches on Use lever 3 on balance unit to set spring resistance Down low spring resistance Up high spring resistance Make sure that spring resistance is the same on left and right balance unit Observe spring strength Sticker for low spring resistance 5 Sticker for high spring resistance 6 Vvvvv Vv 22 Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER 8 2 Safety devices Risk of injury due to damaged safety equipment
24. olour screen incl touch function in com bination with Table holder for control and display unit Q Software package Balancing individual therapy LI Position sensor DOUC D D D D OL D LL LDLDLLDL D Art no A002 565 9 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 6 OVERVIEW 12 3 4 5 6 7 8 22 21 14 18 17 Ball catch pin Retaining ring for pelvic support set Star shaped handle for pelvic support Pelvic support set Pelvic support Electric lift Table unit Release lever for balance function Locking ring for balance function Position sensor Height adjustment for handrails Height adjustment of table unit Vertical pipe of balance unit Knee support Securing system for knee support set Height adjustment for knee support set Transport castors with brake Balance unit with settings for spring resistance Tread unit Base unit Knee support set Handrail 10 Art A002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL TRAINER 7 START UP 7 1 Unpacking Unpack THERA Trainer balo Remove THERA Trainer balo from packaging P Check THERA Trainer balo incl all accessories options for transport damage gt Check if delivery is complete P Inform supplier or forwarding agent immediately about any damage gt Make sure that voltage supply matches voltage of electric lift N 2 Installation of THERA Trainer balo
25. osed user manual Vw L DL Art no A002 565 29 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 10 CLEANING AND DISINFECTION Danger to life due to electric shock Prior to any cleaning or disinfection switch off electric lift Prior to any cleaning or disinfection unplug the power plug of the electric lift Make sure that no cleaning agent or disinfectant gets into the THERA Trainer balo If any cleaning agent or disinfectant gets into the THERA Trainer balo contact a trained dealer immediately Danger v Risk of infection due to contaminated accessories options gt Wear gloves for cleaning and disinfection Material damage due to incorrect cleaning or disinfection P Never use cleaning agents that are aggressive abrasive or caustic or contain solvents Never use cleaning agents that contain alcohol cleaning solvent or ammonia Use exclusively mild and environment friendly cleaning agents and disinfectants Use exclusively disinfectants that conform to country specific regulations Observe safety instructions by manufacturers of cleaning agents and disinfectants Caution Vv Ww wv iv Clean disinfect THERA Trainer balo as follows owitch off electric lift and pull power plug Pull power plug of control and display unit Check electronic components for damage If any damage is found do not clean but contact trained dealer Clean surface of THERA Trainer balo
26. reaches the pelvic sup port set Fix retaining ring with clamping lever Slide retaining ring 2 for left hand handrail already on left hand handrail up to pelvic support set Fix retaining ring with clamping lever ro additional safety put ball catch pins 1 on both handrails into the next free ole Make sure that the ball catch pin goes completely through both holes V vv VVVVYV The pelvic support set is perfectly secured Adjusting the width Setpelvic supports to fit the width of the user s pelvis P Loosen star shaped handle 4 on back of pelvic support Setdistance of pelvic support individually gt Tighten star shaped handle Adjusting the center cushion for pelvic support P Adjust center cushion 5 to provide additional pressure relief in the area of the lumbar spine and the coccyx Use two center cushions at most Art A002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL TRAINER Adjusting the upper body support The upper body support stabilises unstable upper bodies It is possible to stabilise Note the users unstable upper bodies to an optimum The upper body support consists of back head and underarm cushions Use upper body support exclusively in combination with pelvic support set 12 3 4 12 3 Installing the securing system P Havea trained dealer carry out the installation P Install securing system 4 on pelvic support set Installing the pel
27. rst vertical pipe Set height using marks 2 Tighten star shaped handle on vertical pipe Set height on second vertical pipe Make sure that height settings of left and right vertical pipe are the same VvvvvV Setting the depth Set depth of knee supports individually to obtain the required flexion or exten sion Pull out safety catch 3 of knee support Position knee support as required 6 pre set positions Release safety catch Make sure that safety catch audibly clicks into place Vwww w Setting the distance Set knee supports so that the distance between them corresponds to dis tance between the user s opened knees Loosen star shaped handle 5 on underside of knee support Adjust distance of knee support to fit the user s individual needs Tighten star shaped handle Make sure that distance is the same on left and right knee support Vvvvv Y Art no A002 565 15 Version 04 2013 THERA 16 THERA TRAINER BALO USER MANUAL Removing a single knee support Remove knee support before user is standing in THERA Trainer balo Pull out safety catch 3 of knee support Pull knee support out of securing system 4 Make sure that user is able to maintain upright standing position safely and without assistance Never remove both knee supports at the same time Vv Lowering the knee supports It is possible to lower the knee supports by 60 mm P Observe extra service instructions Adju
28. s ee ee eee eee 25 O 2 CCUG 2 oe tan oo ion oe ee BG oe ee o aca Pede T RR COR ee ee ee ee ee 25 9 3 Lifting and lowering without electric lift eens 28 9 4 Starting up the control and display unit ee eee 29 10 CLEANING AND DISINFECTION eee 31 11 MAINTENANCE AND REPAIR ccc hh hts 32 11 1 Replacing the balance unit 2 0 0 0 0 ee ee ees 32 11 2 Replacing the patient belt with leg straps and bottom 8 32 11 3 Replacing the fuSe 1 32 114 PUIG PIS Cg ph Son eh dURC RC Sy SUP See ge Sn ae pw eed a eS ee 392 32 12 TECHNICAL eerie sees ee eee ade ew oes 33 13 STANDARDS AND LAWS eens 33 14 DISPOSAL rau 1x3 ibus ee ea ee ee we due eae een ee ee ee ee 33 15 NOTES ON ELECTROMAGNETIC COMPATIBILITY eee 34 15 1 Lines line lengths and accessories 1 0 ee eens 34 15 2 Warning notice regarding installation eee eens 94 15 3 Level of conformity sss su casee naianei ee ee ee ee eee es 34 15 4 Electromagnetic
29. should be below 3 V m Art no A002 565 35 Version 04 2013 THERAW THERA TRAINER BALO TRAINER USER MANUAL 15 6 Recommended protective distances between portable and mobile HF telecommunication devices and THERA Trainer balo The electric lift is designed for operation in an electromagnetic environment as described below The customer or the user of the electric lift can help to prevent electromagnetic disturbances by observing the minimum distance between portable and mobile HF telecommunication devices transmitters and the electric lift as indicated below depending on the output power of the telecommunication device Power rating of transmitter Protective distance depending on transmission frequency W m p TSO KFztoBOMH2 OMe B00 MHz 0M5 ase 000 37 n7 17 The distance for any transmitters the nominal power of which is not indicated in the table above can be determined by means of the equation given P is the nominal power of the transmitter in Watts W as indicated by the transmitter manufacturer NOTE 1 An additional factor 10 3 was used for calculating the recommended protective dis tance for transmitters in the frequency range between 80 MHz and 2 5 GHz This reduces the probability of a mobile portable communication device that was brought to the patient area by mistake causing a disturbance NOTE 2 These guidelines may not be applicable in every case Buildings objects and per
30. sons influence the propagation of electromagnetic waves by absorption and reflec tion 16 WARRANTY In accordance with legal regulations the manufacturer grants a manufacturer s warranty for the THERA Trainer balo if it is handled with due care The basis is the date of delivery Within this period of time the manufacturer will replace free of charge any faulty parts of the THERA Trainer balo or repair free of charge the THERA Trainer balo in the factory or an authorised workshop Excluded from manufacturer s warranty Wear parts Opened devices Unauthorised accessories or external devices Devices repaired by persons other than trained dealers Any damage due to incorrect use LDDDCUL 36 Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER NOTES Art no A002 565 37 Version 04 2013 THERA NOTES 38 TRAINER THERA TRAINER BALO USER MANUAL Art no A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER NOTES Art no A002 565 39 Version 04 2013 MANUFACTURER THERA Trainer a trademark by medica Medizintechnik GmbH Blumenweg 8 88454 Hochdorf Germany Phone 49 7355 93 14 0 Fax 49 7355 93 14 15 E mail info thera trainer de Internet www thera trainer de Base unit A002 308 Version 04 2013 For declarations of conformity see www thera trainer de
31. ss and hold button Belts of electric lift move upward 1 gt Release button Electric lift stops lifting process Button Arrow Press and hold button Belts of electric lift move downward down 2 Release button Electric lift stops lowering process 9 2 Electric lift Danger of injury due to not using a wheelchair When lifting up or sitting the user down gt Always position wheelchair directly behind user gt Lock brakes of wheelchair Warning Note A pelvic support set for additional safety is always required when using the electric lift The electric lift permits simple and comfortable verticalisation straightening for high dependency or overweight users P Donotuse electric lift of THERA Trainer balo continuously Maximum 10 lifts within 5 minutes when loaded 24 Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER Starting up the electric lift P Plug power plug into socket outlet gt Switch on electric lift with ON OFF button gt Make sure that SAFETY STOP button is unlocked Green LED is on P Check if SAFETY STOP button is functional Unlock SAFETY STOP button THERA Trainer balo is ready for use Applying the patient belt with leg straps and bottom enlarged Use electric lift exclusively in combination with a patient belt Note The patient belt is equipped with two removable leg straps which prevent the pati ent belt from slipping 1
32. sting the forefoot securing system The forefoot securing system secures the feet on the tread with Velcro straps 1 2 3 Ji mw m NE qa d v Pi 9 B cs e c5 es zm miim gt Find the optimal position for the user s feet on the quick securing system for heels on the tread of the THERA Trainer balo Adjusting the forefoot securing system Put screws 1 on both forefoot securing systems 2 into small holes 3 and tighten them P Secure the user s feet on treads with velcro straps X Before every training session check if forefoot securing systems are cor rectly secured Art A002 565 Version 04 2013 THERA TRAINER BALO USER MANUAL Adjusting the forefoot quick securing system The forefoot quick securing system secures the feet on the tread with Velcro straps E 12 amp M rmm EN T c Find the optimal position for the user s feet on the quick securing system for heels on the tread of the THERA Trainer balo Adjusting the forefoot quick securing system Push down winged screw 1 on both forefoot quick securing systems and turn them by 90 Remove forefoot quick securing systems 2 and position them individually in the holes 3 Press down winged screw and turn it by 90 Secure the user s feet on treads with velcro straps Before every training session check if forefoot quick securing systems are corre
33. tact discharge Floors should be wooden concrete according to IEC indirect 8 kV air discharge or ceramic tiled If the floor contains 61000 4 2 8 kV air discharge synthetic materials the relative air humidity must be at least 30 2 kV for supply lines The quality of the supply voltage 1 kV for input and out should correspond to that of a typical put lines business or hospital environment Fast transient electri cal disturbances bursts according to IEC 61000 4 4 Surges according to IEC 61000 4 5 2 kV for supply lines 1 kV for input and output lines 1 kV differential mode 1 kV differential mode The quality of the supply voltage voltage symmetrical voltage symmetrical should correspond to that of a typical 2 kV common mode 2 kV common mode business or hospital environment voltage asymmetrical voltage asymmetrical Voltage dips short 5 U for 0 5 periods lt 5 U1 for 0 5 periods The quality of the supply voltage interruptions and fluc gt 95 dip gt 95 dip should correspond to that of a typical tuations of the supply 40 U1 for 5 periods 40 96 for 5 periods business or hospital environment If voltage 60 dip 60 dip the user of the electric lift requires according to IEC 70 U for 25 periods 70 96 Uy for 25 periods continuous functioning in case of 61000 4 11 3096 dip 3096 dip power supply interruptions we lt 5 Ux for5s lt 5 U for5s recommend
34. ug provided sip and puff hose into electric lift To lift the user gt Blow air into sip and puff hose Belts move down Pull down right and left belt Close patient belt by putting buckle tongues into buckles Make sure that buckle tongues audibly click into place Make sure that base bottom edge of patient belt is under the user s but tocks Suck air out of sip and puff hose Vv vVVY The electric lift slowly lifts the user To lower the user gt Blow air into sip and puff hose The electric lift slowly lowers the user gt Open patient belt by pulling buckle tongues out of belt buckles gt Suck air out of sip and puff hose Belts move up gt Remove patient belt from user 26 Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER 9 3 Lifting and lowering without electric lift Danger of injury due to faulty fuse gt Make sure that the ball catch pin goes completely through both holes when applying the pelvic support set Danger of injury due to not using a wheelchair When lifting up or sitting the user down gt Always position wheelchair directly behind user gt Lock brakes of wheelchair If necessary lift or lower the user without the electric lift with the help of an assis Note tant who is trained for the process To lift the user gt Set height see 8 1 Preparation for training of Knee supports of table unit of handrails
35. usively trained dealers do any repair or maintenance work In case of damage malfunctions etc of the THERA Trainer balo contact a trained dealer immediately Consult the manufacturer before any modification and modify THERA Trainer balo exclusively with the manufacturer s approval Disinfect THERA Trainer balo before every training Do not smoke while exercising Make sure that THERA Trainer balo does not get wet Do not use THERA Trainer balo to transport persons If any symptoms of illness occur during or after training seek medical advice immediately Make sure that buckle tongues audibly click into place in belt buckles Make sure that SAFETY STOP button is easily accessible for user and trained assistant at all times When laying cables make sure that the user s movements are not limited the movements of the THERA Trainer balo are not limited there is no risk of persons falling over or being limited by cables Use the manufacturer s original parts exclusively Use THERA Trainer balo and battery charger exclusively with undamaged and functional cables Take care not to pinch any fingers when adjusting settings e g height of table unit on THERA Trainer balo Electric lift of THERA Trainer balo use exclusively with correctly set supply voltage do not use continuously maximum 10 lifts within 5 minutes when loaded then let it cool down for 10 minutes use exclusively with the fuses i
36. vic support set Have a trained dealer carry out the installation Remove retaining screw on left hand handrail bottom with a Phillips screw driver Remove retaining ring and pelvic support set Slide first pair of retaining rings 3 provided on both handrails in front of the pelvic support set Slide pelvic support set the right way around onto handrails Slide second pair of retaining rings 2 on handrails Screw retaining screw into left hand handrail and tighten Vvvv vv vv Securing the user Loosen second pair of retaining rings 2 and remove retaining ring from right hand handrail Pull pelvic support set off right hand handrail and fold it down on left hand handrail Position user in front of THERA Trainer balo Use table unit to support the user s upper body have a second assistant sup port the upper body if necessary Put a cushion under the upper body if necessary Install the pelvic support set For additional safety put ball catch pins 1 on both handrails into the next free hole When user is secured with pelvic support set push upper body support into securing system V vvv vv v Nw Art no A002 565 19 Version 04 2013 THERA Note 20 THERA TRAINER BALO USER MANUAL Pushing the upper body support into the securing system Pull out safety catch 7 on securing system Push upper body support into securing system Set height as required Release safety catch Make sure that sa
37. wee oo ewes G 6 3 AINTENDED USE os eee ees EM ee ee eee eee tees 7 Sl WICICQUONS eee ha oe ees T OM ME vorne m T 4 FORESEEABLE MISUSE 4 dx RR Rd d ACRI UE RAD RES o Rex CU eR RR a RC RC e RC 7 4 1 Contraindications x uu 9 0 4 083 RU tou 0 m EE ode o 0 pif 0 ERE QR RR eC 8 4 2 MISUSE auci Eo 3 e dt QR dE c id de oe a a o I c e UE Ge edo Od deo a 8 5 SCOPE DELIVERY AND DESCRIPTION OF DE LIVERED EQUIPMENT 9 5 SCOPS Ol L 9 5 2 Basic equipment 2 0 ee ee eee eee 9 D 9 OPIO peor se PX EAE eee EE peed REPRISE UE ERE PPS Ed B acer ote obese 9 o a E EP UE EE Ra ace byes Rc dE UE RR 10 T 1n Tm 11 TN NPAC uer urscsetceREPAPESPS e Rage ESE EN STEERPIATRSSSESTENU MESS HERES RENE 11 7 2 Installation of THERA Trainer 8 s 11 7 3 Transport of THERA Trainer 8 ee 13 o OPERATION 2m cae dba we bee eet 9E CRX CREE UR eee ee ea eee RUP E MC ens 14 8 1 Preparation for training 0 0 0 ee eee ee eens 14 9 2 Sally dacudimdntdgeuewe cae our ks serrer err RDOTSREq OPE ESEGe PEE ES Oud 24 9 CONTRO eee end ee eae EE eae ed m eR aba RE NUS bees s eee 25 9 1 Control element
38. with a soft damp cloth Clean foils and stickers with care To clean surfaces of THERA Trainer balo use exclusively disinfectants approved in accordance with country specific directives Allow THERA Trainer balo to dry V VVV VVYV Disinfecting the sip and puff hose P Put sip and puff hose into a disinfectant solution suitable for medical instru ments Disinfect sip and puff hose before every use Replace sip and puff hose if damaged Replace sip and puff hose after 30 disinfections at the lastest www 30 Art A002 565 Version 04 2013 THERA TRAINER BALO THERAW USER MANUAL TRAINER 11 MAINTENANCE AND REPAIR 11 1 Replacing the balance unit According to the manufacturer s specifications the balance unit of the Note THERA Trainer balo must be replaced after five years 11 2 Replacing the patient belt with leg straps and bottom enlarged According to the manufacturer s specifications the patient belt with leg straps and Note bottom enlarged on the THERA Trainer balo must be replaced after 5 years 11 3 Replacing the fuse 1 1 Fuse slot Material damage due to incorrect fuse d Use exclusively fuses recommended by the manufacturer siehe 12 Technical data Caution Fuse used Fuse type Q 2x 2A slow acting highbreak e g Littelfuse series 215 002P Replace fuse as follows Make sure that electric lift is without power Open fuse slot on motor housing 1 Pull out fuse ho
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