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made for movement Innowalk Pro 2 User Manual Download Page 66

 

Users manual for Innowalk Pro 2 
Version: 1.06 

–

 Version date: 06.12.2023 

 

Page 

66

 of 

78

 

 

7.11 Tests and approvals  

The technology behind Innowalk is patented and has a registered trademark. 

Made for Movement Group AS declares that the product is in compliance with essential safety and 
performance requirements and other relevant provisions of the following regulations and standards: 

 

EU 2017/745 Medical Device Regulation (EU MDR) 
FOR-2005-12-15-1690 Forskrift om medisinsk utstyr 
SI 2002/618 UK Medical Device Regulation (UK MDR) 
NEK IEC 60601-1  

3.1 edition 

NEK IEC 60601-1-2   

4.1 edition 

NEK IEC 60601-1-6   

3. edition 

NEK IEC 60601-1-11    1. Edition 
NEK EN 62366 :2020   1.1 edition 
NS-EN ISO 14971 :2019 
NS-EN ISO 13485 :2016 
NS-EN 21856 :2022        
SS-EN 21856: 2022 
NS-EN 60529 :2013 
 
The product is CE and UKCA approved.   
 

  

 

 

Declaration of conformity is available upon request. 

This users manual is delivered with the product. The users manual can also be downloaded from our 
website: www.madeformovement.com  
 

  

 

7.12 Chapter not in use 

…

 

 

Summary of Contents for Innowalk Pro 2

Page 1: ...Users manual Innowalk Pro 2...

Page 2: ...he leg support 13 4 7 Transfer the user out of the Innowalk 15 5 Use 16 5 1 Remote control 16 5 2 Speed indication 19 5 3 Spasm Control 19 5 4 Front tilt 21 5 5 Emergency stop 22 5 6 Duration of use 2...

Page 3: ...Arm movement handles 55 7 8 3 Chapter not in use 56 7 8 4 Build up soles for Medium and Large 57 7 8 5 Shoulder straps 58 7 8 6 Remote control 58 7 8 7 Power cable 58 7 8 8 Transport handle 58 7 8 9 A...

Page 4: ...7 16 Indoor and outdoor transportation 69 7 17 Chapter not in use 69 7 18 Warranty 70 7 19 Separation distance 71 Appendix 1 Training of operator 73 Appendix 2 Inspection Checklist 74 Appendix 3 Meas...

Page 5: ...ight bearing for people with moderate to severe disabilities Innowalk Pro is developed to meet requirements for use in professional environments This users manual gives a detailed description on how t...

Page 6: ...Innowalk The use of the quick guide presupposes that the patient has been assessed by a clinician with medical responsibility and approved to be a candidate for using the device and the Innowalk has b...

Page 7: ...the operator 1 Belts Check that all belts and seams are intact without visible damages and Velcro locks well 2 Chest and hip support Push pull and rotate the chest and hip support in all directions Ch...

Page 8: ...erred to the Innowalk Open the chest and hip belt Swing out the chest support Rotate the swivel seat if this function is used during transfer Lay down the leg supports on the skis The leg supports can...

Page 9: ...e seat to ease the transfer from eg a wheelchair The person who assists in the transfer of the user should place his her body in a position which makes the transfer as light and as short as possible T...

Page 10: ...e security but in a loose position during raising up and lowering down the user Picture 4 Secure the user Important Support the users upper body when positioned on the seat until the chest support is...

Page 11: ...automatically when back in its starting position Pay attention to the users hands when turning the seat so the hands don t get caught under the seat as this can cause pinching to the fingers hand The...

Page 12: ...tes Make sure that the users heel is in contact with the heel cap on the foot plate Pull the straps over the feet through the roller clip and tighten securely It is important that the straps have enou...

Page 13: ...ched at the leg support hook and the other end at the pulley hook The loops on the guide straps can be used to tailor the alignment of the user in the Innowalk Which loop used is defined at first time...

Page 14: ...10 Swing out upper part the leg support Important The tension over the users knees is regulated by adjusting the length of the guide strap Note that the length of the guide strap is in accordance with...

Page 15: ...fer out Make sure the seat is in locked position before the user is transferred Always pay attention to the users legs when rotating the seat to ensure the feet move freely and are not tangled or caug...

Page 16: ...e Innowalk Pro Medium and Large uses a 8 button remote To activate the functions on the Innowalk buttons on the remote control needs to be pressed and on some buttons held down The Innowalk has no aut...

Page 17: ...sponsible person sets up the Innowalk for the user the max standing inclination the user shall be raised up to should be noted down During use the inclination must never exceed the noted level as this...

Page 18: ...tention to the user during standing up sitting down Important Never increase seat height more than what is possible and safe for the user Important Do not use a higher speed and acceleration than what...

Page 19: ...asm that exceeds the threshold set the Innowalk motor will pause When the spasm is over the Innowalk will slowly start again The adjustment is performed by turning the indicator between the values of...

Page 20: ...Users manual for Innowalk Pro 2 Version 1 06 Version date 06 12 2023 Page 20 of 78 Picture 14 Spasm control indicator...

Page 21: ...user if weak to hold the head and upper body in an upright position while in standing If desired the tilt can be lowered before the movement starts Front tilt function should not be used when the swiv...

Page 22: ...y stop switch to stop the motor and cut all power to the Innowalk To release the emergency stop switch turn the switch in the direction of the arrow until it pops out again The system will now have po...

Page 23: ...general observe reactions that might occur due to new or changed physical or physiological conditions If inappropriate alignment hyper extension of the knees or heels lifting from the foot plate Stop...

Page 24: ...left arrow the seat depth will be increased to fit larger users See illustrations for reference Adjustments shall be done primarily before the user is placed in the product Very minor adjustments can...

Page 25: ...d the descent will stop If possible we recommend two persons to operate the emergency seat lowering to minimise the risk of injuring the operator 4 Lower the seat to the lowest position 5 Release the...

Page 26: ...cement Important The transport wheels must never be used when a person is in the Innowalk Important The transport wheels must never be in contact with the floor during use Important Please be careful...

Page 27: ...ey arm moves in the direction of the seat Swivel the pulley arm so the wheel hook can be attached to the wheel pin Remove the guide strap form the hook on one side Turn the crank arm clockwise until t...

Page 28: ...that the Innowalk is standing on the rear feet before use Turn the crank armanti clockwise to raise the wheels back under the cover and the wheel pin is back to the starting position The rear feet ar...

Page 29: ...the users limitations such as range of motion in angles knees and hips and lower back upper body and or head control asymmetries amount others into consideration The following adjustments must be fitt...

Page 30: ...e performed in relation to this 6 1 Foot plates The Innowalk Pro has three different foot plates sizes the Medium foot plates is a version with shorter ranges for the leg steel than the Large foot pla...

Page 31: ...shoe bracket and slide the complete bracket with the foot plate to the desired position Use the front edge of the shoe bracket as reference point against the engraved scale Tighten the handle screw s...

Page 32: ...the users stance Loosen the two handle screws one at the front and one at the rear and adjust the sideways position of the foot plate The value of the position can be read at the front of the bracket...

Page 33: ...top can be adjusted according to each users need and each side must be adjusted separately To adjust the cam stop so the leg support moves away from the leg turn the cam stop knob clockwise Anti clock...

Page 34: ...of the leg support height Unscrew the leg support height knob approximately one turn and simply slide the upper part of the leg support to the desired position The two arms will be interlocked when t...

Page 35: ...usted so there is a 90 angle in the knee joint between the users thighs and calf when the users feet are rested at the foot plates Picture 35 Height of seat scale Important Only fine adjustment of the...

Page 36: ...seat Adjustment of the seat depth is covered in chapter 5 7 E seat 6 7 Hip support The hip support width can be changed by loosening the hip support wingnuts under the seat on both sides Adjust by sli...

Page 37: ...clamp and above the center of the knob Repeat the settings at both sides Open and close the chest support Operating the release knob with a push of the button at the top to release it this will allow...

Page 38: ...he height of the head rest can be tuned by loosening the height adjustment screws sliding the head rest bracket up down to the desired position and tightening the screws again Important The head rest...

Page 39: ...s the stretch over the users knees For larger adjustment intervals different loops in the guide straps can be used The correct loop to use is determined in the initial adjustment by the responsible cl...

Page 40: ...of the lower and upper limbs in sitting and standing position The assisted movement of the lower limbs is close to a normal gait pattern with flexion and extension of hips knees and ankle joints The...

Page 41: ...se events and negative side effects caused by the movement in the Innowalk Pro were reported in any studies There have been studies where patients did not complete the intervention period due to illne...

Page 42: ...Major deformities spine lower and upper limbs Severe or fixed contractures in the lower and upper limbs Lower limbs Hip and knee flexion contractures 40 pes equinus 25 Upper limbs not able to reach g...

Page 43: ...ve skills glasses lenses hearing aids is possible Coordinators and operators must have received training in accordance with the MFM training programme Appendix 1 from a Made for Movement representativ...

Page 44: ...o Medium Innowalk Pro Large Recommended height of the user 150 200cm Max weight of the user 110kg Picture 43 Innowalk Pro Large There are minor differences between the models The electrical system is...

Page 45: ...the user is in the Innowalk Pro even when the Tray is being used This symbol indicates where the emergency stop button is placed This symbol indicates which Innowalk Pro model the accessory belongs to...

Page 46: ...Page 46 of 78 Do not dispose in household waste Read the users manual before use Manufacturer and manufacturer address Date of manufacture Serial number Medical Device Hand wash Side panel for spasm...

Page 47: ...n 1 06 Version date 06 12 2023 Page 47 of 78 Warning Pre check on motor cover Machine sign example Packaging symbols Symbol for keep away from rain moisture water wet areas Symbol for this side up Sym...

Page 48: ...d by Made for Movement This will lead to non compliance of the certification 12 The product is a medical device and must under no circumstance be used by persons who the product is not fitted to 13 Th...

Page 49: ...Innowalk shall only be used indoor and have room temperature before being used 4 Innowalk shall while being used be placed at a flat and even surface 5 Innowalk shall not be moved while the user is i...

Page 50: ...your Made for Movement representative Additional warnings for Innowalk Pro 2 in addition to Innowalk warnings 1 Always pay attention to the users feet and hands when rotating the swivel seat Ensure th...

Page 51: ...8mm 15mm foam 15mm foam 15mm foam Back support Synthetic leather 0 8mm 15mm foam 20mm foam 20mm foam Chest support Synthetic leather 0 8mm 20mm foam 30mm foam 30mm foam Seat Synthetic leather 0 8mm 15...

Page 52: ...he Innowalk Padding straps velcro Most metal parts not covered by the motor cover The remote control and control panel buttons Stickers and labels The power unit with power cable The power unit can ge...

Page 53: ...ning the swing out knob on the tube clamp then lifting the tray tube slightly up and rotating it outwards To adjust the height of the tray loosen the height adjustment knob slide the tray up down to t...

Page 54: ...he same time Tip The tube bracket is designed to be placed on either left or right side of the column the operator may change the placement due to user preferences or space constraints For Innowalk Pr...

Page 55: ...indication indications and precautions for use of arm moving handles See chapter 7 1 Attachment and adjustment of arm moving handles To fasten the arm handles Loosen the clamps Insert the arm handles...

Page 56: ...al for Innowalk Pro 2 Version 1 06 Version date 06 12 2023 Page 56 of 78 Picture 49 Arm movement Picture 50 Adjustment knobs 7 8 3 Chapter not in use Chapter not in use Handles Clamps Adjustment knobs...

Page 57: ...of up to 2 cm or to move the foot forward at the foot plate if the user has small feet The responsible medical clinician will assess and decide on the need for build up soles for the individual user...

Page 58: ...be ordered by contacting Made for Movement Do not use the Innowalk with a broken remote control 7 8 7 Power cable If the power cable is damaged or lost a new one must be ordered by contacting Made for...

Page 59: ...and after approx 8 seconds you will hear a longer high pitch beep and you will see the seat actuator move the seat towards an upright position When the actuators reach the upright end position a confi...

Page 60: ...nnowalk Pro Medium Largest width cm 77 Length cm 170 Highest seat height cm 87 Lowest seat height cm 57 Max weight of user kg 65 Recommended height of user cm 110 165 Weight of the product kg 154 Data...

Page 61: ...ablets The Innowalk is a stand alone medical equipment ME where the attachment of phone tablet is not considered nor evaluated as part of the ME system The USB is for charging and has no other functio...

Page 62: ...tepless Deceleration 60 to 0 RPM 0 3 sec Instantly Pressing the Stop button at full speed Deceleration 60 to 10 RPM 10 sec Holding the slower button from max speed until slowest speed is reached Stepl...

Page 63: ...t off and pulling out the inlet power to the Power supply Always remember to disconnect the device after use Important Only the built in power supply can be used 7 10 3 Fuse Indicator light The Innowa...

Page 64: ...product is used under these conditions remove your hand from the buttons on the remote control plug and control panel when the operations is performed to avoid warm hands and or discomfort Do not be i...

Page 65: ...7 10 6 Motor 24V DC current supply 200W brushless servo motor 7 10 7 Motor control Brushless DC motor driver Digital speed control This is an electrostatic sensitive unit Electrical devices such as I...

Page 66: ...ice Regulation EU MDR FOR 2005 12 15 1690 Forskrift om medisinsk utstyr SI 2002 618 UK Medical Device Regulation UK MDR NEK IEC 60601 1 3 1 edition NEK IEC 60601 1 2 4 1 edition NEK IEC 60601 1 6 3 ed...

Page 67: ...ections and eventual repairs are not performed The two years warranty will also not be valid if the annual inspection and repairs are not executed Maintenance information Made for Movement develops an...

Page 68: ...mponents and print circuit boards should be delivered to an approved depot or be sent to Made for Movement Group AS Covers metal parts etc can be handled as normal waste and be recycled at an approved...

Page 69: ...owalk is to be installed in a high floor building without a lift the Innowalk can be sent out in 2 modules to ease carrying the modules to the desired floor for assembly Please contact Made for Moveme...

Page 70: ...ed by the warranty must be approved in advance by Made for Movement Warranty claims should be sent Made for Movement within reasonable time 2 months at most Claims put forward after this might lose th...

Page 71: ...mance of the communication device Please read the safe distance in the table below Rated maximum output power of transmitter Separation distance in relation to the frequency of transmitter in meter 80...

Page 72: ...e for Movement Limited 167 169 Great Portland Street Fifth Floor London W1W 5PF England United Kingdom Office 44 3301136366 Manufacturer Made for Movement Group AS Roedmyrlia 2 3735 Skien Norway Tel 4...

Page 73: ...for use Pre Check Safety features Entering and exiting the product Seat height adjustment Seat depth adjustments E seat Using and locking the swivel seat Attaching belts and leg support Adjusting hea...

Page 74: ...on 1 06 Version date 06 12 2023 Page 74 of 78 Appendix 2 Inspection Checklist Please see separate document for what to check on the inspection This shall only be performed by Made for Movement MFM it...

Page 75: ...Users manual for Innowalk Pro 2 Version 1 06 Version date 06 12 2023 Page 75 of 78 Appendix 3 Measurement Form Please see separate document for measurement forms Example below...

Page 76: ...Users manual for Innowalk Pro 2 Version 1 06 Version date 06 12 2023 Page 76 of 78...

Page 77: ...2 Version 1 06 Version date 06 12 2023 Page 77 of 78 Appendix 4 List of accessories Extra equipment Please see chapter 7 8 Extra equipment for details 1 Tray 2 Arm movement 3 Soles 4 Shoulder straps 5...

Page 78: ...ook 2 onto the locking arm 3 After hook 2 is engaged turn handle 1 clockwise to lift the rear of the product Product can now be moved Push on back column ______________________________________________...

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