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9. Identification.

9.1 EU Declaration of Conformity

EU Konformitätserklärung

EU Declaration of Conformity

Firma /

Company

Schuchmann GmbH & Co. KG

Rudolf-Runge-Str. 3 · 49143 Bissendorf · Deutschland /

Germany

Tel. +49 (0) 5402 / 40 71 00 · Fax +49 (0) 5402 / 40 71 109

erklärt in alleiniger Verantwortung, dass das nachfolgend genannte Produkt der Risikoklasse 1

declares under our sole responsibility that the following product(s) of Class 1 Medical Devices

Datei: Konformitätserklärung dynamic pacer

Stand: Rev. 4.0

Seite: 1

„

dynamic pacer. / pacer.

“

Gehtrainer

/ gaittrainer

Art.-Nr. /

Item-No.:

33 01 2xx, 33 02 2xx, 33 03 2xx, 33 04 2xx / 33 00 2xx

Basis UDI-DI /

Basic UDI-DI:

4251040200004000330XXXX9L

den einschlägigen Bestimmungen der im folgenden aufgeführten Richtlinien und Standards entspricht:

is / are in conformity with the requirements of the below listed directives and standards:

Verordnung (EU) 2017/745 über Medizinprodukte vom 05. April 2017

Regulation (EU) 2017/745 on medical devices of 5 April 2017

DIN EN 12182:2012

Technische Hilfen für behinderte Menschen

Technical aids for disabled persons

DIN EN ISO 14971:2013

Medizinprodukte - Anwendung des Risikomanagements auf
Medizinprodukte

Medical devices - Application of risk management to medical devices

DIN EN ISO 11199-3:2005

Gehhilfen für beidarmige Handhabung – Anforderung und Prüfverfahren
– Teil 3: Gehwagen

Walking aids manipulated by both arms – Requirements and test
methods – Part 3: Walking tables

Diese Konformitätserklärung gilt nur für Produkte mit den oben genannten Artikelnummern und
ist gültig bis zum 31.12.2023.

This declaration of conformity applies only for products with above-named Item-numbers
and is valid until 31.12.2023.

Datum /

Date:

01.04.2020

Unterschrift /

Sign:

Name /

Name:

Torsten Schuchmann

Funktion /

Function:

Sicherheitsbeauftragter für Medizinprodukte /

Safety officer for medical devices

Содержание rifton dynamic pacer

Страница 1: ...Instructions for use dynamic pacer The dynamic gait trainer dynamic pacer ...

Страница 2: ...s for use carefully prior to initial commissioning of the product and to observe them Please note that guidelines and representations in these Instructions for use may deviate from your product due to differing equipment We reserve the right to make technical modifica tions Important information Ensure that these Instructions for use remain with the product Your schuchmann Team ...

Страница 3: ... for basic model 08 2 5 1 pacer Size 0 mini 08 2 5 2 dynamic pacer Size 1 4 08 2 6 List of accessories 08 2 7 Product overview 09 2 7 1 pacer Size 0 mini 09 2 7 2 dynamic pacer Size 1 4 09 3 Settings 10 3 1 Top frame 10 3 1 1 Standard top frames 10 3 1 2 Dynamic top frame 11 3 2 Sub frames 12 3 2 1 Standard sub frame 12 3 2 2 Combination sub frame size 2 3 12 3 2 3 Treadmill sub frame for size 1 3...

Страница 4: ...ior gait trainer 32 5 2 As posterior gait trainer 34 6 Cleaning and maintaining 35 6 1 Cleaning and disinfecting 35 6 1 1 Cleaning 35 6 1 2 Disinfection 35 6 2 Servicing 35 6 3 Maintenance 35 6 3 1 Maintenance specifications 36 6 3 2 Maintenance plan 36 6 3 Spare parts 37 6 5 Duration of use and re use 37 7 Technical data 38 7 1 Dimensions 38 8 Guarantee 39 9 Identification 40 9 1 EU Declaration o...

Страница 5: ...reserve and protect the environment to prevent environmental pollution and to improve the recycling of raw materials please note the disposal instructions in points 1 3 1 and 1 3 2 1 3 1 Packaging The packaging of the product should be kept for any future transport that might be required Should you have to return the product for repairs or in case of a guarantee claim please if possible use the or...

Страница 6: ...o carrying 2 3 Application areas use according to the intended purpose The dynamicpacer gait trainer is a medical product of risk class 1 and is sui ted for indoor and outdoor use It supports users when learning to walk and in the event of impaired mobility Any other use or use over and above this purpose shall be considered not in accordance with the intended purpose 2 3 1 Indication The dynamic ...

Страница 7: ...re tighten the screw connections you have loosened Hanging on heavy bags or other items can negatively influence the stability For safety reasons only use accessories and spare parts by Schuch mann as the product as a whole represents a tested unit In case of combination of the gait trainer with components from other manufactu rers e g armrests the consultant physician must consider the methods of...

Страница 8: ...c for the support of accessories continuously adjustable using gas pressure spring support 2 6 List of accessories Padded armrests and lower arm supports Function and parking handbrake size 1 4 Hand rims Multi positioning saddle MPS size 1 4 Therapy table Additional push handles Accessories bag Push bar for accompanying escort Pelvis positioning aid Hip positioning aid Pad for hip positioning aid ...

Страница 9: ...tance measurement system Base frame Castors 2 7 Product overview The Fig below is intended to show you the designation of the most important components as well as the terms which you will find in these Instructions for use 2 7 1 pacer Size 0 mini 2 7 2 dynamic pacer Size 1 4 Standard top frames with combination sub fra me for size 2 3 Treadmill sub frame for size 1 3 Therapy table ...

Страница 10: ...ystem in which the different top frame and sub frame can be combined Please see the following table to see which sizes can be combined with each other In order to mount the top frame onto the sub frame press the button A and insert the axis of the top frame into the opening on the sub frame until it noticeably clicks in The top frame should be removed for transport All top frames provide sufficien...

Страница 11: ...anged To do this turn the screw D with the Allen key clockwise in order to increase the dynamic and anti clockwise in order to reduce the dynamic In order to activate deactivate the horizontal dynamic support E press the switch F switch forwards activated switch backwards deactivated Please ensure that no hands are located in the area of the dynamic support Always use armrests or arm supports see ...

Страница 12: ...dmill sub frame for size 1 3 The treadmill sub frame is intended for use over the treadmill and is also suitable for users with a higher width space requirement In addition to the height adjustment of the top frame see Points 3 1 1 and 3 1 2 the height can also be adjusted on the sub frame To do this press the button F The sub frame is available in two sizes for dimensions see Point 7 In the tread...

Страница 13: ...tently swaying Press button B to activate To deactivate press button C If the direction lock is activated on all castors the user can only move forwards or backwards If the direction locks are only activated on the rear wheels the user is sta bilised and yet they can still steer 3 3 2 Parking brake In order to press the parking brake push the lever D down with your foot To release it push the leve...

Страница 14: ...s A large selection of the accessories are mounted onto the top frame using an adapter C To mount the adapter C proceed as follows 1 Release the handle D and press it downwards 2 Lift the bar E up 3 Position the adapter C onto the frame and close the bar 4 Press the handle D up again and re tighten it The positioning of the accessories on the frame is dependent on the posi tion of the user their p...

Страница 15: ...es A Change the position of the adapters D including the push handles A To adjust the height of the push hand les A Press the button E and bring the push handles A into the required position An audible clicking noise is heard when the push handles A engage in the adapter D In order to change the alignment of the push handles A Press the button E pull the respective push handle A out of the adapter...

Страница 16: ... the grip rings down A including that of the adapter F To adjust the height of the grip rings A Press the button G bring the grip ring A into the required height and then release the button G again An audible clicking noise is heard when the grip ring A enga ges in the adapter F To change the alignment of the grip rings A Press the button G pull the grip ring A out of the adapter F and insert the ...

Страница 17: ...the bar E 4 Press the twist grip D up again and re tighten it The positioning of the handles A on the fra me is dependent on the position of the user their physical capabilities and the quantity of mounted accessories Adjust the angle of the handles A Pull the clamping lever F upwards move the handle A to the required angle and then push the clamping lever F down again Release the twist grip D to ...

Страница 18: ...ng the armrest A into the required position and release the button D again An audible clicking noise is heard when the armrest A engages in the adapter clamp E To adjust the handles F 1 Loosen the wing screw G 2 Push the handles F for different lower arm lengths forwards or backwards or from left to right The arm strap H and the hand strap I provide appropriate safety for the user so that their ar...

Страница 19: ...de To adjust the height of the arm supports A To adjust the width xxxxtttft Press the button D bring the arm supports A into the required position and release the button D again An audible clicking noise is heard when the arm support A engages in the adapter clamp E To move the entire arm support A 1 Loosen the wing screw F 2 Push the adapter clamp E with arm support A into the required posi tion ...

Страница 20: ... the bar E 4 Press the twist grip D up again and re tighten it The positioning of the chest structure A on the frame is dependent on the position of the user their physical capabilities and the quantity of mounted accessories Adjust the angle of the chest structure A Pull the clamping lever F upwards move the chest structure A to the required ang le and then press the clamping lever F down again T...

Страница 21: ... A Press the buttons E bring the torso support A into the required height and let go of the buttons E again An audible clicking noise is heard when the adapters have engaged In order to reposition or remove the entire torso support A Loosen the adapter clamps B Push the torso support A backwards or forwards In order to remove the adapter clamps B including the torso support A see Point 4 2 The str...

Страница 22: ...quired position To change the height of the hip positioning aid A at the rear Press the buttons F bring the push hand les D into the required position and relea se the buttons F again An audible clicking noise is heard when the push handles have engaged The fine adjustments in height are under taken via the straps G and H To do this pull on the respective strap to bring the hip positioning aid A t...

Страница 23: ...d B through the crossed straps C on the hip positioning pad 2 Pull the straps D of the hip positioning pad A to the middle of the hip positioning pad B Then pull the flap E to the centre and close the press studs 3 Now attach the hip positioning aid B and the hip positioning pad to the gait trainer see Point 4 10 4 Accessories A Front Rear Rear Rear Rear Front Front Front b C D D E ...

Страница 24: ...ings To set the brake release the lock E and or tighten this until the required brake effect is reached A gap of approx 1 5 mm should remain between the rear wheel and brake body The function and parking handbrake can only be used on the combination sub frame see Point 3 2 2 and in connection with the padded armrests see Point 4 6 and the lower arm pads With the aid of the function and parking han...

Страница 25: ... handles E including the adapter clamps F on the top frame and or base frame into the required position To change the height of the rear pelvic posi tioning aid A Press the button G bring the push hand les E into the required position and release the button G again An audible clicking noise is heard when the push handles E have engaged The fine adjustments in height are underta ken via the straps ...

Страница 26: ...he upper thigh positioning aid A into the required position 2 To fold away the thigh positioning aid A upwards or downwards Loosen the screw D Bring the upper thigh positioning aid A into the required position 3 To position the upper thigh positioning aid A to a different area of the frame Loosen the screw E Bring the upper thigh positioning aid A including the adapter clamp into the requi red pos...

Страница 27: ...erside of the sub frame or base frame Adjustment In order to fasten the ankle posi tioning aid E on the user s ankles open the lock F place the strap around the ankles and close the lock F again The strap G permits the individual adjustment to the inside leg length of the user To do this simply adjust it to the correct length In order to pre adjust the inside leg length for the user or to limit it...

Страница 28: ...of the therapy table A Press the button F on the adapter clamp B and bring the therapy table into the required position An audible clicking noise is heard when the therapy table has enga ged In order to remove mount the transparent plate G of the therapy table A Insert your fingers into the holes H from the rear and press the plate G out using some force Mount the plate G by inserting the moulds I...

Страница 29: ...at angle press the button G and bring the MPS into the required position In order to adjust the seat depth press the button H and bring the MPS into the required position In order to adjust or to remove the hip system in depth press the button I In order to remove the seat first remove the hip system and pull the seat as far to the rear as possible whilst keeping the button H pressed Then simultan...

Страница 30: ... B with the hip system C can be turned when using the dynamic pacer as posterior walker To do this press the button D and pull the seat backwards as far as it will go Now press the button D and both but tons E at the same time and pull the seat further backwards To be able remove the seat from the bra cket F press now the button G and pull out the hip system C until you can remove the seat B toget...

Страница 31: ...n it clockwise always half a turn until the required strength is reached and then close it again In the pacer Size 0 mini E the adapter clamp F of the push bar is positioned in the middle on the frame G to guarantee op timum stability To attach tighten the twist grip H When assembled the push bar can be po sitioned both in front of and or behind the user I so that the user can be pushed or pulled ...

Страница 32: ... Ankle positioning aid Point 4 15 3 Release The rings at the rear part of the hip or pelvic positioning aid The safety locks in the rear part of the torso support The belts on the arm supports upper thigh guidance and ankle positioning aid 4 Place the user into the gait trainer Close the safety locks on the torso support 5 Pull the hip or pelvic positioning aids over the user s legs and hook the r...

Страница 33: ...see Points 4 4 4 6 and 4 7 4 Adjust the pelvis thigh positioning aid Adjust the upper thigh and pelvic positioning aid and the straps in order to adjust the inside leg length for the user see Points 4 13 and 4 14 The upper thigh positioning aid is important to adjust the distance between the upper thighs It also prevents rotation of the user in the gait trainer 5 Adjust the ankle positioning aids ...

Страница 34: ...ccessories onto the rear top frame or base frame 4 Release the directional stability if necessary see Point 3 3 5 Should further accessories be required please observe the recommen dations for anterior positioning in reverse order see Point 5 1 6 Release the brakes on the castors see Point 3 3 Position the user in the gait trainer so that the user s centre of gravity lies bet ween the castors Use ...

Страница 35: ...plied with a soft cloth Alternatively wipes pre soaked with disinfectant can be used to wipe the products over the entire surface In both cases care must be taken to ensure complete wetting Disinfection in fully automatic disinfection systems is also possible and recommended The exposure times may vary and can be found in the manufacturer s ins tructions for the products used 6 2 Servicing Please ...

Страница 36: ...ty of the brakes backwards stop friction brakes parking brakes Functionality of the rollers concentricity smooth running Check the pads and covers for damage Check the harness for damage clamping device closures seams Legibility of the type label Final complete functional check of the aid Check that all mounting parts and associated accessories are correctly fastened 6 3 2 Maintenance plan Mainten...

Страница 37: ...ime period if it is in a safe condition The expected duration of use does not refer to wear parts such as for example wheels gas pressure springs The maintenance and evaluation of the condition and if applicable the potential for re use must be decided by the specialist dealer The product is suited for re use Prior to forwarding please follow the clea ning and disinfection instructions stated in P...

Страница 38: ...admill sub frames 58 89 cm 60 93 cm 76 119 cm Height of sub frame without top frame Standard combination sub frame 28 cm 37 cm 41 cm 47 cm Treadmill sub frames 53 cm 53 cm 53 cm Weight Standard sub frame 4 6 kg 5 2 kg 6 8 kg 7 kg 10 2 kg Combination sub frame 8 4 kg 8 7 kg Narrow treadmill sub frame 12 5 kg 12 5 kg 12 5 kg Wide treadmill sub frame 12 7 kg 12 7 kg 12 7 kg Standard top frames 2 7 kg...

Страница 39: ...ts This begins with the delivery or handover of the goods Should a verifiable material or manufacturing fault occur within this time period we shall after carriage paid return to us view the indicated damage and if applicable either repair or deliver a new product at our discretion ...

Страница 40: ...elow listed directives and standards Verordnung EU 2017 745 über Medizinprodukte vom 05 April 2017 Regulation EU 2017 745 on medical devices of 5 April 2017 DIN EN 12182 2012 Technische Hilfen für behinderte Menschen Technical aids for disabled persons DIN EN ISO 14971 2013 Medizinprodukte Anwendung des Risikomanagements auf Medizinprodukte Medical devices Application of risk management to medical...

Страница 41: ... 9 5 Name and address of the manufacturer specialist dealer supplying the product This product was manufactured by This product has been delivered by the following specialist dealer Schuchmann GmbH Co KG Rudolf Runge Str 3 49143 Bissendorf Germany Phone 49 0 5402 40 71 00 Fax 49 0 5402 40 71 109 info schuchmann de www schuchmann de A b Product name Item number Serial number schuchmann de info schu...

Страница 42: ...42 Notes ...

Страница 43: ...43 Notes ...

Страница 44: ...schuchmann de GA 33 EN_1 0 ...

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