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19

8. Identification.

8.1 EC declaration of conformity

Company

  Schuchmann GmbH & Co.KG

 

 

Dütestr. 3

 

 

D-49205 Hasbergen

 

 

Tel.: +49 (0) 54 05 / 909 - 0

 

 

Fax: +49 (0) 54 05 / 909 - 109

declares on their sole responsibility that the product named below, classified 
in product class 1,

smilla.

 The practical therapy chair for everyday use.

Art. No.:  13 00 100 (Size 0 KITA)     13 00 000 (Size 0) 
 

   13 01 100  (Size 1 KITA)      13 01 000 (Size 1) 

               13 02 000 (Size 2) 

accords with the relevant provisions in the regulations and guidelines listed 
below:

•  EC Directive 93/42/EEC on medical products from 14th June 1993
•  DIN EN 12182:2012 Technical aids for disabled persons- General

 

  requirements and test methods

•  DIN EN ISO 14971:2013 Medical devices -- Application of risk 

 

  management to medical devices

•  DIN EN 14988-1:2012 Children‘s high chairs - Part 1: Safety requirements
•  DIN EN 14988-2:2012 Children‘s high chairs - Part 2: Test methods

This declaration of conformity applies only for products with the article 
numbers stated above and is valid until 01.02.2020.

Date

    

 

12.01.2017

Signature     

                                   

    

Name

   

 

Torsten Schuchmann

Function

    

Safety Representative for Medical Products

Содержание SMILLA

Страница 1: ...Instructions for use smilla The practical seating aid for everyday use smilla ...

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

Страница 3: ...late and armrest height 09 3 2 Seat depth 10 3 3 Foot plate depth 10 3 4 Foot and seat plate angle 10 3 4 1 Foot and seat plate angle via fast adjustment 11 3 5 Back angle 11 3 6 Back height 12 4 Accessories 12 4 1 Headrest 12 4 2 Thorax pelotte pads 13 4 3 Thigh guide 13 4 4 Wooden therapy table 14 4 5 Castors 14 4 6 Abduction wedge 15 4 7 Begurtung 15 5 Repairs and cleaning 16 5 1 Cleaning 16 5 ...

Страница 4: ...t sunlight 1 3 Safe disposal In order to preserve and protect the environment to prevent environmental pollution and to improve the recycling of raw materials please note the dis posal instructions in points 1 3 1 and 1 3 2 1 3 1 Packaging The product packaging should be stored in case the product needs to be transported again Should you have to return the product for repairs or in case of a guara...

Страница 5: ... anyone sitting on it Make sure that all screw connections and buttons are tightened before lif ting the therapy chair The chair can only be lifted using the foot or seat plate holders or the main frame 2 3 Application areas use according to the intended purpose Indications The smilla therapy chair has been designed for children and teenagers who are unable to sit or stand independently Therapy ch...

Страница 6: ...two months and tightened if necessary Please remember that the child can easily use their feet to push off a table with a solid frame and tip over backwards with the therapy chair Do not leave the child unattended in the therapy chair Ensure that all straps are properly fastened Do not let the child play around the therapy chair when it is not in the intended position for use Always place the ther...

Страница 7: ...s intended The gliders and surface must be kept clean Covers The seat and back pads of the smilla therapy chair are covered with a wearresistant and breathable fabric in the basic version This can be remo ved from the pad using the zip to clean or wash it in the washing machine max 30 Please do not dry the cover in a dryer and do not use aggressive cleaning agents or similar products Push rollers ...

Страница 8: ...uct overview with accessories Strap assembly kit for the back area Chest shoulder strap Groin harness standard T shaped Pelvic harness 4 point pelvic harness Fast angle adjustment of the foot support and seat surface Base foot Height and angle adjustable backrest Seat plate adjustable in height angle and depth Foot plate adjustable in height angle and depth Height adjustable armrest Headrest Back ...

Страница 9: ...ld be adjusted to the size of the child and the respective table height situation Once you have adjusted the seat pla te position the armrests so that the child s lower arms can rest comfortably on them The foot plate is at the right height when the soles of the feet can rest on it and the thighs rest on the seat plate Loosen the hexagon socket screws A to adjust the armrest height and bring the a...

Страница 10: ...en und nicht über die Vorderkante hinausra gen Um die Fußplattentiefe einzustellen lösen Sie die Drehgriffe C unterhalb der Fußplatte und schieben diese in die korrekte Position 3 4 Foot and seat plate angle The seat and foot plates can be adjusted in four different angles 5 0 7 5 and 15 using a gauge pattern D In order to set the seat or foot plate angle the hexagon socket screws F H on both side...

Страница 11: ...fast angle adjustment can be opera ted using only one hand Adjustments may only be undertaken if the user is not in the therapy chair 3 5 Back angle The backrest should rest fully against the back and should be adjusted to the respective required position of the spine The back angle can be adjusted from 3 to 17 5 In order to adjust the angle of the backrest loosen the tur ning handles D on both si...

Страница 12: ...4 1 Headrest In the correct position the headrest serves as a support surface for the head so that the centre of the headrest makes tangenti al contact with the head Make sure that the upper edge of the headrest is positioned at the same height as the top of the head The headrest can be adjusted in height using a gauge pattern in 3 cm steps In order to put the headrest in the right position remove...

Страница 13: ... the pelotte pad at the required angle or width and retighten the socket screws 4 3 Thigh guide The thigh guide can be adjusted in depth width and angle Loosen the hexagon socket screws C under the seat plate to change the angle and width of the thigh guide Now bring the thigh guide to the required position and tighten the hexagon socket screws C again In order to set the depth of the thigh guide ...

Страница 14: ... the turning screws C again The height of the wooden the rapy table can be adjusted using the armrests see point 3 1 The wooden therapy table may not be subjectedtoaloadofmorethan10kg When adjusting the therapy chair there is a risk of trapping or crushing limbs After each adjustment please retighten all screw connections 4 5 Castors smilla can be optionally equipped with 4 castors 2 of which have...

Страница 15: ...ction wedge is not engaged until you hear a click 4 7 Begurtung There is range of straps available for smilla which allow even better posi tioning of the user The straps should be mounted using the strap assembly kits for the seat or back area You have the choice between a chest shoul der strap groin harness standard or T shaped groin harness pelvic harness and a 4 point pelvic harness Our fixa ti...

Страница 16: ... with the product stating the serial number of the therapy chair see point 8 5 Necessary spare parts and accessories must only be installed by trained personnel 5 4 Nutzungsdauer und Wiedereinsatz The expected duration of use of our product dependent on the usage in tensity and amount of re use totals up to 8 years if the usage takes place in accordance with the information in these Instructions f...

Страница 17: ... cm 34 cm E Back angle 3 17 5 F Seat angle 5 0 7 5 15 G Foot angle 5 0 7 5 15 H Foot support height min Standard 13 cm mit 50 mm Dop pellaufrolle 18 cm mit 75 mm Dop pellaufrolle 21 cm H Foot support height min with fast ang le adjustment Standard 8 cm mit 50 mm Dop pellaufrolle 13 cm mit 75 mm Dop pellaufrolle 16 cm Max load 30 kg 30 kg 45 kg 45 kg 60 kg Weight 9 2 kg 9 7 kg 9 6 kg 10 2 kg 12 kg ...

Страница 18: ...s This begins with the delivery or handover of the goods Should a verifiable ma terial or manufacturing fault occur within this time period we shall after car riage paid return to us view the indicated damage and if applicable either repair or deliver a new product at our discretion ...

Страница 19: ... the regulations and guidelines listed below EC Directive 93 42 EEC on medical products from 14th June 1993 DIN EN 12182 2012 Technical aids for disabled persons General requirements and test methods DIN EN ISO 14971 2013 Medical devices Application of risk management to medical devices DIN EN 14988 1 2012 Children s high chairs Part 1 Safety requirements DIN EN 14988 2 2012 Children s high chairs...

Страница 20: ...ories see point 4 8 4 Issue of the document Instructions for use smilla Change status J Issue 09 2018 8 5 Name and address of the manufacturer specialist dealer supplying the product This product was manufactured by 20 8 Identification Product name Article number Serial number This product has been delivered by the following specialist dealer Schuchmann GmbH Co KG Dütestraße 3 49205 Hasbergen Tel ...

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