User Guide and Technical Description

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TOM Child Bed (115,140)

1999/1st Edition 9200-0065

User Guide and Technical Description _________________________________________________________________ LINET, spol. s r. o. Tel.: + 420312 / 524 139, 576 111 Fax: + 420312 / 522 668 Želevčice 5 274 01 Slaný Czech Republic

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Dear customers, Thank you for buying a product from our company. We believe you will be satisfied with it during its whole lifetime. Thanks to a careful selection of materials, state-of-the-art production technology and careful work of our staff, our beds reach such parameters that guarantee a high quality, reliability and a permanent use value.

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_________________________________________________ Table of Contents User Guide Instructions Purpose of Use Technical Details Device Safety Device Description Function Description Delivery Safety Instructions Assembly Function Check-up Positioning Back Part Positioning Setting Height and Incline of Bed Level Setting Side Grids Accessories First Cleaning Disinfection / Sterilization Troubleshooting Maintenance Wear Functionality Wheels Environmental protection Spare Parts Warranty Contact

4 4 4 4 4 5 5 5 6 6 6 6 6 7 7 7 7 8 8 8 8 8 8 10 10 12

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User Guide Instructions This user guide does not only address service staff trained to take care of children but also people who have been entrusted with looking after and taking care of a child. ! Every product handling must be based on a thorough knowledge and observance of the user guide. Therefore, keep this user guide in a safe place until the child bed is no more in use. It is recommended that the user guide be attached to the bed.

Purpose of Use The child bed is primarily used in children clinics and hospitals. The bed solely serves this purpose. Other methods of use must be consulted with LINET s.r.o. in advance.

Technical Details MAX. LENGHT (cm) MAX. WIDTH (cm) Bed level height settings Back rest positioning Tr/Atr adjustment

TOM 140 TOM 115 165 131 83 63 78 - 109 cm in 10 positions 78 - 109 cm in 10 positions to 70˚ 12˚/12˚ 12˚/12˚

Device Safety The product complies with safety regulations of DIN 66078/EN-2 and MED PrG. The product has a CE mark in accordance with Directive 93/42/EWG for medical products.

Device Description

5

4 7

1. Siderail 2. Siderail control pedal 3. Wheel brake 4. Anti-shock wheel 5. Back part handle control 6. Toy basket lath 7. Bed level height setting

6 3

2

1

Function Description Depending on the model, the following positions may be set using back part or height positioning: _________________________________________________________________ 4 TOM Child Bed st August 1999, 1 Edition

_________________________________________________ Back

Trendelenburg's position

Height

Anti-Trendelenburg's position

Positioning is done mechanically - using an appropriate lever. (see. the Positioning section)

Variants

Variants of the model

Model Number …

Model

Colour tint

2 …TOM 115 3 …TOM 140

3 … RAL 1015 4 … RAL 7035 B … RAL 9002 C … RAL 9010

1 3 3 1 x

0 0 1 x

white coffee grey light grey white

0 2 A 0

Delivery The child bed is usually delivered fully assembled, or expert staff assembles the bed on site. The completeness should be checked against delivery documents. Any insufficiencies or defects must be immediately communicated to the forwarding agent and supplier and must be recorded in the delivery certificate.

Safety Instructions It is necessary to read through and observe the safety instructions prior to using the child bed. It is necessary to read through and observe the safety instructions prior to using the child bed.  The child bed may only be used on flat and solid floors.  When setting various positions, make sure that the no persons, body parts or other objects are located in the positioning area.  Do not put the side grid under a load grater than 25 kg vertically and 25 kg horizontally.  Prevent the child from excessive leaning on the side grid with its upper body.  The child bed may be used up to a maximum weight of 75 kg of the child. If the bed level is in the highest position, there is a danger of pinching the fingers when lowering the side grid. The lock must be open when lowering Lock open the side grid !

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________________________________________________ if a child is in the bed, the lock must be closed !

Lock closed

Assembly If need be, simple assembly tasks may be carried out by trained authorized persons.

Function Check-up Prior to every new use of the child bed, a function check-up must be performed, i.e. whether all positions may be set up to the maximum positions and whether the positioning can be done easily.

Positioning Back Part Positioning  Upwards By turning the hand wheel counter-clockwise, the backrest can be moved up.  Downwards By turning the hand wheel clockwise, the backrest can be moved down. (see figure)

Setting Incline and Height of Bad Level Height Loosen the bar fixed in the cog-rack by pulling toward yourself (out of the cog-rack). Then set the required height by placing the bar in the same cog-rack position for both the head and legs. Incline By fixing the bar in different positions of the cog-rack for head and leg parts, you can set various inclines of the bed level (Trendelenburg's / anti-Trendelenburg's position).

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Setting Siderails  Downwards First raise the siderail (1), and while stepping on the pedal (2), let it drop to the required position (3). By stepping off the pedal (2) you will fix the required height.  Upwards First raise the siderail (1), then step on the pedal (2) and raise the siderail. Then step off the pedal (2) so that the side grid position can be fixed.

Accessories The child bed may be equipped with the following accessories: -

toy basket diaper basket holder infusion post diaper basket waste bowl holder

First Cleaning Prior to using the bed for the first time, the child bed must be wiped with a dry mop.

Disinfection / Sterilization The child bed must be disinfected on a regular basis, at least prior to every change of patient. The child bed must not be disinfected in a washing machine or using a water stream. To disinfect the child bed, the following substances are recommended, which may only be replaced by equivalent products: Terralin, Perform, Sargotan (Schülke & Mayr GmbH, Norderstedt). The products must be used in accordance with instructions stipulated by the manufacturer! This namely applies to substance doses and a possible danger when combining it with other products.

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Troubleshooting Defects Positions cannot be changed using the mechanism or

Possible causes 1. The mechanism is blocked

Help 1. Check mobile parts and remove any strange objects (rugs or other material)

Improper operation

Use in accordance with the user guide. 2. Have expert staff perform an overall checkup

Side grid mechanism does 2. A strange object in the not work properly mechanism or the mechanism is defective

Warning! The bed must not be further used!

Maintenance The child bed should be maintained regularly. If more and more defects are determined through maintenance, which could not be repaired, the bed must be put out of operation and used no more. The following points and relevant parts must be checked and maintained at least twice a year: Perfect condition of the side grid safety locks and the positioning mechanism must be checked at least once in six months.

Wear The child bed must be checked whether there are any worn spots, scraped places or other wear and damage. Their causes must be determined and the defects repaired by replacing the individual parts. Any position fixing and alterations must be easily feasible. Side grid guides in the head and leg parts (fronts) should be sprayed with a silicon lubrication spray.

Functionality Check whether all settings can be done up to the maximum positions.

Wheels Check the functionality of the wheels and remove any dust accumulated, material reeled (threads, hair etc.).

Environmental protection The company LINET, spol. s r.o. is aware of the necessity to protect the environment for future generations and therefore devotes great attention to the development, innovation – planning, production and use of such technology and materials that are environmentally friendly. This product is constructed from materials that are environmentally friendly! The product does not contain dangerous substances based on cadmium, mercury, _________________________________________________________________ 8 TOM Child Bed st August 1999, 1 Edition

_________________________________________________ asbestos, PCB or CFC! The operational noise-level of the product meets the requirements for the protection of public health against undesirable noise and vibration in protected indoor building premises. Wooden parts used in the product are not made from exotic wood such as mahogany, jacaranda, ebony, teak, grenadil or santo, and do not come from the Amazonian rainforests or other virgin forests. All waste packaging left over from when the product is made operational is marked in accordance with the legal regulations on packaging. Sort the waste packaging, which is left over once the product is made operational by following the graphic symbols and deliver it to a person authorised to further utilise it. The product contains recyclable steel, plastic and electronic components – to optimise recycling once the operation of the product ends, separate the individual parts so that the raw materials from which the product is made can be put to further use (see CHART).

The product may contain lead accumulators (AKB) marked with this graphic symbol: Once the service life of these accumulators ends, deliver them to a person authorised for recollection (you will not have to pay a recollection charge!). The product is not designed for removal as part of communal waste!

Information for the users of electric and electronic equipment (see CHART): This symbol on the product or accompanying documentation means that the electric or electronic components used (waste from electric and electronic equipment = OEEZ/WEEE) may not be disposed of (destroyed) together with communal waste. In order to correctly eliminate the entire product, deliver OEEZ/WEEE to the workplaces of firms specialised in this task, where they will be accepted free of charge. By removing this product appropriately you will help preserve valuable natural resources and help prevent potential negative effects on the environment and human health, which could result from the incorrect destruction of waste. You can request further details from authorised environmental protection authorities, or the closest collection point for separated waste collection. Fines may be imposed under national regulations if an incorrect procedure for waste removal is used. _________________________________________________________________ 9 TOM Child Bed August 1999, 1st Edition

________________________________________________ Information for users about the removal of electric and electronic equipment in other countries outside the European Union: The symbol shown above is valid only in the countries of the European Union. You can apply to your authorities or the equipment seller for detailed information about the correct way of removing separated OEEZ/WEEE (electric and electronic equipment) and lead accumulators. Protect your health and the environment. Thank you.

Spare Parts Please contact the nearest service department, commercial department or your supplier for more detailed information.

Warranty You have purchased a child bed - a product by LINET. The bed has been produced with a due care using high quality materials and modern production technology. The child bed is subject to a 24-month warranty starting on the purchase date. The warranty applies to all defects and faults due to material and workmanship. It does not cover defects and faults caused by improper handling and external causes. If any time during the warranty period there is a cause for a rightful claim, the defects will be repaired free of charge. You can claim a warranty repair based on the delivery certificate or an invoice with the purchase date. Our commercial and delivery terms apply.

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EC CONFORMITY DECLARATION Date of issue:

27. 9. 2001

Conformity declaration issued by:

Commercial name

Linet spol. s r. o.

Registered address

Želevčice 5, 274 01 Slaný, Czech Republic

Reg. No.

00507814

Telephone

+420 312 576 111

Fax

+420 312 522 668

As the producer of the product name (brand): Variants of the product:

TOM 115/140

Description and function designation: Clssification of the product as the medical device:

1331XXXXXXXXX (the variants are specified in the technical documentation of the product) Positionable children bed for children hospital units Class I nonsterile, without measuring function

A) Declaration I declare that the said product is safe under the conditions of common use in compliance with the instructions and that measures have been taken to ensure the conformity of all the products brought to market with basic requirements of directives related thereto, stated in paragraph B.

B) Fulfilled technical requirements This product's characteristics comply with the technical parameters related to it and stated in MDD 93/42/EEC which stipulates the technical parameters for healthcare products.

C) Means of assessing conformity Conformity was assessed by the procedure stated MDD 93/42/EEC, Annex VII.

Ing. Zbyněk Frolík company director

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Contacts LINET spol. s r.o. Želevčice 5, 274 01 Slaný, Czech Republic Please direct your inquiries to: connection: − Commercial Department Tel.: +420 312 / 524 139, 576 111 − Service and Claim Department Tel.: +420 312 / 576 259, 524 139 Fax: +420 312 / 522 668 E-mail: [email protected] http//www.linet.cz

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