LINET Tom 2 Parts list manual

D9U001K2B-0101
Version: 09
Publication Date: 2018-08
Tom 2
Paediatric hospital bed
User manual and technical
description

D9U001K2B-0101_09
2
Manufacturer:
LINET spol. s r. o.
Želevčice 5, 274 01 Slaný
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
http://www.linet.cz
Tom 2
Paediatric hospital bed
Author: LINET, s.r.o.
Related links: www.linet.cz
D9U001K2B-0101
Version: 09
Publication date: 2018-08
Copyright © LINET, s.r.o., 2018
Translation © LINET, 2018
All rights reserved. All trademarks and brands are the property of the appropriate owners. The manufacturer
reserves the right to changes in the contents of this manual that relate to the product´s technical regulations. It is
for this reason that the contents of this manual may indicate differences from the current manufacture of the
product. Reproduction of this user manual, also excerpts, only with prior permission of the publisher. Subject to
changes due to technical developments. All technical data are rated data and are subject to construction and
manufacturing tolerances.

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Table of Contents
1Symbols ...........................................................................................................................5
1.1Warning Notices..................................................................................................................................5
1.2Other symbols.....................................................................................................................................5
1.3Symbols and Labels on the Product ...................................................................................................6
1.4Description of label with UDI...............................................................................................................8
1.5Definitions ...........................................................................................................................................9
1.6Abbreviations ......................................................................................................................................9
2Safety and Dangers.......................................................................................................10
2.1Safety instructions.............................................................................................................................11
2.2Conditions of Use..............................................................................................................................12
2.3Intended Use.....................................................................................................................................12
3Standards and Regulations ..........................................................................................13
4Functioning....................................................................................................................14
4.1Correct use........................................................................................................................................14
4.2Incorrect Use.....................................................................................................................................14
5Scope of Delivery and Bed Variants.............................................................................15
5.1Scope of Delivery..............................................................................................................................15
5.2Bed Variants......................................................................................................................................15
5.3Applied parts type B..........................................................................................................................15
6Setup..............................................................................................................................16
6.1Transport...........................................................................................................................................16
6.2Setup ...............................................................................................................................................16
7Battery Activation..........................................................................................................17
7.1 Placement of Control Section ..........................................................................................................17
7.2 Removing the Isolating Foil..............................................................................................................17
7.3 Isolating Foil.....................................................................................................................................17
8Assembly .......................................................................................................................18
8.1Potential Equalisation........................................................................................................................18
8.2Mattress Platform..............................................................................................................................19
8.3Tom 2 (1K) –Telescopic siderails with fixed bed ends.....................................................................20
8.4Tom 2 (1K) –Telescopic siderails with removable bed ends ...........................................................21
8.5Removable bed ends........................................................................................................................22
9Operation .......................................................................................................................24
9.1Initial Operation.................................................................................................................................24
9.2Battery...............................................................................................................................................24
9.3Status Faulty Battery.........................................................................................................................25
9.4Status Discharged Battery ................................................................................................................26
9.5Removing the Bed from Service.......................................................................................................26
10 Manipulation..................................................................................................................27
10.1 Mini ACP (supervisor control panel)............................................................................................28
10.2 Night Bed Lightning .....................................................................................................................29
10.3 CPR Back Rest Release (optionally available) ...........................................................................30
10.4 Auto-Regression..........................................................................................................................30
10.5 Siderails.......................................................................................................................................31

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10.6 Castor Control and Bed Transport...............................................................................................35
10.7 Accessories .................................................................................................................................36
11 Mattress .........................................................................................................................38
11.1 EffectaCare 20P and CliniCare 10P............................................................................................38
11.2 Rotating of the mattress ..............................................................................................................38
11.3 Technical specification of the mattress........................................................................................39
11.4 Mattress cleaning and disinfectants ............................................................................................40
12 Cleaning and Disinfection of the Bed ..........................................................................43
12.1 Safety Instructions for Cleaning and Disinfection of the Bed ......................................................43
12.2 General Instructions for Cleaning and Disinfection .....................................................................44
12.3 Choosing of Detergents or Disinfections.....................................................................................45
13 Troubleshooting............................................................................................................46
14 Maintenance...................................................................................................................47
14.1 Maintenance Work.......................................................................................................................47
14.2 Functioning ..................................................................................................................................48
15 Disposal .........................................................................................................................50
15.1 Environmental Protection ............................................................................................................50
15.2 Disposal.......................................................................................................................................50
16 Warranty.........................................................................................................................51
17 Declaration of Conformity.............................................................................................52
18 Technical Specifications...............................................................................................53
18.1 Basic Specification and Bed Dimensions....................................................................................53
18.2 Environmental conditions ............................................................................................................53
18.3 Electrical Specification.................................................................................................................53
18.4 Electronic System of Tom 2.........................................................................................................54

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1 Symbols
1.1 Warning Notices
1.1.1 Types of Warning Notices
Warning notices are differentiated by the type of danger using the following key words:
Caution -risk of material damage.
Warning -risk of physical injury.
Danger - risk of fatal injury.
1.1.2 Structure of Warning Notices
1.2 Other symbols
1.2.1 Instructions
Structure of instructions:
Perform this step.
Result, if necessary.
1.2.2 Lists
Structure of bulleted lists:
List level 1
List level 2
Structure of numbered lists:
a. List level 1
b. List level 1
1. List level 2
2. List level 2
SIGNAL WORDS!
Type and source of danger!

Measures to avoid the danger.

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1.3 Symbols and Labels on the Product
Read user manual.
Attention
Thermal protection of transformer
Only suitable for indoor use
Protection against accidents due to electrical current –
Applied part type B
Safety isolation transformer, general
CE mark
Jack for attachment of conductor for potential
equalisation
Safe Working Load
Maximum weight of patient
Use mattress recommended by manufacturer
Weight of empty bed
Maximum mass of medical bed
(Weight of empty bed + Safe Working Load)

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Safety class II
Switched-mode power supply
Machine wash max. 95°C (recommended 71°C for 3
minutes)
Do not bleach
Do not iron
Suitable for dry cleaning
Dry normal, low heat
WEEE symbol (recycle as electronic waste, do not put
into the household waste)

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1.4 Description of label with UDI
1
Address of Distributor
2
Manufacturing Date (Year-Month-Day)
3
DI (Device Identifier) / GTIN (Global Trade Item Number)
4
1D Bar code GS1-128 (Serial Number)
5
Symbols
6
Configuration number
7
Electrical Specification
8
Serial Number
9
PI (Product Identifier)
10
2D Bar Code (GS1 DataMatrix) DI+PI=UDI
1
Fig. Serial Label with UDI (Tom 2)
3
4
5
6
7
8
9
2
10

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1.5 Definitions
Basic Bed Configuration
the pricelist model configuration, not including a mattress
Bed Weight
The value depends on the product configuration,
accessories or customer adjustments.
Clearance of Undercarriage
the height from the floor to the lowest point of the
undercarriage between the castors, for the manipulation of
accessories under a braked bed in the standard position
Duty Cycle
cycle of operation of the motor: time of activity/time of rest
Maximum Patient Weight
Maximum Patient Weight depends on the application
environment according to IEC 60601-2-52. For application
environment 1 (intensive/critical care) and 2 (acute care)
reduce Safe working Load by 65 kg. For application
environment 3 (long-term care) and 5 (ambulatory care)
reduce Safe working Load by 35 kg.
Safe Working Load
the highest allowable load on the bed (patient, mattress,
accessories and the load supported by those accessories)
Siderail Height
the height of the upper crossbar or the edges of the
siderails (not the highest point of the siderail controls) from
the patient surface
Standard Bed Position
The height of the patient surface with regard to the floor
is 400 mm
The mattress support platform, including the individual
parts, has to be in a horizontal (level - 0°) position.
The siderails are always locked in the upper position.
The basic position of the integrated extension.
1.6 Abbreviations
AC
Alternating Current
CE
European Conformity
CPR
Cardiopulmonary Resuscitation
dB
Sound Intensity Unit
DC
Direct Current
EMC
Electromagnetic Compatibility
FET
Field-effect transistor
HF
High Frequency
ICU
Intensive Care Unit
INT.
Duty Cycle
IV
Intravenous
LED
Light Emitting Diodes
ME
Medical Electrical (Equipment)
OFF
Deactivated
ON
Activated
REF
Reference number (product type depending on configuration)
SCU
System Control Unit
SN
Serial number
SWL
Safe Working Load
UDI
Unique Device Identification (for medical devices)
USB
Universal Serial Bus

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2 Safety and Dangers
WARNING!
Tom 2 bed should be left in its lowest position when the patient is unattended in order to reduce risk of
injury due to falls!
WARNING!
Siderails of Tom 2 should be located in the „up“ position to reduce the risk of the patient accidentally
slipping or rolling off the mattress!
WARNING!
Incompatible siderails and mattresses can cause an entrapment hazard!
WARNING!
Inappropriate handling of the power supply cord, e. g. by kinking, shearing or other mechanical
damages is hazardous!
WARNING!
When routing cables from other equipment in the Tom 2 bed avoid squeezing those between parts of
the Tom 2 bed!
WARNING!
Tom 2 bed should not be used with bed hoists and bed lifts!
WARNING!
Incompatible mattresses can create hazards.
WARNING!
To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
WARNING!
No modification of this equipment is allowed.
WARNING!
Do not modify this equipment without authorization of the manufacturer.

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2.1 Safety instructions
It is necessary to read the user manual before operating the bed.
Follow the instructions carefully.
Use the bed exclusively in its original condition.
If necessary, check the bed functions daily or at each staff rotation.
Use the bed exclusively with the correct mains supply.
Ensure the bed is operated by training and qualified personnel.
Ensure the bed is only moved or positioned upon even, hard floor surfaces listed in chapter “Transport”.
The bed is size adjusted for patients from 6 months to 4 years. Maximal height of patient is 100 cm. The
bed is not designed for older or younger patients.
Replace any damaged parts immediately with original spare parts.
Ensure maintenance and installations are performed only by qualified personnel who have been trained by
the manufacturer.
Do not apply excess weight or load to the bed according to SWL (safe working load).
Only one patient can use the bed at any time.
Take care to avoid injuries or squeezing when operating moving parts.
When using lifting poles or infusion stands, ensure nothing will be damaged when you move or adjust the
bed.
Ensure castors are braked when the bed is not being moved, regardless of whether the bed is occupied or
empty.
Ensure that siderails are operated by healthcare personnel only.
Never use the bed in areas where there is a hazard or risk of explosion.
Never handle the mains plug with wet hands.
Unplug the mains cable by pulling on the plug only.
Position the mains cable so there are no loops or bends in the cable; protect the cable from mechanical
wear and tear.
Incorrect handling of the mains cable can cause an electric shock hazard, other serious injuries or
damage to the bed.
Ensure the specified duty cycle (on-time) is not exceeded (see INT. on product label).
Ensure moving parts of the bed are not blocked.
To prevent failures, use exclusively the manufacturer’s original accessories and mattresses.
Adjust bed height when transporting the bed in order to facilitate overcoming possible obstacles.
Ensure the bed and its components are exclusively modified with the manufacturer´s approval.
Any non-observance of this manual may lead to injuries or material damage.
Ensure there is no risk of crushing or otherwise injuring the patient’s limbs (e.g. between siderails and
mattress platform, between movable parts etc.) before positioning the bed or folding down the siderails.
Close box for linen before using the Reverse Trendelenburg.
WARNING!
If this equipment is modified, appropriate inspection and testing must be conducted to ensure
continued safe use of the equipment.
WARNING!
An additional MULTIPLE SOCKET-OUTLET or extension cord shall not be connected to the MEDICAL
ELECTRICAL SYSTEM.
WARNING!
During specific investigations or treatments the significant risks of reciprocal interference posed by
ME equipment may occur.

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Do not put any objects (e.g. accessories, infusions, cables) between or on siderails and movable parts. Or
between mattress platform and undercarriage of the bed.
Ensure that nobody can get injured while folding the siderails.
Ensure no injuries will occur when folding the siderails.
Ensure there is no risk of damaging the MiniACP panel.
To prevent collisions, do not put oxygen bottle holders directly under the mattress platform.
Only use oxygen bottle holder approved by manufacturer.
Hospital personnel are fully responsible for bed adjustments and leaving patient without supervision in
accordance with evaluation of patient’s health status and mental status.
2.2 Conditions of Use
The bed may not be used and stored in indoor environments:
Where there is a risk of explosion.
Containing inflammable anaesthetics.
The bed is designed for use in rooms for medical purposes. Electrical installations must therefore meet local stan-
dards laying down the necessary conditions for electrical installations.
Disconnect the bed from the mains in exceptional cases (i.e. lightnings, earthquake).
2.3 Intended Use
Purpose of product:
Tom 2 is electronically positionable paediatric bed for standard and critical care. It is intended for body of
patient as support during hospitalization, during mobilization and during transport of patient. Tom 2
medical bed is not intended for neonatology.
Patient:
Tom 2 medical bed is intended for patients with maximum height of 100 cm. Weight of patient + mattress
+ accesories can not be higher than safe working load (SWL - 75 kg).
Personnel:
Training and qualified medical staff (nurse, doctor) with medical school or university (EU), familiar with the
manual.
Hospital staff is responsible for assessing if the physical and psychological state of the patient is in
accordance with use of Tom 2 medical bed!
Location:
The bed is determined for hospital environment with intensive, standart and long-term care. The stable
undercarriage with 4 castors makes it possible for the bed to be handled by one person. However, the
manufacturer recommends that at least two persons handle the bed.

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3 Standards and Regulations
The bed complies with the following standards and directives:
EN 60601-1:2006/A1:2013
EN 60601-1-2:2007
EN 60601-1-6:2010
EN ISO 15223-1:2012
EN ISO 10993-5:2009
EN ISO 10993-10:2014
EN ISO 14971:2012
DIN 32623:2009
93/42/EEC
2011/65/EU
The manufacturer adheres to a certified quality management system in compliance with the following
standards:
ISO 9001
ISO 14001
ISO 13485

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4 Functioning
4.1 Correct use
The bed is determined for hospital environment with intensive, standart and long-term care.
Ensure the bed is operated only by trained and qualified hospital staff.
Do not continue to use the bed which is not in pristine condition.
4.2 Incorrect Use
The bed is not suitable for adults.
The bed is not suitable for private use.
Ensure the safe working load is not exceeded.
NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please
contact LINET®.
LINET®’s efforts in research, design and manufacture ensure LINET®products are of the highest quality and fit
for their intended purpose. However, LINET®can take no responsibility for any damage to the products or any
harm to patients, staff or other individuals resulting from:
Not following the instructions in the manual, including warning notices.
Using the product for a purpose other than the intended purpose stated in the relevant documentation
provided by LINET®(see Correct Use).
DANGER!
Risk of injury or death due to use of incorrect equipment!

Ensure the bed and its components are exclusively modified with the manufacturer´s approval.

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5 Scope of Delivery and Bed Variants
5.1 Scope of Delivery
Delivery:
The bed is delivered completely assembled. Upon receipt, check that the shipment is complete as
specified on the delivery note. Notify the carrier and supplier of any deficiencies or damages immediately
as well as in writing or make a note on the delivery note.
5.2 Bed Variants
Features –Tom 2 Model 1K (model no. see product label):
Mattress Platform
Two pieces mattress platform with plastic parts
Siderails
Telescopic siderails
Bed Ends
Removable polycarbonate bed ends
Removable polycarbonate bed ends with decorative motive
Castors
100 mm Tente Motion, with individual braking system
125 mm Tente Integral, with central braking system
Control Elements
Mini ACP (supervisor control panel)
Other
Box for linen (diapers/toys)
Pair of accessories rails
CPR unlocking of back rest
Integrated infusion stand in head end
Powder Coating Colors
RAL 9002 (white) with pastel blue plastic parts
RAL 9002 (white) with pastel green plastic parts
5.3 Applied parts type B
All the accesories the patient can reach are type B applied parts.
List of type B applied parts:
Siderails
Bed ends
Mattress platform
CAUTION!
Damage to the bed due to incorrect use!

Use 100 mm and 125 mm castors exclusively on flat, even surfaces without any gaps!

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6 Setup
6.1 Transport
For safe transport, observe the following:
Ensure no cables are run over when moving a bed.
Ensure the mains cable is disconnect from the mains.
Ensure the mains cable is attached with a hook (at the head end of the bed).
Ensure the castors are unlocked before moving the bed during the loading/unloading process (see Castor
Control and Bed Transport).
Ensure the siderails are lifted and locked while the patient is on the bed during the transport.
Move the bed only on suitable floor surfaces.
Suitable surfaces:
Tile
Hard linoleum
Hard flooring
Unsuitable surfaces:
Soft, unsealed or defective flooring
Soft wooden flooring
Soft and porous stone floors
Carpeted floors with underlay
Soft linoleum
For longer distances, ensure the castor steering function (main control) is activated.
Ensure the brakes are released while moving the bed.
6.2 Setup
Set up the bed as follows:
Unpack the bed.
Remove isolating foil from mains control box (see Battery Activation).
Check the delivery (see Scope of Delivery).
Install equipment and accessories (see Assembly).
Set up the bed exclusively on a suitable floor surface (see Transport).
Ensure the mains cable does not collide or get stretched when adjusting the bed. Check the plug is
inserted correctly.
Do not leave any extension cords or power strips loose on the floor.
Ensure all the required mechanical and electrical prevention mechanisms are available on site.
There is no mains switch on the bed, i.e. the mains cable is the only means to isolate the bed from the
mains.
Ensure the mains cable is always accessible.
The plug on the mains cable should only be changed and maintained by qualified and trained service
technicians authorised by the manufacturer.
6.2.1 Connection to the mains
Where the integrity of the external protective conductor in the installation or its arrangement is in doubt
operate the bed from internal battery only.
NOTE: Attachment plug is means of disconnecting bed from the mains.

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7 Battery Activation
7.1 Placement of Control Section
7.2 Removing the Isolating Foil
7.3 Isolating Foil
Check if isolating foil is complete and undamaged as shown:
If isolating foil is damaged, contact the manufacturer’s service department immediately.
NOTE: It is recommended to wear gloves when removing the isolating foil.
Pull

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8 Assembly
8.1 Potential Equalisation
The bed is equipped with a standard protective connector. This connector is used for potential equalisation
between the bed and any intravascular or intracardiac device connected to the patient to protect the patient from
static electric shocks.
Fig. Potential equalisation connector –male Fig. Potential equalisation connector –female
Use equalisation connector if:
The patient is connected to any intravascular or intracardiac device.
Before connecting the patient to an intravascular/intracardiac device:
Connect the ground wire of the device to the potential equalisation connector on the bed on which
the patient in question is lying.
Use a standard hospital connector.
Make sure the connectors match.
Make sure there is no possibility of accidental disconnection.
Before moving the bed:
Disconnect the patient from the intravascular or intracardiac device.
Disconnect the potential equalisation connector.
WARNING!
Risk of injury when working on the bed!

Ensure the bed is disconnected from the mains connection prior to assembly, disassembly and
maintenance.

Ensure the castors are locked prior to assembly, disassembly and maintenance.
CAUTION!
Material damage due to incorrect assembly!

Ensure the assembly is performed only by seller´s customer service or trained hospital personnel.

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8.2 Mattress Platform
The mattress platform consists of plastic sections.
Correct placement of the patient on the bed:
Fig. The patient orientation on the bed (Mini ACP is located at the foots of the patient).

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8.3 Tom 2 (1K) –Telescopic siderails with fixed bed ends
Fig. Overview Tom 2 –Telescopic Siderails
1. Foot end
2. Telescopic siderails in upper position
3. Integrated infusion stand
4. Head end
5. Mattress platform with mattress
6. Siderail release mechanism
7. CPR control lever –back rest release
8. Telescopic siderails folded down
9. Castor 125 mm (Tente Linea double)
10. Box for linen (diapers/toys)
11. Mini ACP (supervisor control panel)
12. Castor control lever
13. Protective bumper 100 mm
CAUTION!
Material damage due to excess load!

Ensure nobody burdens side rails or bed ends.