LINET Tom 2 Operating instructions

Tom 2

Paediatric hospital bed

D9U001K40-0101

Version: 17

Publication Date: 2023-02

Instructions for Use

and Technical Description

D9U001K40-0101_172

Manufacturer:

L I N E T spol. s r.o.

Želevčice 5

274 01 Slaný

Tel.: +420 312 576 111

Fax: +420 312 522 668

E-mail: [email protected]

http://www.linet.com

Service department: [email protected]

Authorized Representative in Great Britain:

LINET UK Ltd

11 Brunel Way

Segensworth East

Fareham

Hampshire

PO15 5TX

United Kingdom

Authorized Representative in Switzerland:

Bigla Care AG

Bernstrasse 3

CH-3421 Lyssach

Switzerland

Authorized Representative in Malaysia:

Emergo Malaysia Sdn. Bhd.

Level 16, 1 Sentral, Jalan Stesen Sentral 5

KL Sentral

50470 Kuala Lumpur

Malaysia

Authorized Representative in Peru:

Drogería Emergo Peru S.R.L.

Calle Las Orquídeas Nro. 585, Int. 1301

San Isidro, Lima

Director Técnico Renato Delgado Rivera

RUC: 205 52 75 65 35

Peru

Authorized Representative in Philippines:

Biomedica Healthcare Inc.

Unit 2103 City land 10, Tower 1

Ayala Corner, Dela Costa Street

Makati City, Metro Manila

Philippines

D9U001K40-0101_17

3

Tom 2

Paediatric hospital bed

Author: L I N E T, s.r.o.

Related links: www.linet.cz

D9U001K40-0101

Version: 17

Publication Date: 2023-02

Translation © L I N E T, s.r.o., 2023

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 dierences from the current manufacture of the product. Reproduction of the instructions for use, 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.

D9U001K40-0101_174

1 Symbols and Denitions .............................................5

1.1 Warning Notices .......................................................... 5

1.1.1 Types of Warning Notices ........................................5

1.1.2 Structure of Warning Notices ...................................5

1.2 Instructions ..................................................................5

1.3 Lists .............................................................................5

1.4 Symbols on the Package ............................................6

1.5 Symbols and Labels on the Bed .................................7

1.6 Symbols and Labels on the Mattress .......................... 11

1.7 Serial Label .................................................................12

1.8 Acoustic signalisation (Tom 2 with PB43RED control unit)

..........................................................................................13

1.9 Acoustic signalisation (Tom 2 with PB11 control unit) .13

1.10 Visual signalisation....................................................13

1.10.1 Mains Power LED (Mini ACP) ................................ 13

1.10.2 Accumulator Indicator (Mini ACP) .......................... 13

1.10.3 Lock LED (Mini ACP) .............................................14

1.11 Night Bed Lighting (Tom 2 with PB43RED control unit)

..........................................................................................14

1.12 Night Bed Lighting (Tom 2 with PB11 control unit) .... 14

1.13 Denitions .................................................................15

1.14 Abbreviations ............................................................16

2 Safety Instructions .......................................................17

2.1 Safety instructions .......................................................19

3 Intended use (Tom 2) ...................................................20

3.1 Application environment – compliance with Paediatric stan-

dard EN 50637 .................................................................20

3.2 User population ........................................................... 20

3.3 Contraindications ........................................................20

3.4 Operator ...................................................................... 20

4 Incorrect Use ................................................................20

5 Product Description ..................................................... 21

5.1 Tom 2 (1K4) – Telescopic siderails with xed head board and

foot board .........................................................................21

5.2 Tom 2 (1K4) – Telescopic siderails with removable head

board and foot board ........................................................22

6 Technical Specication ...............................................23

6.1 Type B Applied Parts ...................................................23

6.2 Mechanical Specications (Tom 2) ............................23

6.3 Environment Conditions .............................................. 24

6.4 Electrical Specication (LINET Control Unit) ...............24

6.5 Electromagnetic compatibility .....................................25

6.5.1 Manufacturer instructions - electromagnetic emissions

..........................................................................................26

6.5.2 Manufacturer instructions - electromagnetic susceptibility

..........................................................................................26

7 Use and Storage Conditions ....................................... 27

8 Scope of Delivery and Bed Variants ........................... 28

8.1 Scope of Delivery ........................................................ 28

8.2 Bed Variants ................................................................28

9 Putting into Service .....................................................29

9.1 Accumulator Activation ................................................ 30

9.1.1 Placement of Control Section ..................................30

9.1.2 Removing the Isolating Foil ......................................30

9.1.3 Isolating Foil ............................................................. 30

9.2 Mattress support platform ...........................................31

9.2.1 Auto-Regression ......................................................31

9.3 Potential Equalisation .................................................32

9.4 Head Board and Foot Board .......................................33

9.5 Before Use ..................................................................35

9.6 Transport ..................................................................... 36

9.7 Firmware .....................................................................37

10 Power Cable ...............................................................37

11 Accumulator ...............................................................38

11.1 Status Faulty Accumulator .........................................39

11.2 Status Discharged Accumulator ................................ 39

11.3 Removing the Bed from Service...............................39

12 Manipulation ............................................................... 40

12.1 Mini ACP (Attendant Control Panel) ..........................40

12.1.1 Central STOP Button .............................................41

12.1.2 Activating GO Button ..............................................41

12.1.3 Position Buttons .....................................................41

12.1.4 Lock .......................................................................41

12.2 CPR Backrest Release (optionally available) ...........43

12.3 Quick lowering of the backrest .................................. 44

12.3.1 Description of the connection of the backrest to the piston

of actuator ........................................................................44

12.3.2 Procedure of the quick lowering of the backrest ...45

12.3.3 Procedure to reconnect the backrest to the piston of

actuator.............................................................................46

12.4 Siderails ....................................................................47

12.4.1 Positions of siderails ..............................................49

12.4.2 Openable siderail bars (optionally) ........................50

12.5 Castor Control and Bed Transport ............................ 51

12.5.1 Castor Control Levers ............................................51

13 Equipment ..................................................................52

13.1 Accessory Rails .........................................................52

14 Mattress ......................................................................52

14.1 EectaCare 20 P and CliniCare 10 P ........................52

14.2 Rotating of the mattress ............................................ 52

14.3 Technical specication of compatible mattress ......... 53

14.4 Mattress cleaning and disinfectants .......................... 54

14.4.1 General Guidance .................................................. 54

14.4.2 Routine Cleaning and Disinfection ......................... 55

14.4.3 Complete Cleaning and Disinfection ...................... 55

14.4.4 Mattress Core ........................................................55

15 Accessories ................................................................56

15.1 Telescopic Infusion Stand ......................................... 56

15.2 Horizontal Oxygen Bottle Holder ...............................57

15.3 Accessory Box ..........................................................57

15.4 Traction Frame B ......................................................57

16 Cleaning/Disinfection ................................................59

16.1 Safety Instructions for Cleaning and Disinfection of the Bed

..........................................................................................60

16.2 General Instructions for Cleaning and Disinfection ... 60

16.2.1 Daily Cleaning ........................................................ 60

16.2.2 Cleaning before Changing Patients .......................60

16.2.3 Complete Cleaning / Cleaning before First Use .....60

16.2.4 Cleaning of Spilled Fluids ......................................60

16.2.5 Damaged Foam Mattress ......................................60

16.3 Modes of Cleaning and Disinfection .........................61

17 Troubleshooting ......................................................... 62

18 Maintenance ...............................................................63

18.1 Regular maintenance ................................................ 63

18.2 Spare Parts ...............................................................63

18.3 Safety Technical Checks ........................................... 63

19 Disposal ......................................................................64

19.1 Environment Protection .............................................64

19.2 Disposal ....................................................................64

19.2.1 Within Europe ........................................................64

19.2.2 Outside Europe ......................................................64

20 Warranty ......................................................................65

21 Standards and Regulations ......................................65

Table of Contents

D9U001K40-0101_17

5

1 Symbols and Denitions

1.1 Warning Notices

1.1.1 Types of Warning Notices

Warning notices are dierentiated by the type of danger using the following key words:

► CAUTION warns about the risk of material damage.

► WARNING warns about the risk of physical injury.

► DANGER warns about the risk of fatal injury.

1.1.2 Structure of Warning Notices

SIGNAL WORDS!

Type and source of danger!

► Measures to avoid the danger.

1.2 Instructions

Structure of instructions:

► Perform this step.

Results, if necessary.

1.3 Lists

Structure of bulleted lists:

■ List level 1

□ List level 2

● List level 3

D9U001K40-0101_176

1.4 Symbols on the Package

FRAGILE, HANDLE WITH CARE

THIS WAY UP

KEEP DRY (PROTECT FROM HUMIDITY)

PAPER RECYCLING SYMBOL

DO NOT USE HAND TRUCK HERE

DO NOT STACK DURING STORAGE

D9U001K40-0101_17

7

1.5 Symbols and Labels on the Bed

READ INSTRUCTIONS FOR USE

WARNING

THERMAL PROTECTION OF TRANSFORMER

ONLY SUITABLE FOR INDOOR USE

PROTECTION AGAINST ACCIDENTS DUE TO ELECTRICAL CURRENT – TYPE B

APPLIED PARTS

SAFETY ISOLATING TRANSFORMER, GENERAL

CE MARK OF CONFORMITY WITH EU REGULATION

JACK FOR ATTACHMENT OF CONDUCTOR FOR POTENTIAL EQUALISATION

SAFE WORKING LOAD

MAXIMUM WEIGHT OF PATIENT

WEIGHT OF BED

D9U001K40-0101_178

MANUFACTURER

MANUFACTURING DATE

REFERENCE NUMBER (PRODUCT TYPE DEPENDING ON CONFIGURATION)

SERIAL NUMBER

GO BUTTON (PRESS TO ACTIVATE CONTROL ELEMENT)

STOP BUTTON (PRESS TO INTERRUPT BED POSITIONING)

WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,

DO NOT PUT INTO THE HOUSEHOLD WASTE)

RECYCLING SYMBOL

DO NOT POLLUTE THE ENVIRONMENT

MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)

D9U001K40-0101_17

9

USE MATTRESS RECOMMENDED BY MANUFACTURER (WITH COMPATIBLE DIMEN-

SIONS)

DESCRIPTION OF ALLOWED LENGTH OF PATIENT

UNIQUE DEVICE IDENTIFICATION (FOR MEDICAL DEVICES)

MEDICAL BED FOR POSITIONING PATIENT IN MEDICAL BED

MAXIMUM MASS OF MOBILE HOSPITAL BED (MAXIMUM MASS OF EMPTY BED +

SAFE WORKING LOAD)

EARTH GROUND

UK CONFORMITY ASSESSED (UKCA) MARKING (PRODUCT NORMATIVELY

HARMONIZED FOR GREAT BRITAIN ECONOMIC AREA)

D9U001K40-0101_1710

AUTHORIZED REPRESENTATIVE IN GREAT BRITAIN

AUTHORIZED REPRESENTATIVE IN SWITZERLAND

REPCH

Fig. Warning Label: Do not leave child unattended when head board or foot board is removed!

Fig. Informational label with allowed length of patient

D9U001K40-0101_17

11

READ INSTRUCTIONS FOR USE

CE MARKING

COVER MATERIALS ARE FIRE RESISTANT

TO BS7175, SOURCE 0, 1 AND 5

DO NOT IRON

DO NOT USE PHENOL

DO NOT WRING

REGULARLY INSPECT THE INSIDE OF THE COVER FOR CONTAMINATION

MACHINE WASH AT MAX. 71°C FOR 3 MINUTES

DO NOT BLEACH

PROFESSIONAL CHEMICAL CLEANING (MODERATE PROCEDURE)

1.6 Symbols and Labels on the Mattress

D9U001K40-0101_1712

DISINFECT USING SOLUTION CONTAINING LESS THAN 1000 ppm OF

CHLORINE (REFER TO INSTRUCTIONS FOR USE)

RINSE WITH WATER

TUMBLE DRY ON LOW HEAT SETTING (MAX. 60°C)

MATTRESS FOOT PART

HANDWASH WITH DETERGENT (INITIAL TEMPERATURE OF HOT WATER

SHOULD NOT EXCEED 50°C)

1.7 Serial Label

Serial label of the Tom 2 bed is placed on the left side of the crossbar at foot end. The serial label contains information about Addre-

ss of Manufacturer, Manufacturing Date (Year-Month-Day), Product Reference Number, Product Serial Number, Global Trade Item

Number (GTIN), Unique Device Identication (UDI), symbols, weight specications and electrical specications.

D9U001K40-0101_17

13

1.8 Acoustic signalisation (Tom 2 with PB43RED control unit)

1.9 Acoustic signalisation (Tom 2 with PB11 control unit)

There are no acoustic signals in the case of Tom 2 bed with PB11 control unit.

SOUND MEANING

CONTINUOUS SOUND overheating

accumulator overcurrent

actuator overload

REPEATED BEEP: 0,6s sound / 2,6s silence STOP error (all STOP buttons are disabled)

REPEATED BEEP: 0,1s sound / 3s silence switching of the transformer winding error (Brazil)

BEEP lasting 0,3s conrmation

stopping or locked function

optionally: transition from tilt (Trendelenburg, Antitrendelenburg)

to horizontal position

BEEP lasting 0,5s lowering to the lowest position

start of service mode or end of service mode

keyboard error (positioning blocked)

BEEP lasting 3s system error

REPEATED BEEP during 3 minutes: 1,1s sound / 1,1s silen-

ce

Brake Signal (only version with Brake Signal)

ACCUMULATOR INDICATOR MEANING

lit accumulator disconnected or faulty

ashing: 1,6s lit / 0,2s not lit accumulator deeply discharged

ashing: 0,1s lit / 0,1s not lit accumulator discharged

ashing: 0,2s lit / 1,6s not lit accumulator is charging

not lit accumulator charged

MAINS POWER LED MEANING

lit connected to the mains

ashing: 0,6s lit / 0,6s not lit keyboard error (ashing inverted to Lock LED)

error (rst fault)

ashing: 0,1s lit / 0,1s not lit service mode

not lit disconnected from the mains power

transformer switching error

1.10 Visual signalisation

1.10.1 Mains Power LED (Mini ACP)

1.10.2 Accumulator Indicator (Mini ACP)

D9U001K40-0101_1714

VISUAL

SIGNALISATION

LOCK LED

lit

2 ashing modes:

1) ashing: 0,2s lit / 0,9s not lit

2) ashing: 0,1s lit / 0,1s not lit not lit

Backrest Lock LED locked 1) lock settings - not selected lock

2) lock settings - selected lock

unlocked

Bed Height, Trendelenburg and An-

titrendelenburg Tilt Lock LED

locked 1) lock settings - not selected lock

2) lock settings - selected lock

unlocked

1.10.3 Lock LED (Mini ACP)

1.11 Night Bed Lighting (Tom 2 with PB43RED control unit)

Tom 2 is equipped with undercarriage lighting. The lighting helps the patient or hospital personnel to better orientate in room with

lowered or turned o light. The lowered intensity of lighting is set up after turning the bed on.

The bed is equipped with three-phase illumination:

1. Lowered intensity of illumination

2. Full intensity of illumination

3. Illumination is turned o

The lowered intensity of illumination is set up after the bed is turned on.

After pressing the GO button:

► The bed illumination will light up at full intensity for 10 minutes.

After 10 minutes the bed illumination will be lowered.

Full intensity of illumination continues until the end of GO period when the bed is disconnected from the mains.

In the case any button is pressed:

► For few seconds the bed illumination will light up at full intensity.

Bed illumination lights up for few seconds after pressing any button when the bed is disconnected from the mains.

Turning o bed illumination:

► Disconnect bed from the mains.

After disconnection of the bed from the mains illumination lights up for few seconds.

1.12 Night Bed Lighting (Tom 2 with PB11 control unit)

Tom 2 is equipped with undercarriage lighting. The lighting helps the patient or hospital personnel to better orientate in room with

lowered or turned o light. The lowered intensity of lighting is set up after turning the bed on.

The bed is equipped with three-phase illumination:

1. Lowered intensity of illumination

2. Full intensity of illumination

3. Illumination is turned o

The lowered intensity of illumination is set up after the bed is turned on.

After pressing the GO button:

► The bed illumination will light up at full intensity for 3 minutes.

After 3 minutes the bed illumination will be lowered.

Full intensity of illumination continues until the end of GO period when the bed is disconnected from the mains.

In the case any button is pressed:

► For few seconds the bed illumination will light up at full intensity.

Bed illumination lights up for few seconds after pressing any button when the bed is disconnected from the mains.

Turning o bed illumination:

► Disconnect bed from the mains.

After disconnection of the bed from the mains illumination lights up for few seconds.

D9U001K40-0101_17

15

1.13 Denitions

Adult Patient having a physical size equal to or more than 146 cm, a mass equal

to or more than 40 kg and a body mass index (BMI) equal to or more than 17

(according to EN 50637).

Application Environment 1 intensive/critical care provided in a hospital where 24 h medical supervision

and constant monitoring is required and provision of life support system/equi-

pment used in medical procedures is essential to maintain or improve the

vital functions of the patient

Application Environment 2 acute care provided in a hospital or other medical facility where medical

supervision and monitoring is required and ME equipment used in medical

procedures is often provided to help maintain or improve the condition of the

patient

Application Environment 3 long-term care in a medical area where medical supervision is required

and monitoring is provided if necessary and ME equipment used in medical

procedures may be provided to help maintain or improve the condition of the

patient

Basic Bed Conguration the pricelist model conguration, not including a mattress

Bed Weight The value depends on the product conguration, accessories or customer

adjustments.

Child Patient having a physical size equal to or less than 155 cm and a mass equal

to or less than 70 kg

Clearance of Undercarriage the height from the oor 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

Auto-Regression Auto-Regression is the kinematic system of mattress support platform ad-

justment whose eect is the reduction of pressure on the patient´s abdomen

and pelvic area. Auto-Regression enlarges the space for pelvic area during

Backrest Adjustment.

Maximum Mass of Mobile Hospital Bed Sum of Maximum Empty Bed Mass and Safe Working Load.

Maximum Patient Weight Maximum Patient Weight depends on the application environment according

to EN 50637. For application environment 1 (intensive/critical care) and 2

(acute care) reduce Safe working Load by 65 kg. For application environ-

ment 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.

The Safe Working Load is the sum of:

– the patient

– the mattress

– the accessories of the medical bed (only if they are supported by the supp-

ort system of

the medical bed) and

– the load supported by those accessories (excluding patient weight).

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 oor 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.

D9U001K40-0101_1716

AC ( ~ ) Alternating Current

ACP Attendant Control Panel

CE European Conformity

CPR Cardiopulmonary Resuscitation

dBA Sound Intensity Unit

DC ( ) Direct Current

CUC Conguration number

EMC Electromagnetic Compatibility

FET Field-eect transistor

HF High Frequency

HPL High Pressure Laminate

HW Hardware

ICU Intensive Care Unit

INT. Duty Cycle

IP Ingress Protection

IV Intravenous

LED Light Emitting Diodes

ME Medical Electrical (Equipment)

ON Activation

OFF Deactivation

ppm parts per million, millionth (1000 ppm = 0,1%)

REF Reference Number (product type depending on conguration)

SCU System Control Unit (active mattress)

SN Serial Number

SW Software

SWL Safe Working Load

UDI Unique Device Identication (for medical devices)

USB Universal Serial Bus

WEEE Waste Electrical and Electronic Equipment

1.14 Abbreviations

D9U001K40-0101_17

17

2 Safety Instructions

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 o 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!

To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

WARNING!

During specic investigations or treatments the signicant risks of reciprocal interference posed by medical

electrical equipment may occur.

WARNING!

No modication of this equipment is allowed.

WARNING!

Do not modify this equipment without authorization of the manufacturer.

WARNING!

If this equipment is modied, 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!

Incompatible mattresses can create hazards.

D9U001K40-0101_1718

DANGER!

Risk of injury or death due to use of incorrect equipment!

Ensure the bed and its components are exclusively modied with the manufacturer´s approval.

WARNING!

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the

competent authority of the Member State in which the user and/or patient is established!

WARNING!

Only authorised and trained person using an appropriate tool is allowed to change fuses and power supplies!

WARNING!

This medical device is not intended for oxygen enriched environment!

WARNING!

This medical device is not intended for use with ammable substances!

WARNING!

This medical device is not portable medical electrical equipment!

WARNING!

Make sure the duty cycle (2 min ON/18 min OFF) is not exceeded during bed positioning!

WARNING!

The Tom 2 medical bed is intended for children!

WARNING!

Equipments in close proximity or attached to the Tom 2 medical bed can cause a hazard, e.g. entrapment or

tipping over.

WARNING!

The Tom 2 medical bed shall not be used for transportation of a patient in any kind of vehicle.

WARNING!

Tente Motion castors with diameter 10 cm are not intended for transport of patient in the Tom 2 bed!

WARNING!

Tom 2 bed must be in the lowest position and in horizontal position with at mattress support platform during

bed transport!

WARNING!

No part of the Tom 2 ME equipment shall be serviced or maintained while in use with a patient!

D9U001K40-0101_17

19

WARNING!

Do not leave child unattended when head board or foot board is removed!

WARNING!

When patient higher than 100 cm is inside the bed, siderails have to be set into the middle position! Top positi-

on of the siderails cannot be used as prevention of leaving bed due to possible patient´s fall over the siderail!

WARNING!

It is forbidden to use Tom equipped with any other type of castors than Tente Integral 150 mm for bed transport

between rooms! In the case of bed with lower diameter of the castors there is a risk of bed overturn during

crossing threshold or similar obstacle when the bed is in the highest position!

2.1 Safety instructions

► It is necessary to read the instructions for use 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 sta rotation.

► Use the bed exclusively with the correct mains supply.

► Ensure that the bed is operated exclusively by qualied personnel who have been trained according to the instructions for

use.

► Ensure the bed is only moved or positioned upon even, hard oor surfaces listed in chapter Transport.

► Replace any damaged parts immediately with original spare parts.

► Ensure maintenance and installations are performed only by qualied personnel who have been trained by the manufactu-

rer.

► 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 specied 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 modied 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 Antitrendelenburg.

► 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 Mini ACP 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.

D9U001K40-0101_1720

3 Intended use (Tom 2)

The intended use is the hospitalization of the patient in the paediatric care units, which includes above all the following

aspects:

► Adjustment of the specic positions needed for the preventive reasons, routine nursing, treatments, mobilization, physio-

therapy, examinations, sleeping, and relaxation. These positions are further specied and described in the clinical evaluation of this

device, together with their potential clinical outcomes and benets.

► Providing the safe environment for the patient during all relevant procedures. The particular requirements on patient safety

are the subject of the clinical evaluation, including evaluation of the risk/benet ratio. The relevant safety issues are the part of the

risk management le.

► Patient in-bed indoor transport out of the patient room only if Tente Integral 150 mm castors are used.

► Providing the suitable working conditions for the caregivers to perform the routine and specic tasks during the patient

hospitalization.

3.1 Application environment – compliance with Paediatric standard EN

50637

Design of the Tom 2 medical bed allows immediate and unimpeded access to the patient from the head end of the medical bed in

emergency situations in application environments 1, 2 and 3. For application environments 1 and 2 the Tom 2 must be congured

with removable head board and foot board. For other application environments Tom 2 medical bed can be congured with remova-

ble or non-removable head board and foot board.

3.2 User population

► Paediatric patients from 75 -125 cm height in the standard and intensive care units (based on individual patient status

assessment by caregiver the patient can utilize dedicated device functions)

► Caregivers (nurses, doctors, technical personnel, transport personnel, cleaning personnel)

3.3 Contraindications

► The medical device is not intended for the adult patients use

► The medical device is not intended for the premature baby

► Certain positions are not suitable for specic diagnoses/medical conditions (e.g., higher ICP patients vs. Trendelenburg).

Sta expert assessment / nursing consideration is needed in all individual case of contraindication

3.4 Operator

► Caregiver

4 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 “Intended use” section above, please contact LINET®.

LINET®’s eorts in research, design and manufacture ensure LINET® products are of the highest quality and t

for their intended purpose. However, LINET® can take no responsibility for any damage to the products or any harm to patients,

sta 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 Intended use).

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LINET Tom 2 Operating instructions

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