LINET Tom 2 Parts list manual

Tom 2
Paediatric hospital bed
D9U001K40-0101
Version: 13
Publication Date: 2020-08
Instructions for Use
and Technical Description

D9U001K40-0101_132
Manufacturer:
LINET spol. s r.o.
Želevčice 5
274 01 Slaný
Tel.: [phone]
Fax: [phone]
E-mail: [email protected]
http://www.LINET.com
Service department: [email protected]
Tom 2
Paediatric hospital bed
Author: LINET, s.r.o.
Related links: www.linet.cz
D9U001K40-0101
Version: 13
Publication Date: 2020-08
Copyright © LINET, s.r.o., 2020
Translation © LINET, 2020
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 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_13 3
1 Symbols and Denitions .............................................4
1.1 Warning Notices..........................................................4
1.1.1 Types of Warning Notices ........................................4
1.1.2 Structure of Warning Notices ...................................4
1.2 Instructions..................................................................4
1.3 Lists.............................................................................4
1.4 Symbols on the Package ............................................5
1.5 Symbols and Labels on the Bed .................................6
1.6 Symbols and Labels on the Mattress..........................9
1.7 Serial Label ................................................................. 11
1.7.1 Serial Label with UDI (Tom 2) .................................. 11
1.7.2 Serial Label (mattress) ............................................. 12
1.7.3 Wash Label (mattress) ............................................. 12
1.8 Acoustic signalisation (Tom 2 with PB43 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 PB43 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 .................................................................. 36
9.6 Transport.....................................................................36
9.7 Firmware ..................................................................... 36
10 Power Cable ...............................................................36
11Accumulator ...............................................................37
11.1 Status Faulty Accumulator.........................................38
11.2 Status Discharged Accumulator ................................ 38
11.3 Removing the Bed from Service...............................38
12 Manipulation...............................................................39
12.1 Mini ACP (Attendant Control Panel)..........................39
12.1.1 Central STOP Button .............................................40
12.1.2 Activating GO Button..............................................40
12.1.3 Position Buttons ..................................................... 40
12.1.4 Lock .......................................................................40
12.2 CPR Backrest Release (optionally available) ...........42
12.3 Quick lowering of the backrest..................................43
12.3.1 Description of the connection of the backrest to the piston
of actuator ........................................................................43
12.3.2 Procedure of the quick lowering of the backrest ... 44
12.3.3 Procedure to reconnect the backrest to the piston of
actuator.............................................................................45
12.4 Siderails ....................................................................46
12.4.1 Positions of siderails ..............................................48
12.4.2 Openable siderail bars (optionally) ........................49
12.5 Castor Control and Bed Transport ............................ 50
12.5.1 Castor Control Levers ............................................ 50
13 Equipment ..................................................................51
13.1Accessory Rails.........................................................51
14 Mattress ......................................................................51
14.1 E󰀨ectaCare 20P and CliniCare 10P..........................51
14.2 Rotating of the mattress............................................ 51
14.3 Technical specication of compatible mattress ......... 52
14.4 Mattress cleaning and disinfectants.......................... 53
14.4.1 General Guidance.................................................. 53
14.4.2 Routine Cleaning and Disinfection......................... 54
14.4.3 Complete Cleaning and Disinfection...................... 54
14.4.4 Mattress Core ........................................................54
15Accessories ................................................................55
15.1 Infusion Stand (integrated)........................................55
16 Cleaning/Disinfection ................................................56
16.1 Safety Instructions for Cleaning and Disinfection of the Bed
..........................................................................................57
16.2 General Instructions for Cleaning and Disinfection... 57
16.2.1 Daily Cleaning........................................................ 57
16.2.2 Cleaning before Changing Patients .......................57
16.2.3 Complete Cleaning / Cleaning before First Use.....57
16.2.4 Cleaning of Spilled Fluids ......................................57
16.2.5 Damaged Foam Mattress ......................................57
16.3 Modes of Cleaning and Disinfection .........................58
17 Troubleshooting .........................................................59
18 Maintenance ...............................................................60
18.1 Regular maintenance................................................ 60
18.2 Spare Parts ............................................................... 60
18.3 Safety Technical Checks...........................................60
19 Disposal ...................................................................... 61
19.1 Environment Protection.............................................61
19.2 Disposal ....................................................................61
19.2.1 Within Europe ........................................................ 61
19.2.2 Outside Europe ...................................................... 61
20 Warranty......................................................................62
21 Standards and Regulations ......................................62
Table of Contents

D9U001K40-0101_134
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_13 5
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_136
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_13 7
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_138
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
MASS OF MOBILE HOSPITAL BED (MASS OF EMPTY BED + SAFE WORKING LOAD)

D9U001K40-0101_13 9
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_1310
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)

D9U001K40-0101_13 11
1.7 Serial Label
Pictures of serial labels below serve just for explanation of the signs and elds on the serial labels.
Fig. Serial Label with UDI (Tom 2)
Fig. Informational label with allowed length of patient
1K4XXXX-YY (Tom 2)
1
5 6 7 8 9
4
2 3
1Address of Manufacturer
2Manufacturing Date (Year-Month-Day)
3DI (Device Identier) / GTIN (Global Trade Item Number)
41D Bar code GS1-128 (Serial Number)
5 Conguration number
6 Electrical Specication
7 Serial Number
8PI (Product Identier)
92D Bar Code (GS1 DataMatrix) DI+PI=UDI
1.7.1 Serial Label with UDI (Tom 2)

D9U001K40-0101_1312
Fig. Wash label (mattress)
Fig. Serial label (mattress
- EectaCare 20 P)
Fig. Serial label (mattress
- CliniCare 10 P)
1.7.2 Serial Label (mattress)
1.7.3 Wash Label (mattress)
75
EffectaCare 20 P
4PCLI1100AS
137x70x10 cm
72
CliniCare 10 P
4PRKI1100AS
137x70x10 cm

D9U001K40-0101_13 13
1.8 Acoustic signalisation (Tom 2 with PB43 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_1314
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 PB43 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_13 15
1.13 Denitions
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.
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
Ergoframe Ergoframe is the kinematic system of Mattress support platform Adjustment
whose e󰀨ect is the elimination of pressure on the patient´s abdomen and pel-
vic area and frictional forces on the patient‘s back and legs.
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 (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 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.
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).
Child Patient having a physical size equal to or less than 155 cm and a mass equal
to or less than 70 kg
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

D9U001K40-0101_1316
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_13 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_1318
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 the 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!
Patient is allowed to use selected control elements only if hospital personnel had assessed that the patient´s
physical and psychological state is in accordance with use of them and only if the hospital personnel had
trained the patient in accordance with the instructions for use!
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.

D9U001K40-0101_13 19
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_1320
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.
► 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 -100 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).