LINET Image 3 Operating instructions

Image 3

Hospital bed for acute care

D9U001AM0-0101

Version: 12

Publication Date: 2023-03

Instructions for Use

and Technical Description

D9U001AM0-0101_122

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

D9U001AM0-0101_12

3

Image 3

Hospital bed for acute care

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

Related links: www.linet.cz

D9U001AM0-0101

Version: 12

Publication Date: 2023-03

Translation © L I N E T, 2022

changes in the contents of the instructions for use that relate to the product´s technical regulations. It is for this reason that the con-

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

D9U001AM0-0101_124

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 Acoustic signalisation (Image 3 with PB43 control unit)

..........................................................................................11

1.7 Acoustic signalisation (Image 3 with PB21 control unit)

..........................................................................................11

1.8 Visual signalisation......................................................12

1.8.1 Mains Power LED (Attendant Control Panel) ...........12

1.8.2 Accumulator Indicator (Attendant Control Panel) ..... 12

1.8.3 Lock LED (Attendant Control Panel) ........................ 12

1.9 Denitions ...................................................................13

1.10 Abbreviations ............................................................14

2 Safety Instructions .......................................................15

3 Intended use ................................................................. 18

3.1 User population ........................................................... 18

3.2 Contraindications ........................................................18

3.3 Operator ...................................................................... 18

4 Incorrect Use ................................................................18

5 Product Description ..................................................... 19

5.1 Image 3 with split Telescopic Siderails ........................ 19

5.2 Image 3 with Collapsible Siderails (3/4 Siderails) .......20

6 Technical Specication ...............................................21

6.1 Identication of Applied parts (Type B) ......................21

6.2 Mechanical Specication (Standard Version) ............ 21

6.3 Mechanical Specications (Washable Version) .......... 22

6.4 Environment Conditions (Standard and Washable Version)

..........................................................................................22

6.5 Electrical Specication (Standard and Washable Version)

..........................................................................................23

6.6 Electromagnetic compatibility .....................................23

6.6.1 Manufacturer instructions - electromagnetic emissions

..........................................................................................24

6.6.2 Manufacturer instructions - electromagnetic susceptibility

..........................................................................................24

7 Use and Storage Conditions ....................................... 25

8 Scope of Delivery and Bed Variants ........................... 26

8.1 Scope of Delivery ........................................................ 26

8.2 Bed Variants ................................................................26

8.2.1 Standard version: Image 3 – 1AM ...........................26

8.2.2 Washable version: Image 3 – 1AMW ......................27

9 Putting into Service .....................................................27

9.1 Accumulator Activation ................................................ 28

9.1.1 Position of Accumulator ...........................................28

9.1.2 Removing the Isolating Foil ......................................28

9.1.3 Isolating Foil ............................................................. 28

9.2 Head Board and Foot Board .......................................29

9.2.1 Foot End of the Washable bed .................................29

9.2.2 Aluminium Head Board and Foot Board ..................30

9.2.3 Plastic Head Board and Foot Board (Clean&Clear design)

..........................................................................................31

9.2.4 Plastic Head Board and Foot Board (design Eleganza 1

and Eleganza 3) ...............................................................33

9.2.5 Powder coated Head Board and Foot Board ...........34

9.3 Mattress Support Platform ..........................................36

9.4 Potential Equalisation .................................................37

9.5 Before Use ..................................................................38

9.6 Transport ..................................................................... 38

9.7 Firmware .....................................................................38

10 Power Supply Cord (Mains Power Cable) ................39

11 Accumulator ...............................................................39

11.1 Status Faulty Accumulator .........................................40

11.2 Status Discharged Accumulator ................................ 40

11.3 Removing the Bed from Service...............................40

11.4 Deactivating the Accumulator ................................... 41

12 Manipulation ............................................................... 41

12.1 Attendant Control Panel (ACP) .................................42

12.1.1 Central STOP Button .............................................42

12.1.2 Activating GO Button ..............................................43

12.1.3 Function Buttons ....................................................43

12.1.4 Lock Buttons (2) ..................................................... 43

12.1.5 Mains Power LED (17) ........................................... 43

12.1.6 Position Buttons .....................................................44

12.1.7 Night Bed Illumination ............................................45

12.2 Attendant Control Panel with SafeSense® 3 Control 46

12.2.1 Central STOP Button .............................................47

12.2.2 Activating GO Button ..............................................47

12.2.3 Function Buttons ....................................................47

12.2.4 Lock Buttons (17, 18 and 19) ................................. 47

12.2.5 Mains Power LED Signalisation (4) .......................48

12.2.6 Accumulator Charge Status LED Signalisation (6) 48

12.2.7 Position Buttons .....................................................48

12.2.8 SafeSense® 3 Display (21) ....................................50

12.3 Handset .....................................................................52

12.3.1 Standard version .................................................... 53

12.3.2 Handset with Plug and Play connector (optional) .53

12.3.3 Washable version ...................................................53

12.4 CPR backrest release ...............................................55

12.5 Siderails ....................................................................57

12.5.1 Telescopic Siderails............................................... 57

12.5.2 Collapsible Siderails (3/4 Siderails) ......................59

12.6 Mechanical Bed Extension ........................................61

12.6.1 Bed Extension Adjustment ..................................... 61

12.7 Calfrest Extension (optional) ..................................... 63

12.7.1 Calfrest Extension Adjustment ............................... 63

12.8 Castor Control and Bed Transport ............................ 64

12.8.1 Bed with Castor Control Levers .............................64

13 Equipment ..................................................................65

13.1 Accessory Rails .........................................................65

13.2 DIN rail (optional) ......................................................65

13.3 Green light (optional) ................................................65

13.4 The Fifth Castor ........................................................65

13.5 Brake Signal (Signalization of Unbraked Bed) .......... 65

13.6 USB connector (optional) ......................................... 66

13.7 Linen Shelf ................................................................67

13.8 SafeSense® 3 ready bed .......................................... 68

14 Mattress ......................................................................68

15 Accessories ................................................................69

15.1 Lifting Pole ................................................................70

15.2 Infusion Stands .........................................................71

15.3 Additional hooks for accessories ...............................72

15.4 Oxygen bottle holder ................................................. 72

15.5 Cannula holder ..........................................................73

15.6 Urinary bottle holder ..................................................73

15.7 Redon bottle holder ...................................................73

15.8 Siderails Extension – Extender® ..............................74

15.9 Image 3 Protector® ................................................... 75

15.10 SafeSense® ............................................................ 76

15.11 SafeSense® 3 .........................................................77

16 Cleaning/Disinfection ................................................78

16.1 Safety Instructions for Cleaning and Disinfection of the Bed

..........................................................................................79

16.2 General Instructions for Cleaning and Disinfection ... 79

16.2.1 Daily Cleaning ........................................................ 79

16.2.2 Cleaning before Changing Patients .......................79

16.2.3 Complete Cleaning / Cleaning before First Use .....79

16.2.4 Cleaning of Spilled Fluids ......................................79

16.2.5 Damaged Foam Mattress ......................................79

16.3 Modes of Cleaning and Disinfection .........................80

16.4 Machine washing ......................................................80

Table of Contents

D9U001AM0-0101_12

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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

16.4.1 Preparing for cleaning ............................................ 81

16.4.2 Machine washing ...................................................82

16.4.3 After machine washing ........................................... 82

16.4.4 Washable Image 3 bed with SafeSense ................82

17 Troubleshooting ......................................................... 86

18 Maintenance ...............................................................87

18.1 Regular maintenance ................................................ 87

18.2 Spare Parts ...............................................................87

18.3 Safety Technical Checks ........................................... 87

18.4 Beds designed for machine washing ........................88

18.4.1 Recommended places for greasing .......................88

19 Disposal ......................................................................90

19.1 Environment Protection .............................................90

19.2 Disposal ....................................................................90

19.2.1 Within Europe ........................................................90

19.2.2 Outside Europe ......................................................90

20 Warranty ......................................................................91

21 Standards and Regulations ......................................91

D9U001AM0-0101_126

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

D9U001AM0-0101_12

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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

WARNING AGAINST CRUSHING OR TRAPPING

MAXIMUM WEIGHT OF PATIENT

D9U001AM0-0101_128

USE MATTRESS RECOMMENDED BY MANUFACTURER

WEIGHT OF BED

DO NOT PUT ANY OBJECTS HERE

BED (WASHABLE VERSION) IS DESIGNED FOR CLEANING IN DECONTAMINATION

DEVICES, WHICH MEETS CRITERIA STATED IN STANDARD AK:BWA 2009 (LABEL IS

PLACED ON THE CROSSBAR OF THE FOOT END OF THE BED)

DESIGNATION OF HOSPITAL BED FOR ADULTS

EAC MARKING (EURASIAN CONFORMITY)

DO NOT OPEN!

RECYCLE SYMBOLS

WEEE SYMBOL (RECYCLE AS ELECTRONIC WASTE,

DO NOT PUT INTO THE HOUSEHOLD WASTE)

MEDICAL DEVICE (COMPATIBLE WITH MEDICAL DEVICE REGULATION)

DO NOT POLLUTE THE ENVIRONMENT

D9U001AM0-0101_12

9

SAFETY MARK – BED CERTIFIED IN TÜV SÜD

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)

HEAD BOARD UNLOCKED OR FOOT BOARD UNLOCKED (PLASTIC HEAD BOARD

AND FOOT BOARD, POWDER COATED HEAD BOARD AND FOOT BOARD)

HEAD BOARD LOCKED OR FOOT BOARD LOCKED (PLASTIC HEAD BOARD AND

FOOT BOARD, POWDER COATED HEAD BOARD AND FOOT BOARD)

UNIQUE DEVICE IDENTIFICATION (FOR MEDICAL DEVICES)

D9U001AM0-0101_1210

DO NOT INSERT LIFTING POLE HERE!

MASS OF MOBILE HOSPITAL BED (MASS OF EMPTY BED + SAFE WORKING LOAD)

UK CONFORMITY ASSESSED (UKCA) MARKING (PRODUCT NORMATIVELY

HARMONIZED FOR GREAT BRITAIN ECONOMIC AREA)

AUTHORIZED REPRESENTATIVE IN GREAT BRITAIN

AUTHORIZED REPRESENTATIVE IN SWITZERLAND

REPCH

D9U001AM0-0101_12

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1.6 Acoustic signalisation (Image 3 with PB43 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)

1.7 Acoustic signalisation (Image 3 with PB21 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)

BEEP lasting 0,3s locked positioning

3 TIMES REPEATED BEEP lasting 0,3s positioning powered by the accumulator

BEEP lasting 0,5s keyboard error (positioning blocked)

lowering to the lowest position

start of service mode

BEEP lasting 3s system error

D9U001AM0-0101_1212

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

1.8 Visual signalisation

VISUAL

SIGNALISATION

LOCK LED

lit

ashing:

0,6s lit / 0,6s not lit not lit

Thighrest Lock LED locked lock

error

keyboard

error

motion

blocked

unlocked

Backrest Lock LED locked lock

error

keyboard

error

motion

blocked

unlocked

Bed Height, Trendelenburg and An-

titrendelenburg Tilt Lock LED

locked lock

error

keyboard

error

motion

blocked

unlocked

1.8.1 Mains Power LED (Attendant Control Panel)

1.8.2 Accumulator Indicator (Attendant Control Panel)

1.8.3 Lock LED (Attendant Control Panel)

D9U001AM0-0101_12

13

1.9 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 IEC 60601-2-52. 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 IEC 60601-2-52).

Mass of mobile hospital bed Sum of empty bed mass and Safe Working Load.

D9U001AM0-0101_1214

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

1.10 Abbreviations

D9U001AM0-0101_12

15

2 Safety Instructions

WARNING!

Image 3 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 Image 3 should be located in the „up“ position to reduce the risk of the patient accidentally sli-

pping 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 Image 3 bed avoid squeezing those between parts of the

Image 3 bed!

WARNING!

Image 3 bed should not be used with bed hoists and bed lifts!

WARNING!

The Image 3 bed is intended for adults.

► Follow chapter Intended use.

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 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.

DANGER!

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

► Always conduct the risk assessments required for the selection of suitable equipment.

D9U001AM0-0101_1216

WARNING!

An additional multiple socket-outlet or extension cord shall not be connected to the medical electrical system.

WARNING!

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

electrical equipment may occur.

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!

D9U001AM0-0101_12

17

Additional Instructions for Correct Use:

► 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 that the patient (health permitting) has been informed about the operation of the bed and all applicable safety

instructions.

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

► 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

manufacturer.

► Do not apply excess weight or load to the bed according to SWL (safe working load).

► Only one adult 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.

► Keep the mattress support platform in the lowest position at any time when the healthcare personnel are not treating the

patient in order to prevent the patient from falling or sustaining injuries.

► Ensure that siderails are operated by healthcare personnel only.

► Never use the bed in areas where there is a hazard or risk of explosion.

► Enable or disable functions on the handset using the Attendant Control Panel as appropriate for the patient’s physical

and mental state. Verify that the function is actually disabled.

► 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 is not exceeded (see INT. on serial label).

► Ensure moving parts of the bed are not blocked.

► To prevent failures, use exclusively the manufacturer’s original accessories and mattresses.

► Ensure the safe working load is not exceeded.

► Adjust bed height to approx. 20 cm below maximum height when transporting the bed in order to facilitate overcoming

possible obstacles.

► Do not exceed the 75 kg safe working load of the mattress support platform extension.

► 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 support

platform, between movable parts etc.) before positioning the bed or folding down the siderails.

► Close linen shelf before using the Antitrendelenburg or Cardiac Chair Position.

► Do not put any objects (e.g. accessories, infusions, cables) between or on siderails and movable parts. Or between

mattress support 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.

► Use exclusively split plastic or split telescopic siderails for confused or disoriented patients or add Protector to the single

collapsible siderails.

► Before setting the extra-low position, ensure there is no risk of any parts of the bed colliding with servers, accessories or

body parts.

► Ensure there is no risk of damaging the cables of the Attendant Control Panel or handset when they are stored on side-

rails or on head board and foot board.

► To prevent collisions, do not put oxygen bottle holders directly under the mattress support platform.

► Always set mattress support platform to its lowest position and single parts of mattress support platform to horizontal

position in case the patient is left on the bed without supervision of personnel and if his health and mental status may indicate inc-

rease risk of falling out of the bed or entrapment.

► Personnel must consider overall adjustment of the bed and locking all of the positioning functions in accordance to health

and mental status of patient, especially if the patient is left without supervision (even for short period of time) of the personnel.

► Manual positioning of parts of the bed which are designed for electronic positioning (e.g. backrest) is forbidden. Otherwise

there is a risk of damaging and dysfunction of the backrest actuator or unprompted fall of the backrest.

D9U001AM0-0101_1218

3 Intended use

The intended use is the hospitalization of the patient in the acute and long-term 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 User population

► Adult patients (weight >= 40 kg, height >= 146 cm, BMI >= 17) in the acute and long-term care units (Application Environ-

ment 2 and 3, as in IEC 60601-2-52)

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

3.2 Contraindications

► The medical device is not intended for the pediatric patients use.

► Certain positions are not suitable for specic diagnoses/medical conditions (e.g. spinal cord injuries vs. Fowler position,

higher ICP patients vs. Trendelenburg). Sta expert assessment / nursing consideration is needed in all individual case of contrain-

dication.

3.3 Operator

► Caregiver

► Patient (based on individual patient status assessment by caregiver the patient can utilize dedicated device functions)

4 Incorrect Use

Image 3 is not suitable for:

■ Patients

□ Not fullling conditions stated in chapter “Intended use”

■ Use

□ Other than described in the instructions for use

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).

D9U001AM0-0101_12

19

5 Product Description

5.1 Image 3 with split Telescopic Siderails

Fig. Image 3 with split Telescopic Siderails

1. Aluminium Head Board

2. Accessory Adaptor for Lifting Pole or Infusion Stand

3. Mattress Holder

4. Backrest

5. Telescopic Siderail

6. Thighrest

7. Calfrest

8. Aluminium Foot Board

9. Foot Board Lock

10. Corner Bumper

11. Linen Shelf

12. Bed Extension Handle

13. Siderail Release Mechanism

14. CPR Lever (Backrest Release)

15. Castor

16. Central Castor Control System Lever

17. Removable Plastic Segment of the Mattre-

ss Support Platform

9

8

10

11

1215 14 13

16

17

1 2 3 5 764

NOTE For safe, easy handling, LINET® recommends that two technicians put the bed into service.

D9U001AM0-0101_1220

5.2 Image 3 with Collapsible Siderails (3/4 Siderails)

Fig. Image 3 with Collapsible Siderails (3/4 Siderails)

NOTE For safe, easy handling, LINET® recommends that two technicians put the bed into service.

9

8

10

1114 13 12

15

16

1 2 3 5 764

1. Plastic Head Board

2. Accessory Adaptor for Lifting Pole or Infusion Stand

3. Mattress Holder

4. Backrest

5. Collapsible Siderail

6. Thighrest

7. Calfrest

8. Plastic Foot Board

9. Foot Board Lock

10. Linen Shelf

11. Corner Bumper

12. Siderail Release Mechanism

13. CPR Lever (Backrest Release)

14. Castor

15. Central Castor Control System Lever

16. Removable Plastic Segment of the Mattre-

ss Support Platform

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LINET Image 3 Operating instructions

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