LINET Image 3 B User Manual And Technical Description

Brand: LINET

Model: Image 3 B

Type: User Manual And Technical Description

D9U001AM2-0101

Version: 04

Publication date: 2018-08

Image 3 B

Bariatric hospital bed for acute care

User manual and technical

description

D9U001AM2-0101_04

Manufacturer:

LINET spol. s r. o.

Želevčice 5

274 01 Slaný

Czech Republic

Tel.: +420 312 576 111

Fax: +420 312 522 668

E-mail: [email protected]

http://www.linet.cz

Image 3 B

Bariatric hospital bed for acute care

Author: LINET, s.r.o.

Related links: www.linet.cz

D9U001AM2-0101

Version: 04

Publication date: 2018-08

Translation © LINET, 2018

reserves the right to changes in the contents of this manual that relate to the product´s technical regulations. It is

for this reason that the contents of this manual may indicate differences from the current manufacture of the

product.

D9U001AM2-0101_04

Table of content

1 Symbols ........................................................................................................................... 5

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

1.2 Other symbols ..................................................................................................................................... 5

1.3 Symbols and Labels on the Product ................................................................................................... 6

1.4 Serial label with UDI ............................................................................................................................ 7

2 Safety and Dangers ......................................................................................................... 8

2.1 Safety instructions ............................................................................................................................... 9

2.2 Conditions of Use ..............................................................................................................................11

2.3 Specifications of Use .........................................................................................................................11

3 Standards and Regulations .......................................................................................... 11

4 Functioning .................................................................................................................... 12

4.1 Correct use ........................................................................................................................................12

4.2 Incorrect Use .....................................................................................................................................12

5 Scope of Delivery and Bed Variants ............................................................................. 13

5.1 Scope of Delivery ..............................................................................................................................13

5.2 Bed Variants ......................................................................................................................................13

5.3 Applied parts type B ..........................................................................................................................14

6 Setup .............................................................................................................................. 15

6.1 Transport ...........................................................................................................................................15

6.2 Setup ...............................................................................................................................................15

7 Battery Activation .......................................................................................................... 16

7.1 Placement of Control Section ..........................................................................................................16

7.2 Removing the Isolating Foil ..............................................................................................................16

7.3 Isolating Foil ......................................................................................................................................16

8 Assembly ....................................................................................................................... 17

8.1 Potential Equalisation........................................................................................................................17

8.2 Mattress platform ..............................................................................................................................18

8.3 Image 3 B (1AM2) - Single Collapsible Side Rails and Powder Coated Bed Ends ..........................19

8.4 Bed Ends ...........................................................................................................................................20

9 Operation ....................................................................................................................... 22

9.1 Initial Operation .................................................................................................................................22

9.2 Battery ...............................................................................................................................................22

9.3 Battery charging ................................................................................................................................23

9.4 Status Faulty Battery .........................................................................................................................24

9.5 Status Discharged Battery ................................................................................................................24

9.6 Removing the Bed from Service .......................................................................................................24

9.7 Deactivating the Battery ....................................................................................................................24

10 Manipulation .................................................................................................................. 25

10.1 Supervisor control panel (nurse controller) .................................................................................26

10.2 Handset .......................................................................................................................................29

10.3 Night Bed Lightning .....................................................................................................................30

10.4 Bed Illumination ...........................................................................................................................30

D9U001AM2-0101_04

10.5 CPR backrest release ..................................................................................................................31

10.6 Side rails ......................................................................................................................................32

10.7 Castor Control and Bed Transport ...............................................................................................33

11 Accessories ................................................................................................................... 34

12 Cleaning and Disinfection ............................................................................................. 39

12.1 Safety Instructions for Cleaning and Disinfection of the Bed ......................................................39

12.2 General Instructions for Cleaning and Disinfection .....................................................................40

12.3 Choosing of Detergents or Disinfections .....................................................................................41

13 Troubleshooting ............................................................................................................ 42

14 Maintenance ................................................................................................................... 43

14.1 Maintenance Work .......................................................................................................................43

14.2 Functioning ..................................................................................................................................44

15 Disposal ......................................................................................................................... 46

15.1 Environmental Protection ............................................................................................................46

15.2 Disposal .......................................................................................................................................46

16 Warranty ......................................................................................................................... 47

17 EC Declaration of Conformity ....................................................................................... 48

18 Technical Specifications ................................................................................................ 49

18.1 Mechanical Specifications ............................................................................................................49

18.2 Environment Conditions ..............................................................................................................49

18.3 Electrical Specification .................................................................................................................50

18.4 PB 4X Electronic System of Image 3 B .......................................................................................51

D9U001AM2-0101_04

1 Symbols

1.1 Warning Notices

1.1.1 Types of Warning Notices

Warning notices are differentiated by the type of danger using the following key words:

 Caution - risk of material damage.

 Warning - risk of physical injury.

 Danger - risk of fatal injury.

1.1.2 Structure of Warning Notices

1.2 Other symbols

1.2.1 Instructions

Structure of instructions:

 Perform this step.

Result, if necessary.

1.2.2 Lists

Structure of bulleted lists:

 List level 1

 List level 2

Structure of numbered lists:

a. List level 1

b. List level 1

1. List level 2

2. List level 2

SIGNAL WORDS!

Type and source of danger!



Measures to avoid the danger.

D9U001AM2-0101_04

1.3 Symbols and Labels on the Product

Read user manual.

Attention

Thermal protection of transformer

Only suitable for indoor use

Protection against accidents due to electrical current

– Type B instruments

Safety isolation 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

Use mattress recommended by manufacturer

Weight of bed

D9U001AM2-0101_04

Do not put any objects here

WEEE symbol (recycle as electronic waste, do not put

into the household waste)

1.4 Serial label with UDI

Address of Distributor

Manufacturing Date (Year-Month-Day)

DI (Device Identifier) / GTIN (Global Trade Item Number)

1D Bar code GS1-128 (Serial Number)

Symbols

Configuration number

Electrical Specification

Serial Number

PI (Product Identifier)

2D Bar Code (GS1 DataMatrix) DI+PI=UDI

Fig. Serial Label with UDI (Image 3 B)

D9U001AM2-0101_04

2 Safety and Dangers

WARNING!

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

accidentally slipping or rolling off the mattress!

WARNING!

Incompatible siderails and mattresses can cause an entrapment hazard!

WARNING!

Inappropriate handling of the power supply cord, e. g. by kinking, shearing or other mechanical

damages is hazardous!

WARNING!

When routing cables from other equipment in the Image 3 B bed avoid squeezing those between parts

of the Image 3 B bed!

WARNING!

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

WARNING!

The 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 modification of this equipment is allowed.

D9U001AM2-0101_04

2.1 Safety instructions

 Follow the instructions carefully.

 Any non-observance of this manual may lead to injuries or material damage.

 Exclusively use the bed if it is in perfect working order.

 If necessary, check the bed functions daily or at each shift change.

 Use the bed exclusively in its original condition.

 Use the bed exclusively with the correct mains supply.

 Ensure that the bed is exclusively operated by qualified personnel .

 Ensure that the patient (health permitting) has been informed about the operation of the bed and all

applicable safety instructions.

 Move the bed exclusively on even, hard-surfaced floors.

 Replace any damaged parts immediately with original spare parts.

 Ensure that maintenance and installation are performed exclusively by qualified personnel who have been

trained by the manufacturer.

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

 During peak loads or unavoidable excess loads (CPR), place mattress platform in the lowest position.

 Ensure that only one adult patient uses the bed at any time.

 Take care to avoid injuries or squeezing when operating moving parts.

 When using lifting poles or infusion stands, ensure that nothing will be damaged when you move or adjust

the bed.

 Ensure that castors are braked when the bed not being moved, regardless of whether the bed is occupied

or empty

 Keep the mattress 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 injuries.

 Ensure that siderails are operated exclusively by healthcare personnel.

 Never use the bed in areas where there is a hazard of explosion.

 Enable or disable functions on the handset using the supervisor 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 exclusively by pulling on the plug.

WARNING!

Do not modify this equipment without authorization of the manufacturer.

WARNING!

If this equipment is modified, appropriate inspection and testing must be

conducted to ensure continued safe use of the equipment.

WARNING!

An additional MULTIPLE SOCKET-OUTLET or extension cord shall not be

connected to the MEDICAL ELECTRICAL SYSTEM.

WARNING!

During specific investigations or treatments the significant risks of reciprocal interference posed by

ME equipment may occur.

D9U001AM2-0101_04

 Position the mains cable so that there are no loops or bends in the cable; protect the cable from

mechanical wear and tear.

 Improper handling of mains cable can cause an electric shock hazard, other serious injuries or damage to

the bed.

 Ensure that the stipulated duty cycle (on-time) is not exceeded (see INT. on product label).

 Ensure that the moving parts of the bed are not blocked.

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

 Ensure that the stipulated safe working load is not exceeded.

 If the patient's condition could lead to an entrapment, leave the mattress support platform in the flat

position while the patient is unattended.

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

overcoming possible obstacles.

 Do not exceed maximum load of 75 kg for mattress platform extension.

 Ensure that the bed and its components are exclusively modified with the manufacturer´s approval.

 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 linen shelf before using the Reverse Trendelenburg position.

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

 Use exclusively split plastic or split telescopic siderails for confused or disoriented patients.

 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 supervisor panel or handset when they are stored on

siderails or bed ends.

 To prevent collisions, do not put oxygen bottle holders directly under mattress platform.

 Always set mattress platform to its lowest position and single parts of mattress 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 increase 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. back rest) is

forbidden. Otherwise there is a risk of damaging and dysfunction of the back rest actuator or unprompted

fall of the back rest.

D9U001AM2-0101_04

2.2 Conditions of Use

The bed may not be used and stored in indoor environments:

 Where there is a risk of explosion.

 Containing inflammable anaesthetics.

The bed is designed for use in rooms for medical purposes. Electrical installations must therefore meet local stan-

dards laying down the necessary conditions for electrical installations.

 Disconnect the bed from the mains in exceptional cases (i.e. a storm).

2.3 Specifications of Use

Medical purpose:

 Hospital bed for acute care, support for patient in various positions (Horizonal position, Trendelenburg,

cardiac chair, etc.)

Patient:

 For patiens older than 15 years. Weight of patient + mattress + accesories can not be higher than safe

working load (SWL). Condition of patient is not important.

Personnel:

 Qualified medical staff (nurse, doctor) with medical school or university (EU). Any person familiar with the

manual. Patient if the condition permits.

Location:

 The bed is determined for application environments 1, 2, 3 and 5 according to EN 60601-2-52:2010. The

stable undercarriage with 4 castors makes it possible for the bed to be handled by one person. However,

the manufacturer recommends that at least two persons handle the bed.

3 Standards and Regulations

The bed complies with the following standards and directives:

 IEC 60601-1:2012

 IEC 60601-1-2:2007 3.ED

 IEC 60601-1-6:2010

 IEC 60601-2-52:2010

 ISO 15223-1:2012

 ISO 10993-5:2009

 ISO 10993-10:2010

 93/42/EEC

 2011/65/EU

The manufacturer adheres to a certified quality management system in compliance with the following

standards:

 ISO 9001:2008

 ISO 14001:2004

 EN ISO 13485:2003

D9U001AM2-0101_04

4 Functioning

4.1 Correct use

Image 3 B is a standard care hospital bed. It is designed for supporting the bariatric patient in several positions

such as horizontal, Trendelenburg, Cardiac Chair etc.

The stable undercarriage with 4 castors makes it possible for the bed to be handled by one person. However, the

manufacturer recommends that at least two persons handle the bed.

Image 3 B is suitable for:

 Patients

 Older than 15 years

 With a maximum weight of 285 kg

 Whose weight (including mattress and accessories) does not exceed the SWL

 Personnel

 Qualified medical staff

 Any person familiar with the manual

 Patient (condition permitting)

 Use

 standard care

 acute care

 uninterrupted operation

 Location

 Application environments 1, 2, 3 and 5 according to EN 60601-2-52:2010

4.2 Incorrect Use

Image 3 B is not suitable for:

 Patients

 Younger than 15 years

 Use

 Other than described in the user manual

NOTE For information concerning uses other than those outlined in the “Correct Use” section above, please

contact LINET®.

LINET®’s efforts in research, design and manufacture ensure LINET® products are of the highest quality and fit

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

harm to patients, staff or other individuals resulting from:

 Not following the instructions in the manual, including warning notices.

 Using the product for a purpose other than the intended purpose stated in the relevant documentation

provided by LINET® (see Correct Use).

DANGER!

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



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

D9U001AM2-0101_04

5 Scope of Delivery and Bed Variants

5.1 Scope of Delivery

Delivery:

 Upon receipt, check that the shipment is complete as specified on the delivery note.

 Notify the carrier and supplier of any deficiencies or damages immediately as well as in writing or make a

note on the delivery note.

 The bed is delivered with deactivated battery. To activate battery see chapter “Battery activation”.

5.2 Bed Variants

Features – Image 3 B Model 1AM2 (model no. see product label):

 Mattress Platform

 mattress platform consisting of removable plastic segments

 Bed Ends

 powder coated with fixed, coloured HPL panels

 aluminium bed ends with fixed coloured HPL panels

 Side rails

 Single collapsible side rails, powder coated

 Castors

 125 mm Tente Linea with individual braking system

 150 mm Tente Linea, with central braking system

 Control Elements

 ACP Nurse control panel (supervisor control panel)

 Handset with illuminated keyboard

 Handset without illuminated keyboard

 Other

 Linen shelf

 Vertical safety bumpers

 One pair of universal accessory holders

 One pair of urine bag holder

 CPR emergency backrest release

 Segufix holders

 Colour concept

 Powder-coated metal parts RAL 9006 (light grey) + RAL 7043 (dark grey)

 Powder-coated metal parts RAL 9002 (white)

CAUTION!

Damage to the bed due to incorrect use!



Use 125 mm castors exclusively on flat, even surfaces without any gaps.

D9U001AM2-0101_04

5.3 Applied parts type B

All the accesories the patient can reach are type B applied parts.

List of type B applied parts:

 ACP Nurse control panel (supervisor control panel)

 Handset

 Satellite controller

 Side rails

 Bed ends

 Mattress platform

D9U001AM2-0101_04

6 Setup

6.1 Transport

For safe transport, observe the following:

 Ensure no cables are run over when moving a bed.

 Ensure the mains cable is attached with a hook (at the head end of the bed).

 Ensure the castors are unlocked before moving the bed during the loading/unloading process (see Castor

Control and Bed Transport).

 Ensure the side rails are lifted and locked while the patient is on the bed during the transport.

 Move the bed only on suitable floor surfaces.

Suitable surfaces:

 Tile

 Hard linoleum

 Hard flooring

Unsuitable surfaces:

 Soft, unsealed or defective flooring

 Soft wooden flooring

 Soft and porous stone floors

 Carpeted floors with underlay

 Soft linoleum

 For longer distances, ensure the castor steering function (main control) is activated.

 Ensure the brakes are released while moving the bed.

6.2 Setup

Set up the bed as follows:

 Unpack the bed.

 Check the delivery (see Scope of Delivery).

 Remove isolating foil from mains control box (see Removing Isolating Foil).

 Install equipment and accessories (see Assembly).

 In case of delivery with dismounted bed ends, mount the head and foot ends (see Bed Ends).

 Set-up the bed only on a suitable floor surface (see Transport).

 Ensure the mains cable does not collide or get stretched when adjusting the bed. Check the plug is

inserted correctly.

 Do not leave any extension cords or power strips loose on the floor.

 Ensure all the required mechanical and electrical prevention mechanisms are available on site.

 There is no mains switch on the bed, i.e. the mains cable is the only means to isolate the bed from the

mains.

 Ensure the mains cable is always accessible.

 The plug on the mains cable should only be changed and maintained by qualified and trained service

technicians authorised by the manufacturer.

D9U001AM2-0101_04

7 Battery Activation

7.1 Placement of Control Section

7.2 Removing the Isolating Foil

7.3 Isolating Foil

Check if isolating foil is complete and undamaged as shown:

If isolating foil is damaged, contact the manufacturer’s service department immediately.

NOTE: It is recommended to wear gloves when removing the isolating foil.

Pull

D9U001AM2-0101_04

8 Assembly

8.1 Potential Equalisation

The bed is equipped with a standard protective connector. This connector is used for potential equalisation

between the bed and any intravascular or intracardiac device connected to the patient to protect the patient from

static electric shocks.

Use equalisation connector if:

 The patient is connected to any intravascular or intracardiac device.

Before connecting the patient to an intravascular/intracardiac device:

 Connect the ground wire of the device to the potential equalisation connector (Fig. 1) on the bed on which

the patient in question is lying.

 Use a standard hospital connector (Fig. 2).

 Make sure the connectors match.

 Make sure there is no possibility of accidental disconnection.

Before moving the bed:

 Disconnect the patient from the intravascular or intracardiac device.

 Disconnect the potential equalisation connector.

WARNING!

Risk of injury when working on the bed!



Ensure the bed is disconnected from the mains connection prior to assembly, disassembly and

maintenance.



Ensure the castors are locked prior to assembly, disassembly and maintenance.

CAUTION!

Material damage due to incorrect assembly!



Ensure the assembly is performed only by seller´s customer service or trained hospital personnel.

Fig. 1 Potential equalisation connector – male

Fig. 2 Potential equalisation connector – female

D9U001AM2-0101_04

8.2 Mattress platform

The mattress platform consists of removable plastic sections.

To remove/install sections of the mattress platform:

 Pull out mattress platform sections.

 Install mattress platform section.

 The correct fitting of section is signalized by hearable “click”.

 Ensure that mattress platform sections are fitted correctly by trying pull the section up with little manpower.

Fig. 3 Label on Mattress Platform Parts

D9U001AM2-0101_04

8.3 Image 3 B (1AM2) - Single Collapsible Side Rails and Powder Coated Bed Ends

1. Foot end of the bed

2. Virtuoso II compressor

3. Side rail release mechanism

4. Side rail extension – Extender®

5. Virtuoso II active mattress for bariatrics

6. Head end of the bed

7. Single collapsible side rails

8. Handset

9. Castor control lever

10. Castor

11. CPR control lever – backrest release

12. Accessories rail

13. Fifth castor

14. Calf rest handle / Mattress holder

15. Housing for the Protector®

16. Bed end unlocking mechanism

17. Supervisor control panel

18. Protective bumper

NOTE For safe, easy handling, LINET® recommends that two technicians assemble the bed.

Fig. 4 Overview Image 3 B – Single Collapsible Side Rails

D9U001AM2-0101_04

8.4 Bed Ends

NOTE: The bed ends may be delivered in several decor colour variants.

8.4.1 Aluminium bed ends

1. Locked

2. Unlocked

WARNING!

Risk of injury when inserting the bed ends!



To insert bed ends into corner posts, hold them by the corner handles on top with both hands.



Install bed ends before the first use.

WARNING!

Risk of injury due to incorrectly installed bed ends!



Ensure bed ends are correctly inserted, especially when moving the bed.



Ensure bed ends locks are locked, especially when moving the bed.

WARNING!

Risk of injury when removing the bed ends!



Before removing bed ends, ensure side rails are folded down and there are no accessories attached to

the bed ends.



If a patient is lying in a bed with the head and/or foot board removed, supervise the bed at all times.

WARNING!

Material damage due to excess load!



Ensure nobody sits on the bed ends.

Fig. 5 Locking the bed end

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LINET Image 3 B User Manual And Technical Description

Brand: LINET

Model: Image 3 B

Type: User Manual And Technical Description

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LINET Image 3 B User Manual And Technical Description

LINET Image 3 B User Manual And Technical Description

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