Njord Atle 180 User manual

Atle 180

INSTRUCTIONS FOR USE

Atle® 180 (20,000) IFU EN Rev K - 06/2023

®

II

To avoid injury, always read these Instructions for Use and accompanied documents before

using the product.

Mandatory to read the Instructions for Use

Design policy and Copyright

® and TM are trademark of Njord Medtech.

As our policy is one of continuous product development and we therefore reserve the right

to change/modify designs/constructions and specications without prior notice. The content

of this publication/document may not be copied either whole or in part without permission/

consent from Njord Medtech.

III

Table of contents

Foreword��1

Read this manual carefully! �� 1

Safety Instructions ��2

Symbols used ��4

Product description��5

Use of Atle® 180��6

General horizontal transfer of patient �� 6

Transfer at bowl-shaped CT-scanner �� 8

Attachment solution with hooks in a stretcher or trauma mattress�� 8

Attachment Solution �� 9

Charging and Hand Control�� 10

Buttons�� 11

Brakes and Emergency Stop�� 11

Cleaning and service��13

Cleaning of Atle® 180 �� 13

Replacement of the wire�� 13

Maintenance �� 15

Troubleshooting �� 17

Atle® Labels ��19

Technical Specification��20

Product data �� 20

Dimensions �� 22

Electromagnetic Compatibility��23

Electromagnetic Compliance �� 23

Electromagnetic Emissions �� 24

Electromagnetic Immunity �� 25

1

Foreword

Read this manual carefully!

The information in this manual is crucial for

proper use and maintenance of Atle® 180.

It will help protect your product as well as

ensure that it performs to your satisfaction.

Transferring a person always constitutes a

potential risk. This document contains safety

related information that must be read and

understood to help prevent injuries.

Njord Medtech recommends and warns

that to avoid injuries attributed to the use of

inadequate parts, only parts designated by

Njord Medtech should be used on products

and other appliances supplied by Njord

Medtech.

Unauthorized modications of Atle® 180

may affect its operational and functional

performance. Njord Medtech will not be held

responsible for accidents, incidents or lack

of performance that occurs as a result of any

unauthorized modication to the product.

If a serious incident occurs during the use of

Atle® 180, affecting the user or patient, the

user or the patient should report the serious

incident to the manufacturer or distributor.

In the European Union, the user should also

report the serious incident to the Competent

Authority in the member state where they are

located.

Manufacturer Information

This product is manufactured by:

Njord International AB

Medicinaregatan 8

413 90 Göteborg

Sweden

hello@njordmedtech.com

www.njordmedtech.com/

Definitions used in this manual

Means: Failure to understand and follow

instructions may result in injury to yourself

and others.

Means: Important information regarding

correct use of the product. Failure to follow

instructions may cause damage to the

product.

NOTE:

WARNING:

2

Keep the manual together with the product

so that it can be used as reference or

provide access to online documentation

at njordmedtech.com. Store the Quick

Reference Guide that comes with the product

well visible to all staff.

Atle® 180 is a medical device for horizontal

patient transfer and used in healthcare in

which the transfers are made from one

care bed to another examination table or

equivalent.

Intended Use

Atle® 180 has been designed to assist

caregivers in hospitals and should only be

used by healthcare professionals in care

environment.

The product is not intended for wet areas

and should not be used inside MRI (magnetic

resonance) examination rooms, i.e. not in

proximity to a magnetic eld.

WARNING: The product is not intended to

be used on inside MRI examination rooms

Atle® 180 should be used in an

indoor environment.

There is no need for medical device specic

training for professional healthcare users to

use Atle® 180.

Operational Life

Atle® 180 has been designed and tested to

achieve up to 40 000 cycles with a load of

180 kg. Corresponding to 4-6 years of use.

Maintenance according to the specications

in the section “Cleaning and Service” in this

manual applies.

Important Safety Instructions

The batteries that power Atle® 180 are

rechargeable and may not be replaced.

The batteries are charged via ordinary main

plugs. Atle® 180 should not and cannot be

used during charging. To avoid a fall accident

the caregiver should be attentive to the cord

and its placing during charging.

The wheels of Atle® 180 can be rotated 360

degrees to enable a smooth handling of the

device. The wheels are for safety reasons

possible to lock and should be locked while

the device is not intended to be in motion.

Use only accessories intended for Atle® 180.

Atle® 180 should only be used to transfer

patients horizontally between the beds. It is

not intended to be used for other transfers

e.g. move the patient to the side. Atle® 180

is not for moving any other type of object.

Safety Precautions

Do not position the system so that it is

difcult to operate the disconnection device.

The power cord to the control unit should

be positioned to avoid a tripping hazard and/

or damage to the cord.

Manufacturer will prove circuit diagrams,

component part list, and product description

to assist the service personnel in service

repair.

Uplug the power cord charger from the

control panel to disconnect the device from

supply mains.

Safety Instructions

NOTE: Atle® 180 should only be used for

two horizontal aligned surfaces

WARNING: Using Atle® 180 beyond its

life span may result in an incident causing

serious injuries

3

Before use

Before rst use, check that all parts

are included according to the product

description, clean Atle® 180 and test the

emergency stop button. Note that the battery

must be charged at least 24 hours before rst

use.

In case of deviation

In need of immediate shutdown during

transfer, the emergency stop switch on the

product is to be used.

Stop transfer immediately in case of irregular

sound from the engine or irregular speed of

transfer.

Policy on Number of Staff Members

Required for Patient Transfer

Atle® 180 is designed for safe usage with

one caregiver. There are circumstances

that may dictate the need for a two-person

transfer. An example of this is moving the

patient from a CT table to a bed. It is the

responsibility of the caregiver to determine

if a one or two-person transfer is more

appropriate.

Safe workload (SWL)

Maximum patient weight for Atle®

180 is 180 kg.

Product label

The main product label has a barcode

ID, serial number and date of manufacture for

the product.

Safety Instructions

1) Between Atle® 180 and bed unit

2) Between the wire and transfer bar

3) On the loops/hooks

4) When changing bobbin

5) At the wire guide

1

2

5

3

4

Fig 1

WARNING: Do not put ngers, hands or

other body parts where space is limited

(see Fig 1). This could pinch, cut or

seriously harm body parts

<180 Kg

WARNING: No modication of this

equipment is allowed

1

4

Atle® 180 unit has a traceability product label with the symbols below, the other symbols can

be found on Atle® 180 or in the Instructions for Use.

CE marking indicating

conformity with European

Community harmonies

legislation

Manufacture – This symbol

points out the manufacturer’s

name and address

Error indication

Battery indication

The Instruction for Use is

recommended to be read

Indicates the product is a

medical device according to the

EU Medical Device Regulation

2017/745

Intended for indoor use only

Points out a risk of pinching

!

The maximum load the device is

tared for safe usage / Maximum

patient weight

Points out the emergency stop

button

Date of manufacture

Class II equipment, double

insulation

Reset Points out the reset button for

the emergency stop

Charging output

Hand

Control Hand control output

STOP

IP 20 Protection class against moisture

<180 Kg

Temperature limitations

Humidity limitations

Serial number

Reference number

Symbols used

Waste electrical and Electronic

Equipment (WEEE) – do not

dispose of this product in general

household or commercial waste

The Instruction for Use must be

read

5

Product description

1) Attachment solution (replaceable) 7) Wire guide

2) Transfer bar 8) Emergency stop

3) Wire (replaceable) 9) Reset button for emergency stop

4) Wheel brake 10) Charger output

5) Hand Control with battery indicator 11) Hand Control output

6) Bobbin (replaceable) 12) Battery charger and power cord

To disconnect the device, pull out the charger from the appliance and/or pull out the plug

from main socket

Fig 2

6

Before transfer

1) Ensure the patient is lying on hirs back in a

centered position with sheets extending >20

cm from the patient’s shoulder and hip.

To facilitate the transfer, sliding boards should

be used. Place optional sliding boards under

the patient. Good positions are under the feet,

the hips and the shoulders.

2) Prepare the transfer by placing the transfer

bar on the sheet, at height with the shoulder

and hip of the patient. Then fold the remaining

sheet over the transfer bar. The transfer bar

should be placed close to the patient.

3) Place the bed parallel to and approximately

0.5 meters from the other unit. Atle is placed

on the long side of the empty unit.

Attachment solution

4) Go to Atle® 180, pull out both wires

simultaneously and place them on the empty

bedside/examination table unit. Open the

loops of the attachment solution.

Attach the loops over the sheet and around

the transfer bar. Tighten the loop around

the transfer bar so that the loop is fastened

tightly. Do the same on the other side (See

“attachment solution”, page 9).

NOTE: Sliding boards should be used for a

more secure and comfortable transfer

Use of Atle® 180

General horizontal transfer of patient

The transfer technique described below can be used for patients lying in bed to transfer them

horizontally between beds, from stretcher to bed and bed to examination table and vice versa.

NOTE: Maximum patient weight at transfer

with Atle® 180 is 180 kg

1

2

3

Fig 3

Fig 4

Fig 5

4

Fig 6

7

During the transfer

5) Ensure that the bed and examination table

are placed at the same height right next to

each other. Lock the wheels on the bed. The

sliding boards must protrude between the bed

and examination table.

Atle® 180 is positioned completely close to

the long side of the empty unit. Adjust the

height of Atle® 180 so that the position of the

wires is 2-3 cm above the mattress; see gure

7. The wires must be positioned in a straight

line from Atle® 180´s output towards the

transfer bar. Finish positioning Atle® 180 by

locking all of the wheels on Atle® 180.

6) Initiate motorized transfer via hand control.

Press the pull button so that the wires are

stretched, then release the button for a

second, contact the patient and inform that

the transfer starts. Press the pull button again

and perform the transfer.

Make sure that the patient is following the

transfer, especially the feet, shoulders and

head. This is done with the help of one hand

by adjusting the sheets associated with the

transfer.

At the end of the transfer

7) End the transfer when the patient is

positioned centered on the new bed unit.

Remove the fastener from the sheet and

transfer bar by pulling out the wires slightly

and widening the loop forward through the

wire holder. Remove the transfer bar and the

sliding boards.

Use of Atle® 180

WARNING: Both beds should be positioned

right next to each other to avoid the risk

of the patient falling between these. For

additional safety measures, sliding boards

should be used

NOTE: Position Atle® 180 completely

close to the bed edge with the position of

the wires 2-3 cm over the mattress on the

examination table, to avoid risk of tipping

WARNING: Avoid moving your arm / hand

between the transfer bar and engine part

when the transfer bar approaches engine

part at end of the transfer to avoid the

squeeze risk

WARNING: To eliminate the squeeze risk,

make sure no body parts of the patients is

between the bed and the examination table

or between bed and Atle® 180

WARNING: To eliminate the squeeze risk,

ensure that the patient does not get stuck

with body parts in relation to the transfer

bar or the wire during the transfer

6

Fig 7

Fig 8

5

8

Transfer at bowl-shaped CT-scanner

When moving from the CT table to another

bed it is recommended that two people carry

out the transfer with Atle® 180.

One person monitors and conducts the

transfer with the hand control in the usual

manner while the other person supports the

patient on the other side of the examination

table during the transfer, over the curved

edge of the CT table. The person who

supports the patient can choose to lift at the

edge of the sheet to create a smooth transfer.

Attachment solution with hooks in a

stretcher or trauma mattress

For all types of mattresses with handles along

the side, the hook is attached to the loop of

the wires and then connected directly to the

handles on the mattress.

Fig 11

Use of Atle® 180

NOTE: It is possible to move the entire

mattress to the examination table with the

help of the patient’s weight and with sliding

boards under the matress

7

Fig 9

Fig 10

Fig 12

WARNING: The pull should be straight

9

Attachment Solution

Before transfer

1) Prior to patient transfer, check that the

sheet is stretched under the patient and lay

the transfer bar on the sheet close to the

patient and with the ends of the transfer bar at

the level of the shoulders and hips. Fold the

sheet over the transfer bar.

2) Pull out the wires simultaneously and place

them on the empty unit, open the loops for

preparation of the attachment solution.

3) Attach the loop around one end of the

transfer bar. Tighten by advancing the wire

holder and then pull the wire. Do the same on

the other side.

After Transfer

4) When the patient transfer has been

completed, release the wires and disconnect

it from the transfer bar.

Fig 13

Fig 14

Fig 15

1

2

3

Use of Atle® 180

NOTE: Place the transfer bar close to the

patient to ensure the optimal position in the

middle of the bed/examination table after

the transfer Fig 16

4

10

Charging and Hand Control

Charging Batteries

The battery pack is the type of rechargeable

Lead. The batteries are charged via the main

power outlet. The Atle® 180 uses a 24 Volts

that can deliver approx. 50 pulls per charge

with a new battery. The battery life is variable

(2-3 years) and is influenced by frequency of

use and weight of patient.

The battery needs to be charged when it is

empty. Only the supplied charger (Mascot

2241P) should be used. For safety reasons,

Atle® 180 cannot be used while charging.

The charging of Atle® 180 is stopped by

unplugging the power cord from the outlet.

The hand control indicates that the battery is

being charged by traveling lights for charging

status.

The battery charges fully in approx. six hours.

Note that the battery must be charged for

at least 24 hours non-stop before rst use.

Battery life is not adversely affected by the

fact that the battery is charged frequently.

Replacement of the battery should be done

by trained staff or by the manufacturer service

staff.

Hand Control

If the light on the right turns red it indicates

that something is wrong (error). The LED is

permanently lit if there is an internal hardware

fault in the control box. On the other hand, if

an error is caused by the user, e.g. that you

try to run a function when the batteries are

charging, the alert LED only lights up while

you are trying to activate a function (i.e. when

you press a button).

Battery indicator

When the light on the left is red, Atle® 180

must be charged. When one light is green,

the battery charge level is less than 33%,

when two lights are green, the battery charge

level is 33% or better, and when all lights

are green, the battery charge level is 66% or

better.

1) On / off button

2) On / off button indicator

3) Reset button for the overcurrent protection

4) Lowering and raising buttons

5) Motorized pull button

6) Error indication

7) Battery level

8) Battery indicator

Only use the supplied hand control.

Use of Atle® 180

NOTE: The battery must be charged for at

least 24 hours non-stop before rst use

Fig 17

WARNING: Replacement of the battery by

inadequately trained personnel could result

in a hazard

Fig 18

11

Use of Atle® 180

Buttons

Pulling button

The button with double arrows is used to pull

the patient towards Atle® 180. The transfer

continues as long as the button is pressed or

until it reaches its limit.

Raising / lowering buttons

The up and down arrows are used to raise

and lower the motor housing. The motor

housing will be be raised or lowered as long

as the button is pressed or until it reaches its

limit.

Reset button

An overcurrent protection is triggered when

Atle® 180 is exposed to too high a load. To

reset the overcurrent protection, the user is

required to press the reset button. The user

can then press the pull button again.

On/off button

When the green light is on, the device is on

and ready to use.

Brakes and Emergency Stop

Brakes

Foot operated brakes are tted on all the four

wheels.

To lock the wheels, press down the back of

the pad.

To release the brakes, push the lower part of

the pad up.

Emergency stop

The user can shut off the power at any time

by pressing the red emergency button on

the control panel. Reset the emergency

stop function by turning the emergency stop

button and then pressing the reset button

next to the red emergency stop button.

While nding the battery level again the error

indication on the hand control will light red

and there might be some sounds but Atle®

180 can be used as normal.

Fig 19

Fig 20

Fig 21

Fig 23

NOTE: When transferering heavier patients,

it is important to lock the wheels, especially

the wheels in the front

WARNING: Without the wheels locked,

Atle® 180 is a risk of tipping

unlocked

locked

NOTE: Only the supplied charger and hand

control should be used

Fig 22

WARNING: Periodic checking or

replacement of the charger is neccessary

12

First-time users should practice the

emergency stop manoeuvre before operating.

After Use

When the expiration date of the device is

reached, the product must be recycled

according to set standards for each country

and hospital.

Use of Atle® 180

Fig 24

Emergency stop Reset button Hand Control

Output

Charger

Output

13

Cleaning of Atle® 180

Surfaces that the caregiver touches must be

cleaned manually after each transfer. Clean

the surfaces of Atle® 180 regularly with

single-use cloths with hot water or pH neutral

detergent. For disinfection use the regular

surface disinfectant.

Pay attention to parts that are most likely to

be touched:

• The hand control

• The control panel

• The handle

• Attachment solution

• The wires

Replacement of the wire

The wire and the bobbin should be replaced

with a new one in case of suspicion or risk of

contamination, visible damage to the surface

layer on the wire or discoloured wire.

The bobbin is replaced as follows.

1) Open the cover to the bobbin by inserting

a nger into the opening on the side of the

cover

2) Take out the wire from the wire guide by

pulling the wire to the side and through the

opening.

3) Remove the bobbin by unscrewing the

screw and pull out the bobbin.

Fig 25

Fig 27

1a

1b

Cleaning and service

WARNING: if the bobbin and wire are

not changed when there is a suspicion of

contamination there is a risk of spreading

an infection

3a

Fig 26

Fig 28

2

14

4) Take a new bobbin and attach it by pushing

it onto the pin. Finish by tightening the screw.

5) Put the wire back into the wire guide.

6) Close the cover

Cleaning and service

5

Fig 31

4

6a

Fig 30

Fig 32

Fig 33

NOTE: Incorrectly placed bobbins may fall

off the pin and the patient transfer cannot

be performed

Fig 29

3b

6b

WARNING: To avoid squeeze risk, do not

use Atle®180 when changing bobbins

15

Maintenance

Replacement of components must be done by medically trained staff or by the manufacturer

service staff.

More severe contamination may require the external parts to be unscrewed, and the internal

components to be cleaned by medical personnel.

Preventive and check-up service is recommended once per year. The hospital’s technician

or the manufacturer’s service technician performs this procedure. Key areas are engine

maintenance, pull test and condition of the wire. After the service has been performed, a

functional test is done without a patient.

Atle® 180 is subject to wear and tear, and the following actions must be performed when

specied to ensure that the product remains within its orginal manufacturing specication.

Cleaning and service

3) Press the emergency stop button to make sure that all electrical power is cut off. No

action should occur when activating the buttons on the hand control

4) Check all the functions on the hand control. Ensure that the hand control cover is

intact

9) Check all the functions on the control panel

5) Check that Atle® 180 can be switched on and off with the power on / off button on

the hand control

7) Check that Atle® 180 can be raised and lowered by pressing the hand control up

and down button

6) Check that Atle® 180 pulls when you press the hand control pull button and that it

stops when you release the button. The wires should moves towards Atle® 180 when it

pulls

8) Check the reset button on the control panel by pressing the appropriate button; you

can transfer with Atle® 180 by pressing the pull button

Points to be inspected by user/service technician

Frequency

Before every use

1) Ensure that the battery charge indicator is within the normal range

Annually

Initially

X

XX

X X

X

XX

X

2) Check that Atle® 180 is charging when a battery charger is connected to Atle® 180;

the charging status LEDs on the hand control will wander. If the battery is not taking

charge or the battery has a short operation time, replacement of the battery is

needed, see points for service technician

X

XX

Note: The list continues on the other side

NOTE: Do not use Atle® 180 while serviced or maintained

16

10) Press the reset button for the emergency stop button to see that all electrical

power is on again

11) Verify the proper functioning of the four wheels, check the brakes and that they

spin well

1) Check all bolts, nuts and locknuts to ensure they are tight

2) If the product does not work as intended, immediately contact Njord Medtech for

support

13) Check that the wires can be pulled out of Atle® 180 by hand without signicant

resistance

15) Check that the wires are not damaged and open the covers over the bobbins and

check that the bobbins are not damaged, if damage see “Replacement of the wire”

16) Check the home position sensors, by pulling the transfer bar all the way into Atle®

180 and Atle® 180 stops pulling automatically (the sensors do not work if engine noise

is heard when the transfer bar is in the home position)

4) Check that Atle® 180 is charging when a battery charger is connected to Atle® 180;

the charging status LEDs on the hand control will wander. If the battery is not taking

charge or the battery has a short operating time, replace the battery*

3) Connect a dynamometer on the opposite side of the bed to Atle® 180, connect the

transfer bar / hooks to the dynamometer and press pull on the hand control. Read that

Atle® 180 gives 1150 - 1300N before the overcurrent protection is triggered

14) Check that the wires are completely loose and can be pulled out

X X

XX

X

X X

12) Check front and rear wheels regularly for hair and debris; clean when necessary X

Points to be inspected by service technician

Frequency

Before every use

Annually

Initially

XX

Cleaning and service

*The battery (power pack RPP10) can be ordered from Njord Medtech or designated distributor

Points to be inspected by user/service technician

Frequency

Before every use

Annually

Initially

17

Troubleshooting

Cleaning and service

Type of error Possible cause Action

The wires cannot be pulled out - The wire is stuck or tangled on

the bobbin

- Open the cover to the bobbin

and release the tangled wire

either by removing/untangling

the wire from the bobbin one

turn at a time or by taking out

the bobbins and pulling the wire

out completely

The transfer bar cannot be

attached

- The attachment solution has

been put on incorrectly

- The sheet is two fold or too

thick

- The attachment solution is

worn out

- Adjust according to

instructions under “Sheet

attachment solution”

- The battery is discharged

- The main power switch is

rejected

- The emergency stop has been

activated

- Overload: the patient is too

heavy

- The patient weighs more than

180 kg

- The mattress texture gives a

very high friction

- The mattress structure and

material allows the patient to

create too much friction

The torque/engine stops

The torque/engine does not

start via the hand control

- Charge Atle® 180

- Turn on the main power switch

- Deactivate the emergency

stop by press the “reset” button

on the control panel

- Atle® 180 is intended for

patients that weigh a maximum

of 180 kg

- Perform manual transfer

- The stop measure stops the

machine over 1200N

Hand control does not respond - The emergency stop button is

activated

- The plug to the hand control is

unplugged

- Battery needs to be changed

- Deactivate the emergency stop

by clicking on the “reset” button

on the control panel

- Summon technical trained

personnel or Service technician

Every time the wires are pulled

in or out, they are at different

lengths

- The wires are wound

differently on the bobbins

- Open the cover to the bobbin

and release the wire one turn

on the bobbin on the side where

the wire pulls short

The error indication on the hand

control glows red and Atle® 180

makes a sound

- The emergency stop button

has been released after

activation

- After the emergency stop has

been restored, Atle® 180 needs

a few minutes to nd the battery

status and while doing this, the

error indication will light up and

Atle® 180 will make light noises,

but it is possible to use Atle as

usual

NJORD Atle 180 User manual

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