Njord Atle 180 User manual

Atle 180

INSTRUCTIONS FOR USE

Atle 180 (20,000) IFU EN Rev J - 10/2022

®

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

Symbol 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

Sheet Attachment Solution �� 9

Charging and Hand Control�� 10

Buttons�� 11

Brakes and Emergency Stop �� 11

Cleaning and service��13

Cleaning of Atle �� 13

Replacement of the wire �� 13

Maintenance �� 15

Atle® Labels ��18

Technical Specication ��19

Product data �� 19

Dimensions �� 21

Electromagnetic Compatibility��22

Electromagnetic Compliance �� 22

Electromagnetic Compatibility��23

Electromagnetic Emissions �� 23

Electromagnetic Immunity �� 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 strongly recommends and

warns that to avoid injuries that can be

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

then 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/

Denitions 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. Store the

quick reference guide that comes with the

product well visible to all staff.

Atle 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 Professional healthcare

facility 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 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.

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.

Atle 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 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, descriptions to assist to

service personnel in parts repair.

Uplug the power cord charger from the

control panel to disconnect the device from

supply mains.

Safety Instructions

NOTE: Atle 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. WARNING: No modication of this

equipment is allowed

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 case of need for immediate shutdown

during transfer, the emergency stop switch

on the hand control is 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 are 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 and bed unit

2) Between the wire and pulling member

3) On the 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

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

Symbol 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) Bobbin (replaceable)

2) Pulling member 8) Wire guide

3) Wire (replaceable) 9) Emergency stop

4) Protective pads 10) Reset button for emergency stop

5) Wheel brake 11) Hand Control output

6) Hand Control with battery indicator 12) Charger output

13) 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) Control that the patient is lying on its back

in a center position and the sheet sticks out

>20 cm from the patient’s shoulder and hips.

To facilitate the transfer sliding plates should

be used. Place optional sliding plates under

the patient, good position is under the feet,

the hips and the shoulders.

2) Prepare the transfer by laying the pulling

member on the sheet, at height with the

shoulder and hip on the patient. Then fold

over the remaining sheet. The pulling member

must lie close to the patient.

3) Place the bed in paralell and around 1/2

meter from the other bed unit.

Sheet attachment solution

4) Go to Atle, pull out both the wires at the

same time and place on the bed unit. Prepare

through open the loops of the attachment

solution.

Attach the loops over the sheet and around

the pulling member. Tighten the loop around

the pulling member so that the loop is

fastened tightly. Do the same on the other

side. (See “fastening device in sheets”, page

9).

NOTE: Sliding plates 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 lying patients from bed to bed,

stretcher to bed and bed to examination table.

NOTE: Maximum patients weight at transfer

with Atle is 180 kg.

1

2

3

4

Fig 3

Fig 4

Fig 5

Fig 6

7

During the transfer

5) Make sure that the bed and the

examination table are placed next to each

other and with the same height. Lock the

wheels on the bed. The remaining parts of

the sliding plates must lie over the bed unit.

Place Atle on the long side of the bed or

examination table. Set the height to Atle so

that the position of the wires is 2-3 cm over

the mattress on the examination table, see

gure below. Atle must stand against the

bed and the exits of the wires must be in line

with the ends of the pulling member. Finish

positioning of Atle by locking all wheels.

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 drag 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 transfer when the patient is positioned

centered on the new bed unit. Remove the

fastener from the sheet and pulling member

by pulling out the wires slightly and widening

the loop forward through the “float”. Remove

the pulling member and the sliding plates.

Use of Atle® 180

WARNING: Both beds should be positioned

close to each other to avoid the risk of

patient falling between these. For additional

safety measures, sliding plates should be

used.

NOTE: Position Atle against 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 pulling member and engine

part when the pulling member approaches

engine part at end of the patient 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

WARNING: To eliminate the squeeze risk,

ensure that the patient does not get stuck

with some body parts in relation to the

pulling member and 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.

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 by attaching as

usual to the sheet and having sliding plates

under the mattress

7

Fig 9

Fig 10

Fig 12

WARNING: The pull should be straight

9

Sheet Attachment Solution

Before moving

1) Prior to patient transfer, check that the

sheet is stretched under the patient and lay

the pulling member on the sheet close to the

patient as possible and with the ends of the

pulling member at the level of the shoulders

and hips. TFold the sheet over pulling

member.

2) Pull out both the wires at the same time

and place on the bed unit, open the loops for

preparation of the attachment solution.

3) Attach the loops around the pulling

member at the ends on the pulling member.

Tighten by advancing the “float” and then pull

on on 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 pulling member.

Fig 13

Fig 14

Fig 15

1

2

3

Use of Atle® 180

4

Fig 16

NOTE: The pulling member must be placed

close to the patient for the patient to end up

in the middle of the bed/examination table

10

Charging and Hand Control

Charging Batteries

The battery pack is the type of rechargeable

Lead. The batteries are changed via the main

power outlet. The Atle® 180 used a 24 Volts

that can deliver around 50 pulls per charge

with a new battery. The battery life is variable

(1-2 year) 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 saftey reasons, ie

to avoid tripping over the cable, Atle cannot

be used underneath charge. Atle 180 is than

de-energized by unplugging the power cord

from the mains. The hand control indicates

that the battery is being charged by traveling

lights for charging status.

It takes around six hours to charge the

battery. Note that the battery must be charged

at least 24 hours before rst use. Battery life

is not adversely affected by the fact that the

battery is charged frequently. Replacement

by the battery should be done by medically

trained staff or by the manufacturer service

staff.

Hand Control

If the light on the right lights up red, it is a

indication 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 must be

charged (you can drag X number of times).

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) Lower 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 at

least 24 hours before rst use.

Fig 17

WARNING: Replacement by the battery of

inadequately trained personnel could result

in a hazard

Fig 18

11

Use of Atle® 180

Buttons

Pulling button

The button with double arrows are used to

pull the patient towards Atle. The transfer will

keep pull 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 lowering as long

as the button is pressed or until it reaches its

limit.

Reset button

When Atle is exposed to a too high load,

an overcurrent protection is triggered. To

reset the overcurrent protection, the user is

required to press the reset button. The user

can then press the pull button again to move

on.

On/off button

When the green is light up the device is on

and ready to use.

Brakes and Emergency Stop

Brakes

Foot operated brakes are tted on all the four

wheels.

To apply brakes, step on the back portion of

pad.

To release brakes, push the top portion of the

pad forwards.

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 turn the emergency stop button

and click on the reset button next to the red

emergency button.

First-time users should practice the

emergency stop manoeuvre before operating

the device with a patient.

Fig 19

Fig 20

Fig 21

Fig 23

NOTE: When moving heavier patients, it is

very important to lock the wheels, especially

the wheels in the front

WARNING: If the wheels are not locked,

there is a risk of Atle tipping over

unlocked

locked

NOTE: Only the supplied charger and hand

control should be used

Fig 22

WARNING: Periodic checking or

replacement of the charger is neccesarily

12

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

Surfaces that the caregiver touches must

be cleaned manually after each transfer.

Clean the surfaces of Atle regularly with one

time use cloth with hot water or pH neutral

detergent. In case of disinfection use the

regular surface disinfectant.

Pay attention to parts that are most likely to

be touched:

• The hand control

• The control box

• 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.

Replacement of the bobbin is done 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, pull

the wire to the side and through the opening.

3) Remove the bobbin by unscrewing the

screw and pulling 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

contaminates there is a risk of spreading a

infection

3a

Fig 26

Fig 28

2

14

4) Take a new bobbin and attach it by pushing

it into the pin. Finish by tightening the screw

again.

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: If the bobbin is placed incorrectly,

the bobbin can fall off the pin and the

patient transfer cannot be performed

Fig 29

3b

6b

WARNING: Do not use Atle®180 when

changing bobbin to avoid squeezing risk

15

Maintenance

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

service staff.

In the event of more severe contamination, the cover and other external parts may need to be

unscrewed and the internal parts need to be cleaned by medical staff.

Preventive service is recommended once per year. This is done either by the company’s

medical technical staff at the hospital or by the manufacturer’s service technicians. 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 and make sure that all electrical power is cut off.

No action should occur when activation the buttons on the hand control

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

is intact

9) Check all the functions on the control box

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

power is on again

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

hand control

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

down button

6) Check that Atle pulls by pressing the hand control pull button and that it stops when

you release the pull button, the pulling member moves towards Atle when it pulls

8) Control the reset button on the controller by pressing the reset, you can drag with

Atle 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 is charging when a battery charger is connected to the Atle, the

charging status LEDs on the controllers start to wander. If the battery does not receive

a charge or a short operating time on the battery, a replacement of the battery is

needed, see points for service technician

X

XX

Note: The list continue on the other side

NOTE: Do not use Atle while serviced or maintained

16

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 ropes can be pulled out of Atle by hand without signicant

resistance and that the end of the ropes does not come loose when the ropes are fully

extended

15) Check that the ropes 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 indicates that the pulling member is in home

position by pulling the pulling member all the way into the Atle then Atle stops pulling

automatically (if engine noise is heard even when the pulling member is at home the

home position sensors do not work)

4) Check that the Atle is charging when a battery charger is connected to the Atle, the

charging status LEDs on the controllers start to wander. If the battery does not receive

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

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

member / hooks to the dynamometer press pull on the hand control read that Atle

gives 700N -50N + 100N before the overcurrent protection trips

14) Check that the ropes 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 (REAC power pack RPP10) can be order from the responsible seller

17

Trouble shooting

Cleaning and service

Type of error Possible cause Measure

The wire cannot be pulled out - The wire is stuck in the

bobbin

- Summon medical technically

trained personnel or Service

technician

The pulling member 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

Error indication on the hand

control glow red (indicates

charging, charging level and

error indication)

- Problem with power supply or

motor.

- Charge the battery (connect

the charger to the device and

the wall socket see that the

charge indicator lights up on the

control, it is a wandering light

The torque/engine does not

start via the hand control

- Charge Atle

- Turn on the main power switch

- Deactivate the emergency

stop by press the “reset” button

on the control box

- Atle is intended for patient

which weights a maximum of

180 kg

- Performs manual transfer

- The stop measure stops the

machine over 700N

- Try to turn off the main switch

and turn it on again.

If the error persists, summon

medical technology trained

personnel or service technician

- Reset the device with the

“reset” button on the control

box

Hand control does not respond - The emergency stop button is

activated

- The plug to the device is

unplugged

- Battery need to be changed

- Deactivate the emergency stop

by click on the “reset” button on

the control box

- Summon medical technically

trained personnel or Service

technician

Sound from the control box -

error indication

- Emergency stop button has

been activated

- The overcurrent protection

can be tripped due to the wire

getting stuck or tangled or too

high load for the pulling

- The height adjustment can

be stuck in the bed so the

overcurrent protection is

triggered

- Deactivate the emergency stop

by turn the emergency stop

button and than press the

“reset”button

NJORD Atle 180 User manual

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