Scale 2016 Instructions for Use Aug 2016

Foreword ...3 Intended Use ...4 Safety Instructions ...4 Preparations ...5 Change the Batteries ...5 Scale Overview ...6 Parts Designation ...7 Product Description / Functions...8 Net Weight / Power On-Off / Scroll button ...8 Hold / Power On / Select button...8 Power button for foot scale ...8 Battery ...8 Net weight ...9 Hold weight ...9 Limit of Indication ...9 Center of Zero ...10 Dual Range (not for suspended scale) ...10 Tilt ...10 Change the Scale Settings ... 11 Main Menu ... 11 Navigate through the menu / sub-menu...12 1. Operation ...12 1.1 UNIT ...12 1.2 PWROFF (Power Off) ...13 UP ...13 Weigh the patient - Gross / Net Weight ...14 Gross weight (6 steps) ...14 Net weight (8 steps) ...15 Cleaning and Disinfection Instructions ...16 Troubleshooting / Error Code ...16 Care and Preventive Maintenance ...17 Caregiver Obligations ...17 Technical Specifications ...18 Labels on the Scale ...20 Approvals and List of Standards...20 Accessories ...21 NAWI Declaration of Conformity (Class III) ...21 Log Book for Class III Scale ...21

WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Mandatory to read the Instructions for Use. Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ArjoHuntleigh 2016. As our policy is one of continuous improvement, we reserve the right to modify designs without prior notice. The content of this publication may not be copied either whole or in part without the consent of ArjoHuntleigh. 2

Foreword Thank you for purchasing ArjoHuntleigh equipment.

Definitions in this IFU

WARNING

Please contact us if you have any questions about the operation or maintenance of your Means: Safety warning. Failure to understand and ArjoHuntleigh equipment. obey this warning may result in injury to you or to Please read and fully understand these others. Instructions for Use (IFU) before using your Scale.

CAUTION

Information in this IFU is necessary to perform the proper operation and maintenance of the equipment. It will help to protect your product and make sure that the equipment performs to your satisfaction. The information in this IFU is important for your safety and must be read and understood to help prevent possible injury. Unauthorized modifications on any ArjoHuntleigh equipment can affect safety. ArjoHuntleigh will not be held responsible for any accidents, incidents or lack of performance that occur as a result of any unauthorized modification to its products.

Means: Failure to follow these instructions may cause damage to all or parts of the system or equipment. NOTE Means: This is important information for the correct use of this system or equipment. Means: The name and address of the manufacturer.

Routine maintenance must be performed on your Scale to maintain safety and reliability of the equipment. See section “Care and Preventive Maintenance” on page 17. If you require further information, please contact ArjoHuntleigh for comprehensive support and maintenance to maximize the long-term safety, reliability and value of the product. The telephone numbers appear on the last page of this IFU.

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Intended Use Patient/Resident assessment We recommend that facilities establish regular assessment routines. Caregivers should assess each resident/patient according to the following criteria prior to use. The patient/resident´s weight must not exceed the safe working of the device on which it will be installed. If the patient/resident does not meet these criteria an alternative equipment/system shall be used.

This equipment must be used in accordance with these safety instructions. Anyone using this equipment must also have read and understood the instructions in these Instructions for Use (IFU). If there is anything you do not completely understand, ask your ArjoHuntleigh representative. The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or other health care facilities. It must be operated by trained caregivers with adequate knowledge of the care environment, its common practices and procedures, and in accordance with the guidelines in the Instructions for Use (IFU). Caregivers shall continuously attend the resident/patient during the usage.

Installation requirements The equipment must be installed by appropriately trained personnel according to the IFU. The scale may also be pre-installed on the lifter.

Expected service life The expected service life or maximum period of useful life of this equipment is ten (10) years when subjected to preventive maintenance as specified in the ‘‘Care and Preventive Maintenance’’ section The Safe Working Load (SWL) or maximum of the IFU. The scale system has been designed capacity the scale will vary according to the device and tested to achieve up to 10000 cycles with its on which it will be installed. Refer to the IFU of the maximum capacity. The expected service life for specific product. consumables such as batteries is dependent upon The Scale system should only be used for the care and usage of the product concerned. purpose specified in the IFU. Any other use is prohibited.

Safety Instructions NOTE Do not touch the chair / stretcher / sling or the patient during the weighing procedure, since it can influence the weighting result.

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Preparations Actions Before First Use (5 steps)

Actions Before Every Use (2 steps)

1. Visually check the package for damage. If the product looks damaged due to freight, make a complaint to the transport agency. Do NOT use the product. 2. The packaging should be recycled according to local regulations. 3. Read this IFU. 4. For assembly and installation of scales that are detachable, see Scale Assembly and Installation Instructions. For a scale with quick connect attachment, see the medical device equipment IFU. 5. Choose a designated area, where this IFU should be kept and is easily accessible at all times.

1. Visually inspect the scale. If any part is damaged - do NOT use the product. 2. Check the battery level.

In between Use Clean and disinfect the product according to section “Cleaning and Disinfection Instructions” on page 16.

Weight Unit The default unit of the scale is in kg. To change the weight unit to lb, see section “1.1 UNIT” on page 12.

Change the Batteries This does not apply to scales attached to Alenti, Miranti and Sara Plus, since they are powered by the product’s main battery.

Fig. 1

Suspended and Pillar Scale (3 steps) (See Fig. 1) 1. Use a screw driver to unscrew the cover. 2. Use the screw driver to remove old batteries and replace with four new AA batteries. 3. Attach the cover using the screw driver.

Fig. 2

Foot Scale (4 steps) (See Fig. 2) 1. Push down and slightly forward on the cover. 2. Pull out the battery holder. 3. Insert / replace the four AA batteries. 4. Secure the battery compartment cover into place by pushing it down and back into position.

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Scale Overview Suspended Scale (Operated by separate batteries) • Maxi 500 • Maxi Twin • Maxi Sky 2 • Maxi Sky 440 • Maxi Sky 600 • Maxi Sky 1000 • Ergolift 600 • Voyager • Voyager Duo • Minstrel • Tenor NOTE Attachments and color may vary upon medical device.

Pillar Scale (Operated by product main battery) • Alenti • Miranti

• Sara Plus (Operated by product main battery)

• Sara 3000 (Operated by separate batteries)

Foot Scale (Operated by separate battery) • Bolero • Calypso

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Parts Designation Weight

Net Weight / Power On-Off / Scroll Button

lb kg

Unit Message / Menu Text

Hold / Power On / Select Button

L/H

Hold Symbol

Battery Symbol

Center of Zero Symbol

Dual Range Symbol

Tilt Symbol

Weight Symbol

Battery compartment Power Button

Data Label

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Product Description / Functions Fig. 3

Net Weight / Power On-Off / Scroll button This button has the following functions: (See Fig. 3) • Power on scale - press once. • Power off the scale - press the button for 5 sec. • Scroll in menu mode. • Set Net weight of patient (Tare).

Fig. 4

Hold / Power On / Select button This button has the following functions. (See Fig. 4) • Power on scale - press once. • Hold the displayed weight. • Select in menu mode.

Fig. 5

Power button for foot scale For Calypso and Bolero hygiene lifts, press the foot button or any scale button to power on the scale. (See Fig. 5)

Fig. 6

Battery The battery symbols indicates the battery charge: • Full • Almost full • Half full • Low The low battery symbol will flash when the battery charge is below 10%. (See Fig. 6) Battery charge below 10% has less than 50 readings left. The battery operation life time is based on the default settings. To change the default setting (power off time function) see section “1.2 PWROFF (Power Off)” on page 13. The battery symbol will not show up on the Alenti, Miranti and Sara Plus scale display since they are powered by the lift itself.

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Fig. 7

Net weight

kg

Fig. 8

This is the Net weight of the patient without any accessories etc. (See Fig. 7) For instruction how to get the Net weight of the patient, see section “Weigh the patient - Gross / Net Weight” on page 14.

Hold weight Memorizes the weight on the scale. (See Fig. 8) Press the Hold button to lock the weight. The lock symbol and weight will display until the unit powers off. • If the scale powers off, restart the scale and press the Hold button once and the memorized weight will display. • If there is more than 10 kg (22 lb) on the scale when pressing the Hold button, the memorized weight will be erased. NOTE The patient needs to be still for the Hold weight function to work.

Fig. 9

Limit of Indication Max weight The maximum weight symbols appears when the patient weight exceeds the maximum weight capacity of the scale depending on product. (See Fig. 9)

Fig. 10

Minus weight (Below zero) Indication of weight below zero. This can occur if there is a weight on the scale before it’s powered on and then removed after the weighing. (See Fig. 10)

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Fig. 11

Center of Zero

kg

Means there is zero weight on the scale / zero on the scale. (See Fig. 11) The deviation from zero is no more than ± 0.25% of the precision.

Dual Range (not for suspended scale)

Fig. 12

The dual range symbol indicates that the weight precision has been changed. This symbol will only appear on the pillar and foot scale. (See Fig. 12)

L/H

The precision range starts at 100 g ( 3.5 oz) and changes to 200 g (7 oz) at a certain weight depending on the product. Once the 200 g (7 oz) precision becomes active it will remain until the weight is back at 0.0 kg /lb. The weight precision will restart at 100 g (3.5 oz).

Fig. 13

Tilt When the scale is tilted, the tilt symbol and text will appear. (See Fig. 13) When tilted, no weight reading will be available.

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Change the Scale Settings Main Menu

Fig. 14

Enter the main menu to change the scale settings. To access the main menu, press BOTH the Net Weight and Hold buttons for 3 seconds. (See Fig. 14)

Fig. 15

Here are the menus and sub-menus to choose from: (See Fig. 15) Main Menu

1. OPERATION 1.1 UNIT 1.2 POWER OFF UP

(Return to Main menu)

2. CONFIGURATION

» 1. Operation 1.1 Unit 1.2 Power Off UP (return to Main menu) » 2. Configuration (only for service technician) » 3. Service (only for service technician) » 4. Special (only for service technician) » EXIT (exit out of Main menu) NOTE Only menu 1 is available for the caregiver. Remaining menus are for service and are password protected.

3. SERVICE 4. SPECIAL EXIT

(Exit out of Main menu)

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Fig. 16

Navigate through the menu / sub-menu

Scroll

• Scroll: press the Net Weight button • Select: press the Hold button (See Fig. 16)

Select

1. Operation

Fig. 17

Operation menu has two sub-menus and a return: (See Fig. 17) • 1.1 UNIT - to change unit display. • 1.2 PWROFF - to change time delay for power off time. • UP - return to the main menu.

Fig. 18

1.1 UNIT kg

Fig. 19

lb

NOTE For a Class III Scale, “kg” is the only option. Once in the 1.1 UNIT menu, follow the steps below to change the weight unit for the scale. 1. Press Hold button to select and edit current unit setting (weight unit will blink). 2. Press Net Weight button to scroll and switch between kilograms (kg) and pounds (lb). 3. Press Hold button again to confirm selection. 4. Press Net Weight button again to exit the unit menu. The unit menu gives a display choice between kg and lb. (See Fig. 18) and (See Fig. 19)

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Fig. 20

1.2 PWROFF (Power Off) Once in the 1.2 PWROFF menu, follow the steps below to change the delay time for the scale. 1. Press Hold button to select and edit current time setting (number will blink). 2. Press Net Weight button to scroll through the number of minutes. 3. Press Hold button again to confirm selection. 4. Press Net Weight button again to exit the power off menu. The time range is from 1-7 minutes. (See Fig. 20) NOTE A longer power off time will affect the battery life.

Fig. 21

UP Scroll and select the UP menu to return to the main menu. (See Fig. 21)

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Weigh the patient - Gross / Net Weight Gross weight (6 steps)

Fig. 22

The weight of the patient including the sling, linens etc. For the Net weight of the patient see section “Net weight (8 steps)” on page 15.

1. Press any button to power on the scale. (See Fig. 22)

Fig. 23

lb kg

2. The display will start of by showing all symbols, followed by the calibration, configuration counter and software version. (See Fig. 23)

L/H

Fig. 24

3. 0.0 kg or 0.0 lb will be shown on the display. (See Fig. 24) kg

4. Place the patient safely onto the medical device, equipment Added weight will be the sling, spreader bar etc. (See Fig. 25)

Fig. 25

NOTE By default, there is a 4 minute time window to get the patient into the medical device equipment. 5. Lift the patient. Suspended scale only: Make sure the patient is in an upright position, to avoid the tilt message on the display.. 6. The scale will now display the Gross weight of the patient. (See Fig. 26)

Fig. 26

NOTE When the weight is flashing it means the weight is not stable.

kg

14

Fig. 27

Net weight (8 steps) The weight of the patient excluding the weight of the sling, spreader bar, linen etc. For the Gross weight of the patient see section “Gross weight (6 steps)” on page 14. 1. Press any button to power on the scale. (See Fig. 27) 2. The display will start of by showing all symbols, followed by the calibration, configuration counter and software version. (See Fig. 23)

Fig. 28

kg

3. 0.0 kg or 0.0 lb will be shown on the display. (See Fig. 28) 4. Weigh the equipment / accessories, for example a spreader bar, sling, linen etc.

Fig. 29

kg

Fig. 30

5. Press the Net weight button. This is the weight at 0.0 kg or lb with the accessories added. (See Fig. 29)

6. Place the patient safely onto the medical device equipment. (See Fig. 30) NOTE By default, there is a 4 minute time window to get the patient into the medical device equipment. 7. Lift the patient. Suspended scale only: Make sure the patient is in an upright position, to avoid the tilt message on the display.

Fig. 31

8. The Net weight of the patient is now displayed. (See Fig. 31) kg

NOTE When the weight is flashing it means the weight is not stable. 15

Cleaning and Disinfection Instructions Removing visible residues (2 steps)

Allowed cleaning chemicals /

1. Use a cloth soaked with water. Accessories 2. Remove visible residues from the scale from top • Soap to bottom. • Cloth • Towel or paper

General cleaning (5 steps)

CAUTION

1. To clean the scale assembly, spray cleaning fluid Do not use methanol-based or on a damped cloth. 2. Rub the product vigorously to promote effective any other type of solvent that may damage the finish or plastic parts. cleaning. 3. Use a clean damped cloth soaked in water to wipe off all of the cleaning chemicals. Allowed Disinfectants • Arjo General Purpose Disinfectant 4. Repeat steps as necessary. • Arjo Disinfectant Cleanser IV 5. Let the parts dry. • Arjo All Purpose Disinfectant • Disinfectant wipes soaked in a 70% v/v solution Disinfection (3 steps) of isopropyl alcohol 1. Rub the scale vigorously using a disinfectant wipe or a cloth soaked in disinfectant. CAUTION 2. Wipe off all remains of the disinfectant with a Do not use disinfectant with more wet cloth soaked in water.

than 0.5% w/w hydrogen peroxide as it may damage product labelling.

3. Wipe the scale dry with a towel or paper.

Troubleshooting / Error Code Problem

Solution

Scale does not turn on when pressing any button. Can’t access the main menu.

• Replace battery. • Check for external damage. If any, call ArjoHuntleigh for service. • Press both buttons for 3 seconds.

Display shows “-” with no load.

1. Power off the scale. 2. Press the Net Weight button • Replace the scale batteries.

to reset to zero.

Blinking battery symbol. (Not applicable to Alenti, Miranti, and Sara Plus) . Loose bolts or loose top / bottom • Call ArjoHuntleigh for service. attachments. Display shows an error code. • Power off the scale. Remove the battery for scales powered by product main battery. See section “Scale Overview” on page 6. If error code won’t go away, contact a service technician. The weight is flashing. • Make sure the scale is still. 16

Care and Preventive Maintenance SCHEDULE Caregiver Obligations Action/Check

Before Each Use / Every Month Between Each Patient Use

Visually check all parts

X

Visually check mechanical attachments

X

Clean/Disinfect

X

Check battery level

X

Periodic inspection of attachments

X

Every Year

Check for battery leakage

X

Calibration: Class III Scales

X

WARNING To avoid injury to both the patient and the caregiver, never modify the equipment or use incompatible parts. Only use ArjoHuntleigh designated parts.

Caregiver Obligations Caregiver obligations shall be carried out by personnel with sufficient knowledge and by following the instructions in this IFU.

Before Every Use Visually check all parts • Suspended scale: Make sure that all the split rings, bolts and Quick-Connect attachments that attach the spreader bar or the strap are secured. • All type of scales: If any part is damaged, contact qualified personnel. Visually check mechanical attachments • Inspect the enclosure for any signs of cracking or damages. If cracked or damaged, do NOT use the scale. Contact your Arjohuntleigh representative for service.

Between Every Patient Use Clean/Disinfect • See section “Cleaning and Disinfection Instructions” on page 16.

Every Month

battery is displayed. See section “Change the Batteries” on page 5 Periodic inspection of attachments • A visual inspections of the scale attachment bolts and brackets is required to make sure they are firmly tightened and with no sign of wear.

Every Year Check for battery leakage (Not applicable for Alenti, Miranti and Sara Plus) • Check for corrosion and oxide on the connectors. Calibration: Class III Scales:

CAUTION Setting the calibration check interval is the responsibility of the end user and will vary upon state regulations. It’s recommended every year if no state regulation rule exists. The Class III scale must be verified, calibrated and sealed by certified personnel only. Contact your local dealer to get more details about this.

• Log Book section retains all the information Check battery level (Not applicable for relevant to the inspection, repair or modification Alenti, Miranti and Sara Plus) See section “Log Book for Class III Scale” on page 21. • Make sure to replace the batteries if low charge 17

Technical Specifications General See the lowest SWL of the medical device equipment that the scale is attached to, including sling and spreader bar, if applicable. 0.7 kg / 1.5 lb - Suspended scales except Maxi Sky 1000 and Tenor 0.9 kg / 2 lb - Maxi Sky 1000 and Tenor Scale weight 5 kg / 11 lb - Alenti and Miranti 8 kg / 18 lb - Sara Plus 9 kg / 20 lb - Bolero, Calypso and Sara 3000 100 g (3.5 oz) accuracy • 2-100 kg (4-220 lb) range - Sara 3000 and Sara Plus • 2-120 kg (4-265 lb) range - Alenti Miranti, Bolero and Calypso • 2-182 kg (4-400 lb) range - Maxi Twin • 2-190 kg (4-418 lb) range - Minstrel 200 g (7 oz) accuracy Scale display range • 100-190 kg (220-418 lb) range - Sara 3000 and Sara Plus depending on weight and • 120-136 kg (265-300 lb) range - Bolero and Calypso • 120-160 kg (265-352 lb) range - Miranti product • 120-182 kg (265-400 lb) range - Alenti • 2-272 kg (4-600 lb) range - Maxi 500, Maxi Sky 2, Maxi Sky 440, Maxi Sky 600, Ergolift 600, Voyager and Voyager Duo • 4-320 kg ( 9-705 lb) range - Tenor 500 g (1.1 lb) accuracy • 10-454 kg (9-1000 lb) - Maxi Sky 1000 Accuracy - depending on +/- 100 g (3.5 oz), +/- 200 g (7 oz) and +/- 500 g (1.1 lb) product and weight Resolution 0.1 kg (0.2 lb), 0.2 kg (0.4 lb) or 0.5 kg (1.1 lb) Battery Alkaline -1.5 Volt DC (4XAA) (suspended, foot scale and Sara 3000) Lead-acid - 24 Volt (Lifter battery - Alenti, Miranti and Sara Plus) IPx5 - Alenti and Miranti Protection class IPx4 - Sara 3000, Sara Plus, Bolero, Calypso and suspended scales

Safe working load (SWL)

Operating forces on buttons Material

5N (finger activation) 10N (foot activation only foot scale) Load bearing components: Stainless steel, Zinc plated steel, aluminum. Enclosure: plastic.

Operating conditions Ambient temperature

+10°C to 40°C (50°F to 104°F)

Relative humidity

Max 90% at 20°C (68°F)

Atmospheric pressure

800 hPa - 1060 hPa

Transport and Storage Ambient temperature

-40°C to + 70°C (-40°F to158°F)

Relative humidity

0% - 93% at 20°C (68°F)

Atmospheric pressure

500 hPa - 1060 hPa 18

Recycling Battery

Alkaline, Lead acid batteries only from lifter (applies only to Alenti, Miranti and Sara Plus Scale) Recyclable. Not for disposal. Environment at danger.

Package

Cardboard (recyclable) and foam.

Product

Electric, aluminium / metal and plastic parts shall be separated and recycled according to marking on the unit.

Allowed Combinations Pillar scale on product: • Alenti, Miranti, Sara 3000 and Sara Plus Foot Scale on product:

• Bolero and Calypso

Suspended scale on products, detachable parts and accessories.

• Tenor • Maxi Twin

• S8559973-24 (Powered DPS)

• Minstrel

• HMX449-1 (4 hook spreader bar)

• Maxi 500

• 700-19341-BOX (DPS with scale) • 700-05505 (2 hook with scale spreader bar)

• Maxi Sky 440 and Voyager

• 700-05725 (Portable scale adaptor) • 700-05461-BOX (2 hook spreader bar)

• Maxi Sky 2

• 700-19415 (2 hook spreader bar) • 700-19420 (2 hook spreader bar) • 700-19430 (4 hook spreader bar) • 700-19475 (Flat manual DPS) • 700-19480 (Open manual DPS) • 700-19350 (Power DPS Medium) • 700-19355 (Power DPS Large) • 700-15695 (Stretcher frame) • 700.05380 (Morgue spreader bar) • 700.05385 (Morgue spreader bar)

• Maxi Sky 600

• 700-05461-BOX (2 hook spreader bar) • 700-19200 (Flat manual DPS) • 700-19340-BOX (Open manual DPS) • 700-19522 (Stretcher frame) • 700.05380 (Morgue spreader bar) • 700.05385 (Morgue spreader bar)

• Ergolift 600

• A5465 (Carry Bar)

• Maxi Sky 1000

• 700-05441 (4 hook spreader bar) • 700-05401-BOX (2 hook bar)

• Voyager Duo

• 700.05491 (2 hook spreader bar)

No other combinations are allowed 19

Labels on the Scale On the labels you can find some of the following symbols / information: Symbol explanation XX-XXXX Model number IPXX Classification of degrees of protection provided by enclosures CALCNT Calibration counter for all other parameters

Direct Current symbol (Located inside the battery cover) Separate electrical and electronic components for recycling in accordance with the European Directive 2012/19/EC (WEEE) Manufacturer name and address

10XXX

CFGCNT Configuration counter mainly for the gravity code

10XXX W1 W2 d=e e

III

Read the IFU before use

Weight one in 100g / 3.5oz range Weight two in 200g / 7oz range Weight accuracy based on weight range Indicates that the scale is a non-automatic weighing instrument of accuracy class III Reference number Serial number

Maximum and minimum temperature Safe Working Load (SWL)

0086

Metrology mark, indicating compliance with Directive 2009/23/EC (NAWI) - for scales manufactured before April 20th, 2016. (For Class III scales only) CE marking in accordance with The Medical Devices Directive 93/42/EEC.

Metrology mark, indicating compliance with Directive 2014/31/EU (NAWI) - for Myy 0126 scales manufactured after April 20th, 2016. (For Class III scales only) yy = year

Approvals and List of Standards STANDARDS

DESCRIPTION

EN45501:2015

Metrological aspects of non-automatic weighing instruments

OIML R 76:2006 Non-automatic weighing instruments (Class III scales only)

2012/19/EU

The device is marked with the WEEE symbol to indicate that it is electronic equipment covered by the Directive 2012/19/EC on waste electrical and electronic equipment. The crossed out wheeled-bin WEEE symbol reminds you that all the electrical and electronic products, batteries and accumulators must be taken to separate collection at end of their working life. Do not dispose these products as unsorted municipal waste. You can return your device and accessories to ArjoHuntleigh or you can contact your local authorities for advice on disposal. 20