NEA8000 Battery Charger for Carendo Instructions for Use Ver 6 Nov 2016

WARNING To avoid injury, always read this Instruction for Use and accompanying 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 AB 2015. 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 AB.

Contents Foreword ... 4 Intended Use ... 5 Safety Instructions ... 6 Preparations ... 7 Installation of Charger ... 7 Charging the Battery ... 8 Cleaning Instructions ... 9 Care and Preventive Maintenance ... 9 Troubleshooting ... 10 Technical Specifications ... 11 Approval List of Standards ... 12 Labels ... 13 Electromagnetic Compatibility ... 14 Parts and Accessories ... 17 ArjoHuntleigh Addresses ...Last Page

3

Foreword Definitions in this IFU

Thank you for purchasing ArjoHuntleigh Equipment Your Battery Charger is a part of a series of quality products designed especially for hospitals, nursing homes and other health care use.

WARNING Means: Safety warning. Failure to understand and obey this warning may result in injury to you or to others.

Please contact us if you have any questions about the operation or maintenance of your ArjoHuntleigh equipment.

CAUTION Means: Failure to follow these instructions may cause damage to all or parts of the system or equipment.

Please read this Instructions for Use thoroughly! Please read this Instructions for Use (IFU) in its entirety before using your Battery Charger. Information in this IFU is crucial to the proper operation and maintenance of the equipment, will help protect your product, and make sure that the equipment performs to your satisfaction. Some of the information in this IFU is important for your safety and must be read and understood to help prevent possible injury.

NOTE Means: This is important information for the correct use of this system or equipment.

Unauthorized modifications on any ArjoHuntleigh equipment may affect its 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: The name and address of the manufacturer.

Service and Support A service routine has to be done on your Battery Charger by ArjoHuntleigh authorised service personnel to ensure the safety and operating procedures of your product. See section Care and Preventive Maintenance on page 9. If you require further information, please contact ArjoHuntleigh for comprehensive support and service programs to maximize the long–term safety, reliability and value of the product. Contact ArjoHuntleigh for replacement parts. The contact information is found on the last page of this IFU.

4

Intended Use This equipment must be used in line with its intended use and in accordance with these safety instructions. Anyone using this equipment must also have read and understood the instructions in this Instructions for Use (IFU). If there is anything you are not sure about, contact your ArjoHuntleigh representative. This charger is intended for charging ArjoHuntleigh battery NEA 0100 only, in accordance with the instructions outlined in the Instructions for Use. All other use must be avoided.

Life time of the equipment The expected life of the Battery Charger NEA8000-XX, is unless otherwise is stated ten (10) years, if subject to preventive maintenance being carried out in accordance with the instruction for Care and Preventive Maintenance found in the Instructions for Use (IFU). Assembly of parts must be mounted according to the instructions in the Instructions for Use (IFU).

5

Safety Instructions WARNING

WARNING

Do NOT cover the charger due to fire hazard.

To avoid electric shock, make sure that the equipment is connected to:

WARNING

• Continuously powered supply mains with protective earth.

To avoid fire, make sure the charger is installed and used in a well ventilated area.

• Separate fuse and ground fault circuit interrupter (GFCI) • A mains disconnection device

WARNING

• Equipotential bonding point

To avoid fire and electric shock, make sure the charger is installed and used in a dry and dust free environment.

All installations must be in accordance with local codes and regulations.

WARNING

WARNING

To avoid strangulation, make sure to never leave children unattended near the equipment.

To avoid bodily injury, do NOT crush, puncture, open, dismantle or otherwise mechanically interfere with the battery.

WARNING

• Should the battery casing crack and cause contents to come in contact with skin or clothing, rinse immediately with plenty of water.

To avoid bodily injury, keep the Battery Charger in a safe place and disconnected when not in use.

• If contents come in contact with the eyes, rinse immediately with plenty of water and seek medical attention.

The exposure to low voltage, in the Battery Charger connector, can be potentially hazardous to children and sensitive persons.

Inhalation of the contents can cause respiratory irritation. Provide fresh air and medical attention.

Battery and Charger Safety Practices

WARNING To avoid explosion or fire, never use the equipment in oxygen rich environment, in presence of heat source or flammable anaesthetic gases.

•

Be careful not to drop the battery.

•

Contact the appropriate local authority for advice when disposing of batteries. Check label on the charger and battery.

•

6

Preparations Actions Before the First Use (9 Steps)

Actions Before Every Use (2 Steps)

1

Visually inspect the Battery Charger for transport damage.

1

Carry out a thorough inspection for damage.

2

2

The package should be recycled according to local regulations.

If any part is missing or damaged – Do NOT use the product!

3

Read the IFU.

4

Unpack the Battery Charger.

5

Select the plug according to the country it will be used in and discard the other plugs.

6

Charge the battery until the indicator LED turns green.

7

Prepare an area that is dry, with good ventilation and out of direct sunlight for storage of the Battery Charger.

8

Choose a designated area where the IFU should be kept, accessible at all times.

9

Make sure to have a rescue plan ready in case of a patient emergency.

NOTE If you have any questions, please contact your local ArjoHuntleigh representative for support and service. The contact information (ArjoHuntleigh addresses) is listed at the end of this IFU.

Installation of Charger Installation

Fig. 1

•

Keep the Battery Charger away from main access areas.

•

The Battery Charger is designed for dry surroundings and may not be installed in bathrooms or any other wet areas (IP2X). Mount the battery holder to a suitable wall with two screws. (See Fig. 1) For screw specifications, see Technical Specifications on page 11. Check label on battery and charger

•

• • •

7

Plug in the Battery Charger to a standard power (AC) outlet. The Battery Charger is not allowed to be used in a patient environment.

Charging the Battery General

WARNING Do NOT charge the battery in a sealed compartment due to fire hazard. CAUTION To avoid breaking the charger when unplugging the battery connector: Grip the plug and don’t pull the cord. •

The charger converts mains voltage to low DC voltage.

•

The charger must only be used for ArjoHuntleigh battery type NEA 0100.

• •

The charger is ready for use as soon as it is plugged in. Disconnect the mains by unplugging the charger.

•

A solid yellow indicator LED indicates that the charger is ready for battery charging, there is no On/Off button on the charger.

Charging Intervals • •

To prolong the life of the battery, charge it at regular intervals, i.e. every night. If the ArjoHuntleigh product is used frequently, it is recommended to use two batteries, one in operation and one being charged.

NOTE It is recommended that a battery not in use is left in the charger. There is no risk of overcharging the battery.

Charging Procedure (5 Steps)

Fig. 1

Charger connector

1

Plug in the charger in a power outlet.

2

Plug the charger connector into the battery. (See Fig. 1)

3

Attach the battery to the charger.

4

Plug the charger connector into the battery.

5

The charger LED indications:

• Step 1 – Orange LED for fast charge • Step 2 – Green LED with short Yellow light intervals until final end charge • Step 3 – Solid green LED indicating a fully charged battery. Charging the battery can take up to 14 hours depending on the battery status (e.g. if the battery is charged for the first time or after a longer storage period). 8

Cleaning Instructions Accessories for Cleaning •

Dry cloths or dry disposable towels

Always Follow these 2 Steps for Proper Cleaning 1

Disconnect the Battery Charger from the mains and unplug the battery.

2

Wipe the Battery Charger and its cable from visible residue using a dry cloth or a dry disposable towel.

Care and Preventive Maintenance The Battery Charger is subject to wear and tear, the following maintenance instructions must be performed when specified to make sure the equipment remains within its original manufacturing specification.

WARNING To avoid malfunction resulting in injury, make sure to conduct regular inspections and follow the recommended maintenance schedule. In some cases due to heavy use of the product and exposure to aggressive environment more frequent inspections should be carried out. Local regulations and standards may be more stringent than the recommended maintenance schedule.

Preventive Maintenance Schedule CAREGIVER OBLIGATIONS Action/Check

Every WEEK

Visually check all exposed parts

X

Visually check battery and charger

X

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

Fig. 1

Visually Check Battery and Charger Visually check the condition of the Battery Charger, its cable and the battery (See Fig. 1). Withdraw and replace immediately if damaged.

9

WARNING To avoid injury and/or unsafe product, the maintenance activities must be carried out at the correct frequency by qualified personnel using correct tools, parts and knowledge of procedure. Qualified personnel must have documented training in maintenance of this device.

QUALIFIED PERSONNEL Action/Check

Every YEAR

Check battery and Battery Charger

X

Check all vital parts for damage

X

NOTE All Caregiver Obligations are to be checked when performing the Qualified Personnel Service.

Troubleshooting Problem

Action

Red or green indicator LED is flashing.

The battery voltage is too low. Replace the battery.

The charge indicator LED does not light up.

•

There is no electricity coming from the AC outlet.

•

The charger is broken.

The charger and/or power supply cord is broken.

Order a new charger. NEVER open the charger to repair it.

10

Technical Specifications General The charger model (Type...)

NEA 8000-WW (Delivered with interchangeable mains plug EU, US, UK) NEA 8000-AU (Delivered with interchangeable mains plug AU, JP)

Mains Supply

100–240 V ~ 50–60 Hz

Power consumption max:

0.4 A

Output voltage, charge current

41 Vdc

Normal charge current

First 0.4 A for 8 h, then 65 mA for 1 h, finally 25 mA ongoing.

Insulation class:

II

Pollution degree

2

Battery weight (NEA 0100, 24V)

1.4 kg (3.08 lbs)

Battery charger weight

0.15 kg (0.33 lbs)

Flammability standard

UL94V–1

Ambient temperature

+10 °C to +40 °C (50 °F to 104 °F) Operation -30 °C to +50 °C (-22 °F to +122 °F) Transport, Storage

Relative humidity

30–75% Operation 10–80% Transport, Storage

Atmospheric pressure

800–1060 hPa Operation 500–1060 hPa Transport, Storage

Power Cord Supply

Not allowed to be replaced

Screw for mounting the charger

Nrd=90 N (Resistance tensile) Vrd=250 N (Resistance shear)

Mains Disconnection Device Mains disconnection device must be visible and accessible at all times. Disconnect mains by unplugging the charger from outlet.

11

WARNING To avoid injury, always follow the allowed combinations listed in this IFU. No other combinations are allowed. Allowed Combination ArjoHuntleigh Battery NEA 0100, 24V ArjoHuntleigh Lift with NEA 0100, 24V

Product ID

Carendo

BIB

Carino

BOC

Maxi Twin

KTB

Maxi Twin Compact

KTC

Carevo

BAC

Sara Combilizer

APA

Disposal of the Charger The device is marked with the WEEE symbol to indicate that it is electronic equipment covered by the Directive 2012/19/EU on waste electrical and electronic equipment. In European countries 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. This requirement applies in the European Union. 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. Follow local regulations.

Approval List of Standards Certificate

Standard

EN/ISO/IEC/UL 60601-1

Medical electrical equipment. Part 1: General requirements for basic safety and essential performance.

EN 60601-1-2

Electromagnetic Compatibility – Requirements and Tests

EN 60601-1-11

Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

CAN/CSA-C22.2 No. 601.1

Medical equipment Certified for Canada

12

Labels Label Explanation Data Label

Label on Package

CE marking in accordance with the Medical Devices Directive 93/42/ EEC.

States technical performance and requirements. For example classified safety standard and input voltage.

The equipment has been EMCtested and fulfils all requirements according to IEC 60601-1-2. Electric safety according to EN 60601-1.

States the serial number, manufacturer address together with information about recommended operation conditions. S R

Symbol Explanation NEA X000XX

The article number of the Battery Charger; NEA 8000-WW or NEA 8000-AU.

Battery No. (Number)

NEA 0100, 24 V

100–240 V ~ 50–60 Hz

Voltage and AC frequency

0.35 A

Power consumption max

IP2X

Protection class: The product must be used in a dry location only. Insulation class:

Data label

Class II Separate electrical and electronic components for recycling in accordance with the European Directive 2012/19/EU (WEEE). Read the IFU before use PSE (Product Safety of Electrical Appliance & Materials) The equipment has been certified for Japan. SE XXXX XXXX

Recognized by Underwrites Laboratories Inc. with respect to electrical shocks, fire and mechanical, hazards and other specified hazards only in accordance with theUL60601-1 and CAN/CSA - C22.2 NO EC (WEEE).

Serial Number

13

Electromagnetic Compatibility Medical electrical equipment needs special precautions regarding EMC (Electromagnetic compatibility) and needs to be used according to the EMC information below. Portable and mobile RF communications equipment can affect the Battery Charger.

WARNING Stacking or placing other electrical equipment next to this device is not recommended, it can interfere with the equipment’s operation and safety. Portable and mobile radio frequency (RF) communications equipment can interfere with this equipment operation and safety.

WARNING The equipment may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take action, such as reorienting, relocating the equipment or shielding the location. Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of the Battery Charger should assure that it is used in such an environment. Emissions Test

Compliance

Electromagnetic Environment – Guidance

RF emissions

Class B

The Battery Charger uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class B

The Battery Charger is suitable for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11 Harmonic emission

Complies

IEC 61000–3–2 Voltage fluctuations/flicker emission

Complies

IEC 61000–3–3

14

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of the Battery Charger should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment – Guidance

Electrostatic discharge (ESD)

± 6 kV contact

± 6 kV contact

± 8 kV air

± 8 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient/burs

± 2 kV for power supply lines

IEC 61000–4–4

± 1 kV for input/ output lines

± 2 kV for power supply lines Mains power quality should be that of a typical commercial or hospital input/output lines not environment. applicable

Surge

± 1 kV line(s) to line(s)

IEC 61000–4–2

IEC 61000–4–5

± 1 kV line(s) to line(s) ± 2 kV line(s) to earth

± 2 kV line(s) to earth Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000–4–11

Power frequency (50/60 Hz) Magnetic field IEC 61000–4–8

<5% UT (>95% dip in UT) for 0.5 cycle

<5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 s

<5% UT (>95% dip in UT) for 5s

3 A/m

3 A/m

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE UT is the a.c. mains voltage prior to application of the test level

15

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Battery Charger is intended for use in the electromagnetic environment specified below. The customer or the user of the Battery Charger should assure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Conducted RF

3 Vrms

3 Vrms

IEC 61000–4–6

150 kHz to 80 MHz

Radiated RF

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the Battery Charger, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

IEC 61000–4–3

80 MHz to 2.5 GHz

3 V/m

Recommended separation distance d=0.35¥P d=1.2¥P 80 MHz to 800 MHz Where P is the maximum output power rating of the transmitters in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol:

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured filed strengths in the location in which the Battery Charger is used exceeds the applicable RF compliance level above, the Battery Charger should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary. b)

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1V/m.

16

Parts and Accessories

Battery holder 8350891-031

Extra Battery NEA 0100, 24V

Battery Charger NEA 8000-WW (delivered with interchangeable mains plug EU, US, UK) NEA 8000-AU (delivered with interchangeable mains plug AU, JP)

17