ARJOHUNTLEIGH CARENDO Instructions for Use Sept 2014

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 AB 2014. 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 Parts Designation ...8 Product Description / Functions ...10 Reclined Function ...10 Lifting Function – High/Low ...10 Care Raiser ...10 Leg Support ...10 Driving Handles ...11 Manoeuvre Handles ...11 Castors ...11 Safety Belt ...11 Hand Control ...12 Back Pillow (Accessory) ...12 Battery Charger ...13 Battery ...13 Seat Cushion ...13 Emergency Lowering ...14 Emergency Stop ...14 Storage Net ...14 Bedpan and Bedpan Holder ...15 Independent Patients ...16 Dependent Patients ...17 Transfer to the Shower ...20 Transfer to the Toilet ...22 Home Care Use ...24 Cleaning and Disinfection Instructions ...26 Battery Instructions ...28 Care and Preventive Maintenance ...30 Troubleshooting ...34 Technical Specifications ...36 Labels ...38 Approvals and List of Standards ...40 Electromagnetic Compatibility ...40 Parts and Accessories ...42 ArjoHuntleigh Addresses ... Last page

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Foreword Thank You for Purchasing ArjoHuntleigh Equipment. Your Carendo shower and toilet chair is part of a series of quality products designed especially for hospitals, nursing homes and other health care use.

Complementary Information

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

Definitions in this IFU

Please Read these Instructions for Use Thoroughly! Please read this Instructions for Use (IFU) in its entirety before using your Carendo shower and toilet chair. Information in this IFU is crucial to the proper operation and maintenance of the equipment. It will help 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.

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

If a DVD accompanies this IFU, please note that the DVD does not replace the information in this IFU. The IFU contains additional important safety instructions.

WARNING

CAUTION 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.

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.

Report Unexpected Operations or Events Contact your local ArjoHuntleigh representative if any unexpected operations or events occur. The contact information appear on the last page of this IFU.

Service and Support A service routine must be performed on your Carendo shower and toilet chair every year by qualified personnel to make sure the safety and operating procedures of your product. See section Care and Preventive Maintenance on page 30. 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 your local ArjoHuntleigh representative for replacement parts. The contact information appear on the last page of this IFU.

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Intended Use Lifetime of the Equipment

This equipment must be used in accordance with these safety instructions. Anyone using the 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 equipment is intended for assisted hygiene care, showering and toileting of adult residents in care environments similar to senior/assisted living, group home, special care, nursing homes, hospitals and home care. The equipment is intended for indoor use.

The equipment must only be used for the purposes stated above. The lifetime of this equipment is ten (10) years and the service life of the safety belt is two (2) years. Depending on the storage of the battery, the use frequency and the charging intervals, the service life of the battery is 2-5 years. The lifetime and service life are stated providing that the preventive maintenance are being carried out in accordance with the instructions for care and maintenance in this IFU.

The Carendo must be used by appropriately trained caregivers with the adequate knowledge of the care environment, it's common practices and procedures, and in accordance with the guidelines in the Instructions for Use (IFU).

Depending on level of wear some equipment parts such as castors and hand control may need to be replaced during the equipment lifetime according to information in this IFU.

Resident Assessment We recommend that facilities establish regular assessment routines. Caregivers should assess each resident according to the following criteria prior to use: •

The residents weight should not exceed 136 kg/ 300 lbs.

•

The resident should understand and respond to instructions to stay seated in an upright position. If a resident does not meet these criteria an alternative lift shall be used.

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Safety Instructions WARNING

WARNING

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

To avoid the device in use from tipping, do not raise or lower other equipment close to it and be aware of stationary object when lowering.

WARNING

NOTE All materials used in this product complies with established biocompatibility standards and have been tested accordingly (ISO 10993).

To avoid entrapment, make sure to keep the patient’s hair, arms and feet close to the body and use designated grab supports during any movement.

NOTE Do not lift the Carendo shower and toilet chair using the armrests; use the chassis. Only one function movement (e.g reclined function) can be done at a time. Pushing on more than one button at a time will stop all movements.

WARNING To avoid the device from tipping and the patient from falling, do not use the equipment on floor with recessed drains, holes or slopes exceeding a ratio of 1:50 (1.15°).

WARNING To avoid falling, make sure that the patient is positioned in accordance with this IFU.

WARNING To avoid falling during transfer, always make sure that the brakes are applies on all equipment being used.

WARNING To avoid falling during patient transfer, always make sure that the brakes on the equipment receiving the patient are applied.

WARNING To avoid entrapment of the patients or caregivers legs or feet, make sure that they are kept clear of all obstacles.

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Preparations Actions Before the First Use

Action Before Every Use

(9 steps) 1 Visually check the package for damage. If the product looks damaged make a complaint to the transport agency.

(4 steps) 1 Check that all parts of the Carendo shower and toilet chair are in place. Compare to section Parts Designation on page 8.

2

The packaging should be recycled according to local regulations.

2

3

Check that all parts of the product are supplied. Compare with the product description in this IFU. If any part is missing or damaged - do NOT use the product.

Check accessories and parts for damage. If any part is missing or damaged - do NOT use the product.

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WARNING

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To prevent cross-contamination, always follow the disinfection instructions in this Instructions for Use.

Unpack the battery charger. Select and attach the adapter correctly suited to your power outlet. See Battery charger IFU.

5

Charge each battery for a minimum of 14 hours (Japan 3.5 hours).

6

Disinfect the product according to section Cleaning and Disinfection Instructions on page 26.

7

Prepare an area that is dry, with good ventilation and out of direct sunlight for storage of the Carendo shower and toilet chair.

8

Choose a designated area, where the Instructions for Use should be kept and is accessible at all times for the users.

9

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

•

4

Assess the patient whether the safety belt is needed.

Carendo Directions The directions right or left and intended driving direction in this IFU are shown below.

Right

Left

NOTE If you have any questions, please contact your local ArjoHuntleigh representative for support and service. See contact information according to ArjoHuntleigh Addresses on page 43.

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Parts Designation 1

Chassis

2

Care Raiser

3

Castors

4

Lifting frame

5

Backrest

6

Neck pillow

7

Transfer handles

8

Manoeuvring handles

9

Storage net

10 Safety belt 11 Seat 12 Leg support 13 Armrests 14 Hand control 15 Battery 16 Battery charger 17 Battery holder 18 Seat cushion 19 Bed pan holder (optional) 20 Bed pan (optional) 21 Back pillow (optional) 22 Emergency stop button 23 Emergency lowering button 24 Hand control connector Applied part: Type B (Entire product) protection against electric shock in accordance with IEC 60601-1.

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Product Description / Functions Fig. 1

Reclined Function A function which makes hygienic care of the patient easier. From a sitting position, a reclined position can be achieved by means of turning gears which makes the backrest move in backwards and upright directions. Corresponding to this movement the leg rest is moving up and down. (See Fig. 1)

Fig. 2

Lifting Function – High/Low The patient can, in a sitting position, be transferred and the chair can be adjusted to a suitable height over the toilet. The lifting/lowering movement is performed by a linear actuator driven by an electric motor. (See Fig. 2)

Fig. 3

Care Raiser A function which makes undressing and changing of incontinence pads of the patient easier. (See Fig. 3) From a sitting position, a raising of the posterior parts of the patient and at the same time a backwards movement of the backrest is activated. (See Fig. 4) These movements are synchronized to each other.

WARNING Fig. 4

To avoid entrapment or pinching of genitals and skin, always use the seat cushion.

Leg Support Supports the patient’s legs, and also prevents the legs from getting jammed under the seat. Moves forward when the chair is adjusted to the reclined position.

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Fig. 1

Driving Handles Driving handles on the backrest give correct driving position for the caregiver. (See Fig. 1)

Fig. 2

Fig. 3

Manoeuvre Handles The manoeuvring handles on the backrest help the caregiver to get the chair in the correct position over the toilet and in the shower. (See Fig. 2)

Castors The Carendo shower and toilet chair is equipped with lockable castors. The castors will brake by pressing the castor lock tab down with your foot (A). (See Fig. 3) The castors are released by pressing up the centre tab (B). (See Fig. 3)

Fig. 4

Safety Belt WARNING To prevent the patient from falling, make sure the safety belts are undamaged. If damaged, do NOT use the safety belts, replace with new ones before use. Secure the patient with the safety belt if needed. The safety belt will secure the patient in the chair. Fasten at the knobs on either side of the backrest. Adjust the length by pulling the safety belt end by the buckle. Make sure the safety belt is close to the patients body. When the safety belt is not in use don’t let the safety belt hang over the floor. (See Fig. 4)

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Hand Control

Fig. 1

Connect the connector of the hand control on the right side of the backrest. (See Fig. 1)

Fig. 2

The hand control has a hook on the back, making it easy to attach it to various parts of the chair. (See Fig. 2)

Fig. 3

Hand control (See Fig.3) A

•

Arrow pointing upwards/downwards for raising or lowering (A).

• •

Reclined (B) and sitting position (C). Green LED, flashing when the Care Raiser is possible to activate (D). Care Raiser (E) and sitting position (C).

E B D

C

•

NOTE A buzzing tone will be heard and the green LED is flashing when sitting position is reached. Fig. 4

NOTE Care raising can only be activated when the green LED is flashing.

Back Pillow (Accessory) An additional pillow to support the back.

Fig. 5

An integrated easy glide function when the chair is adjusted to reclined position. Easy to adjust according to the length of the patient. (See Fig. 4-5) See separate instructions accompanying the product.

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Battery Charger

Fig. 1

The battery holder should be attached to a suitable wall and the charger connected to a properly grounded wall socket. (See Fig. 1) NOTE The battery charger is designed for use in a dry location and should not be installed in bathrooms, etc. See NEA 8000 Battery Charger IFU.

Battery

Fig. 2

B

A

The battery is placed at the left side of the chair. (See Fig. 2 A-B) NOTE See to that the rounded ridge of the battery is turned upwards.

Seat Cushion Fig. 3 A

B

C

D

A seat cushion that provides comfort and protection against pinching. (See Fig. 3 A-D)

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Emergency Lowering

Fig. 1

In case of electrical malfunction, the chair can be lowered by pushing the green button. (See Fig. 1) NOTE This function should only be used in emergency.

Emergency Stop

Fig. 2 A

B

In any case of emergency, all functions can be stopped by pushing the red button (A). To reset this function, turn the red button clockwise (B). (See Fig. 2)

Fig. 3

Storage Net A net on the backside of the backrest where shampoo, soap, incontinence pads etc. can be kept. (See Fig. 3)

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Fig. 1

Bedpan and Bedpan Holder

WARNING To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture. A bedpan holder can be mounted under the seat. (See Fig. 1-2) See separate instruction Bedpan Holder.

Fig. 2

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Independent Patients

WARNING To avoid entrapment or pinching of genitals and skin, always use the seat cushion.

Fig. 1

Fig. 2

From a standing position or using a walking frame (5 steps) 1 Place the Carendo shower and toilet chair and adjust the height so that the edge of the seat touches the back of the patient's knees. 2

Activate the brake.

3

Let the patient hold on the armrest so that he/she can lean on it. (See Fig. 1)

4

Help the patient to sit down.

5

Raise the Carendo shower and toilet chair to a height which is convenient for moving the patient.

From a wheelchair (3 steps) For the patient to be able to move from a wheelchair without lifting aids, the individual must be strong enough to move himself/ herself sideways and/or be able to stand up. 1

Apply the castor brakes on the wheelchair.

2

Lower the Carendo shower and toilet chair so that its seat is at the same level as the wheelchair seat, or as close as possible.

3

Apply the brakes on the Carendo shower and toilet chair.

The patient can now move himself/herself from the wheelchair to the Carendo shower and toilet chair by placing his/her hands on the hand rest of the Carendo shower and toilet chair. (See Fig. 2)

Fig. 3

From a sitting to a standing position (3 steps) 1 Lower the Carendo shower and toilet chair until the patient's feet are in contact with the floor. 2

Activate the brake.

3

Help the patient to stand up. (See Fig. 3)

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Dependent Patients

WARNING Fig. 1

To avoid entrapment or pinching of genitals and skin, always use the seat cushion. From the wheelchair/chair to the Carendo shower and toilet chair with a passive lift (5 steps) Follow the separate operating instructions regarding the passive lift.

Fig. 2

1

Apply the brakes on the Carendo shower and toilet chair.

2

Place the passive lift with the patient as close as possible to the Carendo shower and toilet chair. Position the patient in the sling directly over the seat of the Carendo shower and toilet chair. (See Fig. 1)

3

Raise the Carendo shower and toilet chair until the seat reaches the patient and there is slack in the sling straps. Unhook and remove the sling. (See Fig. 2)

4

Secure the patient with the safety belt if needed.

5

Transfer the patient to shower or toilet.

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Fig. 1

Fig. 2

Fig. 3

From the bed to the Carendo shower and toilet chair with a ceiling lift (5 steps) Follow the separate operating instructions regarding the ceiling lift. 1

Place the Carendo shower and toilet chair under the ceiling lift with the patient in the sling. (See Fig. 1)

2

Apply the brakes on the Carendo shower and toilet chair.

3

Lower the sling with the patient until he/she reaches the seat of the Carendo shower and toilet chair. Unhook and remove the sling.

4

Secure the patient with the safety belt if needed.

5

Transfer the patient to shower or toilet.

From the wheelchair/chair to the Carendo shower and toilet chair with an active lift (6 steps) Follow the separate operating instructions regarding the active lift. 1

Apply the brakes on the Carendo shower and toilet chair.

2

Place the active lift with the patient as close as possible to the Carendo shower and toilet chair. Position the patient directly over the seat of the Carendo shower and toilet chair. (See Fig. 2)

3

Apply the brakes on the active lift.

4

Lower the patient till he/she reaches the seat of the Carendo shower and toilet chair. Unhook sling and remove, if present. (See Fig. 3)

5

Secure the patient with the safety belt if needed.

6

Transfer the patient to shower or toilet.

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Intentionally left blank

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Transfer to the Shower Fig. 1

Fig. 2

(18 steps) 1 Place the Carendo shower and toilet chair with the patient in the shower room. 2

Apply the castor brakes.

3

Raise the chair in a sitting position to a comfortable height for the caregiver.

4

Activate the Care Raiser on the hand control.

5

Pull down the trousers to the knees. (See Fig. 1) If the patient uses incontinence pads, remove them by pulling from behind. (See Fig. 2)

6

Raise the Carendo shower and toilet chair to a sitting position with the hand control.

WARNING To avoid entrapment, make sure to keep the patient’s hair, arms and feet close to the body and use designated grab supports during any movement. 7

Undress the patient.

8

Activate the reclined position on the hand control.

WARNING Fig. 3

To avoid entrapment or pinching of genitals, make sure there is enough clearance during movement over the tub edge, toilet, bedpan or other furniture. 9

Wash and shower the patient in this position. (See Fig. 3) Continue with the steps on the next page.

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Fig. 4

10 Adjust the height of the chair for a correct working posture during hair wash and pedicure. (See Fig. 4-5) 11 Dry the patient with a towel. 12 Adjust the Carendo shower and toilet chair to a sitting position. 13 Dry the back of the patient.

Fig. 5

Fig. 6

14 Dress the upper part of the body and pull up the trousers to the knees. (See Fig. 6) 15 Activate the Care Raiser on the hand control.

Fig. 7

16 Put on the incontinence pads, if used, and pull up the trousers completely. (See Fig. 7) 17 Adjust the Carendo shower and toilet chair back to a sitting position and lower the chair. Secure the patient with the safety belt, if needed.

WARNING To avoid entrapment, make sure to keep the patient’s hair, arms and feet close to the body and use designated grab supports during any movement. 18 Release the brakes and start the transfer.

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