ARJOHUNTLEIGH Carenvo 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 2013. 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.

Contents Foreword ...4 Intended Use ...5 Safety Instructions ...6 Preparations ...7 Carevo Models ...8 Carevo Directions ...9 Parts Designation ...10 Product Description / Functions ...12 Control Panel ...12 Button Functions ...12 Castor Brakes ...12 Straight Steering Device ...12 Emergency Stop Button ...13 Safety Stop Function ...13 Ergo-access Area ...13 Flexi Zone ...13 Comfort Handles ...14 Side Supports ...14 Adjustable Back Support ...15 Attach/Remove Mattress ...15 Drainage Plug ...16 Drainage ...16 Head Pillow ...17 Shower Handle Holder ...17 Battery ...17 Transfer from Bed to Carevo ...18 Transfer from Carevo to Bed ...21 Transfer from Sling Lift to Carevo ...24 Transfer from Carevo to Sling Lift ...26 Shower the patient in the Carevo ...28 Home Care Use ...32 Cleaning and Disinfection Instructions ...34 Battery Instructions ...38 Care and Preventive Maintenance ...39 Alarms and Sounds ...42 Troubleshooting ...43 Technical Specifications ...44 Dimensions ...46 Labels on the Carevo ...48 Approvals and List of Standards ...50 Electromagnetic compatibility ...52 Parts and Accessories ...54 ArjoHuntleigh Addresses ... Last page

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Foreword Thank You for Purchasing ArjoHuntleigh Equipment. Your Carevo™ is a part of a series of quality products designed especially for hospitals, nursing homes and other health care use. Please contact us if you have any questions about the operation or maintenance of your ArjoHuntleigh equipment.

Complementary Information.

Please Read these Instructions for Use Thoroughly! Please read this Instructions for Use (IFU) in its entirety before using your Carevo. 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.

WARNING

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.

Definitions in this IFU

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

CAUTION

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

•

NOTE

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

Report Unexpected Operations or Events

•

TIPS

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

Means: This is information that will ease a certain task in the work flow.

Service and Support A service routine must be performed on your Carevo every year by qualified personnel to make sure the safety and operating procedures of your product. See section, Care and Preventive Maintenance.

Means: The name and address of the manufacturer.

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 This equipment must be used in line with its intended use and in accordance with the safety instructions. If there is anything you are not sure about, contact your ArjoHuntleigh representative.

Lifetime of the Equipment

This equipment is intended for assisted hygiene care, especially dressing/undressing and showering of patients in care environments like senior/assisted living, group home, special care, nursing homes, hospitals and home care.

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 the Instructions for use (IFU).

The expected lifetime of this equipment is ten (10) years but depending on the storage of the battery, the use frequency and the charging intervals, the service life of the battery is 2-5 years.

Depending on level of wear some equipment parts such as castors and mattress may need to be replaced during the equipment lifetime according to information in the Instructions for Use (IFU).

The Carevo equipment must be used by appropriately 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. The patient transfer to and from the Carevo can be performed with a ceiling lift, mobile passive lift or by lateral transfer to and from a bed, using an appropriate sliding aid. The Carevo should only be used for the purpose specified in these Instructions for Use (IFU). Any other use is prohibited.

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

The product is intended mainly for patients who are passive and totally dependent. To remain in a safe laying position on the Carevo, the patient must have limited physical capacity to move or be able to understand and respond to instructions to remain in such a position. If the patient does not meet this description, an alternative equipment/ system shall be used.

•

Prior to transfers and other patient handling, assessment of the patient and environment shall be performed so that staffing is in accordance with the need for the specific task.

•

The patient weight shall not exceed 182 kg (400 lbs.)

•

The product is intended for patients taller than 120 cm (3 feet 11 inches)

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Safety Instructions WARNING

CAUTION

To avoid injury, make sure that the patient is not left unattended at any time.

To avoid equipment damage only lift one end (head end or foot end) of the Carevo at a time. Never lift the foot end and the head end at the same time.

WARNING CAUTION

To avoid patient from falling out of the device make sure that all side supports are in a locked position.

To avoid equipment damage, never use sharp objects in the presence of the Carevo. It can cause punctures on the mattress.

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

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

WARNING To avoid the device from tipping and the patient from falling, do NOT sit on the head or foot end of the device.

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

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Preparations Actions Before Every Use (5 Steps)

Actions Before the First Use (11 Steps)

1

Check that all parts are in place. Compare with the Parts Designation list in this IFU.

1

Visually inspect Carevo for transport damage.

2

The package should be recycled according to local regulations.

2

Carry out a thorough inspection for damage, including mattress punctures.

3

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

3

If any part is missing or damaged - do NOT use the product!

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

4 Read the IFU. 5

Unpack the battery charger. For charging and charger installation instructions see NEA 8000 Battery Charger IFU.

6

Charge the battery for 24 hours.

7

Perform a functionality test on the Carevo. See section, Care and Preventive Maintenance.

8

Disinfect the product. See section, Cleaning and Disinfection Instructions.

9

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

5

Make sure that the battery is fully charged. See NEA 8000 Battery Charger IFU.

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

10 Choose a designated area where the IFU should be kept, accessible at all times. 11 Make sure to have a rescue plan ready in case of a patient emergency.

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Carevo Models Carevo without adjustable back support (standard) BAC1101-01 (Europe and North America) BAC1102-01 (Japan) BAC1103-01 (Australia) Length: 2000 mm (78 3/4” inches) Carevo with an adjustable back support BAC1111-01 (Europe and North America) BAC1112-01 (Japan) BAC1113-01 (Australia) Length: 2000 mm (78 3/4” inches)

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Carevo Directions Position the patient in the Carevo with the patient’s head towards the head end and feet towards the foot end. Make sure the patient’s hips are centrally positioned over the flexi zone. (See Fig. 1)

Fig. 1

Foot end Head end

NOTE Carevo is designed with a slight tilt down towards the drain.

Flexi zone Fig. 2

Emergency stop button

The caregiver needs to be positioned at the head end of the Carevo during transport. In case of an emergency the caregiver will be close to the emergency stop button. (See Fig. 2)

Transport direction

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Parts Designation Carevo includes the following parts: 1

Mattress

2

Control panels (one on each side support and head panel)

3

Head pillow

4

Opening handles

5

Castor brake lever (located all four castors)

6

Lower drainage

7

Drainage connection

8

Upper drainage

9

Lower drainage outlet

10 Mattress guide holes (one on each support plate) 11 Support plates (one for the head end and one for the foot end) 12 Shower handle holder 13 Flexi zone 14 Comfort handles 15 Head panel 16 Side support (one on each side of the Carevo) 17 Pillar 18 Castor base 19 Drainage hose holders 20 Foot panel 21 Mattress guides 22 Drainage plug 23 Emergency stop button 24 Battery 25 Battery compartment 26 Straight steering lever (green lever on two castors) Entire Product Applied part: Type B Protection against electric shock in accordance with IEC 60601-1.

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Product Description / Functions Control Panel Fig. 1

The control panel is located on each side support and on the head panel. There are two types of control panels depending on the Carevo model. The models are: • •

Fig. 2

Carevo model without adjustable back support (See Fig. 1) Carevo model with adjustable back support (See Fig. 2)

Button Functions: Press to raise the Carevo.

Press to lower the Carevo

Press to raise the adjustable back support.

Press to lower the adjustable back support. Fig. 3

Castor Brakes The castor brakes are located on all four castors. Fig. 4

Apply the brakes: Press down on the gray castor brake lever. (See Fig. 3) Release the brakes: Slightly kick up the gray castor brake lever. (See Fig. 4)

Straight Steering Device Fig. 5

Fig. 6

Most often used when one caregiver is transporting the Carevo. For easier manoeuvring in corridors and around corners, use the straight steering device. The straight steering devices are green and located on two castors diagonally from each other. Apply the straight steering lever furthest away from where the caregiver is standing. Do not apply both straight steering levers, since it will make the Carevo hard to manoeuvre. Apply straight steering: press down on the green straight steering lever. (See Fig. 5) Release the straight steering: slightly kick up the green straight steering lever. (See Fig. 6)

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Emergency Stop Button

Fig. 1

The emergency stop button is not intended to interrupt operation during normal use. If, for any reason the Carevo does not respond to the control panel, push the emergency stop button to stop any movement. (See Fig. 1) Contact qualified personnel if that happens. If the emergency button is pushed in by accident, turn the emergency stop button clockwise to reset it. The emergency stop button will pop back out by itself. Emergency stop symbol

Safety Stop Function If the Carevo is stopped by an object during lowering, the safety stop function will automatically be activated. Raise the Carevo and move it away from the object and continue lowering.

Fig. 2

Ergo-access Area The ergo-access area is located in the middle of each side support. (See Fig. 2) It’s designed for the caregiver to be able to: •

stand in a more ergonomic posture and

•

be able to reach the patient better. TIPS Use the ergo-access area to better reach the patient. Remember to move around the Carevo to avoid twisting and leaning forward when standing in the ergo-access area.

Fig. 3

Flexi Zone Fig. 4

Human figure

The flexi zone is constructed as a suspension area to distribute pressure on the patient’s lower back, coccyx and hips. (See Fig. 3)

For an optimal comfort level, position the patient’s buttocks centrally in the flexi zone.

Human figure

The mattress has a graphic outline with an illustrated human figure on each side. Position the patient’s buttocks within the graphic outline on the mattress. (See Fig. 4)

Fig. 5 Bend the patient’s knee to better see if the patient’s buttocks are positioned correctly within the graphic outline. Align the patient’s hip crease with the illustrated human figures. (See Fig. 5)

Human figure 13

Comfort Handles

Fig. 1

There are two comfort handles located on the Carevo, one on each side support. The patient can use the comfort handle as support when laying on the side. Holding on to the comfort handle can add a sense of security for the patient as well as a feeling of being able to help out. (See Fig. 1)

Side Supports The two side supports are there to secure the patient.

Fig. 2 View from head/foot end A

A B

B

C Fig. 3

C

WARNING To avoid the patient from falling out of the device make sure that all side supports are in a locked position. The side support has three positions: (See Fig. 2) A Inner position, B Outer position C Down folded position

Fold down the side support: Lift both opening handles up on the side support and let the side support fall towards you. (See Fig. 3)

Fig. 4

Fold up the side support from down folded position: Pull the side support up. Depending on the speed of the side support being pulled, it can lock in either the outer or inner position. For the outer position, pull up more slowly. (See Fig. 4) Change between inner position and outer position: Lift the opening handles and raise/lower the side support to the selected position until it locks and clicks into place. TIPS Before rolling a patient, adjust the side support to the outer position for more space.

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Fig. 1

Adjustable Back Support Some Carevo models (BAC1111-01, BAC1112-01 and BAC1113-01) are equipped with an electronic adjustable back support. Use the control panels to operate the adjustable back support. (See Fig. 1) Press to raise the adjustable back support.

Press to lower the adjustable back support.

Fig. 2

CAUTION To avoid the Carevo adjustable back support from electrical overheating during constant use of lowering/raising, make sure to lower/raise the back support for a maximum of 2 minutes. Then wait for 6 minutes before lowering/raising the back support again.

Attach/Remove Mattress Attach: Find the position of the drainage outlet and let the mattress guides fall into the mattress guide holes located on the support plates. (See Fig. 2)

Fig. 3

Remove: 1 Remove the drainage plug from the mattress. 2

Pull the mattress up and away from the support plates. (See Fig. 3)

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Fig. 1

Drainage Plug Place the drainage plug in the mattress drainage for shallow bathing. Remove the drainage plug during showering. (See Fig. 1) The drainage plug is attached to the foot panel by a string. When not in use let it hang freely.

Fig. 2

Drainage The Carevo upper drainage and a lower drainage is located under the foot panel. Remove the lower drainage: Grab and squeeze the sides of the lower drainage connector and pull it down. (See Fig. 2)

Fig. 3

Attach the lower drainage: Push the lower drainage with the drainage connector up to the upper drainage until it clicks into place. (See Fig. 3)

Fig. 4

Position of drainage hose during transport/storage: Connect the lower drainage outlet to the drainage hose holder located on the foot panel. (See Fig. 4)

Fig. 5

Position of drainage hose during a shower: Connect the lower drainage outlet to the drainage hose holder on the castor base and position it over the floor drain (See Fig. 5) or

Fig. 6

Completely remove the lower drainage and position the upper drainage over a toilet or a flush sink. (See Fig. 6)

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Fig. 1

Head Pillow The head pillow is shaped to fit into the head end of the mattress. Position it according to the illustration. (See Fig. 1) The head pillow provides warmth and comfort for the patient.

Fig. 2

Shower Handle Holder The shower handle holder is located on each side support. Attach the shower handle to the shower handle holder when needed. (See Fig. 2) • •

Fig. 3

For the caregiver, the attachment will provide a better reach of the shower handle during the shower routine. For the patient, the attached shower handle can be used to sprinkle water over the patient, to keep him/her warm.

Battery The battery is located under the head panel. Carevo uses the NEA0100-083 battery. (See Fig. 3) The rounded ridge of the battery needs to be upward when inserting it into the Carevo battery compartment. (See Fig. 4) Remove the battery by pulling it straight out.

Fig. 4

Low charge warning A buzzer sound will go off when the battery reaches a low charge. The battery should then be recharged as soon as possible. For charger and charger installation instructions, see NEA 8000 Battery Charger IFU.

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Transfer from Bed to Carevo Fig. 1

Lateral Transfer (21 Steps) (For lateral transfers always use a sliding aid. For sliding aid instructions, see respective sliding aid IFU.)

Fig. 2

Fig. 3

1

Fold down the Carevo side support on the transfer side and lower the adjustable back support, if available.

2

Apply the brakes on the bed.

3

Adjust the bed to an ergonomic height.

4

Place the sliding aid (tube/sheet) under the patient. (Use local technique) (See Fig. 1)

5

Place a pillow under the patient’s head.

6

Fold down the bed rail on the transfer side.

7

Position the Carevo next to the bed’s transfer side.

8

Fold down the Carevo mattress on the transfer side. Press down and fixate the Carevo mattress corners between the head/foot panel and support plate. (See Fig. 2)

9

Adjust the Carevo height so that its slightly lower than the bed. (See Fig. 3) NOTE If there is a gap between the bed and Carevo, place a sliding board in between the two to bridge the gap.

10

WARNING 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. Push the Carevo against the bed

continue with the steps on the next page

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Fig. 4 11

WARNING To avoid falling during a transfer always make sure that the brakes are applied on all equipment being used. Apply all four castor brakes on the Carevo. (See Fig. 4)

Fig. 5 12

WARNING 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. Transfer the patient with the sliding aid (tube /sheet) from bed to the Carevo. Make sure to keep an eye on the patient’s head during the transfer. Examples of transfer with a sliding aids are:

Fig. 6

• Tube (See Fig. 5) • Sliding sheet (See Fig. 6) NOTE The number of caregivers and their positions during the transfer depends on the sliding aid being used and the patient assessment.

Fig. 7

13 If the mattress accidently gets bumped out of position, it will create bumps under the mattress. This can be uncomfortable for the patient to lie on. Make sure the mattress is in its right position.

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Fig. 8

WARNING To make sure that the patient cannot slip out through the side support, make sure that the mattress sides are up and not folded underneath the patient. For better comfort, position the patient correctly on the flexi zone. Make sure the patient’s buttocks are within the graphic outline on the mattress. (See Fig. 7) The patient’s hip creases should be aligned with the illustrated human figure. (See Fig. 8) Use the sliding aid to adjust the patient’s position.) continue with the steps on the next page 19

Fig. 9

15 Replace the bed pillow with the Carevo head pillow.

16 Remove the sliding aid from under the patient’s body. (Use local technique) (See Fig. 9)

Fig. 10

17 Release the castor brakes on the Carevo. (See Fig. 10)

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Fig. 11

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.

WARNING To avoid the patient from falling out of the device make sure that all side supports are in a locked position. Carefully move the Carevo away from the bed enough to fold up the side support on the Carevo. (See Fig. 11)

Fig. 12

19 Adjust the Carevo to an ergonomic height. (See Fig. 12) 20 Raise the Carevo adjustable back support, if available. (See Fig. 12) 21 Transport the patient to the bath room.

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Transfer from Carevo to Bed Fig. 1

Lateral Transfer (20 Steps) (For lateral transfers always use a sliding aid. For sliding aid instructions, see respective sliding aid IFU.) 1

Apply the brakes on the bed.

2 Adjust the bed to an ergonomic height. Fig. 2

3

Fold down the bed rail on the transfer side.

4

Apply all four castor brakes on the Carevo. (See Fig. 1)

5

Lower the adjustable back support on the Carevo, if available.

6

Place the sliding aid under the patient. (Use local technique) (See Fig.2)

7

Release the castor brakes on the Carevo. (See Fig.3)

Fig. 3 8 Position the Carevo close to the bed with enough space to later fold down the Carevo side support on the transfer side.

Fig. 4

9

Adjust the Carevo height so that it’s slightly higher than the bed.

10

WARNING To avoid entrapment make sure to keep the patients hair, arms and feet close to the body and use designated grab supports during any movement. Position the Carevo close to the bed and fold down the Carevo side support on the transfer side. (See Fig. 4) continue with the steps on the next page

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