PRELUDE Instructions for Use 2011

® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ARJO Hospital Equipment AB 2011. ArjoHuntleigh products are patented or patent pending. Patent information is available by contacting $UMR+XQWOHLJK. Our policy is one of continuous development, and we therefore reserve the right to make technical alterations without notice. The content of this publication may not be copied either whole or in part without the consent of ARJO Hospital Equipment AB.

Contents Foreword ... 4 Intended Use ... 5 Safety Instructions ... 6 Preparations ... 7 Parts Designation ... 8 Product Description / Functions... 10 Splash guard... 10 Chair ... 10 Assist resident into the Prelude™... 12 Ambulatory residents... 12 Resident without an aid ... 12 Transfer directly from wheelchair ... 14 Transfer using an ArjoHuntleigh lift hygiene chair... 16 Transfer using an ArjoHuntleigh standing and raising aid... 18 Disinfection Instructions ... 20 Microbiological Formation Prevention... 21 Accessories for disinfecting the Prelude ... 21 Replacing disinfectant bottle in the Shower and Disinfection panel... 22 Disinfecting the Prelude... 24 Disinfecting lift hygiene chair in the Prelude ... 26 Care and Preventive Maintenance ... 28 Technical Specification... 32 Labels on the Prelude... 34 Accessories... 36 Addresses ... 37

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Foreword Thank you for purchasing ArjoHuntleigh equipment

If you require further information, please contact ArjoHuntleigh for comprehensive support and service programs to maximize the longterm safety, reliability and value of the product. Contact your local ArjoHuntleigh representative for replacement parts. The telephone number appears on the last page of this Instructions for Use (IFU).

Your Prelude is a part of a series of quality products designed especially for hospitals, nursing homes and other health care use. We are dedicated to serving your needs and providing the best products available along with training that will bring your staff maximum benefit from every ArjoHuntleigh product.

Definitions in this IFU

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

WARNING

Please read this Instructions for Use thoroughly!

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

Please read this Instructions for Use (IFU) in its entirety before using your Prelude. Information in this IFU is crucial to the proper operation and maintenance of the equipment, will help protect your product, and ensure 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.

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CAUTION

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

ArjoHuntleigh strongly advise and warn that only ArjoHuntleigh designed parts, which are designed for the purpose, should be used on equipment and other appliances supplied by ArjoHuntleigh, to avoid injuries or malfunctions caused by the use of inadequate parts.

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 must be performed on your Prelude every year by qualified personnel to ensure the safety and operating procedures of your product. See chapter, Care and Preventive Maintenance. 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.

Installation & Service requirements The equipment must only be used for the purposes stated, and must be installed according to ArjoHuntleigh’s Assembly and Installation Instructions, which can only be superseded by local code. The useful life of this equipment, unless otherwise stated is ten (10) years, subject to required preventive maintenance as specified in the Instructions for Use (IFU), the Assembly and Installation Instructions and the Spare Part Catalogue.

This equipment is intended for showering hospital or care facility residents under the supervision of trained skilled nursing staff in accordance with the instructions outlined in the Instructions for Use (IFU). All other uses must be avoided. Equipment must be disinfected according to the instructions established in the Instructions for Use (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 safe working load (SWL) should not exceed 125 kg (275 lbs). Active and semi-active residents (i.e. able to sit upright self supported on the side of a bed or toilet) can use the Prelude. Correct transfer aid shall be used, if needed.

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Safety Instructions

WARNING Failure to clean equipment according to instructions can cause crosscontamination. Make sure that there is enough disinfectant in the bottle before starting the disinfection process.

WARNING Make sure to refer to the compatible products IFU when using it together with the Prelude to avoid bodily injury.

WARNING Never leave the resident unattended at any time due to risk of the resident standing up in the Prelude and falling or other dangerous situations.

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Preparations Actions before first use

Actions before every use

1 Visually check the package for damage. If the product looks damaged due to freight, make a complaint to the transport agency. 2 The packaging should be recycled according to local regulations. 3 Install the Prelude by qualified personnel. See separate Assembly and Installation Instructions. 4 Check that all parts of the product are supplied. Compare with the Parts Designation page in this IFU. If any part is missing or damaged - DO NOT use the product. 5 Read the IFU. 6 Clean the product according to the disinfection instructions in this IFU. 7 Perform a functionality test. See chapter, Care and Preventive Maintenance. 8 Choose a designated area, where the IFU should be kept and is easily accessible at all times. 9 Make sure to have a rescue plan ready in case of a resident emergency. 10 If you have any questions, please contact your local ArjoHuntleigh representative for support and service. The contact number appears on the last page of this IFU.

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Check that all parts are in place. Compare to the Parts Designation page. 2 If any part is missing or damaged - DO NOT use the product. 3

WARNING To prevent cross-contamination always disinfect after every use.

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Parts Designation The Prelude include the following parts: 1

Back rest

2 Safety belt 3 Lock (chair in inner position) 4 Lock (chair in outer position) 5 Grab bar 6

Chair

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Chair rails

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Drainage

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Toilet function

10 Splash guard (2 types) 11 Hair wash basin (Accessory)

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Model with toilet function

Product Description / Functions Splash guard

Chair

WARNING

WARNING

When removing the splash guard from the Prelude, pull it in a direction away from the face to avoid injury.

To prevent injury, make sure that the chair is locked before attempting to transfer the resident.

Remove the splash guard by lifting it upwards before assisting the resident to the Prelude. (Figure 1.)

The chair of the Prelude can slide back and forth and automatically locks to its outer and inner position. Outer position: Is used for transfers from an ordinary wheelchair and from an ArjoHuntleigh standing and raising aid. Inner position: Is used for residents without an aid and for showering when resident is already transferred to the chair. (Figure 2.) For the resident to leave the chair do the following: 1 Release the lock located to the left of the chair. (Figure 2.) 2

Slide the chair forward until it locks.

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Now the chair is ready for the resident to be transferred back to the wheelchair or standing and raising aid. (Figure 2.)

If an ArjoHuntleigh lift hygiene chair is used to transfer to the Prelude, remove the chair as follows: 1

Release the inner lock and move the chair forward until front wheels are positioned at the bow shaped section of the rails. (Figure 3.)

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Lift the front of the chair up and let the front wheels separate from the rails. (Figure 4.)

3 Move the chair forward until the back wheels will separate from the rails and lift the chair up.

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Assist resident into the Prelude Ambulatory residents

7 Let the resident wash himself or herself if capable.

The procedure for entering into the Prelude vary depending on the condition of the resident and the aid being used.

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Non-ambulatory residents are recommended to enter into the Prelude with the help of an ArjoHuntleigh lift hygiene chair or a standing and raising aid.

9 Use the flush function if the Shower & Disinfection panel is equipped with a flush valve or a flush button.

Resident without an aid (13 steps)

10 Remove the splash guard for easy shower access to lower body, legs and feet. (Figure 4.)

1 Remove the splash guard. (Figure 1.) 2

Make sure the chair is locked in its inner position. (Figure 1.)

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Assist the resident into the Prelude. (Figure 2.)

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WARNING

11 Make sure to rinse away all soap, shampoo and bath oil collected at the bottom of the Prelude. 12 When leaving the Prelude it is easier for the resident to back out, while holding on to the grab bars. 13 Make sure to disinfect the Prelude after every use to prevent cross-contamination. See chapter, Disinfection Instructions.

To prevent fingers being pinched, make sure the resident’s hands are not on the chair rails. When the resident enters the Prelude, make sure they place their hands on the grab bar for better balance. (Figure 2.) 5 Reposition the splash guard. 6

Place a towel around the residents shoulders after having washed and rinsed the upper body.

WARNING

To prevent scalding, always check the water temperature with your naked hand before directing the water onto the resident. Do not use gloves as it may insulate to the extent that the water temperature can be misjudged. Set the shower controls, then shower and shampoo the resident from his or her head downwards. (Figure 3.) 12

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Transfer directly from wheelchair (14 steps)

8 Reposition the splash guard. 9

Sitting residents who are able to stand on their legs may be transferred directly from the wheelchair to the Prelude.

To prevent scalding, always check the water temperature with your naked hand before directing the water on the resident. Do not use gloves as it may insulate to the extent that the water temperature can be misjudged. (Figure 4.)

1 Remove the splash guard and slide the chair to its outer locked position. 2

Remove the seat in the Prelude with toilet function if showering an incontinent resident. (Figure 1.)

Set shower controls, then shower and shampoo the resident from his or her head downwards. (Figure 5.)

3 Park the wheelchair next to the Prelude. Apply the brakes and fold back/remove the side of the wheelchair. (Figure 2.) 4

10 Place a towel around the residents shoulders after having washed and rinsed the upper body.

WARNING Make sure that the chair is locked in its outer position before attempting to transfer the resident, to avoid bodily injury.

11 Use the flush function if the Shower & Disinfection panel is equipped with a flush valve or a flush button. 12 Remove the splash guard for easy shower access to lower body, legs and feet. (Figure 6.)

Assist the resident onto the chair of the Prelude and attach the safety belt. 5

13 Make sure to rinse away all soap, shampoo and bath oil collected at the bottom of the Prelude.

WARNING Assist the resident with their legs over the threshold of the Prelude, in order to avoid bodily injury.

14 Make sure to disinfect the Prelude after every use to prevent cross-contamination. See chapter, Disinfection Instructions.

Help the resident placing his or her feet inside the Prelude before sliding the chair to its inner locked position. (Figure 3.) 6 Release the lock for the outer position and push the chair slightly inwards. 7

WARNING

WARNING To prevent fingers being pinched, make sure the resident’s hands are not on the chair rails.

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Transfer using an ArjoHuntleigh lift hygiene chair (14 steps)

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Sitting residents may be transferred from their bed or wheelchair with the help of an ArjoHuntleigh lift hygiene chair. (Figure 1.)

1 Remove the splash guard and the chair from the Prelude, before transferring the resident from their bed or wheelchair.

To prevent scalding, always check the water temperature with your naked hand before directing the water on the resident. Do not use gloves as it may insulate to the extent that the water temperature can be misjudged.

2 Position the lift hygiene chair in front of the Prelude with the resident’s back towards the Prelude. 3

WARNING

WARNING

Set shower controls, then shower and shampoo the resident from his or her head downwards. (Figure 4.)

Always make sure that the lift hygiene chair is raised high enough for the resident’s legs to clear the threshold of the Prelude to avoid bodily injury.

9 Adjust the height of the lift hygiene chair for easy access during showering. (Figure 5.)

Raise the lift hygiene chair and push it carefully as far as possible into the Prelude. (Figure 2.)

10 Place a towel around the residents shoulders after having washed and rinsed the upper body.

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First, apply the castor brakes and lower the resident to an ergonomic working height. Then fold away the hand rest.

11 Use the flush function if the Shower & Disinfection panel is equipped with a flush valve or a flush button.

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WARNING

12 Remove the splash guard for easy shower access to lower body, legs and feet. (Figure 5.)

To prevent fingers being pinched, make sure the resident’s hands are not on the chair rails.

13 Make sure to rinse away all soap, shampoo and bath oil collected at the bottom of the Prelude.

6 Loosen the lift hygiene chair safety belt and undress the resident then fasten the safety belt back again. (Figure 3.)

14 Make sure to disinfect the Prelude after every use to prevent cross-contamination. See chapter, Disinfection Instructions.

7 Reposition the splash guard.

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Transfer using ArjoHuntleigh standing and raising aid (18 steps) 1

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WARNING Assist the resident with their legs over the threshold of the Prelude, in order to avoid bodily injury.

Remove the splash guard and slide the chair to its outer locked position. (Figure 1 and 2.)

Release the outer lock and carefully push the chair slightly inwards. Help the resident to place their feet inside the Prelude before sliding the chair to its inner locked position. (Figure 6.)

Remove the chair in the Prelude with toilet function if showering an incontinent resident.

3 Bring the standing and raising aid to the resident, apply the brakes and attach the sling to the resident. Raise the resident to a standing position.

12 Reposition the splash guard. 13

WARNING

4 Release the brakes on the standing and raising aid and pull it away from the wheelchair. (Figure 3.) 5 Apply the brakes again while taking down the resident’s trousers. 6

Release the brakes and transfer the resident to the Prelude (Figure 4.)

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WARNING

To prevent scalding, always check the water temperature with your naked hand before directing the water on the resident. Do not use gloves as it may insulate to the extent that the water temperature can be misjudged.

Make sure that the chair is locked in its outer position before attempting to transfer the resident, in order to avoid bodily injury.

Set shower controls, then shower and shampoo the resident from his or her head downwards. (Figure 7.) 14 Place a towel around the residents shoulders after having washed and rinsed the upper body.

Lower the resident onto the chair. (Figure 5.) 8 Remove the sling and assist the resident to take his or her feet off the foot pad. Push the standing and raising aid aside.

15 Use the flush function if the Shower & Disinfection panel is equipped with a flush valve or a flush button.

9 Attach the safety belt around the resident’s chest.

16 Remove the splash guard for easy shower access to lower body, legs and feet. (Figure 8.)

10 Remove residents shoes, socks and trousers before undressing the upper body. 11

17 Make sure to rinse away all soap, shampoo and bath oil collected at the bottom of the Prelude.

WARNING To prevent fingers being pinched, make sure the resident’s hands are not on the chair rails.

18 Make sure to disinfect the Prelude after every use to prevent cross-contamination. See chapter, Disinfection Instructions. 18

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Disinfection Instructions Thorough disinfection and cleaning routines are necessary to prevent the build-up of bacteria on and in the equipment and to prevent cross-contamination. This is particularly vital in cases where there is a shared facility.

For optimal performance only use ArjoHuntleigh Disinfectants.

CAUTION To prevent equipment surface damage only use Arjo Clean™.

WARNING If you have any questions regarding disinfecting the equipment or wish to order cleaning fluid, please contact your ArjoHuntleigh Customer Service.

WARNING

Always use protective gloves and protective eye wear when dealing with disinfectant. Avoid getting it on your skin, in your eyes or on your clothes. If contact occurs, rinse with extensive amounts of water. If skin or eyes become irritated, consult a physician. Carefully follow the instructions on the ArjoHuntleigh disinfectant bottle.

The disinfection procedure must be carried out after every shower. No resident is allowed in the Prelude during the disinfection procedure. Failure to clean equipment according to instructions can cause crosscontamination.

CAUTION Use only disinfecting chemicals specifically formulated for bathing systems. Other chemicals may damage the equipment or be harmful to the residents. Polishing or corrosive agents must not be used. Do not use the following substances in the Prelude: Iodine, bromide, methylene blue, potassium permanganate etc. (discolouration) Citric acid, chlorine, heavy metal chlorides, petroleum based solvents, trichloroethylene, phenol based disinfectants or similar solvents (damages the plastic surfaces). Do not wash the product with a high pressure washer.

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Microbiological Formation Prevention.

Accessories for disinfecting the Prelude.

In order to enhance the on-site curative actions (chlorine or thermal shock), which do not guarantee a reduction of the contamination long term, make sure to follow the instructions below.

1 Protective gloves. 2 Protective eye wear 3 Soft bristle brush 4 Toilet brush 5 Cloth or paper towels 6 Disinfection fluid 7 Shower & Disinfection panel (option) 8 Towel

Installation Precautions In order to limit the growth of bacterial flora, it is necessary to take action at four levels: •

Avoid stagnating water and ensure proper water circulation;

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Take precautions against the formation of scale and corrosion based on to the water quality;

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Maintain a high water temperature from production to the different distribution circuits;

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Mix hot and cold water as close as possible to the point of use

Use • Make sure that the water circulates in the Shower & Disinfection panel on a daily basis even if the Shower & Disinfection panel and the Prelude are not used; and particular to make sure to remove any water that may be left behind in the hose. •

Let the water flow approximately 5 minutes before the first shower of the day.

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Clean and disinfect the Prelude according to the IFU before the first shower of the day and after each resident.

Do not forget to contact ArjoHuntleigh for the annual Care and Preventive Maintenance visit.

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