Enterprise 5000X (E5X) Instructions for Use Rev 19

Contents Warnings, Cautions and Notes... 4 General Warnings ... 4

1. Introduction ... 6

Product overview – Head Board On Mattress Platform ... 8 Head Board On Base (Optional) ... 9 Folding split side rails (Optional) ... 10

2. Clinical Applications ... 11

Intended use ... 11 Indications ... 11 Contra-indications ... 12

3. Installation ... 13

Mattresses... 15

4. Operation ... 17

Brakes and steering ... 17 Foot Pedal for Adjustment of Bed Height (Optional) ... 18 How to use the 5th Wheel (Optional) ... 19 Side rails (Optional)... 20 CPR backrest release ... 24 X-ray cassette tray (Optional)... 25 Bed length adjustment ... 27 Bedstripper (linen shelf) (Optional)... 29 Lifting pole and accessory sockets... 30 Drainage bag rails ... 31 Head and foot boards... 31 Mattress platform sections ... 32 Head and foot boards... 32 Underbed light (Optional) ... 32 Adjusting the mattress platform ... 33 Patient handset ... 34 Attendant Control Panel (ACP) ... 36 Adjusting the calf position... 38 Function lockout ... 39 Backup battery ... 40 Duty cycle lockout ... 41

5. Product Care ... 42

Decontamination ... 42 Preventive maintenance ... 44 Battery test ... 46 Troubleshooting ... 47 Fault indications ... 48 Product lifetime ... 48

6. Accessories and Cables ... 48 7. Technical Data ... 50 8. Warranty and Service... 55 9. Electromagnetic Compatibility ... 56

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Warnings, Cautions and Notes

WARNING

Indicates possible hazards in procedures or conditions which, if not correctly followed, could result in death, injury or other serious adverse reactions.

CAUTION

Indicates possible hazards in procedures or conditions which, if not correctly followed, could result in equipment damage or failure.

NOTE

Explains or amplifies a procedure or condition.

General Warnings

WARNING Keep these instructions in a safe place; you may need to refer to them later on. Read and understand these instructions before operating the bed. Carers must be trained in the proper use of this product, its functions and controls, and any accessories. These instructions are mandatory for the safe and effective use of this product, including the safety of patients and carers. Unauthorised modifications or repairs to this product may affect its safety and will invalidate any warranty. Arjo accepts no liability for any incident, accident or reduction in performance that may occur as a result of such repairs or modifications. To avoid the risk of electric shock, this product must only be connected to an electricity supply with a protective earth. Do not smoke or use naked flames near this equipment and do not expose it to extremes of temperature. Do not use electrically powered beds in the presence of flammable gases such as anaesthetic agents e.g. in operating theatres. The bed is intended for indoor use only and should not be used outside a normal hospital environment. Do not use accessories that have not been designed or approved for use with the bed. The user should carry out a risk assessment before using the bed with equipment from other suppliers or manufacturers.

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WARNING Always apply the brakes when the bed is stationary. To reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended. Patients should not be left in the Trendelenburg position when unattended. To reduce the risk of overbalancing, do not allow the patient to get on or off the bed when the mattress platform is in a tilted (head down or foot down) position. Where risk assessment indicates that a patient is at high risk of entrapment owing to their medical condition or other circumstances, and where there is no medical benefit from their being left in a contoured position, place the mattress platform in the flat position and disable the controls (Function lockout) when the patient is unattended. When the bed is operated, make sure that obstacles such as feet, oxygen bottles, bedside furniture or any other objects do not restrict its movement. To avoid potential damage or injury, do not leave oxygen bottle or any other obstacles under the bed frame while operated. When moving or operating the bed, take care that any attached accessories (e.g. lifting pole) do not strike doors, ceilings, etc. Hold the head board or foot board when pushing or pulling the bed; do not hold the side rails or any attached accessories. Before operating the bed, make sure the patient is positioned correctly to avoid entrapment or imbalance. Take care not to squeeze or trap trailing cables from the handset/ACP and other equipment between moving parts of the bed. Take care not to allow clothing or bed linen to become snagged on moving parts of the bed. Do not place the bed on an incline greater than 7° as this may, in extreme circumstances, cause the bed to overbalance. This product complies with the requirements of applicable standards for electromagnetic compatibility (EMC). However, medical electrical equipment requires special precautions regarding EMC and should be installed and used in accordance with the EMC information in the product service manual. Medical electrical equipment can be affected by portable and mobile radio frequency communications equipment e.g. cellular telephones. If a serious incident occurs in relation to this medical device, affecting the user, or the patient then the user or patient should report the serious incident to the medical device manufacturer or the distributor. In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located.

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1. Introduction These instructions contain information for the installation, use and maintenance of the Arjo Enterprise® 5000X range of acute care hospital beds. These beds have multiple functions to provide the optimum nursing position for both patient and carer.

Standard features •

Electrical adjustment of bed height and leg section elevation

•

Electrically operated retracting backrest

•

Bio-Contour® advanced profiling system

•

Auto-Chair facility

•

Electrical adjustment of head down tilt (Trendelenburg) and foot down tilt (reverse Trendelenburg)

•

Manual selection of calf section vascular position

•

Mattress support surface with removable panels

•

Adjustable length mattress platform

•

Drainage bag rails

Optional features •

¾ length folding side rails with 3 or 5 bar

•

Folding split side rails

•

125mm (single wheel) or 150mm (single or dual wheel) castors

•

Bedstripper (linen shelf)

•

Underbed lights

•

Full width brake bar

•

5th Wheel

•

DIN accessory rails

•

Radio translucent backrest with X-ray cassette tray

•

Flat or curved platform sections

•

Patient handset with optional functionality

•

Lockable foot board and head board

•

IndiGo™ Intuitive Drive Assist

•

Foot Pedal for Adjustment of Bed Height

Optional features are specified by the customer at the time of ordering. The chosen options are indicated by the equipment model number.

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The model number and serial number located on the bed frame below the head board.

can be found on the specification label; this is

Specification label

CAUTION Before using the bed, ensure that the “Power In” rating on the specification label is compatible with the local electricity supply.

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Product overview – Head Board On Mattress Platform

A. Bedstripper (linen shelf) (Optional)

L. Lifting pole socket

B. Attendant Control Panel (ACP)

M. Roller buffer

C. Foot board

N. Castor

D. Calf extension sheet

O. Drainage bag rail

E. Calf section

P. Side rail operating knob

F. Thigh section

Q. CPR release handle

G. Seat section

R. Brake pedal

H. 3 bar folding side rail (Optional)

S. Extension catch bar

I. Backrest section

T. Accessory socket

J. Patient handset

U. Extension locking handle

K. Head board on mattress platform

NOTE

5th Wheel (Optional) is not shown on the picture, see page 19. 8

Head Board On Base (Optional) The bed can be optionally configured with the head board mounted on the base of the bed. The bed can also be configured with 3 or 5 bar easily removable side rails. The easily removable side rails are described more in section “To remove and install the 3 bar or 5 bar ¾ length folding side rail:” in Chapter 4.

A. Lifting pole socket on base frame B. Head board on base frame C. Backrest with X-ray cassette tray D. 3 or 5 bar removable side rails E. Flat deck for seat section F. Flat deck for thigh section G. Flat deck for calf section

NOTE

Flat deck sheets are supplied as standard when the backrest with X-ray cassette tray is present. In this configuration all other functionality of the bed remains identical.

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Folding split side rails (Optional) The bed can be optionally configured to use folding split side rails. In this configuration a side rail release lever is located directly below the side rail. The release lever is described more in section “To lower the folding split side rails:” in Chapter 4.

A. Head end side rail B. Foot end side rail C. Side rail release lever In this configuration all other functionality of the bed remains identical.

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2. Clinical Applications WARNING To ensure the patient can use the bed safely, their age, size and condition should be assessed by a clinically qualified person. The use of head down tilt (Trendelenburg) or foot down tilt (reverse Trendelenburg) may be contraindicated for certain medical conditions. The tilt facility should only be used under the guidance of a clinically qualified person after assessment of the patient’s condition.

Intended use

The bed is suitable for use in Application Environments 1, 2 and 3 as defined in IEC 60601-2-52. Application Environment 1 Intensive/critical care provided in a hospital where 24-hour medical supervision and constant monitoring is required, e.g. ITU, ICU and CCU. Application Environment 2 Acute care provided in a hospital or other medical facility where medical supervision and monitoring is required, e.g. general medical and surgical wards. Application Environment 3 Long term care in a medical area where medical supervision is required and monitoring is provided if necessary, e.g. nursing homes and geriatric facilities.

Indications

The bed is appropriate for high dependency patients who pose a movement and handling risk and / or whose clinical condition requires that they are positioned with minimal physical handling. Patients with a moderate amount of independence can, at the carer’s discretion, use the controls to adjust their own position. The mattress platform can be positioned to assist with treatment of a patient as required within the clinical settings defined in Application Environments 1, 2 and 3.

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Contraindications

The maximum recommended patient weight is 185kg. The safe working load of the bed is 250kg.

The safe working load is calculated as follows (in accordance with IEC 60601-2-52): Maximum patient weight 185kg Mattress 20kg Accessories (including attached loads) 45kg TOTAL 250kg

WARNING If the combined weight of the mattress and accessories exceeds 65kg, the maximum patient weight must be reduced accordingly. The recommended patient size is; weight equal or above 40kg (88lb), height between 146cm (57 ins.) and 190cm (74 ins.) and BMI equal or above 17.

At the discretion of the carer, patients taller than 190cm may be accommodated by extending the bed - refer to “Bed length adjustment” in Chapter 4. Ensure that the patient’s height does not exceed the “In-bed length” shown in Chapter 7.

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3. Installation Connect the mains plug to a suitable socket outlet. Make sure the mains plug is easily accessible so it can be disconnected quickly in an emergency. When the bed is connected to the electricity supply, indicators will light on the control box (1) and Attendant Control Panel. The power supply cord (2) is fitted with a plastic hook (3). When not in use or before moving the bed, clip the hook onto the head board, coil up the cable and place it over the hook as shown. To isolate the bed from the electricity supply, disconnect the mains plug from the socket outlet. 3

2

4

1

Cable storage and potential equalisation terminal A potential equalisation terminal (4) is located at the head end of the bed. When other electrical equipment is within reach of the patient or carer, potential differences between the equipment can be minimised by connecting together their potential equalisation terminals.

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WARNING If the power cord or mains plug is damaged, the complete assembly must be replaced by authorised service personnel. Do not remove the fitted plug, or use a rewireable plug or adapter. Make sure the power supply cord is not stretched, kinked or crushed. Do not allow the power supply cord to trail on the floor where it may cause a trip hazard. Make sure the power supply cord does not become entangled with moving parts of the bed. Disconnect the power supply cord from the electricity supply, and store it as shown, before moving the bed.

CAUTION Before the first use, or if the bed has been unused for more than three months, connect the bed to the electricity supply for at least 24 hours to allow the backup battery to recharge fully. Failure to do this may reduce the life of the battery. The bed should be positioned with the roller buffers at least 20cm from the rear wall to prevent the head board striking the wall when the bed is in head down tilt (Trendelenburg).

Recommended positioning from rear wall

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Mattresses

WARNING Always use a mattress of the correct size and type. Incompatible mattresses can create hazards. Entrapment hazards may exist when using a very soft mattress, even if it is the correct size. The maximum recommended mattress thickness for use with side rails is 18cm. Read the instructions for use supplied with the mattress. Where the maximum patient weight specified for the mattress is different to that specified for the bed, the lower value applies. A label on the calf extension sheet indicates the correct mattress size:

Mattress size label NOTE The numbers 1, 2 and 3 on the label indicate different mattress platform lengths; refer to “Bed length adjustment” in Chapter 4.

Continued on next page

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Mattresses and side rails (Optional)

When choosing bed and mattress combinations, it is important to consider the use of side rails based on clinical assessment of each individual patient and in line with local policy. When assessing the suitability of a mattress for use with side rails, the following factors should be considered: •

The bed is designed to provide an acceptable side rail height when used with a foam mattress up to 18cm thick.

•

Specialist powered air / foam replacement mattresses will typically envelop the patient when loaded and can generally be deeper than a foam mattress without compromising safety. Other makes of specialist mattress replacement must be assessed individually prior to use to verify sufficient clearance is maintained.

•

Mattress overlays are not recommended for use with this bed.

•

To ensure compliance with IEC 60601-2-52, an approved Arjo mattress should be used. Compliance with this standard when using other mattresses must be validated by the user.

• For more information on suitable mattresses and mattress

replacements, contact your local Arjo office or approved distributor. A list of Arjo offices can be found at the back of this manual.

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4. Operation WARNING Operate the brake pedals with your feet while wearing suitable shoes. Do not operate the pedals with your hands.

Brakes and steering

BRAKE Using the steering castor

The brake pedals at the foot end of the bed have three positions as shown: •

BRAKE: brakes are applied on all four castors.

•

FREE: all four castors are free to rotate and swivel.

•

STEER: all four castors can rotate, but the steering castor (see below) is locked so that it cannot swivel. This helps to keep the bed on a straight line.

FREE

STEER

Position the bed so that all the castors line up in the direction of travel. Raise the pedals to lock the steering castor and move the bed by pushing it from the opposite end.

NOTE

The steering castor may be at either end of the bed, as specified by the customer.

NOTE Brake pedal appearance may alter slightly on actual product, but functionality and user instructions remain unchanged.

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Brake bar (Optional)

The brake pedals may be linked by a full width brake bar (1) which makes it easier to operate the pedals.

1

Head end brake pedals

Foot Pedal for Adjustment of Bed Height (Optional)

Brake bar Brake pedals are provided at the head end of the bed. These operate in the same way as the foot end pedals.

Bed height can be adjusted from bed control panels and from the foot pedal located near the foot end of the bed.

Lift cover of pedal with foot and press left side to raise the bed height. Press right side of pedal to lower the bed height.

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How to use the 5th Wheel (Optional) The 5th wheel provides improved mobility and steering. . Activate 5th Wheel: 1. Step down on the head end of the 5th wheel activation pedal (A). (See Fig. 1) The 5th wheel (B) will lower until it has contact with the floor. 2. Check that the brakes are unlocked and the brake pedal is in the “Free” position. (See Fig. 2) 3. The bed is ready for movement. Deactivate 5th Wheel: 1. Step down on the foot end of the 5th wheel activation pedal (A). (See Fig. 1) 2. Make sure the 5th wheel (B) is raised from the floor.

B

Foot end A Head end Fig. 1 - 5th wheel activation pedal

Place Brake Pedal in “Free” position

Fig. 2 - Free Position

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Side rails (Optional) The bed can be fitted with ¾ length 3 bar or 5 bar side rails or folding split side rails.

WARNING - beds supplied without side rails The clinically qualified person responsible should consider the age, size and condition of the patient before allowing them to occupy the bed. Do not install side rails (including those made by Arjo) on the bed.

WARNING - beds supplied with side rails The clinically qualified person responsible should consider the age, size and condition of the patient before allowing the use of side rails. Side rails are not intended to restrain patients who make a deliberate attempt to exit the bed. The bed must only be used with the side rails supplied. Do not use another manufacturer’s side rails. Ensure that the mattress is suitable for use with side rails - refer to Chapter 3 for guidance. Side rail contact points are identified by this symbol. Keep hands and fingers away from these areas. When using removable ¾ length side rails, do not fit different side rails to those originally supplied by Arjo with the bed. Make sure the serial number label on the side rail corresponds to the serial number on the bed – refer to page 7 for a description of the bed serial number. When the removable side rails are fitted make sure the securing pin is assembled and fitted correctly.

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To lower the ¾ length folding side rail: Hold the top rail (1) just behind the hinge. Pull the blue operating knob (2) and lower the side rail towards the foot end of the bed (3).

3

1

2

¾ length folding side rail operation To raise the side rail: Hold the top rail (1) just behind the hinge. Pull the side rail up until it locks in the raised position with an audible “click”.

WARNING Make sure the locking mechanism is securely engaged when the side rail is raised. Do not leave the side rail in the raised position if the locking bolt (4) is visible behind the blue operating knob.

4

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