Enterprise 9000X (E9X) Instructions for Use Rev 13

Contents Warnings, Cautions and Notes ... 4 General Warnings ... 5

1.

Introduction ...7 Product overview ... 9

2.

Clinical Applications...10 Intended use ... 10 Indications... 10 Contra-indications ... 11

3.

Installation ...12 Weighing system ... 13 Electricity supply ... 14 Underbed light ... 14 Mattresses ... 15

4.

Operation ...16 Brakes and steering... 16 Foot Pedal for Adjustment of Bed Height (Optional) ... 17 How to use the 5th Wheel (Optional) ... 18 Split side rails ... 19 CPR backrest release ... 20 X-ray cassette tray (Optional) ... 21 Operation ... 21 Bed length adjustment ... 23 Bedstripper (linen shelf) (Optional) ... 25 Lifting pole and accessory sockets ... 26 Drainage bag rails... 27 Head and foot boards ... 28 Adjusting the mattress platform ... 29 Patient controls ... 30 Caregiver controls ... 30 Patient handset (Optional) ... 32 Attendant Control Panel (ACP) ... 33 Function lockout ... 35 Adjusting the calf position ... 36 Backup battery ... 37 Duty cycle lockout ... 38

5.

Advanced Features ...39 Patient weighing system ... 39 VariZone™ patient movement detection ... 44 Anti-entrapment system (Optional) ... 46

6.

Product Care ...47 Mattress platform sections ... 47 Decontamination ... 48 Preventive maintenance ... 49 Troubleshooting ... 52 Fault indications ... 54 Product lifetime ... 54

7. Accessories and Cables ...55 8. Technical Data ...56 9. Warranty and Service ...62 10. Electromagnetic Compatibility ...63

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Warnings, Cautions and Notes

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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. Caregivers 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 caregivers. 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. 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.

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WARNING 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 when the patient is unattended. It is recommended to use the Function Lockout facility on the Attendant Control Panel to prevent unintended movement in situations where objects may press against the patient’s controls. 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. The bed can only be moved on firm surfaces. Gradients must not exceed an angle of 10 degrees. When moving or operating the bed, take care that any accessories attached to it (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 when using equipment that needs to be positioned under the base frame to ensure there is no contact with any part of the bed frame or components. Take care not to squeeze or trap trailing cables from 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. When operating moving parts of the bed, ensure the bed does not come into contact with adjacent equipment which could be damaged by the beds operation. 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® 9000X acute care hospital bed. These beds have multiple functions to provide the optimum nursing position for both patient and caregiver. Standard features: • Folding split side rails with integrated controls • 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 • Underbed lights • 125mm single wheel castors • Patient weighing and patient egress detection Optional features: • Anti-Entrapment System • 150mm (single or dual wheel) castors • Bedstripper (linen shelf) • 5th Wheel • DIN accessory rails • Lockable foot board and head board • Radio translucent backrest with X-ray cassette tray • Flat deck sheets • IndiGo™ Intuitive Drive Assist • Full width brake bar • Foot Pedal for Adjustment of Bed Height NOTE Do not combine curved deck sheets with flat deck sheets. 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 can be found on the specification label; this is located on the control box tray.

ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, SWEDEN

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

Fig. 1 - Product overview A. Head board

O. Brake pedal / bar

B. Head end split side rail

P. Accessory socket

C. Caregiver controls

Q. Extension catch bar

D. Backrest section

R. CPR release handle

E. Foot end split side rail F. Patient controls

S. Weighing / movement detection system controls

G. Attendant Control Panel (ACP)

T. Drainage bag rail

H. Seat section

U. Split side rail release lever

I.

V. Anti-entrapment sensor (Optional)

Thigh section

J. Calf section

W. Castor

K. Calf extension sheet

X. Lifting pole socket

L. Foot board

Y. Head end brake pedal (Optional)

M. Bedstripper (linen shelf) (Optional)

Z. Roller buffer

N. Extension locking handle NOTE 5th Wheel (Optional) is not shown on the picture, see page 18. NOTE Flat deck sheets are supplied as standard when the backrest with X-ray cassette tray is present. 9

2. Clinical Applications WARNING To ensure the patient can use the bed safely, their age 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. The weighing system is intended to provide reference data only. The weighing system is not intended to provide readings upon which medication dosage decisions are made.

Intended use The product is intended to provide support to patients during a stay in

Indications

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hospital or other care facility. The product allows positioning for CPR and Trendelenburg and is equipped with a weighing system. The weighing system is intended to provide reference data only. The weighing system is not intended to provide readings upon which medication dosage decisions are made. The bed is suitable for use in the following situations: • Intensive/critical care provided in a hospital where 24-hour medical supervision and constant monitoring is required, e.g. ITU, ICU and CCU. • Acute care provided in a hospital or other medical facility where medical supervision and monitoring is required, e.g. general medical and surgical wards. • 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. 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 caregiver’s discretion, use the controls to adjust their own position. The mattress platform can be positioned to assist with such clinical procedures as may be required in the Application Environments defined above.

Contraindications

The bed is not suitable for use in the following situations: • A domestic area, i.e. home healthcare. • Outpatient care. • By patients under 40kg in weight. • By children under 12 years old. The maximum recommended patient weight is 185kg. The safe working load (SWL) 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.

40 kg

146 cm BMI 17

The recommended patient size is: weight equal or above 40kg, height between146cm and 190cm, and BMI equal or above 17. At the discretion of the carer, patients taller than190cm may be accomodated 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 The following chapter describes how to install the bed.

WARNING If the power supply cord or 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 or trapped between the bed frame and head board. Disconnect the power supply cord from the electricity supply, and store it as shown, before moving the bed. Before the first use, or if the bed has been unused for more than three months, read and understand this IFU and test the functionality of the bed to verify correct operation. Refer to “Preventive maintenance” on page 49 for a list of functional tests.

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. After charging, check that the battery is fully serviceable by carrying out a battery test as shown on page 51.

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Weighing system

Position the bed on a flat, level surface and apply the brakes (see page 16). Remove the four transport locking bolts (1) and washers (2); there are two locking bolts at the head end of the bed and two at the foot end.

2

2

1

1

Fig. 2 - Removing the transport bolts Retain the bolts and washers in case the bed needs to be transported at a later date. CAUTION To prevent damage to the weighing mechanism, replace the transport locking bolts and washers before transporting the bed. This is not necessary when moving the bed short distances over smooth surfaces. When replacing the transport locking bolts care must be take to avoid trapping or damaging any cables.

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Electricity supply

Connect the mains plug to a suitable socket outlet. Make sure the plug is easily accessible so it can be disconnected quickly in an emergency.

2 3

1

Fig. 3 - Power supply cord and potential equalisation terminal When the bed is connected to the electricity supply, an indicator will light on the Attendant Control Panel (see page 33). The power supply cord (1) is fitted with a plastic hook (2). 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. A potential equalisation terminal (3) is located at the head end of the bed. When other electrical equipment is within reach of the patient or caregiver, potential differences between the equipment can be minimised by connecting together their potential equalisation terminals.

Underbed light

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The underbed light illuminates the floor on either side of the bed. The underbed light is always on unless the bed is in its low power state; refer to the section “Low power mode” on page 38.

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 split 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: 1 - 191cm 2 - 202cm 3 - 214cm

12.5 - 18cm 88cm

Mattress size label NOTE The numbers 1, 2 and 3 on the label indicate different mattress platform lengths; refer to “Bed length adjustment” on page 23. Mattresses and When choosing bed and mattress combinations, it is important to consider split side rails the use of split 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 split side rails, the following factors should be considered: • The bed is designed to provide an acceptable split 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 The following chapter describes how to operate the bed.

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

Brakes and steering The brake pedals at the foot end of the bed are linked by a full width bar which makes it easier to operate the pedals, especially when the mattress platform is at low height. The pedals have three positions as shown below: • 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.

BRAKE Using the steering castor

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 of the steering castor.

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 un-changed.

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Head end brake Brake pedals (1) are at the head end of the bed. These operate in the same pedals way as the foot end pedals.

1 Fig. 4 - Head end brake pedal

Foot Pedal for Adjustment of Bed Height (Optional) 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. 5) 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. 6) 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. 5) 2. Make sure the 5th wheel (B) is raised from the floor.

B

Foot End

A

Head End

Fig. 5 - 5th wheel activation pedal

Place Brake Pedal in “Free” position

Fig. 6 - Free Position 18

Split side rails

WARNING The clinically qualified person responsible should consider the age, size and condition of the patient before allowing the use of split side rails. Split side rails are not intended to restrain patients who make a deliberate attempt to exit the bed. Ensure that the mattress is suitable for use with split side rails - see “Mattresses and split side rails” on page 15. To prevent possible entrapment, make sure the patient’s head and limbs are clear of the split side rails when adjusting the mattress platform. Split side rail contact points are identified by this symbol. Keep hands and fingers away from these areas.

To lower the split side rail: Hold either split side rail handle (1). Pull the blue release lever (2) and lower the split side rail (3), holding the split side rail until it is completely lowered. The split side rail folds down below the mattress platform. 1

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2 Fig. 7 - Split side rail operation NOTE The head end and foot end split side rails operate in the same way. To raise the split side rail: Hold either split side rail handle (1). Pull the split side rail up and away from the bed until it locks in the raised position.

WARNING Make sure the locking mechanism is securely engaged when the split side rails are raised. 19

CPR backrest release Manual CPR release handles are located below the calf section on either side of the bed. If the patient suffers a cardiac arrest, pull the CPR release handle (1). This will lower the backrest (2) to enable cardio-pulmonary resuscitation to be carried out.

2

1

Fig. 8 - CPR backrest release

WARNING The backrest can fall quickly; keep hands clear to avoid trapping. Caution The manual CPR release should only be used in an emergency; repeated everyday use can cause premature wear.

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X-ray cassette tray (Optional) The X-ray cassette tray allows thoracic X-ray photography with the backrest at any angle and without the patient moving from the bed.

WARNING Position the mattress platform at an ergonomic height to allow easy loading and removal of X-ray cassettes. Return the X-ray cassette tray to its closed position below the backrest before raising or lowering the backrest. Do not sit or place heavy objects on the X-ray cassette tray. Ensure the X-ray cassette tray is held securely in place by the catch at all times.

Operation

Apply the brakes. Remove the head board from the bed. Pull the knob (1) to release the catch and slide the tray out (2) as far as will go.

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1 X-ray cassette tray operation Release the knob to hold the tray in the fully open position (3). Position the X-ray cassette (4) on the tray with its bottom edge against the lip at the foot end of the tray.

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