Citadel Bed Frame System Instruction for Use Rev A Aug 2014

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies unless otherwise stated. © ArjoHuntleigh 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 wholly or in part without the consent of ArjoHuntleigh.

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Table of Contents General Warnings ...6 Product Overview...10 Introduction...11 • Optional features:...12 Clinical Applications...13 • Intended Use...13 • Indications...13 • Contraindications...13 • General Product Information...13 • Risks and Precautions...13 • Precautions...14 • Safety Information...14 Installation...17 • Weighing System Preparation...17 • Electricity Supply...18 • Potential Equalization Terminal...19 • Bed Length Adjustment...19 • Mattresses...21 • Lifting Pole and Accessory Sockets...22 • Drainage Bag Rails...23 Operating Instructions...24 • Brakes and Steering...24 • Side Rails...25 • Head and Foot Boards...26 • Patient Restraints...26 • Under Bed Light...28 • Backup Battery...28 • Recharging the Backup Battery...29 • Duty Cycle Lockout...29 • Electrical Connections ...29 Control Panels...34 • Attendant Control (ACP)...34 • Nurse Control...34 • Patient Control Panels...34 • Patient Handset (Optional Feature)...37 • Weigh Scale Panels (With and Without Unit Selection)...38 • Weighing Accuracy ...39 • Weighing Initialization ...40 • Weighing ...40 • Weighing Units (If Equipped) ...41 • Auto Compensation...41 • Weighing System Error Codes ...42 4

Citadel Bed Frame System

• Angle Indication...42 • VariZone Patient Movement Detection / Exit Detection...43 • VariZone Operation ...44 • Anti-Entrapment System...45 • Monitor Bed Status Through the RS232 Connection...46 Patient Placement...48 • Power On ...48 • Preparation for Patient Placement ...48 • Completion of Patient Placement...49 Nursing Care...50 • CPR...50 • CPR Backrest Release...51 • Patient Bathing...51 • Patient Transfer from the Citadel Bed Frame System...52 • Patient Transport...52 Care and Cleaning...53 • Deck Sections...53 • Decontamination...53 • General Recommendations...54 • Cleaning the Citadel Bed Frame System While in Use...55 Preventive Maintenance...56 • Weighing System...57 • Battery Test ...57 Troubleshooting...58 • Error Codes...59 • Fault Indications...60 • Product Lifetime...60 Accessories...60 EMC Information...61 Warranty and Service...65 Specifications...66 Explanation of Symbols Used...68 Questions and Information...69

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General Warnings The following warnings should be considered prior to using this product: Before using the bed, make sure that the Power in rating on the specification label is compatible with the local electricity supply. To make sure 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 function should only be used under the guidance of a clinically-qualified person after assessment of the patient’s condition. If the combined weight of the mattress and accessories exceeds 43 kg, the maximum patient weight is reduced accordingly. If the power cord or plug is damaged, the complete assembly must be replaced by authorized service personnel. Do not remove the fitted plug, or use a rewireable plug or adapter. Make sure the power cord is not stretched, kinked or crushed. Do not allow the power cord to trail on the floor where it may cause a trip hazard. Make sure the power cord does not become entangled with moving parts of the bed or trapped between the bed frame and head board. Always adjust the bed frame and deck to the same length and make sure both are latched securely in position. 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 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. To prevent possible entrapment, make sure the patient’s head and limbs are clear of the side rails when adjusting the deck.

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Citadel Bed Frame System

Make sure the locking mechanism is securely engaged when the side rails are raised. Do not activate the turning feature on any mattress system when patient restraints are in use. Patient restraints should be used in compliance with all applicable federal and state regulations and in accordance with the healthcare facility’s own policies and procedures. Patient restraints, even when correctly used, can result in entrapment or injury, particularly if the patient is disorientated or restless. The decision to use patient restraints must be made by the clinician overseeing the care of the individual patient, following a fully documented risk assessment. Patient restraints are not intended as substitutes for good nursing practice. ArjoHuntleigh makes no recommendations regarding the use of such restraints. To make sure the battery is kept fully charged and prevent damage to the battery, the bed should be connected to the electricity supply at all times during normal use. The battery is intended for emergency, short term use only. Its life will be reduced if it is used to power the bed for long periods. Only connect devices designed to be used with the bed. Connecting devices not designed to be used with the bed may result in damage to the equipment or to the bed. At minimum height, clearance underneath the side rails is reduced. Keep your feet away from the areas below the side rails and take extra care when using patient hoists or similar equipment. The weighing system should only be used by staff trained in the correct use of the weighing function. The weighing system should only be used in closely supervised environments, where factors influencing patient weight (such as additions to the bed) can be controlled as described in the following instructions for use. Scale Readings - Scales / patient weights are for reference only. Scale readings should not be relied upon for medication dosage. All equipment on the weighed portion of the unit is included in weight displayed.

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The weighing system MUST be zeroed every time a new patient is to be placed on the bed. The weighing system MUST be zeroed every time a mattress is changed. The weighing system cannot be zeroed if a mattress or accessories weighing more than 45 kg (99 lb) are fitted. To make sure the bed can be zeroed correctly, only use ArjoHuntleigh approved mattresses. Data retrieved from the RS232 connection not intended to be used to make clinical decisions. All patient diagnosis, treatment and care should be performed under the supervision of an appropriate healthcare professional. The manual CPR release should only be used in an emergency; repeated everyday use can cause permanent wear. Disconnect the bed from the electricity supply before starting any cleaning or maintenance activity. The bed will still operate on battery power if the function has not been locked on the Attendant Control Panel. To prevent cross contamination or equipment damage, ArjoHuntleigh recommends that the Citadel Bed Frame System be cleaned during use and between patients according to the instructions below. Local protocols and regulations / procedures for blood borne pathogens may be used provided the manufacturer’s instructions are followed. Always disconnect the Citadel Bed Frame System from mains wall outlet before cleaning. Failure do so could result in equipment damage and / or electric shock. Do not allow fluid to penetrate the Citadel Bed Frame System control panels. If the bed is stored for a long time, it should be connected to the electricity supply for 24 hours every three months to recharge the backup battery, otherwise it may become unserviceable.

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Citadel Bed Frame System

Product Overview

H

K

L

N M

V

S

Figure 1: Product overview

A. Head Board B. Head End Side Rail C. Care Giver Controls D. Backrest Section E. Foot End Side Rail F. Patient Controls G. Attendant Control Panel (ACP) H. Seat Section I. Thigh Section J. Foot Board K. Extension Locking Handle L. Accessory Socket

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M. Extension Catch Bar N. CPR Release Handle O. Weighing / Movement Detection System Controls P. Drainage Bag Rail Q. Side Rail Release Lever R. Caster S. Anti-Entrapment Sensor T. Lifting Pole Socket U. Roller Buffer V. Foot End Brake Pedal

Citadel Bed Frame System

Introduction These instructions contain information for the installation, use and maintenance of the ArjoHuntleigh Citadel™ Bed Frame System. These beds have multiple functions to provide the optimum nursing position for both patient and care giver. All Citadel beds have the following standard features: • Folding split side rails with integrated bed controls • Electrical adjustment of bed height and leg section elevation • Electrically operated retracting backrest • Auto-Chair facility • Electrical adjustment of head down tilt (Trendelenburg) and foot down tilt (reverse Trendelenburg) • Electrical adjustment of calf section vascular position • Mattress support surface with removable panels • Adjustable length deck • Drainage bag rails • Under bed lights • 125 mm single wheel casters • Patient weighing and VariZone patient egress detection • Anti-Entrapment System

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Optional features: • One-way nurse call • Two-way nurse call • Environmental controls • RS232 connection allowing transfer of bed status data • 150 mm (single or dual wheel) casters • Additional brake pedals at head end • DIN accessory rails • Foot pedal for adjustment of bed height. • Patient handset Optional features are specified by the customer at the time of ordering. The chosen options are indicated by the equipment model number. The model number and serial number can be found on the specification label which is located on the bed frame below the head board.

2014/05

ArjoHuntleigh AB Hans Michelsensgaten 10 211 20 Malmö Sweden

Before using the bed, make sure that the Power in rating on the specification label is compatible with the local electricity supply. Figure 2: Specification label

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Clinical Applications To make sure 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 function should only be used under the guidance of a clinically-qualified person after assessment of the patient’s condition.

Intended Use The Citadel Bed Frame System is intended for the acute and post-acute care settings.

Indications The Citadel Bed Frame System is indicated for medical purposes to aid the patient and staff during the performance of routine care.

Contraindications The Citadel Bed Frame System is contraindicated for patients weighing in excess of 227 kg (500 lb). The care giver should refer to and follow any contraindications in the product labeling for the pressure redistribution surface being used with the Citadel Bed Frame System. The bed is not suitable for patients under 40kg (88 lbs) in weight.

General Product Information If the combined weight of the mattress and accessories exceeds 45 kg (99 lb), the maximum patient weight must be reduced accordingly. Safe working load (SWL) ... 270 kg (595 lb) Maximum patient weight... 227 kg (500 lb) The recommended patient height is between 146 cm (57 in) and 190 cm (74 in). At the discretion of the care giver, patients taller than 190 cm (74 in) may be accommodated by extending the bed - refer to bed length adjustment on page 19. Make sure that the patient’s height does not exceed the in-bed length.

Risks and Precautions Patient Migration – Specialty surfaces have different shear and support characteristics than conventional surfaces and may increase the risk of patient movement, sinking and / or migration into hazardous positions of entrapment and / or inadvertent bed exit. Monitor patients frequently to guard against patient entrapment. Citadel Bed Frame System

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Side Rails and Restraints – WARNING: Use or non-use of restraints, including side rails, can be critical to patient safety. Serious or fatal injury can result from the use (potential entrapment) or non-use (potential patient falls) of side rails or other restraints. See related Safety Information section of this guide. Skeletal Traction or Unstable Fracture (if not contraindicated) – With skeletal traction, unstable pelvic fracture or any other unstable fracture (to the extent not contraindicated), maintain physician directed angle of articulation and guard against risks of patient migration or inadvertent deflation of surface. Electromagnetic Interference – Although this equipment conforms with the intent of the directive 89 / 336 / EEC in relation to electromagnetic compatibility, all electrical equipment may produce interference. If interference is suspected, move equipment away from sensitive devices or contact the manufacturer. Shock Hazard – Electrical shock hazard; do not remove electrical compartment covers. Refer to qualified service personnel.

Precautions Precautions may need to be taken when using this product with certain patient conditions, including, but not limited to: • hemodynamic instability • severe agitation • uncontrollable claustrophobia or fear of confinement • uncontrollable diarrhea • pregnancy • extensive facial trauma • any other unstable fracture • ICP monitoring or intracranial drainage devices

Safety Information General Protocols – Follow all applicable safety rules and institution protocols concerning patient and care giver safety. Brakes – Set all caster brakes before transferring patient. Bed Height – To minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended. Fluids – Avoid spilling fluids on unit controls. If spills do occur, unplug unit, clean fluid from unit, wearing rubber gloves to avoid any possibility of shock. Once fluid is removed, check operation of components in area of spill.

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Fluids remaining on controls can cause corrosion, which may cause components to fail or to operate erratically, possibly producing hazards for patient and staff. Oxygen Use - Make sure that the unit is not contained in an oxygen enriched environment. Possible fire hazard when bed is used with oxygen administering equipment other than the nasal prongs, mask or half bed length tent type. Oxygen tent should not extend below mattress support level. Lock-Outs – Lock-outs for bed functions should be used at staff’s discretion to make sure against unintentional operation of bed. Power Cord – Make sure power cord is kept free from all pinch points, moving parts and is not trapped under casters. Improper handling of power cord can cause damage to the cord, which may produce risk of fire or electric shock. Pull the power cord out of the mains wall outlet to remove power from the unit. Avoid Fire Hazards – To minimize the risk of fire, connect the unit’s power cord directly into a wall-mounted outlet. Do not use extension cords or multiple outlet strips. In the US, review and follow FDA’s Safety Tips for Preventing Hospital Bed Fires. Outside the US, consult the local Competent Authority or Government Agency for Medical Device Safety for specific local guidance. Disposal – At the end of useful life, dispose of waste according to local requirements or contact the manufacturer for advice. There may be special requirements for disposal of batteries, leaded foam and / or angle sensors (if present in this product). Improper disposal of any component may result in regulatory non-compliance. Moving Parts - Keep all equipment, tubes and lines, loose clothing, hair and parts of the body away from moving parts and pinch points. Patient Entrance / Exit – Care giver should always aid patient in exiting the bed. Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency. Side Rails / Patient Restraints - Whether and how to use side rails or restraints is a decision that should be based on each patient’s needs and should be made by the patient and the patient’s family, physician and care givers, with facility protocols in mind. Care givers should assess risks and benefits of side rail / restraint use (including entrapment and patient falls from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and / or family. Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of bed and from patient entrapment in or around the side rails, restraints or other accessories. In the US, for a description of entrapment hazards, vulnerable patient profile and guidance to further reduce entrapment risks, refer to FDA’s Hospital Bed System Dimensional and Assessment Guidance To Reduce Entrapment. Outside the US, consult the local Competent Authority or Government Agency for Medical Device Safety for specific local guidance. Consult a care giver and carefully consider the use of bolsters, Citadel Bed Frame System

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positioning aids or floor pads, especially with confused, restless or agitated patients. It is recommended that side rails (if used) be locked in the full upright position when the patient is unattended. Make sure a capable patient knows how to get out of bed safely (and, if necessary, how to release the side rails) in case of fire or other emergency. Monitor patients frequently to guard against patient entrapment. When selecting a standard mattress, make sure the distance between top of side rails (if used) and top of mattress (without compression) is at least 220 mm (8.66 in) to help prevent inadvertent bed exit or falls. Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk. Make sure the distance between top of side rails (if used) and top of a speciality mattress (without compression) is approximately 11.4 cm (4.5 in) or greater. Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk. Skin Care – Monitor skin conditions regularly and consider adjunct or alternative therapies for high acuity patients. Give extra attention to skin over any raised side bolster and to any other possible pressure points and locations where moisture or incontinence may occur or collect. Early intervention may be essential to preventing skin breakdown. Maximum Recommended Patient Weight - Total patient weight capacity should not exceed 227 kg (500 lb). The use of accessories on the bed may decrease the patient weight capacity of the bed. Contact ArjoHuntleigh Customer Service for questions concerning the use of accessories and see the Questions and Information section of this guide for contact information. I.V. and Drainage Tubes – Prior to activating any positioning function assess the security of all invasive lines and tubes to accommodate the desired angle of articulation and minimize the risk of binding, disconnecting or dislodging. Tubes and lines should always have sufficient slack for articulation and patient movement. Turning - CAUTION: Prior to engaging any mattress turn feature, make sure that bed frame has side rails and that all side rails are fully engaged in their full upright and locked position. Do not activate the turning feature on any mattress system when patient restraints are in use. Scale Readings - Scales / patient weights are for reference only. Scale readings should not be relied upon for medication dosage. All equipment on the weighed portion of the unit is included in weight displayed.

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Installation The following chapter describes how to install the bed.

Weighing System Preparation 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. When replacing the transport locking bolts care must be taken to avoid trapping or damaging any cables. Position the bed on a flat, level surface and apply the brakes. 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 1

2 1

Figure 3: Removing the transport bolts

Retain the bolts and washers in case the bed needs to be transported at a later date.

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Electricity Supply If the power cord or plug is damaged, the complete assembly must be replaced by authorized service personnel. Do not remove the fitted plug, or use a rewireable plug or adapter. Make sure the power cord is not stretched, kinked or crushed. Do not allow the power cord to trail on the floor where it may cause a trip hazard. Make sure the power cord does not become entangled with moving parts of the bed or trapped between the bed frame and head board. Unplug the power cord from the electricity supply, and store it, before moving the bed. Connect the mains plug to a suitable outlet. Make sure the plug is easily accessible so it can be unplugged quickly in an emergency. When the bed is connected to the electricity supply, the Power On Indicator LED will light on the Attendant Control Panel (see page 34). 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. 2

3 1

Figure 4: Power supply cord and potential equalization terminal

To isolate the bed from the electricity supply, unplug the mains plug from the outlet.

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Potential Equalization Terminal A potential equalization terminal (3) is located at the head end of the bed. When other electrical equipment is within reach of the patient or care giver, potential differences between the equipment can be minimized by connecting together their potential equalization terminals. 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 57.

Bed Length Adjustment Install a suitable foam mattress extension (squab) at the foot end when the bed is extended with a foam mattress. Always adjust the bed frame and deck to the same length and make sure both are latched securely in position. Take care not to pinch your fingers when lifting the catch bar. The length of the bed is adjustable to two set positions and an additional transport position. These are typically used as follows: 1. Transport, for maneuvering the bed in confined spaces. No mattress should be sized for this length as it is only to be used as a temporary transport length, when necessary. 2. Standard length, for normal use. Sets deck length at 203 cm (79.9 in). 3. Extended, to accommodate very tall patients. Sets deck length at 215 cm (84.6 in).

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To extend the bed frame: 1. Level the deck before adjusting the bed length. 2. Rotate the blue extension locking handle (1) located under the foot end of bed and pull out the bed frame (2) to the required position and release the handle. Ensure extension locks in position.

2

1 Figure 5: Extending the bed frame

To extend the deck: 1. Lift the blue extension locking handles on either side of the bed (1). Pull out the bed frame (2) to the required position and release the handles. Ensure extension locks in position.

2

1

Figure 6: Extending the deck

After extending the deck make sure the calf extension sheet is clipped over the end of the deck frame. 2. To shorten the bed: Reverse the above procedure.

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Mattresses 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 between 15 cm (6 in) and 20.5 cm (8 in). • Specialty 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 specialty mattress replacement must be assessed individually prior to use to verify sufficient clearance is maintained. Make sure the distance between top of side rails (if used) and top of a speciality mattress (without compression) is approximately 4.5 in (11.4 cm) or greater. Consider individual patient size, position (relative to the top of the side rail) and patient condition in assessing fall risk. • To make sure compliance with EN 60601-2-52:2010, an approved ArjoHuntleigh 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 ArjoHuntleigh office or an ArjoHuntleigh approved distributor. A list of ArjoHuntleigh offices can be found at the back of this manual. A label on the calf extension sheet indicates the mattress size: No mattress should be sized for length one as this is only a temporary transport position.

830.229 Rev A

Figure 7: Mattress size label

The numbers 1, 2 and 3 on the label indicate different deck lengths; refer to Bed Length Adjustment on page 19. 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, Citadel Bed Frame System

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even if it is the correct size. The maximum recommended standard mattress thickness for use with side rails is 20.5 cm (8 in). 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.

Lifting Pole and Accessory Sockets Lifting pole sockets (1) are located at the head end of the deck. Sockets to support compatible accessories are located at the head end (2) and foot end (3) of the bed.

1

2

Figure 8: Lifting pole and accessory sockets (head end)

3

3

Figure 9: Accessory sockets (foot end)

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