Citadel Bed Frame System Instruction for Use Rev B Dec 2015

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies unless otherwise stated. © ArjoHuntleigh 2015 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.

Table of Contents General Warnings ...5 • Safety Information...8 • Power Drive System Safety Information ...10 Introduction...12 • Product Overview...12 • Optional features...13 • Clinical Applications...15 • Intended Use...15 • Indications...15 • Contraindications...15 • General Product Information...16 Installation...17 • Weighing System Preparation...17 • Power Drive Shipping Pin Removal...17 • Electricity Supply...18 • Potential Equalization Terminal...19 • Electrical Connections ...19 • Power Cord...19 • Nurse Call and RS232 Connections...19 • Auxiliary Power Outlet...20 • Skin IQ Family Power Cable ...21 • Skin IQ Installation...21 • Mattresses...21 Operating Instructions...23 • Lifting Pole and Accessory Sockets...23 • Drainage Bag Rails...24 • Bed Length Adjustment...24 • Bed Width Adjustment...26 • Foot Pedal for Adjustment of Bed Height...27 • Brakes and Steering...27 • Side Rails...28 • Head and Foot Boards...29 • Patient Restraints...29 • Under Bed Light...30 • Backup Battery...31 • Recharging the Backup Battery...32 • Over-Use Lockout...32 • Attendant Control Panel, Nurse Control Panel and Patient Control Panel ���������������������33 • Patient Handset (Optional Feature)...36 • Weigh Scale Panels (With and Without Unit Selection)...37 • Weighing Accuracy ...38 • Weighing Initialization ...39 Citadel Plus Bariatric Care System

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• Weighing ...39 • Weighing Units ...40 • Auto Compensation...40 • Weighing System Error Codes ...41 • Angle Indication...41 • VariZone Patient Movement / Exit Detection...42 • VariZone Operation ...43 • Anti-Entrapment System...44 • RS232 Connection...45 • Controls for Television and Lighting...46 Power Drive...47 • Preparation for Transport...47 • Power Drive LEDs...47 • Operating Power Drive...48 Patient Placement...50 • Power On ...50 • Preparation for Patient Placement ...50 • Completion of Patient Placement...51 Nursing Care...52 • CPR...52 • CPR Backrest Release...53 • Patient Bathing...53 • Patient Transfer from the Citadel Plus Bariatric Bed Frame System ������������������������������54 • Patient Transport...54 Care and Cleaning...55 • Deck Sections...55 • Decontamination...55 • General Recommendations...57 • Cleaning the Citadel Plus Bariatric Bed Frame System While in Use ����������������������������57 Preventive Maintenance...58 • Weighing System...59 • Battery Test ...59 Troubleshooting...60 • Error Codes...61 • Fault Indications...62 • Product Lifetime...62 Accessories...62 EMC Information...63 Warranty and Service...67 Specifications...68 Explanation of Symbols Used...70 Questions and Contact Information...72

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Citadel Plus Bariatric Care System

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. All accessories added to the system reduce the safe working load of the frame by the same amount. 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. Make sure the locking mechanism is securely engaged when the side rails are raised.

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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. 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. 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. 6

Citadel Plus Bariatric Care System

The weighing system cannot be zeroed if a mattress or accessories weighing more than 50 kg (110 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 mains wall outlet 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 Plus Bariatric Care System be cleaned during use and between patients according to the Care and Cleaning section in this IFU. Local protocols and regulations / procedures for blood borne pathogens may be used provided the manufacturer’s instructions are followed. Always disconnect the Citadel Plus Bariatric Care System from mains wall outlet before cleaning. Failure do so could result in equipment damage and / or electric shock. Do not allow fluids to penetrate the Citadel Plus Bariatric Care 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. Multiple people may be required to manually transport the bed depending on patient weight and floor conditions. Assembly, operations, extensions, re-adjustments, modifications, technical maintenance or repairs must be performed by qualified personnel authorized by ArjoHuntleigh. Contact ArjoHuntleigh for information regarding maintenance and repair. The nurse call button on Citadel Plus has not been evaluated for the requirements of Clause 17 (Normal Operation) of UL 1069. The user is responsible to determine the operability of the nurse call button with all systems to which the medical device is connected.

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Safety Information General Protocols – Follow all applicable safety rules and institution protocols concerning patient and caregiver 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. 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 prevent 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 – Caregiver 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 caregivers, with facility protocols in mind. Caregivers should assess risks and benefits of side rail / restraint use (including entrapment and patient falls from bed) in conjunction with individual 8

Citadel Plus Bariatric Care System

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 specific local guidance on Medical Device Safety. Consult a care giver and carefully consider the use of bolsters, 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 (as defined by IEC 60601-2-52:2009), make sure the distance between top of side rails (if used) and top of mattress (without compression) is at least 22 cm (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 (as defined by IEC 60601-2-52:2009) (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 454 kg (1000 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 Contact 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.

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Turning - 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. 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. 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 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.

Power Drive System Safety Information To minimize the risk of serious injury, carefully read and follow all Safety Information and Operating Instructions before operating Power Drive System. Also make sure all physician orders and facility protocols are followed. Steep Slopes - When operating on slopes, always use slow speed. Do not operate on slopes in excess of > 7°. Wet Surfaces - Do not operate power drive system on wet surfaces. Indoor Use Only - Do not operate power drive on outside walkways, outside ramps or parking lots. Unplug - Ensure power cord is unplugged from wall and properly stored before transport. Clear Area - Ensure area beneath power drive system is clear before engaging drive system. Clear Path - Ensure pathway is clear of cords, hoses and obstacles before driving bed forward or backwards.

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Citadel Plus Bariatric Care System

Avoid Trapping People - Ensure there is space to operate before forward or reverse movement. Take caution in crowded areas to prevent trapping a patient or caretaker between bed frame and wall, furniture, equipment or other objects. Crowded Areas - Operate with caution in crowded hallways, elevators and rooms. Navigate Slowly - Use slow speed when moving bed around corners and through elevators and rooms. Limited Space Maneuvering - To maneuver the bed in small or tight areas, disengage the power drive from the floor and manually move the bed in the desired direction. Automatic Brakes - When the Forward or Reverse switch is released, the power drive system will stop; brakes are automatically engaged to prevent continued movement.

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INTRODUCTION These instructions contain information for the installation, use and maintenance of the ArjoHuntleigh Citadel™ Plus Bariatric Care System. These beds have multiple functions to help provide optimal care and safety for both patient and care giver.

Product Overview A

B

C D E F

G H

X V

W I

U

J T

K S

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L Q

P O

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Figure 1: Product overview

A. Foot Board P. Power Drive Lift Pedal B. Foot End Side Rail Q. Power Drive C. Thigh Section R. Drainage Bag Rail D. Seat Section S. Attendant Control Panel (ACP) E. Backrest Section T. Foot End Brake Pedal F. Patient Controls U. CPR Release Handle G. Head End Side Rail V. Width Extensions (total of eight H. Power Drive Controls (see page 48) see page 26) I. Head Board W. Care Giver Controls J. Accessory Socket X. Roller Buffer K. Anti-Entrapment Sensor Not shown in this view: L. Caster Y. Leg Extension Latch M. Lifting Pole Socket (see page 25) N. Side Rail Release Lever O. Weighing / Movement Detection System Z. Blue Extension Locking Handle (see page 25) Controls 12

Citadel Plus Bariatric Care System

All Citadel Plus 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 mattress support surface • Drainage bag rails • Under bed lights • 150 mm dual casters • Patient weighing and VariZone™ patient egress detection • Anti-Entrapment System • Width extension (adjustable width mattress support surface)

Optional features • One-way nurse call • Two-way nurse call • Environmental controls • RS232 connection allowing transfer of bed status data • DIN accessory rails • Foot pedal for adjustment of bed height • Patient handset • Power Drive • Hinged power drive handles 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 which is located on the bed frame below the head board.

Before using the bed, make sure that the power-in rating on the specification label is compatible with the local electricity supply.

Citadel Bariatric Care System

ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, SWEDEN www.arjohuntleigh.com YYYY-MM-DD MADE IN POLAND

0086 IPX4

522 kg 1150 lb

DUTY 10% 2 min ON / 18 min OFF POWER in 115V~ 9.5 A MAX 60Hz

E348583

Citadel Bariatric Care System

Figure 2: Specification label

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Citadel Plus Bariatric Care System

CLINICAL APPLICATIONS Intended Use The Citadel Plus Bariatric Care System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment. 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.

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

Contraindications The Citadel Plus Bariatric Care System is contraindicated for patients weighing in excess of 454 kg (1000 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 Plus Bariatric Care System. Width extensions retracted: The bed is not suitable for patients under 45 kg (100 lb) in weight. Width extensions expanded: The bed is not suitable for patients with a Body Mass Index (BMI) <30.

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.

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General Product Information Safe working load (SWL)... 522 kg (1150 lb) Maximum patient weight... 454 kg (1000 lb) The recommended patient height is between 146 cm (58 in) and 190 cm (75 in). At the discretion of the care giver, patients taller than 190 cm (75 in) may be accommodated by extending the bed - refer to bed length adjustment on page 24. Make sure that the patient’s height does not exceed the in-bed length.

Figure 3: Recommended Patient Height and Weight

All accessories added to the system reduce the safe working load of the frame by the same amount.

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Citadel Plus Bariatric Care System

INSTALLATION The following chapter describes how to install the bed.

Weighing System Preparation 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.

Max 522 kg (1150 lb)

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CPR

2

2

1

1

Figure 4: Removing the transport bolts

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

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.

Power Drive Shipping Pin Removal Do not lower power drive wheels without removing shipping pin. If transporting frame to a new facility, insert shipping pin to lock the power drive pedal. Before attempting to lower power drive wheels, remove the shipping pin (1) and store (2). 2 1

Figure 5: Removing the shipping pin Citadel Plus Bariatric Care System

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Electricity Supply 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 59. 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 33). The footboard (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 6: Power supply cord and potential equalization terminal

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

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.

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Citadel Plus Bariatric Care System

Potential Equalization Terminal A potential equalization terminal (Figure 6, item 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.

Electrical Connections The Citadel Plus Bariatric Care System contains the following electrical connections. Frame: • Power Cord • Nurse Call Connector • RS232 Connector (if specified) • Auxiliary Power Outlet • Skin IQ™ Family Power Cable

Power Cord The power cord is located at the head end of the bed. 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.

Nurse Call and RS232 Connections 1. Connect one end of the nurse call cable to the 37-pin D-type outlet, located below the head end of the bed on the patient's right hand side. 2. Connect the other end of the nurse call cable to a compatible nurse call system. The type of connector will vary depending on the nurse call system. 3. Connect one end of an RS232 cable to the 9-pin D-type outlet, located below the head end of the bed on the patient's right hand side. 4. Connect the other end of the RS232 cable to a device capable of receiving data through an RS232 connection. Connection to the nurse call and RS232 connector must be made with the correct cables. Use of the wrong cables may cause malfunction of the bed or devices connected to the nurse call or RS232 connectors.

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Verify correct operation of the nurse call system before placing a patient on the bed. Do not allow the nurse call or RS232 cables to trail on the floor where they may cause a trip hazard. Unplug both cables before moving the bed. Do not allow the cables to touch the bed frame as this may affect the accuracy of the weighing system. 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. Only use cables with an in-line breakaway connector (below). Failure to do so could result in damage to the bed or to other hospital equipment.

Breakaway connection

Connect to bed

Connect to Nurse call system

Figure 7: Example of an in-line breakaway connector

Auxiliary Power Outlet (Optional Feature) Auxiliary power outlet is provided as a convenience for powering devices intended to be placed at or near the foot end of the bed.

Do not connect any critical or life-sustaining equipment to auxiliary outlet. These devices should be connected to hospital outlets. Devices connected to this outlet shall not exceed: • 115 VAC / 15A • 230 VAC / 8A

This outlet does not remain powered when the bed is on battery backup.

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Citadel Plus Bariatric Care System