ARJOHUNTLEIGH AUTO LOGIC Instructions for Use Rev 6 Nov 2017

WARNING To avoid injury, always read this Instructions for Use and accompanied documents before using the product. Mandatory to read the Instructions for Use

Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. © ArjoHuntleigh AB 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 whole or in part without the consent of ArjoHuntleigh AB.

Contents General Safety... iii Introduction...1 About this Manual... 1 Intended Use... 1 About Auto Logic... 1 Clinical Applications...6 Indications... 6 Contraindications... 6 Cautions... 6 Care of the Patient When Sitting... 6 Installation...7 Preparing the Systems for Use... 7 Installing the Mattress... 7 To Complete the Mattress Installation... 8 Installing the Pump... 9 Installing the Aura Logic Seat Cushion... 10 Controls, Alarms and Indicators...12 Controls... 12 Alarms and Indicators... 13 Operation...15 Quick Start... 15 Comfort Control... 16 Autofirm... 16 Power Fail Condition... 17 To Disconnect the Tubeset... 17 Transport Mode... 17 Shut Down... 17 To Deflate and Store the Auto Logic Mattress... 18 To Deflate the Aura Logic Seat Cushion... 18 CPR Control... 19 Battery Pack...20 Installing the Battery Pack... 20 Checking the Status of the Battery Pack... 21 Charging the Battery Pack... 22 Battery Storage and Disposal... 23 Decontamination...24 Routine Maintenance...25 Auto Logic and Aura Logic Systems... 25 Auto Logic and Aura Logic Pump... 25

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Auto Logic 110, 175 & 200 Mattresses and Aura Logic Seat Cushion... 25 Serial Labels... 25 Troubleshooting & Alarm Condition...26 Technical Description...27

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General Safety Before you connect the system pump to a mains socket, read carefully all the installation instructions contained within this manual. The system has been designed to comply with regulatory safety standards including: • EN60601-1:2006/A1:2013 and IEC 60601-1:2005/A1:2012. • EN60601-1-11:2010; IEC 60601-1-11:2010 and IEC60601-1-8:2012. • ANSI/AAMI ES 60601-1(2005)+AMD(2012)and CAN/CSA-C22.2 No.60601-1(2008)+ (2014).

Safety Warnings • It is the responsibility of the care giver to ensure that the user can use this product safely. • Whilst the patient is unattended, the decision to use safety sides should be based on clinical assessment and in line with local policy. • Alignment of the bed frame, safety sides and the mattress should leave no gap wide enough to entrap a patient's head or body, or to allow egress to occur in a hazardous manner where entanglement with the mains power cable and tubeset or air hoses may result. Care should be exercised to prevent occurrence of gaps by compression or movement of the mattress. Death or serious injury may occur. • Make sure that the mains power cable and tubeset or air hoses are positioned to avoid causing a trip or other hazard, and are clear of moving bed mechanisms or other possible entrapment areas. The mains power cable of this pump is designed to allow movement of the bed, and should be fitted into the cable management flaps along the sides of the mattress, as described in this manual. • When using a seat cushion, the tubeset may be a trip hazard; position the tubeset so that it does not create a trip hazard, and always supervise babies and small children when the product is in use. • Electrical equipment may be hazardous if misused. There are no user-serviceable parts inside the pump. The pump's case must only be removed by authorised technical personnel. No modification of this equipment is allowed. • The mains power socket/plug must be accessible at all times. To disconnect the pump completely from the electricity supply, remove the plug from the mains power socket. • The CPR control and/or the CPR indicator tag must be visible and accessible at all times. • Disconnect the pump from the mains power socket before cleaning and inspecting. • Keep the pump away from sources of liquids and do not immerse in water. • Do not use the pump in the presence of uncontained flammable liquids or gasses. • The cover of this product is vapour permeable but not air permeable and may present a suffocation risk. • Do not use the mattress without a cover, it provides a protective barrier. • Bags supplied with this equipment may present a suffocation risk; to avoid the risk of suffocation keep the bags away from babies and small children. • There is no Transport facility on the seat cushion. • Only the pump and mattress combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress combinations are used.

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• The battery socket cover on the bottom of the pump must be retained in position at all times. If there is a need to remove it, then it should be stored in a safe place away from babies and small children for subsequent reinstalling. • Due to the inherently lower flame retardancy of the high performance Ventilate IS2 fabric, it is NOT suitable for use in the homecare environment. • The operator should stay around the pump to prevent from missing the system alarm.

Safety Warnings - Battery Pack (Optional) THE BATTERY PACK IS NOT SUITABLE FOR USE IN THE HOMECARE ENVIRONMENT. The following instructions are important for the safe use of the battery pack and to keep the user (resident/care giver) from harm: • The battery pack BBP600 for the Auto Logic® pump is rechargeable. For maximum battery life, charge the battery at least once every five months when the product is not in use. • Only use the battery pack designed for use with the pump. If unsure, do not use the battery pack. Make sure the battery pack belongs to the pump by comparing the battery pack label with the“Technical Description” on page 27. If the battery pack type cannot be confirmed, contact your local ArjoHuntleigh office. • Do not expose the battery pack or charger to open flames. • Do not expose the battery pack connector to water. • To avoid bodily injury, do not crush, puncture, open, dismantle or otherwise mechanically interfere with the battery pack. • Should the battery pack casing crack and cause contents to come in contact with skin or clothing, rinse immediately with plenty of water. • If contents come in contact with the eyes, rinse immediately with plenty of water and seek medical attention. • Inhalation of the contents can cause respiratory irritation. Provide fresh air and medical attention. • Stop using the battery pack if any damage or deformation is noted. Contact your local ArjoHuntleigh office before further use. • Refer to the “Battery Storage and Disposal” on page 23 for the correct disposal and recycling of the battery pack.

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Precautions For your own safety and the safety of the equipment, always take the following precautions: • Placing extra layers between the patient and the mattress potentially reduces the benefits provided by the mattress and should be avoided or kept to a minimum. As part of sensible pressure area care, it is advisable to avoid wearing clothing which may cause areas of localised high pressure due to creases, seams, etc. Placing objects in pockets should be avoided for the same reason. • Do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc. • In the event of a fire, a leak in the seat or mattress could propagate the fire. • Do not store the system in direct sunlight. • Do not use phenol-based solutions to clean the system. • Make sure the system is clean and dry prior to use or storage. • Never use sharp objects or electrically heated under blankets on or under the system. • Store the pump and mattress in the protective bags supplied. • Pets and children must be supervised in the vicinity of the system. Electromagnetic Compatibility (EMC) This product complies with the requirements of applicable EMC Standards. Medical electrical equipment needs special precautions regarding EMC and needs to be installed in accordance with the following instructions: • The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance. • Portable and mobile radio frequency (RF) communications equipment (e.g. mobile/cell phones) can affect medical electrical equipment. • If this equipment needs to be used adjacent to other electrical equipment, normal operation must be checked before use. • For detailed EMC information contact ArjoHuntleigh service personnel. Environmental Protection Incorrect disposal of this equipment and its component parts, particularly batteries or other electrical components, may produce substances that are hazardous to the environment. To minimise these hazards, contact ArjoHuntleigh for information on correct disposal. Expected Service Life The Auto Logic pump has an expected service life of seven years. To maintain the condition of the pump, have the pump serviced regularly according to the schedule recommended by ArjoHuntleigh. Do NOT use unapproved accessories or attempt to modify, disassemble or otherwise misuse the Auto Logic system. Failure to observe this caution could result in injury, or in extreme cases, death.

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1. Introduction About this Manual

This manual is your introduction to the Auto Logic Dual Mode support systems and the Aura Logic® seat cushion. You must read and fully understand this manual before using the system. Use this manual to initially set up the mattress or seat cushion, keep it as a reference for day-to-day routines and as a guide to maintenance. If you have any difficulties in setting-up or using the Auto Logic and Aura Logic systems, contact your ArjoHuntleigh sales office, listed at the end of this manual.

Intended Use

The intended use of this product is to prevent and/or manage pressure ulcers for patients up to 200 kg (440 lb). The Auto Logic system should be used as part of a prescribed plan of care (refer to “Indications” on page 6).

About Auto Logic

Auto Logic Pump

The Auto Logic systems comprise a mattress replacement, overlay or seat cushion, all operated by the same pump. The pump incorporates Self Set Technology (SST), which adjusts air pressure every 10 minutes for the Active (Alternating) mode and 20 minutes for the Reactive (Constant Lower Pressure) (CLP) mode to suit the Body Mass Index (BMI) and position of the patient. Both support systems can be used on standard hospital beds. A full technical description of the Auto Logic system can be found in the Service Manual, part number SER0006, available from your ArjoHuntleigh sales office. The Auto Logic pump comprises a moulded case with non slip feet on the base and rear and integral hanging brackets. The controls are situated on the top of the pump and a sophisticated alarm system differentiates between normal operation and genuine system faults. If an alarm situation is detected an indicator illuminates on the top and front of the pump and an audible warning sounds. The Autofirm system, once activated, creates a temporary firm surface to allow nursing procedures to be performed. 1

Control Panel Power and Alarm Indicators

Hanging Brackets

Auto Logic 110 Mattress Overlay

The Auto Logic 110 mattress overlay comprises the following components:

Detachable Cover

3 Static Head Cells (Dark Blue) Cover Attachment Zips

Cable Management

CPR Unit 2 Standard Cells (Dark Blue) 10 Side Supporting Cell-in-Cells (Light Blue) Fixed Tubeset Serial Label (Inside Base Cover)

5 Standard Cells (Dark Blue) Overlay Base Cover (Including Micro Air Loss System) Corner Straps

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Detachable Cover

Cells

Micro Air Loss System

CPR Function

Tubeset

The standard cover comprises a 2-way stretch PU coated knitted fabric zipped to a durable polyester base. The zips are protected by flaps to prevent ingress of contaminants and allow easy removal of the cover for cleaning. Alternative covers with advanced properties, such as Glide IS2 and Ventilate IS2 are also available (Refer to “COVER SPECIFICATION” on page 30). The mattress comprises 20 polyurethane (PU) cells providing support to the user in either Active (Alternating) or Reactive (Constant Lower Pressure) modes. The cells are slightly curved to reduce patient movement down the mattress. The side supporting cells incorporate Cell-in-Cell technology to help the transfer of patients on and off the bed by keeping the edges of the mattress firm. A micro air loss system is incorporated into the base cover which de-humidifies the air surrounding the cells to reduce heat build up within the mattress and ensure patient comfort. This system is separate from the cell inflation to enable both micro air loss and patient transport modes to be incorporated into the mattress. A CPR (Cardio-Pulmonary Resuscitation) control is positioned at the head end of the mattress to enable the air to be evacuated in under 10 seconds. The tubeset has a 3-way pneumatic connection which incorporates a flexible, compact anti-kink tube that is resistant to crushing and any subsequent obstruction of air flow.

 If the tubeset is disconnected from the pump, the Overlay Base Cover

mattress automatically changes to Transport mode. The base cover for the mattress overlay is PU coated polyester on the underside. Four corner retention straps are incorporated, which slide under the corners of the base mattress.

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Auto Logic 175 & 200 Mattress Replacement

The Auto Logic 175 & 200 mattress replacements are of a similar construction to the overlay with the addition of a non-slip base. Within the non-slip base, the 175 mattress includes a foam underlay and the 200 mattress has an air filled zoned sub-mattress both of which replace the need for a mattress on the bed. The base can be removed to convert the mattress replacement to an overlay, refer to ArjoHuntleigh for more information.

Detachable Cover

3 Static Head Cells (Dark Blue) Cover Attachment Zips

Cable Management

CPR Unit 2 Standard Cells (Dark Blue)

Fixed Tubeset

Securing Straps

Air Sub-Mattress (200 Only)

10 Side Supporting Cell-in-Cells (Light Blue) 5 Standard Cells (Dark Blue) 175 - Non-slip base including foam underlay 200 - Air Filled Zoned Sub-Mattress (Non-Slip)

The Sub-Mattress provides an integral constant pressure support which removes the need for a standard mattress. The pressure in the central zone of the pad is automatically adjusted in line with the Active (Alternating)/Reactive (Constant Lower Pressure) (CLP) of the mattress. The pressure in the perimeter zone of the pad is maintained at a higher level to help transfer of patients on and off the bed. On the underside of the Sub-Mattress there are eight straps to attach the mattress replacement to the bed frame. The straps can be moved to any of the 10 anchor points to allow attachment of the mattress to different bed frames.

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Aura Logic Seat Cushion

The Aura Logic seat cushion is an Active (Alternating) pressure redistribution system that can be used on standard hospital chairs.

Detachable Cover

Deflation Valves (on underside for packing & storage)

Alternating Cells

Zip

Non-Slip Base

Serial Label (Inside Base Cover) Fixed Tubeset

Fixing Straps

Caution The optional battery pack is not suitable for use in the homecare environment. Battery Pack (Optional)

The Battery Pack is an optional extra that allows the pump to operate for a minimum of eight hours without a mains power supply. The Battery Pack easily slides onto the base of the pump and will recharge itself when the pump is operating from the mains power supply.

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2. Clinical Applications Indications

The Auto Logic systems are indicated for the prevention and/or management of all categories1 of pressure ulcer, when combined with an individualised, comprehensive pressure ulcer protocol: for example, repositioning, nutritional support, skin care. Selection should be based upon a holistic assessment of the patient’s individual care needs. These systems represent one aspect of a pressure ulcer management protocol; all other aspects of care should be considered by the prescribing clinician. If existing wounds do not improve or the patient's condition changes the overall therapy regimen should be reviewed by the prescribing clinician. The above are guidelines only and should not replace clinical judgement. The Auto Logic mattress and cushion are designed for patients weighing up to 200kg (440 lb).

Contraindications

Do not use Auto Logic systems for patients with unstable spinal fractures.

Cautions

If patients have other unstable fractures, or conditions which may be complicated by a soft or moving surface, advice should be sought from an appropriate clinician before use. While the Auto Logic systems have been designed to manage patients up to the weight limits indicated above, those approaching this upper limit are likely to have additional care and mobility needs and may be better suited to a specialist bariatric system. Active (Alternating) therapy cushions may be unsuitable for patients with poor sitting posture or pelvic deformity; advice from a seating specialist should be sought.

Care of the Patient When Sitting

Seated patients are at increased risk of pressure ulcers particularly if they are immobile or have wounds over the seating area. For optimal outcome, provide a pressure redistributing seat cushion in a chair which promotes a good sitting posture and has a level base seat to support the cushion, in addition to an individualised repositioning programme.

 Mattress and cushion combinations may have different upper weight limits. Cushions should be used in combination with pressure-redistributing mattresses to provide 24-hour therapy. 1. NPUAP/EPUAP International Pressure Ulcer Guideline, 2009.

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3. Installation WARNING Bags supplied with this equipment may present a suffocation risk; to avoid the risk of suffocation keep the bags away from babies and small children. Preparing the Systems for Use

Remove the system from the packaging. You should have the following items: • Auto Logic pump including mains power cord and hanging brackets. • Auto Logic 110 mattress overlay, Auto Logic 175 or 200 mattress replacement or the Aura Logic seat cushion, which all have integral tubesets and covers.  Do not use the mattress or seat cushion without the cover. • Battery Pack (optional).

Installing the Mattress Caution Do not use the mattress overlay directly on the bed frame. Auto Logic 110 Mattress Overlay

1. Place the overlay on top of the base mattress, with the tubeset located near the foot end of the bed and the CPR at the head end. The cells of the mattress must be uppermost. 2. Secure the overlay to the base mattress by placing and tightening the four long straps under the corners of the base mattress.

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Auto Logic 175 or 200 Mattress Replacement

1. Remove the existing mattress from the bed frame and check that there are no protruding bed springs or sharp objects on the bed frame surface. 2. Unroll the mattress onto the bed frame and ensure that the tubeset is located near the foot end of the bed and the CPR at the head end. The cells of the mattress must be uppermost. 3. Attach the mattress to the bed frame using the eight fastener straps.

 The eight fastener straps can be moved to any of the 10 anchor points on the base of the mattress replacement. This allows for attaching the mattress to different types of bed frame.

 If the bed can be profiled to any position (i.e. raised or lowered), attach the mattress to the movable parts of the bed only.

 Care should be taken at all times to check that tubes/lines are positioned correctly. To Complete the Mattress Installation

Complete the installation of the mattress overlay or the mattress replacement as follows: 1. If not already fitted, place the protective cover over the mattress. Ensure that the ArjoHuntleigh logo is uppermost and at the foot end of the mattress.

k “Clic

”

2. Zip the cover onto the mattress starting from the head end and taking care not to trap any material in the zip. 3. Ensure that the CPR unit is clicked into the closed position.

 The CPR must be accessible at all times. WARNING Make sure that the mains power cable is positioned to avoid causing a hazard and is clear of moving bed mechanisms or other possible entrapment areas. Refer to “Cable Management” on page 9.

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Installing the Pump

1. Position the pump, feet down, on any convenient horizontal surface or alternatively suspend from the bed foot rail by means of the swing out hooks. 2. Ensure that the mattress/seat tubeset is not “kinked” or twisted and connect it to the pump until it clicks into place. Ensure that the tubeset is securely connected to the pump. 3. Insert the mains power plug into a suitable mains power socket.

” ick l C “

Battery Pack Cable Management

If you have a battery pack, refer to “Installing the Battery Pack” on page 20. If using the mattress replacement or mattress overlay, the power cable can be positioned in the cable management flap running down the side of the mattress as follows: 1. Locate the flap running along the mattress on the opposite side to the tubeset and CPR. 2. Run the straight part of the cable along the side of the mattress securing the flap round the cable using the press studs.

System Operation

The system is now ready for use. Refer to “Controls, Alarms and Indicators” on page 12 and “Operation” on page 15 for day-to-day operating instructions.

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Installing the Aura Logic Seat Cushion

The system should be installed as follows: 1. Check that there are no sharp objects on the chair which may puncture the cushion. 2. Place the cushion on top of the chair surface. From a standing position in front of the chair and facing it, ensure that: • The cells are uppermost. • The tubeset appears from the front right corner of the cushion. • The cells in the seat cushion are in a horizontal position across the chair, with the ‘V’ shape pointing towards the front.

Cautions • Do not use the Aura Logic seat cushion without a foam cushion beneath it. • Always use the Aura Logic seat cushion with the protective top cover. • Always use the Aura Logic seat cushion in the correct orientation. • Avoid trailing cables - ensure that cables and tubing are positioned beneath the chair to avoid causing a hazard. • Position the tubeset so it does not create a trip hazard and always supervise babies and small children when the product is in use.

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3. Secure the seat cushion to the chair by using the fixing straps as shown in the following illustrations. 4. If the chair is of the open sided construction, then fix the cushion as shown below:

5. If the chair is of the closed side type with a removable seat cushion, fix the seat cushion as shown below:

6. If the chair is of the closed side type with a nonremovable seat cushion, then security will rely on the anti-slip base material of the seat cushion. 7. Place the protective cover over the seat cushion and ensure that the ArjoHuntleigh logo and the orientation icon, printed on the cover, are uppermost and at the front of the seat. 8. Zip the cover onto the seat cushion, taking care not to trap any material in the zip. 9. Connect to the Auto Logic pump, refer to page 9.

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4. Controls, Alarms and Indicators Controls Wait Indicator

Run/Standby

Low Pressure Indicator Autofirm

Alarm Mute

Comfort Controls

Reactive (CLP) Mode

Battery Low Indicator Service Indicator

Run/Standby Button

Power Fail Indicator

Pressing the Run/Standby button will activate the pump. The green indicators on the control panel and the front of the pump will illuminate when the pump is on. To switch the pump to Standby, the button must be pressed for two seconds. This prevents accidental operation. The green indicator will blink twice every 2 seconds to indicate to the user that the pump is in Standby.

 Unless Transport mode is required, always put the Alarm Mute

Reactive (CLP) Mode

pump into Standby before disconnecting mattress or seatpad. During an alarm condition (except Power Fail Alarm), the sound of the alarm can be silenced by pressing this button. The yellow indicator then remains on but the alarms will be silenced for 15 minutes or until the alarm condition has been corrected. Selects the Reactive (Constant Lower Pressure) (CLP), non-alternating mode. The yellow indicator illuminates when the pump is in this mode. When the Active (Alternating) mode (default) is selected, the yellow indicator will be switched off. Press the Reactive (CLP) Mode button for approximately 4 seconds to activate the reactive mode. The change in the mode will occur at the end of the next 12