ARJOHUNTLEIGH ALPHA RESPONSE Instructions for Use July 2014

Contents General Safety... iii Introduction... 1 About this Manual... 1 Intended Use... 1 About Alpha Response... 1 Pump... 2 Mattress: Overlay and Replacement... 3 Seat Cushion... 3 Clinical Applications... 4 Indications... 4 Contraindications... 4 Cautions... 4 Care of the patient when sitting... 4 Installation... 5 Preparing the Systems for Use... 5 Installing the Mattress... 5 Installing the Seat Cushion... 7 Installing the Pump... 9 Controls, Alarms and Indicators... 11 Control Panel... 11 Alarms... 15 Mattress - Pump Operation... 16 Installing the System... 16 Initial Inflation... 16 Mattress Operation... 17 Stopping Therapy... 18 To Deflate the Mattress... 18 To Store the Mattress... 19 Transport Mode... 19 CPR Control... 20 Seat Cushion - Pump Operation... 21 General... 21 Seat Cushion Operation... 21 To Deflate the Seat Cushion... 22 Decontamination... 23 Routine Maintenance... 25 Alpha Response System... 25 Pump... 25 Mattress Replacement, Overlay and Seat Cushion... 25 Serial Labels... 25 Troubleshooting... 26

(i)

Technical Specification... 27

(ii)

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: • EN60601-1:1990/A13:1996 and IEC 60601-1:1988/A2:1995. • UL60601-1, UL2601-1 and CAN/CSA C22.2 No. 601.1-M90. • EN60601-1:2006, EN60601-1-11:2010 and IEC 60601-1:2005. • AAMI/ANSI ES60601-1:2006 and CAN/CSA C22.2 No.60601.1(2008).

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 mode on the seat cushion. • Only the pump and mattress or seat combination as indicated by ArjoHuntleigh should be used. The correct function of the product cannot be guaranteed if incorrect pump and mattress or seat combinations are used.

(iii)

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 use or 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 Alpha Response™ 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 Alpha Response system. Failure to observe this caution could result in injury, or in extreme cases, death. Design Policy and Copyright ® and ™ are trademarks belonging to the ArjoHuntleigh group of companies. 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. © ArjoHuntleigh 2013

(iv)

1.

Introduction About this Manual

This manual is your introduction to the Alpha Response™ system. Use it to initially set up the system and keep it as a reference for day-to-day routines and as a guide to maintenance. You must read and fully understand this manual before using the system. If you have any difficulties in setting-up or using the Alpha Response system, 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 160 kg (352 lb). The Alpha Response system should be used as part of a prescribed plan of care (refer to “Indications” on page 4).

About Alpha Response

The Alpha Response system is a pressure redistributing mattress replacement, mattress overlay or seat cushion system designed to complement pressure ulcer treatment and prevention protocols. The product offers two therapeutic modes: • Active1 (Alternating) mode which periodically redistributes pressure away from vulnerable areas by inflating and deflating the cells beneath the body every 10 minutes. • Reactive1 (Constant Lower Pressure or CLP) mode where the cell pressure is reduced and held constant across the surface in order to lower the pressure exerted on the body. The product also offers an additional option, Transport Mode, where therapy is interrupted and the mattress cells become static in order to assist with patient transport. The mattresses can be used on standard hospital and normal domestic beds. Beds with divided sections for independent elevation of a patient's head and/or knees can be adjusted with these mattresses in position. The seat cushion can be used on standard hospital and normal domestic chairs.

1. International Pressure Ulcer Prevention and Treatment Guideline (2009). www.epuap.org

1

The pump has three settings for the patient weight range: • Light: 40-70 kg • Normal: 70-120 kg • Heavy: 120-160 kg The pump will automatically detect whether a mattress or seat cushion is connected. If the backrest on the bed is raised (the patient is in a semi-recumbent position), the system detects the new position and automatically increases the pressure in the mattress cells to provide optimal pressure redistribution to the patient. A full technical description of the Alpha Response system can be found in the Service Manual, part number SER0021, available from your ArjoHuntleigh sales office. Pump LCD Screen, Controls and LED Indicator

Carry Handle

Tubeset Connector

2

Swing-out Bed-Hooks

Mattress: Overlay and Replacement 3 Static Head Cells

14 Standard Cells

Detachable Cover

HEAD END

CPR Control

FOOT END

Securing Straps Cable Management Flap Tubeset

Transportation Loop

Seat Cushion Detachable Cover

Active (Alternating) Cells

Deflation Valves (on underside for packing and storage)

Fixing Straps Base Cover

Tubeset

3

2. Clinical Applications Indications

Contraindications Cautions

The Alpha Response 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 Alpha Response mattress and cushion are designed for patients weighing up to 160 kg (352 lb). Do not use Alpha Response systems for patients with unstable spinal fractures. 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 Alpha Response 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 therapy (alternating) 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.

4

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: • Alpha Response pump including mains power cable. • Alpha Response mattress overlay, Alpha Response mattress replacement or Alpha Response seat cushion, which all have integral tubesets and top covers.  Do not use the mattress or seat cushion without a cover.

Installing the Mattress Caution Do not use the mattress overlay directly on the bed frame. 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 mattress cover must be uppermost. 2. Attach the mattress to the bed frame using the four strap assemblies on the underside of the mattress replacement: • The strap assemblies are attached to four of the five pairs of anchor points, their position depending on the type of bed frame. One strap assembly must be at the head end of the mattress and a second must be at the foot end. The remaining two can be attached to any of the three pairs of anchor points in the middle of the mattress. • Pass each half of the strap assembly under the base mattress, connect them together and pull the strap assembly tight.

5

Top View

View on Underside of Mattress

Head End

Base Mattress

Strap

Mattress Replacement

Foot End

Typical Strap Anchor Points

Strap Assemblies

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 at the foot end of the bed and the CPR at the head end. 3. Attach the mattress to the bed frame using the eight fastener straps. The eight fastener straps can be moved to any of the ten anchor points on the bottom of the mattress replacement. This allows for attaching the mattress to different types of bed frame.

 If the bed has divided sections for independent

elevation of a patient's head and/or knees, attach the mattress to the movable parts of the bed frame only.

 One strap assembly must be at the head end of the mattress and a second must be at the foot end. WARNING The CPR control and CPR indicator tag must be visible and accessible at all times. Closing the CPR Control

On the mattress overlay or mattress replacement, make sure the CPR control is closed: • The CPR control consists of a connector in the side of the mattress with a removable plug fitted. • Make sure the CPR plug is fully pushed into the connector on the mattress. 6

1

2

Installing the Seat Cushion Cautions • Do not use the seat cushion without a foam cushion beneath it. • Always use the seat cushion with the protective top cover. • Always use the seat cushion in the correct orientation. • Avoid trailing cables - make sure that cables and tubes 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. 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. Stand in front of the chair and look towards it. Make sure 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.

7

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 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.

8

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. Insert the mains power plug into a suitable mains power socket.

Bed Foot-Rail

Swing-Out Hook

Mains Power Plug

Cable Management in Mattresses

The mains power cable should be put through one of the cable management flaps which are on each side of the mattress, as follows: 1. Locate one of the cable management flaps. 2. If necessary, open the press studs along the flap. 3. Run the mains power cable along the side of the mattress securing the flap round the cable using the press studs.

Connecting the Tubeset

Make sure the mattress/seat tubeset is not “kinked” or twisted, and push the tubeset connector firmly onto the pump until it clicks into place.  Make sure that the tubeset is securely connected to the pump.

9

ck”

i “Cl

1

Disconnecting the Tubeset

2

To disconnect the tubeset at any time, push down the release button on the top of the tubeset connector and pull the tubeset connector away from the pump. This will put the mattress into Transport Mode and will not deflate the mattress. To deflate the mattress, refer to “To Deflate the Mattress” on page 18.  There is no transport mode on the Alpha Response seat cushion.

Release Button 1

System Operation

2

The system is now ready for use. Refer to “Controls, Alarms and Indicators” on page 11 and “Mattress Pump Operation” on page 16 for day-to-day operating instructions.

10

4. Controls, Alarms and Indicators Control Panel Weight Range Icons

LCD Screen

Activity Indicator LED Indicator

Run/Standby Button Mode Selection Icon Weight/Mode Select Buttons

LCD Screen

Run/Standby Button LED Indicator

Run/Standby Button

Mattress/Seat Mode Icon

Select Button

This displays the operating mode and status of the pump, as follows: • Mattress/Seat Status. • Weight Range (or Mattress Mode, if selected by the Mode Selection). • Mode Selection. • Activity Indicator. Press the Run/Standby button to put the pump into the Run mode; the LED indicator changes to green. To put the pump into Standby, press the Run/Standby button for approximately three seconds; this prevents accidental operation. The LCD screen goes blank and the LED indicator changes to amber. After you put the pump in Standby, if you press the Run/ Standby button within approximately 15 seconds the pump goes straight to the Run mode and continues the previous therapy; if you wait more than 15 seconds the pump re-initialises and restarts the initial mattress/seat cushion inflation sequence. If the mains power is disconnected from the pump while the pump is operating, the pump enters the Power Fail Alarm mode (refer to “Alarms” on page 15). Press and hold the Run/Standby button; the alarm stops and the pump switches off completely.

11

LED Indicator

Mattress/Seat Status

The multicolour LED adjacent to the Run/Standby button indicates the status of the pump, as follows: Amber (Constant)

External power is applied to the pump, but the pump is in Standby.

Green (Constant)

The pump is in Run mode and operating.

Red (Flashing)

The pump has detected an alarm condition.

There are five mattress/seat mode icons which can be displayed, as follows: Mattress Backrest Horizontal Active (Alternating) Mode Mattress Backrest Horizontal Reactive (CLP) Mode Mattress Backrest Raised Active (Alternating) Mode Mattress Backrest Raised Reactive (CLP) Mode Seat Active (Alternating) Mode

The function of the Select button depends on the pump control change being carried out and the icon that is displayed on the LCD screen directly above the button. Mode Selection Icon This “double-arrow” icon indicates that the pump is in normal therapy mode, and pressing the Select button below it will select either the Weight Range icons or the Mode icons. When the Weight Range or Mode is being changed, the Mode Selection icon changes to a “tick” and flash. Pressing the Select button under the “tick” confirms the new selection.  If the Select button is not pressed for five seconds when the flashing “tick” is displayed, the requested pump status change is ignored, the “tick” reverts back to the Mode Selection icon and the pump continues in its current state. Select Button

12

Weight Range

There are three Weight Range icons displayed on the LCD screen, the relative size of each “person” icon corresponding to the patient weight range. The selected weight range is indicated by the corresponding icon being solid and the other two icons as outlines.  Patient comfort and clinical judgement should be used to select the correct weight range setting.

Light Weight Weight Range: 40-70 kg

Normal Weight Weight Range: 70-120 kg

Heavy Weight Weight Range: 120-160 kg

To change the Weight Range, do the following: 1. Press the Weight/Mode Select buttons to highlight the new Weight Range icon; the new icon is solid and flashing. 2. The Mode Selection icon changes:

3. Press the Select button to confirm the new Weight Range setting.

13

Mode

If the Select button is pressed during therapy when the Mode Selection icon is displayed, then the Weight Range icons are replaced by two Mode icons. The selected Mode is indicated by the corresponding icon being solid and surrounded by a square and the remaining icon as an outline: Active (Alternating) Mode Backrest Horizontal

Reactive (CLP) Mode Backrest Horizontal

To change the Mode, do the following: 1. Make sure the Mode Selection icon is displayed. 2. Press the Select button, and the two Mode icons are then displayed. 3. Press the Weight/Mode Select buttons to highlight the new Mode icon. The new Mode icon is solid with a square border. 4. The new Mode icon and square flashes and the Mode Selection icon changes:

5. Press the Select button to confirm the new Mode. 6. Press the Select button again and the two Mode icons are replaced by the Weight Range icons. Activity Indicator

After the mattress has inflated and the system is in the normal operating mode, an Activity Indicator icon is displayed in the top right corner of the LCD screen: • The Activity Indicator rotates in a clockwise direction to show that the pump is operating normally. • The Activity Indicator stops rotating and starts flashing if the pressure changes dramatically e.g. if the patient moves heavily on the mattress or if the Weight Range is changed. Once the pump pressure has stabilised around its target pressure the Activity Indicator stops flashing and starts rotating again.

14

Alarms

1. When the pump detects an alarm condition: • The corresponding visual alarm is displayed on the LCD screen, as detailed below. • The LED indicator on the control panel flashes alternately red and green. • An audible alarm is sounded, which increases in pitch if the alarm is ignored. 2. Press the Run/Standby button to stop the alarm. 3. Refer to Section 9, Page 26 “Troubleshooting” for the alarms, their possible causes and their remedies.

 If the operation of the pump changes during use,

refer to Troubleshooting procedures on page 26 of this IFU before calling a service engineer or contacting your local ArjoHuntleigh sales office.

15