ARJOHUNTLEIGH ALPHA RESPONSE Service Manual Issue 1 Feb 2010

Alpha Response Service Manual

Contents

CONTENTS CHAPTER 1 Introduction... 1 About This Manual... 1 Numbering and Cross-Referencing in this Manual... 1 Warnings, Cautions and Notes... 1 General... 1 Regulatory... 1 Precautions... 1 Electromagnetic Compatibility (EMC)... 1 Environmental Protection... 2 Design Policy and Copyright... 2 About the Alpha RESPONSE System... 2 General... 2 System Variants... 2 Effectivity... 2 Pump... 3 Mattress Replacement and Mattress Overlay... 4 Seat Cushion... 4 Pump Schematics... 5 Controls, Alarms and Indicators... 7 LCD Screen... 7 Run/Standby Button... 7 LED Indicator... 7 Mattress/Seat Status... 8 Select Button... 8 Mode Selection Icons... 8 Weight Range... 9 Mode (for Mattress systems only)... 9 Activity Indicator... 10 Alarms... 10 System Setup... 11 The System... 11 Connecting/Disconnecting the Tubeset... 11 To Close, or Reset, the CPR Control on the Mattress... 11 To Activate, or Open, the CPR Control on the Mattress... 12 To Deflate the Mattress... 12 To Store the Mattress... 12

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Transport Mode... 12

CHAPTER 2 Troubleshooting... 13 General... 13 Troubleshooting Table... 13 Hardware Error Messages and Error Codes... 14 Communicator Error Codes for Multiple Faults... 17 Faulty Battery?... 18

CHAPTER 3 Maintenance... 19 Maintenance Procedures... 19 Serial Labels... 19 Examining the Pump to See if a Service is Due... 19 Pump Service... 20 Pump Maintenance Checks... 20 Mattress Replacement and Mattress Overlay Service... 21 Mattress Replacement and Mattress Overlay Maintenance Checks... 21 Seat Cushion Service... 21 Seat Cushion Maintenance Checks... 22

CHAPTER 4 Testing... 23 Test Requirements... 23 Pump Tests... 23 Test Equipment... 24 Setting up the TAPP Communicator... 25 Running the TAPP Communicator Software... 25 Description of TAPP Communicator Service Screen... 29 Tubeset and Power Fail Tests... 30 Pump Flow and Pressure Tests... 32 Errors Detected During the Flow and Pressure Tests... 32 Basic Pump Tests... 32 Flow and Pressure Tests... 35 Setting Serial Numbers for New Sub-Assemblies... 39 Engineering Settings... 40 Contrast Adjustment... 40 Bed Profile (Applicable to RoW Pumps only)... 41

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Electrical Safety Testing... 42 Test Equipment... 42 Electrical Safety Checks - Class II (Double Insulated)... 42 Insulation Resistance Test... 42 Dielectric Strength Test (Flash Test)... 42 Inflation Test of the Mattress Replacement, Overlay or Seat Cushion... 43 Test Equipment... 43 Test Procedure... 44

CHAPTER 5 Pump Repair... 45 General... 45 Testing... 45 Replacing the Case Inlet Filter... 46 Replacing the Mains Power Cable, USB Cover and Rear Labels... 47 Replacing the Rear Case Assembly, Replacing the Rubber Feet... 48 Replacing the O-Rings on the Outlet Manifold Assembly... 49 Layout of Sub-Assemblies in the Front Case Assembly... 50 Removing the Compressor AV Mounts... 51 Installing the Compressor AV Mounts... 51 Replacing the AV Pillars... 52 Replacing the Inlet Filter Felt on the Compressor Assembly... 53 Removing the Compressor & Bracket Assembly... 55 Installing the Compressor & Bracket Assembly... 55 Removing the Outlet Manifold Assembly... 57 Installing the Outlet Manifold Assembly... 57 Removing the Motor & Pressure Module Assembly... 59 Installing the Motor & Pressure Module Assembly... 59 Removing the Display PCB Assembly... 61 Disconnecting the Membrane Label from the Display PCB Assembly... 61 Installing the Display PCB Assembly... 62 Connecting the Membrane Label to the Display PCB Assembly... 63 Replacing the Rechargeable Battery... 64 Replacing the Display Membrane Label... 65 Removing the Power Supply PCB Assembly... 67 Installing the Power Supply PCB Assembly... 67 Replacing the Bio-Filter, Tubes and Connectors... 69 Replacing the Front Case Moulding... 70 Replacing the Rear Case Assembly... 71

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CHAPTER 6 Mattress Replacement & Overlay Repair... 73 General... 73 Replacing the Top Cover Assembly... 75 Removing a Cell Assembly... 75 Installing a Cell Assembly... 75 Removing the Tubeset Assembly... 77 Installing the Tubeset Assembly... 77 Removing the Manifold Assembly... 79 Installing the Manifold Assembly... 79 Removing the CPR Box Assembly on the Mattress Replacement... 81 Installing the CPR Box Assembly on the Mattress Replacement... 81 Removing the CPR Box Assembly on the Mattress Overlay... 81 Installing the CPR Box Assembly on the Mattress Overlay... 81 Removing the Profile Valve Main Assembly (All Variants Except USA)... 83 Installing the Profile Valve Main Assembly (All Variants Except USA)... 83 Removing the Loop Sheet Assembly... 84 Installing the Loop Sheet Assembly... 84 Removing the B-Pad Assembly (Mattress Replacement Only)... 84 Installing the B-Pad Assembly (Mattress Replacement Only)... 84 Removing the Base Cover Assembly... 84 Installing the Base Cover Assembly... 85

CHAPTER 7 Seat Cushion Repair... 87 General... 87 Removing the Top Cover Assembly... 87 Installing the Top Cover Assembly... 87 Removing the Welded Cell Assembly... 89 Installing the Welded Cell Assembly... 89 Removing the Pump Tubeset Assembly... 90 Installing the Pump Tubeset Assembly... 90 Removing a Retaining Strap Assembly... 90 Installing a Retaining Strap Assembly... 90 Replacing the Base Assembly... 92

CHAPTER 8 Technical Specification... 93

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CHAPTER 9 Parts List... 97 Overall Assembly Parts List... 97 Pump Parts List... 98 Mattress Parts List... 100 Seat Cushion Parts List... 101

CHAPTER 10 Service Contact Details... 103

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Introduction

CHAPTER 1 INTRODUCTION 1

About This Manual

ArjoHuntleigh strongly recommend that their equipment is only serviced by trained personnel and provide courses for customers who wish to become licensed to service their own equipment. In no event will ArjoHuntleigh be responsible for any service performed by customers or third parties. This manual contains information on the maintenance, servicing, repair, troubleshooting and testing for the Alpha RESPONSE™ System. Refer to “Effectivity” on page 2 for a list of all Alpha RESPONSE models and part numbers included in this manual. Read and understand this manual before attempting to service or repair the equipment.

Numbering and Cross-Referencing in this Manual For all chapters in this manual: • Section and paragraph numbering re-start at “1”. • Page, figure and table numbering continue from the previous chapter. • Cross-references which include a chapter number (and/or chapter title) refer to text in a different chapter. Cross-references which do NOT include any chapter number (or chapter title) refer to text within the same chapter.

Warnings, Cautions and Notes WARNINGS given in this manual identify possible hazards in procedures or conditions which, if not correctly followed, could result in death, injury or other serious adverse reactions. CAUTIONS given in this manual identify possible hazards in procedures or conditions which, if not correctly followed, could result in equipment failure or damage. Notes given in this manual are used to explain or amplify a procedure or condition.

2

General

Regulatory The Alpha RESPONSE 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 and CAN/CSA C22.2 No. 601.1-M90.

Precautions For your own safety and the safety of the equipment, always take the following precautions: • Do not expose the system, especially the mattress, to naked flames, such as cigarettes, etc. • 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 or seat cushion in protective bags.

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 confirmed before use.

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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.

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. (© ArjoHuntleigh 2010)

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About the Alpha RESPONSE System

General 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. The pump has three settings for the patient weight range: • Light: 40 - 70 kg (88 - 154 lb). • Normal: 70 - 120 kg (154 - 265 lb). • Heavy: 120 - 160 kg (265 - 353 lb). The pump will automatically detect whether a mattress or seat cushion is connected. •

System Variants If the backrest on the bed is raised (the patient is in a semi-recumbent position), the pressure in the mattress is increased to provide optimal pressure redistribution to the patient. There are two variants of the Alpha RESPONSE system, depending on how the system detects the position of the backrest and increases the mattress pressure: • On UK, Euro and RoW systems (except the USA), the system automatically detects the new backrest position and increases the pressure in the mattress cells. • On USA-only systems, the clinician (or patient) has to manually select the Backrest Raised mode on the pump which will increase the pressure in the mattress cells.

4 •

•

Effectivity This manual applies to all variants of the Alpha RESPONSE systems, comprising a pump and mattress (replacement or overlay) or seat cushion; both variants of pumps, as detailed in “System Variants” on page 2, are detailed in this manual. Refer to Chapter 9 “Parts List”, Page 97, “Overall Assembly Parts List” for a detailed list of all the assemblies covered by this service manual.

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

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Introduction

Pump

LCD Screen, Controls and LED Indicator

Tubeset Connector

Carry Handle

Tubeset Connector

Mains Power Cable

Swing-out Bed-Hooks

Figure 1 - Pump - Front and Rear Views

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Mattress Replacement and Mattress Overlay 3 Static Head Cells

Detachable Cover

14 Standard Cells

HEAD END

CPR Control

FOOT END

Securing Straps

Tubeset

Tubeset Transportation Loop

Cable Management Flap

Figure 2 - Mattress - Replacement and Overlay

7

Seat Cushion

Detachable Cover

Active (Alternating) Cells

Deflation Valves (on underside for packing and storage)

Fixing Straps

Base Cover

Tubeset Figure 3 - Seat Cushion

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Pump Schematics

Figure 4 - Pneumatic Schematic

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Figure 5 - Electrical Schematic

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Controls, Alarms and Indicators Weight Range Icons

LCD Screen

Activity Indicator LED Indicator

Run/Standby Button

Mode Selection Icon Weight/Mode Select Buttons

Mattress/Seat Mode Icon

Select Button

Figure 6 - Pump Control Panel

LCD Screen 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.

Run/Standby Button Press the Run/Standby button to put the pump into the Run mode; the LED indicator will change to green. To put the pump into Standby, press the Run/Standby button for approximately 3 seconds; this prevents accidental operation. The LCD screen will go blank and the LED indicator will change to amber. After you put the pump in Standby, if you press the Run/Standby button within approximately 15 seconds the pump will go straight to the Run mode and continue the previous therapy; if you wait more than 15 seconds the pump will re-initialise and restart the initial mattress/seat cushion inflation sequence. If the mains power is disconnected from the pump while the pump is operating, the pump will enter the Power Fail Alarm mode. Press and hold the Run/Standby button; the alarm will stop and the pump will switch off completely.

LED Indicator The multicolour LED adjacent to the Run/Standby button indicates the status of the pump, as follows:

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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.

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Mattress/Seat Status There are 5 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(a)

a. Note: There is no Reactive (CLP) Mode when a seat is connected to the pump.

Select Button The function of the Select button depends on whether a mattress or seat is connected to the pump, what change is being carried out to the pump and the Mode Selection Icon currently being displayed on the LCD screen directly above the button.

Mode Selection Icons •

“Double-Arrow” Icon (Mattress only)

•

This is displayed when a mattress is connected to the pump. It indicates that the pump is in normal therapy mode, and pressing the Select button below it will select the Mode icons (or revert to the Weight Range icons). No icon is displayed above the Select button if a seat cushion is connected to the pump, since the seat only operates in one mode: Active (Alternating) Mode.

•

Flashing “Tick” Icon (Mattress and Seat)

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When the Weight Range or Mode is being changed, a flashing “tick” will be displayed. • Pressing the Select button under the “tick” will confirm the new selection. Note: If the Select button is not pressed for 5 seconds when the “tick” is displayed, the requested pump status change will be ignored, the “tick” will revert to the “Double-arrow” icon (mattress) or go blank (seat) and the pump will continue in its current state.

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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.

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 will be solid and flashing. 2. The Mode Selection icon will change to a flashing “tick”. 3. Press the Select button to confirm the new Weight Range setting.

Mode (for Mattress systems only) Note: Mode selection only applies when a mattress replacement or mattress overlay is connected to the pump, since a seat cushion only operates in one mode (Active (Alternating) Mode). The two variants of Alpha RESPONSE pump have different Mode displays as follows: UK, Euro and RoW Pump Variants (except the USA) If the Select button is pressed during therapy when the Mode Selection icon is displayed, then the Weight Range icons are replaced by 2 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

USA-only Pump Variants If the Select button is pressed during therapy when the Mode Selection icon is displayed, then the Weight Range icons are replaced by 4 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:

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Active (Alternating) Mode Backrest Horizontal

Reactive (CLP) Mode Backrest Horizontal

Active (Alternating) Mode Backrest Raised(a)

Reactive (CLP) Mode Backrest Raised(a)

a. If the backrest on the bed is raised (the patient is in a semi-recumbent position), the Backrest Raised mode (either Active or Reactive depending on the therapeutic mode) should be manually selected to increase the pressure in the mattress cells.

To change the Mode on mattress systems, do the following: 1. Make sure the “double-arrow” Mode Selection icon is displayed. 2. Press the Select button, and the Mode icons are then displayed: • 2 icons for UK, Euro and RoW pump variants (except the USA). • 4 icons for USA-only pump variants. 3. Press the Weight/Mode Select buttons to highlight the new Mode icon. The new Mode icon will be solid with a square border. 4. The new Mode icon and square will flash and the Mode Selection icon will change to a flashing “tick”. 5. Press the Select button to confirm the new Mode. 6. Press the Select button again and the 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 will stop rotating and start 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 will stop flashing and start rotating again.

Alarms 1.

2. 3.

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. Press the Run/Standby button to stop the alarm. Refer to Chapter 2 “Troubleshooting” for the alarms, their possible causes and their remedies.

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Introduction

System Setup

The System The Alpha RESPONSE system comprises: • Alpha RESPONSE pump including mains power cable. • Either the Alpha RESPONSE mattress replacement, Alpha RESPONSE mattress overlay or Alpha RESPONSE seat cushion, which all have integral tubesets.

Connecting/Disconnecting the Tubeset To connect the mattress or seat cushion tubeset onto the pump: 1. Make sure the tubeset is not “kinked” or twisted, and push the tubeset connector firmly onto the pump until it clicks into place. 2.

Make sure that the tubeset is securely connected to the pump.

” lick C “

1

2

To disconnect the tubeset: 1. Push down the release button on the top of the tubeset connector and pull the tubeset connector away from the pump. 2. 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.

Release Button

1

2

To Close, or Reset, the CPR Control on the Mattress If a mattress is connected to the pump, to close the CPR control: 1. Push the CPR plug into the connector on the mattress. 2.

Make sure the plug is securely fitted.

2

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To Activate, or Open, the CPR Control on the Mattress 1.

Use a quick, firm pull on the CPR tag to remove the CPR plug. The air will be rapidly evacuated from the mattress. 2. The plug is fastened to the mattress by a strap. Note: If the pump is operating when the CPR is activated, the Low Pressure alarm may be activated.

2

1

To Deflate the Mattress 1. 2. 3.

Stop the therapy and put the pump into Standby. Disconnect the tubeset from the pump (refer to “Connecting/Disconnecting the Tubeset” on page 11). Activate the CPR control at the head end of the mattress to deflate it (refer to “To Activate, or Open, the CPR Control on the Mattress” on page 12).

To Store the Mattress Following deflation: 1. Start rolling the mattress from the foot end towards the head end; stop after ONE turn of the mattress. 2. Bring the tubeset connector over the mattress and secure. 3. Continue to roll the mattress from the foot end towards the head end. Note: Make sure the mattress is dry before rolling it up. 3

1

2

Transport Mode To transport a patient who is lying on the Alpha RESPONSE mattress: 1. Stop the therapy and put the pump into Standby. 2. Disconnect the tubeset from the pump (refer to “Connecting/Disconnecting the Tubeset” on page 11). This will automatically put the mattress into transport mode. 3. To resume normal operation, reconnect the tubeset to the pump and restart the therapy.

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Troubleshooting

CHAPTER 2 TROUBLESHOOTING 1

General

1.1

1.2

When the pump detects an alarm condition: 1.1.1 The corresponding visual alarm is displayed on the LCD screen (refer to Table 1). 1.1.2 The LED indicator on the control panel flashes alternately red and green. 1.1.3 An audible alarm is sounded, which increases in pitch if the alarm is ignored. After diagnosing the fault, press the Run/Standby button to reset the alarm.

2

Troubleshooting Table Table 1 - Troubleshooting LCD Screen

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Fault

Possible Cause

Remedy

Mattress Inflating

Pump is inflating the mattress replacement or mattress overlay.

The “egg timer” is replaced by the patient body icon when mattress inflation is complete.

Seat Inflating

Pump is inflating the seat cushion.

The “egg timer” is replaced by the patient body icon when seat cushion inflation is complete.

1. No tubeset connected No Mattress to pump. or Seat (mattress and 2. Tubeset fitted but not connected securely. seat graphics alternate)

1. Connect a mattress or seat tubeset to the pump. 2. Remove and reconnect tubeset; push tubeset onto pump until a “click” is heard.

Low Pressure 1. Tubeset is not connected properly. 2. CPR control not fully closed. 3. There is a leak in the system.

1. Reconnect tubeset; push tubeset onto pump until a “click” is heard. 2. Make sure CPR plug is fully pushed into CPR grommet. 3. Inspect the inside of the pump and mattress/seat cushion for any tubes which are leaking due to damage or not fitted correctly. Refit or replace the affected part.

High Pressure

1. Tubeset is “kinked” or blocked. 2. Pump has detected an internal fault.

1. Inspect and remove any “kinks” or blockages in the tubeset. 2. Inspect the inside of the pump and mattress/seat cushion for any tubes which are occluded due to damage or not fitted correctly. Refit or replace the affected part.

Power Fail

External mains power supply has been removed while the pump is operating.

Reconnect the mains power supply to the pump.

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