Cairwave Model 7303 Service Manual Issue 3 Feb 2003

LIST OF CONTENTS Section

Title

1.

SAFETY STATEMENT

2.

INTRODUCTION General System Description

3.

SETTING UP/OPERATION Setting Up Operation Cardio Pulmonary Resuscitation Transport Mode Profiling and Gatching Caircover Replacement Deflation, Removal, Carrying and Storage Alarms and Fault Finding

4.

CONSTRUCTION OF PRODUCT Major Elements of the System Mattress Patient Management Unit Technical Details

5.

INFECTION CONTROL AND CLEANING Infection Control Cleaning Guidelines

6.

EQUIPMENT MAINTENANCE General Patient Management Unit Mattress Service Mode

7.

TEST EQUIPMENT

8.

PARTS LIST PMU Assembly Mattresses Air Connector

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SECTION 1 - SAFETY STATEMENT 1.1.

The CAIRWAVE Therapy System must be used in accordance with the manufacturer's instructions.

1.2.

The mains electricity supply within the building where the CAIRWAVE Therapy System is to be used must comply with IEE Regulations.

1.3.

Only personnel trained or formally approved by Pegasus Ltd in operation and maintenance of Pegasus systems may perform maintenance, modification or repair work on Pegasus Ltd Power Control Units.

1.4.

Unqualified personnel attempting to work on Pegasus Ltd Power Control Units risk serious injury to themselves and others, and possibly death by electrocution. Do not work, or attempt to work on Pegasus Power Units unless you are properly qualified to do so.

1.5.

Pegasus Ltd systems are designed to comply with all relevant electrical safety, manufacturing and performance standards published by IS0, IEE & BSI.

1.6

Materials used for cleaning procedures may be subject to COSHH regulations - manufacturer's Instructions for Use must be followed at all times.

1.7

Materials used for maintenance and repair may be subject to COSHH regulations - manufacturer's Instructions for Use must be followed at all times.

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SECTION 2 - INTRODUCTION 2.1

GENERAL

The CAIRWAVE Therapy System is suitable for patients showing any of the following characteristics: Assessed to be at risk up to and including those at very high risk of pressure sores Suffering any grade of pressure sore Immobile while in bed Altered sensory perception The CAIRWAVE Therapy System completely eliminates skin surface pressure at frequent intervals. This unique ‘Zero Pressure’ phase encourages the blood flow necessary to maintain healthy tissue, thereby giving therapy to and prevention from pressure sores even in the most vulnerable patients. By frequently eliminating pressure under the patient, the CAIRWAVE Therapy System also removes the need for repositioning to prevent pressure sores and is equivalent to turning a patient every 7.5 minutes. The ergonomic design of the system including its CAIRCOVER and quiet operation, ensure comfort and restfulness for the patient. The needs of the carer have also been incorporated in the development of the CAIRWAVE Therapy System with the optimum user-friendliness and the automatic adjustment to patient characteristics. Special attention has been given to the ease of cleaning.

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2.2

SYSTEM DESCRIPTION

The CAIRWAVE Therapy system consists of a multicell mattress and a Patient Management Unit, together with associated pipework. The specially constructed mattress comprises a series of transverse cells, which are inflated and deflated in sequence. This creates a series of pressure waves which travel beneath the patient from foot to head. To support the patient there are three head end cells and two longitudinal side cells that remain fully inflated at all of the time. The mattress, which replaces the normal bed mattress, is covered by a removal zipped cover, which protects the mattress from soiling, by body fluids. The Patient Management Unit (PMU), is microprocessor controlled, and supplies the air to inflate the mattress through umbilical connected to the unit. The air pressure in the mattress is continuously monitored, and the system is completely self-regulating. Audio and visual alarms activate if a fault condition exist. An audio alarm sounds when the unit is switched off, or if the mains supply is disconnected. The PMU may be suspended on the footboard of the bed, or stood on the floor.

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3.1

SETTING UP

SECTION 3 - SETTING UP/OPERATION

The CAIRWAVE Therapy System can be used on standard hospital, domestic and profiling beds. Follow these easy steps: 1.

Lower the bed if possible. Remove the existing mattress from the bed frame.

2.

Check that there is nothing to damage the CAIRWAVE Therapy System mattress, such as sharp edges or springs. If your bed frame does not have a solid base the use of a fracture board or similar firm base is advisable to ensure maximum benefit.

3.

Place the mattress on the bed with the umbilical at the foot end of the bed.

4.

Loosely secure to the bed frame using the cover straps provided. Do not fasten straps to removable head or footboards, or between fixed and moving parts of the bed frame.

5.

Plug the socket of the mains lead into the Patient Management Unit (PMU). The mains switch, power socket and fuses are situated on the right-hand side of the PMU, with a fuse rating label alongside.

POWER SOCKET

MAINS SWITCH (ILLUMINATED WHEN ON)

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FUSE RATING/ SERIAL NUMBER LABEL

COVER (FUSES UNDER)

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6.

Secure the lead to the back of the PMU using the cable clamp provided. CABLE CLAMP TO PMU POWER SOCKET

MAINS LEAD

ALTERNATIVE ROUTE TO MAINS SOCKET

TO MAINS SOCKET

7.

Open the hooks on the rear of the PMU, place over the foot of the bed and close until the hooks are tight against the bed frame and the PMU is held securely. Alternatively place the PMU on the floor at the foot of the bed.

8.

Connect the umbilical connector into the PMU and turn to the Normal position. UMBILICAL CONNECTOR RECEPTACLE

ALIGN MARKER WITH WHITE DOT

Unit Connection / Disconnection (Transport)

ALIGN MARKER WITH GREEN DOT

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9.

Plug the mains lead into a suitable electrical socket and switch ON the PMU. The audible alarm will sound and all the lights on the front panel will illuminate for approximately 2 seconds. The unit will then go into Fast Inflation Mode.

10.

After approximately ten minutes your mattress will reach full inflation pressure, indicated by a constant green light, check the straps, tighten where necessary. If required, straighten and smooth out the CAIRCOVER.

11.

The CAIRWAVE Therapy System is now ready for use. For maximum benefit, use only one sheet loosely placed over the mattress. If the sheet is tucked in ensure that it is left loose over the mattress to avoid hammocking.

12.

Once a patient is placed on the mattress the system will adjust automatically to the patient characteristics (weight / position) to provide optimum clinical benefit.

13.

If your mattress does not perform as described above, please refer to Alarms and Fault Finding.

3.2

OPERATION

Patient Management Unit Front Panel Functions NORMAL MODE INDICATOR (CONSTANT LIGHT)

CHECK AIR CONNECTOR INDICATOR LIGHT

STATIC MODE INDICATOR (CONSTANT LIGHT)

NORMAL MODE SELECT BUTTON

CPR MODE INDICATOR LIGHT

STATIC MODE SELECT BUTTON

AUDIO ALARM RESET BUTTON

SERVICE REQUIRED INDICATOR LIGHT

SYSTEM ALARM INDICATOR LIGHT

Front Panel Label The Patient Management Unit (PMU) front panel both controls and indicates the various functions of the CAIRWAVE Therapy System, including sophisticated audio and visual indicators. These functions are described as follows:

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Fast Inflation Mode (Fast Mattress Inflation) When switched ON with the umbilical connector in Normal position and the mattress fully deflated, the system will automatically go into Fast Inflation Mode for approximately 10 minutes to ensure the mattress inflates quickly, allowing the system to be used in the shortest possible time. While the system is in Fast Inflate Mode, the amber Static Mode indicator light will continually flash. If the system is switched ON with a partially inflated mattress, Fast Inflation will continue for a shorter period before reverting to Normal Mode. Normal Mode (Normal System Operation) When the Fast Inflation Mode is completed the system will automatically go into Normal Mode, with the mattress cells inflating and deflating (cycling) and the green Normal Mode indicator light constantly illuminated. When a patient is placed on the mattress in the Normal Mode, the system will, if necessary, automatically adjust to the patient characteristics (weight / position) to give optimum benefit. Static Mode (Mattress not Cycling)

WARNING:

The patient will not receive the benefits of the CAIRWAVE Therapy System while it is in Static Mode. Therefore the system should be returned to Normal Mode as soon as possible.

Some nursing procedures may require a static, fully inflated mattress. This is achieved by pressing the Static pushbutton to initiate Static Mode, a single beep will sound to indicate Static Mode is selected. Static Mode enables the PMU to inflate all cells fully and to maintain full inflation. When Static Mode is selected, the amber Static Mode indicator light will illuminate. The mattress will be maintained in Static Mode for 30 minutes, at which time the system will automatically revert to Normal Mode. To extend the duration of Static Mode, press the Static Mode pushbutton within the last 5 minutes of the Static Mode and it will be extended for a further 30 minutes. NOTE: an alarm will sound when Static Mode reaches its last five minutes to enable the extension to be made. The timed extension can only be carried out once, after which the system will then revert to Normal Mode. Static Mode cannot be re-selected for 30 minutes after the completion of the extension time. Normal Mode can be reselected at any time by pressing the Normal Mode pushbutton. Cardio Pulmonary Resuscitation (CPR) When the system has been set to the CPR Mode the alarm will sound for a few seconds and the red heart will flash. Cancel the alarm by pressing the Audio Alarm Reset pushbutton. The flashing red heart will cancel when CPR is no longer selected or if the Patient Management Unit (PMU) is switched off, (see Cardio Pulmonary Resuscitation).

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Alarm Functions CHECK UMBILICAL CONNECTOR indicator light The amber Check Umbilical Connector indicator light will flash when the umbilical connector is not correctly in place or is in the Transport Mode with the PMU turned on. SERVICE REQUIRED indicator light The amber Service Required indicator light will flash after 10,000 hours of use, when a routine system service will be required - contact the Service Organisation. The system will continue to function normally whilst in this state. SYSTEM ALARM indicator light The red System Alarm indicator light will flash and the audible alarm will sound if there is a system fault. The audible alarm will also sound when the system loses power or is switched off, when CPR is selected, when the system is in Transport Mode, or when the system reaches the last 5 minutes of Static Mode. There will be a single beep when the Static or Normal Mode pushbuttons are pressed to select the desired mode. To reset the System Alarm indicator light the PMU must be switched off. ALARM RESET button Resets the audio alarm when pressed.

3.3

CARDIO PULMONARY RESUSCITATION (CPR)

In the event of cardiac arrest, turn the umbilical connector to the CPR position. The mattress will immediately begin to deflate.

FOR RAPID DEFLATION TURN CONNECTOR FULLY IN DIRECTION OF ARROW (DO NOT DISCONNECT)

♥ CPR When the connector is turned to the CPR position the alarm will sound for a few seconds and the red heart will flash. Cancel the alarm by pressing the Audio Alarm Reset pushbutton. The flashing red heart will cancel when CPR is no longer selected or if the Patient Management Unit (PMU) is switched off.

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If CPR is required while the bed is being moved and the system is in Transport Mode, ensure the connector is disconnected from the PMU, turn the umbilical connector to the deflate position. This will allow the mattress to deflate to enable CPR to be carried out.

ALIGN MARKER WITH RED DOT

Deflation or ♥ CPR during Transport 3.4

TRANSPORT MODE (Mattress not Cycling)

WARNING:

NOTE:

The patient will not receive the benefits of the CAIRWAVE Therapy System while it is in Transport Mode, therefore the system should be returned to Normal Mode as soon as possible.

Prior to disconnecting the mattress for transport, it is recommended that Static Mode is selected to inflate all cells to provide maximum support for the patient during transport.

When moving the bed with the mattress still inflated, or if there is a power failure, turn the air connector to the ‘Transport’ position and disconnect. This will maintain the cells in their present state for approximately 24 hours. UMBILICAL CONNECTOR RECEPTACLE

ALIGN MARKER WITH WHITE DOT

Unit Connection/Disconnection (Transport) The amber Check Umbilical Connector indicator light will flash and the audio alarm will sound until the Patient Management Unit (PMU) is switched OFF. Turn OFF the PMU and unplug from the mains supply. An audible alarm will sound - cancel the alarm by pressing the Alarm Reset pushbutton. The bed can now be moved. When the bed has been moved to its new location, connect the PMU to the mains supply as soon as possible and turn ON. Reconnect the umbilical connector and turn to the Normal position. The system will default to Fast Inflation Mode, then automatically revert to Normal Mode. LFT4622 CAIRWAVE MODEL 7303

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3.5

PROFILING AND GATCHING

Your CAIRWAVE Therapy System can be used in a profiled position to provide pressure relief for patients sitting up in bed, and/or when knees are raised. CAUTION:

Fastening securing straps to the bed head may impede its removal in an emergency.

Profiling (Sitting Up) If using a bed with a manually operated back rest, release the mattress securing straps, lift the head end of the mattress and adjust the back rest to the required angle. Move the mattress to the desired position and, using the centre and foot end straps, secure the mattress to the main bed frame. If using a bed with a powered/mechanical back rest, release the mattress securing straps and raise the back rest to the required position. Move the mattress to the desired position and secure to the moving parts of the bed ensuring the straps are positioned and fastened so they are not stretched or do not interfere with the bed mechanism when used in its various positions.

DO NOT FASTEN STRAPS TO REMOVABLE BED HEAD

MATTRESS SECURING STRAPS

Gatching (Bending at the Knees) Release the mattress securing straps. Gatch the knee section as required, being careful not to disturb the Patient Management Unit by putting unnecessary strain on the umbilical. Move the mattress to the desired position and secure to the moving parts of the bed ensuring the straps are positioned and fastened so they are not stretched or do not interfere with the bed mechanism when used in its various positions.

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MATTRESS SECURING STRAPS

3.6

CAIRCOVER REPLACEMENT

To remove the CAIRCOVER and umbilical cover: 1.

Fully unzip the cover and remove the top section.

2.

Release the strap securing the umbilical cover to the mattress pipes and remove the umbilical cover.

3.

Undo the 6 clips securing the mattress to the CAIRCOVER bottom section, pull the umbilical through the sleeve in the cover and lift the mattress out of the cover bottom section.

LOOP

HOOKS

DISCONNECT HOOKS FROM LOOPS (6 POSITIONS)

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Replacement is the reverse of the removal, with the following additions: 1.

When fitting the umbilical cover, ensure the elasticated end fits fully into the groove on the umbilical connector. Loosely refit the strap around the internal pipes. UMBILICAL CONNECTOR

GROOVE UMBILICAL COVER

FIT ELASTICATED END OF AIRPIPE COVER INTO GROOVE

2.

Inflate the mattress, pull down on the top cover sides to straighten the cover then smooth down to ensure the cover sits over the mattress snugly.

SMOOTH DOWN COVER AFTER REFITTING

PULL DOWN ON TOP COVER SIDES TO STRAIGHTEN

3.7

DEFLATION, REMOVAL, CARRYING AND STORAGE

Deflation To deflate your CAIRWAVE Therapy System, follow these easy steps: 1.

With the system operating normally, turn the umbilical connector to the CPR position. The mattress will immediately start to deflate, the audible alarm will sound and the red heart will flash. Cancel the audio alarm by pressing the alarm-reset button.

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FOR RAPID DEFLATION TURN CONNECTOR FULLY IN DIRECTION OF ARROW (DO NOT DISCONNECT)

2.

When deflated, disconnect the mattress, switch off the Patient Management Unit (PMU), cancel the alarm and disconnect from the mains supply.

3.

When in Transport Mode, turn the umbilical connector to the Deflation position. The mattress will immediately start to deflate. If you wish to deflate quicker, apply downward pressure to the mattress and press out as much air as possible.

ALIGN MARKER WITH RED DOT

Deflation or ♥ CPR during Transport Removal Carry out mattress deflation as detailed above. Undo the mattress securing straps. Roll the mattress, with the top surface inwards, from the head end. Remove the PMU from the bed and fold the hooks into the recesses in the back. Carrying and Storage To help with carrying and storage of your CAIRWAVE Therapy System, high quality carry bags for the mattress and the PMU are available. For details, please contact your supplier.

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3.8

ALARMS AND FAULT FINDING

Alarm Your CAIRWAVE Therapy System is equipped with sophisticated audio and visual indicators. These alert the user to the status of the available mains supply and any system defect. In normal conditions with mains power available, the Patient Management Unit (PMU) turned on and the mattress fully inflated and cycling, the Normal Mode indicator light on the PMU front panel will be green and the mains light on the switch socket illuminated. If at any time the mains power should be removed from the PMU, an audible alarm will be heard. The audible alarm may be cancelled by pressing the Alarm Reset Pushbutton on the PMU, the System Alarm indicator light can be cancelled by switching OFF the PMU. Should your system develop a fault whilst in use, the System Alarm indicator light will turn red and an audible alarm will be heard. This alarm may be cancelled by switching OFF the PMU and then pressing the Alarm Reset Pushbutton. Fault Finding SYMPTOM

ACTION

No Lights on PMU

Check PMU is connected to the mains power supply and that the PMU mains switch is turned ON

‘Check Air Connector’ indicator light flashing and alarm sounding

Reset audio alarm by pressing the Alarm Reset pushbutton Check umbilical connector is connected and turned to the Normal position. The Check Umbilical Connector indicator light will automatically reset and extinguish

If problem persists, contact your supplier.

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SECTION 4 – CONSTRUCTION OF PRODUCT

4.1

MAJOR ELEMENTS OF SYSTEM

The product comprises two major elements: a multicell mattress and a microprocessor controlled Patient Management Unit (PMU).

4.2.

MATTRESS

The mattress comprises two layers of 18 transverse cells, one above the other, separated by two longitudinal tubes (formers), one along each side. The longitudinal tubes each have 17 short loops at regular intervals along their length. These thread through eyelets in the side flaps of the upper and lower decks such that the transverse cells in the upper layer are located vertically above the corresponding cells in the lower layer. 'H' connectors are used to hod these together. The loops are slightly longer on one of the formers to accommodate the airpipes. Additionally, two loops thread through holes at each end of the mattress and are held in position using an 'H' connector through each loop. The cells and formers are chemically bonded to pneumatic tubing. This is formed into a harness that terminates at the male part of the umbilical connector. This enables connection to the PMU. The standard mattress is constructed so that 3 upper deck cells at the head end and the 2 longitudinal tubes remain fully inflated at all times when the system is in use. The remainder of the cells are interconnected so there are 3 sets of cells in each deck, each set cycling from, fully inflated, part inflated to fully deflated sequentially, to create the CAIRWAVE action. The cells in each deck cycle so that vertically aligned cells are in the same state, with the exception of the three upper deck head cells. The mattress cover is in two halves, joined together with a zip. The top cover is extended at the sides to provide a 'skirt', which covers the zip and has instructions printed on it. The cover protects the mattress and the bed base from soiling by body fluids. It has a smooth surface finish to facilitate cleaning. The cover for the umbilical is manufactured from the same material as the mattress cover and is removable for ease of cleaning. The umbilical terminates in a connector to enable pneumatic connection to the PMU and to select any of the following three operating modes: Transport

Will not allow air to or from the mattress.

Normal

Normal operation

CPR

For fast mattress deflation to allow CPR

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4.3

PATIENT MANAGEMENT UNIT (PMU)

The 7303 PMU comprises a chassis assembly containing the working parts housed within the protective casing: Casing The casing consists of a front moulding with a control panel and connection access and a back section with hook assembly for attaching to a bed, held together by six socket-headed screws. Connections, controls and information are as follows: Mains switch socket -

Umbilical connector Receptacle Control Panel -

A 1 amp double-pole, fused, switched socket mounted into a protective recess in the sidewall of the casing. The remote control socket is fixed adjacent to the power socket. A fuse rating label is also adjacent to the power socket. The umbilical connector receptacle enables pneumatic connection to the mattress and has three positions marked on it. The control panel houses all the alarm indicators and pushbuttons and has an ECU (ECU2), to enable control of the indicators, attached to the back of the panel.

The back of the PMU incorporates the following: Hooks -

To enable the power unit to be suspended from the bed frame.

Rubber bumpers -

To give protection to the bed footboard and prevent any mechanical vibration being transmitted to the bed.

Air intake holes -

Sited under the hook assembly.

When closed, the casing is sealed to IP44. A 'Cautions' label is affixed to the back, alongside the manufacturer's label, which bears electrical ratings information and the serial number of the unit. Chassis Assembly The chassis assembly has the following attached: 4 x Air Pumps -

2 x Air Supply Pumps 2 x Vacuum Pumps

1 x Silencer 1 x Accumulator 1 x Rotorvalve 1 x Switch Assembly 1 x Switch Assembly 2 x manifolds -

Intermediate and High Pressure Switches Over Pressure and Vacuum Switches Pressure Manifold Vacuum Manifold Main ECU (ECU1)

1 x Electronic Control Unit 1 x Air Connector Receptacle 1 x Mains Switch and Plate Assembly

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4.4

TECHNICAL DETAILS

Cycle Control

Purpose designed distributor valve supplying operating air to the inflatable cells with vacuum assisted air removal

Cycle Time

7.5 minutes

Supply Voltage

220/240Vac 50Hz

Power Rating

Maximum 100VA. Constant running rate approximately 50VA

Fuse Rating

1A Antisurge (x2)

Noise Level

NC30

Nominal Dimensions

Mattress (Inflated)

Patient Management Unit

1930mm long

175mm deep

880mm wide

510mm wide

210mm high

260mm high

Weight 9.5kg

Weight 8.65k

Electrical Safety EMC

Conforms to EN 60601-1-1 Conforms to EN 60601-1-2

Classification

Class 1, Type B

Flammability Rating

Mattress Cover Materials comply with BS7175 Ignition Sources 0, 1 and 5

Mode of Operation

Continuous

Symbols

Fused with two 1A Antisurge Fuses

Alternating Current Mains Switch

- 1 (On) Power connected to the mains supply

- 0 (Off) Power disconnected from mains supply Type B

This product carries the CE mark in accordance with EC Directive on Medical Devices (93/42/EEC).

Pegasus Limited cannot be held responsible for any damage caused to our products (by foreign objects – needles, sharps, eating utensils, etc) other than due to normal wear and tear as defined in the product warranty agreement. Nor for any injury or incident which relates to the use of cot sides, profiling or any other mechanical or electrical device used in conjunction with this product unless supplied and/or manufactured by Pegasus Limited

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SECTION 5 – INFECTION CONTROL/CLEANING

5.1

INFECTION CONTROL

Infection control and routine cleaning must be carried out in accordance with your local Infection Control Policy. 5.2

CLEANING GUIDELINES

WARNING:

ENSURE THE PMU IS DISCONNECTED FROM THE MAINS ELECTRICITY SUPPLY BEFORE CLEANING.

CAUTIONS:

1.

Do not immerse the PMU in water.

2.

Do not use high temperature autoclave or Phenolic based products for cleaning.

It is recommended the system is cleaned between users or approximately every 2 weeks if in constant use. NOTE:

Ensure the Patient Management Unit is turned off and is disconnected from the mains supply before cleaning. In many cases it will not be necessary to remove the mattress from the bed prior to cleaning.

The Patient Management Unit can be cleaned by wiping down with a cloth dampened with one of the solutions in ‘1.’ or ‘2.’ below, or decontaminated using ETO (Ethylene Oxide) or Draeger system. Your mattress, CAIRCOVER and umbilical cover can be cleaned using the following simple procedure in accordance with your Local Infection Control Policy (check with a registered nurse or medical practitioner for details): 1.

Liberally swabbing with hot water at 60°C containing detergent, then drying.

2.

Swabbing with a solution of sodium hypochlorite (up to 10,000 parts per million available chlorine) - then drying.

The CAIRCOVER and umbilical cover can also be machine washed to a maximum temperature of 90°C. The CAIRCOVER and mattress must be dry prior to refitting. Do not tumble dry. The system may also be decontaminated by using ETO (Ethylene Oxide) or the Draeger method. The CAIRCOVER top may be low temperature autoclaved (75°C) using autoclave paper to protect the coated surface. For further information, contact your supplier.

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