Quattro Acute Mattress User Manual

Manufacturer’s Declaration of Conformity

PRODUCT IDENTIFICATION PRODUCT:QUATTRO ACUTE SYSTEM TYPE:PRESSURE RELIEF DEVICE

Tested by:

EMC PROJECTS LTD, BTTG

Standards:

EN 60601-1-2:1993 BS 7177

Test Report No:

5531/03 12511/1/STC004

Manufacturer:

Talley Group Limited, Premier Way, Abbey Park Industrial Estate, Romsey, Hampshire, SO51 9AQ, UK

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DECLARATION To our knowledge the product conforms with Directive 93/42/EEC for medical equipment.

Specification

Pump Unit Construction: Dimensions: Weight: Mains Cable: Electricity Supply: Full Load Wattage: Fuse Rating: Cycle Time:

ABS Plastic 335mm x 165mm x 233mm 3.4kg 5 metres 230V +/- 10% 50Hz 18W 2 x 500mA Variable

Contents

Page INTRODUCTION

2

CAUTION INFORMATION

3

LIST OF COMPONENTS

4

INSTALLATION

5

USER GUIDELINES

9

CARE AND MAINTENANCE

11

FAULT FINDING

13

Talley Medical products are manufactured to comply with BSI, IEC, UL, CSA and other European safety standards.

WEIGHT CONVERSION TABLE

15

SPECIFICATION

16

Talley Medical design and manufacture products to ISO9001, EN46001 and ISO13485 standards, and comply with Medical Directive (93/42/EEC).

MANUFACTURER’S DECLARATION OF CONFORMITY

17

Other voltages available. Mattress Construction:

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Dimensions: Weight: Type:

PU coated nylon base, PU coated stretch nylon cover, polyurethane cells 1980mm x 880mm x 240mm (approx.) 13.2kg 27 Deep Cells in mattress replacement configuration

Talley Medical reserves the right to modify the specification of any product without prior notice in line with a policy of continual product development. Our standard terms and conditions apply.

Thank you for choosing to use the Talley Medical QUATTRO ACUTE™ mattress replacement system. In doing so you have selected an effective product for the prevention and management of pressure ulcers for patients at very high risk, within the acute hospital environment. This system is constructed from a patented cell design which almost eliminates lateral tension in the mattress surface so leading to greater immersion into the mattress, and consequently producing reduced interface pressure readings. In addition to the excellent flotation qualities provided by the QUATTRO ACUTE™ mattress, the system also benefits from QUATTRO THERAPY™ with ODS™, featuring a unique 1 in 4 cell cycle, a low air loss feature which maintains the patient’s skin at an ambient temperature and lower humidity level, and a cell design which allows optimum therapy, comfort and security for the patient. The QUATTRO ACUTE™ also features static mode for continuous low pressure therapy, maximum inflation mode, a CPR rapid deflation device and a patient transport facility.

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The QUATTRO ACUTE™ system will benefit from careful installation and use, providing a long and effective service life. Please read this user manual in order to achieve the best possible results.

WEIGHT CONVERSION TABLE - stone and lbs to kgs (Conversions are correct to the nearest 0.1kg (100gm); i.e. approx. 3oz.) Stone 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9 9 9 9 9 10

lbs 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0

Kgs 31.8 32.7 33.6 34.5 35.4 36.3 37.2 38.1 39.0 39.9 40.8 41.7 42.6 43.5 44.5 45.4 46.3 47.2 48.1 49.0 49.9 50.8 51.7 52.6 53.5 54.4 55.3 56.2 57.2 58.1 59.0 59.9 60.8 61.7 62.6 63.5

Stone 10 10 10 10 10 10 11 11 11 11 11 11 11 12 12 12 12 12 12 12 13 13 13 13 13 13 13 14 14 14 14 14 14 14 15 15

lbs 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2

Kgs 64.4 65.3 66.2 67.1 68.0 68.9 69.6 70.8 71.7 72.6 73.5 74.4 75.3 76.2 77.1 78.0 78.9 79.8 80.7 81.6 82.6 83.5 84.4 85.3 86.2 87.1 88.0 88.9 89.8 90.7 91.6 92.5 93.4 94.3 95.2 96.2

Stone 15 15 15 15 15 16 16 16 16 16 16 16 17 17 17 17 17 17 17 18 18 18 18 18 18 18 19 19 19 19 19 19 19 20

lbs 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0 2 4 6 8 10 12 0

Kgs 97.0 98.0 98.9 99.8 100.7 101.6 102.5 103.4 104.3 105.2 106.1 107.0 107.9 108.9 109.8 110.7 111.6 112.5 113.4 114.3 115.2 116.1 117.0 117.9 118.8 119.7 120.7 121.6 122.5 123.4 124.3 125.2 126.1 127.0

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Introduction

Caution

The QUATTRO ACUTE™ may also display the following information:-

Before using this product ensure that:

O Service due O Kinked tube

O the electricity supply is of the type indicated on the power unit.

O Uncalibrated

Contact Talley Medical to arrange service. Check tubing and mattress hose for kinks or obstruction. Contact Talley Medical for recalibration

If you have any queries relating to this system please call our 24 Hour Helpline on 0845 7585301.

O the mains lead is free from damage and is positioned so as not to cause an obstruction. O the system is not used in the presence of flammable anaesthetics. Do not place mattress or power unit on or near a heat source. Do not use with hot water bottles or electric blankets. Although the materials used in the manufacture of all components of the QUATTRO ACUTE™ comply to the latest fire safety regulations, Talley Medical advise against smoking whilst the system is in use, to prevent the accidental secondary ignition of associated items which may be flammable, such as bed linen. In order for the system to operate effectively, please avoid placing objects on the mattress surface that may obstruct the movement of air between the cells. For the same reason, please discourage people from sitting on the edge or on the end of the mattress whilst it is in use.

Alternating pressure therapy should not be used for patients with unstable fractures, gross oedema, burns or an intolerance to motion. We recommend the use of safety side rails with this system.

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The system is used as part of a pressure ulcer prevention programme, not solely relied upon for this purpose.

List of Components

Fault Finding

Your Talley Medical QUATTRO ACUTE™ system should comprise the following items - please ensure you have all of these before installation.

All alarms can be reset by pressing the MUTE button once. This also cancels the fault displays. MUTE also silences the audible alarm. The QUATTRO ACUTE has a fault log that records the last 5 faults via the DATA display mode.

O QUATTRO ACUTE™ power unit. O Separate mains power lead. O QUATTRO ACUTE™ mattress replacement. O Mattress replacement top cover (supplied attached to mattress). O System carry bag.

AC Fail Fault – indicates a mains power failure, a continuous alarm will sound if power is interrupted, e.g. pump switched off, power cut, disconnection of mains lead. Press MUTE or re-connect to power supply. Rotor System Fault – indicates automatic sequential cycle has stopped or there is a fault in the system. Switch power off, press MUTE button, then switch power on again. If fault re-occurs, contact Talley Medical. Low Pressure – will alert if pressure falls below minimum allowable levels. Check that hose is connected to pump correctly. Check that CPR device is fully closed, i.e. no white plastic is visible. Check that internal cell are connected and that no cell is punctured. Press the MUTE button to clear alarm. Note that alarm will reoccur if fault persists, if fault re-occurs, contact Talley Medical. EMI Fault – indicates that the unit detects the pressure sensor amplifier is adversely affected by external RF fields. This will clear when interference ceases.

NOTE: If problems reoccur, contact Talley Medical.

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OTHER ALARMS There is a PUMP OR TRIAC fault that indicates a triac failure or an open pump coil fault. Should this occur, contact Talley Medical.

Installation

Power Unit Always disconnect the power unit from the electricity supply before cleaning. The QUATTRO ACUTE™ power unit can be wiped down with a damp cloth or alcohol wipe. Do not use solvents. The unit contains no user servicable parts, and should only be serviced by a competent electrical engineer, or returned to Talley Medical, or your local authorised dealer. All Talley Medical products should be serviced annually by Talley Medical or authorised dealer in order to comply with warranty conditions. It is the customer’s responsibility to ensure the following prior to collection: O the system is cleaned of any obvious contaminants. O contamination status is documented as per the NHS Guidelines HSG(93)26. O assistance is given to Talley Medical personnel to bag the equipment if the mattress has been in a known or suspected infectious environment.

How to install and set up your Talley Medical QUATTRO ACUTE™ system:1. Ensure bed frame to be used has no existing mattress components, and is free from items which could cause damage to the QUATTRO ACUTE™ mattress. It should be noted that this system is intended to completely replace the existing mattress.

Fig. 1

2. Place the QUATTRO ACUTE™ mattress on the bed frame with the mattress hose on the right hand side and the green cover uppermost - the words 'FOOT END' should be visible at the foot end of the bed. 3. Fasten the mattress security straps to the bed frame, allowing for the moving components on profiling electric beds (Fig. 1). The straps are important as they stop the system becoming detached from the bed frame and causing possible injur y to the patient.

5. Attach mattress air supply hose to power unit by aligning black line on mattress hose connector with black line on power unit connector and pushing together. Rotate mattress hose connector clockwise until green indicator fills window on power unit connector (Fig. 2).

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4. Suspend the QUATTRO ACUTE™ power unit from the foot board of the bed having first adjusted the hanger brackets as instructed at the rear of the unit. Alternatively the power unit may be placed on the floor.

Care and Maintenance

The QUATTRO ACUTE™ system will provide years of efficient service if it is cared for in the following way:

Fig. 2

7. Switch the power on at outlet, and at side of power unit adjacent to power lead entry. 8. The system will display STARTING UP, then INITIALISING whilst the mattress inflates (this will take approximately 20 minutes). Note: It is important that during the INITIALISING phase the mattress connector is not disconnected from the power unit. If this is done, the power unit must be switched off, MUTE button pressed when the audible alarm is made, the mattress connector re-engaged, and the power unit restarted. If system displays UNCALIBRATED or SERVICE DUE when switched on, the system will continue to operate but should be recalibrated or serviced as soon as possible. 9. When bottom sheet is added to mattress, ensure that it is left loose to allow the mattress surface to conform with the patient's body as much as possible.

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10. Allow mattress to inflate before positioning patient on mattress. 11. Once inflated the system will automatically default to ACTIVE mode with medium comfort setting (3). 12. Place the carry bag and user manual in a safe place for future use.

Cover Always keep the mattress cover as clean as is practicable. The material is waterproof and vapour permeable. The cover may be removed and will withstand the thermal disinfection washing procedures described in the Department of Health Circular HC(95)18. For day to day cleaning purposes it is suggested that covers are cleaned using hot water and soap or neutral detergent, or chlorine releasing agents at a concentration of 1000 ppm. Covers can also be machine washed and tumble-dried at temperatures not exceeding 71oC. Do not use bleach, chlorine releasing agents in concentrations over 1000 ppm, solvents or alcohol-based cleansers, e.g. Phenicol. Hibiscrub, Clearsol, Stericol, Hycoline as these will destroy the mattress materials. Alcohol wipes may be used sparingly. Do not Autoclave. Mattress Components The individual cells can also be wiped clean with a mild antiseptic solution. Care should be taken to avoid puncturing these cells with sharp objects. All cells are replaceable and can be obtained easily from Talley Medical.

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6. Plug the smaller end of the power lead into the left hand side of the QUATTRO ACUTE™ power unit, and the other end into mains outlet in wall. Ensure that mains lead and tubing cannot become trapped in bed frame.

mattress hose connector anti-clockwise until black lines align, and pull mattress hose connector away. The mattress will remain inflated, so supporting the patient. The QUATTRO ACUTE™ mattress can be used on profiling bedframes. Back rests or pillows for support should be placed beneath the QUATTRO ACUTE™ mattress to allow uninterrupted body contact with the mattress surface. Place bottom sheet loosely on the mattress to allow the mattress surface greater contact with the patient’s body. Avoid using fitted sheets. The use of incontinence sheets may reduce the effect of the mattress. To remove air from the mattress when dismantling the system, use CPR facility as described above.

THERAPY MODE The QUATTRO ACUTE™ system features two therapy modes; ACTIVE (1 in 4 alternating air pressure cycle) and STATIC (for continuous low pressure therapy). Pressing the THERAPY MODE button will toggle between modes. The default mode is ACTIVE therapy. On switching to STATIC MODE, the system displays PLEASE WAIT and requires approximately 2 minutes to initialise. COMFORT CONTROL Allows adjustment of support pressure of mattress between soft and firm. The comfort control setting can be adjusted using the up and down arrow buttons [ACTIVE:- soft: 1 (14mmHg) - firm: 6 (35mmHg) / STATIC:- soft: 1 (10mmHg) - firm: 6 (32mmHg)]. The automatic default comfort setting (3) is suitable for patients with an average height to weight ratio (or Body Mass Index). However, if the patient's BMI is above or below average increase or decrease the comfort control setting according for a firmer or softer mattress.

MUTE Press to silence alarm and to clear alarm display from display screen. NB. After power failure / switching the power off, pressing MUTE cancels the systems previous settings. The default setting of ACTIVE mode is invoked. (Note that previous settings are automatically

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DATA Pressing the DATA button at any time switches the display into DATA mode. Use the up and down arrow buttons to scroll through the product data and user information set. Pressing the DATA button again returns the display to the previous mode. NB. Used for accessing information only, does not affect mode of operation.

User Guidelines

cancelled if the duration between switch off and switch on is greater than 12 seconds. If power returns before a period of 12 seconds has passed and the MUTE button has not been pressed, the system will return to the previous mode of operation.) MAX. INFLATE Necessary for some nursing procedures, the MAX INFLATE mode inflates the mattress to maximum static pressure (35mmHg) for a period of 15 minutes. When in either ACTIVE or STATIC mode press the MAX INFLATE button to inflate mattress. The system displays PLEASE WAIT followed by READY and a 5 second audible alarm when maximum pressure is achieved. After 15 minutes the system automatically returns to the previous mode of operation.

Pressure Setting/User Weight Guidelines The automatic default comfort setting (3) is suitable for patients with an average height to weight ratio (or Body Mass Index). However, if the patient's BMI is above or below average increase or decrease the comfort control setting according for a firmer or softer mattress. The comfort control setting can be adjusted using the up and down arrow buttons (soft: 1 - firm: 6). Check periodically to ensure patient support and comfort. As a guide, maximum user weight should not exceed 250kg (39 stone). If the patient is in a sitting position on the mattress, increase the comfor t control setting to setting 6 to prevent the patient from sinking through the mattress.

Fig. 1

Patient Transport Facility (Fig. 2) Press MAX. INFLATE button to fully inflate mattress. When maximum pressure is achieved, detach mattress air supply hose from power unit by rotating

Fig. 2

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CPR Facility (Fig. 1) For CPR, pull the red handle of the CPR device situated on the right hand side of the mattress (viewed from foot end). If re-inflating the mattress, make sure the CPR device is fully closed, i.e. the red CPR device is pushed together with no white plastic visible.