B.A.S.E. Alternating Cushion User Manual PART NUMBER 50-02-20-100-2

Contents

Page INTRODUCTION

3

CAUTION INFORMATION

4

LIST OF COMPONENTS

5

INSTALLATION

6

USER GUIDELINES

7

CARE AND MAINTENANCE

8

FAULT FINDING

10

WEIGHT CONVERSION TABLE

11

SPECIFICATION

12

MANUFACTURER’S DECLARATION OF CONFORMITY

13

NOTES

14

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Introduction Thank you for choosing to use the Talley Medical B.A.S.E.™ ALTERNATING cushion system. In doing so you have selected an effective product for the prevention and management of pressure ulcers for patients at high risk. The B.A.S.E.™ ALTERNATING cushion is constructed from rows of air filled bellows, incorporated in a foam support to prevent lateral deflection, which adapt to the body’s contours and feature a 1-in-2 alternating pressure cycle for pressure relief. The B.A.S.E.™ ALTERNATING cushion is operated by the advanced micro-processor controlled DUOCARE™ pump which features adjustable patient comfort control and visual and audible operation status and fault indicators. The B.A.S.E.™ ALTERNATING cushion can also be used with the DUOCARE™ mattress overlay system to provide 24 hour pressure relief. The B.A.S.E.™ ALTERNATING cushion 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.

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Caution Before using this product ensure that: l

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

l

the mains lead is free from damage and is positioned so as not to cause an obstruction.

l

the system is not used in the presence of flammable anaesthetics.

Do not place cushion 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 B.A.S.E.™ ALTERNATING cushion system 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. It should be noted that the use of the B.A.S.E.™ ALTERNATING cushion will increase the patient’s seated height by approximately 5cm, and care should be taken to ensure the patient’s comfort and security regarding height of foot and arm rests. The system is used as part of a pressure ulcer prevention programme, not solely relied upon for this purpose. Alternating pressure therapy should not be used for patients with unstable fractures, gross oedema, burns or an intolerance to motion. The equipment conforms to IEC 60601-1-2 for electromagnetic interference, however should the equipment be subjected to electromagnetic interference outside this then the unit should be reset.

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List of Components Your Talley Medical B.A.S.E.™ ALTERNATING cushion system should comprise the following items - please ensure you have all of these before installation. l DUOCARE™ power unit l Separate mains power lead l B.A.S.E.™ ALTERNATING TS204 cushion

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Cushion Installation 1. Remove all packaging from the cushion and power unit. 2. Place the cushion on the chair, ensuring that the cushion is placed the correct way up and the FRONT label forward most in the chair. 3. Attach air supply hoses from cushion to power unit by pairing male and female CPC connectors on hoses and on right hand side of power unit and push together until they click into place, as described on the power unit's labelling (see fig. 1). 4. Plug the smaller end of the power lead into the left hand side of the DUOCARE™ power unit, and the other end into mains outlet in wall.

Fig. 1

5. Switch the power on at outlet, and at side of power unit adjacent to power lead entry. 6. Set the pressure selector on the front of the power unit to maximum position. 7. The cushion will now take approximately 10 minutes to fully inflate.

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User Guidelines Pressure Setting/User Weight Guidelines The pressure setting on the DUOCARE™ power unit should be set to maximum when using with the B.A.S.E.™ ALTERNATING cushion, but may be decreased slightly for comfort. Check pressure setting periodically. As a guide, maximum user weight should not exceed 102kg (16 stone). It should be noted that the use of the B.A.S.E.™ ALTERNATING cushion will increase the patient’s seated height by approximately 5cm, and care should be taken to ensure the patient’s comfort and security regarding height of foot and arm rests. If using the B.A.S.E.™ ALTERNATING cushion in conjunction with the DUOCARE mattress overlay system, after disconnecting mattress from power unit prior to connecting cushion, join mattress tubes together to seal air within mattress. The mattress will remain inflated whilst the power unit is operating the cushion and will be ready for immediate use once re-connected to the power unit.

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Care and Maintenance The B.A.S.E.™ ALTERNATING cushion system will provide years of efficient service if it is cared for in the following way: Cover Always keep the cushion 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 71°C. 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 cover materials. Alcohol wipes may be used sparingly. Do not Autoclave. Cushion Components The individual bellow 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. Do not immerse the foam section in water. Power Unit Always disconnect the power unit from the electricity supply before cleaning. The DUOCARE™ power unit can be wiped down with a damp cloth or alcohol wipe. Do not use solvents.

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The power unit contains no user serviceable 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: l the system is cleaned of any obvious contaminants. l

contamination status is documented as per the NHS Guidelines HSG(93)26.

l

assistance is given to Talley Medical personnel to bag the equipment if it has been in a known or suspected infectious environment.

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Fault Finding The DUOCARE™ power unit has several alarm systems to warn of possible malfunction. All alarms can be reset by pressing the reset button twice, or silenced by pressing once. Mains Failure Alarm - this will sound when the power is interrupted by either a power cut, mains lead disconnection or the power switch is turned off. Reset by pressing the reset button at the front of the unit adjacent to the pressure control or alternatively re-connect to power supply. Low Pressure Alarm - if this alarm sounds, the pressure within the system is insufficient for correct operation. Check that hose is connected to cushion and pump correctly. Check that internal cell connections are correct and that no bellow cell is punctured. Reset by pressing reset button twice. If problem reoccurs, contact Talley Medical. System Fault Alarm - this alarm indicates an electronics fault with the microprocessor controlled air pressure regulator. Reset by pressing reset button twice. If alarm persists, contact Talley Medical. Cycle Fault Alarm - a warning that the automatic sequential cycle has stopped. Reset by pressing reset button twice. If alarm persists, contact Talley Medical. Cycle Fault and Low Pressure Alarms - shown together indicates internal pump fault. Reset by pressing reset button twice. If alarm persists, contact Talley Medical. Cycle Fault and System Fault Alarms - shown together indicates pump control failure. Reset by pressing reset button twice. If alarm persists, contact Talley Medical. Low Pressure and System Fault Alarms - shown together indicates mains power irregularity. Reset by pressing reset button twice. If alarm persists, contact Talley Medical. If you have any queries relating to this system please call our 24 Hour Helpline on 0845 7585301.

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WEIGHT CONVERSION TABLE - Stone & lbs to kgs (Conversions are correct to the nearest 0.1kg (100gm); i.e. approx. 3oz.)

Stone lbs 5 0 5 2 5 4 5 6 5 8 5 10 5 12 6 0 6 2 6 4 6 6 6 8 6 10 6 12 7 0 7 2 7 4 7 6 7 8 7 10 7 12 8 0 8 2 8 4 8 6 8 8 8 10 8 12 9 0 9 2 9 4 9 6 9 8 9 10 9 12 10 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 11

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

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 12W 500mA 10 minutes

Other voltages available. Cushion Construction: Dimensions: Weight: Type:

PU coated stretch nylon cover, PVC bellow cells, CMHR foam 430mm x 430mm x 70mm 1.9kg 8 rows of 6 bellow cell strips in a 1-in-2 alternating air pressure cycle

Talley Medical products are manufactured to comply with BSI, IEC, UL, CSA and other European safety standards. Talley Medical design and manufacture products to ISO9001, EN46001 and ISO13485 standards, and comply with Medical Directive (93/42/EEC). 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.

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Manufacturer’s Declaration of Conformity PRODUCT IDENTIFICATION PRODUCT:B.A.S.E. ALTERNATING CUSHION SYSTEM TYPE:PRESSURE RELIEF DEVICE DECLARATION To our knowledge the product conforms with Directive 93/42/EEC for medical equipment. Tested by:

EMC PROJECTS LTD, BTTG

Standards:

EN 60601-1-2:1993 FCC CFR Part 15B Section 15.107 & 15.109 BS 7175, ISO 3795, BS 5852

Test Report No:

4621/01

Manufacturer:

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

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Notes

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EXPLANATION OF LABEL SYMBOLS AND STATEMENTS ATTENTION Consult accompanying documents

Medical Devices Directive 93/42/EEC Class II Equipment (Double Insulated)

Electrical Protection Type B This is a functional earth and not a protective earth

WARNING

This is a statement that alerts the user to the possibility of serious injury or other adverse reactions with the use or misuse of the device

CAUTION

This is a statement that alerts the user to the possibility of a problem with the system associated with its use or misuse Set to maximum pressure setting when patient is in a sitting position

USER MANUAL PART NUMBER 50-02-20-100/2

TALLEY GROUP LIMITED Premier Way, Abbey Park Industrial Estate, Romsey, Hampshire SO51 9AQ England Tel: (0)1794 503500 Fax: (0)1794 503555 e-mail: [email protected] 15 Web: www.talleymedical.com