User Manual
10 Pages
Preview
Page 1
EXPLANATION OF LABEL SYMBOLS AND STATEMENTS
ATTENTION Consult accompanying documents
Medical Devices Directive 93/42/EEC
Electrical Protection Type B
Class
Deep Cell Prime Mattress Replacement System ™
Equipment (Double Insulated)
This is a functional earth and not a protective earth
WARNING
CAUTION
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 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 50-02-13-100/3
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] Web: www.talleymedical.com
User Manual
Notes
Notes
Contents
PAGE 16
Page INTRODUCTION
2
CAUTION INFORMATION
3
LIST OF COMPONENTS
4
INSTALLATION
5
USER GUIDELINES
8
CARE AND MAINTENANCE
9
FAULT FINDING
11
WEIGHT CONVERSION TABLE
12
SPECIFICATION
13
MANUFACTURER’S DECLARATION OF CONFORMITY
14
Introduction
Notes
Thank you for choosing to use the Talley Medical DEEP CELL PRIME™ 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. 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 DEEP CELL PRIME™ 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 DEEP CELL PRIME™ system has a patient transport facility should the patient need to be moved whilst on the inflated mattress.
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The DEEP CELL PRIME™ 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.
Manufacturer’s Declaration of Conformity
Caution
Before using this product ensure that: PRODUCT IDENTIFICATION PRODUCT:DEEP CELL PRIME 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 7177
Test Report No:
4621/01 12511/1/STC004
Manufacturer:
Talley Group Limited, Premier Way, Abbey Park Industrial Estate, Romsey, Hampshire, SO51 9AQ, UK
O the electricity supply is of the type indicated on the power unit. 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 DEEP CELL PRIME™ 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.
Contraindications for 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
Specification
Your Talley Medical DEEP CELL PRIME™ system should comprise the following items - please ensure you have all of these before installation.
Pump Unit Construction: Dimensions: Weight: Mains Cable: Electricity Supply: Full Load Wattage: Fuse Rating: Cycle Time:
O DEEP CELL PRIME™ power unit. O Separate mains power lead. O DEEP CELL PRIME™ mattress replacement.
ABS Plastic 325mm x 165mm x 233mm 3.4kg 5 metres 230V +/- 10% 50Hz 18W 500mA 30 minutes
O Mattress air supply hose set. Other voltages available. O Mattress replacement top cover (supplied attached to mattress). O System carry bag.
Mattress Construction: Dimensions: Weight: Type:
PU coated nylon base, PU coated stretch nylon cover, polyurethane cells 1980mm x 880mm x 240mm (inflatable support area) 12.0kg 27 Deep Cells in mattress replacement configuration operating in a 1-in-4 alternating air pressure cycle
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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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Talley Medical products are manufactured to comply with BSI, IEC, UL, CSA and other European safety standards.
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(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
Installation
How to install and set up your Talley Medical DEEP CELL PRIME™ system. 1. Ensure bed frame to be used has no existing mattress components, and is free from items which could cause damage to the DEEP CELL PRIME™ mattress. It should be noted that this system is intended to completely replace existing mattresses.
Fig. 1
2. Place the DEEP CELL PRIME™ mattress on the bed frame with the air inlet connectors on the right hand side and the turquoise 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 injury to the patient. 4. Suspend the DEEP CELL PRIME™ 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. 5. Attach air supply hose plate to power unit using clamp handle as described on the power unit’s labelling (Fig. 2).
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WEIGHT CONVERSION TABLE - stone and lbs to kgs
Fault Finding
6. Attach the five male connectors at the end of the air supply hose to the five air inlet female connectors situated towards the foot end of the right hand side of the mattress, ensuring the colour coded connectors are matched. Push on connectors until they click into place (Fig. 3).
The DEEP CELL PRIME™ 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. Fig. 2
Fig. 3
7. Plug the smaller end of the power lead into the left hand side of the DEEP CELL PRIME™ power unit, and the other end into mains outlet in wall.
Low Pressure Alarm – If this alarm sounds, the pressure within the system is insufficient for correct operation. Check that hose is connected to mattress and pump correctly. Check that internal cell connections are correct and that no cell is punctured. Reset by pressing RESET button twice. If problem reoccurs, contact Talley Medical.
Ensure that mains lead and tubing cannot become trapped in bed frame.
9. Set the pressure selection on the front of the DEEP CELL PRIME™ power unit to the position required according to the patient’s weight. A chart for this purpose is situated next to the pressure selector. The pressure setting guidelines indicated on the power unit assume that the patient has an average height to weight ratio (or Body Mass Index). However if the patient’s height to weight ratio is above or below average, increase or decrease the pressure setting accordingly. The mattress will take approximately 20 minutes to inflate.
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.
If you have any queries relating to this system please call our 24 Hour Helpline on 0845 7585301.
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8. Switch the power on at outlet, and at side of power unit adjacent to power lead entry.
Power Unit Always disconnect the power unit from the electricity supply before cleaning. The DEEP CELL PRIME™ power unit can be wiped down with a damp cloth or alcohol wipe. Do not use solvents.
10. 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. 11. Allow mattress to partly inflate before positioning patient on mattress.
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.
12. Place the carry bag and user manual in a safe place for future use.
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.
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O assistance is given to Talley Medical personnel to bag the equipment if the mattress has been in a known or suspected infectious environment.
User Guidelines
Care and Maintenance
Pressure Setting/User Weight Guidelines The pressure setting guidelines indicated on the power unit assume that the patient has an average height to weight ratio (or Body Mass Index). However if the patient’s height to weight ratio is above or below average, increase or decrease the pressure setting accordingly. As a guide, maximum user weight should not exceed 250kg (39 stone). Check pressure setting periodically.
The DEEP CELL PRIME™ system will provide years of efficient service if it is cared for in the following way:
The DEEP CELL PRIME™ mattress can be used on profiling bedframes. Back rests or pillows for support should be placed beneath the DEEP CELL PRIME™ 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.
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Fig. 1
Patient Transport Facility (Fig. 1) Detach hose from mattress by simply pressing the darker grey CPC buttons on the five connectors to disconnect each one and pull hose away. The mattress will remain inflated, so supporting the patient.
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. Do not immerse the mattress in water, unless air supply hose set has been disconnected, as fluid may enter the air cells or tubing.
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If the patient is in a sitting position on the mattress, increase the pressure to the maximum setting to prevent the patient from sinking through the mattress.
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.