Trinity HR Dynamic User & Service Manual Ver 2.0 July 2003

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Table Of Contents TABLE OF CONTENTS... 2 MANUFACTURERS DECLARATION OF CONFORMITY... 3 EXPLANATION OF LABEL SYMBOLS AND STATEMENTS. ... 4 TG600 SYSTEM SAFETY INFORMATION ... 4 Classification ... 6 PORTABLE SEQUENTIAL CUSHION SYSTEM... 7 GENERAL INFORMATION... 7 REPAIRS ... 7 Specification... 8 Control Unit ... 8 Cushion ... 8 MAINTENANCE INFORMATION... 9 PRESSURE CONTROL... 9 PUMP MODULE ASSEMBLY ... 9 CYCLE CONTROL VALVE ... 9 ELECTRONIC CONTROL ... 9 CLEANING INSTRUCTIONS... 9 PUMP UNIT INDICATORS ... 10 BATTERY CHARGER POWER SUPPLY (99-01-50-18 / 1.000)... 11 CE, TUV, UL, CSA APPROVALS ... 11 CLEANING INSTRUCTIONS... 11 CHARGER 12V VEHICLE ADAPTOR (99-01-14-05 / 01.000) ... 11 BATTERY CAPSULE PACK (97-11-05-01 / 01.000) ... 12 Fitting the battery capsule pack. ... 12 Using the battery capsule pack. ... 12 Charging the battery capsule pack... 13 Charger operation ... 13 DEVICE OPERATION... 15 HR DYNAMIC CUSHION (99-01-11-34 / 01.000)... 16 CLEANING INSTRUCTIONS... 16 TG600 REFERENCE PHOTOS... 20 UK MAINS LEAD (15-08-20-09 / 01.000) ... 21 EUROPEAN MAINS LEAD (15-08-20-12 / 01.000) ... 21 NORTH AMERICA MAINS LEAD (15-08-20-11 / 01.000) ... 22 AUSTRALIA MAINS LEAD (15-08-20-13 / 01.000) ... 22 TG600 ISOMETRIC DRAWING ... 23 TG600 SPARES LIST ... 23 CIRCUIT CARD DIAGRAM... 25 TG600 CIRCUIT DIAGRAM... 26 TG600 PNEUMATIC DIAGRAM ... 27 USER NOTES... 28

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Manufacturers Declaration of Conformity

PRODUCT IDENTIFICATION PRODUCT:TYPE:-

MOBILE SEATING SYSTEMS PRESSURE RELIEF DEVICE

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

UL, BTTG

Standards:

UL544, C22.2, BS 5852 pt2., BS 7177, BS EN 597-1, BS EN 597-2, BS 7175, ISO 3795

Test Report No:

E79531, 2/2794, 2/10087/1, 2/10087/2 2/9930/1,2,3,4

Manufacturer:

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

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Explanation of Label Symbols and Statements

ATTENTION Consult accompanying documents

Medical Devices Directive 93/42/EEC

Electrical Protection Type B

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.

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TG600 System Safety Information CAUTION: • Before plugging the power unit into the mains supply, check that the voltage supply is the same as that indicated on the power unit. •

Use of an attachment not recommended or sold by the power unit manufacturer may result in a risk of fire, electric shock, or injury to persons.

•

To reduce risk of damage to electric plugs and cord, pull by plug rather than cord when disconnecting from power or unit.

•

Make sure cord is located so that it will not be stepped on, tripped over, or otherwise subjected to stress.

•

Do not use an extension cord.

•

Do not operate power unit with damaged cord or plugs - replace them immediately.

•

Do not operate power unit if it has received a sharp blow, been dropped, or otherwise damaged in any way; take it to a qualified serviceman.

•

Do not disassemble power unit; take it to a qualified serviceman when service or repair is required. Incorrect re-assembly may result in a risk of electric shock or fire.

•

To reduce the risk of electric shock , unplug power unit from outlet before attempting any maintenance or cleaning. Turning off controls will not reduce the risk

NOTE: DANGER Risk of explosion if used in the presence of flammable anaesthetics. CAUTION To reduce risk of electric shock do not disassemble case. No user serviceable parts inside. Refer servicing to qualified personnel. When servicing use only identical replacement parts. WARNING Mains adaptor must be earthed.

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Classification Class 1 medical device in accordance with the Council Directive 93/42/EEC. Protection type against electric shock : Class 1 equipment in accordance with EN 60601-1, 2nd edition. Protection degree against electric shock ; Type B equipment in accordance with EM 60601-1, 2nd edition. Class B equipment in accordance with EN 55011.

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Portable Sequential Cushion System The TRINITY H.R. DYNAMIC™ mobile sequential cushion system is designed to help prevent the onset of pressure ulcers in home or hospital bound seated patients. This is achieved by means of a battery operated air pump unit inflating a cushion containing 4 rows of air cells, which are sequentially deflated automatically to provide relief. This allows a distribution of weight and a dynamic movement to reduce high interface pressures concentrating in specific points. The TRINITY H.R. DYNAMIC™ mobile sequential cushion inflation pressure is fully adjustable, monitored by the pump module, giving an audio and visual warning should the pressure drop below the alarm level. The alarm module gives an audio and visual alarm, should the pump unit stop cycling, and on a low battery condition.

General Information The TRINITY H.R. DYNAMIC™ mobile sequential cushion system consists of the following:TG600 MOBILE PUMP UNIT... ………. . Part No. 99-01-06-32 / 01.000 (REFER TO FIG 1 PAGE 16) TRINITY HR DYNAMIC CUSHION...Part No. 99-01-11-34 / 01.000 (REFER TO FIG 2 PAGE 16) BATTERY CAPSULE ASSEMBLY... …… . . ...Part No. 97-11-05-01 / 01.000 (REFER TO FIG 3 PAGE 16) 15V, 2A SWITCH MODE POWER SUPPLY... Part No. 99-01-50-18 / 01.000 (REFER TO FIG 4 PAGE 16) CHARGER 12V VEHCLE ADAPTOR... Part No. 99-01-14-05 / 01.000 (REFER TO FIG 5 PAGE 16) MAINS LEAD... ……………………………Part No. Depending on Country (REFER TO FIG 6,7,8 & 9 PAGES 17-18)

Repairs It is strongly recommended that for all repairs items be returned to TALLEY GROUP LIMITED or an AUTHORISED agent ONLY.

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Specification Control Unit Model Ref ……………………… TG600 MOBILE PUMP UNIT Construction ……………………… ABS Plastic Dimensions ………………………..205 x 205 x 84mm Weight ……………………………..1.5 kgm Pressure Range ………………… 30-100mmHg Segment Time (Auto Variable) … 72-138 seconds (Initialisation 8 x 138 Max) Noise Level ……………………… 45-50 dBA

Mains Adaptor / Charging Unit Output Voltage…………………….15V Output Current…………………….2A Mains Input Voltage………………100-240V 50/60Hz Dimensions………………………..110 x 60 x 33mm

Cushion Model Ref ………………………… TRINITY HR DYNAMIC™ cushion Construction………………………..PU coated stretch nylon cover, PU air cells, profiled CMHR foam Dimensions…………………………450mm x 430mm x 80mm Weight………………………………1.5kg Type…………………………………4 rows of air cells in a 1-in-4 alternating air pressure cycle (REFER TO PAGE 15 & 16)

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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Maintenance Information This unit should be handled as you would any piece of fine equipment to ensure trouble-free use over long periods.

Pressure Control Air pressure in the cushion is controlled by the comfort selector knob.

Pump Module Assembly Low voltage vibrator device utilising variable frequency computer controlled drive.

Cycle Control Valve This controls the sequential cycle by deflating each of the four rows of cells in sequence. Operated by electronic controlled system.

Electronic Control The circuit board monitors air pressure, cycle control valve, pump, rotor conditions and battery voltage. It controls pump, cycle control valve and generates fault alarms via on board sounder and the fault indicator lamps on the case top.

Cleaning Instructions Portable Sequential Pump Module:- Clean with a dry cloth ONLY. CAUTION:- DO NOT IMMERSE IN WATER. ALL MAINTENANCE SHOULD BE CARRIED OUT BY A COMPETENT ELECTRICIAN.

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Pump Unit Indicators The indicator system provides an audio warning and visual means of indication under the following conditions:Normal Operation. The Green power LED is illuminated, the red fault LED’s and sounder are off if there are no active alarm conditions. Low battery voltage warning. Green LED lights 1 second on 1 second off. Sounder  second on and 5 seconds off. Repeated until unit switched off. Operates when battery voltage drops to 5.95 volts. Recharge battery! Rotation fault alarm. Red rotation fault LED illuminated continuously. Sounder on for one second, off for one second. Repeated until unit switched off. Operated if the cycle control valve system fails to operate, refer to trained personnel. Low pressure fault alarm. Red low-pressure fault LED illuminated continuously. Sounder on for one second, off for one second. Repeated until unit switched off. If this fault is displayed check for loose air connections, holes in cells or tubing, then refer to trained personnel. Motor over-current alarm. Red rotation fault LED and sounder are activated alternatively for 1 second on, 1 second off, repeated until unit switched off. Operated if the rotation motor or drive circuit draws excessive current. Refer to trained personnel. Pump over-current alarm. Red low-pressure fault LED and sounder are activated alternatively for 1 second on, 1 second off, repeated until unit switched off. Operated if the pump or drive circuit draws excessive current. Refer to trained personnel. Switch off to clear any alarm condition. Pump shutdown indication. When ever the pump unit stops operating, ether by pressing the start/stop key or due to battery exhausted condition, A distinctive warning of the sounder operating three times with both fault indicators momentarily illuminating. Note: the indicator lamps and sounder are all operated when the pump unit is started to verify their continued operation.

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Battery Charger Power Supply (99-01-50-18 / 1.000) This is a fixed voltage, switch mode, regulated power supply. The output is short circuit protected with automatic thermal and overload recovery. The regulated output ensures a constant DC supply with minimal ripple. Output is via a flying lead with a 2.1mm DC plug. Mains input for all models is via an IEC connector. CE, TUV, UL, CSA APPROVALS Output Voltage :15V Output Current :2A Mains Input voltage :100-240V 50/60Hz. Dimensions :110 x 60 x 33mm (REFER TO FIG 4 PAGE 16) CLEANING INSTRUCTIONS Disconnect from electricity supply and clean with a dry cloth ONLY. CAUTION:- DO NOT IMMERSE IN WATER. THE BATTERY CHARGER IS A NON SERVICEABLE ITEM. DO NOT APPLY PORTABLE APPLIANCE TEST

Charger 12V Vehicle Adaptor (99-01-14-05 / 01.000) This is a fused adaptor used to supply 12V to the battery for charging from a standard vehicle cigar lighter outlet. The indicator on the adaptor vehicle plug will illuminate when power is available at the socket, remember some vehicles require the ignition to be switched on before power is available at the socket. (REFER TO FIG 5 PAGE 16)

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Battery Capsule Pack (97-11-05-01 / 01.000) The battery capsule pack consists of a 6Volt NiMH 2.1AH cell pack with Integral Charge Controller with charger status indicator. The battery capsule pack is a sealed unit and other than charging does not require maintenance. The operation and the lifetime of the battery are greatly affected by how you handle the battery capsule pack. Take good care of the battery pack and follow the guidelines presented below. Fitting the Battery Capsule Pack The battery capsule pack slides into the pump case as indicated and locks into position, note the pack can only fit one way. To release the battery capsule pack depress the release button adjacent to the battery capsule pack, the pack will pop up allowing easy withdrawal. Using the Battery Capsule Pack A new battery's full performance is achieved only after two or three complete charge and discharge cycles. The battery capsule pack can be charged out of the pump unit, in the pump unit and with reduced capacity, whilst the pump is operating. The mains power pack and vehicle adaptor will allow recharging of the battery capsule pack whilst the pump is operating but they can not permanently power the pump unit, as after charging the battery the charger does not operate once the green charged lamp is illuminated, all power is drawn from the battery even if the charger power supply is still connected. The charger power supply would require to be disconnected and reconnected or switched off and on again to start a new charge cycle. Note the sensitivity of the charger control to voltage fluctuations will normally terminate the fast charge prematurely if the pump is operating. Use only the mains power pack and vehicle adaptor supplied with the system, the battery capsule pack requires a 3Amp fused supply of 12 to 16 Volt DC. The battery capsule pack can be charged and discharged up to 500 times but will eventually loose capacity. When pump operation times are noticeably shorter than normal, it is time to replace the battery capsule pack. For best operation times completely discharge the battery from time to time by leaving the power unit running until it turns itself off. Do not attempt to discharge the battery capsule pack by any other means.

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If left unused a fully charged battery will discharge itself over time. Do not leave the battery in the pump if not being used. Recharge the battery capsule pack prior to storage and repeat the recharge every six months, preferably with a full discharge before charge as indicated above. Temperature extremes will affect the ability of your battery pack to charge, the status indicator will continue to flash red until the correct temperature is reached. It is best to allow the battery capsule pack to cool down or warm up first. Use the battery capsule pack only for its intended purpose. Never use any battery capsule pack which is damaged or worn out. The battery capsule pack is short circuit protected but may damage the connecting object. Accidental short circuiting can occur when a metal object (coin, clip or pen) causes direct connection of the + and - terminals of the battery pack (metal strips visible through the back of the battery capsule pack) for example when you carry a spare battery in your pocket or purse. If the battery does become short circuited the internal resettable fuse will reconnect the circuit after about 30 seconds. Leaving the battery in hot or cold places, such as in a closed car in summer or winter conditions, will reduce the capacity and lifetime of the battery pack. Always try to keep the battery between 15°C and 25°C (59°F and 77°F) especially when charging. When Discharging the capacity will be limited at temperatures above 45°C (113°F).and below -10°C (14°F). Do not dispose of the battery pack in a fire, or in municipal waste. They should be recycled, disposed of properly or returned to TALLEY GROUP LTD for disposal. Charging the Battery Capsule Pack For mains operation connect the 2.1mm plug into the socket on the top of the battery capsule pack. Connect the mains power pack to an AC wall outlet and switch on. Note the mains cord is fitted to the power pack via an IEC connector. The power pack green indicator will illuminate. For operation with the vehicle adaptor connect the 2.1mm plug into the socket on the top of the battery capsule pack. Connect the vehicle plug to a 12v accessory (cigar lighter) outlet, note that the ignition may be required to be switched on before the adaptor will operate, the indicator on the plug will illuminate if power is available. Charger Operation The battery capsule pack internal charge controller looks after all aspects of charging the battery capsule pack, The status indicator on the top of the battery capsule pack adjacent to the charge socket indicates the current operation to the user.

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When power is applied to the charge socket the status indicator will flash red until conditions are suitable for fast charge to commence. During this time a low level charge is applied if the battery voltage is too low, or temperature conditions are inappropriate for fast charging whereupon the system will wait until the temperature returns to a suitable value. Status indicator will be continuously red while fast charging is in progress. This operation will normally give the bulk of the charge to the battery. It is terminated by a number of conditions dictated by monitoring battery cell temperature and voltage changes. Termination will normally occur when the battery is fully bulk charged, but will also terminate if abnormal conditions occur for safety, such as unsuitable cell temperature or voltage. The system next enters a charge top off phase with an amber indicator (red and green indicated simultaneously). A standard charge rate is applied for up to 3 hours to maximise battery capacity as the temperature falls after the fast charge. The fully charged status is indicated by the Green indicator. The battery capsule pack may safely be left connected to the charger indefinitely as during the charged indicator state a very low trickle charge is applied to offset the battery self discharge. The charge may be terminated during the top off phase (amber indicated) without great loss of battery capacity if the pack is required quickly. Battery capsule will become warm during fast charging. The battery does not have to be fully discharged before recharge, as the charger system will safely fill used capacity. It should be noted however that repeated partial recharging will inevitably reduce the net battery capacity to that which is being used as the unused capacity will degrade. Therefore you should fully discharge the battery pack from time to time by allowing the pump unit to run until it switches itself off, having exhausted the battery capsule pack, no other method of discharge should be attempted. If the charge period appears occasionally abnormally short this may be due to random chemical effects causing the charger to terminate prematurely. It is best to discharge the battery a short period and then recharge again. This may occur especially at high or low temperatures. If the battery pack system fails this is normally indicated by the status indicator flashing red indefinitely. The pack is not serviceable and should be replaced. If the mains power pack or vehicle adaptor fails to give an output the battery capsule pack indicator will not illuminate at all. Note that the mains power pack is not serviceable but the vehicle adaptor does include a 3Amp fuse in the vehicle plug. (REFER TO FIG 3 PAGE 16) 50-50-15-02 V2 Page 14 TRINITY HR DYNAMIC™ SEATING SYSTEM USER & SERVICE MANUAL

Device Operation 1. Clip in Battery Capsule Pack. 2. Switch on unit 3. Pump unit will undertake a short lamp and sounder test at start-up (3 lamps will indicate and sounder will operate). 4. Next green light will come on and pump will start. 5. Set comfort setting as required. 6. To stop press the stop button (Sounder operate three times and both fault lamps will operate momentarily). 7. Note the Stop button is only operative after the initial lamp and sounder test (green lamp is illuminated). The pump unit will operate for many hours with a fully charged battery pack and will give an indication of low battery level when the associated warning alarm is issued, The green lamp will flash on and off and the sounder will operate every 5 seconds. The battery will exhaust after a period and the pump unit will shut down. The length of time the pump will operate after the low battery warning starts is dependant on many variables of settings and battery cell conditions but the unit is intended to run for about 1 hour but this is impossible to guarantee and some may run a great deal longer. The user should undertake to check how long their particular battery lasts after the warning starts. Note every battery may be different. Note that if the system appears to run the battery down more rapidly or the pump is operating for longer periods than normal and the inflation cycle slows there may be a slow leak or poor seal in the air system. As no low pressure alarm is issued the system is quite safe to use but should be serviced promptly to regain maximum efficiency from the system. The normal inflation cycle is about 10 minutes long consisting of eight periods of 72 seconds minimum, but the segment times may extent to 136 seconds each if the required air pressures are not achieved sooner. Longer period times are a good indicator that imperfect seals have occurred with time. If a major leak occurs or the pump fails then the low pressure alarm will operate. All systems faults that may give rise to potential risk will issue an alarm with a sounder on and off at 1 second intervals. If this occurs seek prompt maintenance.

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Trinity HR Dynamic™ Cushion (99-01-11-34 / 01.000) DESCRIPTION

PART NUMBER

HR DYNAMIC CELL ASSEMBLY

97-06-12-37 / 01.000 (REFER TO FIG 2A PAGE 16)

NET COVER ASSEMBLY (INTERLINER)

97-09-16-01 / 01.000 (REFER TO FIG 2B PAGE 16)

HR DYNAMIC, TEAL BLUE COVER ASSY

97-09-16-04 / 01.000 (REFER TO FIG 2C PAGE 16)

TRIPPLE CHOICE PROFILED CUSHION FOAM 97-06-04-25 / 01.000 (REFER TO FIG 2D PAGE 16) 5-WAY TUBE, CPC, GREY REFLEX ASSEMBLY 97-20-02-20 / 01.001 (REFER TO FIG 2E PAGE 16)

Cleaning Instructions 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 mattress materials. Alcohol wipes may be used sparingly. Do not Autoclave. Cushion Components The individual air 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.

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Cushion Installation NB. If using on a wheelchair, it is recommended that an anti-sag pad is placed under your TRINITY HR DYNAMIC™ cushion to maximise its performance. 1. Remove all packaging from the cushion and power unit. Ensure cover and interliner are fitted correctly to cushion. Zip should be to the rear, with the shaped side of the cushion facing upwards. 2. Place the cushion on the chair as far back as possible, ensuring that the cushion is placed the correct way up and the FRONT label forward most in the chair. NB. Check that footrests and armrests (if fitted) are correctly re-adjusted. Check patient is still correctly supported by the backrest. CAUTION: The patient may now be in an unstable condition if arm or backrest is too low. 3. Suspend pump unit from chair in a convenient position, using pouch provided or optional seat suspension holder. CAUTION: Do not allow the power unit to impair the use of the chair or to compromise its safety by obscuring brake levers etc. 4. Fitting the Battery Pack - The battery pack slides into the pump case as indicated and locks into position (note the pack can only fit one way). To release, depress the release button adjacent to the battery pack. The pack will pop up allowing easy withdrawal. Only use with TG660 battery. 5. Connect cushion hose socket to pump outlet plug by lining up the alignment slot on the hose socket with the pump plug rib projection. Press together firmly until the green button springs out. To remove press green button on hose connector and pull apart. (Fig.1) FIG 1

6. Rotate pressure selector knob to recommended pressure - this will vary according to patient's weight - see Pressure Adjustment Guidelines (Page 18). 50-50-15-02 V2 Page 17 TRINITY HR DYNAMIC™ SEATING SYSTEM USER & SERVICE MANUAL

7. Switch on pump by pressing on/off button, alarm sounder will 'beep' once. To switch off, press on/off button for a second time. Alarm sounder will 'beep' three times. 8. To recharge battery, connect charger plug to charging socket on battery as indicated. Battery will fully charge in 5 hours, and may be charged while in use, or removed from unit. Battery will need charging when green power light starts to flash.

The pump is designed to include fault diagnostics. In the event of there being a fault, an audible alarm will sound and the fault indicator lamp will illuminate to the colour representing the type of fault. If any fault shows, refer to Pump Unit Indicators on page 9.

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Cushion Pressure Adjustment Guidelines Patients Weight

Pressure

Up to 44 Kgs

65 mmHg

45 to 64 Kgs

80 mmHg

65 to 84 Kgs

90 mmHg

85 to 100 Kgs

100 mmHg

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