FISHER PAYKEL SleepStyle™ 200 Series Humidified CPAP System User Manual

SleepStyle™ 200 Series Humidified CPAP System

Operating Manual

SECTION

English………………………………………………………….. A

Français…………………………………………………………. B

Español………………………………………………………….. C

PACKAGE CONTENTS A
B

2 x

1 x

1 x

1 x

1 x

1 x 1 x 1 x

English

SleepStyleTM 200 Series
HUMIDIFIED CPAP SYSTEMS
The SleepStyleTM 200 Series are a range of CPAP systems designed for use in the home for the treatment of OSA. For further assistance, please contact your local F&P office ­ see reverse for addresses. Please keep this manual for future reference.
TABLE OF CONTENTS
1. Symbol Definitions ………………………………………………………………………………………………………………………………………………. A – 2 2. Warnings …………………………………………………………………………………………………………………………………………………………….. A – 2 3. Oxygen Use Warnings …………………………………………………………………………………………………………………………………………. A – 2 4. Intended Use ………………………………………………………………………………………………………………………………………………………. A – 2 5. Description of the device …………………………………………………………………………………………………………………………………….. A – 3
5.1 Important Parts of Your Device – Standard CPAP Range ………………………………………………………………………………….. A – 3 5.2 Important Parts of Your Device – Integrated CPAP Range ………………………………………………………………………………… A – 3 5.3 Accessories ……………………………………………………………………………………………………………………………………………………. A – 3 6. Cleaning & Maintenance ……………………………………………………………………………………………………………………………………… A – 4 7. Setup Instructions ……………………………………………………………………………………………………………………………………………….. A – 4 8. Controls and Display – Integrated CPAP Range …………………………………………………………………………………………………….. A – 5 8.1 Display Descriptions and Functions ………………………………………………………………………………………………………………… A – 5 8.2 Patient Menu Summary – Integrated CPAP Range …………………………………………………………………………………………… A – 6 8.3 Patient Menu – Additional Settings Summary – Integrated CPAP Range …………………………………………………………… A – 6 9. Controls and Display – Standard CPAP Range ……………………………………………………………………………………………………… A – 7 9.1 Display Descriptions and Functions ………………………………………………………………………………………………………………… A – 7 9.2 Patient Menu Summary – Standard CPAP Range ……………………………………………………………………………………………… A – 8 9.3 Patient Menu – Additional Settings Summary – Standard CPAP Range …………………………………………………………….. A – 8 10. Frequently Asked Questions ………………………………………………………………………………………………………………………………… A – 9 11. Product Specifications …………………………………………………………………………………………………………………………………………. A – 9 12. Operating Conditions ………………………………………………………………………………………………………………………………………….. A – 10 13. Storage and Transport Conditions ……………………………………………………………………………………………………………………….. A – 10 14. Troubleshooting ………………………………………………………………………………………………………………………………………………….. A – 10 15. Appendix ……………………………………………………………………………………………………………………………………………………………. A – 10
PLEASE READ ALL INSTRUCTIONS BEFORE INITIAL USE Caution: USA Federal Law restricts this device for sale by or on the order of a physician.
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1. SYMBOL DEFINITIONS

TypeBF

ATTENTION

AppliedPart

Consult

accompanying

documents
2. WARNINGS

DripProof

Alternating Current

Classll DoubleInsulated

Standbyor On/Off

93/42/EEC ClassIIb

PLEASENOTE:-ThismanualreferstotheSleepStyleTM 200 Series

CPAPunitas”thedevice”.

1. The device should only be used with masks, connectors

and delivery tubes recommended by Fisher & Paykel

Healthcare, or by your physician or respiratory therapist.

2. Never operate the device if:

a) it has a damaged power cord or plug, b) the tube has

been damaged with holes, tears or kinks, c) it has been

dropped or damaged, d) it has been dropped into water,

e) it is not working properly, f) it is connected to a PC

during CPAP treatment.

Return the device to an authorised service center for

examination and repair.

3. Do not use the device when the room temperature

exceeds 35°C (95°F) as this may lead to an elevated airflow

temperature which may give rise to an irritation of the airways.

4. Ensure an air filter is fitted when operating your device.

5. 6. 7.

Remove the humidification chamber before filling. Do not fill the chamber with boiling water. When handling the device with chamber and water

avoid

tilting the device to prevent any chance of water entering

the device enclosure.

• 8. Place your device on a level surface lower than your head
     height to prevent water entering the respiratory tubing

should the device be knocked over.

9. Do not store or use your device where it can fall or be

pulled into water. If water has entered the device enclosure,

disconnect the power cord and discontinue use. Seek

advice from your homecare provider.

10.Never block the air openings of the device or place it on a soft surface such as a bed or couch, where the filter area may be blocked. Keep the air openings free of lint, hair or the like.
11.Ensure the device is dry before plugging into the power socket.
12.A mask should not be used unless the device is switched on, and operating properly. The vent hole(s) associated with the mask should never be blocked.
13.Due to the operating temperature of the heater plate, avoid making contact to the exposed heater plate or chamber base.
14.At low CPAP pressures, the flow through the mask may be insufficient to clear all exhaled gas from the tubing, and consequently some re-breathing may occur.
15.Adjusting the pressure control can result in ineffective therapy. The pressure control must only be adjusted by a healthcare professional.
16.Never drop or insert any object into any opening or tube. 17.Always switch off the device and unplug the power cord
from the power socket before cleaning.
*18.Empty all the water from the chamber before transporting
your device. 19.Refer all maintenance to qualified service personnel except
as outlined in this manual.

• Only applicable to integrated CPAP devices

3. OXYGEN USE WARNINGS

If supplemental oxygen is used with the device, the oxygen flow must be turned off when the device is not operating. This
ensures that oxygen will not flow through the tube and accumulate in the device enclosure.
· The device should be located in a position where ventilation around the device is not restricted. · It is recommended that supplemental oxygen be administered at the mask. · Oxygen should not be used while smoking or in the presence of an open flame. · The use of oxygen in therapy requires that special care be taken to reduce the risk of fire. Any materials which will burn in
air and some that will not are easily ignited and burn rapidly in high concentrations of oxygen. Accordingly, for safety it is
necessary that all sources of ignition be kept away from the product and preferably out of the room in which it is being used.
· A spontaneous and violent ignition may occur if oil, grease or greasy substances come in contact with oxygen under pressure. These substances must be kept away from oxygen regulators, cylinder valves, tubing and connections, and all other oxygen
equipment.
· At a fixed flow rate of supplemental oxygen flow, the inhaled oxygen concentration will vary, depending on the pressure settings, patient breathing pattern, mask selection and leak rate.

4. INTENDED USE

The device is used to assist with patient breathing while sleeping, for the purpose of treating Obstructive Sleep Apnea (OSA). This is done by the delivery of Continuous Positive Airway Pressure (CPAP) in order to prevent airway obstruction. The addition of heated respiratory humidification to the device relieves the drying and irritating effects on the patient airways which usually arises from use of a CPAP system. The CPAP device is for use on adult patients at home or in the sleep lab. Please refer to the HC230-Series Product range listed in the Appendix section of this manual.
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English

5. DESCRIPTION OF THE DEVICE
5.1 Important Parts of Your Device – Standard Range
FILTER HOLDER

POWER CORD ON/OFF BUTTON

AIR FILTER

DISPLAY

SERIAL PORT

900HC010 CONNECTOR 900HC221 TUBE

5.2 Important Parts of Your Device – Integrated Range

FILTER HOLDER

POWER CORD ON/OFF BUTTON

AIR FILTER

HEATERPLATE

900HC221 TUBE

SERIAL PORT
DISPLAY DISPLAY

CHAMBER GUARD

WATER CHAMBER

5.3 Accessories

HC013 HC014 HC385S HC355* 900HC010 900HC221 900HC240

Conversion Kit ­ Cold Humidification Conversion Kit ­ Heated Humidification Standard Humidification Chamber Extended Life Humidification Chamber Connector Tube Filter

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900HC010 CONNECTOR

FUNNEL

WATER LEVEL LINE

900HC230 900HC232 900HC607 900HC236 900HC226

Compliance Maximizer Software Compliance Download Serial Cable Titration Maximizer Software Isolated Serial Adaptor Lead Extension Kit

*Not available in all countries

6. CLEANING & MAINTENANCE

1. Switch off the device and unplug from the power socket.
2. Wipe the exterior of the device with a clean, damp (not wet) cloth and mild dishwashing detergent. Do not use harsh abrasives or solvents, as these may damage the device.
3. DAILY Clean chamber and tube.
· Remove the breathing tube from the chamber. · Rinse the tube with soapy water. Hang up hose with hose ends pointing to floor to dry. · Remove the chamber by pushing down the finger guard and pulling out the chamber. · Pour out & discard the remaining water. · Clean the chamber with soapy water, rinse and dry.
4. WEEKLY Thoroughly clean the chamber
· Soak the inside of the chamber for 10 minutes in a solution of one part white vinegar to two parts water.
5. Replace the air filter when it becomes significantly discoloured, at least once every 3 months or after 1000 hours machine running time.
· Remove the filter holder from the back of the device and take out the filter. · Replace the old filter with a new filter: Ensure the vertical black line is facing
towards the device.

7. SETUP INSTRUCTIONS
HOW TO SET UP YOUR SYSTEM
1. Remove your device from its packaging. 2. Place the device on a low shelf or on the floor beside your bed,
so that the device is positioned below head height. 3. Chamber Setup (only applicable to integrated CPAP devices)
a. Remove one water chamber from the packaging. b. Remove the blue caps and discard them (Fig.1). c. Fill the chamber up to the water filling line with distilled water only
(Fig.2). Never fill the chamber while it is attached to the device. When moving your device, ensure that the water chamber is empty. Device failure due to water damage is not covered by warranty. d. To attach the water chamber to the device, press down the finger
guard and slide the chamber on (Fig.3) (Fig. 4). e. When the chamber is fitted correctly, the finger guard will click into
place. 4. One end of the tube has a white plastic connector.
Push this onto the outlet on top of the chamber (Fig.5) or CPAP outlet (Fig.5a). 5. Connect the other end of the tube to the mask. 6. Plug the device power cord into your household power socket and into the rear of the device. 7. Switch on the device by pressing the on/off button (See Fig.6 ). The current humidity setting is displayed. 8. For changing the setting refer to section 8 “Controls and Display”.

Fig.1 Fig.3 Fig.5 Fig.6

Fig.2 Fig.4 Fig.5a

Your device is now ready for use.

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8. CONTROLS AND DISPLAY – INTEGRATED CPAP RANGE

8.1 DISPLAY DESCRIPTION AND FUNCTIONS

On/Offbutton

English

Rampbutton

Upbutton
IncreaseSetting
Downbutton
DecreaseSetting
Modebutton
Stepthroughtheoptions

<

KEY

FUNCTION&DESCRIPTION ON/OFF SwitchesthedeviceON&OFF
RAMP Reducespressuretoalower leveltohelpyoufallasleep. Thepressurewillgraduallyreturn tofulloperatingpressure over20minutes INCREASE/DECREASE Adjustssettingsupordown MODE Tostepthroughoptions

OPERATION

TOSWITCH”ON”

Pressbuttonbriefly

Thedevicewilldefaulttodisplaythehumiditysetting.

TOSWITCH”OFF” Removeyourmask Pressbuttonbriefly

TOSTARTTHERAMP

Pressthebutton

NB:toresetrampduringacyclethedevicemustbeswitchedofffirst

TOSWITCH”OFF” Pressthebutton

Presstheandbuttontoraiseorlowersettings

Presssequentiallytostepthroughandviewoptionsavailable

< <

< <
<

PATIENTMENU

ForviewingofCPAPsettings,humidity, compliancedata,altitudeandpressuresettings

DISPLAY

OPERATION

TOVIEWITEMS Pressthe” “buttontosequentiallyview: HumiditySetting(defaultdisplay) Foradjustinghumiditylevelstominimizeupperairwaysideeffects
fromCPAPuse.Pressandbuttonstoraiseorlowersettings

hr Totalrunhours
Displaysthetotalnumberofhoursthedevicehasbeen switchedon(includeshourswithoutmaskuse)

hr/

Averagecompliancehourspernight* Displaysaveragenumberofhoursthedevicehasbeen

usedatnightwiththemaskon

Checksum* Displaysinformationformedicalpractitionerordealeruse
tocheckcompliance

Altitudesetting Displaysaltitudesetting

cmH2O

Pressuresetting Displayspressuresetting

PATIENTMENU-ADDITIONALSETTINGS DISPLAY

OPERATION

Toaccessadditionalsettings:
FromtheDefaultsetting”HUMIDITY” Pressthe” “keyfor3seconds Toviewsubsequentitems: Pressthe” “key

Altitude Select”m”formetresof”ft”forfeetusing theandkeys

< <

< <

3000

Altitudelevel -Setthealtitudelevelbypressingtheandkeys -Press toexitmenu
NOTE:Failuretoselectcorrectaltitudesetting(foranygivenlocation) willhaveanadverseeffectondeliveredpressure.

cmH2O

ActualPressure Displaysactualpressure
NOTE:OnlyavailableondeviceswithAutomaticAltitudeAdjustment/Leak Compensationfeature

N*OOTnEly:MavaaniluaablleaodnjudsetmviceenstwofitahltCitoumdpeliiasncneotMfoenaittourrinegd.onunitswherethereistheAutomaticAltitudeAdjustment/LeakCompensationfeature

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8.2 PATIENT MENU SUMMARY – INTEGRATED CPAP RANGE

Presstoactivate Ramp
Increase Decrease
MODE

Pressoncetoswitch deviceon/off
Display

MODELS HC233 HC234

Hum(iddeitfyauSlet)tting

TotalRhurnTime

AverageHours pernight * hr/

Checksum*

AltitudeSetting

<

MODEL HC238

<

or

0,1,2,3,4

+-0.5INCREMENT

Hum(iddeitfyauSlet)tting

TotalRhurnTime

AverageHours pernight * hr/

Checksum*

PSreesttsinugre
cmH2O

<

<

or

0,1,2,3,4

+-0.5INCREMENT

*OnlyavailableondeviceswithComplianceMonitoring.

8.3 PATIENT MENU – ADDITIONAL SETTINGS SUMMARY – INTEGRATED CPAP RANGE

PSreesttsinugre
cmH2O
RETURN TODEFAULT
RETURN TODEFAULT

MODE

MODELS HC233 HC234 MODEL HC238

PAATDIEVNATNCMEEDNU
Holdfor3seconds
PAATDIEVNATNCMEEDNU
Holdfor3seconds

ft or

m

3000

RETURN TODEFAULT

< <

or

Select Units for Altitude

or

Increase/Decrease altitude Level

< <

ACTUAL PRESSURE
cmH2O

RETURN TODEFAULT

Warning:Failuretoselectcorrectaltitudesetting(foranygivenlocation)willhaveanadverseeffectondeliveredpressure.

A-6

<
< < <
English

9. CONTROLS AND DISPLAY – STANDARD CPAP RANGE

9.1 DISPLAY DESCRIPTION AND FUNCTIONS

On/Offbutton

Rampbutton
Upbutton
IncreaseSetting
Downbutton
DecreaseSetting
Modebutton
Stepthroughtheoptions

< < <
<

KEY

FUNCTION&DESCRIPTION

OPERATION

ON/OFF SwitchesthedeviceON&OFF
RAMP Reducespressuretoalower leveltohelpyoufallasleep. Thepressurewillgraduallyreturn tofulloperatingpressure over20minutes INCREASE/DECREASE Adjustssettingsupordown

TOSWITCH”ON” Pressbuttonbriefly Thedevicewilldefaulttodisplaythehumiditysetting. TOSWITCH”OFF” Removeyourmask Pressbuttonbriefly TOSTARTTHERAMP Pressthebutton NB:toresetrampduringacyclethedevicemustbeswitchedofffirst TOSWITCH”OFF” Pressthebutton
Presstheandbuttontoraiseorlowersettings

MODE Tostepthroughoptions

Presssequentiallytostepthroughandviewoptionsavailable

PATIENTMENU

ForviewingofCPAPsettings,humidity, compliancedata,altitudeandpressuresettings

DISPLAY

OPERATION

TOVIEWITEMS

Pressthe” “buttontosequentiallyview:

23x

ModelType(defaultdisplay) Displaysmodeltypeasdefaultsetting

hr Totalrunhours
Displaysthetotalnumberofhoursthedevicehasbeen switchedon(includeshourswithoutmaskuse)

hr/

Averagecompliancehourspernight* Displaysaveragenumberofhoursthedevicehasbeen

usedatnightwiththemaskon

Checksum* Displaysinformationformedicalpractitionerordealeruse
tocheckcompliance

Altitudesetting Displaysaltitudesetting

cmH2O

Pressuresetting Displayspressuresetting

PATIENTMENU-ADDITIONALSETTINGS DISPLAY

OPERATION

Toaccessadditionalsettings:
FromtheDefaultsetting Pressthe” “keyfor3seconds Toviewsubsequentitems: Pressthe” “key.

3000 cmH2O

Altitude Select”m”formetresof”ft”forfeetusing theandkeys
Altitudelevel -Setthealtitudelevelbypressingtheandkeys -Press toexitmenu
NOTE:Failuretoselectcorrectaltitudesetting(foranygiven location)willhaveanadverseeffectondeliveredpressure.
ActualPressure Displaysactualpressure
NOTE:OnlyavailableondeviceswithAutomaticAltitudeAdjustment/ LeakCompensationfeature

N*OOTnEly:MavaaniluaablleaodnjudsetmviceenstwofitahltCitoumdpeliiasncneotMfoenaittuorreindg.onunitswherethereistheAutomaticAltitudeAdjustment/LeakCompensationfeature

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9.2 PATIENT MENU SUMMARY – STANDARD CPAP RANGE

Presstoactivate Ramp
Increase Decrease
MODE

Pressoncetoswitch deviceon/off
Display

MODELS HC231 HC232

Model
(dTeyfapuelt)

MODEL HC236

Model
(dTeyfapuelt)

TotalRhurnTime

AverageHours pernight * hr/

Checksum*

AltitudeSetting

PSreesttsinugre
cmH2O
RETURN TODEFAULT

TotalRhurnTime

AverageHours pernight * hr/

Checksum*

PSreesttsinugre
cmH2O

RETURN TODEFAULT

*OnlyavailableondeviceswithComplianceMonitoring.
9.3 PATIENT MENU – ADDITIONAL SETTINGS SUMMARY – STANDARD CPAP RANGE

MODE

MODELS HC231 HC232 MODEL HC236

PAATDIEVNATNCMEEDNU
Holdfor3seconds
PAATDIEVNATNCMEEDNU
Holdfor3seconds

ft or

m

3000

RETURN TODEFAULT

< <

or

Select Units for Altitude

or

Increase/Decrease altitude Level

< <

ACTUAL PRESSURE
cmH2O

RETURN TODEFAULT

Warning:Failuretoselectcorrectaltitudesetting(foranygivenlocation)willhaveanadverseeffectondeliveredpressure.

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English

10. FREQUENTLY ASKED QUESTIONS
For integrated CPAP devices:
a. When I wake up in the morning, my nose and throat feel dry. What can I do? Try increasing your humidity setting. If this does not help, please contact your clinician for advice.
b. How do I prevent condensation in the tubing? The humidity setting enables adjustment of humidity, so that there should be fine misting in the six inches (183cm) of the breathing tube closest to your face. If the humidity setting is too high for the conditions, condensation may occur in the breathing tube. Note: Using greater than 6′ (183 cm) of tubing will increase condensation.
There are several ways of reducing condensation in the tube: i Ensure the device is not positioned in a cool draft. ii Decrease the humidity setting on your device slightly. Gradually decrease the setting until the condensation no
longer occurs. iii Warm the air in the room.
c. Do I have to use distilled water with my device? The use of distilled water will maximize the life of the water chamber. Water from the faucet will often contain minerals which can damage the chamber, causing pitting in the base, even if the water is passed through a filter.
d. When do I replace my water chamber? Replace the chamber if the plastic walls of the chamber become cracked or cloudy or the chamber base becomes pitted. (Note: If the chamber leaks at all, it should be replaced immediately).
Can I use my device in other countries? Yes. Simply use the appropriate electrical socket adaptor and the device will automatically adapt to any voltage supply. Note: When moving your device, ensure that the water chamber is empty. Machine failure due to water damage is not covered by warranty.
Can I use supplemental oxygen with my device? Yes, oxygen can be administered at the mask. Turn the device on before turning on the oxygen. Ensure that the oxygen source is turned off before turning off the device to avoid oxygen accumulating in the machine.

11. SPECIFICATIONS

DIMENSIONS:

275mm x 170mm x 140mm (10.8″ x 6.7″ x 5.5”)

WEIGHT:

1.9kg (4.2lbs)

(3.0kg packaged in bag incl. accessories)

ELECTRICAL RATINGS

Supply Frequency:

50-60 Hz

Supply Voltage and Current: 100-115V~ (1.2A, 1.3A max),

220-240V~ (0.8A, 1.8A max)

Note: These values represent

average current

DC to AC Inverter requirements: 115V – 200W/300W surge

230V – 300W/500W surge

Heater Plate : Heater Plate Temperature:

85W max 65°C (149°F) max

PERFORMANCE Pressure Range Altitude Range

4 to 20 cmH2O 0 to 3000m, or 0 to 9000 ft

STANDARDS COMPLIANCE Designed to conform to the requirements of:

EN / IEC 60601-1 UL60601-1 CSA C22.2/No.601.1 AS3200.1.0

The device complies with the electromagnetic compatibility requirements of IEC 60601-1-2. In certain circumstances, the device may affect or be affected by nearby equipment due to the effects of electromagnetic interference. If this should happen, try moving your unit or the location of the device causing interference, or alternatively consult your homecare provider.

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12. OPERATING CONDITIONS:

AMBIENT TEMPERATURE: 5 – 35°C

HUMIDITY:

10 – 95% RH

ALTITUDE:

0 – 3000m (9000ft)

Above 1500m (4500 ft) the maximum operating pressure will be reduced.

13. STORAGE AND TRANSPORT CONDITIONS:
The device should be stored and transported in environmental conditions of: -10 to 60°C .

14. TROUBLESHOOTING:
If you feel that your device is not operating correctly, consult your homecare dealer. Do not attempt to repair the device yourself.
Fisher & Paykel Healthcare have a policy of continued product improvement and reserve the right to alter specifications without notice.
15. APPENDIX

The following table lists the main difference in features across the HC230 Product Range.

Features Standard CPAP
Fully Integrated CPAP with Heated Humidification
Patient Compliance Monitoring (LCD & Full Download)
Auto Altitude Adjustment
Leak Compensation
Ambient Tracking PLUS
Proportional Ramp

Product Code

HC231 HC232 HC233 HC234 HC236 HC238

Note: Some models may not be available for sale in certain countries

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Fisher&PaykelHealthcareOffices: INTERNATIONALPOBox14348,Panmure,Auckland1741,NewZealandTel:+6495740100Fax:+6495740158Email:info@fphcare.comWebSite:www.fphcare.com USA Tel:+18004463908or+19494534000Fax:+19494534001 AUSTRALIATel:+61 3 9879 5022 Fax:+61 3 9879 5232 AUSTRIA Tel: 0800 29 31 23 Fax: 0800 29 31 22 BENELUX Tel:+31 78 644 0924 Fax:+31 78 644 0914 CHINA Tel:+862032053486Fax:+862032052132FRANCETel:+33164465201Fax:+33164465221GERMANYTel:+497182937770Fax:+4971829377799 INDIA Tel:+91 80 4123 6041 Fax:+91-80-4123 6044 IRISH REPUBLIC Tel: 1800 409 011 ITALY Tel:+39 06 7839 2939 Fax:+39 06 7814 7709 JAPAN Tel:+81 3 3661 7205 Fax:+81 3 3661 7206 MIDDLE EAST Tel: +9 71 4 360 0849 Fax: +9 71 4 368 8110 SPAIN Tel:+34 902 013 346 Fax:+34 902 013 379 SWITZERLANDTel:0800834763Fax:0800834754UK(EUAuthorisedRepresentative)Tel:+441628626136Fax:+441628626146Nthn Ireland Tel:0800132189
185043325 REV F

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