FISHER PAYKEL SleepStyle™ 200 Series Humidified CPAP System User Manual
- June 7, 2024
- Fisher & Paykel
Table of Contents
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.
A-1
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.
-
- Place your device on a level surface lower than your head
height to prevent water entering the respiratory tubing
- Place your device on a level surface lower than your head
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.
A-2
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
A-3
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.
A-4
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
A-5
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
A-7
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.
A-8
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.
A-9
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
A-10
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