Fisher & Paykel SleepStyle 600 CPAP Series Operating Manual

Operating Manual

SECTION

English .................................................................... A

(Chinese Simplified) ................................ B

Dansk ...................................................................... C

Deutsch ................................................................... D

Español .................................................................... E

Français ................................................................... F

Greek ...................................................................... G

Italiano .................................................................... H

(Japanese) ..................................................... I

(Korean) .......................................................... J

Nederlands ............................................................... K

Norsk ...................................................................... L

Português ................................................................. M

Suomi ...................................................................... N

Svenska ................................................................... O

(Chinese Traditional) ................................ P

Türkçe ..................................................................... Q

This product is covered by one or more of the following patents or patent applications in the corresponding countries listed below.

HC604 USA: US6598604, US6398197, US7111624, US6953354, US7086399, US7616871, Australia: AU761713, AU756477, AU2003204474,
AU2003265025, AU2004266551, AU2009201906, Japan: JP4436758, Europe: EP1369141, EP1542757, EP1656173 , EP1055431 (GB, IT),
Hong Kong: HK1074178

HC608 USA: US6598604, US6398197, US7111624, US6953354, US7086399, US7616871, Australia: AU761713, AU756477, AU2003204474,
AU2003265025, AU2004266551, AU2009201906, Japan, JP4436758, Europe: EP1369141, EP1542757, EP1656173, EP1055431 (GB, IT),
Hong Kong: HK1074178

A - 1

English

The SleepStyle™ 600 CPAP Series has integrated
heated humidification and a heated breathing
tube. It is designed for use in the home or sleep
laboratory, for the treatment of Obstructive Sleep
Apnea.

For further assistance, please contact your local
Fisher & Paykel Healthcare office – see back cover
for details.
Please keep this manual for future reference.

Table of ConTenTs

1. Symbol Definitions ............................................................................................................................................................................... A - 2

2. Warnings, Cautions and Contraindications ....................................................................................................................................... A - 2

3. Description of the Device .................................................................................................................................................................... A - 3

3.1 Package Contents .......................................................................................................................................................................... A - 3

3.2 Important Parts of the Device ....................................................................................................................................................... A - 3

3.3 Accessories ...................................................................................................................................................................................... A - 3

3.4 ThermoSmart™ Technology .......................................................................................................................................................... A - 4

4. Intended Use ......................................................................................................................................................................................... A - 4

5. Oxygen Use Warnings ......................................................................................................................................................................... A - 4

6. Cleaning and Maintenance ................................................................................................................................................................. A - 5

7. Setup Instructions ................................................................................................................................................................................. A - 5

8. Controls and Display ............................................................................................................................................................................ A - 6

8.1 Display Description and Functions .............................................................................................................................................. A - 6

8.2 Patient Menu Summary ................................................................................................................................................................. A - 7

8.3 Patient Menu - Additional Settings Summary ............................................................................................................................ A - 7

9. Frequently Asked Questions ............................................................................................................................................................... A - 8

10. Operating Conditions .......................................................................................................................................................................... A - 8

11. Storage and Transport Conditions ..................................................................................................................................................... A - 8

12. Troubleshooting .................................................................................................................................................................................... A - 8

13. Warranty ................................................................................................................................................................................................. A - 8

14. Device and Consumables Disposal Instructions ..................................................................................................................... A - 8

15. Product Specifications ......................................................................................................................................................................... A - 9

16. Appendix ............................................................................................................................................................................................... A - 9

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 - 2

1. symbol DefiniTions

Type BF

Applied Part

Alternating Current

Drip Proof

93/42/EEC

Class IIb

Class II

Double Insulated

Power
On/Off

2. Warnings, Cautions and ContraindiCations

NOTES

• This manual refers to the SleepStyle™ 600 CPAP Series unit as

“the device”.

• If required to use CPAP by a referring physician, you should

use your device every time you sleep. Should your device
stop working for any reason, contact your healthcare provider
immediately.

• The user of this system shall have sole responsibility and

liability for any injury to persons or damage to property
resulting from operation of the device which is not in
accordance with the operating instructions supplied.

• The device should only be used with ISO 17510-2 compliant

masks, connectors and delivery tubes recommended by
Fisher & Paykel Healthcare, or your healthcare provider.

• Do not use the device when the room temperature exceeds

95 °F (35 °C) as this may lead to an elevated airflow
temperature which may give rise to an irritation of the airways.

• Refer all repairs and maintenance to Fisher & Paykel Healthcare.

WARNINGS
To avoid electric shock from your device, do not:

• Operate the device if the power cord or plug is damaged.

• Operate the device if it has been dropped in water.

• Plug the device into the power socket if it is wet.

• Clean the device while connected to the power socket.

• Store or use the device where it can tilt, fall or be pulled

into water. If water has entered the unit enclosure, disconnect
the power cord and discontinue use. Seek advice from
Fisher & Paykel Healthcare.

To avoid choking or inhalation of a foreign body:

• Never place any object into any opening of the tube.

• Ensure the air filter is fitted during device use.

To ensure optimal therapy, do not:

• Operate the device if dropped or damaged.

• Operate the device if it is not working properly.

• Adjust the pressure. Pressure must only be adjusted by a

healthcare professional.

• Operate the device if the breathing tube has been damaged

with holes, tears or kinks.

• Block the exhaust flow on the mask.

• Use the mask if the unit is turned off or not operating properly.

• Use an insulating sleeve or any similar accessories which are

not approved by Fisher & Paykel Healthcare. These may affect
the humidification performance.

• Try to remove the heated breathing tube without pushing the

sleeve up first. This will avoid damage to the connection port.

To avoid burns, do not:

• Fill the chamber with boiling water.

• Touch the exposed heater plate or chamber base.

• Position the breathing tube in such a way that it can come into

prolonged contact with skin.

To avoid the risk of fire while using oxygen, do not:

• Turn oxygen flow on when the device is not operating; this can

lead to accumulation of oxygen within the device.

• Locate the device in a position where ventilation around the

device is restricted.

• Use oxygen while smoking or in the presence of an open

flame.

• Use any materials which will burn in air or ignite easily at high

oxygen concentration.

• Keep any source of ignition near the product. To avoid ignition,

it is preferable to keep all sources of ignition out of the room
where supplemental oxygen is being used.

• Keep oxygen regulators, cylinder valves, tubing, connections

and all other oxygen equipment near oil, grease or greasy
substances. Spontaneous and violent ignition may occur
if these substances come into contact with oxygen under
pressure.

• Operate the device without the cover over the serial port

adaptor.

Other:

• Place the device on a level surface lower than head height

to prevent water entering the tubing. If water does enter the
tubing, drain excess condensate. Water in the tubing may
result in aspiration.

• The device is intended to be used with CPAP masks and

connectors that have exhaust flow holes to allow continuous
flow of air out of the mask. When the device is turned on and
operating properly new air flushes exhaled air out of the mask
through the exhaust flow holes. At low CPAP pressures and
in the event of power failure or machine malfunction, remove
the mask immediately, as flow through the mask may be
insufficient to clear all exhaled gas and CO2 re-breathing may
occur which can be hazardous.

• Failure to select the correct altitude level (for any given

location) will have an adverse effect on delivered pressure.

• This device is not intended for life support.

• Avoid unnecessary removal of the power cord from the rear of

the device. If removal is necessary then hold the connector and
remove. Avoid pulling on the power cord (refer to Section 3.2).

CAUTIONS
To prevent water damage to your device:

• Remove the humidification chamber from the device before

filling.

• Empty water from the chamber before transporting the device.

If the device is required to be handled with water in the
chamber, avoid tilting the device to prevent water entering its
enclosure.

Other:

• To prevent damage to your PC, only operate the device if

it is connected to a PC via an isolated serial port adapter

(900HC236).

• To prevent airway irritation, do not use the device when room

temperature exceeds 95 °F (35 °C).

CONTRAINDICATIONS

• Research indicates the following pre-existing conditions may

contraindicate the use of positive pressure for some patients:
pneumothorax, bullous lung disease, pneumocephalus,
cerebrospinal fluid leak, recent cranial surgery or trauma,
abnormalities of the cribriform plate, pathologically low blood
pressure or in patients whose upper airways are bypassed.

PRECAUTIONS

• The safety and effectiveness of positive pressure has not been

established in patients with respiratory failure or COPD.

ADVERSE EFFECTS

• Nosebleeds, ear and sinus discomfort may occur from the use

of positive pressure therapy.

Please contact your physician if you have any questions
concerning your therapy.

ATTENTION

Consult

accompanying

documents

A - 3

3. DesCripTion of The DeviCe

3.1 Package Contents

3.2 Important Parts of the Device

Accessories

1 x SleepStyle™ 600 CPAP Series

POWER CORD

and CONNECTOR

THERMOSMART™ HEATED BREATHING TUBE

CONNECTOR

with

SLEEVE

THERMOSMART™ HEATED BREATHING TUBE
CONNECTION PORT

WATER CHAMBER

WATER FILL LINE (vertical)

FINGER GUARD

HEATERPLATE

WATER LEVEL LINE

FILTER HOLDER

DISPLAY

AIR FILTER

ON/OFF BUTTON

3.3 Accessories

HC365 Standard Humidification Chamber

HC360* Extended Life Humidification Chamber

900HC522 ThermoSmart™ Heated Breathing Tube

to fit 22 mm (.86") conical connector

*Not available in all countries

900HC240 Filter (2-Pack)

900HC604 Outlet Cleaning Kit HC600

900HC627 Elbow Funnel (10-Pack)

English

1 x Spare Air Filter

1 x Power Cord

2 x Water Chamber

1 x Funnel

1 x ThermoSmart™

Heated

Breathing Tube

FUNNEL

A - 4

3.4 ThermoSmart™ Technology

This device has been designed for optimal patient comfort and offers the unique heated breathing tube technology ThermoSmart™.
ThermoSmart™ Technology allows for the delivery of optimal (higher and customized) levels of humidity to the patient, independent of
ambient temperature.

This device can be adjusted on two levels to achieve optimal comfort:

ThermoSmart™ Humidity setting: this setting regulates the temperature of the heater plate, adjusting the humidity levels for the

comfort of the patient. Adjustment can be made from 1 to 4 with increments of 0.5. The device is preset to 2.5 which is suitable for

most patients.

• If you experience dryness or find the air too cool: increase the setting.

• If you find there is too much moisture in the tube or the air feels too hot: decrease the setting.

• If you do not achieve optimal comfort with this setting further adjustments can be made by altering your ThermoSmart™ Climate

setting.

ThermoSmart™ Climate setting: this setting provides further adjustment options by optimizing the delivered humidity. Adjustment

can be made from 1 to 3 with increments of 1. The device is preset to 2 which is suitable for most patients. Note, if the climate setting

is adjusted, the humidity setting will revert back to the default setting.

• ThermoSmart™ Climate setting 3 is recommended for oral CPAP delivery.

• If you feel the range of settings offered by the ThermoSmart™ Humidity Setting are too dry or too cool: Increase the

ThermoSmart™ Climate setting.

• If you feel the range of settings offered by the ThermoSmart™ Humidity Setting are too warm or too humid: Reduce the

ThermoSmart™ Climate setting.

It is recommended to keep the (heated breathing) tube on top of bedding for the best humidity performance. To operate ThermoSmart™
Humidity and Climate settings, refer to section 8 “Controls and Display” of this manual.

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 device is for use on adult patients at home or in the sleep lab. Please refer to the SleepStyle™ 600 Series product range listed in the

appendix section of this manual.

5. oxygen Use Warnings

If oxygen is required, it is recommended that supplemental oxygen be administered at the mask. Please see instructions specific to
your mask type.

NOTE:

• At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary, depending on the pressure settings,

patient’s breathing pattern, mask selection and leak rate.

Before using oxygen with the device please see oxygen warnings in Section 2.

A - 5

English

6. Cleaning anD mainTenanCe

PLEASE NOTE: The device should be cleaned as required.

1. Switch off the device and unplug from the power socket. Wait for the water to cool, then remove chamber.

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 the chamber, heated breathing tube and heated breathing tube connection port.

• Remove the heated breathing tube from the device by pulling the sleeve upwards to unlock the connector. Then remove the

connector.

• Wash the heated breathing tube with soapy water, rinse and then hang-up the heated breathing

tube with its ends pointing to the floor to dry.

• Remove the chamber by pushing down the finger guard and pulling out the chamber.

• Pour out and discard the remaining water.

• For standard (HC365) chambers, clean and wash with soapy water, then rinse and dry.

• The extended life (HC360) chamber requires disassembly before cleaning. Push the base off the

chamber top as shown in Fig. 1. Ensure the round seal at the base is not loose or damaged.
Wash the chamber top and base in a mild dishwashing detergent. Rinse thoroughly and dry. This

chamber may also be cleaned in a domestic dishwashing machine.

• Thoroughly wipe the inside of the heated breathing tube connection port with a clean damp, low

lint cloth.

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 and rinse well with

distilled water.

5. MAINTENANCE

• Replace the air filter when it becomes significantly discoloured, at least once every three months or after 1000 hours machine run

time. To do this, remove the filter holder from the back of the device as shown in Fig. 2. Ensure the vertical black line of the new

filter is facing towards the device, and fit both back to the device.

• Replace the chamber if it is cracked, discoloured or scratched.

• Replace the heated breathing tube after 4000 hours usage or once per year. A damaged tube needs to be replaced immediately.

7. seTUp insTrUCTions

When the chamber is fitted and filled, the device must remain upright, so that water
cannot enter the enclosure.

1. Remove your device from its packaging.

2. Place the device on a low shelf or on the floor beside your bed, the unit needs
to be placed below head height.

3. Remove water chamber from the packaging.

4. Remove the blue caps and discard them (Fig. 1).

5. Fill the chamber up to the water filling line with distilled water only (Fig. 2).

Never fill the chamber through the heated breathing tube connector port.
When moving your device, ensure that the water chamber is empty.
Machine failure due to water damage is not covered by warranty.

6. To attach the water chamber to the device, press down the finger guard and
slide the chamber on (Figs. 3 and 4).

7. When the chamber is fitted correctly, the finger guard will click into place.

8. One end of the heated breathing tube has a grey plastic connector. Lift the
sleeve and slide connector on to the device. Push the sleeve down to lock
(Figs. 5, 6 and 7).

9. Connect the other end of the heated breathing tube to the mask.

10. Plug the device power cord into your household power socket.

11. Switch on the device by pressing the on/off button (Fig. 8). The current
ThermoSmart™ Humidity setting is displayed.

12. For changing the setting refer to section 8 “Controls and Display”.

Your device is now ready for use.

Fig. 2

Fig. 3

Fig. 4

Fig. 5

Fig. 6

Fig. 7

Fig. 8

Fig. 1

Fig. 1

Fig. 2

A - 6

ThermoSmart™ Climate setting*

To change the delivered temperature: Press for warmer more humid air

delivery. Press for cooler and drier air delivery.* Refer to Section 3.4

Altitude

Select “m” for metres or “ft” for feet using and keys

Altitude setting

- Set the altitude level by pressing and keys

- Press to exit menu

Actual Pressure (Displays actual pressure)

- Display reverts to default if the menu is not exited. Press button in order to

exit menu (only available in HC608)

8. ConTrols anD Display

Mode button

Step through the options

Down button

Decrease Setting

Up button

Increase Setting

Ramp button

On/Off button

8.1 Display Description and Functions

KEY FUNCTION & DESCRIPTION OPERATION

TO SWITCH “ON”

Press button down briefly
The device will default to display the ThermoSmart™ Humidity setting

TO SWITCH “OFF”

Remove your mask
Press button briefly

TO SWITCH “ON”

Press

(NB: to reset ramp during a cycle the device must be switched off first)

TO SWITCH “OFF”

Press

Press and button to raise or lower settings

Press sequentially to step through and view options available

<

<

PATIENT MENU DISPLAY OPERATION

For viewing CPAP settings, humidity,
compliance data, altitude and pressure
settings

TO VIEW ITEMS

Press key to sequentially view:

ThermoSmart™ Humidity setting (default display)

For adjusting ThermoSmart™ Humidity setting levels to minimize upper airway

side effects from CPAP use
Press and button to raise or lower settings

Total run hours: displays the total number of hours the device has been

switched on (includes hours without mask use)

Average compliance hours per night: displays average number of hours

the device has been used at night with the mask on

Check sum: displays information for the medical practitioner or the dealer to

check compliance

Altitude setting: displays altitude setting. Press or to change altitude

Pressure setting: displays pressure setting

cmH2O

hr

hr/

ON/OFF

Switches the device ON and OFF

RAMP

Reduces pressure to a lower level
to help you fall asleep. The pressure
will gradually return to full operating
pressure over 20 minutes

INCREASE/DECREASE

Adjusts settings up or down

MODE

To step through options

PATIENT MENU - Additional Settings DISPLAY OPERATION

To access additional settings:

From the Default setting

“THERMOSMART™
HUMIDITY”

Press the key for 3 seconds

3000

cmH2O

Warning: Failure to select correct altitude setting (for any given location) will have an adverse effect on delivered pressure.

* When the ThermoSmart™ Climate setting is altered the Humidity Setting will revert back to default setting 2.5

8.2 Patient Menu Summary

Increase

Decrease

Press to activate

Ramp

Press once to switch

device on/off

Display

Mode

ThermoSmart™

Humidity Setting

(default)

Altitude Setting

Pressure

Setting

cmH2O

0,1,2,3,4

<

<

or

Check sumTotal Run Time

hr

Average Hours

per night*

hr/

Return to

Default

ThermoSmart™

Humidity Setting

(default)

Pressure

Setting

cmH2O

Check sumTotal Run Time

hr

Average Hours

per night*

hr/

Return to

Default

Model

HC604

Model

HC608

Model
HC604

Model
HC608

Return to Default

or

m

Increase/Decrease

Altitude Level

Hold for 3 seconds

ft

<

<

or

<

<

or

Select Units
for Altitude

3000

<

<

or

Increase/Decrease

ThermoSmart™ Climate Setting

Return to Default

Hold for 3 seconds

Actual

Pressure

cmH2O

Advanced

Patient Menu

Advanced

Patient Menu

Mode

Warning: Failure to select correct altitude setting (for any given location) will have an adverse effect on delivered pressure.

A - 7

8.3 Patient Menu - Additional Settings Summary

English

±

0.5 Increment

A - 8

9.

freqUenTly askeD qUesTions

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.

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.

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 without a heated breathing tube?

Yes you can, but you will not gain the optimum humidity performance the device offers.
The device will then not display the heated breathing tube symbol and show the following display:

What happens to my device during power failure?

Remove the mask immediately. Upon restoration of the power supply, the device will restart in the same operation mode with the
same settings as before the power failure. Refer to Section 2 for additional information.

10. operaTing ConDiTions

AMBIENT TEMPERATURE: 41 - 95 ºF (5 - 35 ºC)
HUMIDITY: 10 - 95% Relative Humidity (RH)

ALTITUDE: 0 - 9000 ft (0 - 3000 m)
Above 1500 m (4500 ft) the maximum operating pressure will be reduced.

11. sTorage anD TransporT ConDiTions

The device should be stored and transported in environmental conditions of: 14 to 140 °F (-10 to 60 °C).

12. TroUbleshooTing

If you feel that your device is not operating correctly, consult your healthcare provider. Do not attempt to repair the device yourself.

13. WarranTy

Please contact your Fisher & Paykel Healthcare Provider regarding warranty.

14. DeviCe anD ConsUmables Disposal insTrUCTions

• Unit Disposal Instructions

This unit contains electronics. Please do not discard as regular rubbish. Dispose according to local guidelines for

disposing of electronics.

• Consumable Disposal Instructions

Place the mask, breathing tube and water chamber in a rubbish bag at the end of use and discard with normal

rubbish.

A - 9

English

16. appenDix

The following table lists the main difference in features across the SleepStyle™ 600 Product Range.

MODEL

HC604
HC608

NOTE:

●

All models are fully integrated with ThermoSmart

™

Technology.

●

Some models are not available for sale in all countries.

Patient Compliance

Monitoring (LCD & Download)

✓

✓

Auto Altitude Adjustment/

Leak Compensation

-

✓

Fully Integrated CPAP with

Heated Humidification

✓

✓

DIMENSIONS: 10.7” x 6.7” x 6.9”

(273 mm x 170 mm x 175 mm)

WEIGHT: 4.6 lbs (2.1 kg) unit only

7.5 lbs (3.4 kg) packaged in bag incl.
accessories

ELECTRICAL RATINGS

Supply Frequency: 50 - 60 Hz
Supply Voltage and Current: 100 - 115 V (1.5 A, max 1.7 A),

220 - 240 V (1.0 A, max 2.0 A)
Note: These values represent average

current.

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

230 V - 300 W/500 W surge

Heater Plate: max. 85 W
Heater Plate Temperature: max. 149 °F (65 °C)
Heated breathing tube
Power Setting: max. 30 W

PERFORMANCE

Pressure Range: 4 to 20 cmH2O
Altitude Range: 0 to 9000 ft, or 0 to 3000 m

STANDARDS COMPLIANCE:

Designed to conform to the
requirements of: IEC 60601-1

UL60601-1
CSA C22.2/No. 601.1
AS3200.1.0
EN60601-1
ISO 17510-1

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 healthcare provider.

15.

proDUCT speCifiCaTions

Warm-up time: 30 min
Humidity delivered: 30 mg/L*
Gas Temperature: max. 98.87 ºF (37.15 ºC)

*measured at 22 ºC ambient temperature: 10 cmH2O at bias flow.

Maximum Flow Rates

CPAP Pressure
Setting (cmH2O) 4 8 12 16 20

Measured pressure at
the patient connection 3 7 11 15 19
port (cmH2O)

Maximum flow rate
(L/Min) at mask 60 78 80 81 83
connection port

Static Pressure Stability (long term)

-0.05 to 0.18 cmH2O pressure difference, measured at the mask
connection port, at the pressure setting of 10 cmH2O

Dynamic Pressure Stability (short term)

CPAP Pressure
Setting (cmH2O) 4 8 12 16 20

Pressure Difference
(cmH2O) at mask .73 .74 .74 .81 .79
connection port

B - 1

SleepStyleTM 600 持续正压气道通气（CPAP）系统是结合了加
温湿化和加热呼吸管路的CPAP机系列产品。可用于睡眠室
和家庭护理，用于治疗阻塞性睡眠呼吸暂停症。

如需更多信息请联系当地的费雪派克医疗保健 (Fisher &

Paykel Healthcare) 公司代表处 - 联系方式详见封底。

请保管好本手册以备今后查阅。

目录

1. 符号定义 ................................................................................................................................................................................................ B - 2

2. 警告、注意和禁忌症 ............................................................................................................................................................................ B - 2

3. 治疗仪说明 ............................................................................................................................................................................................ B - 3

3.1 包装内容 .......................................................................................................................................................................................... B - 3

3.2 治疗仪的重要组件 .......................................................................................................................................................................... B - 3

3.3 附件 .................................................................................................................................................................................................. B - 3

3.4 智能加热ThermoSmart™ 技术 .......................................................................................................................................................... B - 4

4. 用途 ........................................................................................................................................................................................................ B - 4

5. 氧气使用警告 ........................................................................................................................................................................................ B - 4

6. 清洁保养 ................................................................................................................................................................................................ B - 5

7. 设置说明 ................................................................................................................................................................................................ B - 5

8. 控制和显示 ............................................................................................................................................................................................ B - 6

8.1 显示说明和功能 .............................................................................................................................................................................. B - 6

8.2 患者菜单摘要 .................................................................................................................................................................................. B - 7

8.3 患者菜单 - 附加设定摘要 .............................................................................................................................................................. B - 7

9. 常见问题解答 ........................................................................................................................................................................................ B - 8

10. 工作条件 ................................................................................................................................................................................................ B - 8

11. 存储及运输条件 .................................................................................................................................................................................... B - 8

12. 故障排除 ................................................................................................................................................................................................ B - 8

13. 保修期 .................................................................................................................................................................................................... B - 8

14. 治疗仪和消耗品处置说明 .................................................................................................................................................................... B - 8

15. 产品规格 ................................................................................................................................................................................................ B - 9

16. 附录 ........................................................................................................................................................................................................ B - 9

使用前请详细阅读手册所有内容。

注意: 美国联邦法律规定本治疗仪为医生处方产品。

持续正压气道通气（CPAP）系统

简体中文

B - 2

1.

符号定义

BF类

应用部件

交流电

防漏水

93/42/EEC

LLB类

第二类产品

双重绝缘

电源

开/关

2. 警告、注意和禁忌症

注

• 本手册中将 SleepStyle™ 600 系列湿化持续正压气道通气

（CPAP）治疗仪称为“治疗仪”。

• 如果医生觉得您需要使用 CPAP治疗仪，您应在每次睡觉时使用

治疗仪。如果治疗仪由于某种原因停止工作，请立即联系医护人
员或供应商。

• 对于因未依照所提供操作说明而使用治疗仪所导致的任何人身伤

害或财产损坏，用户应承担全部责任。

• 治疗仪只能与由 费雪派克医疗保健公司Fisher & Paykel Healthcare，

医护人员或供应商推荐的符合 ISO 17510-2 标准的面罩、接头和
呼吸管路搭配使用。

• 不要在室温超过35°C（95°F）的环境下使用治疗仪，因为这会

导致气流温度升高，有可能对气道造成损伤。

• 有关维修和保养的所有事宜请咨询费雪派克医疗保健公司

Fisher& Paykel Healthcare。

警告
为避免治疗仪漏电，请注意以下几点：

• 如果电源线或插头有损坏，请勿使用治疗仪。

• 如果治疗仪曾掉进水里，请勿使用。

• 若治疗仪已弄湿，请勿将其插入电源插座。

• 若治疗仪已连接到电源插座，请勿对其进行清洁。

• 请勿在容易倾斜、坠入、或拖入水中的地方放置或使用治疗仪。

如果主机外壳已进水，请拔掉电源线并停止使用，并咨询 费雪
派克医疗保健公司Fisher & Paykel Healthcare。

为避免堵塞或吸入异物，请注意以下几点：

• 切勿将任何物体塞入管路的任何开口。

• 确保在治疗仪使用时已安装空气过滤片。

为确保实施最佳治疗，请注意以下几点：

• 如果治疗仪曾摔落或有损坏，请勿使用。

• 如果治疗仪不能正常工作，请勿使用。

• 请勿自行调节压力。只能由专业医护人员或供应商来调节压力。

• 如果呼吸管出现裂孔、裂缝或扭结，请勿使用治疗仪。

• 请勿堵塞面罩上的排气孔。

• 如果治疗仪已关闭或不能正常运行，请勿使用面罩。

• 请勿使用任何未经费雪派克医疗保健公司 Fisher & Paykel Healthcare

认可的绝缘护套或同类附件。否则可能会影响湿化性能。

• 只有先将护套向上推，然后才能尝试拔下加热呼吸管。以防止损

坏连接端口。

为避免发生灼伤，请注意以下几点：

• 请勿向水罐内注入沸水。

• 请勿触摸暴露的加热板或水罐底部。

• 将呼吸管妥善放置在合适的位置，请勿让它长时间接触皮肤。

使用氧气时为避免引起火灾，请注意以下几点：

• 请勿在治疗仪不开机时打开氧气源；否则会导致氧气在治疗仪内

积聚。

• 治疗仪应放置通风条件不受阻碍的地方。

• 氧气不应在吸烟或有明火的场合下使用。

• 请勿使用任何能在空气中燃烧或在高浓度氧气条件下燃烧的

材料。

• 请勿将治疗仪置于任何易燃源附近。为避免起火，最好不要在正

使用氧气的房间内放置任何易燃源。

• 保持氧减压阀、氧气瓶阀、供氧管路、接头和其它所有氧气设备

远离油、油脂或油脂状物质。如果这些物质与加压氧气接触，可
能会自燃和大火。

• 串行接口转换器未加盖前，请勿使用治疗仪。

其他事项：

• 治疗仪放置的高度比睡觉时头部的位置要低，以防止水倒流入管

路。万一有水进入管路，应排掉多余的冷凝水。否则管路中积聚
的水可能会被患者吸入。

• 治疗仪要求与 带有排气孔的CPAP 面罩或接头搭配使用，让气流

能够不断地从面罩中排出。在治疗仪开机并正常运行时，新鲜空
气会将呼出气体通过面罩排气孔清除。在低 CPAP 压力条件下，
万一发生停电或机器故障，应立即摘下面罩，因为通过面罩的气
流可能不足以把呼出气体全部清除，从而可能导致二氧化碳再吸
入的危险。

• 如果未能选择正确的海拔高度（对任何已知的位置），会影响压

力输出。

• 本治疗仪不用于生命支持。

• 避免在没必要的情况下拔下治疗仪背面的电源线。如需要拔下，

请在拔出时握住接头，避免拖拽电源线。（请参阅第 3.2 节）。

注意
为防止治疗仪因进水而受损，请注意以下几点：

• 注水前，请从治疗仪上取下湿化水罐。

• 移动治疗仪前，请倒空水罐中的水。如果在水罐中有水的情形下

需要移动治疗仪，应防止治疗仪倾斜以免进水。

其他事项：

• 只有通过绝缘串行电缆 (900HC236) 将治疗仪连接到电脑后，才

能使用，以免损伤你的电脑。

• 不要在室温超过35°C（95°F）的环境下使用治疗仪，因为这会

导致气流温度升高，有可能对气道造成损伤。

禁忌症

• 研究表明，某些出现下列情况的患者可能不适宜使用正压通气治

疗：出现气胸、肺大泡疾病、气颅、脑脊液渗漏，近期有过颅脑
手术或创伤、筛板异常、病理性低血压，或者已接受气管插管或
气管切开。

注意事项

• 正压通气治疗对呼吸衰竭或慢性肺阻塞(COPD) 患者的安全性和

有效性还有待证实。

副作用

• 正压通气治疗有可能引起鼻出血、耳和鼻窦不适。
如果您对接受的治疗有任何疑问，请联系您的医生。

注意

请查阅随机

文件

B - 3

3.

治疗仪说明

3.1 包装内容

3.2 治疗仪的重要组件

附件

1 x

SleepStyle™ 600

持续正压

气道通气 (

CPAP

) 系统

电源线和接头

ThermoSmart™ 加热呼吸管

带锁套的连接头

ThermoSmart™ 加热呼吸管连接口

水罐

水位控制线(垂直)

手指护板

加热板

水位线

空气过滤片支架

显示屏

空气过滤片

电源开关

3.3 附件

HC365 标准湿化水罐

HC360* 耐用湿化水罐

900HC522 智能加热 ThermoSmart™ 加热呼吸管，

接到 22 mm (0.86") 圆锥形接头

*部分地区不适用

900HC240 过滤片(2 包)

900HC604 出气口清洁工具 HC600

900HC627 弯头漏斗10 个

1 x 备用空气过滤片

1 x 电源线

2 x 水罐

1 x 漏斗

1 x ThermoSmart™ 加

热呼吸管

漏斗

简体中文

B - 4

3.4 智能加热ThermoSmart™ 技术

本装置通过采用独特的管道智能加热 ThermoSmart™ 技术使患者有最佳的舒适度。智能加热 ThermoSmart™ 技术使输送到患者的湿度水平达到
最佳（更高和个性化），而且不受环境温度的影响。

本治疗机可在两种设置上调整以达到最佳舒适度:

智能加热 ThermoSmart™ 湿度设 定模式：该设定调节加热盘的温度以调整湿度从而满足患者对舒适度的要求。调节范围为1到 4, 调整

步幅为 0.5。治疗机在出厂时已预先设定在2.5, 这是适合大多数患者的设定值。

• 如您感觉干燥或空气太凉, 请调高设定。

• 如您觉得管子里湿气太大或感到空气太热, 请调低设定。

• 如您在这一设置上不能获得最佳的舒适度, 您还可进一步调整智能加热ThermoSmart™ Climate气候设定。

智能加热 ThermoSmart™ 气候设定模式：该模式可以提供进一步调节选择来提供最佳湿化输送。调节范围为1到3, 调整步幅为1。治疗

机在出厂时已预先设定在 2, 这是适合大多数患者的设定值。注意: 如对气候设定模式做过调整, 湿度设定模式会回到默认值。

• 对使用口式 CPAP 供气的患者, 建议将ThermoSmart™ Climate气候设定调到3。

• 如您觉得智能加热 ThermoSmart™ Humidity 湿度设定的一系列设定太干或太凉, 请调高气候设定。

• 如您觉得智能加热 ThermoSmart™ Humidity 湿度设定的一系列设定太热或太湿, 请调低气候设定。

建议把（加热呼吸）管放在被褥的上方以获得最好的湿化效果。请参照本手册的第8节“控制与显示”来操作智能加热 ThermoSmart™ Humidity
湿度设定和智能加热 ThermoSmart™ Climate 气候设定。

4.

用途

本治疗仪用于支持患者睡眠时的呼吸, 目的是治疗阻碍性睡眠呼吸暂停症（OSA）。通过提供持续气道正压（CPAP）来 避 免 气 道 阻 塞 。增 加 了 对
吸入气体进行加热湿化功能, 避免由于使用普通 CPAP 装置而造成的呼吸道干燥不适。本治疗仪仅适用于成人在家或睡眠实验室使用。请查阅
本手册附录中列出的 SleepStyle

TM

600 持续正压气道通气（CPA P）系统产品范围。

5. 氧气使用警告

如需使用氧气，建议通过面罩给予供氧。请参阅您面罩类型的使用说明。

注：

• 在辅助用氧流量固定的情况下，吸入的氧气浓度会根据设定压力、患者呼吸模式、面罩选择和漏气量的不同而变化。

氧气辅助治疗仪器使用前，请参阅第二节所述的氧气使用警告。

B - 5

6.

清洁保养

请注意: 要按要求来清洁本治疗仪。

1. 关 闭 治 疗 仪 ，并 从 电 源 插 座 上 拔 下 插 头 。等 到 水 冷 却 后 ，取 下 水 罐 。

2. 用干净、微湿（不是湿透）的软布和中性的洗洁精擦拭治疗仪的表面。不要使用粗糙的去污粉或溶剂，这些东西可能会导致治疗仪损坏。

3. 每天清洁

清洁水罐, 加热呼吸管和加热呼吸管的连接头。

• 向上拔起锁套, 松开连接头, 把加热呼吸管从治疗仪上取下, 然后取下连接头。

• 用肥皂水清洗加热呼吸管, 用水冲洗干净, 然后将加热呼吸管子两端朝下悬挂晾干。

• 按下手指护板, 将水罐向外拔, 取下水罐。

• 倒干净水罐里面剩下的水。

• 如使用标准水罐 (HC365), 请用肥皂水清洗后, 用水冲洗, 晾干。

• 如是耐用型水罐 (HC360), 要先拆卸后再清洁。如图1所示将水罐上部和底座分开。确保在底座上的圆形

密封没有松动或损坏。用洗洁精清洗水罐和底座后, 用水冲洗干净, 晾干。这个水罐也可以放在家用洗
碗机里清洗。

• 用清洁潮湿低棉绒布彻底擦 拭加热呼吸管连接端口内表面。

4. 每周清洁

彻底清洗水罐

• 用一份白醋两份水混合的溶液浸泡水罐内部 10 分钟。然后用蒸馏水冲洗晾干。

5. 保养

• 当空气过滤片出现明显变色时, 更换空气过滤片, 至少每 3 个月或机器运行时间超过 1000 小时要更

换一次。更换时, 如图 2 所示从仪器的背面拆下过滤片支架。确保新过滤片上黑色垂直线的一面朝里,
将换好的过滤片和支架装回治疗仪。

• 如水罐有开裂, 变色, 或划痕, 更换水罐。

• 使用时间每达到 4000 小时或一年要更换加热呼吸管。如管子损坏要立即更换。

7.

设置说明

一旦水罐加满水并装回仪器, 治疗仪一定要保持竖立, 以防水流进仪器内部。

1. 从包装盒中取出治疗仪。

2. 将治疗仪放在你床边的低架子或地板上, 确保放置后治疗仪低于睡觉时头高度。

3. 从包装盒中取出水罐。

4. 取 下 蓝 色 盖 子 并 将 其 弃 置（ 图 1 ）。

5. 给水罐加入蒸馏水到黑色水位控制线（图 2）。

不能通过加热呼吸管连接端口加水。当搬动治疗仪时，确保水罐是空的。治疗仪进
水而造成的损坏是不在保修范围内的。

6. 压下手指护板然后将水罐滑入治疗仪（图 3, 图 4）。

7. 水罐安放正确时, 手指护板会弹回原位。

8. 加热呼吸管路一端有一个灰白色的塑料连接头。拔高锁套然后将连接头接入治疗仪,

向下按压锁套以固定连接（图 5，图 6，图 7）。

9. 将加热呼吸管的另一端和面罩相连接。

10. 把治疗仪电源插头插入家里电源插座上。

11. 按电源开关键开启治疗仪（图 8）。治疗仪显示现有智能加热 Th ermoSma rt™ Humidity

湿度设 定。

12. 如需改变设定值, 请参阅第8节“控制和显示”。

您的治疗仪已经做好使用准备了。

图 2

图 3

图 4

图 5

图 6

图 7

图 8

图 1

图 1

图 2

简体中文

B - 6

智能加热 ThermoSmart™ Climate 气候设定 *

要改变所要的温度 : 按 键获得更暖 更湿的空气。按 键获得

较冷较干的空气 *。参照 3.4 节。

海拔高度 : 使用 和 键 选择海拔高度单位。用米制选择“m”,

用英制选择“f t”。

海拔高度设定

- 按压 和 键设定海拔高度

- 按压 键退出菜单

实际压力 ( 显示实际压力 )

- 如不退出菜单 , 显示回到默认值。要退出菜单 , 按压 键 ( 仅适

用 HC608 型号 )。

8.

控制和显示

8.1 显示描述和功能

图例 功能和描述 操作

启动

按压 按键。
治疗仪显示默认的智能加热 ThermoSmart ™ Humidity 湿度设定。

关闭

取下您的面罩。
按压 按键。

启动

按压

注意 : 如要再次启动延时升压功能 , 请先关闭治疗仪后重新开机。

关闭

按压 .

按压 和 增加或 减少设 定值。

按压以逐个切换并显示可用选项。

<

<

患者菜单 显示 操作

显示 CPAP 设定，湿度设定，顺
应性数据，海拔和压力设定。

显示项目

按压 逐个观看。

智能加热 ThermoSmart™ Humidity 湿度设定 (显示默认值)

调整智能加热 ThermoSma rt ™ Humidity 湿度设定水平以减少使用

CPAP 治疗对上气道带来的副作用。按 和 按键来提高或降 低
设定值。

总运行时间 : 显示治疗仪启动后的总运行时间 ( 包括没有佩

带面罩的时间 )。

每晚平均使用小时数 : 显示佩带面罩后每晚使用治疗仪的平

均小时数。

核查系数 ：给临床医师或服务商显示顺应性检查所需信息。

海拔高度设定 : 显示海拔高度设定。按 或 改变海拔

高度。

压力设定 : 显示压力设定。

cmH2O

hr

hr/

开/关

治疗仪开关

延时升压

降低 压力至较低水平以帮助您 顺
利入睡。在启动后 20 分钟内压
力将逐 渐升高到您需要的治疗压
力。

增加 / 减少

往上或往下调节设定值。

模式

逐个切换选项。

患者菜单簿 - 附加设定 显示 操作

进入附加设定 :

从默认
智能加热

THERMOSMART™

HUMIDITY

湿度设定

按压 键 3 秒钟。

3000

cmH2O

警告 : ( 在任何给定区域 ) 选择错 误的海拔高度可能对输出压力造成不利影响。

* 改变 ThermoSmart™ Climate 气候设定会使 ThermoSmart™ Humidity 湿度设定回到默认设定值 2.5。

模式按键

逐个切换选项

向下按键

减少设定

向上按键

增加设定

延时升压按键

开 / 关按键

8.2 患者菜单摘要

cmH2O

0,1,2,3,4

<

<

或

cmH2O

或

m

增加/减少

海拔高度

按压3秒钟

ft

<

<

或

<

<

或

选择海拔
高度单位

3000

<

<

或

增加/减少智能加热

ThermoSmart™ Climate 气候设定

返回默认值

按压3秒钟

实际压力

cmH2O

高级患者菜单

高级患者菜单

警告: (在任何给定区域)选择错误的海拔高度可能对输出压力造成不利影响。

B - 7

8.3 患者菜单- 附加设定摘要

调整步幅

±

0.5

模式

型号

HC604

型号

HC608

返回默认值

智能加热

ThermoSmart™ Humidity

湿度设定(默认值)

海拔高度设定

压力设定

核查系数

仪器总运行时间

hr

每晚平均

使用时间*

hr/

返回默认值

智能加热

ThermoSmart™ Humidity

湿度设定(默认值)

压力设定

核查系数

仪器总运行时间

hr

每晚平均

使用时间*

hr/

返回默认值

型号

HC604

型号

HC608

增加

减少

按压激活延

时升压

按一次治疗仪

启动/关闭

显示

模式

简体中文

B - 8

9.

常见问题解答

我的治疗仪是否必须使用蒸馏水？

使用蒸馏水可以最大限度地延长水罐的使用寿命。水龙头出来的水带有可损坏水罐的矿物质，即使采用过滤器过滤，也会造成底部腐蚀。

我可以在其它国家使用我的治疗仪吗？

可以。只要使用合适的电源转换插座。治疗仪会根据不同的供电电压自动调整。
注意：在移动您的治疗仪时请确保水罐是空的。治疗仪进水造成的损坏不在保修范围之内。

我的 治疗仪可以同氧气一起使用 吗？

可以。氧气可以通过 面罩 输送。在接通氧气前请先启动 治疗仪，并 确 保在 治疗仪关 机前先 关闭 氧气输送 以避免氧气在 治疗仪内积 聚。

什么时候 更换我的水罐？

如发现水罐的塑料壁有裂痕或变成雾状和不透明或水罐底部凹陷（如果水罐漏水则需立即更换。）

我的治疗仪可以不使用加热呼吸管路吗？

可以。但是您就不会获得由治疗仪提供的最佳湿化功能了。
在这种情况下，治疗仪不会显示加热呼吸管路符号而是显示以下信息:

如果发生停电，我的治疗仪会出现什么情况？

应立即摘下面罩。在恢复供电后，治疗仪会重新启动并进入停电前所用操作模式和设置。有关更多信息，请参阅第 2 节。

10.

工作条件

环境温度： 5 - 35 °C (41 - 95 °F)
湿度： 10 至 95% 相对湿度 (RH)

海拔高度： 0 - 3000米（0 - 9000 英尺）

高于1500米（4500英尺）时最大工作压力将下降。

11.

存储及运输条件

治疗仪存储和运输环境条件: -10 - 60 °C (14 -140 °F)。

12.

故障排除

如果您认为治疗仪运行不正常，请咨询医护人员或供应商。切勿自行尝试维修治疗仪。

13.

保修期

有关保修期的问题，请和您所在地费雪派克医疗保健公司 (Fisher & Paykel Healthcare) 产品供应商联系。

14. 治疗仪和消耗品处置说明

• 主机处置说明
本治疗仪主机含有电子元器件。请勿将主机作为普通垃圾丢弃。应依据当地有关处置电子设备的规定进行处理。

• 消耗品处置说明
请将不能继续使用的面罩、呼吸管和水罐置于垃圾袋中，并作为普通垃圾丢弃。

16.

附录

以下表格列出了 SleepStyle™ 600 系列各款功能的主要差别。

型号

HC604
HC608

注意:

●

所有型号都带有智能加热 ThermoSmart™ 技术。

●

某些型号不是在所有国家都有销售。

患者顺应性监测

(液晶显示和下载)

✓

✓

自动海拔高度调节/

漏气补偿

-

✓

B - 9

加温湿化一体化

持续正压通气 CPAP 治疗仪

✓

✓

尺寸： 10.7” x 6.7” x 6.9”

(273 mm x 170 mm x 175 mm)

重量： 4.6 lbs (2.1 kg) 仅主机

7.5 lbs (3.4 kg) 含包装及附件

电气额定值：
电源频率： 50 至 60 Hz
电源电压和电流： 100 - 115 V (1.5 A, 最大 1.7 A),

220 - 240 V (1.0 A, 最大 2.0 A)
注：这些值均代表平均电流。
直流转交流变换器要求： 115 V - 200 W/300 W （电涌）
230 V - 300 W/500 W （电涌）

加热板： 最大 85 W
加热板温度： 最大 149°F (65°C)
加热呼吸管功率设定: 最大 30 W

性能
压力范围： 4 至 20 cmH2O
高度范围： 0 至 9000 ft 或 0 至 3000 m

标准合规性：
旨在符合以下标准的要求： IEC 60601-1

UL60601-1
CSA C22.2/No. 601.1
AS3200.1.0
EN60601-1
ISO 17510-1

本治疗仪符合电磁兼容性标准IEC 60601-1-2。在某些情况下，由于电磁
干扰的作用，治疗仪可能本身受到影响或影响附近的便携式移动射频
通信设备。如果出现这种情况，可尝试移动您的治疗仪或移开干扰设
备的位置，也可咨询您的医护人员或供应商。

15.

产品规格

预热时间： 30 分钟
输送的湿度： 30 mg/L*
气体温度： 最大值 = 98.87 ºF (37.15 ºC)

*22 °C 环境温度下测得：持续气流下 10 cmH2O。

最大流量

CPAP 压力设置
(cmH2O) 4 8 12 16 20

患者侧连接端
口处测得的 3 7 11 15 19
压力 (cmH2O)

面罩连接端
口处最大流量 60 78 80 81 83
(L/Min)

静态压力稳定性（长期）

10 cmH2O 压力设置下 -0.05 至 0.18 cmH2O 压力差（面罩连接端口处测
得）

动态压力稳定性（短期）

CPAP 压力设置
(cmH2O) 4 8 12 16 20

面罩连接端口处
压力差 (cmH2O) 0.73 0.74 0.74 0.81 0.79

简体中文

C - 1

SleepStyle™ 600 CPAP Serien har kombineret
opvarmet fugtning med en opvarmet patientslange.
Den er udviklet til brug i hjemmet eller på
søvnlaboratoriet til behandling af Obstruktiv
Søvn Apnea.

Yderligere assistance fås ved henvendelse til Deres
lokale Fisher & Paykel Healthcare repræsentant – se
bagsiden for adresser.
Gem venligst denne brugsanvisning til senere
reference.

inDholDsforTegnelse

1. Symbolforklaring ................................................................................................................................................................................... C - 2

2. Advarsler, forsigtighedsregler og kontraindikationer ...................................................................................................................... C - 2

3. Beskrivelse af apparatet ....................................................................................................................................................................... C - 3

3.1 Pakningens indhold ........................................................................................................................................................................ C - 3

3.2 Vigtige dele på apparatet ............................................................................................................................................................. C - 3

3.3 Tilbehør ........................................................................................................................................................................................... C - 3

3.4 ThermoSmart™ Teknologi ............................................................................................................................................................. C - 4

4. Tilsigtet brug ......................................................................................................................................................................................... C - 4

5. Advarsler ved brug af ilt ...................................................................................................................................................................... C - 4

6. Rengøring og Vedligeholdelse ........................................................................................................................................................... C - 5

7. Installationsvejledning .......................................................................................................................................................................... C - 5

8. Styring og display ................................................................................................................................................................................. C - 6

8.1 Beskrivelse af displayet og funktionerne .................................................................................................................................... C - 6

8.2 Patient-menu oversigt ................................................................................................................................................................... C - 7

8.3 Patient-menu – yderligere indstillinger oversigt ......................................................................................................................... C - 7

9. Ofte stillede spørgsmål ....................................................................................................................................................................... C - 8

10. Driftsbetingelser ................................................................................................................................................................................... C - 8

11. Betingelser under opbevaring og transport ..................................................................................................................................... C - 8

12. Problemløser ......................................................................................................................................................................................... C - 8

13. Garanti ................................................................................................................................................................................................... C - 8

14. Bortskaffelse af apparat og forbrugsvarer ......................................................................................................................................... C - 8

15. Produktspecifikationer ......................................................................................................................................................................... C - 9

16. Bilag ........................................................................................................................................................................................................ C - 9

LÆS VENLIGST ALLE INSTRUKTIONER INDEN DE BRUGER APPARATET FØRSTE GANG

Dansk

C - 2

1. symbolforklaring

Type BF

Anvendt del

Vekselstrøm

Dryp tæt

93/42/EEC

Klasse IIb

Klasse II

dobbelt isoleret

Tænd/sluk

BEMÆRK

Se de medfølgende

dokumenter

2. advarsler, forsigtighedsregler og kontraindikationer

HENVISNINGER

• Denne brugsanvisning henviser til SleepStyle™ 600 CPAP

seriens enhed som ”apparatet”.

• Hvis en henvisende læge foreskriver brugen af CPAP, skal De

bruge apparatet, hver gang De sover. Kontakt Deres læge med

det samme, hvis Deres apparat af en eller anden grund holder
op med at fungere.

• Brugeren af dette system er ene og alene ansvarlig for

personskader eller materielle skader som følge af anvendelse
af apparatet, som ikke er i overensstemmelse med den
vedlagte brugsanvisning.

• Apparatet må kun anvendes med masker, stik og

tilførselsslanger, der opfylder ISO 17510-2, og som er anbefalet
af Fisher & Paykel Healthcare eller Deres læge.

• Brug ikke apparatet, hvis rumtemperaturen overstiger 95 °F

(35 °C), da det kan medføre en forhøjet lufttilførselstemperatur,

hvilket kan forårsage irritation af luftvejene.

• Al reparation og vedligeholdelse skal henvises til Fisher &Paykel

Healthcare.

ADVARSLER
For at undgå elektrisk stød fra Deres apparat må

Deikke:

• Betjene apparatet, hvis netledningen eller -stikket er

beskadiget.

• Betjene apparatet, hvis det har været tabt i vand.

• Tilslutte apparatet til stikkontakten, hvis det er vådt.

• Rengøre apparatet, mens det er tilsluttet til stikkontakten.

• Opbevare eller bruge apparatet, hvis det kan vælte, falde eller

trækkes ned i vand. Hvis der er trængt vand ind i enhedens
indre, skal netledningen afbrydes og brugen standses. Kontakt

Fisher & Paykel Healthcare.

For at undgå kvælning eller inhalering af et
fremmedlegeme:

• Placér aldrig en genstand i nogen af slangens åbninger.

• Sørg for, at luftfilteret er påsat under brug af apparatet.

For at sikre optimal behandling må De ikke:

• Betjene apparatet, hvis det er tabt eller beskadiget.

• Betjene apparatet, hvis det ikke fungerer korrekt.

• Justere trykket. Tryk må kun justeres af sundhedspersonale.

• Betjene apparatet, hvis luftslangen er blevet beskadiget med

huller, revner eller knæk.

• Blokere udåndingsstrømmen på masken.

• Bruge masken, hvis enheden er slukket eller ikke fungerer

korrekt.

• Bruge en isoleringsmuffe eller lignende tilbehør, som ikke

er godkendt af Fisher & Paykel Healthcare. De kan påvirke

befugtningsfunktionen.

• Prøve at fjerne den opvarmede luftslange uden at skubbe

muffen op først. Dermed undgås det at beskadige

forbindelsesporten.

For at undgå forbrændinger må De ikke:

• Fylde kammeret med kogende vand.

• Berøre den blotlagte varmeplade eller kammerets bund.

• Placere luftslangen, så den kan komme i kontakt med huden

ilængere tid.

For at undgå brandfare under brug af ilt må De ikke:

• Åbne ilttilførslen, når apparatet ikke er i drift. Det kan medføre

ophobning af ilt inde i apparatet.

• Placere apparatet på et sted, hvor ventilationen omkring

apparatet er begrænset.

• Bruge ilt, mens De ryger eller er i nærheden af åben ild.

• Bruge materialer, som brænder i luft eller som er let

antændelige ved høje iltkoncentrationer.

• Holde nogen antændingskilde i nærheden af produktet. For at
undgå antænding anbefales det at holde alle antændingskilder

ud af rummet, hvor supplerende ilt anvendes.

• Opbevare iltregulatorer, cylinderventiler, slanger, mellemstykker
og alt andet iltrelateret udstyr i nærheden af olie, fedt eller
fedtholdige stoffer. Spontan og voldsom antænding kan

forekomme, hvis disse stoffer kommer i kontakt med ilt

undertryk.

• Betjene apparatet uden dækslet over den serielle portadapter.

Andet:

• Placér apparatet på en jævn overflade, der er lavere end

hovedhøjden, for at forhindre, at der kommer vand ind i
slangen. Aftap overskydende kondens, hvis der kommer vand

ind i slangen. Vand i slangen kan medføre aspiration.

• Apparatet er bestemt til at blive brugt med CPAP-masker
og -stik, der har udåndingshuller for at tillade en konstant
luftstrøm ud af masken. Når apparatet er tændt og fungerer
korrekt, skyller frisk luft udåndingsluften ud gennem maskens
udåndingshuller. Ved lave CPAP-tryk og ved strømsvigt eller

fejl ved apparatet skal masken straks fjernes, da luftstrømmen

gennem masken kan være utilstrækkelig til at fjerne al den
udåndede luft. Det kan medføre, at der genindåndes CO2,
hvilket kan være sundhedsfarligt.

• Hvis der ikke vælges det rigtige højdeniveau (for enhver
placering), vil det have en negativ virkning på det tilførte tryk.

• Dette apparat er ikke beregnet til kunstigt åndedræt.

• Undgå unødvendig fjernelse af netledningen på bagsiden
af apparatet. Hold i stikket, og træk det ud, hvis det er
nødvendigt at fjerne netledningen. Undgå at trække i

netledningen (se afsnit 3.2).

FORSIGTIGHEDSREGLER
For at undgå vandskade på Deres apparat:

• Fjern befugtningskammeret fra apparatet, inden det fyldes

med vand.

• Hæld vand ud af kammeret, før apparatet transporteres. Hvis
det er nødvendigt at håndtere apparatet, mens der er vand
i kammeret, må apparatet ikke vippes for at forhindre, at der

kommer vand ind i det.

Andet:

• For at undgå at beskadige Deres pc må De kun betjene

apparatet, hvis det er tilsluttet til en pc med en isoleret seriel

portadapter (900HC236).

• For at undgå luftvejsirritation må apparatet ikke bruges, når

rumtemperaturen overstiger 95 °F (35 °C).

KONTRAINDIKATIONER

• Videnskabelig forskning viser, at behandling med positivt

tryk er kontraindiceret for visse patienter ved følgende

præeksisterende tilstande: Pneumothorax, bulløs
lungesygdom, pneumocephalus, cerebrospinalvæskelækage,

nylig kraniekirurgi eller -traume, abnormiteter af den
cribriforme plade, patologisk lavt blodtryk, eller hos patienter
med bypass i de øvre luftveje.

ADVARSLER

• Sikkerheden og effektiviteten af positivt tryk er ikke påvist
for patienter med åndedrætssvigt eller kronisk, obstruktiv
lungesygdom (KOL).

KONTRAINDIKATIONER

• Næseblod og ubehag i ører og bihuler kan forekomme ved

behandling med positivt tryk.

Kontakt Deres læge, hvis De har spørgsmål vedrørende Deres

behandling.

C - 3

3. beskrivelse af apparaTeT

3.1 Indpakningens indehold

3.2 Udstyrets vigtigste dele

Tilbehør

1 x SleepStyle™ 600 CPAP Serien

NETLEDNING

og STIK

THERMOSMART™ OPVARMET
PATIENTSLANGE

PORT MED MUFFE

THERMOSMART™ OPVARMET
PATIENTSLANGE PORT

VANDKAMMER

VANDOPFYLDNINGSNIVEAU

(vertikal)

FINGERBESKYTTLESE

VARMEPLADE

VANDOPFYLDNIGSNIVEAU

FILTERHOLDER

DISPLAY

LUFTFILTER

TÆND/SLUK KNAP

3.3 Tilbehør

HC365 Standard Fugterkammer

HC360* Extended Life Fugterkammer

900HC522 ThermoSmart™ opvarmet luftslange, der passer til

den koniske konnektor på 22 mm (0,86")

*Ikke tilgængelig i alle lande

900HC240 Filter (2-pakke)

900HC604 Rengøringskit HC600

900HC627 Bøjet Tragt 10 pakke

1 x Reserve Luftfilter

1 x Strømledning

2 x Vandkammer

1 x Tragt

1 x ThermoSmart™

Opvarmet

Patientslange

TRAGT

Dansk

C - 4

3.4 ThermoSmart™ Teknologi

Dette apparat er designet for optimal komfort og det byder på ThermoSmart™, den unikke teknologi i den opvarmede patientslange.
Takket være ThermoSmart™ teknologien, leveres optimale (højere og brugervenlige) fugtighedsniveauer til patienten, uafhængig af den

omgivende temperatur.

Dette apparat kan justeres på to niveauer for at opnå optimal komfort:

ThermoSmart™ Fugtighedsindstilling: Denne indstilling regulerer temperaturen på varmepladen, og derigennem justeres

fugtighedsniveauet til patientens komfort. Der kan justeres mellem 1 og 4 med 0,5 spring. Apparatet er forindstillet på 2,5, som

passer de fleste patienter.

• Hvis De oplever tørhed eller synes at luften er for kold: øges indstillingen.

• Hvis De synes at der er for meget fugt i luftslangen eller hvis luften føles for varm: mindskes indstillingen.

• Hvis De ikke opnår optimal komfort med denne indstilling, kan videre justeringer foretages ved at ændre på ThermoSmart™
Klimaindstillingen.

ThermoSmart™ Klimaindstilling: Denne indstilling giver flere justeringsmuligheder ved at optimere den tilførte fugtighed. Der kan

justeres mellem 1 og 3 med 1 spring. Apparatet er forindstillet på 2, som passer de fleste patienter. Bemærk, hvis klimaindstillingen

justeres, tilbagestilles fugtighedsindstillingen til default indstillingen.

• ThermoSmart™ Klimaindstilling 3 anbefales ved oral tilførsel.

• Hvis De synes, at indstillingsområdet i ThermoSmart™ indstillingen for fugtigheden er for tørt eller for koldt: Forøg

ThermoSmart™ klimaindstillingen.

• Hvis De synes, at indstillingsområdet i ThermoSmart™ indstillingen for fugtigheden er for varmt eller for fugtigt: Reducér

ThermoSmart™ klimaindstillingen.

Det anbefales at holde luftslangen over dynen for at opnå den bedste befugtning. For at betjene ThermoSmart™ Komfort og

ThermoSmart™ Klimaindstillingerne, henvises til afsnit 8 “Styring og Display”.

4. TilsigTeT formål

Apparatet anvendes til at hjælpe patienten med at trække vejret under søvn, med det formål at behandle Obstruktiv Søvn Apnea (OSA).
Det gøres ved at levere Continuous Positive Airway Pressure (CPAP) (kontinuerligt positivt tryk på luftvejene) for at undgå spærring af
luftvejene. Tilføjelsen af opvarmet fugtning til apparatet afhjælper udtørringen og irritationen på patientens luftveje, som almindeligvis
opstår ved brug af et CPAP-system. Apparatet er tænkt til brug af voksne patienter i hjemmet eller i søvnlaboratoriet.

5. aDvarsler veD brUg af ilT

Hvis ilt er nødvendig, anbefales det, at supplerende ilt gives gennem masken. Se anvisninger, der er gældende for Deres masketype.

BEMÆRK:

• Ved et konstant flow af supplerende ilt vil den inhalerede koncentration af ilt variere, afhængigt af trykindstillingen, patientens

åndedrætsmønster, valget af maske og udsivningshastigheden.

Læs iltadvarslerne i afsnit 2, før der bruges ilt med apparatet.

C - 5

6. rengøring & veDligeholDelse

BEMÆRK VENLIGST: Apparatet bør gøres rent som angivet.

1. Sluk apparatet, og træk stikket ud af stikkontakten. Afvent, at vandet køler af, fjern derefter kammeret.

2. Tør apparatet af udenpå med en ren, fugtig (ikke våd) klud og et mildt opvaskemiddel. Skrappe skuremidler eller opløsningsmidler
må ikke bruges, da disse kan skade apparatet.

3. DAGLIGT

Rengør kammeret, den opvarmede patientslange og porten til den opvarmede patientslange.

• Tag den opvarmede patientslange af apparatet ved at trække muffen op for at løsne forbindelsesstykket. Derefter kan det tages af.

• Vask den opvarmede patientslange i sæbevand, skyl den og hæng den til tørre med enderne ned

til gulvet.

• Fjern kammeret ved at trykke fingerværnet ned og trække kamret ud.

• Hæld det resterende vand ud.

• Standard (HC365) kamre renses og vaskes i sæbevand og skylles og tørres.

• Extended life (HC360) kamre skilles ad, inden de rengøres. Tryk basen fra kamrets top som vist

på Fig. 1. Sørg for, at den runde tætning ikke sidder løs eller er beskadiget. Kamrets top samt
base vaskes med et mildt opvaskemiddel. De skylles grundigt og tørres. Dette kammer kan også

rengøres i en opvaskemaskine til husholdninger.

• Tør grundigt indersiden af porten på den opvarmede patientslange med en ren, fugtig, støvfri klud.

4. UGENTLIGT

Gør kammeret grundigt rent.

• Sæt indersiden af kamret i blød i 10 minutter i en opløsning af en del hvid eddike til fem dele vand,

og skyl det grundigt i destilleret vand.

5. VEDLIGEHOLDELSE

• Udskift luftfiltret når det er betydeligt affarvet, mindst hver tredje måned eller efter 1000 timers drift. Det gøres ved at fjerne

filteret fra apparatets bagside som vist i Fig. 2. Sørg for at den lodrette sorte linje på det nye filter peger mod apparatet og
begge placeres tilbage på apparatet.

• Kamret erstattes, hvis det er revnet, affarvet eller kradset.

• Den opvarmede patientslange erstattes efter 4000 times brug eller en gang årligt. Når slangen er beskadiget, skal den erstattes

omgående.

7. insTallaTionsvejleDning

Når kammeret er installeret og fyldt med vand, er det vigtigt, at apparatet hele tiden
står opret, så at der ikke trænger vand ind i apparatets indre.

1. Fjern apparatet fra indpakningen.

2. Sæt apparatet på en lav hylde eller på gulvet ved siden af Deres seng. Enheden
skal stå et sted under hovedhøjde.

3. Vandkammeret tages ud af dets emballage.

4. De blå kapsler tages af og kasseres (Fig. 1).

5. Fyld vandkammeret med vand til vandopfyldningsniveauet (Fig. 2).

Kammeret må aldrig fyldes gennem porten til den opvarmede
patientslange. Når De flytter apparatet, sørg for at vandkammeret er tomt.
Maskinsvigt på grund af vandskade dækkes ikke af garantien.

6. For at fastgøre vandkammeret på apparatet, tryk fingerværnet ned og glid
kamret på (Fig. 3 og 4).

7. Når Kammeret er anbragt rigtigt, klikker fingerværnet på plads igen.

8. Den ene ende af den opvarmede patientslange har et plast forbindelsesstykke.
Løft muffen og glid forbindelsesstykket på apparatet. Træk muffen ned for at
lukke (Fig. 5, 6 og 7).

9. Forbind den anden ende af den opvarmede patientslange med masken.

10. Sæt stikket i stikkontakten.

11. Tænd for apparatet ved at trykke på Tænd/sluk knappen (Fig. 8). Den aktuelle
ThermoSmart™ fugtighedsindstilling vises.

12. For at ændre indstillingen henvises til afsnittet 8 “Styring og Display”.

Nu er Deres apparat klar til brug.

Fig. 2

Fig. 3

Fig. 4

Fig. 5

Fig. 6

Fig. 7

Fig. 8

Fig. 1

Fig. 1

Fig. 2

Dansk

C - 6

Opvarmet patientslange*

For at ændre temperaturen: Tryk på for levering af varmere og fugtigere luft.

Tryk på for levering af køligere og mere tør luft.* Der henvises til afsnit 3.4

Højde

Vælg ”m” for meter eller ”ft” for fod ved brug af og tasterne

Højdeniveau indstilling

- Indstil højdeniveauet ved at trykke på og tangenterne

- Tryk for at forlade menuen

Aktuelt tryk (Viser aktuelt tryk)

- Hvis man ikke forlader menuen, tilbagestilles displayet til standardindstillingen

Tryk på knappen for at forlade menuen (findes kun i HC608)

8. sTyring og Display

Mode knappen

Gå mulighederne igennem

Ned knappen

Formindske indstillingen

Op knappen

Forøge indstillingen

Trappe knappen

Tænd/sluk

knappen

8.1 Beskrivelse Af Displayet Og Funftioner

KNAP FUNKTION & BESKRIVELSE DRIFT

FOR AT TÆNDE

Tryk kort på knappen
Som standard viser apparatet ThermoSmart™ fugtighedsindstillingen

FOR AT SLUKKE

Tag masken af
Tryk kort på knappen

FOR AT TÆNDE

Tryk på

(BEMÆRK: For at genindstille TRAPPE i en cyklus, skal apparatet først slukkes)

FOR AT SLUKKE

Tryk på

Tryk på og knapperne for at øge eller mindske indstillingerne

Tryk fortløbende for at gennemgå og se de forhåndenværende muligheder

<

<

PATIENT MENU DISPLAY DRIFT

For at se CPAP-indstillingerne, og
hvordan fugtigheden, kontroldata,
højden og trykket er indstillet

FOR AT SE PUNKTERNE

Tryk på tasten for at se respektive:

ThermoSmart™ Fugtighedsindstillingen (default display)

For at justere ThermoSmart™ Fugtighedsniveauet, hvilket reducerer bivirkningerne
til et minimum på de øvre luftveje, på grund af anvendelsen af CPAP.

Tryk på og knapperne for at øge eller mindske indstillingen

Totalt antal timer i drift: viser det totale antal timer som apparatet har

været tændt (timerne uden at masken blev brugt er indregnet)

Gennemsnitsantallet af kontroltimer per nat: viser gennemsnitstiden

apparatet har været i brug om natten med masken på

Kontrolsum: viser information til søvntekninker eller forhandleren til at

kontrollere compliance

Højdeindstilling: viser højdeindstillingen. Tryk eller for at ændre højde

Trykindstilling: viser trykindstillingen

cmH2O

hr

hr/

TÆND/SLUK

Tænder og slukker for apparatet

TRAPPE

Reducerer trykket til et lavere niveau
for at hjælpe Dem med at falde i søvn.
Trykket kommer gradvist op på det
fulde arbejdstryk i løbet af 20 minutter

FORØGE/FORMINDSKE

Juster indstillingerne op eller nedad

FUNKTION

For at gå mulighederne igennem

PATIENT MENU - Yderligere Indstillinger DISPLAY DRIFT

For at få adgang til yderligere
indstillinger:

Fra Default indstillingen

”THERMOSMART™
FUGTIGHED”

Tryk på tasten i 3 sekunder

3000

cmH2O

Advarsel: Hvis man undlader at vælge det rigtige højdeniveau (for hvilket som helst sted), har det en ugunstig effekt på trykleveringen.

* Når der ændres på Thermosmart™ Klimaindstillingen, stilles Fugtighedsindstillingen automatisk tilbage til default indstillingen 2.5.