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EN Instructions for Use for devices of type WM 090 TD

prisma SMART prisma SOFT

Sleep therapy devices

Contents

Contents

1

Introduction

4

1.1

Intended use …………………………………………………………………………………

4

1.2

Description of function …………………………………………………………………..

4

1.3

User qualifications ………………………………………………………………………….

4

1.4

Indications ……………………………………………………………………………………

4

1.5

Contraindications …………………………………………………………………………..

5

1.6

Side effects …………………………………………………………………………………..

5

2

Safety

6

2.1

Safety information …………………………………………………………………………

6

2.2

General information ……………………………………………………………………….

6

2.3

Warnings in this document ……………………………………………………………..

8

3

Product description

9

3.1

Overview ……………………………………………………………………………………..

9

3.2

Operating states ………………………………………………………………………….

10

3.3

Control panel ………………………………………………………………………………

10

3.4

Symbols in the display …………………………………………………………………..

11

3.5

Accessories …………………………………………………………………………………

12

4

Preparation and operation

13

4.1

Set up and connect the device ……………………………………………………….

13

4.2

Start therapy ……………………………………………………………………………….

15

4.3

End therapy/switch off device ………………………………………………………..

15

4.4

Set humidifier ……………………………………………………………………………..

15

4.5

Performing the mask test ………………………………………………………………

16

4.6

Switch softSTART on and off ………………………………………………………….

17

4.7

Use SD card (optional) …………………………………………………………………..

18

5

Menu settings

19

5.1

Function of the keys ……………………………………………………………………..

19

5.2

Settings menu ……………………………………………………………………………..

19

5.3

Info menu/read out operating hours ……………………………………………….

21

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WM 68201a 06/2016

Contents

6

Hygiene treatment

22

6.1

General information ……………………………………………………………………..

22

6.2

Cleaning intervals ………………………………………………………………………..

22

6.3

Hygiene treatment for device …………………………………………………………

23

6.4

Hygiene treatment for breathing tube ……………………………………………..

25

7

Function check

25

8

Troubleshooting

26

8.1

Device faults ……………………………………………………………………………….

26

8.2

Display messages …………………………………………………………………………

27

9

Servicing

28

10

Storage

28

11

Disposal

28

12

Appendix

29

12.1Technical data ……………………………………………………………………………..

29

12.2Marks and symbols ………………………………………………………………………

33

12.3Scope of supply …………………………………………………………………………..

35

12.4Accessories and replacement parts ………………………………………………….

36

12.5Warranty ……………………………………………………………………………………

36

12.6Declaration of conformity ……………………………………………………………..

36

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EN | 3

1 Introduction

1 Introduction

1.1 Intended use

Devices of the WM 090 TD type are pressure-controlled, non-invasive, non-life- supporting therapy devices for treating sleep-related breathing disorders (SRBDs) using a mask. The devices are used on persons weighing 30 kg or more. CPAP mode can be used on persons aged 3 years upwards. The device may only be used on a physician’s instructions. (auto)CPAP mode provides positive airway pressure for treating obstructive sleep apnea in patients who breathe spontaneously. Devices of the WM 090 TD type are used in clinical facilities and in the domestic environment. In the domestic environment, the devices also accompany the owner on trips away.

1.2 Description of function

A blower takes in ambient air through a filter and pumps it to the patient at therapy pressure through the patient circuit and the patient/ventilator interface. The user interface is for displaying and setting the available parameters. Therapy data are saved on the SD card and can be evaluated using PC software.

1.3 User qualifications

The person operating the device is referred to in these Instructions for Use as the user. A patient, on the other hand, is the person receiving the therapy.

As an owner/operator or user you must be familiar with the operation of this medical device. The owner/operator is responsible for ensuring the compatibility of the device and of all the components or accessories connected to the patient before use.

When the device is handed over to the patient, as the attending physician or medical specialist you must provide instruction in the function of the device.

1.4 Indications

prisma SOFT

CPAP therapy device for treating patients with obstructive sleep apnea with a constant pressure requirement.

prisma SMART

APAP therapy device for treating patients with obstructive sleep apnea with a variable pressure requirement. Therapy pressure adapts automatically to the patient’s pressure requirement.

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1 Introduction

1.5 Contraindications

The following contraindications are known – in the individual case, responsibility for deciding whether to use the device rests with the attending physician. Threatening situations have not ever been observed.

Cardiac decompensation, severe cardiac arrhythmias, severe hypotension, especially in combination with intravascular volume depletion, severe epistaxis, high risk of barotrauma, severe lung disease (e.g. COPD), pneumothorax or pneumomediastinum, pneumoencephalus, head injury, status following brain surgery and following surgical procedures on the hypophysis or middle or inner ear, acute inflammation of the nasal sinuses (sinusitis), middle ear infection (otitis media) or perforated eardrum, dehydration.

1.6 Side effects

When using the device, the following undesired side effects may occur in short-term or long-term use: pressure points from the mask and the forehead cushion on the face, reddening of the facial skin, dry throat, mouth, nose, feeling of pressure in the sinuses, irritated mucous membrane in the eyes, gastrointestinal insufflation of air («bloating»), nosebleeds, reduced auditory capacity.

These are general side effects not attributable specifically to use of devices of the WM 090 TD type.

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2 Safety

2 Safety

2.1 Safety information

2.1.1 Handling the device, the components and the accessories

If the device is damaged or its function is restricted, patients, users and people in the vicinity may be injured.

⇒Only operate the device and its components if they are externally undamaged.

⇒Perform a function check at regular intervals (see «7 Function check», page 25).

⇒Only operate device within the specified ambient conditions (see «12.1 Technical data», page 29).

⇒Do not reuse disposables. Disposables may be contaminated and/or their function may be impaired.

⇒Water and dirt in the device may damage the device.

⇒Only transport the device with the cover fitted.

⇒Transport the device in the associated carrying bag.

⇒Do not transport or tilt the device with the humidifier full.

⇒Use the gray air filter.

⇒Use the white pollen filter (optional accessory) if required.

2.1.2 Energy supply

Operating the device outside the specified energy supply may injure the user and damage the device.

⇒Operate the device only with the power supply unit provided on voltages from 100 V to 240 V.

⇒Use the DC adapter for operation on voltages of 12 V or 24 V.

⇒Keep access to the power supply connector and the power supply free at all times.

2.1.3 Handling oxygen

Supplying oxygen without a special safety device can lead to fire and injure people.

⇒Follow the Instructions for Use for the oxygen supply system.

⇒Set up oxygen sources at a distance of over 1 m from the device.

⇒At the end of therapy, shut off the oxygen supply and allow the device to run on briefly to flush residual oxygen out of the device.

2.2 General information

•The use of third-party articles may lead to incompatibility with the device. In such cases, please be aware that any claim under warranty and liability will be void if neither the accessories nor the genuine replacement parts recommended in the Instructions for Use are used.

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2Safety

•Have measures such as repairs, servicing and maintenance work carried out by the manufacturer or by specialists expressly so authorized by the manufacturer.

•Connect only the devices and modules permitted in accordance with these Instructions for Use. The devices must meet the product standard applicable to them. Non-medical equipment should be positioned away from the patient’s vicinity.

•The device is subject to special precautions with regard to EMC (electromagnetic compatibility). Maintain the recommended safety distances (see «12.1.5 Safety distances», page 33) between the device and devices which emit high-frequency radiation (e.g. cellphones) to prevent malfunctions.

•In combination with the device itself, the use of tube heating will generate a slightly higher temperature at the patient connection opening.

•The operator is responsible for ensuring that the setting of the therapeutic pressure has been determined for each patient individually with the device configuration to be used.

•The operator should regularly assess the effectiveness of the therapeutic settings.

•To prevent infection or bacterial contamination, follow the section about hygiene treatment (see «6 Hygiene treatment», page 22).

•Keep therapy device and accessories away from children and pets. Store therapy device in transportation case when not in use or being transported.

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2 Safety

2.3 Warnings in this document

Warnings indicate information relevant to safety.

Within procedures, you will find warnings in front of a step which contains a hazard to persons or objects.

Warning!

Indicates an unusually significant hazardous situation. If you ignore this instruction, severe irreversible or fatal injuries may result.

Caution!

Indicates a hazard. If you do not follow this instruction, mild or moderate injuries may result

Note!

Indicates a harmful situation. If you do not follow this instruction, material damage may result.

Indicates useful information within procedures.

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3 Product description

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3 Product description

3.1Overview 1 2

3

4 5

6

13

9

7

10 12

8

11

1Humidifier connection with cover

2Release catch

3Control panel with display

4Interface for connecting the communication module

5Handle

6Filter compartment

7Connection for power supply cable

8Breathing tube with connection for mask

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3 Product description

9SD card slot

10Power supply unit

11SD card

12Power cord

13Device outlet port

3.2 Operating states

•On: therapy is running.

•Standby: blower is off, but immediately operational if the On/off key is pressed briefly. Settings can be made on the device when it is in standby mode.

•Off: the device is de-energized. No settings can be made and the display remains dark.

3.3 Control panel

p

r

i

T

s

m

a S

R

1

4

2

3

5

1 key*

2 key*

3 On/Off key*

4 Menu key*

5 softSTART key*

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3 Product description

The keys of the device may have different functions. If there is a symbol above the key in

*the display, the key adopts the function of the symbol in question. If there is no symbol above the key, the key retains its original function.

3.4Symbols in the display

SYMBOL DESCRIPTION

Orange symbol: expert area active.

White symbol: parameters enabled for patient.

Parameter is disabled for patient.

Info menu

Settings menu

SoftSTART symbol

Green symbol: SD card inserted. When the symbol is flashing, data are being written to the SD card.

Orange symbol: SD card fault

Leak display. Mask or tube leaking.

White symbol: Humidifier connected.

Green symbol: Humidifier switched on.

Back to start screen

Cancel

Forward one menu item

Back one menu item

Confirms the current selection.

Selection adopted successfully.

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3 Product description

3.5 Accessories

1

2

3

1Humidifier

2Pollen filter (white)

312-24 V DC adapter

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4 Preparation and operation

4 Preparation and operation

4.1 Set up and connect the device

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Risk of injury due to contaminated or infected patient circuit!

A contaminated or infected patient circuit may transmit contamination or infections to the next patient.

⇒Do not reprocess disposable patient circuits.

⇒Subject reusable patient circuits to the correct hygiene treatment.

Material damage from overheating!

Excessive temperatures may lead to the device overheating and damage the device.

⇒Do not cover device and power supply unit with textiles (e.g. bedclothes).

⇒Do not operate device in the vicinity of a radiator.

⇒Do not expose device to direct sunlight.

⇒Do not operate device in the carrying bag.

1. Connect the power supply unit to the device.

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4 Preparation and operation

2.Connect the power cord to the power supply unit and the socket.

The operating hours of the device are displayed briefly. The device switches to standby.

Risk of injury if breathing tube routed incorrectly!

An incorrectly routed breathing tube may injure the patient.

⇒Never wrap the breathing tube around the neck.

⇒Do not crush the breathing tube.

3. Push breathing tube onto the device outlet port.

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4 Preparation and operation

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Risk of suffocation if full-face masks without an exhalation system are used! If full-face masks without an exhalation system are used, the CO2 concentration may rise to critical values and put the patient at risk.

⇒Use full-face masks with an external exhalation system if there is no integrated exhalation system.

⇒Follow the Instructions for Use for the exhalation system.

4.Connect the mask to the breathing tube (see Instructions for Use for the breathing mask).

The proper position and arrangement of the mask on the face of the patient is critical for uniform use of the device.

4.2 Start therapy

Requirement

Device is set up and connected (see «4.1 Set up and connect the device», page 13).

1.If the display is dark: press any key briefly. The device switches to standby.

2.Briefly press the On/off key . or

If the autoSTART function is activated: breathe into the mask. Current therapy pressure appears in the display. Therapy starts.

For more information on autoSTART (see «5 Menu settings», page 19).

4.3End therapy/switch off device

1.Briefly press the On/off key . or

If the autoSTART function is activated: remove mask.

The device displays the therapy hours for the current day and then switches to standby.

To save energy, you can disconnect the plug from the socket during the day.

4.4 Set humidifier

Requirement

Humidifier is connected and filled with water (see Instructions for Use for humidifier).

The humidifier symbol can be seen in the display.

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4 Preparation and operation

1.Start therapy (see «4.2 Start therapy», page 15).

The humidifier switches on automatically. The humidifier symbol goes green .

2.To increase the humidifier stage: press the key.

3.To decrease the humidifier stage: press the key.

4. To switch off the humidifier: press the

key until 0 appears in the display.

•The humidifier stage suitable for you depends on room temperature and humidity. If you have dry airways in the morning, heating output is set too low. If condensation has formed in the breathing tube in the morning, heating output is set too high.

•When the water level in the humidifier is too low, the device switches off the humidifier automatically.

•If the humidifier symbol is flashing, you need to fill the humidifier with water (see Instructions for Use for humidifier).

4.5Performing the mask test

Requirement: Therapy is running.

1. Press menu button .

2.To start the mask test: Press .

The remaining time and the mask test pressure are displayed.

3.If necessary: Press or button to change the mask test pressure.

4.Check mask for leaks.

Proper mask location: Green checkmark.

Mediocre mask location: Leakage display turns orange.

Poor mask location: Leakage display flashes.

5.If necessary: Adjust mask.

6.Wait until the device has completed the mask test. or

Press .

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4 Preparation and operation

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4.6 Switch softSTART on and off

Requirement

Therapy is running. softSTART is activated by the physician.

If the soft start is activated, the device automatically turns on every time therapy is started.

1. Press the softSTART key briefly to switch on softSTART manually.

Remaining time and the current softSTART pressure are displayed.

2.Press the softSTART key briefly to switch off softSTART.

•If you press the softSTART key when the device is on standby, the device switches to the patient menu and you can adjust the softSTART time (see «5.2 Settings menu», page 19).

•To deactivate softSTART, set the softSTART time to OFF

4.7Use SD card (optional)

If an SD card is present, the device automatically saves the therapy data to the SD card. An SD card is not required to operate the device.

Requirement

The device is on standby.

Loss of data if power is interrupted!

If the device is disconnected from the power supply during the save process, data may be lost.

⇒Leave the device connected to the power supply during the save process (SD card

symbol flashing).

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4 Preparation and operation

1.Push the SD card into the SD card slot until you hear it engage. The SD card symbol appears in the display.

2.To remove it, press the SD card briefly and remove the SD card. In doing so, please note: do not remove the SD card while the SD card symbol is flashing.

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5 Menu settings

5 Menu settings

5.1 Function of the keys

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The keys of the device may have different functions. If there is a symbol above the key in the display (e.g. above the softSTART key), the key adopts the function of the symbol in question. If there is no symbol above the key (e.g. in the case of the key), the key retains its original function.

5.2 Settings menu

5.2.1 Navigate in the menu

Requirement

The device is on standby.

1. Press the menu key .

2.To call up the settings menu: press .

3.Make settings in the menu.

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5 Menu settings

FUNCTION KEY DESCRIPTION

Scroll forward through menu

Scroll back through menu

Increase value

Reduce value

Confirm value

Discard value

Exit menu. Switch back to start screen.

5.2.2 Menu structure

You can set the following parameters if your physician has enabled them for you.

PARAMETER

DESCRIPTION

Here you can set the time for which ventilation pressure rises to

softSTART (t)

therapy pressure during the softSTART. If this function cannot be

selected, it needs to be enabled by the physician or specialist

dealer.

If autoSTART is activated (ON), the device can be switched on by a

autoSTART

breath (> 0.5 hPa) being taken into the mask and switches off

automatically after 5 seconds without a breath being taken.

Switch autoSTART to OFF to switch off this function.

The device temporarily reduces therapy pressure in stages1 and 2

before the transition to exhalation.

softPAP

softPAP breathing relief is suitable for patients who find it

unpleasant to exhale against a high pressure. Switch softPAP to

OFF to deactivate this function.

Time

You can set the current time here.

Format time

Here you can set whether the time is to be displayed in the form

display

0-24 (24-h clock) or 0-12 (12-h clock).

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5 Menu settings

5.3 Info menu/read out operating hours

Requirement

The device is on standby.

1. Press the menu key .

2.To call up the info menu: press .

3.Navigate to the desired value with the or keys:

DISPLAY

MEANING

0000 h

Total operating hours of the device

1 d

Operating hours for the last day.

7 d

Operating hours for the last 7 days.

28 d

Operating hours for the last 28 days.

182 d

Operating hours for the last 182 days.

366 d

Operating hours for the last 366 days.

•Data are displayed only if they really are present in the device.

•Each therapy day begins and ends at 12 noon. Data recorded from midnight to 12 noon are assigned to the previous calendar day.

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6 Hygiene treatment

6 Hygiene treatment

Risk of infection when the device is used again!

If the device is used by several patients, infections may be transmitted to the next patient.

⇒If the device is used again: have the device subjected to a hygiene treatment by the manufacturer or an authorized specialist dealer.

6.1General information

•Wear appropriate safety gear for the disinfecting process.

•Refer to the Instructions for Use for the disinfectant used.

•Following a hygiene treatment by the authorized specialist dealer, the device is suitable for using again with other patients.

6.2 Cleaning intervals

INTERVAL

ACTION

Clean device (see «6.3 Hygiene treatment for device», page 23)

Weekly

Clean breathing tube (see «6.4 Hygiene treatment for breathing

tube», page 25)

Clean air filter (see «6.3.1 Clean air filter (gray filter)», page 24)

Monthly

Replace pollen filter (see «6.3.2 Replace optional pollen filter (white

filter)», page 24)

Every 6 months

Replace air filter

Annually

Replace breathing tube

As required

In the clinical sphere: disinfect breathing tube (see «6.4 Hygiene

treatment for breathing tube», page 25)

On change of

Have specialist dealer perform a hygiene treatment on the device

patient

before using it again.

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6 Hygiene treatment

6.3 Hygiene treatment for device

Risk of injury from electric shock!

Ingress of liquids may lead to a short-circuit, injure the user and damage the device.

⇒Disconnect the device from the power supply before the hygiene treatment.

⇒Do not immerse the device and components in liquids.

⇒Do not pour liquids over the device and components.

1.Subject the device and components to a hygiene treatment in accordance with the table below.

PART

CLEANING

DISINFECTING

STERILIZATION

Housing including

Wipe down: use

device outlet port/

water or mild

inlet

detergent

Disinfect by wiping

Wipe down: use

(recommended

High-gloss surfaces

water or mild

products:

Not permitted

on the housing

detergent; do not use

terralin® protect or

microfiber cloths

perform advanced

Alcohol EP)

Power cord and

Wipe down: use

water or mild

power supply unit

detergent

2.Replace mask, breathing tube, air filter and pollen filter (if present).

3.Perform function check (see «7 Function check», page 25).

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6 Hygiene treatment

6.3.1 Clean air filter (gray filter)

1

1.Clean air filter 1 under running water.

2.Allow air filter 1 to dry.

6.3.2Replace optional pollen filter (white filter)

2

1

1.Remove air filter 1 .

2.Replace white pollen filter 2 .

3.Replace air filter 1 in the holder.

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7 Function check

6.4 Hygiene treatment for breathing tube

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Risk of material damage as a result of ingress of liquids!

The device may be damaged by the ingress of liquids.

⇒ Use the breathing tube only when completely dry.

1.

Subject the breathing tube to a hygiene treatment in accordance with the table

below.

CLEANING

DISINFECTING

STERILIZATION

With hot water and

Disinfect by immersion

(Recommended product:

Not permitted

detergent

gigasept FF®)

2.

Rinse off breathing tube with clean water and shake thoroughly.

3.

Dry breathing tube.

If you use a heated breathing tube, see the Instructions for Use for the breathing tube.

7 Function check

Carry out a function check after each hygiene treatment and maintenance task, but at least every 6 months.

1.Check device for external damage.

2.Check connectors and cables for external damage.

3.Check that components are correctly connected to the device.

4.Connect device to the power supply and switch it on (see «4.1 Set up and connect the device», page 13).

5.If softSTART is active: press softSTART key to cancel softSTART.

6.Close the opening of the breathing mask.

7.Compare the pressure shown in the display with the prescribed pressure.

8.If one of the items is not OK or pressure deviates by > 1 hPa: do not use device and contact your specialist dealer.

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8 Troubleshooting

8 Troubleshooting

If you are unable to remedy faults with the aid of the table, or in the event of unexpected operation or an incident, contact the manufacturer or your authorized specialist dealer. To avoid exacerbating the damage, do not continue operating the device.

You can find an explanation of the symbols which may appear in the display in the product description (see «3.4 Symbols in the display», page 11).

8.1 Device faults

FAULT/FAULT MESSAGE

CAUSE

REMEDY

No running noise, nothing

Check that the power cord

No power supply.

is securely connected.

in the display.

Check function of socket.

Therapy cannot be started

autoSTART function not

Activate autoSTART

by taking a breath.

activated.

function.

Device does not switch off

autoSTART function may

be restricted in the case of

Contact your specialist

after approx. 5 seconds

accessories with a high

dealer.

once mask is removed.

resistance.

softSTART cannot be

softSTART function is

Ask the physician whether

the function can be

switched on.

disabled.

enabled.

Clean air filter. If necessary:

Air filter dirty.

replace filter (see «6

Hygiene treatment», page

Device does not reach the

22).

set target pressure.

Adjust headgear so that

Breathing mask leaking.

the mask is tight.

If necessary, replace faulty

mask.

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8 Troubleshooting

8.2 Display messages

If the message Err (xxx) appears in the display, look in the table for the error code displayed. Remedy the error in accordance with the description.

ERROR CODE

CAUSE

REMEDY

(108)

Device has lost the

Contact specialist dealer and have device

saved time.

repaired.

Remove humidifier from device and re-

Humidifier not

connect it.

(204)

If the message continues to be displayed,

working properly.

contact an authorized specialist dealer and

have the device and the humidifier checked.

(601), (610) or

Faulty SD card

Remove and reinsert SD card. If the message

(609)

persists, replace the SD card.

(603)

SD card full

Delete data from the SD card/Use new SD

card.

Remove humidifier or side cover from device

Leak on humidifier or

and re-connect.

(701)

at the cover on the

If the message continues to be displayed,

side

contact an authorized specialist dealer and

have the device and the humidifier checked.

Disconnect the device from the power supply

All other error

and reconnect it (see 4.1, p.13).

Electronics problems

If the message continues to be displayed,

codes

contact an authorized specialist dealer and

have the device and the humidifier checked.

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9 Servicing

9 Servicing

The device is designed for a service life of 6 years.

If used in accordance with the intended use, the device requires no servicing during this period.

If the device is used beyond this period, it needs checking by an authorized specialist dealer.

10 Storage

Store the device under the specified ambient conditions. Clean the device before storing it.

11 Disposal

Do not dispose of the product or any rechargeable batteries with domestic waste. To dispose of properly, contact a licensed, certified electronic scrap disposal merchant. This address is available from your Environment Officer or from your local authority.

The device packaging (cardboard and inserts) can be disposed of in paper recycling facilities.

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12 Appendix

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12 Appendix

12.1 Technical data 12.1.1 Device

SPECIFICATION

DEVICE

Product class to 93/42/EEC

IIa

Dimensions W x H x D in cm

17 x 13.5 x 18

Weight

1.34 kg

Temperature range

– operation

+5 °C to +40 °C

– storage

-25 °C to +70 °C

Rel. humidity, non-condensing

for

– operation

10% to 93%

– storage

10% to 95%

Air pressure range

700 hPa to 1060 hPa, corresponds to an altitude of 3000

m above mean sea level

Connection diameter of

19.5 (fits standard tapered connector)

breathing tube in mm

Power capacity

Max. 40 VA

System interface

24 V DC

Max. 5 VA

Current consumption in

operation (therapy)

230 V

0.13 A

115 V

0.22 A

on standby

230 V

0.036 A

115 V

0.053 A

Classification to DIN EN 60601-

1-11:

class of protection against

Protection class II

electric shock

degree of protection against

Type BF

electric shock

protection against damaging

IP21

ingress of water and solids

EN | 29

12 Appendix

SPECIFICATION

DEVICE

Classification to DIN EN 60601-

1:

Continuous duty

duty cycle

Application part

Breathing mask

Electromagnetic compatibility

Test parameters and limit values can be obtained from

the manufacturer on request.

(EMC) to DIN EN 60601-1-2

EN 55011 B

Radio interference suppression

IEC 61000-4 Parts 2 to 6, Part 11, Part 8

Radio interference immunity

IEC 61000-3 Parts 2 and 3

Mean sound pressure level/

approx. 26 db(A) at 10 hPa (corresponds to a sound

operation to ISO 80601-2-70

power level of 34 db(A))

Mean sound pressure level/

approx. 27.5 db(A) at 10 hPa (corresponds to a sound

operation to ISO 80601-2-70

power level of 35.5 db(A))

with humidifier

CPAP operating pressure range

4 hPa to 20 hPa

Pressure accuracy

0.5 hPa ± 3% of the measured value

P limmax (maximum pressure in