Priručnik Medisana IN 165 Inhalator

Priručnik

Safety instructions

• This device must only be used for the purpose described in these instructions. The

manufacturer is not liable for damage resulting from improper use.

• Do not use the device in the presence of ammable anaesthetic mixtures with oxygen

or nitrous oxide (laughing gas).

• This device is not suitable for the anaesthesia and ventilation of the lungs.

• This device may only be used with the original accessories, which are listed in these

instructions.

• Do not use the device, if you spot damage or you notice something unusual.

• Never open the device.

• This device consists of delicate components and must be handled with care. Observe

the storage and operating conditions in the chapter “Technical Data”.

• Protect the device from: - water and moisture, - extreme temperatures, - knocks and

drops, - dirt and dust, - strong sunlight, - heat and cold

• Adhere to the safety regulations applicable to electrical appliances, in particular the

following: - Never touch the device with wet or moist hands. - Position the device on a

level and stable surface during use. - Do not pull the power cable or the device to re-

move the plug from the socket. - The power cable plug is used to disconnect the device

from the power supply, it must therefore always remain accessible during use.

• Before connecting the device, make sure that the electrical data on the label on the

bottom of the device match the data of the mains.

• In case the mains plug of the device does not t into the socket, contact qualied

personnel to replace the mains plug. In general, the use of adapters and extension

cables is advised against. If it is essential to use them, then they must meet the safety

regulations. In this case, however, the permitted limit values, which are specied on the

adapters and extension cables, must always be adhered to.

• Do not leave the device plugged in when not in use; remove the plug from the socket

when the device is not being used.

• The installation must be carried out in accordance with the manufacturer’s specica-

tions. Incorrect installation can cause damage to people, animals and objects, for

which the manufacturer cannot be held liable.

• Do not replace the charging cable of this device. In the case of a faulty cable, contact a

technical assistance centre approved by the manufacturer.

• The charging cable should always be fully unwound to avoid dangerous overheating.

• Before every cleaning or maintenance operation, the device must be switched off and

the power cable removed from the socket.

• Only use the medicine prescribed to you by your doctor and follow the instructions of

your doctor regarding dosage, duration and frequency of the therapy.

• Only use the parts specied by the doctor in accordance with your specic illness.

• Only use the nose piece if expressly instructed to do so by your doctor. Make sure that

the tubes are NEVER inserted into the nose, but are only held as near as possible in

front of the nose.

• Check on the package insert of the medicine, whether there are contraindications for

use with the usual systems for inhalation therapy.

• When positioning the device, make sure that the On/Off switch can be easily reached.

• For reasons of hygiene, do not use the same accessories for more than one person.

• Do not tilt the nebuliser by more than 60°.

• Do not use the device near strong electromagnetic elds such as mobile phones or

radio equipment. Keep a minimum distance of 0.3 m to such devices when using this

device.

• Make sure that children do not use the device unsupervised; some parts are so small

that they could be swallowed. Tubes and lines of the device must be laid in such a

way, that there is no risk of tripping, they are not kinked and the risk of strangulation is

eliminated.

• The use of this device is not a replacement for visiting the doctor.

Intended use

The compressor nebulizer IN 165 from medisana is an aerosoltherapy system suitable for

domestic use.

Preparing the device

Before the rst use, we recommend cleaning all components - as described in the chapter

”Cleaning and disinfection”. In between, you can charge the device with the USB cable

w

and USB charging adapter

e

included. To do this, connect the larger of the two connectors

of the cable to the USB charging adapter and plug the other end of the cable into the char-

ging socket

3

of the inhaler. The charge level is displayed with the 4 LEDs

2

.

The current version of this instruction manual can be found at www.medisana.com

In the course of constant product improvements, we reserve the right to make

technical and design changes without prior notice.

Warranty and repair conditions

In case of warranty please contact your specialist shop or the service centre directly.

If you need to return the device, please indicate the defect and enclose a copy of the purchase

receipt.

The following warranty conditions apply:

1. All medisana products are guaranteed for 3 years from the date of purchase.

The date of purchase is to be proven in case of warranty by the purchase receipt or invoice.

2. Defects due to material or manufacturing defects shall be repaired free of charge within the war-

ranty period.

3. A warranty service does not extend the warranty period for either the device or for replaced com-

ponents.

4. The following are excluded from the warranty:

a. Any damage caused by improper handling, e.g. by non-observance of the instruction manual.

b. Damage due to repair or intervention by the purchaser or unauthorised third parties.

c. Transport damage that has occurred on the way from the manufacturer to the consumer

or when sending it to the service centre.

d. Accessories that are subject to normal wear and tear.

5. Liability for direct or indirect consequential damage caused by the device is also excluded when

the damage on the device is recognised as a warranty claim.

DE/GB

This instruction manual belongs to this device.

The instruction manual includes important

information on the initial start-up and handling.

Read this instruction manual completely. Failure

to follow these instructions may result in

serious injury or damage to the device.

WARNING

These warnings must be followed to prevent

possible injury to the user.

NOTICE

These instructions must be followed to prevent

possible injury to the device.

NOTE

These instructions provide you with useful

additional information regarding installation

or operation.

Information about protection type against foreign

objects and water.

This product is subject to European Directive

2012/19/EU on waste electrical and electronic

equipment and is marked accordingly.

Protection class II

Catalogue number On / Off

Device classication:

Medical device

Type BF

Importer Distributer

LOT number

Serial number

Temperature range

Humidity range

Manufacturer

Date of manufacture

Authorised EU representative

Device and controls

Malfunctions and countermeasures

The device cannot be switched on

• Make sure the charging cable is properly plugged in/Charge the battery.

• Make sure that the device has been operated within the operating period specied in these in-

structions (30 min. on / 30 min. off).

The device is only misting a little or not at all

• Make sure that the air tube

7

is properly attached on both ends.

• Make sure that the air tube

7

is not compressed, bent, dirty or blocked. If necessary, replace it

with a new one.

• Make sure that the nebuliser

8

is completely assembled and the atomiser head has been cor-

rectly positioned and is not blocked.

• Make sure that the required inhalation solution is lled in the correct amount (up to 6 ml).

0123

IP21 IP21

Globalcare Medical Technology Co., Ltd.

7th Building, 39 Middle Industrial Main Road, European Industrial Zone, Xiaolan Town, 528415

Zhongshan City, Guangdong Province, PEOPLE’S REPUBLIC OF CHINA

Phone : +86 760 22589901 http://www.globalcare.com.hk/contact/

EC REP

Name

Power supply

Nebulisation amount (average)

Particle size

max. pressure

Noise level

Nebuliser ll quantity

Operating period

Expected service life

Operating conditions

Storage and transport conditions

Weight

Dimensions

Length of the power cable

IP class

Reference to standards

Item number

EAN number

medisana Inhaler IN 165, type: GCE845

Input: 100-240 V~ 50-60 Hz; Output: 5V DC, 2A

0.25 ml/min.

2.9 μm

1.1 bar

45 dBA

min. 2 ml; max. 6 ml

30 min. on / 30 min. off

400 hours

10 - 40 °C / 50 - 104 °F

10 - 95 % relative maximum humidity

700 - 1060 hPa air pressure

-20 - +60 °C / -4 - +140 °F

10 - 95 % relative maximum humidity

700 - 1060 hPa air pressure

240 g

10.8 x 7.2 x 4.4 cm

150 cm

IP 21

EN 60601-1; EN 60601-2; 93/42/EWG

54556

40 15588 54556 6

This device must not be disposed of with domestic waste.

All users are obliged to bring all electrical or electronic devices to a collection point in their

town/city or to a retailer, whether the devices contain any hazardous materials or not, so

that they can be disposed of in an environmentally responsible manner.

Please contact your local authority or retailer with regard to disposal procedures.

Technical data

This device meets the requirements of the Directive concerning medical devices 93/42/EEC.

Device in Class II in relation to protection against electric shocks. Nebuliser, mouthpiece and masks

are applied parts of type BF.

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

GB Instruction manual Inhaler IN 165

I / O

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

Ambient pressure

limitation

Please report any serious incident that has occurred in relation to the device injury or ad-

verse event to the local competent authority and to the Manufacturer or to the European

Authorised Representative (EC REP).

Vigilance contact point: https://ec.europa.eu/growth/sectors/medical-devices/contacts/

EC REP

Donawa Lifescience consulting Srl,

Piazza Albania, 10, 00153 Rome, Italy

https://www.donawa.com/wli/main/contatti.index

CAUTION /

注意！查阅随机文件

Type BF applied part /

BF型应用设备

Read the instructions for use /

请阅读说明书

Device in protection class 2 /

二类设备

Manufacturer / 制造商

Keep dry / 保持干燥 / 怕雨

WEEE

S

N

Serial number

Permissible storage and transport

temperature and humidity

Storage/Transport

Operation

Permissible operating temperature

and humidity

Medical device

Distributor

Date of manufacture

Do not use outdoors

(indoor use only)

Single patient multiple use

PA

2020F213-44

中国GCC血压计计量证号

REF

Reference number

LOT

Batch number

I

ON

OFF

Dispose of packaging in an

environmentally friendly manner

70°C 95%

-25°C

Storage/Transport

10% 700hPa

1060hPa

10°C

40°C

95%

700hPa

1060hPa

Operating

10%

Importer

Please read this instruction manual carefully, in particular the

safety instructions, before using the device. Keep the instruction

manual in a safe place for later reference.

If you pass the device on to a third party, this instruction manual

must remain with the device.

GB IMPORTANT INFORMATION! KEEP IN A SAFE PLACE!

Application

You have two options for the power supply of your inhaler:

Charge the device as described in ‚Preparing the device‘ (for example for use while travelling) or use

the cable and adapter as a direct power supply.

To start the treatment, briey press the On/Off button

1

.

While inhaling, sit upright and in a relaxed position at a table (not in an armchair), so as not to com-

press the airways and therefore not to impair the effectiveness of the treatment. Do not lie downduring

the inhalation. Stop the inhalation if you feel unwell.

After you have nished inhaling for the amount of time recommended by your doctor, press the On/Off

button

1

in order to switch off the device and remove the plug from the electrical socket.

Empty the remaining inhalation solution from the nebulizer and clean the device as described in the

chapter “Cleaning and disinfection”.

• This device was developed for operation in 30 minutes On / 30 minutes Off mode. Please switch

off the device after 30 minutes and wait a further 30 minutes, before you continue the treatment.

• The device does not require calibration. Modication of the device is not permitted.

Scope of delivery

• 1 medisana Inhaler IN 165 (

1

On/Off button,

2

Charging indicator,

3

Micro-USB port

(charging socket),

4

Position of the air lter,

5

Connection for the air tube)

• 1 Instruction manual

• Accessories:

6

Nosepiece,

7

2 Air tubes,

8

Nebulizer,

9

Mouthpiece,

0

Adult face mask,

q

Child face mask & Baby face mask without illustration (with adapter

q

a),

w

Micro-USB cable

(charging cable),

e

USB charging adapter,

r

5 x Air lter (replacement at position

4

), Storage

bag (without illustration)

Cleaning and disinfection

• Clean all accessories thoroughly after each treatment in order to remove residues of medicinal

product and possible impurities.

• Use a soft, dry cloth and a non-abrasive cleaning agent to clean the compressor.

• Make sure that there is no intrusion of liquids into the device and the power cable is disconnected.

Cleaning and disinfection of the accessories

Follow the instructions for cleaning and disinfecting the accessories exactly, as they are fundamental

for the performance of the device and the success of the therapy.

Before and after each application

1. Turn the upper part of the nebulizer

8

anticlockwise in order to open the nebulizer and remove the

atomiser head.

2. Wash all parts of the nebulizer, the mouthpiece

9

and the nosepiece

6

. Then place in boiling water

for 5 minutes.

3. Wash the masks and the air tube with warm water.

4. Assemble the nebulizer parts again and connect the nebulizer to the air tube.

5. Switch the device on and leave in use for 10-15 minutes.

Use only cold sterilisation solutions in accordance with the manufacturer’s instructions.

Do not boil or autoclave masks and the air tube.

Maintenance and care

Replacement of the nebulizer

Replace the nebulizer

8

after a longer period of non-use, if it has deformations or cracks or if the

atomiser head is blocked by dried-up medicine, dust, etc. We recommend replacing the nebulizer

after 6 to 12 months depending on use. Only use the original nebulizer!

Replacement of the air lter

Under normal conditions of use, the air lter

4

/

r

should be replaced after about 500 hours of use or

once a year. We recommend regularly checking (10-12 applications) and replacing the air lter, if it is

discoloured grey or brown or if it feels moist. Remove the air lter (Position

4

) replace it with a new

one. Do not try to clean the lter for reuse. The air lter must not be repaired or maintained,

while it is being used by a patient.

Only use original lters! Do not use the device without a lter!

Open the nebulizer

8

by turning the cover anticlockwise.

Make sure the atomizer head is properly seated on the cylindrical head of the

nebulizer.

Fill the nebulizer with the inhalation solution prescribed by your doctor. Make sure

that the maximum level (6 ml) is not exceeded.

Close the nebulizer

8

by turning the cover clockwise.

Insert the air tube

7

into the nebulizer

8

and connect the other end of the tube

to the inhaler (Position

5

).

Insert the mouthpiece or nosepiece or mask directly into the nebulizer (put on the

child and baby mask

q

with the help of the adapter

q

a).

WARNING

Make sure that children do not get hold of the packaging lms.

There is a risk of suffocation!

Aerosol properties according to EN 13544-1 APPENDIX CC

Aerosol emission: 0.51 ml

Aerosol emission rate: 0.16 ml/min.

Particle size (MMAD): 2.9 μm

~

Alternating

current

Single patient

multiple use (for

accessories only)

Explanation of symbols

8

9 0

76

r

w

e

q

21 3

4 5

q

a

Ocjena

Više o ovom priručniku

Razumijemo da je lijepo imati papirnati priručnik za svoj Medisana IN 165 Inhalator. Uvijek možete preuzeti priručnik s naše web stranice i sami ga ispisati. Ako želite imati originalni priručnik, preporučujemo da kontaktirate Medisana. Oni bi mogli osigurati originalni priručnik. Tražite li priručnik za svoj Medisana IN 165 Inhalator na drugom jeziku? Odaberite željeni jezik na našoj početnoj stranici i potražite broj modela da vidite imamo li ga na raspolaganju.

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