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 flammable 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 fit into the socket, contact qualified
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 specified 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 specifica
-
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 specified by the doctor in accordance with your specific 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 fields 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 first 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 classification:
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 specified 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 filled 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 fill 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
SN
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
SN
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
SN
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
SN
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
SN
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
SN
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
SN
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
SN
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
SN
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
SN
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, briefly 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 finished 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. Modification 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 filter,
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 filter (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 filter
Under normal conditions of use, the air filter
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 filter, if it is
discoloured grey or brown or if it feels moist. Remove the air filter (Position
4
) replace it with a new
one.
Do not try to clean the filter for reuse. The air filter must not be repaired or maintained,
while it is being used by a patient.
Only use original filters! Do not use the device without a filter!
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 films.
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
7
6
r
w
e
q
2
1
3
4 5
q
a