Medisana IN 155 Manual De Instrucciones página 2

DE/GB GB
GB Instruction manual Inhaler IN 155
Device and controls
w
7 8
Safety instructions
•
9 •
7 a
•
•
6
•
•
0
•
0 a
•
5 q
e •
CAUTION /
REF
Reference number
注意！查阅随机文件
•
4
REF
Reference number
•
Type BF applied part /
REF LOT
Reference number 3
Batch number
BF型应用设备
CAUTION /
1
LOT
Batch number 注意！查阅随机文件
Read the instructions for use /
I
LOT
2 •
Batch number 请阅读说明书
ON
Type BF applied part /
I
BF型应用设备
•
Device in protection class 2 /
ON
I
Explanation of symbols
Read the instructions for use / 二类设备
OFF
ON
This instruction manual belongs to this device.
请阅读说明书 •
The instruction manual includes important
information on the initial start-up and handling.
OFF
•
Read this instruction manual completely. Failure Device in protection class 2 /
Manufacturer / 制造商
to follow these instructions may result in
Dispose of packaging in an •
二类设备
OFF
serious injury or damage to the device. environmentally friendly manner
•
WARNING
Dispose of packaging in an
These warnings must be followed to prevent
environmentally friendly manner Manufacturer / 制造商 Keep dry / 保持干燥 / 怕雨
possible injury to the user. •
Dispose of packaging in an
environmentally friendly manner
•
NOTICE
CAUTION /
CAUTION /
These instructions must be followed to prevent
Importer
Keep dry / 保持干燥 / 怕雨
注意！查阅随机文件 WEEE
possible injury to the device. 注意！查阅随机文件
•
NOTE
Importer
Type BF applied part /
These instructions provide you with useful
Type BF applied part /
WEEE
•
additional information regarding installation
BF型应用设备 SN
Importer Serial number
BF型应用设备
or operation. •
•
Read the instructions for use /
REF Information about protection type against foreign
IP21 IP21 Read the instructions for use /
Reference number SN
Serial number
•
objects and water.
请阅读说明书
Storage/Transport
请阅读说明书
Permissible storage and transport
temperature and humidity
This product is subject to European Directive
LOT
Batch number •
Storage/Transport
2012/19/EU on waste electrical and electronic Device in protection class 2 /
Permissible storage and transport
Device in protection class 2 /
temperature and humidity
equipment and is marked accordingly.
I 二类设备
二类设备
Operation
ON Permissible operating temperature
~
Alternating and humidity
Operation
Protection class II CAUTION / Permissible operating temperature
•
current
and humidity
Manufacturer / 制造商
OFF
Manufacturer / 制造商
注意！查阅随机文件
REF
I / O
Catalogue number Reference number On / Off
Please report any serious incident that has occurred in relation to the device injury or ad-
Medical device
Dispose of packaging in an
Device classification: environmentally friendly manner Type BF applied part /
Medical device verse event to the local competent authority and to the Manufacturer or to the European
Medical device
Keep dry / 保持干燥 / 怕雨
Type BF
Keep dry / 保持干燥 / 怕雨
BF型应用设备
LOT
Authorised Representative (EC REP).
Batch number
Vigilance contact point: https://ec.europa.eu/growth/sectors/medical-devices/contacts/
Read the instructions for use /
Importer Distributor
Storage/Transport
Importer Distributer Distributor
WEEE
I
WEEE
请阅读说明书
70°C 95% 1060hPa
Intended use
ON
LOT number
The compressor nebulizer IN 155 from medisana is an aerosoltherapy system suitable for
Storage/Transport
-25°C 10% 700hPa
Device in protection class 2 /
SN domestic use.
Serial number Date of manufacture
70°C SN 95% 1060hPa
Serial number Date of manufacture
Serial number
Storage/Transport
二类设备 Operating
OFF
°C 10% 700hPa Ambient pressure
70°C 95% 1060hPa 95% 1060hPa Preparing the device
40°C
Temperature range
limitation
Storage/Transport
Before the first use, we recommend cleaning all components - as described in the
Storage/Transport Permissible storage and transport Do not use outdoors
Operating
-25°C 10% Permissible storage and transport 700hPa 10°C 700hPa
temperature and humidity 10% Do not use outdoors
Manufacturer / 制造商
temperature and humidity chapter "Cleaning and disinfection".
(indoor use only)
95% Dispose of packaging in an 1060hPa
40°C
Operating (indoor use only)
environmentally friendly manner
Humidity range
C 700hPa
1060hPa
10% 40°C 95%
Operation
Permissible operating temperature
Operation
Permissible operating temperature Single patient
Manufacturer and humidity Single patient multiple use
Keep dry / 保持干燥 / 怕雨 and humidity
10°C 700hPa
multiple use (for
Storage/Transport 10%
Single patient multiple use
70°C 95% 1060hPa accessories only)
Date of manufacture
-25°C 10% 700hPa
Importer PA
Medical device
Operating 中国GCC血压计计量证号
WEEE Medical device
EC REP Authorised EU representative
40°C 95% 1060hPa
2020F213-44 PA
10°C 700hPa
10%
中国GCC血压计计量证号
2020F213-44
0123
SN
Distributor Serial number
Distributor
Storage/Transport
IMPORTANT INFORMATION! KEEP IN A SAFE PLACE!
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.
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 fol-
lowing: - 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 remove the
plug from the socket. - The power cable plug is used to disconnect the device from the
REF
Reference number
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 bot-
tom 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 person-
LOT
Batch number
nel 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.
REF
Reference number
In this case, however, the permitted limit values, which are specified on the adapters and
I
extension cables, must always be adhered to.
ON
Do not leave the device plugged in when not in use; remove the plug from the socket
LOT
when the device is not being used.
Batch number
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
OFF
I
the manufacturer cannot be held liable.
ON
Do not replace the power cable of this device. In the case of a faulty cable, contact a
technical assistance centre approved by the manufacturer.
Dispose of packaging in an
The power cable should always be fully unwound to avoid dangerous overheating.
environmentally friendly manner
OFF
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
Dispose of packaging in an
your doctor regarding dosage, duration and frequency of the therapy.
environmentally friendly manner
Only use the parts specified by the doctor in accordance with your specific illness.
Importer
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 REF
REF Reference number
Reference number
front of the nose.
Importer
Check on the package insert of the medicine, whether there are contraindications for use
with the usual systems for inhalation therapy.
LOT
LOT Batch number
Batch number
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.
I
Do not tilt the nebuliser by more than 60°.
I
Do not use the device near strong electromagnetic fields such as mobile phones or radio ON
ON
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, OFF
OFF
that there is no risk of tripping, they are not kinked and the risk of strangulation is elimi-
nated.
The use of this device is not a replacement for visiting the doctor.
Dispose of packaging in an
REF
Reference number Dispose of packaging in an
environmentally friendly manner
environmentally friendly manner
LOT Storage/Transport
Batch number
Storage/Transport
1060hPa
70°C 95%
Importer 70°C 95% 1060hPa
Importer
-25°C 10% 700hPa
I
-25°C 10% 700hPa
ON
Operating
Operating
1060hPa
40°C 1060hPa 95%
40°C 95%
10°C 700hPa 700hPa
10°C
10% 10%
OFF
Dispose of packaging in an
environmentally friendly manner
Importer
Storage/Transport
Storage/Transport
70°C 95% 1060hPa
70°C 95% 1060hPa
10% 700hPa
-25°C
10% 700hPa
-25°C
Operating
Operating
40°C 95% 1060hPa
40°C 95% 1060hPa
700hPa
10°C
10% 700hPa
Application
1. Assembe the nebuliser set . Make sure that all parts are complete.
w
2. Fill the nebuliser with the inhalation solution prescribed by your doctor. Ensure that the maximum
level is not exceeded.
3. Connect the nebuliser via the air tube to the connector on the compressor and plug the
7 6 3
power cable into the electrical outlet (230V 50 Hz AC).
4. To start treatment, turn the On/Off button to the "I" position.
4
- The mouthpiece guarantees better delivery of the medicine into the lungs.
- Choose between the adult and child resp. baby face mask
9 0
and make sure that the mask fully covers the mouth and nose area.
- Use all accessories including the nose piece as prescribed by your doctor.
5
5. Whilst inhaling, sit upright and in a relaxed position at a table (not in an armchair), so as not to
compress the airways and therefore not impair the effectiveness of the treatment. Do not lie down
whilst inhaling. Stop the inhalation if you feel unwell.
6. After you have finished inhaling for the amount of time recommended by your doctor, switch the
On/Off switch to the "O" position, in order to switch off the device and remove the plug from the
4
electrical outlet.
7. Empty the remaining inhalation solution from the nebuliser and clean the device as set out 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.
Use of the nasal shower
e
1. Remove cover: Turn the cover 90° (anticlockwise)
2. Fill container with rinsing solution (adhere to manufacturer's instructions!)
3. Screw cover back on (clockwise).
4. Connect the nasal shower to the tube . The other end of the tube should already be con-
6
nected to the main device at position .
3
5. Place the nose piece onto the nostril and breath through the nose.
6. Switch the inhaler on and guide your finger over the small opening on the lower part of
4
the nasal shower to begin with the treatment.
During use, you should breath in and out slowly through the nose and tilt your head slightly to the
opposite side of the affected nostril, so that the salt spray can flow deep into your nostril. You can
pause or stop the wash by removing your finger from the opening.
Empty the remaining rinsing solution from the
nasal shower after the treatment and clean the
device as set out in the chapter "Cleaning and
disinfection".
Scope of delivery
• 1 medisana Inhaler IN 155 ( position of the air filter, holder for the nebuliser set,
1 2
connector for the air tube, On/Off switch)
3 4
• 1 Instruction manual
• Accessories: nose piece, 2 air tubes, nebuliser, a atomiser head (
5 6 7 7
nebuliser set), mouthpiece, adult face mask, Children and baby face mask (with adapter
8 9 0
a), air filter (replacement on position ), storage bag, nasal shower
0 q 1 e
WARNING
Make sure that children do not get hold of the packaging films.
There is a risk of suffocation!
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 ingress 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 therapeutic success.
Before and after each application
1. Turn the upper part of the nebuliser anticlockwise in order to open the nebuliser and remove the
7
atomiser head a.
7
2. Wash all parts of the nebuliser, the mouthpiece , the nose piece
8 5
under running water. After that, dip in boiling water for 5 minutes (15 minutes for the nasal shower).
3. Wash the masks and the air tube with warm water.
4. Assemble the nebuliser parts again and connect the nebuliser 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 air tube.
Maintenance and care
Replacement of the nebuliser
Replace the nebuliser after a relatively long period of non-use, if it has deformations or cracks or
7
if the atomiser head a is blocked by a dried-up medicine, dust, etc. We recommend replacing the
7
nebuliser after 6 to 12 months depending on use. Only use the original nebuliser!
Replacement of the air filter
Under normal conditions of use, the air filter should be replaced after about 200 working hours or
q
after each 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
one. Do not try to clean the filter for reuse. The air filter must not be repaired or maintained,
whilst it is being used by a patient.
Only use original filter! Do not use the device without filter!
Malfunctions and countermeasures
The device cannot be switched on
• Make sure that the power cable is correctly plugged into the electrical output.
• Make sure that the On/Off switch is in the "I" position.
4
• 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 is properly attached on both ends.
6
(use adapter a herewith)
0
• Make sure that the air tube is not compressed, bent, dirty or blocked. If necessary, replace it
6
with a new one.
• Make sure that the nebuliser is completely assembled and the coloured atomiser head
7
been correctly positioned and is not blocked.
• Make sure that the required inhalation solution has been poured in.
Technical data
Name medisana Inhaler IN 155, Type: GCE847
Power supply 230 V~ 50 Hz
Nebulisation amount (average) 0.35 ml/min.
Particle size 3.07 μm
max. pressure 2.3 bar
Noise level 52 dBA, 1 m
Nebuliser fill quantity min. 2 ml; max. 8 ml
Residual amount 1.68 ml
Operating period 30 min. on / 30 min. off
Expected service life 1000 hours
Operating conditions 10 - 40 °C / 50 - 104 °F
10 - 95 % relative maximum humidity
700 - 1060 hPa air pressure
Storage and transport conditions -25 - +70 °C / -13 - +158 °F
10 - 95 % relative maximum humidity
700 - 1060 hPa air pressure
Weight 1450 g
Dimensions 18 x 14 x 9.4 cm
Length of the power cable 180 cm
IP class IP 21
Reference to standards EN 13544-1; EN 60601-1; EN 60601-2; EN 60601-1-6;
IEC 60601-1-11
Item number 54555
EAN number 40 15588 54555 9
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.
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.
assembling the
w
In the course of constant product improvements, we reserve the right to make
technical and design changes without prior notice.
The current version of this instruction manual can be found at www.medisana.com
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:
and the nasal shower
e
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.
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
) replace it with a new
1
Phone : +86 760 22589901
EC REP
Donawa Lifescience consulting Srl,
Piazza Albania, 10, 00153 Rome, Italy
https://www.donawa.com/wli/main/contatti.index
a has
7
http://www.globalcare.com.hk/contact/