JFR Medical P005 User manual

Humidifier
UserManual
Humidificador
Manualdeinstrucciones
EN ES
Umidificador do ar de
respiração
Manualdeoperaçoes
DE PT
Atemluftbefeuchter
Gebrauchsanweisung
  
 
Hudimificateur d’air
Noticed’utilisation
FR AR
Umidificatore d’aria
inspirata
IstruzioniperI’uso
IT

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English .....................................................................................1
Deutsch ................................................................................ 17
Français ............................................................................... 33
 
Italiano ................................................................................. 49
Español ................................................................................ 65
Portugues ........................................................................... 81
 ..................................................................................... 97
EN
DE
FR
IT
ES
PT
AR

1
TableofContents
1. Introduction............................................................................... 2
1.1 Functionality...................................................................................2
1.2 IndicationsForUse ......................................................................2
1.3 Contraindications .........................................................................2
2. ImpoartantSafeguards........................................................... 3
3. PartsOverview.......................................................................... 4
4. Assembly..................................................................................... 4
5. SetUp............................................................................................ 5
5.1 FillingTheChamber ....................................................................5
5.2 HumiditySettings .........................................................................6
5.3 DailyCleaning.................................................................................7
5.4 WeeklyCleaning............................................................................9
6. Maintenance.............................................................................10
7. Transport..................................................................................10
8. Disposal.....................................................................................10
9. Troubleshooting.....................................................................11
10. SymbolDefinition...................................................................13
11. ScopeOfDelivery....................................................................15
11.1StandardScopeOfDelivery.................................................. 15
11.2SpareParts................................................................................... 15
12. TechnicalSpecifications.......................................................15

2INTRODUCTION
1. INTRODUCTION
Please read the complete user manual carefully before using the Heated
Humidifier as well as keep this manual for future reference.
The Humidifier is an optional accessory to the Positive Airway Pressure (PAP)
device from JFR Medical. All the function and setting instructions can be
found in the manual of the therapy device.
Do not use the humidifier with any other therapy device.
1.1 Functionality
The humidifier is designed to moisten the air delivered from the therapy device
through heated water, to increase patient comfort and compliance with the
therapy. It can be operated by the patient and clinician in combination with a
compatible therapy device. Please refer to the user manual of the therapy de-
vice for instructions.
1.2 IndicationsForUse
The humidifier is for use only as recommended by a physician to reduce the
dryness of throat, nose and mouth. The humidifier water chamber is intend-
ed for single-patient use only. This is to avoid the risk of cross-infection. The
instructions from the clinician must be followed.
1.3 Contraindications
Classification:ISO 80601-2-74:Category II
The Heated Humidifier is contraindicated for use with patients whose up-
per airway has been bypassed.
Please refer to the instructions for use that accompanied your therapy device
for any additional contraindications that may be specific to the use of that de-
vice.
Please contact with your clinician or healthcare provider for further question
before using the humidifier.

IMPOARTANT SAFEGUARDS 3
2. IMPOARTANTSAFEGUARDS
• Be sure to read and understand all safety instructions supplied with your
therapy device.
• Replace the water chamber after 6 months of use.
• JFR Medical has no liability for the use of non-compliance with the safety
instructions and the guarantee expires.
Danger
• Never open or remove parts from the humidifier cradle. There is a risk of
electric shock.
• The equipment is not suitable for use in the presence of a flammable
anesthetic mixture with air or with oxygen or nitrous oxide.
 Warning
• Never block the air openings of the cradle or chamber. Do not insert any
objects into any opening or tubes.
• Do not use the humidifier if there is damage in any way.
Caution
• Do not place the device in or on any container that can collect or hold
water.
• Repairs and adjustments must be performed by JFR Medical-authorized
service personnel only.
• Use only the respiratory tubing which applies to ISO 5367.
• Only use the water chamber from JFR Medical with your humidifier cradle.
The use of other components may damage the device or interfere with the
therapy.
• Use only the sealing gasket from JFR Medical.
• Please follow the hygiene guidelines of your physician or healthcare pro-
vider and use a bacterial filter if necessary which applies to DIN EN ISO
23328-1/23328-2 with your therapy.
• Do not move the device during operation.

4PARTS OVERVIEW
3. PARTSOVERVIEW
The illustrations can be found at the beginning of this manual.
HUMIDIFIERCRADLE
1. Holding fence
2. Air inlet of the humidifier
3. Air outlet
4. Connection socket for the therapy device
5. Release button
6. Unlocking handle to the water chamber
WATERCHAMBER
7. Cover for water chamber
8. Locking clamps
9. Level indicator
10. Water bowl
11. Sealing gasket
BOTTOMOFHUMIDIFIERCRADLE
12. Heating plate
13. Air outlet of the water chamber
14. Air inlet of the water chamber
4. ASSEMBLY
Place the therapy device on the humidifier cradle as shown in the instructions
of your therapy device.
Note!
Readandunderstandtheentiremanualofyourtherapydevicebeforeattempting
tousethishumidifier.
Usethehumidifierunderthedescribedoperatingconditionsintechnicalspecifica‐
tion.
Ifthehumidifierisusedbyasecondperson,itmustbesanitized.

SET UP 5
5. SETUP
5.1 FillingTheChamber
Note!
Donotattempttofillthewaterchamberwhileitisstillinsidethehumidifiercradle.
Cleanthewaterchamberbeforefirstuse.
1.
Remove the water chamber from the
humidifier cradle.
2.
Hold the chamber upright and fill with
distilled water to the maximum fill line
100%.
3.
Carefully tip the chamber water back to
the level position. The water in the fill
ports will flow into the chamber when it
is tipped back to the level position.
4.
Slide the chamber back into the
humidifier cradle. Ensure the chamber is
fully engaged with the humidifier cradle
and the unlocking handle to the water
chamber in place when inserted.

6SET UP
Note!
Wheninstallingthewaterchamber,donotallowanywatertospillintothe
humidifierortherapydevice.Useonlyroomtemperaturedistilledwaterinthe
chamber.Donotputanychemicalsoradditivesintothewater.Possibleairway
irritationordamagetothewaterchambermayresult.
5.2 HumiditySettings
The heating control and the status can be found on the display of the therapy
device. Please refer to the relevant section in the user manual of your therapy
device.
Caution
• Do not fill the water chamber above the maxi-
mum fill line. If the water chamber is overfilled,
water may leak into the therapy device, humidi-
fier, or onto your furniture. Damage to the humidi-
fier or therapy device may occur.
•No chemicals in the water.
• Never touch the heating plate on the humidifier
cradle. Never touch the heat transfer plate on the
bottom of the water chamber. These plates can
reach temperature as high as 74°C during opera-
tion.
• The heating plate must be turned off from Humid-
ifier Settings when the device is being used with-
out water.
• Never place the device on a soft surface such as
a bed or couch during operation. Do not position
it where it may be stepped on when getting out of
bed.
• The height of the system must always be lower
than the interface mask during use to prevent
water from getting into the mask.

SET UP 7
5.3 DailyCleaning
Note!
Afterturnofftheheaterordisconnectfrompower,allowthehumidifierheat
transferplateandwatertocooldownforatleast10minutes.Aburnmayresult
from:touchingtheheattransferplate,comingincontactwiththeheatedwater,or
touchingtheheatingplate.
Donotwashthehumidifiercradleinthedishwasher,thermaldisinfectoror
sterilizer!Damagetothedevicemayoccur.Inadditiontohandwashing,the
disassembledwaterchambermayalsobewashedinthedishwasheronlyontop
shelfandingentleorglassrinsecirclemode,thetemperatureshouldnotmorethan
55°C.
1.
Turn off the heater.
(Allow the device to cool for at least 10
minutes.)
2.
Press down on the unlocking handle to
the water chamber of the humidifier and
remove the chamber from the cradle.
3.
Empty the water chamber and open the
locking clamps on both sides and press
the opening lever on the water chamber
to separate both halves of the water
chamber.
4.
When required, the sealing gasket can
be removed from the water bowl to the
water chamber and washed by hand.

8SET UP
Note!
Useonlymildsoapywatertocleanthecomponents!
Donotuseanysolutionsthatcontainbleach,chlorine,alcohol,scentedoilsorother
aromatic‐basedingredientstocleanthehumidifiercomponents.Thesesolutions
mayreducethelifeoftheproduct.
5.
Clean all parts of the water chamber
with mild soapy water.
6.
Rinse all parts of the water chamber
with clean water.
7.
Allow the individual parts to dry
completely before reassembly.
8.
Insert the sealing gasket(11) into the
groove on the water bowl. Inspect the
fitting of the gasket to ensure it is fully in
place and the sealing gasket handle is
on the top left side.
9.
Snap the water bowl and cover together
by inserting the tabs slightly on the bowl
into the slots on the cover. Gently push
down the cover and lock the water
chamber with the clamps on both sides.
Note!
Inspectthesealinggasket(11)beforeeach
usetoensurethatitisproperlyseatedin
thegroovearoundtheentirechamberand
thesealinggaskethandleisonthebottom
leftside.
11
1.
2.
3.
Click

SET UP 9
5.4 WeeklyCleaning
The humidifier cradle should be cleaned weekly.
1.
Turn off the heater.
(Allow the device to cool for at least 10
minutes.)
2.
Detach device from cradle,first remove
water chamber then press therapy
device release button.
3.
Wipe the cradle with clean and not
much too damp cloth.
4.
Do not allow water to collect on the
heating plate. Wipe it with a clean cloth
if necessary.
5.
Put the therapy device back on the
humidifier as soon as all parts dry.

10 MAINTENANCE
6. MAINTENANCE
7. TRANSPORT
Do not move with the humidifier while the water chamber has water in it！
Disconnect the humidifier from the therapy device (if a therapy device is con-
nected) and pack the humidifier and user manual in the carrying bag. The dry
water chamber remains in the humidifier cradle during transport.
8. DISPOSAL
The humidifier cradle and the water chamber must not be disposed of with
the household waste.
Please contact your authorised collection point or an authorised municipal au-
thority waste disposal company for correct disposal or send the device back to
your service partner.
The packaging can be disposed of with the normal household waste.
Water Chamber Clean the chamber daily.The chamber should be
replaced according to the recommended sched-
ule time of 6 months. Inspect the water chamber
for signs of wear or damage when cleaning and
replace if damaged.
Do not use the humidifier if the water chamber is
leaking or damaged in any way.
Humidifier Cradle Inspect the humidifier cradle for signs of wear or
damage when cleaning.
Never operate the humidifier if any parts are
damaged, if it is not working properly, or if the
humidifier has been dropped or mishandled.
Have any damaged parts replaced before con-
tinuing use.

TROUBLESHOOTING 11
9. TROUBLESHOOTING
The table below lists some of the problems you may experience with your
humidifier and possible solutions.
Warning
If you notice any unexplained changes in the performance
of this device, if it is making unusual or harsh sounds, if it
has been dropped or mishandled, or if the enclosure is
broken, disconnect the mains cable from the therapy
device and discontinue use. Contact your healthcare
provider.
Problem Possible Cause Measure
The device reports a
mask leak but my
mask seems to be
fitting well.
The humidifier chamber is
not fully engaged or is
missing.
Slide the humidifier chamber
fully into the cradle. Verify the
unlocking handle to the water
chamber clicks into place.
The silicone cover for air
outlet is missing from the
back of the device or not
fully inserted.
Make sure the silicone cover
for air outlet is fully inserted
into the back of the device.
Refer to Assembly in the
manual of therapy device for
instructions on system setup.
The gasket seal between
the two bowls of the water
chamber is missing.
Insert the gasket seal into the
water chamber. Follow the
instructions for cleaning the
water chamber.

12 TROUBLESHOOTING
Note!
Formoreinformationontroubleshootingyourtherapydevice,seethemanual
includedwithyourtherapydevice.
The heater setting is
not visible on the
LCD display.
The therapy device is not
fully seated onto the
humidifier cradle.
Be sure the therapy device is
properly placed on the
humidifier.Refer to the
instructions of therapy device
in Assembly.
If the problem continues,
contact your healthcare
provider.
Excessive
condensation or
water in tubing.
Humidification is too high. Reduce humidifier heater
setting.
The humidifier is placed
higher than the patient
Move unit to a lower position.
Room temperature
fluctuates from higher to
lower levels through the
night.
Increase room temperature.
The humidifier chamber is
overfilled.
Water level in chamber should
not be above the maximum
100% level.

SYMBOL DEFINITION 13
10. SYMBOLDEFINITION
Symbolsontapeplate
Symbol Meaning
Manufacturer
Date of manufacture
Serial number
Model number
Alternating current
Protection rating II
Type BF - (Body Floating)
In direct contact with patients for diagnosis, treatment or therapy.
May NOT have direct contact with the heart.
IP21
Protection from: IP21
Protection against the ingress of solid foreign bodies 12.5 mm
diameter and larger, and against vertically falling water droplets.
CE declaration of conformity
The product cannot be disposed of in domestic waste.

14 SYMBOL DEFINITION
Symbolsonthedevice
Symbolsinthepatientmanual
Symbol Meaning
Follow user instructions
Alternating current
Symbol Meaning
Danger
Urgent safety information for hazards that will cause serious injury or
death.
Warning
Important safety information for hazards that might cause serious
injury.
Caution
Information for preventing damage to the product.
Note !
Information to which you should pay special attention.

SCOPE OF DELIVERY 15
11. SCOPEOFDELIVERY
11.1 Standardscopeofdelivery
11.2 SpareParts
12. TECHNICALSPECIFICATIONS
Part Ordernumber
Respiratory humidifier P005
Water Chamber P005E001
Part Ordernumber
Sealing gasket P005E002
Physical
Sizes, W x H x D:
Weight:
168 mm x 100 mm x 217 mm
440 g (Without water)
Operating conditions
Temperature range:
Relative air humidity range:
Air pressure range:
+5 °C to +40 °C
15% to 90% non-condensing
700 hPa to 1060 hPa
Transport/storage conditions
Temperature range:
Relative air humidity range:
Air pressure range:
-25 °C to + 70 °C
15% - 90% non-condensing
600 hPa to 1060 hPa
Heater power consumption:
Power supply:
85W
Input range:100-240V,
50/60 Hz

16 TECHNICAL SPECIFICATIONS
Note!
Actualaveragepowerconsumptionwillvarydependingonfactorssuchas
temperaturesetting,setpressure,theuseofaccessories,heightabovesealeveland
ambienttemperature.
Maximum Recommended Pressure:
Maximum Pressure:
30 hPa
50 hPa
Water Capacity: To maximum fill line 100% : 380 ml
Heater temperature: Approximately + 40 °C to + 74 °C
Maximum gas temperature: + 43 °C
Pressure Drop: No pressure drop in humidifier.
Input air temperature: + 5 °C to + 40°C
Operating Mode: Max. 16 hours
Product category in accordance with
Directive 93/42/EEC: II a
Classification to
IEC 60601-1:2013
against electric shock: BF type class II
IP protection class:
IP 21
Protection from: IP21
Protection against the ingress of solid
foreign bodies 12.5 mm diameter and
larger, and against vertically falling
water droplets.
Guarantee
Humidifier cradle:
Water Chamber:
24 Months
6 Months
Humidity Output
According to ISO 80601-2-74 on 23°C
without heated tube:
- 5hPa (12 l/min) = 13 mg/l
- 10hPa (18l/min) = 15 mg/l
- 20hPa (28l/min) = 17 mg/l

17
Inhaltsverzeichnis
1. EINLEITUNG..............................................................................18
1.1 Funktionsweise ....................................................................... 18
1.2 Anwendung............................................................................... 18
1.3 Kontraindikation .................................................................... 18
2. WichtigeSicherheitshinweise............................................19
3. Teileübersicht.........................................................................20
4. Installation...............................................................................20
5. Bedienungsanleitung............................................................21
5.1 BefullenderKammer............................................................ 21
5.2 Heizungseinstellungen......................................................... 22
5.3 TaglicheReinigung ................................................................ 23
5.4 WochentlicheReinigung ..................................................... 25
6. Instandhaltung........................................................................26
7. Transport..................................................................................26
8. Entsorgung...............................................................................26
9. Fehlerbehebung......................................................................27
10. SymbolDefinitionen..............................................................29
11. Lieferumfang............................................................................31
11.1 SerienmaßigerLieferumfang ............................................ 31
11.2 Ersatzteil .................................................................................... 31
12. TechnischeSpezifikationen................................................31