Mirage ProPulse Irrigator User manual
1
®
®
®
IRRIGATOR
REF PP17P
1
®
®
®
IRRIGATOR
REF PP17P
1
®
®
®
IRRIGATOR
REF PP17P
2 | en
2
®
®
Propulse ProScoop™
INS0040
®
Propulse Head Lamp
INS0036
®
Propulse Cleaning Tablets
(x200 per pack)
CL0001
®
Propulse QrX™ Single Use
Tip (x100 per pack)
KIT5002
®
Propulse ProTect™ Cape
KIT1012
®
Propulse Carry Case
KIT1005
3 | en
INTENDED PURPOSE
WARNINGS AND CAUTIONS
®
It is recommended that the Propulse Ear Irrigator is serviced annually
4 | en
®
®
Please note: Damage caused to your Ear Irrigator by the use of accessories,
consumables or service agents not recommended by Mirage Health Group, will invalidate
your warranty.
DO NOT IRRIGATE
4
12
3
5
9
6
8
7
COMPONENT / PARTS INDENTIFICATION
Please note
5 | en
TECHNICAL DATA
IPX1
GUIDE TO SYMBOLS
I
O
6 | en
OPERATING INSTRUCTIONS
prior to first use
and
every prior
OPERATING INSTRUCTIONS
prior to first use
and
every prior
7 | en
7
®
1) Remove the reservoir from the Propulse Ear Irrigator.
2) Remove the old Mushroom Valve from the reservoir and discard
3) Insert a new Mushroom Valve without bending or exer�ng undue force on the legs of the
Mushroom Valve, into the reservoir.
4) Check the condi�on of the ‘O’ ring on the base of the reservoir and if worn replace with a new
unit specific ‘O’ ring.
5) Return the reservoir to the machine
DETAILED INFORMATION
Fi�ng the Footswitch
The footswitch is connected to the main unit by a socket in the side of the device. The
®
Propulse
®
Propulse Ear Irrigator will NOT operate unless the footswitch is connected.
Filling the water reservoir
It is recommended that:
i) The water reservoir is removed from the device for filling and that the lid is always in place when
the water container is in-situ on the device.
ii) The water reservoir should be filled to the horizontal line on the front. This helps to eliminate the
risk of spillage.
iii) Water at 40°C is recommended. Higher temperatures increase the risk of scalding and burns to
the pa�ent. Lower temperatures increase the risk of pa�ent discomfort and dizziness.
®
Fi�ng the Propulse QrX™ Tip
® ®
The Propulse Ear Irrigator is designed to be used only with Propulse QrX™ Single Use Tips.
®
Use one Propulse QrX™ Tip per treatment.
®
To fit a Propulse QrX™ Tip
1) Remove Tip from packaging - Tips are non-sterile.
2) Push Tip into Handle un�l a click can be heard.
®
To remove a Propulse QrX™ Tip
1) Retract the QrX™ Locking Collar using a thumb.
2) Grasp the used QrX™ Tip between forefinger and thumb and pull gently from the QrX™ Handle.
3) Dispose of the used Tip in accordance with local authority guidelines. DO NOT REUSE TIPS.
®
Propulse QrX™ Tips are available to purchase in boxes of 100 individually wrapped (non-sterile)
® ®
�ps from your normal Propulse supplier or from Mirage directly (UK only). Propulse QrX™ Tips
® ®
are clearly branded with the Propulse logo on the �p and its packaging. Only branded Propulse
®
QrX™ Tips should be used with the Propulse Ear Irrigator.
Replacing the Mushroom Valve
The Mushroom Valve is specifically designed to prevent water flowing out of the reservoir whilst
filling. Should a replacement Mushroom Valve be required, please follow the steps below -
.
This will help prevent possible damage to the water inlet valve.
8 | en
8
Guidance and Manufacturer’s Declaration – Electromagnetic emissions
The Propulse is intended for use in the electromagnetic environment specified below. The customer
or user of the Propulse should assure that it is used in such an environment.
Emission tests Compliance Electromagnetic environment – guidance
RF emissions
CISPR 11
Group 1 The Propulse uses only energy for its internal function.
Therefore, its RF emissions are not likely to cause any
interference in nearby electronic equipment.
RF emissions
CISPR 11
Class A The Propulse is suitable for use in all establishments
other than domestic and those directly connected to the
public low-voltage power supply network that supplies
buildings used for domestic purposes.
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
fluctuation/flicker
emissions IEC
61000-3-3
Complies
Guidance and Manufacturer's Declaration – Electromagnetic Immunity
The Propulse is intended for use in the electromagnetic environment specified below. The customer
or the user of the Propulse should assure that it is used in such an environment
Immunity test IEC 60601 test level Compliance level Electromagnetic environment -
guidance
Electrostatic
discharge (ESD) IEC
61000-4-2
6 kV contact
8 kV air
6 kV contact
8 kV air
Floors should be wood, concrete
or ceramic tile. If floors are
covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for
input/output lines
2 kV for power
supply lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
1 kV differential
mode
2 kV common
mode
1 kV differential
mode
2 kV common
mode
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on
power supply input
lines
IEC 61000-4-11
< 5 % UT (> 95 %
dip in UT) for 0.5
cycle 40 % UT (60
% dip in UT) for 5
cycles 70 % UT (30
% dip in UT) for 25
cycles
< 5 % UT (> 95 %
dip in UT) for 5 s
< 5 % UT (> 95 %
dip in UT) for 0.5
cycle 40 % UT (60
% dip in UT) for 5
cycles 70 % UT
(30 % dip in UT)
for 25 cycles
< 5 % UT (> 95 %
dip in UT) for 5 s
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the Propulse requires
continued operation during power
mains interruptions, it is
recommended that the Propulse
be powered from an
uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m Not applicable Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE UT is the A.C. mains voltage prior to application of the test level.
9 | en
99
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Propulse is intended for the use in the electromagnetic environment specified below.
The customer or the user of the Propulse should assure that it is used in such an environment
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Propulse, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter:
Recommended protection distance:
d = 1.17 vP
d = 1.17 vP for 80 MHz to 800 MHz
d = 2,3 vP for 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) acc. To the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey, a should be less than the compliance
level in each frequency range.
b
Interference
may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflections from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Propulse is used exceeds the applicable RF compliance level
above, the Propulse should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Propulse.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended Separation Distance between portable and mobile
RF Communications Equipment and the Propulse
The Propulse is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Propulse can help prevent
electromagnetic interference by maintaining minimum distance between portable and mobile RF
communications equipment (transmitters) and the Propulse as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to the transmit frequency
(m)
150 kHz to 80 MHz
d = 1.17 v P
80 MHz to 800 MHz
d = 1.17 v P
800 MHz to 2,5 GHz
d = 2.33 v P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is the maximum output power rating of the transmitter in watt (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
99
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The Propulse is intended for the use in the electromagnetic environment specified below.
The customer or the user of the Propulse should assure that it is used in such an environment
Immunity test IEC 60601 test level Compliance
level
Electromagnetic environment – guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
Portable and mobile RF communications
equipment should be used no closer to any
part of the Propulse, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter:
Recommended protection distance:
d = 1.17 vP
d = 1.17 vP for 80 MHz to 800 MHz
d = 2,3 vP for 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) acc. To the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey, a should be less than the compliance
level in each frequency range.
b
Interference
may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflections from structures, objects and people.
a. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Propulse is used exceeds the applicable RF compliance level
above, the Propulse should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as reorienting or relocating the Propulse.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Recommended Separation Distance between portable and mobile
RF Communications Equipment and the Propulse
The Propulse is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the Propulse can help prevent
electromagnetic interference by maintaining minimum distance between portable and mobile RF
communications equipment (transmitters) and the Propulse as recommended below, according to
the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter (W)
Separation distance according to the transmit frequency
(m)
150 kHz to 80 MHz
d = 1.17 v P
80 MHz to 800 MHz
d = 1.17 v P
800 MHz to 2,5 GHz
d = 2.33 v P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where p is the maximum output power rating of the transmitter in watt (W) according
to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
10 | en
Cleaning Instruc�ons
Ensure the unit has been cleaned prior to first use.
Cleaning
11 | en
Power Adaptor
12 | en
Contraindica�on to irriga�on
Cau�on when irriga�ng with water in the
following groups of pa�ents
Ra�onale
Ra�onale
13 | en
Maintenance & Safety Inspec�ons
®
To ensure op�mum performance the Propulse Ear Irrigator should be serviced every 12 months.
Service or repairs conducted by unauthorised agencies/organisa�ons invalidate any or implied
warran�es from Mirage.
14 | en
Warranty
The Propulse® Ear Irrigator carries a twelve month warranty (*subject to conditions) from the date
of original purchase
The warranty does not cover:
15 | en
15
This symbol on the products and/or accompanying documents means that used
electrical and electronic products should not be mixed with general waste. Please
return to Mirage Health Group or dispose of through locally approved disposal service
for electronic equipment. Penal�es may be applicable for incorrect disposal of this
waste, in accordance with na�onal legisla�on.
Disposal should be in accordance with local authority guidelines and regula�ons for the disposal of
clinical waste. Propulse® QrX™ Tips should not be disposed of in municipal waste.
Before the Propulse® Ear Irrigator is transported, the reservoir must be emp�ed and the machine
should be operated un�l the handle and hose are empty of liquid. The reservoir should then be
dried using a paper towel.
For safe transporta�on of Propulse® Ear Irrigator, Mirage recommends that the Propulse® Carry
Case is used to prevent damage or contamina�on.
For internal cleaning, please refer to page 10.
16 | en
1
®
®
®
IRRIGATOR
REF PP17P
1
®
®
®
IRRIGATOR
REF PP17P
1
®
®
®
IRRIGATOR
REF PP17P
1
PP17P
®
EAR IRRIGATOR
REF
®
2 | de
®
Propulse
®
QrX™ Einweg-
Düse (x100 pro Packung)
KIT5002
Propulse
®
ProScoop™
INS0040
Propulse
®
Reinigungstabletten
(x200 pro Packung)
CL0001
Propulse
®
Kopfleuchte
INS0036
Propulse
®
ProTect™ Umhang
KIT1012
Propulse
®
Tragetasche
KIT1005
2
®
®
Propulse ProScoop™
INS0040
®
Propulse Head Lamp
INS0036
®
Propulse Cleaning Tablets
(x200 per pack)
CL0001
®
Propulse QrX™ Single Use
Tip (x100 per pack)
KIT5002
®
Propulse ProTect™ Cape
KIT1012
®
Propulse Carry Case
KIT1005
2
®
®
Propulse ProScoop™
INS0040
®
Propulse Head Lamp
INS0036
®
Propulse Cleaning Tablets
(x200 per pack)
CL0001
®
Propulse QrX™ Single Use
Tip (x100 per pack)
KIT5002
®
Propulse ProTect™ Cape
KIT1012
®
Propulse Carry Case
KIT1005
3 | de
VORGESEHENER ZWECK
Das Propulse® Ear Irrigator dient zur:
a)
Erleichterten Entfernung von Cerumen und Fremdkörpern, die nicht hygroskopisch vom
Gehörgang stammen.
b)
Entfernung von Ausfluss, Keratin oder Schmutz von dem äußeren Gehörgang durch die Beigabe
von warmen Wasser.
Gründe, warum dieses Verfahren genutzt werden sollte:
a)
Um Otitis Externa korrekt zu behandeln, bei der der Gehörgang durch Schmutz versperrt wird.
b)
Um die Schallleitung in das Ohr zu verbessern, wenn angenommen wird, dass der
Ohrpfropf zu einem Hördefekt führt.
c)
Um den äußeren Gehörgang und das Trommelfell zu untersuchen.
d)
Um die Ursache für Beschwerden zu entfernen.
Dieses Verfahren sollte AUSSCHLIESSLICH von entsprechend ausgebildetem medizinischem
Fachpersonal durchgeführt werden.
WARNUNGS - UND VORSICHTSHINWEISE
Vor Benutzung des Propulse® Ear Irrigatormuss diese Gebrauchsanleitung
vollständig gelesen und verstanden werden.
Nur entsprechend geschultes Personal darf das Gerät verwenden. Mirage kann Hinweise
zur Verfügbarkeit von Schulungen geben, die von relevanten Organisationen angeboten
werden.
Die Propulse® QrX™ Düse ist nur für den einmaligen Gebrauch geeignet und sollte nach
Gebrauch örtlichen Richtlinien entsprechend ordnungsgemäß entsorgt werden.
Die Wiederbenutzung der Propulse® QrX™ Düse erhöht das Risiko
einer Kreuzinfektion. Das Propulse Ohrspülsystem darf nicht in
Wasser eingetaucht werden.
Reinigen Sie das Gerät nur so, wie es in dieser Gebrauchsanleitung beschrieben wird (Siehe Seite
10).
Falls Änderungen in der Leistung auftreten, schalten Sie das Propulse® Ear
Irrigator aus, ziehen Sie den Stecker aus der Steckdose und verwenden Sie es
NICHT (Siehe Seite 11).
Dieses Gerät darf nicht vom Benutzer gewartet werden
(Siehe Seite 13). Bitte verwenden Sie ausschließlich
empfohlenes Propulse® Zubehör.
Verwenden Sie Propulse® Zubehör nicht mit anderen Geräten.
Falls das Gerät für Hausbesuche verwendet werden soll, wird dringend empfohlen, eine
Propulse® Tragetasche zu verwenden, um Schäden und Kontaminierung zu vermeiden.
Propulse® Ear Irrigator ist nicht reparierbar und muss
Ihrem Propulse® Händler oder Mirage Health Group (nur für Kunden in Großbritannien)
für Wartungs- und/oder Reparaturdienste zurückgegeben werden. Es wird empfohlen,
das Propulse® Ear Irrigator jährlich zu warten.
4 | de
VERMEIDEN SIE SPÜLUNGEN der Ohren wenn:
a)
Kein Einverständnis gegeben wurde und/oder der Patient unkooperativ ist.
b)
Vorherige Komplikationen nach dem Verfahren auftraten.
c)
Innerhalb der letzten sechs Wochen eine Mittelohrinfektion diagnostiziert wurde.
d)
Der Patient sich einer Ohroperation unterzogen hat (ausgenommen von Paukendrainagen, die
über 18 Monate zurückliegen und der Patient aus der HNO-Abteilung entlassen wurde.)
e)
Der Patient eine Perforation hat oder innerhalb des letzten Jahres mit einer mukösen Absonderung
diagnostiziert wurde.
f)
Der Patient eine Gaumenspalte hat (behoben oder nicht).
g)
Akute Otitis externa, ein ödematöser Ohrkanal zusammen mit Schmerzen und
Empfindlichkeit der Ohrmuschel vorliegen.
h)
Falls der Patient über Schmerzen klagt - SOFORT AUFHÖREN.
*Siehe Kontraindikationen auf Seite 12.
3
1. Speicher
2. Deckel
3. QrX™ Düse
4. Griff und Schlauch
5. Halterung
6. Wasserfluss/-druck Kontrollschalter
7. Ein-/Ausschalter
8. Fußschalter
9. Netzstromadapter
Die Bestandteile des Propulse® Ear Irrigator sind:
a)
Die Haupteinheit und die folgenden
Benutzerkontrollen: Ein An-/Ausschalter
Ein Fußschalter, der (wenn gedrückt) den Wasserfluss freisetzt. Das Wasser stoppt, wenn der
Fußschalter losgelassen wird.
Ein Netzstromadapter
b)
Der Wassercontainer/-speicher (1) kann zum einfacheren Auffüllen und Säubern entfernt werden.
Eine horizontale Linie markiert die korrekte Wasserhöhe für den normalen Gebrauch sowie die
korrekte Wasserhöhe für die Auflösung einer Reinigungstablette.
c)
Pilzförmiges Ventil –damit das Wasser im Speicher verbleibt, wenn dieser vom Propulse®
Gerät entfernt wird.
d)
Griff und nicht entfernbarer Schlauch. Im Griff befinden sich die Propulse® QrX™ Einweg-
Düsen.
e)
Der Fußschalter - ist mit dem Hauptgerät mittels Klinkenstöpsel/-buchse verbunden. Das
Gerät funktioniert nur, wenn der Fußschalter eingesteckt ist.
Bitte beachten Sie: Wenn durch den Gebrauch von Zubehör, Hilfsmitteln oder einem
Wartungsdienst, der nicht von Mirage Health Group empfohlenen wird, Schäden an Ihrem
Propulse® Ohrspülsystem entstanden sind, wird die Garantie ungültig.
Bitte beachten Sie: Restwasser in Griff und Schlauch fließt weiter, wenn der Griff nicht vertikal oder in
einer Position unterhalb des Geräts gehalten wird. Um den Fluss von Restwasser zu verhindern, wird
empfohlen, den Griff wieder in der Halterung am Gerät zu befestigen.
KENNZEICHNUNG DER
BESTANDTEILE/EINZELTEILE
1
2
7
4
8
6
5
9
®
®
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