Mirage Propulse II User manual

Propulse II
Electronic Ear Irrigator
User Manual
Mirage Health Group Ltd
12 Singer Way, Woburn Road Industrial Estate, Kempston,
Bedfordshire MK42 7AE UK
Tel: [phone] Fax: [phone]
Overseas Tel: [phone] Fax: [phone]
www.miragehealthgroup.com
email: [email protected]
[email protected]
EAR CARE TRAINING
Ear Care Training is available and can be purchased
Further details are available from Mirage on 0845 130 5440
Copyright Mirage Health Group Ltd
November 2003
OPERATINGSWITCH
POWERSUPPLYON
PRESSURE/FLOWREGULATOR
min.max.
800ml
700
600
500
400
300
fl.oz
.oz
25
20
15
10
5

The Propulse II Ear Irrigator must only be used with the footswitch
with which it is supplied. The manufacturer cannot accept responsibility if any
other footswitch is used, neither can it accept responsibility if the footswitch
supplied is used for any other purpose.
The Propulse II Ear Irrigator must not be immersed in water. Cleaning should be done
by hand, wiping with a damp cloth only (see cleaning guidelines).
The Propulse II Ear Irrigator is not user repairable and must be returned to the
manufacturer for repair. The address is:
MIRAGE SERVICE DEPARTMENT
53 Purbeck Drive, Lostock, Bolton, Lancashire BL6 4JF
Tel: [phone]
It is recommended that copies of this User Manual, supplies of disposable
“one use” jet tips and Propulse Cleaning tablets are available at all points of use
of the Propulse II Ear Irrigator.
Additional user manuals are available from Mirage Health Group Ltd.
Technical support and advice is available from the Mirage Service Department at the
above address.
Please note: this product is fitted with a safety fuse to protect the product from
overheating, and will cut out if the following occurs:
1) The product is left switched on at the mains when not in use.
2) CONTINUOUS water flow of more than 10 minutes - note this should not
prohibit normal operation of the product, see ‘Using the Propulse II’
Should the fuse cut out, please contact Mirage Service Department on the
above number.
Page 3
1. Water Container / Reservoir
2. Disposable “One Use” Jet Tip
3. Jet Tip Holder
4. Lid
5. Water Jet ‘Stop Button’
6. Pressure/Flow Control Knob
7. Operating Switch
8. Green ‘Power On’ Light
9. Foot Switch Socket
10. Foot Switch
IMPORTANT INFORMATION
It is important that you read this user manual before using the Propulse II
Ear Irrigator.
The Propulse II Ear Irrigator is a medical device intended for the removal of cerumen,
keratin and/or foreign bodies from the human ear by irrigation. The manufacturer
cannot accept responsibility if it is used for any other purpose.
It is strongly recommended that the Propulse II Ear Irrigator is only used by
suitably trained clinicians. Details of training resources are available from Mirage
NB The cost of training is NOT included in the cost of the irrigator.
Page 2
OPERATINGSWITCH
POWERSUPPLY ON
PRESSURE/FLOWREGULATOR
min.max.
800 ml
700
600
500
400
300
fl.oz
.oz
25
20
15
10
5
3.
5.
2.
1.
4.
8. 6.
7.
9.
10.

SAFETY INFORMATION
The Propulse II is CE marked for and complies with:
Medical Devices Directive - CE 0499
Electrical Safety - EN60601-1
EMC Safety - EN55014;- EN61000;- EN60601
DESCRIPTION
The Propulse II Ear Irrigator consists of:
a) The main body - containing the motor and pump, a power cord terminating in a
UK standard 13 amp mains plug, (or appropriate overseas plug) a green ‘power
supply on’ indicator (8) and user controls.
Note: The green ‘power supply on’ light indicates that the device is connected to
the mains power supply only. It does not indicate that the operating switch
is in the ON ( ) position.
User Controls are:
i) An operating switch (7) - this switch powers the equipment on ( ) and off ( ) in
conjunction with the footswitch. (See ‘d’ next page).
ii) A pressure/flow control knob (6) that determines the pressure and flow of the water
at the water jet tip.
iii) A water jet stop button (5) (see water jet tip holder next page).
b) the water container / reservoir (1) - the clear plastic container and it’s
detachable lid is removable for filling and cleaning.
Page 5
TECHNICAL DATA
Voltage rating 220 to 240 V AC
Power rating 20 VA
Frequency 50 to 60 Hz
Static Pressure (with ‘stop button’ closed):
Minimum setting 0.27 bar (27 kpa) to 1.11 bar (111 kpa)
Maximum setting 1.35 bar (135 kpa) to 3.45 bar( 345 kpa)
Water jet pulses (at 50 Hz) :1200 ~ (at 60 Hz) :1440
Maximum operating time 10 minutes (with a recommended
rest time of 2 hours)
Storage temperature range -5°C to 65°C
Storage relative humidity Up to 80%
Guide to safety symbol:
Class II Equipment
Attention Consult Accompanying Documents
Type B. F. Equipment
IPX4 Protected Against Splashing Water
Page 4

Filling the water container
Although the mains voltage is isolated from exposed wiring in the device, it is
recommended that:
i) The water container / reservoir (1) 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 container is not overfilled.
iii) The water used to fill or clean the water container does not exceed normal
body temperature.
Fitting the disposable “one use” jet tip applicators
The Propulse II Ear Irrigator is supplied with ten disposable “one use” jet tip applicators
(2) – use one disposable “one use” jet tip per patient.
To remove a jet tip applicator pull the jet tip applicator directly from the jet tip holder
body, without using a sideways movement.
To fit, or change, a jet tip applicator reverse the above procedure.
Disposable “one use” angled jet tips are available in boxes of 100 individually
wrapped tips from your normal Propulse supplier or from Mirage direct.
USING THE PROPULSE II EAR IRRIGATOR
The clinical criteria for use of the Propulse II should be noted before treatment
is commenced.
1) Follow the setting up procedure.
2) Make sure the Foot Switch plug is fully inserted into the foot switch socket (9).
3) Set the Pressure/Flow control knob (6) to it’s lowest setting (fully anti-clockwise).
4) Switch the Operating Switch (7) from to .
5) Press the Foot Switch (10).
6) Turn the Pressure/Flow control knob slowly clockwise from the MIN position until
the pressure/flow of the water is compatible with the treatment requirements and
patient comfort.
7) Follow the Cleaning Guidelines.
Page 7
c) the water jet tip holder (3) - is attached to the main body of the device by a
coiled tube. This tube is not detachable.
The water jet tip holder accommodates disposable “one use” jet tip applicators.
Only disposable “one use” jet tip applicators designed for the Propulse II Ear
Irrigator must be used. The manufacturer cannot accept responsibility for
damage or injury, however caused, through the use of non-approved jet
tip applicators.
The water jet tip holder incorporates a water jet stop button (5).
This button will stop the flow of water when it is pressed fully in.
The pressure/flow set by the pressure/flow control knob will be resumed upon
release of the water stop button, or by pressing or depressing the footswitch.
d) the foot switch (10) - attached to the main body by a detachable socket
connection. The device will only function if the foot switch is connected and
the operating switch is in the ON ( ) position.
Pressing the footswitch causes the device to produce water at the water jet tip
applicator at the pressure/flow set by the pressure/flow control knob.
SETTING - UP PROCEDURE
Initial cleaning
Although the device has been thoroughly cleaned after manufacture it is recommended
that it is cleaned and sterilised prior to use. (See Cleaning Guidelines).
The Propulse II Ear Irrigator must only be used with a mains power supply that is the
same as that indicated on the data panel on the base of the device.
The manufacturer cannot accept responsibility for damage or injury, however
sustained, from connecting the device to a non-compatible power supply.
Adapters should not be used when connecting the device to the power supply.
Caution: The product is not permanently disconnected from the mains in the
off ( ) position. Please remove the plug from mains when not in use to
prevent overheating.
Page 6

8) Carry out the treatment as detailed in the sections:
●Guidelines for ear irrigation.
●Equipment.
●Procedure.
GUIDELINES FOR EAR IRRIGATION USING THE
PROPULSE II ELECTRONIC EAR IRRIGATOR
PRINCIPLES - Irrigating the ear is carried out to:
a) Facilitate the removal of cerumen and foreign bodies which are not hygroscopic,
from the external auditory meatus.
b) Remove discharge, keratin or debris from the external auditory meatus.
We recommend this procedure is only carried out by a trained nurse or doctor.
REASONS for using this procedure
In order to:
a) Correctly treat an ear infection or otitis externa where the meatus is obscured by
debris and is too painful to toilet.
b) Improve conduction of sound into the ear, where impacted wax is believed to be
the cause of a hearing defect.
c) Examine the external auditory meatus and the tympanic membrane.
d) Remove a cause of discomfort.
DO NOT IRRIGATE the ears when:
a) There has been a past history of ear problems such as tympanic membrane
perforation.
b) There is a recent history of otalgia, or recent past, or present middle ear infection.
c) There have been untoward experiences following this procedure in the past.
d) There is a healed old perforation. Irrigate with care as the healed area is more
susceptible to rupture.
e) Grommets are in place (except in certain circumstances).
f) NEVER irrigate mastoid cavities.
g) The patient has a cleft palate (repaired or not).
Equipment
●Waterproof cape and towel.
●Auriscope.
●Propulse Head Lamp or Head mirror and light and spare batteries
●Propulse machine (with foot control).
●Jug containing tap water to 40 degrees C.
●Noots tank.
●Jobson Horne probe and cotton wool.
●Tissues and receivers for dirty swabs and instruments
●Sufficient disposable “one use” jet tips for the treatment programme.
This procedure should be carried out with both participants seated and
under direct vision, using a headlight or head mirror and light source
throughout the procedure.
PROCEDURE
1) Check whether the patient has had his ears irrigated previously, or if there are any
contraindications why irrigation should not be performed.
2) Explain the procedure to the patient and ask the patient to sit in an examination
chair with the head tilted towards the affected ear. (A child could sit on an adults
knee and the child’s head held steady).
3) Inspect the ear to be irrigated with the auriscope.
4) Place the protective cape and towel in position and ask the patient to hold the
noots tank under the ear.
5) Check your Propulse Headlamp is in place. Check the temperature of the water
and fill the reservoir of the Propulse machine. Set the pressure at minimum,
remember any variation by more than a few degrees from 38 may cause the
patient to feel dizzy. If this occurs, stop irrigating and ask the patient to stare at a
fixed object for a few minutes until the dizziness passes.
6) Connect a new disposable “one use” jet tip applicator to the jet tip holder of
machine with firm push action. Push until ‘click’ is felt.
Page 8 Page 9

7) Direct the irrigator tip into the noots tank and switch on the machine for 10-20
seconds in order to circulate the water through the system and eliminate any trapped
water air or cold water. This also enables the noise of the machine to be more easily
accepted by the patient and the initial flow of water is discarded, thus removing any
static water remaining in the tube. Ensure the light from the headlight is shining over
the ear throughout the whole procedure.
8) Twist the jet tip so that the water can be aimed in the right direction.
9) Gently pull the pinna upwards and backwards to straighten the meatus.
(Directly backwards in children).
10) Place the tip of the nozzle into the external auditory meatal entrance. Warn the
patient that you are about to start and that he/she may feel a little dizzy, but
the procedure will be stopped if he/she feels dizzy or has any pain. Switch on the
machine (using the foot control) and direct the stream of water along the roof of
the meatus and towards the posterior wall eg ‘5 to’ and ‘5 past’ clock positions,
right and left ears respectively. Increase the pressure switch as determined by the
aural condition. It is advisable that a maximum of 2 reservoirs of water are used in
any one procedure.
11) Periodically inspect the meatus with the auriscope and inspect the solution running
into the receiver.
12) After removal of wax or debris, dry mop excess water from meatus under direct
vision using the Jobson Horne probe and best quality cotton wool, because
stagnation of water and any abrasion of skin during the procedure predisposes to
otitis externa or possible pseudomonal infection.
13) Examine ear, both meatus and tympanic membranes and treat as required or refer
to doctor if necessary.
14) Remove and discard disposable “one use” angled jet tip.
Record all findings and treatments according to UKCC guide on accountability.
Give advice regarding ear care and any relevant information.
NB: Irrigating may cause discomfort but should never cause pain.
If patient complains of pain - STOP IMMEDIATELY.
Instructions and guidelines reproduced by kind permission of the Primary Ear Care Centre.
Page 10
CLEANING GUIDELINES
●Disinfecting Tablets for the Propulse II Ear Irrigator – the importance of using
the correct strength cleaning solution cannot be overstated. A solution that is too
strong will in time damage the Propulse and one that is too weak will fail to provide
the correct level of cleaning and disinfecting. To this end the manufacturer has
introduced a specific strength disinfectant tablet to clean the Propulse correctly.
●Propulse II Electronic Ear Irrigator cleaning & disinfecting instructions
To clean the Propulse each day PRIOR to use:
1) Simply place one tablet into the reservoir, fill with warm water to the 500ml mark
on the reservoir and wait for tablet to completely dissolve.
2) Run the Propulse II Electronic Ear Irrigator for a few seconds to fill the pump and
flexible tubing.
3) Leave to stand for 10 minutes.
4) Empty the reservoir of the solution, then fill the reservoir with cool boiled water and
flush through the whole system to ensure no cleaning solution is left.
5) This cleaning & disinfecting procedure should be used prior to each days usage of
the ear irrigator.
6) DO NOT leave the solution in the unit for longer than as stated.
Simple to use and effective in use
These tablets are available direct from your normal
Propulse supplier or from Mirage direct.
ALWAYS USE A NEW JET TIP FOR EACH PATIENT.
Please note: Damage caused to your Propulse II ear irrigator by not using the
recommended cleaning agent may invalidate your warranty.
Page 11