PRAXISDIENST REF PP17P Propulse Ear Irrigator Instruction Manual

: July 20, 2024
: PRAXISDIENST

Table of Contents

PRAXISDIENST REF PP17P Propulse Ear Irrigator
Product Information
Product Usage Instructions
FAQ
INTENDED PURPOSE
COMPONENT PARTS IDENTIFICATION
TECHNICAL DATA
OPERATING INSTRUCTIONS
DETAILED INFORMATION
Cleaning Instructions
Maintenance & Safety Inspections
Warranty
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

PRAXISDIENST REF PP17P Propulse Ear Irrigator

Product Information

Specifications

Performance: Flow rate up to 300ml/minute
Maximum operating time: 10 minutes of continuous use (with a recommended rest time of 2 hours)
Storage and transport temperature: Not specified
Power adaptor: Input 100-240v ~ 50/60Hz Max 0.45A, Output 9v DC2A
Electrical Safety: EN60601-1
EMC Compliance: EN60601-1-2

Product Usage Instructions

These instructions are for general use. For detailed information, refer to the second half of the manual.

Remove the old Mushroom Valve from the reservoir.
Insert the new Mushroom Valve into the reservoir.
Check the condition of the ‘O’ ring on the base of the reservoir and replace if worn.
Return the reservoir to the machine.

The Propulse is intended for use in specific electromagnetic environments. Ensure proper usage in such environments to prevent interference.

FAQ

Q: Can I use the irrigator without a qualified healthcare professional?
A: No, this procedure should ONLY be carried out by a suitably qualified healthcare professional.
Q: What should I do if there is residual water flow in the handle and hose?
A: To prevent residual flow, ensure the handle is held vertically or returned to its holder on the machine.

INTENDED PURPOSE

The Propulse® Ear Irrigator is intended to:

Facilitate the removal of cerumen and foreign bodies that are not hygroscopic from the meatus.
Remove discharge, kerana, or debris from the external auditory meatus by irrigating with warm water.

The reasons for using this procedure are to

Correctly treat otitis externa where the meatus is obscured by debris.
Improve conduction of sound into the ear, where impacted wax is believed to be the cause of a hearing defect.
Examine the external auditory meatus and the tympanic membrane.
Remove a cause of discomfort.

This procedure should ONLY be carried out by a suitably qualified healthcare professional.

WARNINGS AND CAUTIONS

This manual must be read and understood before the Propulse® Ear Irrigator is used.
Only suitably trained staff should use the device. Mirage can advise on the availability of training courses offered by relevant organizations.
The Propulse® QrX™ Tip is “Single Use” and should be disposed of under local authority guidelines after use.
Reuse of the Propulse® QrX™ Tip increases the risk of cross-infection.
Propulse® Ear Irrigator must not be immersed in water.
Only clean the device as specified in this manual.
If any changes in performance occur, turn off the Propulse® Ear Irrigator, disconnect from the mains electricity supply, and DO NOT use it.
The device has no user-serviceable parts.
Use recommended Propulse® accessories only.
Do not use Propulse® accessories with other devices.
If the device is to be used for domestic visits, it is strongly recommended that a Propulse® Carry
The case is used to prevent damage and contamination.
The Propulse® Ear Irrigator is not user-repairable and should be returned to your Propulse® supplier or Mirage Health Group (UK customers only) for service and/or repair. It is recommended that the Propulse® Ear Irrigator is serviced annually.

Please note: Damage caused to your Propulse ®Ear Irrigator by the use of accessories, consumables or service agents not recommended by Mirage Health Group, will invalidate your warranty.

DO NOT IRRIGATE the ears if

Consent is not given and/or the patient is uncooperative.
Previous complications occurred following this procedure.
There is a history of a middle ear infection in the last six weeks.
The patient has undergone ear surgery (apart from grommets that have extruded at least 18 months previously and the patient has been discharged from the ENT dept.)
The patient has a perforation or there is a history of a mucous discharge in the last year.
The patient has a cleft palate (repaired or not).
In the presence of acute otitis externa; an oedematous ear canal combined with pain and tenderness of the pinna.
If a patient complains of pain – STOP IMMEDIATELY.
*Please refer to Contraindications.

COMPONENT PARTS IDENTIFICATION

Reservoir
Lid
QrX™ trip
Handle and Hose
Handle holder
Waterflow/Pressure control switch
On/Off switch
Footswitch
Mains power adaptor

The Propulse® Ear Irrigator consists of:

The main unit and the following user controls:
- An On/Off switch
- A footswitch which (when pressed) starts the flow of water. The water stops when the footswitch is released.
- A mains power adaptor
Water container/reservoir (1) is removable to facilitate filling and cleaning. The horizontal line indicates the correct level of water required for normal use, as well as the correct level of water required to dissolve cleaning tablets.
Mushroom Valve – to retain the water in the reservoir when it is removed from the Propulse® machine.
Handle and non-detachable hose. The Handle accommodates the Propulse® QrX™ Single-Use
Tips.
The footswitch – is connected to the main body via a jack plug/socket connection. The device will only function if the footswitch is connected.

Please note: Residual water in the handle and hose will continue to flow if the handle is not held in the vertical position or, if the handle is held in a position that is lower than the machine. To prevent residual flow, it is recommended that the handle be returned to its holder on the machine.

TECHNICAL DATA

Performance

Flow rate: Up to 300ml/minute
Maximum operating time: 10 minutes of continuous use with a recommended rest time of 2 hours
Storage and transport temperature: 5° to 45°C
Power adaptor: Input 100-240v ~ 50/60Hz Max 0.45A Output 9v DC2A
Electrical Safety: EN60601-1
EMC Compliance: EN60601-1-2

GUIDE TO SYMBOLS

OPERATING INSTRUCTIONS

These instructions are for general use. When required, refer to the detailed information in the second half of this manual.

Ensure that ONLY suitably trained clinicians operate the device.
Ensure that the warnings and cautions are observed.
Ensure that the patient exhibits no contraindications (refer to page 12).
Ensure the unit has been cleaned before first use, and every day before use (refer to page 10 for detailed cleaning guidance).
The device may only be operated whilst connected to the mains electrical supply using the Power Adaptor and footswitch provided.
The reservoir should be removed before filling.
The water reservoir must be filled to the horizontal line on the front of the reservoir.
Monitor temperature regularly to ensure that patient comfort and safety is maintained. Refill as necessary.
Fit a new Propulse® QrX™ Single Use Tip to the Handle.
Adjust the Waterflow Switch (6) to an appropriate level.
Turn the On/Off Switch (7) to the position marked “|”.
Adjust the water flow to an appropriate value that is compatible with the treatment requirements and patient comfort.
Direct the irrigator tip into the noots tank and switch on the machine for 10-20 seconds to circulate the water through the system and eliminate any trapped air or cold water.
Ensure the water is warm before presentation to the patient.
During treatment, you can pause the flow by releasing the footswitch.
After treatment empty the reservoir and operate the device to purge any residual water.
Remove the Propulse® QrX™ Tip and dispose of it under local authority guidelines.
Turn off the On/Off switch after use and disconnect from the power supply.
Clean the Propulse® Ear Irrigator unit every morning before use, with a Propulse cleaning tablet (See page 10).
The Propulse® Ear Irrigator should only be transported in a Propulse® approved carry case to prevent damage or contamination.
If any changes in performance occur, turn off the Propulse® Ear Irrigator, disconnect from the mains electricity supply and DO NOT use. Please refer the machine to Mirage.

DETAILED INFORMATION

Fitting the Footswitch
The Propulse® footswitch is connected to the main unit by a socket in the side of the device. The Propulse® Ear Irrigator will NOT operate unless the footswitch is connected.

Filling the water reservoir
It is recommended that:

The water reservoir is removed from the device for filling and the lid is always in place when the water container is in situ on the device.
The water reservoir should be filled to the horizontal line on the front. This helps to eliminate the risk of spillage.
Water at 40°C is recommended. Higher temperatures increase the risk of scalding and burns to the patient. Lower temperatures increase the risk of patient discomfort and dizziness.

Fitting 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

Remove Tip from packaging – Tips are non-sterile.
Push Tip into Handle until a click can be heard.

To remove a Propulse® QrX™ Tip

Retract the QrX™ Locking Collar using a thumb.
Grasp the used QrX™ Tip between the forefinger and thumb and pull gently from the QrX™ Handle.
Dispose of the used Tip under local authority guidelines. DO NOT REUSE TIPS.

Propulse® QrX™ Tips are available to purchase in boxes of 100 individually wrapped (non-sterile) tips from your normal Propulse® supplier or from Mirage directly (UK only). Propulse® QrX™ Tips are clearly branded with the Propulse® logo on the tip 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 from flowing out of the reservoir whilst filling. Should a replacement Mushroom Valve be required, please follow the steps below –
Firstly, ensure you are fitting the correct mushroom valve for this model Propulse® Ear Irrigator.
This will help prevent possible damage to the water inlet valve

Remove the reservoir from the Propulse® Ear Irrigator.
Remove the old Mushroom Valve from the reservoir and discard
Insert a new Mushroom Valve without bending or exerting undue force on the legs of the Mushroom Valve, into the reservoir.
Check the condition of the ‘O’ ring on the base of the reservoir and if worn replace with a new unit-specific ‘O’ ring.
Return the reservoir to the machine

Cleaning Instructions

The importance of using the correct strength cleaning solution cannot be overstated. A solution that is too strong will in time damage the Propulse® Ear Irrigator. A solution that is too weak will fail to provide the correct level of cleaning and decontamination. Mirage Health Group recommends the use of Propulse® CHLOR-CLEAN® Tablets. They are easy and effective to use and provide a measured / specific strength of cleaning solution that is safe and kind to the Propulse® internal components.
Ensure the unit has been cleaned before first use.

Place warm tap water into the reservoir up to the horizontal line on the front.
Place one Propulse® CHLOR-CLEAN® tablet into the reservoir and allow it to dissolve completely.
Once dissolved run the machine until the cleaning solution leaves the handle. This ensures that the cleaning solution has reached all of the internal components.
Leave the solution in place for 10 minutes.
After 10 minutes remove the reservoir with the remaining cleaning solution and discard.
Fill the reservoir with clean, well-run, cold tap water and return to the Propulse®.
Run the Propulse® ensuring that all remaining cleaning solution has been flushed through.
Remove reservoir, discard the water, and dry the reservoir thoroughly with a paper towel.
Return the reservoir to the Propulse® – it is now ready for use.

Cleaning

Do not attempt to clean the Propulse® QrX™ Tip. Use one Propulse® QrX™ Tip per patient treatment and discard to clinical waste after use as this reduces the risk of cross-infection between patients.
External cleaning of the Propulse® Ear Irrigator should be done by hand, wiping with a damp cloth only. Apply liquids to the cloth not the unit. Do not immerse the unit in water. Mild detergents and disinfectants may be used externally.

Power Adaptor

Connect the outlet lead of the Power Adaptor to the Power Adaptor socket marked on the end of the product and to the main electrical supply. Make sure the cord and Power Adaptor are positioned so that they will not be subjected to damage or stress or present a trip hazard.
Only use a Propulse® branded Power Adaptor.
To reduce the risk of electric shock, unplug the unit from the power source before attempting to clean it externally.
The Power Adaptor must not be used outdoors or in damp areas.
The Propulse® Power Adaptor will have been supplied with an appropriate plug for your region OR a selection of international plugs. Please fit the appropriate plug for your region.
If there are any problems connecting to the mains electrical supply consult a qualified electrician.

Maintenance & Safety Inspections

To ensure optimum performance the Propulse® Ear Irrigator should be serviced every 12 months.
Service or repairs conducted by unauthorized agencies/organizations invalidate any or implied warranties from Mirage.
The Propulse® Ear Irrigator should undergo routine electrical safety testing to ensure that it remains safe to use, under EN ISO 62353:2014
Users of the Propulse® Ear Irrigator should carry out regular inspections to ensure that the handle and hose, power adaptor and cable, reservoir, footswitch and main body of the machine are free from damage prior to use. If any damage is evident, the
Propulse® Ear Irrigator should NOT be used until replacement parts have been fitted.
Only Propulse® branded items should be used with the Propulse® Ear Irrigator.
The Propulse® Ear Irrigator is not user-repairable and should be returned to your Propulse” supplier or Mirage Health Group (UK customers only) for service and/or repair:

Mirage Health Group Service Centre

11 Tewin Court, Welwyn Garden City,
Hertfordshire
AL7 1AU
UK
Tel – +44 (0) 845 130 5445

The clinical procedures relating to the use of ear irrigators can be found on the following websites:

www.earcarecentre.com
www.entnursing.com/earcare.htm
Mirage is not responsible for the content or maintenance of third-party internet sites.
Mirage can also advise on the availability of training courses offered by the relevant organizations.
Additional information on use of the Propulse® can be found at: http://www.youtube.com/user/MirageHealthGroup.

Warranty

The Propulse® Ear Irrigator carries a twelve-month warranty (*subject to conditions) from the date of original purchase. Should any defect arise due to faulty material or workmanship, Mirage Health Group will, upon receipt of the faulty Propulse® Ear
Irrigator, proof of purchase, information relating to the nature of the fault and details of where the item was purchased, rectify the fault at no cost to you.
Should any of the “Accessory” items (listed below) prove to be faulty as a result of defective material or workmanship, Mirage Health Group will rectify the issue free of charge upon receipt of the faulty accessory (*subject to conditions).
“Accessory” items are: Footswitch; Reservoir / Tank and Lid; Mushroom Valve and Washer; QrX™ Tip; Power Supply Lead and Power Transformer.
Conditions of Warranty (applicable to Propulse® Electronic Ear Irrigator and “Accessory” items).

The warranty does not cover

Accidental damage or damage caused by misuse.
Faults caused due to lack of maintenance.
Damage caused by using the Propulse® Ear Irrigator for any use other than its intended use.
Damage caused as a result of repair by any unauthorized agents – ONLY Mirage Health Group should undertake repairs.
Damage caused by the use of accessories/cleaning products that have not been recommended by Mirage Health Group as suitable for your model irrigator.

This warranty is in addition to, and does not diminish your statutory or legal rights.
Additional user manuals and other accessories are available from Mirage Health Group Ltd at:

Mirage Health Group
11 Tewin Court, Welwyn Garden City,
Hertfordshire AL7 1AU UK
Tel – +44 (0) 845 130 5440
Fax – +44 (0) 845 130 6440
www.miragehealthgroup.com
uksales@miragehealthgroup.com
internationalsales@miragehealthgroup.com

Environmental Protection
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 it through a locally approved disposal service for electronic equipment. Penalties may be applicable for incorrect disposal of this waste, under national legislation.

Disposing of used Propulse® QrX™ Tips
Disposal should be under local authority guidelines and regulations for the disposal of clinical waste. Propulse® QrX™ Tips should not be disposed of in municipal waste.
Transportation
Before the Propulse® Ear Irrigator is transported, the reservoir must be emptied and the machine should be operated until the handle and hose are empty of liquid. The reservoir should then be dried using a paper towel.
For safe transportation of the Propulse® Ear Irrigator, Mirage recommends that the Propulse® Carry Case is used to prevent damage or contamination. For internal cleaning, please refer.

Medical Device Management Ltd