Instruction Manual
80 Pages
Preview
Page 1
®
REF PP17P
®
®
IRRIGATOR
2797 10191020 v1.5
®
Propulse® ProScoop™ INS0040
Propulse® Cleaning Tablets (x200 per pack) CL0001
Propulse® Head Lamp INS0036
Propulse® QrX™ Single Use Tip (x100 per pack) KIT5002
Propulse® ProTect™ Cape KIT1012
Propulse® Carry Case KIT1005
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INTENDED PURPOSE The Propulse® Ear Irrigator is intended to: a) Facilitate the removal of cerumen and foreign bodies that are not hygroscopic from the meatus. b) Remove discharge, kera�n or debris from the external auditory meatus by irriga�on with warm water. Reasons for using this procedure are to: a) Correctly treat o��s externa where the meatus is obscured by debris. b) Improve conduc�on 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. 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 organisa�ons. The Propulse® QrX™ Tip is “Single Use” and should be disposed of in accordance with local authority guidelines a�er use. Reuse of the Propulse® QrX™ Tip increases the risk of cross-infec�on. Propulse Ear Irrigator must not be immersed in water. Only clean the device as specified in this manual (See page 10). If any changes in performance occur, turn off the Propulse® Ear Irrigator, disconnect from the mains electricity supply and DO NOT use (See page 11). The device has no user serviceable parts (See page 13). Use recommended Propulse® accessories only. Do not use Propulse® accessories with other devices. If the device is to be used for domes�c visits, it is strongly recommended that a Propulse® Carry Case is used to prevent damage and contamina�on. 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.
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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: a) Consent is not given and/or the pa�ent is uncoopera�ve. b) Previous complica�ons occurred following this procedure. c) There is a history of a middle ear infec�on in the last six weeks. d) The pa�ent has undergone ear surgery (apart from grommets that have extruded at least 18 months previously and the pa�ent has been discharged from the ENT dept.) e) The pa�ent has a perfora�on or there is a history of a mucous discharge in the last year. f) The pa�ent has a cle� palate (repaired or not). g) In the presence of acute o��s externa; an oedematous ear canal combined with pain and tenderness of the pinna. h) If pa�ent complains of pain - STOP IMMEDIATELY. *Please refer to Contraindica�ons on �a�e ��� COMPONENT / PARTS INDENTIFICATION 3
2 ®
1
7
4 ®
8 6
5
1.
Reservoir
2.
Lid
3.
QrX™ �p
4.
Handle and Hose
5.
Handle holder
6.
Waterflow/Pressure control switch
7.
On/Off switch
8.
Footswitch
9.
Mains power adaptor
9
The Propulse® Ear Irrigator consists of: a) 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 b)
Water container/reservoir (1) is removable to facilitate filling and cleaning. Horizontal line indicates the correct level of water required for normal use, as well as the correct level of water required to dissolve cleaning tablet.
c)
Mushroom Valve – to retain the water in the reservoir when it is removed from the Propulse® machine.
d)
Handle and non-detachable hose. The Handle accommodates the Propulse® QrX™ Single Use Tips.
e)
The footswitch - is connected to the main body via a jack plug/socket connec�on. The device will only func�on if the footswitch is connected.
Please note: Residual water in the handle and hose will con�nue to flow if the handle is not held in the ver�cal posi�on or, if the handle is held in a posi�on that is lower than the machine. To prevent residual flow, it is recommended that the handle be returned to its holder on the machine.
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TECHNICAL DATA Performance: Flow rate:
Up to 300ml/minute
Water jet pulses:
1200 per minute (approximately)
Maximum opera�ng �me:
10 minutes con�nuous use (with a recommended rest �me of 2 hours)
Storage temperature range:
-5°C to 65°C
Storage rela�ve humidity:
up to 80%
Power adaptor:
Input 100-240v ~ 50/60Hz Max 0.45A Output 9v DC2A
Electrical Safety:
EN6061-1
EMC Compliance:
EN60601-1-2
GUIDE TO SYMBOLS A�en�on - Consult Accompanying Documents Type BF Electrical safety
IPX1
Protected against water droplets Single use item Conforms to the Medical Device Direc�ve 93/42/EEC Must be disposed of in accordance with European waste electrical and electronic equipment direc�ve 2002/96/EC Manufactured by
I O 9v
Power On Power Off DC Current Variable Flow Rate
10min/2hr Duty Cycle Read Instruc�on Manual Indoor use only
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OPERATING INSTRUCTIONS These instruc�ons are for general use. When required, refer to the detailed informa�on in the second half of this manual. Ensure that ONLY suitably trained clinicians operate the device. Ensure that the warnings and cau�ons are observed. Ensure that the pa�ent exhibits no contraindica�ons (refer to page 12). Ensure the unit has been cleaned prior to first use, and every day prior to 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 prior to filling. The water reservoir must be filled to the horizontal line on the front of the reservoir. Monitor temperature regularly to ensure that pa�ent 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 posi�on marked “I”. Adjust the waterflow to an appropriate value that is compa�ble with the treatment requirements and pa�ent comfort. Direct the irrigator �p 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 air or cold water. Ensure the water is warm before presenta�on to the pa�ent. During treatment you can pause the flow by releasing the footswitch. A�er treatment empty the reservoir and operate the device to purge any residual water. Remove the Propulse® QrX™ Tip and dispose of in accordance with local authority guidelines. Turn off the On/Off switch a�er use and disconnect from the power supply. Clean the Propulse® Ear Irrigator unit every morning prior to 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 contamina�on. 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.
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DETAILED INFORMATION Fi�ng 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: 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 Firstly� e�sure you are ���g the correct mushroom valve for this model Propulse® Ear Irrigator. This will help prevent possible damage to the water inlet valve. 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
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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 Group 1 The Propulse uses only energy for its internal function. CISPR 11 Therefore, its RF emissions are not likely to cause any interference in nearby electronic equipment. RF emissions Class A The Propulse is suitable for use in all establishments CISPR 11 other than domestic and those directly connected to the public low-voltage power supply network that supplies Harmonic Class A buildings used for domestic purposes. emissions IEC 61000-3-2 Voltage Complies fluctuation/flicker emissions IEC 61000-3-3 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 6 kV contact 6 kV contact Floors should be wood, concrete discharge (ESD) IEC 8 kV air 8 kV air or ceramic tile. If floors are 61000-4-2 covered with synthetic material, the relative humidity should be at least 30%. 2 kV for power Mains power quality should be Electrical fast 2 kV for power supply lines that of a typical commercial or transient/ burst supply lines Not applicable hospital environment. IEC 61000-4-4 1 kV for input/output lines Surge 1 kV differential 1 kV differential Mains power quality should be IEC 61000-4-5 mode mode that of a typical commercial or 2 kV common 2 kV common hospital environment. mode mode Mains power quality should be < 5 % UT (> 95 % Voltage dips, short < 5 % UT (> 95 % that of a typical commercial or dip in UT) for 0.5 dip in UT) for 0.5 interruptions and hospital environment. If the user cycle 40 % UT (60 cycle 40 % UT (60 voltage variations of the Propulse requires % dip in UT) for 5 % dip in UT) for 5 on continued operation during power cycles 70 % UT power supply input cycles 70 % UT (30 mains interruptions, it is (30 % dip in UT) % dip in UT) for 25 lines recommended that the Propulse for 25 cycles cycles IEC 61000-4-11 be powered from an < 5 % UT (> 95 % < 5 % UT (> 95 % uninterruptible power supply or a dip in UT) for 5 s dip in UT) for 5 s battery. Power frequency 3 A/m Not applicable Power frequency magnetic fields (50/60 Hz) should be at levels characteristic magnetic field of a typical location in a typical IEC 61000-4-8 commercial or hospital environment. NOTE UT is the A.C. mains voltage prior to application of the test level.
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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 Electromagnetic environment – guidance level 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: Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3
3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2,5 GHz
3 Vrms
Recommended protection distance: d = 1.17 vP
3 V/m
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, acco rding to the maximum output power of the communications equipment. Rated maximum Separation distance according to the transmit frequency output power of (m) transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz d = 1.17 v P d = 1.17 v P 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.
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Cleaning Instruc�ons The importance of using the correct strength cleaning solu�on cannot be overstated. A solu�on that is too strong will in �me damage the Propulse® Ear Irrigator. A solu�on that is too weak will fail to provide the correct level of cleaning and decontamina�on. Mirage Health Group recommends the use of Propulse® CHLOR-CLEAN® Tablets. They are easy and effec�ve to use and provide a measured / specific strength of cleaning solu�on that is safe and kind to the Propulse® internal components. Ensure the unit has been cleaned prior to first use. 1.
Place warm tap water into the reservoir up to the horizontal line on the front.
2.
Place one Propulse® CHLOR-CLEAN® tablet into the reservoir and allow it to dissolve completely. Once dissolved run the machine un�l the cleaning solu�on leaves the handle. This ensures that the cleaning solu�on has reached all of the internal components. Leave the solu�on in place for 10 minutes.
3. 4. 5.
A�er 10 minutes remove the reservoir with the remaining cleaning solu�on and discard.
6.
Fill the reservoir with clean, well run, cold tap water and return to the Propulse®.
7.
Run the Propulse® ensuring that all remaining cleaning solu�on has been flushed through.
8.
Remove reservoir, discard water and dry reservoir thoroughly with a paper towel.
9.
Return reservoir to the Propulse® - it is now ready for use.
Cleaning Do not a�empt to clean the Propulse® QrX™ Tip. Use one Propulse® QrX™ Tip per pa�ent treatment and discard to clinical waste a�er use as this reduces the risk of cross infec�on between pa�ents. 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.
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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 mains electrical supply. Make sure the cord and Power Adaptor are posi�oned 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 a�emp�ng 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 selec�on of interna�onal plugs. Please fit the appropriate plug for your region. If there are any problems connec�ng to the mains electrical supply consult a qualified electrician.
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Contraindica�on to irriga�on
Ra�onale
If the pa�ent has experienced any complica�ons from a previous episode of irriga�on with water.
If the pa�ent did not tolerate a previous episode of irriga�on it would be unwise to repeat the procedure in case the symptoms are exacerbated.
There has been evidence of a middle ear infec�on (���s Media) in the last 2 months.
The tympanic membrane may be vulnerable to damage due to the adverse effect infected fluid may have on the ear drum.
The pa�ent has undergone any form of ear surgery apart from grommets, which are documented to be extruded from the tympanic membrane for over 2 years and the pa�ent is discharged from the ENT department.
There will be a weakness to the structure of the ear canal and tympanic membrane a�er surgery. This does not include cosme�c surgery to the pinna (for example repair of bat ears). If the tympanic membrane is intact 2 years post grommet extrusion, there should not be an increased risk of damage to the tympanic membrane.
There is a suspected or actual perfora�on present or there is a history of mucous discharge from the ear in the last 2 years.
A mucous discharge would indicate a perfora�on and water entry under pressure could cause infec�on or damage the delicate middle ear structures.
If the pa�ent has a cle� palate (regardless of whether it has been repaired or not).
A cle� palate indicates an underdeveloped facial skeleton and as such the tympanic membrane and middle ear structures could be more vulnerable to damage.
In the presence of acute o��s externa (pain, swollen ear canal and tenderness of the pinna).
Although it is essen�al to thoroughly clean the infected ear canal, when it is swollen debris should be removed by microsuc�on.
Profound hearing loss in one ear.
There is a risk associated with any interven�on and when a pa�ent completely relies on one ear for hearing (as the other ear has a profound hearing loss) any risk to this ear is unacceptable.
Cau�on when irriga�ng with water in the following groups of pa�ents
Ra�onale
Pa�ent is taking an��coagulants.
The lining of the ear canal is delicate and there is a higher risk of bleeding so ensure trauma to the ear canal is avoided.
The pa�ent is diabe�c.
The pH of wax in pa�ents who are diabe�c is a higher pH than average, increasing their vulnerability to infec�on.
Tinnitus.
Although wax impac�on can cause �nnitus, trauma to the tympanic membrane may exacerbate this.
Ver�go.
This is also a symptom of wax impac�on but irriga�on can trigger an episode so ensure appropriate water temperature and pa�ent safety.
Radiotherapy that has involved the ear canal.
A radiated ear canal can develop bony necrosis so wax should be removed before it becomes hard and trauma to the canal should be avoided.
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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. The Propulse® Ear Irrigator should under-go rou�ne electrical safety tes�ng to ensure that it remains safe to use, in accordance with EN ISO 62353:2014 Users of the Propulse® Ear Irrigator should carry out regular inspec�ons 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 un�l replacement parts have been ��ed. 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, Her�ordshire AL7 1AU UK Tel - +44 (0) 845 130 5445
The clinical procedures rela�ng 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 organisa�ons. Addi�onal informa�on on use of the Propulse® can be found at: h�p://www.youtube.com/user/MirageHealthGroup
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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, informa�on rela�ng to the nature of the fault and details of where the item was purchased, rec�fy the fault at no cost to you. Should any of the “Accessory” items (listed below) prove to be faulty as a result of defec�ve material or workmanship, Mirage Health Group will rec�fy the issue free of charge upon receipt of the faulty accessory (�sub�ect to condi�ons). “Accessory” items are: Footswitch; Reservoir / Tank and Lid; Mushroom Valve and Washer; QrX™ Tip; Power Supply Lead and Power Transformer. �Condi�ons 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 unauthorised 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 addi�on to, and does not diminish your statutory or legal rights. Addi�onal user manuals and other accessories are available from Mirage Health Group Ltd at:
Mirage Health Group 11 Tewin Court, Welwyn Garden City, Her�ordshire AL7 1AU �� Tel - +44 (0) 845 130 5440 Fax - +44 (0) 845 130 6440 www.miragehealthgroup.com [email protected] interna�[email protected]
© 2020 Copyright Mirage Health Group Ltd Issue date: October 2020 doc 01.5
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Environmental Prote��on
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. Disposing of used Propulse® QrX™ Tips 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.
Transporta�on 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.
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®
REF PP17P
®
®
EAR IRRIGATOR
2797
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®
REF PP17P
®
®
IRRIGATOR IRRIGATEUR
2797
®
REF PP17P
®
®
IRRIGATOR
2797