User Manual
57 Pages
Preview
Page 1
Copyright notice No part of this Manual or program may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the prior written consent of GN Otometrics A/S. Copyright© 2011, GN Otometrics A/S Printed in Denmark by GN Otometrics A/S, Denmark All information, illustrations, and specifications in this manual are based on the latest product information available at the time of publication. GN Otometrics A/S reserves the right to make changes at any time without notice. GN Otometrics A/S 9 Hoerskaetten DK-2630 Taastrup Denmark T: +45 45 75 55 55, F: +45 45 75 55 59 www.otometrics.com Version release date 13. September 2011 Technical support Please contact your supplier.
FM template version: 01-02-2010
1.0 F
UK 1.2
Intended use
Compact unit for stimulation of the vestibule.
Distinguished by its easy operation, it can be used in a hospital and in a practice.
May also be used for irrigations of the auditory canal during examintaions.
The unit is available with different water flow quantities
for the stimulation mode resp. irrigation mode. The respective flow quantity of the special unit is stated on the type plate.
This unit may not be used if the auditory canal is inflamed or contaminated.
This unit is designed for short-time use on patients.
1.3
Function
Operating the main switch ( , fig. 1) automatically
activates the thermal process for reducing bacterial count (see section 4.4.1) .
The unit automaticaly switches to the irrigation mode
where the autitory canal can be rinsed with water warmed up to 37°C.
The unit operation can be changed to the stimulation mode for stimulating the vestibule with a reduced flow of water. The Aquamatic TM II is equipped with a timer for preselecting the stimulation time.
1.2
Affectation
Appareil compact facile à utiliser pour la stimulation du vestibule dans les cliniques et les cabinets médicaux.
Egalement utilisable comme appareil de traitement pour le rinçage du conduit auditif.
L'unité est disponible avec débits d'eau differents pour le
mode de stimulation ou bien le mode de rinçage. Le débit d'eau de votre unité est indiqué sur la plaque signalétique.
Ne pas utiliser si le conduit auditif fait l’objet d’une inflammation ou d’une contamination.
Le produit est prévu pour une utilisation de courte durée sur le patient.
1.3
Fonctionnement
Une fois l’interrupteur principal actionné ( , illustra-
tion 1), le processus thermique de réduction de l'indice de germination est activé (voir paragraphe 4.4.1).
Ensuite, passage automatique au mode de rinçage. On peut ici effectuer des rinçages du conduit auditif avec de l’eau chaude à 37°C.
Possibilité de passer au mode de stimulation, lequel permet de stimuler le vestibule avec un débit réduit. Le Aquamatic TM II comprend un minuteur pour le préréglage de la durée de stimulation.
2.0 F
UK
Page 14 - 15
2.0 Safety advice The Aquamatic TM II unit is produced according to IEC 601/EN 60601 and listed in the following classes: • VDE Class of protection 1 • Class IIa (EEC 93/42).
The equipment must only be connected to a power outlet with a correctly installed ground/earthing contact according to local and state requlations.
The unit must be installed by a specialist authorized by GN Otometrics (see chapter 3.3).
The Aquamatic TM II may be used in supervised
operation by qualified personnel which have been au thorised by GN Otometrics and which have been trained in the operation of the equipment (IEC 601-1/EN 60601-1).
The mains voltage specified on the type plate must match the power supply system.
Prior to every use of the equipment, verify that the device is technically safe and in proper working condition. Damaged leads must be replaced immediately!
Correct configuration in assembly of country-specific connections green/yellow: blue: black resp. brown:
protective conductor (PE) neutral conductor (N) phase (L)
The control panel must be visible and in reach of the operator. Ensure the equipment is stable prior to use.
In the thermal process for reducing bacterial count hot water is being ducted through the irrigation handle. Please do not take the handle from its holder or spray water!
Metal parts can be hot! Prior to spraying, the water temperature must be checked by the user!
Switch off main power switch after use and close the water valve of water supply.
The Aquamatic TM II should only be operated in rooms
used for medical purposes, and never in areas subject to explosion hazards.
12
All additional equipment, which is connected to the analog and digital interfaces of the unit, must meet the requirements of relevant EN specifications (for inst. EN 60950 for data processing equipment and EN 60601 for electrical medical appliances). In addition, configurations must satisfy system specification EN 60601-1-1. When additional equipment is connected to the signal input or signal output section on the unit, the person making the connection is deamed "a system configuration operator" and as such is responsible for meeting the requirements of system specification EN 60601-1-1. For answers to additional questions, please contact your local specialist supplier or GN Otometrics technical service. The irrigation jet must not get into contact with contaminated material.
Only use the warm water jet when a tube tip is installed! Take caution to avoid injury to the eardrum when introducing the water jet !
For hygienic reasons jet connections must be changed after each patient. This also prevents retrograde germination of the warm water system.
Use only for irrigation of auditory canal ! GN Otometrics is not liable for personal injury and damage to property if • original GN Otometrics parts are not used, • the operating instructions are not completely followed, • assembly, new settings, alterations, extensions and repairs have been carried out by personnel not authorised by GN Otometrics.
2.0 UK 2.1 Important instructions for the maintenance of the hygiene status of warm water irrigation units For loosening cerumen in the auditory meatus and for the stimulation of the labyrinthine system, GN Otometrics offers the warm water units Hygrotherm plus (37°C) and Aquamatic TM II (20° - 47°C). These units heat the drinking water which comes from the household connection to the preselected temperature. The operating instructions must be followed, or the increased number of pathogens in the rinse water can affect the health of sensitive patients. Requirement for taking into use
The water which is provided by the household connection must at least meet the WHO guidelines or the country-specific guiedelines for drinking water.
Connection
Fresh water must flow through the wall connection for a period of approx. 1 minute prior to the unit being connected.*
Ensure that the installation is hygienically carried out! Disinfect the threaded connections with 70 % alcohol* before screwing them into place.
Wear disposable gloves* when carrying out maintenance work on parts which come into contact with the water.
Carry out thermal cleaning at least 3 times before patient use.* * This work is carried out by the GN Otometrics service technician.
Running operation
Before beginning the surgical operation, switch on the unit and await the thermal cleaning process.
After the device had been idle for a long period of time, (weekend, during holidays, etc.) the thermal cleaning process must be initiated and repeated.
We recommend that the device be switched off and on every 2 hours and not longer than 4 hours to start the thermal cleaning mode.
Immediately replace and autoclave contact parts such as the jet connection each time it is used for a different patient (for prevention of retrograde germification).
Before every use, spray water and check the temperature.
Service
Ensure that the suspended particle filter is hygienically changed (see commissioning) (dipose of filter and carefully clean the filter glass). Ensure that no contact is made with the contaminated parts.
Carry out thermal cleaning after each service.
We recommend that the number of germs in the water be regularly determined at the input and output of the unit.
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3.0 F
UK 3.3
Connections
3.3
Raccords
3.3.1 Electrical connection
3.3.1 Raccord électrique
Connect the power cable to the socket on the unit (,
Reliez la fiche de contact avec l’alimentation du réseau
fig. 2). Insert the power plug in a correctly installed socket with a ground/earthing contact.
(, illustration 2).
Reliez la fiche de contact avec une prise à contact de protection correctement installée.
3.3.2 Connecting a nystagmograph
3.3.2 Raccord d'un nystagmographe
When controlling an ENG (electro-nystagmograph) or a
Lors de la commande d’un nystagmographe électrique
At the end of the stimulation time, a trigger signal for
A la fin du temps de stimulation, un signal de déclenche-
CNG (computer-nystagmograph) at output (, fig. 2), please connect only recording equipment approved by GN Otometrics. Connecting cable available from A GN Otometrics (see section 8.0).
a nystagmograph is available at the rear 3-pole DIN socket. This outlet is an electrically isolated photo transi stor. The emitter connection which has to be connected to the ground line of the trigger inlet at the nystagmo graph is attached to pin 3. The open-collector connection is located on pin 1 and is to be connected to the positive supply voltage (+5 V or +12 V) by means of a pull-up resistance. The maximum collector voltage of the transistor may not exceed 80 MA.
ou d’un nystagmographe informatique à la sortie ( , illustration 2), ne brancher que des appareils d’enregistrement autorisés par GN Otometrics. Fiche de raccord disponible chez GN Otometrics(voir paragraphe 8.0).
ment pour un nystagmographe est disponible à l’arrière sur une fiche DIN 3 pôle. Cette sortie est isolée électriquement. La broche 3 de la fiche DIN doit être reliée à la Terre. La broche 1 de la fiche DIN correspond au (+5 V or +12 V) avec une intensité maximale de 80 MA.
3.3.3 Raccord de compensation de potentiel 3.3.3 Equipotentiality connection Connection for potential compensation (, fig. 2). Connecting cable available from GN Otometrics (see section 8.0).
3.3.4 Water connection Local requirements: • • • • •
Water-tap with G3/4" external thread. Drinking-water! Input water pressure: +2000...+6000 hPa. Feed temperature: +7...+19.5°C (recommended), but at least 0.5°C below the required lowest cold stimulation value. Drainage fittings (Art.No. 502.0880.0) as to DIN 1988.
Connection to water supply and waste water: • • • • • •
Prior to connecting the unit to the water supply the feed line must be flushed clean by opening the water tap for a minute and allowing free flow of the tap water. Connect the filter unit to the water-tap by means of adaptor and gasket. Insert the gaskets in the cap nuts of the water supply hose. Join the nuts with the filter connection and the unit connection (, fig. 3). Insert the gaskets in the cap nuts of the waste water hose Join the nuts with the unit connection (, fig. 3) and the drainage fittings.
Raccord pour la compensation de potentiel ( , illus-
tration 2). Câble de raccord disponible chez GN Otometrics (voir paragraphe 8.0).
3.3.4 Raccord d'eau Exigences vous incombant: • • • • •
Robinet d'eau avec G3/4" filet extérieur. Eau potable! Pression de service de l'eau: +2000...+6000 hPa. Température d'arrivée de l'eau.: +7...+19,5°C (recommandé), mais au moins 0,5°C sous le valeur plus inférieur souhaité pour le stimulation foird. Garniture d'évacuation (N° art. 502.0880.0) selon DIN 1988.
Raccord à l’alimentation en eau et pour l’écoulement
des eaux usées: • Avant de raccorder le système au réseau d'alimenta tion d'eau, nettoyer la conduite en ouvrant le robinet d'eau pendant une minute et en laissant couler librement l'eau. • Fermer l’unité de filtrage à l’aide de l’adaptateur et la garniture d’étanchéité au robinet. • Placer les bagues d’étanchéité dans les écrous raccords du tuyau d’arrivée. • Visser les écrous avec le raccord de filtre du tuyau d’évacuation et le raccord à l'appareil (, illustr. 3). • Placer les bagues d’étanchéité sur les écrous raccords du tuyau d’arrivée d’eau. • Visser les écrous avec le raccord à l’appareil (, illustration 3) et la garniture d’évacuation.
Fermer le robinet quand l'appareil n'est pas en service!
23
3.0 F
UK 3.3.5 Connecting the irrigation handle
3.3.5 Raccord de la poignée de rinçage
Insert a "three-holes gasket" (, fig. 4) in the double-
Visser le "tube double" ( , illustration 4) avec une
barrelled hose and screw it ( , fig. 4) on the unit connection (, fig. 3).
Use only "three-holes gaskets" or the unit will not function correctly!
"garniture en place à trois trous" (, illustration 4) sur le raccord d'appareil (, illustration 3).
N'utiliser que des "garnitures à trois trous", car l'appareil ne fonctionne pas bien autrement!
Insert a "three-holes gasket" in the irrigation handle and
Visser la poignée de rinçage avec la garniture à trois
Open the water-tap.
Ouvrez le robinet.
3.4
3.4
screw it on the free end of the double-barrelled hose. Check whether all connections are tight.
Start-up
Insert the handle in its holder; the jet must point to the reverse side of the unit.
Switch on the unit (, fig. 1). The unit will display a test mode with digital numbers " 8 8"and an audible signal.
Automatic activation of the thermal process will begin for reducing bacterial count. Duration: 5 min.
When the thermal process is complete , the unit will switch to the irrigation mode (37°C).
When the irrigation mode is not used (handle is not removed from its support) the unit change into the energy saving mode after 5 min.
trous“ en place“ sur l’extrémité libre du tuyau double. Vérifiez si toutes les jonctions sont étanches.
Mise en service
Accrocher la poignée dans la fixation de sorte que la
buse de rinçage indique dans le sens de la face arrière de l’appareil.
Mettre l’appareil en marche (, illustration 1). Test automatique d’affichage avec suite numérique de chiffres «8 8» et signal d’avertissement acoustique.
Activation automatique du processus thermique de réduction de l'indice de germination. Durée: 5 minutes.
Changement automatique au mode de rinçage (37°C). En cas de non utilisation du mode rinçage dans l’espace de 5 min. (la poignée n’est pas prise de la fixation) changement automatique en mode de réduction d'énergie.
25
4.0 4.0 Operation
UK
4.0 Commande
Avant la mise en marche, veiller à ce que la poignée soit
accrochée dans sa fixation (la buse de rinçage doit indiquer dans le sens de la face arrière de l’appareil!).
Before switching on the unit, make sure that the handle is in its holder (jet must point to reverse side of the unit).
4.1 Adjusting temperatures Number of temperature levels: 3 • •
One level fixed to 37°C irrigation temperature. Two variable temperature levels (20°C - 47°C) (48°C + 49°C only for testing purposes).
Temperate setting by coding switches (, , fig. 1). • left switch: for adjusting the "ten" partition • right switch: for adjusting the "one" partition lower keys (+): Temperature increase upper keys(-): Temperature decrease
Standard settings: • • •
Level for irrigation mode: 37°C fixed Level for cold stimulation: 30°C Level for warm stimulation: 44°C
4.2 Selecting temperature levels After operating the main power switch, the automatic
activation of the thermal process begins for reducing bacterial count, followed by the automatic activation of the temperature level "irrigation mode" (37°C).
4.1 Réglage des températures Nombre des niveaux de température: 3
dont: • Un niveau réglé fixe sur 37°C température de rinçage. • Deux niveaux variables de températures (20°C - 47°C) (48°C + 49°C dans des buts de tests).
Réglage de température par touche de codage (, , illustration 1). • Touche gauche: pour le réglage des dizaines • Touche droite: pour le réglage des unités Bouton inférieur de commutation (+): Augmentation de la température Bouton supérieur de commutation (-): Diminution de la température
Réglages standard: • • •
respective key (, , , fig. 1).
4.4 Adjusting flow quantity With the lever for water flow (, fig. 6) you can adjust the flow quantity at the irrigation handle.
2 adjusting possibilities:
High:Flow quantity for rinsing the auditory canal Low: Flow quantity for stimulating the vestibular organ
With the adjusting screw (, fig. 6) you can precisely preselect the flow quantity.
Periodically check the water flow for the stimulation of the vestibular organ and readjust, if necessary.
37°C fixe 30°C 44°C
Une fois l’interrupteur principal activé, activation automatique du processus thermique de réduction de l'indice de germination, puis activation automatique du niveau de température „mode de rinçage (37°C).
Pour la sélection du niveau de température souhaité,
appuyez sur la touche respective ( , , , illustration 1). Affichage du niveau actif par diodes lumineuses. Affichage de la température d’eau (valeur réelle) en °C.
4.3 Adjusting stimulation time By means of coding switch (, fig. 1).
Niveau mode de rinçage: Niveau stimulation froid: Niveau stimulation chaud:
4.2 Sélectionner les niveaux de températures
For selecting the desired temperature level, use the Display of the active level by illuminated diodes. Display of the water temperature (current value) in °C.
F
4.3 Réglage de la durée de stimulation A l'aide de la touche de codage (, illustration 1).
4.4 Réglage du débit d'eau Avec le levier du débit d'eau (, illustration 6) on peut ajuster la quantité d'eau.
Il y a deux positions: High: Augmentation du débit d'eau pour les rinçages du conduit auditif Low: Réduction du débit d'eau pour stimulation du vestibule Avec le vis moletée (, illustration 6) on a la possibilité d'ajuster avec précision le débit d'eau.
Pour la stimulation du vestibule on doit controller le débit d'eau periodiquement et si necessaire ajuster.
27
4.0 F
UK 4.5 Description of modes
4.5 Description des modes opératoires
4.5.1 Thermal process for reducing bacterial count
4.5.1 Processus thermique de réduction de l'indice de germination
Purpose: Reduction of bacteria count in the warm water circuit to prevent or clear a contaminated system.
But: Réduction de l'indice de germination dans le circuit d'eau chaude au cas où des germes auraient pénétré dans le system.
Activation: Occurs each time the unit is switched on. Condition for starting the correct thermal process for reducing bacterial count: • The irrigation handle must be inserted in the holder on the side (jet pointing to reverse side of the unit). If not, a warning signal is given (warning also sounds when the handle is removed during the thermal cleaning procedure). Additionally, the error code "F0" is shown (disappears when handle is returned). • In the thermal process for reducing bacterial count, hot water is passing through the irrigation handle. Please do not take handle from its holder or splash off water! • Metal parts of the irrigation handle and of the double barrelled hose will be hot! Please do not touch metal parts during the thermal cleaning procedure! • During the thermal process for reducing bacterial count, the temperature display shows a 'd' on the first segment and the remaining time (in minutes) on the second segment.
Activation: Après chaque mise en marche. Condition pour le lancement du processus thermique de réduction de l'indice de germination correcte: • La poignée doit se trouver dans la fixation latérale (la buse indique dans le sens de la face arrière de l’appareil). Si ce n’est pas le cas, un signal retentit (retentit de même quand on retire la poignée pen dant le nettoyage thermique). Affichage supplémentaire du code d’erreur «F0» (s’éteint lors de la remise en place de la poignée). • Dans le processus thermique de réduction de l'indice de germination, de l’eau très chaude passe par la poignée. Ne pas sortir la poignée de la fixation ou arroser avec de l’eau! • Les pièces métalliques à la poignée de rinçage et au tuyau double chauffent! Ne pas les toucher pendant le nettoyage thermique! • Pendant le processus thermique de réduction de l'indice de germination, un 'd' apparaît à l'affichage de température au premier segment et au deuxième segment est affichée la durée restante.
After cooling down to 37°C the unit will automatically switch into irrigation mode.
Puis refroidissement à 37°C et passage automatique au mode de rinçage.
4.5.2 Irrigation mode
4.5.2 Mode de rinçage
Purpose: Rinsing of the auditory canal.
But: Pour les rinçages du conduit auditif.
Properties: Temperature: 37°C, permanently set. Position of the adjusting lever: High (see fig. 6, page 26).
Caractéristiques: Température: 37°C, réglage fixe. Position du levier du débit d'eau: High (voir illustration 6, page 26).
Activation: Automatically after completion of thermal cleaning procedure and taking out the handle or by key (, fig. 1).
Activation: Automatique une fois le processus thermique de réduction de l'indice de germination terminé et le retrait de la poignée ou par la touche (, illustration 1).
When the irrigation mode is not used (handle remains in
En cas de non utilisation du mode de rinçage (la poignée
Reactivation of the irrigation mode by taking the handle
Réactivation du mode de rinçage en retirant la poignée
holder) the Aquamatic II changes into the energy saving mode after 5 min. TM
out of the holder or activating a key on the temperature control unit.
Repeated activation of the 37°C key effects switching-off of the heating system. Water with feed temperature is available.
reste dans la fixation), le Aquamatic TM II passe en mode de réduction d'énergie après 5 min. voire en activant une touche sur l’unité de régulation de température.
Une nouvelle activation de la touche 37°C provoque la mise à l’arrêt du chauffage. L’eau avec température d’arrivée est à disposition.
29
4.0 UK 4.5.3 Stimulation mode Purpose: Stimulation of the vestibule. Properties: Temperature: according to pre-set cold or warm water stimulation level Position of the adjusting lever: Low (see fig. 6, page 26) Duration: as pre-set by means of timer. Activation: Initial selection of the type of stimulation is done by actuating either warm-stimulation or cold-stimulation key ( , , fig. 1) (see section 4.1 for pre-setting of temperature). Water with pre-set temperature value flows to handle.
Wait for 20 seconds. Operate the "timer-start-key". Preparation for stimulation: •
Operate unit 15 seconds in holding position, so that the jet can be positioned correctly in the auditory canal.
During this period, the water is directed, via the handle, into the drain in order to guarantee an optimum temperature stability; with an optical indication by the flashing figure in temperature display. Do not start stimulation by operating the release lever at the handle until you hear the audible signal!
Carrying out the thermo-stimulation by actuating release lever at handle (, fig. 4).
At the end of the stimulation period a control signal for a recording unit is issued at the nystagmograph output.
After completion of the stimulation the unit remains in a
F 4.5.3 Mode de stimulation But: Stimulation du vestibule. Caractéristiques: Température: selon niveau stimulation chaud ou froid sélectionné
Position du levier du débit d'eau: Low (voir illustration 6, page 26)
Durée: selon préréglage avec le minuteur. Activation: Tout d'abord choix du type de stimulation à l'aide de la touche de stimulation chaud ou froid (, , illustration 1) (préréglage temp. voir 4.1) De l'eau à la température préréglé coule vers la poignée.
Attendez 20 sec. Activation de la "touche de démarrage minuteur. Préparation pour la stimulation: •
Appareil 15 sec. en position d’attente afin de positionner le bout de buse dans le conduit auditif.
L’eau est pendant ce temps conduite dans l’évacuation; affichage optique par valeur clignotante dans le display de température.
Exécution de la stimulation thermique par le levier de déclenchement à la poignée (, illustration 4).
A la sortie de commande nystagmographe, un signal de commande est émis pour un appareil enregistreur une fois la durée de stimulation terminée.
Une fois la stimulation terminée, appareil 15 sec. en position d’attente afin de pouvoir retirer la poignée du conduit auditif: L’eau coule pendant ce temps dans l’évacuation; nouvel affichage optique par température clignotante.
holding position for 15 seconds so that the handle may be removed from the auditory canal. During this time, water flows into the drain; again an optical indication is made by flashing temperature value. Repeated actuation of the "timer-start-key" leads to stopping the timer operation.
Une nouvelle activation de la „touche de démarrage
Second actuation of the currently active key effects deacti-
Le chauffage est complètement éteint. Stimulation avec de l'eau froide (temp. d'arrivée).
vation of the pertaining stage.
minuteur“ provoque l’arrêt du service du minuteur.
Une deuxième activation de la touche étant active provoque la désactivation du niveau correspondant.
Heating is switched off completely. Stimulation with cold water (feed temperature).
4.5.4 Mode de réduction d'énergie 4.5.4 Energy saving mode Purpose: Reduction of energy consumption. Activation: Actuation of key "heating on/off" (, fig. 1). Heating is switched off.
After five minutes of non-use of the unit.
But: Réduction de la consommation d'énergie. Activation: Actionnement de la touche "chauffage marche/arrêt" (, illustration 1). Le chauffage est éteint. Après la non utilisation de l'appareil pendant cinq minutes. 31
5.0 F
UK 5.2
Page 36
Recommended instrument disinfectants
Disinfectant
Ingredients (in 100 g)
Manufacturer
GIGASEPT FF (Application concentrate)
succinic acid dialdehyde 11.0 g dimethoxy tetrahydrofurane 3.0 g corrosion protection components non-ionic tensides and odoriphores
Schülke & Mayr, Norderstedt
Sekusept PLUS (Application concentrate)
glucoprotamine 25.0 g non-ionical tensides dissolvents, complexing agents
Henkel, Düsseldorf
Mucozit-T new (Application concentrate)
bi3 (3-aminoprophyl)laurylamine 8.0 % alkyldimethylbenzylammoniumchloride 19.0 % cocospropylendiamine-1,5 guanidinium-acet. 7.0 %
Merz & Co., Frankfurt/Main
5.3
Recommended surface disinfectants
Disinfectant
Ingredients (in 100 g)
Manufacturer
TERRALIN (Application concentrate)
Benzal conium chloride 20 Phenoxypropanole 35
Schülke & Mayr, Norderstedt
QUATOHEX (Application concentrate)
Didecyl dimethyl ammonium chloride 14 g Benzal conium chloride 10 g Bi-guanidinium acetate 7,5 g Polymer biguanid 0,5 g Cleaning agents
Braun, Melsungen
Incidin Plus (Application concentrate)
Glucoprotamin 26,0 Nonionic tensides Solvents, complexing agents
g
Henkel, Düsseldorf
Pursept-A (Disinfectant spray or disinfectant cloths)
Ethanol 38,9 Glyoxal 0,1 QAV 0,05
g g g
Merz & Co., Frankfurt/M.
g g
If using aldehyde-containing or amine-containing disinfectants at the same object, this may result in discolourations.
35
6.0 UK
6.0
F
Page 43 - 45
Maintenance and service
Decalcification and changing of filter (see sections 6.4, 6.5) should be carried out immediately by the user when required.
Saftey-technical inspection 6.1
Functional test Test
Switch unit several times on and off. Correct function of mains pilot lamp and solenoid valve (clacking). Automatic activation of the thermal process for reducing bacterial count.
Shut-off main water tap and observe temperature indication. After a few seconds error signal will appear "F1" (= no water).
Testing the displays. All optical and audible indicators issue their signal during the first second after switching on (in particular segmental test "8 8 ").
Set all temperature setting switches on 40°C and test consecutively by touching the corresponding keys whether in all ranges 40°C is reached in ACTUAL temperature indication. • Spray off and check water temperature by hand. • Carry out the same test with temperatures 37°C and 28°C. The particular combination of temperatures 40°C, 37°C and 28°C, as well as the test in all ranges ensures a comprehensive test of all contacts of the pre-setting switches, in ON- as well as in OFF-position, and also testing of all components involved in temperature control of the DESIRED temperature control system. Therefore, carrying out a test in one range only, or at only one temperature is not permissible.
Set temperature at 49°C. The electronic excess-temperature protection must respond (in the temperature display error code "F7" appears).
Measure temperature of water splashed off at standard settings: 30°, 37° and 44°C. The value may not deviate more than ± 0,5° ± 1/2 digit, i.e. 1°C in total. Typically, however, values are better than ± 0,5°C. This measurement is critical !
Measuring probes or thermometers which are too large may cause faulty measurements because of substantial heat removal, inertia, and because their temperature sensitivity is not localised on a point but spread over a larger surface. Use measuring instruments with an immersion probe, having a minimum precision of 0.3°C and a resolution of 0.1°C.
After setting the temperature, wait at least 1 minute before measuring to allow temperature stabilization of the double-barrelled hose and handle.
See also section 4.5.3!
40
6.0 UK 6.2
Visual inspection Test
Check unit for external damage (damage to cables, hoses, filter and irrigation handle).
Check hose system for external indications of leaks (drops, water spots, corrosion deposits etc.).
Inspect unit, disconnected from the main power supply and with open housing, for internal damage, leaks, corrosion, and deposits (mineral scale). Close housing again and tighten screws. Re-connect main power cable.
Check fuses for correct protection value and melting characteristics.
Check sign plates and inscriptions for completeness and readability.
6.3
Electrical test Test
6.4
Measure protective conductor resistance according to VDE 0751 (max. 0.3 Ohm). Measure and compare with "first value measured" of unit leakage current according to VDE 0751 (measured during operation). The "value measured first" may not be exceeded by more than 50%. Document and record the evaluation and tests according to VDE 0751.
Decalcification If the tap water in the area, where the unit is used, is known for mineral precipitation, preventive decalcification should
be carried out:
• • • • • • • •
Close water tap. If applicable, dismantle filter when mounted vertically at water tap. Unscrew screwed glass of filter. Fill screwed glass with approx. 100 ml of decalcifier on acetic / citric, or lactic acid base (for inst. Citrosteril, by Fresenius). Screw glass on again. Install filter vertically again, if applicable. Open water tap again. Switch on the unit. Decalcification takes place automatically in the thermal process for reducing bacterial count. After the unit has been in this mode for 5 minutes the water passages have been decalcified and cleaned, and also sufficiently flushed. The Aquamatic TM II is again fully ready for operation. When water passages are heavily calcified, a modified procedure may become necessary, with a prolonged reaction period for the decalcifier.
Recommendation: Calcification safety device 502.0995.0.
41
6.0 UK 6.5
Replacement of filter
When the filter cartridge is very dirty (dark colour) the filter
cartridge is to be exchanged as follows: • Close water tap of supply. • Switch on unit to reduce pressure in the filter body. • Switch off unit after appearance of "F 1". • Unscrew Plexiglass cup (, fig. 7) from filter body (, fig. 7) by turning anti-clockwise. • Extract filter cartridge (, fig. 7) and replace by new one (Art.No. 502.0891.0).
The filter element must not come into contact with
contaminated objects in order to prevent the ingress of germs into the water system.
Fig. 7. Water filter
Filter body Filter cartridge Sealing ring Plexiglass cup
42
7.0 F
UK
7.0
Page 48
Trouble-shooting
Error in temperature display
"F0"
Handle is not in its support
• Insert handle in its support to allow thermal process for reducing bacterial count to start (jet connection must point to the back of the unit.
• Replace handle (Art.No. 502.0963.0) "F1"
No water (water pressure < 0,5 bar
• Check, whether the water supply delivers a pressure of at least 2 bar (did you open the water-tap?).
• Filter clogged? "F2"
-5V is missing (supply voltage on the control board)
"F3"
Break of the safety NTC
"F4"
Safety switching does not react (49°C comparator)
"F5"
Break of the regulating NTC
"F6"
Different switch settings in the handle holder
"F7"
Temperature too high (>48°C), display only in the stimulation and irrigation mode but not in the thermal cleaning procedure
"F8"
Short-circuit of the regulating NTC
• Inform the service staff.
• Inform the service staff. • Have the safety switching (temperature controller) checked by the service staff.
• Inform the service staff. • Handle must be correctly inserted in its support. • Inform the service staff. • Check, whether temperature setting is too high.
If necessary, adjust desired temperature to a value of <48°C by means of the coding switches.
• Inform the service staff. • Have temperature feeler of the regulating NTC checked by the service staff.
"F9"
No heating performance (excess temperature switch), def. semi-conductor relay or regulator)
• Inform the service staff (internal excess temperature switch might have released).
If, errors cannot be corrected inform the GN Otometrics service staff of your supplier. Do not attempt to repair the unit
47
8.0 UK
8.0
Accessories and spare parts
8.1
Accessories
F
Page 51
Description
REF
Calcification safety device...502.0995.0 Jet connection extra long, straight (110 mm)...508.0429.0 Rinsing connection (Teflon) for stimulating the Vestibular organ...501.0355.0 Extension of supply hose G3/4a-G3/4i, L =1,5 m...501.0315.6 Waste water hose, special length, G1/4a-G1/4a (please indicate desired length)...502.0881.1 Drainage fittings as to DIN 1988...502.0880.0 Connecting cable for a nystagmograph...502.0850.0 Connecting cable for the equipotential compensation, L = 5m...008.0596.0
8.2
Spare parts Description
REF
Aquamatic TM II, basic unit, 220-240 V AC, 50/60 Hz... Aquamatic TM II, basic unit, 110-127 V AC, 50/60 Hz Irrigation handle 4+...502.0963.0 Double-barrelled hose...510.0412.0 Jet connection short, straight (80mm)...508.0427.0 Splash protection...501.0331.0 Rubber bush for splash protection...501.0331.1 Throttling nozzle 0.5 mm (150 ml/min...502.0946.0 Throttling nozzle 0.7 mm (250 ml/min)...502.0946.1 Three-holes gasket...501.0320.0 Hose tips for jet connection (30 pcs.)...502.0844.0 G3/4a-G3/4i, L = 3 m...502.0768.1 Cap nut G3/4 (to be included in order)...052.0035.1 Water filter complete...502.0890.0 Filter element for water filter...502.0891.0 Gasket (for G1/4a) 13x18x1...055.0018.0 G1/4a-G3/4a reducer (filter G1/4 to water hose G3/4)...502.0724.1 Supply hose with connection G3/4i, L = 3 m...501.0315.7 Waste water hose with connection G1/4, L = 3 m...502.0882.0 Gasket (für G1/4i) 10x15x1...055.0003.0 Power cable with protective contact socket (Germany), L = 3m...507.0859.0 Power cable with British plug BS1363A (UK), L = 2,5m...008.0762.0 Fuse F 8 A (quick-acting) 250 V breaking capacity H (1500 A)...008.0767.0 Fuse for special voltage (110-127VAC): F 15A (quick-acting) breaking capacity 10kA...008.0766.0 Front foil Aquamatic TM II ... Operating instructions...502.0900.i
50
9.0 9.0
Specifications
F
UK
Voltage range
220 - 240 V~ ± 10 % 50/60 Hz Special voltage: 100 - 127 V~ ± 10 % 50/60 Hz
Current input
6.8 A (220 - 240 V~); 14.8 A (100 - 127 V~)
Power cable Power consumption
3m 1500 W
Operating modes
Thermal process for reducing bacterial count; Irrigation mode; Stimulation mode; Heating off (energy saving)
Stimulation time Timer indication Water temperature Temperature indication
adjustable by timer from 1 up to 99 sec. Accuracy ± 0.5 s ± ½ digit 20°C - 47°C Accuracy ± 0.6 °C ± ½ digit (can only be guarantee with unchanged ambient conditions) +7...+19.5°C Drinking-water
Feed temperature of the water Water quality
Page 54
Water flow in the irrigation mode (high flow)
450 ml/min: standard unit and variant 250/450 ml/min 400 ml/min: variant 400/400 ml/min 500 ml/min: variant 500/500 ml/min
Water flow in the stimulation mode (low flow)
150 ml/min: standard unit 150/450 ml/min (adjustable) 250 ml/min: variant 250/450 ml/min (adjustable) 400 ml/min: variant 400/400 ml/min (adjustable) 500 ml/min: variant 500/500 ml/min (adjustable)
Operating pressure
at least: +2000 hPa (2 bar); max: +6000 hPa (6 bar)
Connections
Power connection ; control output for a nystagmograph; equipotential equalization; water supply G 3/4" external thread; water drainage G 1/4" external thread; connection for double-barrelled hose
Operating time
Continuous operation
Fuses Protective earth conductor resistance Earth leakage current Enclosure leakage current Patient leakage current
quick-acting 8 A (220-240 V~); quick-acting 15 A (110-127 V~) 0,1 Ω max. 0.5 mA max. 0.1 mA max. 0.1 mA max.
Ambient conditions Transport/storage Operation
-20...+50°C; 5...90 % humidity without condensing, air pressure 700...1060 hPa +10...+35°C; 20...80 % humidity without condensing, air pressure 700...1060 hPa
Dimensions HxWxD
14.5 x 37 x 31.5 cm
Weight
approx. 5.5 kg
Protection class (EN 60601-1)
I
Degree of protection
Type B
Protection category
IPX0
Classification acc. to Annex IX EEC directions 93/42/EEC
IIa
CE marking
CE 0124
Rules applied
EN 60601-1: 1990 + A1:1993 + A2:1995 EN 60601-1-2: 1993 (EMV / EMC)
Canadian Classification Device group PNC Risk Class Description
Ear, nose, throat 77ETP 2 STIMULATOR, CALORIC (WATER)
Issue of the Technical Specifications: 01.02.06
53