Operating Instructions
72 Pages
Preview
Page 1
Deutsch English
Variotherm plus
Gebrauchsanweisung Operating Instructions Mode d'emploi
Français
gültig für Geräte mit Lieferdatum ab Juli 2002 valid for appliances delivered after July 2002 valable pour des appareils livrés à partir du Juillet 2002 502.0900.i
2014-08 Index: 29
1.0 F
UK 1.2
Intended use
1.2
Affectation
Name:
ATMOS® Variotherm
Nom :
ATMOS® Variotherm
Main function:
Device for rinsing the auditory canal and stimulation of the vestibular organ
Fonction principale :
Appareil destiné au lavage du canal auditif et à la stimulation de l’organe vestibulaire.
Med. indications /application: Stimulation of the vestibular organ Specifications of the main function: Produces a jet of water for the ear irrigation at body temperature (37°C) with a flow rate of 400 ml/min for the removal of cerumen Stimulation of the vestibular organ with a defined flow and a fixed temperature for the functional testing. Application organ:
Auditory canal to the drumhead
Duration of application: For the short-term application (max. 60 minutes) on patients.
Indication médicale / Utilisation : Stimulation de l’organe vestibulaire Spécification de la Fonction principale : Production d’un jet d’eau pour le rinçage d’oreille à température corporelle (37°C) avec un flux de 400 ml/min pour l’élimination du cérumen. Stimulation de l’organe vestibulaire à flux défini et à température préréglée pour le contrôle du fonctionnement. Organe concerné :
Canal auditif jusqu’au tympan
Durée d’utilisation :
Utilisation temporaire sur le patient (jusqu’à 60 minutes)
Application environment:For ENT doctors and phoniatricians in clinics and practices. The therapy with the ATMOS irrigation device may only be performed by medically trained staff.
Environnement d’utilisation : A l’hôpital ou en cabinet ORL ou de phoniatrie. La thérapie avec les appareils d’irrigation et de lavage ATMOS ne doit être effectuée que par un personnel médical spécialisé.
Contraindications:
Do not apply to an infected resp. contaminated auditory canal or to a perforated eardrum.
Contre-indications :
The product is:
x active
Ne pas utiliser en cas d’inflammation du canal auditif ou en cas de canal auditif contaminé, ni en cas de tympan perforé.
Sterility:
Not necessary
Le produit est :
x actif
Stérilité :
non nécessaire
□ not active
Single use product / reprocessing: No single use product
1.3
Function
Operating the main switch on the examination unit automatically activates the thermal process for reducing bacterial count (see section 4.4.1) .
Then, automatic change into the energy saving mode. When removing the irrigation handle from its holder,
automatic change into the irrigation mode. Here, the auditory canal can be rinsed with water warmed up to 37°C and a flow of at least 400 ml/min.
Possibility to change into the stimulation mode for stimu-
lating the vestibule with a reduced flow of water. The Variotherm plus is equipped with a timer for preselecting the stimulation time.
□ non actif
Produit à usage unique / Retraitement : ce n’est pas un produit à usage unique
1.3
Fonctionnement
Une fois l’interrupteur principal de l'unité de traitement
actionné, le processus thermique de réduction de l'indice de germination est activé (voir paragraphe 4.4.1).
Ensuite, passage automatique au mode de réduction d'énergie.
Activation automatique du mode de rinçage lors de la
prise du pistolet irrigateur du support. Ici, il est possible de réaliser des rinçages du conduit auditif avec de l'eau à 37°C et un débit minimal de 400 ml/minute.
Possibilité de passer au mode de stimulation, lequel
permet de stimuler le vestibule avec un débit réduit. Le Variotherm plus comprend un minuteur pour le préréglage de la durée de stimulation.
7
2.0 2.0 Safety advice
UK
F
Page 14 - 15
The Variotherm plus 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 ATMOS (see chapter 3.3).
The Variotherm plus may be used in supervised
operation by qualified personnel which have been authorised by ATMOS 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)
It is essential that the country-specific requirements for
connection of medical equipment to the public drinking water supply are considered. When in doubt, please contact your local ATMOS partner.
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 Variotherm plus should only be operated in rooms used for medical purposes, and never in areas subject to explosion hazards and in oxygen rich environments.
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 ATMOS 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 ! ATMOS is not liable for personal injury and damage to
property if • original ATMOS 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 ATMOS.
Please note:
A medical insulating transformer with earth leakage monitor or any similar safety system acc. to EN 60 601-1 is required, if several devices are connected over one common power supply. The transformer must corre spond to the power consumption of all the devices to be connected.
The flow rate has to be checked after switch on or
at least once a day with a measuring cup. The quantity of 500 ml/min may not be exceeded. The water jet has to be straight.
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, ATMOS offers the warm water units Hygrotherm plus (37°C) and Variotherm plus (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 ATMOS 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.
Exchange and disinfection required for contact parts such as the jet connection after each patient (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. In the case of a complaint, data measurements must be prove whether the contaminents are "water" or "skin" bacteria. 13
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.
screw it on the free end of the double-barrelled hose. Check whether all connections are tight.
3.4
Start-up
Insert the handle in its holder; the jet must point to the reverse side of the unit.
trous“ en place“ sur l’extrémité libre du tuyau double. Vérifiez si toutes les jonctions sont étanches.
3.4
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.
Switch on the unit (, fig. 1).
Mettre l’appareil en marche (, illustration 1).
The unit will display a test mode with digital numbers
Test automatique d’affichage avec suite numérique de
Automatic activation of the thermal process will begin for
Activation automatique du processus thermique de
When the thermal process is complete , the unit will switch
Changement automatique au mode de rinçage (37°C).
" 8 8"and an audible signal. reducing bacterial count. Duration: 5 min.
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.
chiffres «8 8» et signal d’avertissement acoustique. réduction de l'indice de germination. Durée: 5 minutes.
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 UK
4.0 Operation
Before switching on the unit, make sure that the handle is
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!).
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
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
Standard settings: • • •
Level for irrigation mode: 37°C fixed Level for cold stimulation: 30°C Level for warm stimulation: 44°C
F
Réglages standard: • • •
Niveau mode de rinçage: Niveau stimulation froid: Niveau stimulation chaud:
37°C fixe 30°C 44°C
4.2 Selecting temperature levels
4.2 Sélectionner les niveaux de températures
After operating the main power switch, the automatic
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).
activation of the thermal process begins for reducing bacterial count, followed by the automatic activation of the temperature level "irrigation mode" (37°C).
For selecting the desired temperature level, use the respective key (, , , fig. 1). Display of the active level by illuminated diodes. Display of the water temperature (current value) in °C.
4.3 Adjusting stimulation time By means of coding switch (, fig. 1).
4.4 Adjusting flow quantity Prior to stimulation turn the set screw (, fig. 6)
Pour la sélection du niveau de température souhaité,
°C.
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 Avant l'irrigation, la vis (, illustration 6) doit être arrêtée en haut.
upwards and arrest it.
2 adjusting possibilities: High:
Low:
Flow quantity for rinsing the auditory canal Flow quantity for stimulating the vestibular organ
appuyez sur la touche respective ( , , , illustration 1). Affichage du niveau actif par diodes lumineuses. Affichage de la température d’eau (valeur réelle) en
Il y a deux positions: High: Low:
Augmentation du débit d'eau pour les rinçages du conduit auditif Réduction du débit d'eau pour stimulation du vestibule
Prior to ear irrigation the set screw is turned downwards, inserted into the handle and then adjusted by turning it downwards again.
Avant le rinçage d'oreille, positionner la vis () vers le bas, la pousser dans la poignée, et en la vissant toujours, l'ajuster vers le bas.
For fine adjustment of the flow the adjusting screw (,
Pour un réglage précis du débit, il faut visser ou devisser
fig. 6) is turned in respectively out.
Periodically check the water flow for the stimulation of the vestibular organ and readjust, if necessary.
la vis d'ajustage (, illustration 6).
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).
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 pendant le nettoyage thermique). Affichage supplémentaire du code d’erreur «F0» (s’éteint lors de la remise en place de la poignée).
•
• •
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 doublebarrelled 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.
After cooling down to 37°C the unit will automatically switch into irrigation mode.
•
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.
•
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 Variotherm plus changes into the energy saving mode after 5 min.
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 Variotherm plus 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 4.5.3 Stimulation mode
UK
4.5.3 Mode de stimulation
F
Purpose: Stimulation of the vestibule.
But: Stimulation du 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.
Caractéristiques: Température: selon niveau stimulation chaud ou froid sélectionné
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: •
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.
Operate unit 15 seconds in holding position, so that the jet can be positioned correctly in the auditory canal.
Préparation pour la stimulation:
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
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.
Second actuation of the currently active key effects deactivation of the pertaining stage. Heating is switched off completely. Stimulation with cold water (feed temperature).
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.
•
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.
Une nouvelle activation de la „touche de démarrage minuteur“ provoque l’arrêt du service du minuteur.
Une deuxième activation de la touche étant active provoque la désactivation du niveau correspondant. Le chauffage est complètement éteint. Stimulation avec de l'eau froide (temp. d'arrivée).
4.5.4 Mode de réduction d'énergie 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 UK 5.2
F
Recommended disinfectants
Recommended instrument disinfectants Ingredients Korsolex basic Glutaral (Application concentrate) (ethylene-dioxy)dimethanol tensides, salts, corrosion inhibitors
(in 100 g) 15.2 g 19.7 g
Sekusept aktiv sodiumpercarbonate, phosphonates (Application concentrate) non-ionic tensides Gigasept FF new succinic acid dialdehyde (Application concentrate) dimethoxy tetrahydrofurane corrosion inhibitors Instruments, automatic Neodisher MediClean NTA forte non-ionic tensides (Application concentrate)enzymes preserving agents Machine disinfection
Ingredients
Dismozon pur magnesium monoperoxyphthalate (Application concentrate) hexahydrate Green & Clean SK alkyl-dimethyl-benzyl-ammonium chloride (Application concentrate) dialkyl-dimethyl-ammonium chloride Alkyldimethylethylbenzylammoniumchlorid Perform
Pentakalium bis(peroxymonosulfate)bis(sulfate)
Page 36
Manufacturer Bode Chemie, Hamburg
Ecolab, Düsseldorf 11.0 g 3.0 g
5-15 g < 5g
(in 100 g) 80 g <1 g
45.0 g
Schülke & Mayr, Norderstedt
Dr. Weigert, Hamburg
Manufacturer Bode Chemie, Hamburg Metasys, Rum (Austria)
Schülke & Mayr, Norderstedt
If using aldehyde-containing or amine-containing disinfectants at the same object, this may result in discolourations.
35
5.0 UK 5.3
Cleaning method for handle with jet connection for water irrigation tip
The ATMOS appliances Variotherm and ATMOS Hygrotherm are used, according to the rules, with disposable hose tips (disposables). These tips must be disposed off after each application to the patient. When using the hose tips ATMOS recommends a reprocessing in line with the below cleaning and disinfection plan.
S
Disinfection Sterilisation
Who Monthly
D
Recommendations
Weekly
C
Cleaning
Reusable parts
When
Daily
How NAfter each procedure
What
Qualified and trained staff who are familiar with reprocessing. (Please fill in the responsible person -> use a water-based overhead marker)
Ear irrigation / Thermal nystagmus stimulation Ear irrigation bowl
X
X2,4,5
Handle
X
X
Jet connection
X
X2,4,5,6
Splash protection
X
X
3
2,4,5
Hose tip (disposable) Rinsing attachment Hygiene filter Rinsing lid with rinsing hose Rinsing bottle
X
X2,4,5
X
X2,4,5
X
X2,4,5,6
Manual or automatic cleaning and disinfection Wipe cleaning and wipe disinfection Manual or automatic cleaning and disinfection Cleaning and disinfection (automatic or manual) Exchange after each application Manual or automatic cleaning and disinfection See operating instructions for hygiene filter Manual or automatic cleaning and disinfection Cleaning and disinfection; cleaning in the dishwasher with the glass care programme
X X X X X X X X X
Recommended disinfectants
Important information Wipe cleaning and wipe disinfection: All surfaces have to be wiped with a clean (disposable) wipe which is damped with disinfectant solution; the entire surface has to be wiped thoroughly and may not be dried afterwards.
3)
Surface disinfection for coated surfaces:
Green & Clean SK (ATMOS) Dismozon® pur (Bode Chemie) Kohrsolin® FF (Bode Chemie) Perform® (Schülke & Mayr) Terralin® Protect (Schülke & Mayr)
Other surfaces:
4)
Instruments - manual disinfection: Korsolex® AF (Bode Chemie) Korsolex® basic (Bode Chemie) Korsolex® plus (Bode Chemie) Korsolex® extra (Bode Chemie) neodisher® Septo MED (Dr. Weigert) neodisher® Septo 3000 (Dr. Weigert) Sekusept® PLUS (Ecolab) Sekusept® aktiv (Ecolab) Gigasept® Instru AF (Schülke & Mayr) Gigazyme® (Schülke & Mayr) Gigasept FF neu (Schülke & Mayr)
5)
Dismozon® pur (Bode Chemie) Kohrsolin® FF (Bode Chemie) Bacillocid® rasant (Bode Chemie) Mikrobac® forte (Bode Chemie) Perform® (Schülke & Mayr) Terralin® Protect (Schülke & Mayr) Surface disinfection FD 312 (Dürr Dental) Quick disinfection B 30 (Orochemie) Instruments - automatic disinfection: Dismoclean® 21 clean (Bode Chemie) Dismoclean® 24 Vario (Bode Chemie) Dismoclean® 28 alka one (Bode Chemie) Dismoclean® twin basic/twin zyme (Bode Chemie) neodisher® FA (Dr. Weigert) neodisher® FA forte (Dr. Weigert) neodisher® MediClean forte (Dr. Weigert) Thermosept® alka clean forte (Schülke & Mayr) Thermosept® RKN-zym (Schülke & Mayr)
Please see the manufacturer‘s instructions for concentration, contact time, temperature and the compatibility of materials.
38
1) 2) 6)
Please observe the manufacturer‘s operating instructions. Alternative to manual cleaning und disinfection: Wash-Disinfector 78°C / 172°F Material dimensionally stable at 134°C
6.0 UK
6.0
Maintenance and service
F
Page 46 - 48
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
Set temperature at 49°C. The electronic excess-temperature protection must respond (in the temperature display error code "F7"
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.
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!
43
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 Variotherm plus 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.
44
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
45
7.0 UK
7.0
F
Trouble-shooting
Page 51
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"
50
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 ATMOS service staff. Do not attempt to repair the unit yourself!
8.0 UK
8.0
Accessories and spare parts
8.1
Accessories Description
F
Page 54
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
Variotherm plus, basic unit, 220-240 V AC, 50/60 Hz ...502.0900.0 Variotherm plus, basic unit, 110-127 V AC, 50/60 Hz ...502.0900.1 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 Variotherm plus ...060.0357.0 Operating instructions ...502.0900.i
53
9.0 9.0
Specifications
UK
F
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 57
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)
UMDNS-Code GMDN-Code REF Canadian Classification Device group PNC Risk Class Description
10-548 34891 502.0900.0
56
Ear, nose, throat 77ETP 2 STIMULATOR, CALORIC (WATER) Issue of the Technical Specifications: April 2005
11.0 Notes on EMC ■ Medical electrical equipment is subject to special precautions with regard to EMC and must be installed acc. to following EMC notes. ■ Portable and mobile HF communication facilities can influence medical electrical equipment. ■ The use of other accessories, other converters and cables than stated may lead to an increased emission or a reduced interference immunity of the equipment or system.
11.1 Guidelines and Manufacturer´s Declaration - Emissions The ATMOS Variotherm plusis intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS Variotherm plusshould ensure that it is used in such an environment.
Emissions Test
Compliance
Electromagnetic Environment - Guidance
RF Emissions CISPR 11
Group 1
The ATMOS Variotherm plususes RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF Emissions CISPR 11
Class B
Harmonics IEC 61000-3-2
Class B
Flicker IEC 61000-3-3
is conform
The ATMOS Variotherm plus is suitable for use in all establishments, including domestic, and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
The device may not be used directly next to other devices or piled up with other devices. If operation next to or piled with other devices is necessary, please watch the device to check its intended operation in this arrangement.
11.2 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS Variotherm plus is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS Variotherm plusshould ensure that it is used in such an environment.
IEC 60601Test Level
Compliance Level
ESD IEC 61000-4-2
± 6 kV Contact
± 6 kV Contact
± 8 kV Air
± 8 kV Air
EFT IEC 61000-4-4
± 2 kV Mains
± 2 kV Mains
± 1 kV I/Os
Inapplicable
Surges IEC 61000-4-5
± 1 kV Differential
± 2 kV Differential
± 1 kV Common
± 1 kV Common
Power Frequency 50/60 Hz Magnetic field IEC 61000-4-8
3 A/m
Inapplicable
Immunity Test
62
Electromagnetic Environment - Guidance Floors should be wood, concrete, or ceramis tile. If floors are synthetic, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Power frequency magnetic fields should be that of a typical commercial or hospital environment.
11.0 Notes on EMC
Immunity Test
IEC 60601Test Level
Compliance Level
Voltage Dips / Dropout < 5 % UT IEC 61000-4-11 (> 95 % Dip of the UT) for 0.5 Cycle
70% UT (30 % Dip of the UT) for 25 Cycles
< 5 % UT Mains power quality should be that (> 95 % Einbruch der UT) of a typical commercial or hospital für 0,5 Periode environment. If the user of the ATMOS Variotherm plus demands 40 % UT continued function even in case of (60% Einbruch der UT) interruptions of the energy supply, für 5 Perioden it is recommended to supply the ATMOS Variotherm plus from an 70% UT uninterruptible current supply or a (30 % Einbruch der UT) battery. für 25 Perioden
< 5 % UT (>95 % Dip of the UT) for 5 s
< 5 % UT (>95 % Einbruch der UT) für 5 s
40 % UT (60% Dip of the UT) for 5 Cycles
NOTE
Electromagnetic Environment - Guidance
UT is the mains alternating current prior to application of the test levels.
11.3 Guidelines and Manufacturer´s Declaration - Immunity The ATMOS Variotherm plus is intended for use in the electromagnetic environment specified below. The customer or user of the ATMOS Variotherm plusshould ensure that it is used in such an environment.
Immunity Test
IEC 60601Test Level
Conducted RF IEC 61000-4-6
3 Veff 150 kHz to 80 MHz
Radiated RF IEC 61000-4-3
3 V/m 80 MHz to 2.5 GHz
Compliance Level
Electromagnetic Environment Guidance
3V
Portable and mobile communications equipment should be separated from the ATMOS Variotherm plus incl. the cables by no less than the distances calculated/listed below.
3 V/m
Recommended distances: d = (3,5 / V1) * √(P) d = (3,5 / E1) * √(P) 80-800 MHz d = (7 / E1) * √(P) 0,8-2,5 GHz where „P“ is the max. power in watts (W) and D is the recommended separation distance in meters (m). Field strengths from fixed transmitters, as determined by an electromagnetic site (a) survey, should be less than the compliance level (b). Interference may occur in the vicinity of equipment containing following symbol.
63
11.0 Notes on EMC
NOTE 1
With 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2
These guidelines might not be applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.
a
The field strength of stationary transmitters, such as base stations of cellular phones and mobile terrain radio equipment, amateur radio transmitters, cbm broadcast and TV stations cannot be predestined exactly. To determine the electromagnetic environment in regard to stationary transmitters, a study of the location is to be considered. If the measured field strength at the location where the ATMOS Variotherm plus is used exceeds the above compliance level, the ATMOS Variotherm plus is to be observed to verify the intended use. If abnormal performance characteristics are noted, additional measures might be necessary, e. g. a changed arrangement or another location for the device.
b
Within the frequency range of 150 kHz to 80 MHz the field strength is to be below 3 V/m.
11.4 Recommended separations between portable and mobile RF Communications equipment and the ATMOS Variotherm plus The ATMOS Variotherm plus is intended for use in electromagnetic environment in which radiated disturbances are controlled. The customer or user of the ATMOS Variotherm plus can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications equipment and the ATMOS Variotherm plus as stated below, according to the maximum output power of the communications equipment.
Separation distance, depending on transmit-frequency m Nominal output of the transmitter
150 kHz bis 80 MHz
80 MHz bis 800 MHz
800 MHz bis 2,5 GHz
d = [ 3,5 / 3] √P
d = [ 3,5 / 3] √P
d = [ 7,0 / 3] √P
0.01
0.12
0.12
0.24
0.1
0.37
0.37
0.74
1
1.2
1.2
2.4
10
3.69
3.69
7.38
100
11.66
11.66
23.32
W
For transmitters for which the maximum nominal output isn´t indicated in the above table, the recommended separation distance d in meters (m) can be determined using the equation belonging to the respective column whereas P is the maximum nominal output of the transmitter in watts (W) acc. to manufacturer´s specification. NOTE 1 With 80 MHz and 800 MHz the higher frequency range applies. NOTE 2 These guidelines are not applicable in any case. The propagation of electromagnetic sizes is influenced by absorptions and reflections of buildings, objects and people.
64
Für Ihre Notizen / For your notes / Pour vos notes
68