Content Introduction ............3 Notes on operating instructions ......3 Intended use ............4 Function ..............4 Explanation of symbols .........4 For your safety ............5 Advice for the user for maintaining hygienic status ..............6 Setting up and starting up .........7 Scope of supply ........... 7 Illustrations ............8 Connections ............11 3.3.1...
Judicious and careful work provides best protection against accidents! Operational safety and readiness for use of the device depend not only on your capabilities, but also on the care and maintenance given to the Variotherm plus. For this reason regular cleaning and service work are a must. Major maintenance and repair work may be carried out only by expert personnel authorised by ATMOS. In case of repairs you should insist that only original spare parts are used. You will then have the warranty that operational safety, readiness for work and the value of your device will be preserved.
1.0 Introduction 1.2 Intended use 1.4 Explanation of symbols Observe operating instructions! Name: ATMOS Variotherm ® According to ISO /7000/0434 DIN Main function: Device for rinsing the auditory canal 30600/1008 IEC 348 and stimulation of the vestibular Type B equipment as to IEC 417...
2.0 For your safety • The Variotherm plus is produced according to IEC 601/ • Only use the warm water jet when a tube tip is installed! EN 60601 and listed in the following classes: • Take caution to avoid injury to the eardrum when - VDE Class of protection 1 introducing the water jet! - Class IIa (EEC 93/42). • For hygienic reasons jet connections must be changed • The device may only be connected to a properly installed after each patient.
2.0 For your safety 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 guidelines 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.* ...
3.0 Setting up and starting up 3.1 Scope of supply Quantity Variotherm plus basic unit Irrigation handle Double-barrelled hose Jet connection short, straight (80 mm) Splash guard Rubber bush for splash guard Three-holes gasket Hose tips for jet connection (30 pcs) G3/4i-G1/4a-screwing (water-tap G3/4 on filter G1/4) Cap nut G3/4 Water filter complete Gasket (f.G1/4a) 13x18x1 G1/4a-G3/4a-reducer (filter G1/4 on water hose G3/4) Water supply hose G3/4i, L = 3 m Waste water hose G1/4i, L = 3 m Gasket (f. G1/4i) 10x15x1...
3.0 Setting up and starting up 3.2 Illustrations Variotherm plus — Fig. 1. Front view Main switch Key switch for heating ON/OFF (energy saving mode) Coding switch for warm-stimulation level Coding switch for cold-stimulation level Coding switch for stimulation time Key switch for selecting the irrigation level (37°C) Key switch for selecting the warm-stimulation level (e.g. 44°C) Key switch for selecting the cold-stimulation level (e.g. 30°C)
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3.0 Setting up and starting up Fig. 2. Rear view Type plate Control output for controlling a nystagmograph Device plug with fuse compartment Equipotential bonding connection p = +2000...+6000hPa t= +7...+19,5°C Fig. 3. Side view Support for handle Connection for double-barrelled hose Connection for waste water hose * Connection for water supply hose *...
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3.0 Setting up and starting up Fig. 4. Irrigation handle Handle Connection for double-barrelled hose Three-holes gasket Adjusting screw Set screw Valve plunger Jet connection Splash guard Double-barrelled hose The sprayer tube must be exchanged after each patient.
• Insert the power plug in a correctly installed socket with earthing contact. 3.3.2 Connecting a nystagmograph • When controlling an ENG (electro-nystagmograph) or a CNG (computer-nystagmograph) at output (, fig. 2), please connect only recording equipment approved by ATMOS. Connecting cable available from ATMOS (see section 8.0). • At the end of the stimulation time, a trigger signal for a nystagmograph is available at the rear 3-pole DIN socket. This outlet is an electrically isolated photo transistor. The emitter connection which has to be connected to the ground line of the trigger inlet at the nystagmograph is attached to pin 3.
3.4 Starting up connected to the public water supply. To comply with the rules according to EN 1717, an unpressurized • Insert the handle in its holder; the jet must point to water separation with overflow is required. reverse side of the unit. Therefore, ATMOS recommends to install the water separation unit ATMOS Aqua Clean, REF 502.1200.0 • Switch on the unit (, fig. 1). between the water supply and the device in order to • Automatic display test with digital numbers " 8 8 " and meet the connection requirements according to EN acoustic warning signal. 1717.
4.0 Operation 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 switch (, , fig. 1). - left switch: for adjusting the "ten" partition - right switch: for adjusting the "one" partition ª lower keys (+): Temperature increase ª 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 •...
4.0 Operation 4.5 Description of operating modes 4.5.3 Stimulation mode Purpose: 4.5.1 Thermal process for reducing bacterial Stimulation of the vestibular organ. count Properties: Purpose: • Temperature: corresponds to the preselected cold or Reduction of bacteria count in the warm water circuit to warm stimulation level prevent or clear a contaminated system. •...
Take care that no liquid penetrates The hose tips must be exchanged after each use. the device. The cleaning agents and disinfectants listed in The surfaces of the Variotherm plus resist most of the section 5.2 are all suitable. common surface disinfectants.
5.0 Cleaning and care 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. What When Qualified and trained staff who are familiar Details with reprocessing. (Please fill in the Parts to be reprocessed Cleaning Disinfection Sterilization responsible person -> use a water-based overhead marker) Ear irrigation / Thermal nystagmus stimulation...
6.3 Sending in the device • Remove and properly dispose of consumables. • Clean and disinfect the product and accessories according to the operating instructions. • Place used accessories with the product. • Fill in the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate. ) This form is enclosed to each delivery and can be found at www.atmosmed.com. • The device must be well padded and packed in suitable packaging. • Place the form QD 434 „Delivery complaint / return shipment“ and the respective decontamination certificate in an envelope. • Affix the envelope to the outside of the package. • Send the product to ATMOS or to your dealer.
7.0 Troubleshooting 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" -5 V is missing (supply voltage on the control •...
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 on 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 (for 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...
9.0 Technical data Voltage 220 - 240 V~ ± 10 %; 50/60 Hz Special voltage 100 - 127 V~ ± 10 %; 50/60 Hz Current consumption max. 6.8 A (220 - 240 V~); 14.8 A (100- 127 V~) Power consumption max. 1500 W 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 Fuses F 8 A (f. 220 - 240 V~); F 15 A (f. 110 - 127 V~) Stimulation time Adjustable by timer from 1 up to 99 sec. Timer indication Indication accuracy ± 0.5 s ± ½ digit Water temperature 20°C - 47°C Temperature indication...
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9.0 Technical data GMDN code 34891 UMDNS code 10-548 ID No. (REF) 502.0900.0 Canadian Classification Device group Ear, nose, throat 77ETP Risk Class Description STIMULATOR, CALORIC (WATER) Issue of the technical data: 2017-01-27...
• The Variotherm plus does not contain any hazardous materials. • The housing is recyclable. • The component parts of the Variotherm plus must be disposed of correctly and the materials are to be separated carefully. • The electronics circuit boards must be fed into the appropriate recycling process.
11.1 Guidelines and Manufacturer´s Declaration - Emissions The ATMOS Variotherm plus is designed for operation in the environment specified below. The customer or user of the ATMOS ® Variotherm plus should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment - Guidance RF Emissions acc.to CISPR 11...
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(> 95 % Dip of the U If the user of the ATMOS Variotherm plus ® for 0.5 Cycle for 0.5 Cycle requires continued operation upon the occurrence of disruptions in the energy supply, the ATMOS Variotherm plus should 40 % U 40 % U ® make use of an uninterruptible power (60% Dip of the U (60% Dip of the U supply or a battery. For 5 cycles For 5 cycles...
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ATMOS Variotherm plus ® The ATMOS Variotherm plus is intended for use in an electromagnetic environment in which HF disturbances are controlled. ® The customer or user of the ATMOS Variotherm plus can thereby help to prevent electromagnetic interference by maintaining a ® minimum distance between portable and mobile HF communication equipment (transmitters) and the ATMOS Variotherm plus - ® depending on the output of the communication device as indicated below. Safety distance, depending on transmit-frequency m Nominal output of the...
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