Atmos Variotherm plus Operating Instructions Manual
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Summary of Contents for Atmos Variotherm plus
- Page 1 English Variotherm plus 0124 GA1GB.140302.0 2022-02 Index 31 Valid for devices delivered after July 2002.
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Page 2: Table Of Contents
Contents Introduction ............3 Notes on operating instructions ......3 Intended use ............4 Function ..............4 Explanation of symbols .........4 For your safety ............5 Important instructions for the maintenance of the hygiene status of warm water irrigation units ..6 Setting up and starting up .........7 Scope of supply ............7 Illustrations ............8 Connections ............11... -
Page 3: Introduction
• The product Variotherm plus bears CE marking CE 0124 according to EU Council Directive 93/42/EEC concerning medical devices and meets the basic requirements of Annex I to this directive. -
Page 4: Intended Use
1.0 Introduction 1.2 Intended use • Possibility to switch to the stimulation mode for stimulat- ing the vestibular organ with a reduced flow of water. The Variotherm plus is equipped with a timer for Product name: Variotherm plus preselecting the stimulation duration. Main functions: Stimulation of the vestibular organ 1.4 Explanation of symbols... -
Page 5: For Your Safety
2.0 For your safety • The Variotherm plus is produced according to IEC 601 / • Only use the warm water jet when a hose tip is installed! EN 60601 and listed in the following classes: • Take caution to avoid injury to the eardrum when insert-... -
Page 6: Important Instructions For The Maintenance Of The Hygiene Status Of Warm Water Irrigation Units
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 stimulating the vestibular organ, ATMOS offers the warm water units Hygrotherm plus (37 °C) and Variotherm plus (20 °C ‒ 47 °C). These units heat the drinking water that comes from the household connection to the preselected temperature. The operating in- structions must be followed, or otherwise the increased number of pathogens in the rinse water can affect the health of sensitive patients. -
Page 7: Setting Up And Starting Up
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 bushing for splash guard Three-hole 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... -
Page 8: Illustrations
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) - Page 9 3.0 Setting up and starting up Fig. 2. Rear view Type plate Control output for controlling a nystagmograph Device socket with fuse compartment Equipotential bonding connection p = +2000...+6000 hPa t = +7...+19.5 °C ...
- Page 10 3.0 Setting up and starting up Fig. 4. Irrigation handle Handle Connection for double-barrelled hose Three-hole gasket Adjusting screw Set screw Valve plunger Jet connection Splash guard Double-barrelled hose The sprayer nozzle must be changed after each patient.
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Page 11: Connections
• 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 chapter 8.0). • At the end of the stimulation time, a trigger signal for a nystagmograph is available at the rear 3-pole DIN socket. -
Page 12: Water Connection
• Insert the handle in its holder; the jet must point to re- ration with overflow is required. verse side of the unit. Therefore, ATMOS recommends installing 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 •... -
Page 13: Operation
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 and 49 °C only for testing purposes •... -
Page 14: Description Of Operating Modes
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. -
Page 15: Cleaning And Care
Take care that no liquid penetrates The hose tips must be changed after each use. the device. The cleaning agents and disinfectants listed in The surfaces of the Variotherm plus resist most common section 5.2 are all suitable. surface disinfectants. -
Page 16: Cleaning Method For Handle With Jet Connection For Water Irrigation Tip
5.3 Cleaning method for handle with jet connection for water irrigation tip The ATMOS devices Variotherm plus and Hygrotherm plus are properly used with disposable hose tips. These hose tips must be disposed of after each application to the patient. When using the hose tips, ATMOS recommends reprocessing according to the cleaning and disinfection plan below. What When... -
Page 17: Maintenance And Service
To carry out these measures, the person must have the necessary test devices and original spare parts. ATMOS recommends: Work should be carried out by an authorized ATMOS service partner. This ensures that repairs and test- ing are carried out professionally, original spare parts are used, and warranty claims remain unaffected. -
Page 18: Troubleshooting
7.0 Troubleshooting Error in temperature display “F0” Handle is not in its holder • Insert handle in its holder to allow thermal process for reducing bacterial count to start (jet connection must point to the back of the unit). • Replace handle (REF 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?). -
Page 19: Accessories And Spare Parts
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... -
Page 20: Technical Data
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 via IEC socket; control output for a nystagmograph; equi- potential 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... - Page 21 9.0 Technical data GMDN code 34891 UMDNS code 10-548 ID No. (REF) 502.0900.0 Issue of the technical data: 2017-01-27...
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Page 22: Disposal
• The housing is fully 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. -
Page 23: Notes On Emc
11.2 Guidelines and Manufacturer’s Declaration ‒ Immunity The Variotherm plus is designed for operation in the electromagnetic environment specified below. The customer or user of the Variotherm plus should ensure that it is used in such an environment. Electromagnetic Environment ‒ Immunity Test... -
Page 24: Notes
NOTE U is the mains alternating current prior to application of the test levels. 11.3 Guidelines and Manufacturer’s Declaration ‒ Immunity The Variotherm plus is designed for operation in the electromagnetic environment specified below. The customer or user of the Variotherm plus should ensure that it is used in such an environment. IEC 60601 Test Immunity Test Compliance Level Electromagnetic Environment ‒... - Page 25 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 field strength measured at the site where the Variotherm plus is used exceeds the compliance level above, the Variotherm plus must be observed to demonstrate proper function. If abnormal performance is observed, additional measures may be necessary, such as reorient- ing or relocating the Variotherm plus.
- Page 26 12.0 For your notes...
- Page 27 12.0 For your notes...
- Page 28 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Phone: +49 7653 689-0 info@atmosmed.com www.atmosmed.com...
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