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Summary of Contents for Atmos Hygrotherm Plus
- Page 1 Operating Instructions Hygrotherm Plus English 0124 GA1GB.140303.0 2024-01 Index 29...
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Page 2: Table Of Contents
Table of contents Introduction.......................4 Notes on the operating instructions ................4 Explanation of pictograms and symbols ..............5 Intended use .......................6 Function ........................7 Scope of delivery ......................7 Transport and storage ....................8 Notes on your safety ..................9 General safety instructions ..................9 Danger to users, patients and third parties ............9 Important notes on the maintenance of the hygiene status of warm water irrigation units ...................... - Page 3 Maintenance and service ................24 Sending in the device ....................24 6.2 Decalcification ......................24 Filter replacement ....................25 Exchanging fuses ..................... 25 Troubleshooting ....................26 Accessories ......................27 Disposal ......................28 Technical data ....................29 Notes on EMC ....................30 Notes ........................31...
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Page 4: Introduction
The Declarations of Conformity and our General Terms and Conditions can be viewed on our website at www.atmosmed.com. The quality management system at ATMOS has been certified accord- ing to international standard EN ISO 13485. These operating instructions apply to the following products: Hygrotherm plus REF 502.1100.0 Introduction... -
Page 5: Explanation Of Pictograms And Symbols
1.2 Explanation of pictograms and symbols In the operating instructions DANGER Warning of a danger resulting directly in fatal or serious injury. Observe the necessary measures. WARNING Warning of a danger of fatal or serious injuries. Observe the necessary measures. CAUTION Warning of a danger of minor injuries. -
Page 6: Intended Use
Heating off (energy saving mode) Connection for waste water Connection for water On/off Handle 1.3 Intended use Product name: Hygrotherm plus Main function: Irrigation of the external ear canal Intended use / Irrigation of the external ear canal purpose: Intended users / Physicians and medical specialists user profile:... -
Page 7: Function
• Then automatic change to irrigation mode. Here, irrigations can be carried out with water warmed up to 37 °C and a flow rate of at least 400 ml/min. 1.5 Scope of delivery Quantity Description Hygrotherm plus main device Irrigation handle with connection hose Jet connection for irrigation handle 80 mm Splash guard for attachment to jet connection Hose tips Water filter, complete, 3/4" A-3/4"l... -
Page 8: Transport And Storage
1.6 Transport and storage Transport the product only in a shipping box that is padded and provides sufficient protection. If you notice transport damage: 1. Document and report the transport damage. 2. Send the device to ATMOS; see chapter “6.1 Sending in the device” on page 24. Ambient conditions for transport and storage: • Temperature: -20...+50 °C • Humidity without condensation: 5...90 % • Pressure: 700...1060 hPa Introduction... -
Page 9: Notes On Your Safety
Explosion and fire hazard! Burns and injuries are possible. • Never operate the product in potentially explosive or oxygenated areas. • Use only original accessories and spare parts from ATMOS. This applies in particular to the power supply unit, power cable and battery. Avoid misuse Your patient can become severely injured. •... -
Page 10: Important Notes On The Maintenance Of The Hygiene Status Of Warm Water Irrigation Units
Burns, cardiac arrhythmia and even fatal injuries are possible. • Do not operate the device if it has been dropped. In this case, clean and disinfect the device and send it to ATMOS for repairs. • Check whether the device or power cable is damaged each time before using the device. -
Page 11: Avoiding Damage To The Device
Wear disposable gloves when carrying out maintenance work on parts that conduct water.* Carry out the thermal cleaning process at least three times before using the device for the first time.* * This work is carried out by an authorized ATMOS service technician. Running operation Before beginning the surgical operation, switch on the unit and await the ther- mal cleaning process. -
Page 12: Setting Up And Starting Up The Device
3 Setting up and starting up the device 3.1 Device overview 3.1.1 Front view Hygrotherm plus — Main switch Heating ON/OFF button (energy saving mode) Temperature display (double-digit, resolution of 1 °C), actual value display 3.1.2 Rear view Type plate Device plug with fuse compartment Equipotential connection 12 Setting up and starting up the device... -
Page 13: Side View
3.1.3 Side view Handle holder Connection for the double-barrelled hose Connection for the waste water hose Connection for the water supply hose 3.1.4 Irrigation handle view ... -
Page 14: Connections
• According to VDE 0107 and VDE 0100, medically used rooms have to be equipped with a leakage current protective circuit (FI protective circuit) with a nominal leakage current of < 0.03 A. Installation must correspond with VDE 0107. • Connect the power cable to the mains connection. • Insert the power plug into a correctly installed socket with earthing contact. 3.2.2 Equipotential bonding connection • Connection for potential equalization. Connection cable available from ATMOS. 14 Setting up and starting up the device... -
Page 15: Water Connection
Connection to water supply and waste water: • There are country-specific regulations for the installation, which are to be consid- ered when connecting the device to the public water supply. To comply with the rules according to EN 1717, an unpressurized water separation with overflow is required. Therefore, ATMOS recommends installing the water separation unit ATMOS Aqua Clean (REF 502.1200.0) between the water supply and the device in order to meet the connection requirements according to EN 1717. Prior to connecting the device 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. 1. Connect the filter unit to the water tap by means of adapter and gasket. -
Page 16: Connecting The Irrigation Handle
5. Screw the nuts to the device connection and the drainage fittings. There is no special calcification safety device integrated in the water system. A cal- cification safety device must be connected when the respective drinking water is of hardness grade 3 (14 - 21°dH resp. 2.5 - 3.8 mmol/l = hard water) and with hardness grade 4 (from 21°dH resp. from 3.8 mmol/l = very hard water). Please contact your local water supplier and/or plumber. Hardness range Total hardness in °dH millimol per litre 1 (soft) ≤ 1.3 ≤ 7.3 Calcification protection system not required 2 (medium) 1.3 to 2.5 7.3 to 14 3 (hard) 2.5 to 3.8 14 to 21.3 Calcification protection system required 4 (very hard) > 3.8 > 21.3... -
Page 17: Operation
4 Operation Before switching on the device, make sure the handle is in its support (irrigation nozzle must point to the rear of the device). 4.1 Selecting the temperature level After operating the main switch, automatic activation of the thermal process to reduce the bacterial count, followed by the automatic activation of the “irrigation mode” tem- perature level (37 °C). 4.2 Operating mode description 4.2.1 Thermal process to reduce the bacterial count Purpose: Reduction of bacteria count in the warm water circuit to prevent or clear a contaminat-... -
Page 18: Energy Saving Mode
Activation: • Automatically after completion of thermal cleaning procedure and taking out the handle. When irrigation mode is not used (handle remains in its support), the Hygrotherm plus switches to energy saving mode after five minutes. • Reactivation of the irrigation mode by removing the handle or pressing a button on the temperature control unit. 4.2.3 Energy saving mode Purpose: •... -
Page 19: Sterilization
The hose tips must be exchanged each time after use. The surfaces of the Hygrotherm plus resist most of the common surface disinfectants. However, do not use any: • Disinfectants containing concentrated organic or inorganic acids because they could cause corrosion damage. -
Page 20: Avoiding Damage To The Device
Risk of infection due to unsuitable sterilization. Deadly diseases may be transmitted. • Make sure all areas of the accessories are easy to access. • Use only suitable load carriers for mechanical sterilization. This applies especially to accessories that contain hollow spaces and lumens that are difficult to reach. • Make sure no air bubbles form in the hollow spaces and lumens of accessories when placing them in sterilization solutions. 5.1.3 Avoiding damage to the device Damage to the device due to cleaning with fixatives. -
Page 21: Preparing And Finishing The Sterilization
Wipe the device surface with a cloth moistened with cleaning agent or disinfectant. Make sure no liquid enters the device. Any spilled disinfectant must be immediately wiped up. Always observe the operating instructions of the manufacturer of the disinfectants, including, in particular, the concentration specifications. The described cleaning and disinfection measures do not replace the relevant instructions that apply to operation. -
Page 22: Cleaning Method For Handle With Nozzle For Irrigation Handle
End of product 12/2014 Dismozon plus Magnesium monoperoxyphthalate hexahydrate (95.8 g) Bode Chemie, Hamburg (granule) Green & Clean SK < 1 g alkyl-dimethyl-benzyl-ammonium chloride, dialkyl- ATMOS, Lenzkirch (Application concentrate) dimethyl-ammonium chloride, alkyl-dimethyl-benzyl- ammonium chloride Perform Pentapotassium bis(peroxymonosulphate)-bis(sulphate) 45.0 g Schülke & Mayr, Norderstedt ... -
Page 23: Recommended Disinfectants
5.6.1 Recommended disinfectants Surface disinfection Other surfaces: Manual disinfection Mechanical disinfec- for painted surfaces: of instruments: tion of instruments: • Green & Clean SK (ATMOS) • Dismozon® plus • Korsolex® AF • Dismoclean® 21 clean (Bode Chemie) (Bode Chemie) (Bode Chemie) • Dismozon® plus (Bode Chemie) -
Page 24: Maintenance And Service
5. The device must be well padded and packed in suitable packaging. 6. Place the QD 434 form “Delivery Complaint / Return Shipment” and the correspond- ing decontamination certificate in an envelope. 7. Affix the envelope to the outside of the package. 8. Send the product to ATMOS or your dealer. 6.2 Decalcification Preventive decalcification should be carried out if the tap water is known for mineral precipitation in the area where the device is used: 1. Close the water tap. -
Page 25: Filter Replacement
6.3 Filter replacement • When the filter cartridge is very dirty (dark colour), exchange the filter cartridge as follows: Filter housing - Close the water supply tap. Filter cartridge - Briefly switch on the unit to reduce Sealing pressure in the filter housing. - Switch off the device when “F1” Plexiglass canister appears. - Unscrew the plexiglass canister anti-clockwise off the filter housing. -
Page 26: Troubleshooting
7 Troubleshooting Error on the temperature display Potential cause Remedy "F0" Handle is not in its support • Insert the handle back in its support to allow the thermal process for reducing the bacterial count to start (nozzle must point to the rear of the device). • Replace the handle (REF 502.0963.0). "F1"... -
Page 27: Accessories
8 Accessories Description Water pre-filter, backwashable (ENT units) 502.0990.0 Water filter, complete, 3/4" A-3/4"l 530.2085.0 Nozzle for irrigation handle, 80 mm 508.0427.0 Nozzle for irrigation handle, 110 mm 508.0429.0 Hose tips 502.0844.0 Splash protection to be slipped on nozzle 501.0331.0 ATMOS Aqua clean (stimulation and irrigation devices) 502.1200.0 Accessories... -
Page 28: Disposal
• The Hygrotherm plus does not contain any hazardous materials. • The housing material is fully recyclable. • The component parts of the Hygrotherm plus must be disposed of correctly and the materials separated carefully. • The electronic circuit boards must be submitted to the appropriate recycling process. -
Page 29: Technical Data
10 Technical data Voltage 220 – 240 V~ ± 10%; 50/60 Hz Current consumption 6.8 A Power consumption 1500 VA Fuses F 8 A / 250 V AC Operating modes • Thermal process for reducing bacterial count • Irrigation mode • Heating off (energy saving mode) Water temperature 37 °C ± 0.5 °C Temperature indication Indication accuracy ± 0.5 s ± ½ digit Flow rate 400 ml/min ± 10 % Feed temperature of the water +7...+36.5 °C Water quality Drinking water... -
Page 30: Notes On Emc
11 Notes on EMC Medical electrical devices are subject to special precautions with regard to EMC and must be installed according to the following EMC instructions. Guidelines and manufacturer’s declaration – Ambient conditions The Hygrotherm plus is suitable for operation in the following environments: • In professional healthcare facilities, such as medical practices, clinics, first aid facili- ties and operating theatres. The following environments are not suitable: • Special environments such as factory or military facilities and medical areas near HF surgical devices, short-wave therapy equipment or within an HF-shielded room of... -
Page 31: Notes
12 Notes Notes... - Page 32 ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch / Germany Tel. : +49 7653 689-0 info@atmosmed.com www.atmosmed.com...
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