otometrics HORTMANN Aquamatic II User Manual Download Page 30

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Declaration of Conformity

FOR

MEDICAL PRODUCTS

ATMOS MedizinTechnik

Name /Address of Manufacturer:

GmbH

Co. KG

Ludwig-Kegel-Strafe 16

79853 Lenzkirch/Germany
Tel. +49 (0) 76 53/6 89-0

hereby declare that the product...

Designation

Aiwos

Aquamatic

Art.Nr.

999.1 200.0

Models

is in conformity with the following standards:

Directions 93/42/EEC on medical products, passed by the commission

on 14th June 1993, last amended on 7th August 2002

The product is marked with the sign:

Lenzkirch, den 03.01 .2006

Place and date of issue

Validity unlimited till further changes of the product

Qd 148-4_CE0124

Ludwig-Kegel-Str. 16

+49 7653 689-0

79853 Lenzkirch

Germany

+49 7653 689-190

Otometrics - Aquamatic II

10 Disposal

Summary of Contents for HORTMANN Aquamatic II

Page 1: ...Aquamatic II User Guide Doc No 7 50 7500 EN 02 Part No 7 50 75000 EN ...

Page 2: ...e latest productinformation available atthe time of publication GN Otometrics A Sreserves the right tomake changes atany time without notice Registeredtrademarks andTrademarks MADSEN IteraII MADSEN OTOflex 100 OTOsuite AURICAL FreeFit AURICAL Visible Speech MADSEN Astera MADSEN Xeta ICS Chartr 200 VNG ENG ICSChartr EP OTOcam300 MADSEN AccuScreen MADSEN AccuLink ICS AirCal AURICAL Aud AURICAL HIT I...

Page 3: ...ction 5 2 Safety advice 7 3 Installation and start up 9 4 Operation 16 5 Cleaning 20 6 Maintenance and service 21 7 Troubleshooting 25 8 Accessories and spare parts 26 9 Specifications 27 10 Disposal 29 Otometrics Aquamatic II 3 ...

Page 4: ...4 Otometrics Aquamatic II ...

Page 5: ...irs only use the Producer spare parts to preserve the equip ment warranty and ensure operational safety readinessfor work and to maintain the value ofthe equipment The product Aquamatic II bears CE Marking CE 0124 according to the EEC guideline ofthe council for medical products93 42 EEC and meets the basic requirements ofthis guideline The quality management system applied at producer has been ce...

Page 6: ... stimulation mode for stimulating the vestibule with a reduced flow of water The Aquamatic II is equipped with a timer for preselecting the stimulation time 1 4 Explanation of symbols Pay attention to operating instructions as to ISO 7000 0434 DIN 30600 1008 IEC 348 Type B equipment as to IEC 417 Fuse as to IEC 417 5016 DIN 30600 0186 Temperature in degree centigrade Timer adjustment in seconds St...

Page 7: ...upervised operationby qualified personnel which have been authorized 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 Damagedleads must be replaced immediate...

Page 8: ...etrics 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 authorized by GN Otometrics 2 1 Important instructions for the maintenance of the hygiene status of warm water irrigation units For loosenin...

Page 9: ...is hygienically changed see commissioning dispose offilter 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 germ count in the water be regularly determined at the input and output of the unit 3 Installation and start up 3 1 Standard delivery Quantity 1 Aquamatic II basic unit 1 Irriga...

Page 10: ...on level E Coding switch for stimulation time F Key switch for selecting the irrigation level 37 C G Key switch for selecting the warm stimulation level e g 44 C H Key switch for selecting the cold stimulation level e g 30 C I Key switch for start stop of the stimulation J Temperature display two figure number res olution 1 C current value indication K Displayof stimulation time two figure number ...

Page 11: ...Fig 2 Rear view A Type plate B Control output for a nystagmograph C Unit plug with fuse compartment D Equipotentiality connection Otometrics Aquamatic II 11 3 Installation and start up ...

Page 12: ...3 Side view A Support for irrigation handle B Connection for double barreled hose C Connection for waste water hose D Connection for water supply hose 12 Otometrics Aquamatic II 3 Installation and start up ...

Page 13: ...ction for double barreled hose C Three hole gasket D Knurled screw E Release lever F Valve plunger G Jet connection H Splash protection I Cap J Double barreled hose K Lever for water flow Otometrics Aquamatic II 13 3 Installation and start up ...

Page 14: ...r plug in a correctly installed socket with aground earthing contact 3 3 2 Connecting a nystagmograph When controlling an ENG electro nystagmograph or aCNG computer nystagmograph at output Fig 2 11 item B please connect only recording equipment approved by GN Otometrics Connecting cable available from GN Oto metrics see Accessories and spare parts 26 14 Otometrics Aquamatic II 3 Installation and s...

Page 15: ...te water Prior to connecting the unit to the water supply the feed line must be flushed clean by opening the water faucet for a minute and allowing free flow ofthe water Connect the filter unit to the water faucet by means of adapter and gasket Insert the gaskets in the cap nuts ofthe water supply hose Join the nuts with the filter connection and the unit connection Fig 3 12 item D Insert the gask...

Page 16: ...he energy sav ing mode after 5 min Fig 6 Irrigation handle A Lever for water flow B Adjusting screw 4 Operation Before switching on the unit make sure that the handle is in its holder jet must point to the rear of the unit 4 1 Adjusting temperatures Number oftemperature levels 3 One level fixed to 37 C irrigation temperature keys below the left and right switches Two variable temperature levels 20...

Page 17: ...evel irrigation mode 37 C For selecting the desired temperature level use the respective key Fig 1 10 items F G and H 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 10 item E 4 4 Adjusting flow quantity With the lever for water flow Fig 6 16 item A you can adjust the flow quantity ...

Page 18: ...portant Metal parts of the irrigation handle and of the double barreled 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 irrigat...

Page 19: ...re stability with an optical indication by the flashing figure in temperature display Do not start stim ulation by operating the release lever at the handle until you hear the audible signal Carryingout the thermo stimulation by actuating release lever at handle Fig 4 13 item E At the end of the stimulation period acontrol signal for a recording unit is issued at the nystagmograph output After com...

Page 20: ...y the main power switch before starting cleaning and disinfection Wipe the unit surface with a cloth moistened with a cleaningor disinfecting solution Make sure that no liquid penetrates the unit You may use all cleansers and disinfectants listed in Recommended surface disinfectants 21 Important Always observe the instructions for use by the manufacturer of the disinfectants above all concentratio...

Page 21: ...14 g Braun Melsungen Benzal conium chloride 10 g Bi guanidinium acetate 7 5 g Polymer biguanid Cleaning agents 0 5 g Incidin Plus Application concentrate Glucoprotamin Nonionic tensides Solvents complexing agents 26 0 g Henkel Düsseldorf Pursept A Disinfectant spray or dis infectant cloths Ethanol 38 9 g Merz Co Frankfurt M Glyoxal 0 1 g QAV 0 05 g Ifusing aldehyde containing or amine containing d...

Page 22: ...temperature at 49 C The electronic excess temperature protection must respond in the temperature display error code F7 appears Measure temperature ofwater 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 ...

Page 23: ...en mounted vertically at water faucet Unscrew screwed glass offilter 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 faucet again Switch on the unit Decalcificationtakes place automatically in the thermal process for reducing bacterial count Afte...

Page 24: ... Unscrew Plexiglass cup Fig 7 24 item D from filter body Fig 7 24 item A by turning anti clockwise Extract filter cartridge Fig 7 24 item B 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 ofgerms into the water system Fig 7 Water filter A Filter body B Filter cartridge C Sealingring D Plexiglass cup 24...

Page 25: ... Inform the service staff F6 Different switch settings in the handle holder Handle must be correctly inserted in its support Inform the service staff F7 Temperature too high 48 C display only in the stimulation and irrigation mode but not in the thermal cleaning procedure Check whether temperature setting is too high Ifneces sary adjust desired temperature to a value of 48 C by means of the coding...

Page 26: ...al compensation L 5m 008 0596 0 8 2 Spare parts Description REF Aquamatic II basic unit 220 240 V AC 50 60 Hz 502 0900 0 Aquamatic II basic unit 110 127 V AC 50 60 Hz 502 0900 1 Irrigation handle 4 502 0963 0 Double barreled 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...

Page 27: ...II 9 Specifications 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 3 m Power consumption 1500 W Operating modes Thermal process for reducingbacterial count Irrigation mode Stim ulation mode Heating off energy saving Stimulation time adjustable by timer from 1 up to 99 sec Timer indication Accuracy 0 5 s digit Wat...

Page 28: ...nductor resistance 0 1 Ω max Earth leakage current 0 5 mA max Enclosure leakage current 0 1 mA max Patient leakage current 0 1 mA max Ambientconditions 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...

Page 29: ...ousing can be completely recycled The component parts ofthe Aquamatic II must be correctly discarded and the materials should be carefully sep arated for recycling Electronics circuit boards must be discarded using the appropriate recycling process Used hose tips which no longer can be disinfected must be discarded into domestic waste immediately Otometrics Aquamatic II 29 10 Disposal ...

Page 30: ... 999 1200 0 Models is in conformity with the following standards Directions 93 42 EEC on medical products passed by the commission on 14th June 1993 last amended on 7th August 2002 The product is marked with the sign Lenzkirch den 03 01 2006 Place and date of issue Validity unlimited till further changes of the product Qd 148 4_CE0124 Ludwig Kegel Str 16 49 7653 689 0 79853 Lenzkirch I Germany 49 ...

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