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Instructions for Use

Simplified EU declaration of conformity

Simplified EU declaration of conformity

Hereby, Carl Zeiss Suzhou Co., Ltd., declares that the radio equipment type EXTARO 300 is in
compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at
the following internet address:

www.zeiss.com/meditec

305935-3500-000 – 2.1 – 2017-12-15

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Содержание EXTARO 300

Страница 1: ...ZEISS EXTARO 300 Instructions for Use...

Страница 2: ...ved for internal use Access to this data by third parties is not permissible and must be prevented Registered trademarks EXTARO Varioskop and VisionGuard are either trademarks or registered trademarks...

Страница 3: ...Mode 14 5 2 2 Orange Color Mode and TrueLight Mode 15 5 2 3 Green Color Mode 16 5 2 4 NoGlare Mode 16 Ergonomics 17 5 3 1 Foldable tube 17 5 3 2 MORA interface 17 Documentation 18 5 4 1 Essential Comm...

Страница 4: ...n Augmented Visualization modes 34 Setting the microscope to parking position 35 Cleaning and disinfection 36 Cleaning 36 8 1 1 Cleaning optical surfaces 36 8 1 2 Prevention of fogging 36 8 1 3 Cleani...

Страница 5: ...equipment and ME systems 51 11 8 3 Electromagnetic immunity for non life supporting ME equipment and ME systems 52 11 8 4 Recommended safety distances between portable and mobile RF communication equ...

Страница 6: ...300 floor stand EXTARO 300 wall mount EXTARO 300 ceiling mount EXTARO 300 floor mount Symbols in the manual Hazard symbols WARNING Hazards that can cause fatal or severe injuries if not avoided CAUTIO...

Страница 7: ...hat no illumination light of the microscope enters the patient s eyes CAUTION Live video images and recorded video sequences video clips cut sequences and single images must not be used for diagnosis...

Страница 8: ...be used in professional healthcare facility environments such as physician offices dental offices clinics hospitals emergency rooms patient rooms intensive care and surgical rooms without high freque...

Страница 9: ...th short suspension arm Floor mount with long suspension arm Wall mount with long suspension arm Ceiling mount with long suspension arm Yoke Angled 120 yoke Straight yoke The straight yoke can only be...

Страница 10: ...t the power socket should be compliant with the specification on this label 6 UDI label 1 YYYY MM DD manufacturing date in the sequence of Year Month Day 2 UDI Unique Device Identification contents 01...

Страница 11: ...12 Service identification label The SIP number is a unique identification number assigned to your system for service purpose 13 System identification label Manufacturer information Serial number Refe...

Страница 12: ...E Loosening the securing screw may cause the tube to fall off Mode Control knob Varioskop 230 for focus adjustment Knob of Magnification Changer Pupillary distance adjustment Diopter setting on eyepie...

Страница 13: ...s on wall adapter Brake of Axis 2 for locking the suspension arm Brake for setting the lowest position of suspension arm Brake of Axis 3 for locking the vertical position of suspension arm Brake of Ax...

Страница 14: ...relief device to prevent inadvertent cable unplugging Video interface and Ethernet connections For wall and ceiling mount the cables Power Ethernet and HDMI are internally routed from within the syst...

Страница 15: ...s an optional accessory to EXTARO 300 surgical microscope Intended use Fluorescence Mode is intended to be used as an aid in the detection and diagnosis of dental caries and as an aid to distinguish c...

Страница 16: ...th colored composite resins Clin Oral Invest 2017 21 347 355 Composite resin under White Light Mode Composite resin under Fluorescence Mode 5 2 2 Orange Color Mode and TrueLight Mode Both Orange Color...

Страница 17: ...the obtrusive light reflections from the tooth surface this mode allows to precisely analyze the color shades of the teeth The elimination of glare helps very much when true color has to be determine...

Страница 18: ...that the tube can be both folded and straightened Folded Stretch out 5 3 2 MORA interface The MORA interface increases the mobility of the OPMI operation microscope about its lateral tilt axis without...

Страница 19: ...to monitor USB port for image video recording e g with a USB disk Trigger from microscope or with remote control It is recommended that the capacity of USB disk not exceed 256GB We recommend the user...

Страница 20: ...roscope or with remote control Network interface including wireless wired Ethernet connection ZEISS Connect iPad app for Camera control including smart recording Chair side patient consultation Media...

Страница 21: ...onnect the camera with the photo adapter Please refer to the product datasheet of EXTARO 300 or consult your authorized ZEISS partner for ordering information of the external camera adapter External c...

Страница 22: ...5935 8022 000 for Varioskop 230 For detailed ordering information of all asepsis products please consult your authorized ZEISS partner CAUTION Risk of infection caused by contamination Clean disinfect...

Страница 23: ...with the following types of iPad only iPad Air 2 iPad Pro 9 7 inch 10 5 inch Using the docking station with other types of iPad or tablet PC would potentially damage that device or the EXTARO 300 sys...

Страница 24: ...n and suspension arm during the move 6 Lock all casters once the system arrives at the desired location CAUTION Risk of toppling during transportation of the system Always hold the stand column at the...

Страница 25: ...lectrical voltage Do not touch the power outlet socket or other signal interfaces while in contact with the patient CAUTION Risk of electric shock caused by inadmissible or defective accessories Never...

Страница 26: ...apes NOTE Risk of overheating Never cover any ventilation openings If ventilation grids on the carrier arm covers are covered e g by drapes this may lead to overheating of the parts inside the carrier...

Страница 27: ...clasped by the bottom structure of Varioskop 230 Unmounting the lens protection cover NOTE Reusability of the lens protection cover Depending on its operational and maintenance condition the lens prot...

Страница 28: ...correctly balanced system brake release may lead to uncontrolled movements of the suspension arm Balance the surgical microscope before surgery without the patient The suspension arm is under spring f...

Страница 29: ...height of suspension arm and the chair to bring the microscope to working area The user should keep his her back upright while working with the microscope The working distance WD of the microscope ca...

Страница 30: ...ndling of magnets in regard of eyepieces that have been removed from the tube Do not place the eyepiece near instruments which may be magnetizable Do not place the eyepiece on sensible devices such as...

Страница 31: ...ngs on it Adjust the height of OPMI to get a proper working distance to the paper and then lock the suspension arm 2 Adjust the varioskop to get a sharp image of the writing on the paper You can obser...

Страница 32: ...image Recording video Long click t 0 8s at the center of the Mode Control knob to start video recording To stop the recoding long click at the center again 7 1 2 Recording image video with the remote...

Страница 33: ...ct as seen under normal daylight Readjust the white balance of the camera if the color temperature of light source is changed 1 Put a blank white sheet of paper below objective lens 2 Press the index...

Страница 34: ...e the set intensity level of the illumination under the corresponding mode Note that the illumination intensity of each mode can be set independently and will be automatically memorized by the microsc...

Страница 35: ...t press t 0 8s activates the TrueLight Mode and a long one t 0 8 results in Orange Color Mode Press the Mode Control knob leftward to activate Green Color Mode Availability of some Augmented Visualiza...

Страница 36: ...Instructions for Use Setting the microscope to parking position Move the suspension arm upward until you hear a clear clicking sound the light source will then be switched off automatically 35 59 305...

Страница 37: ...wer or a clean grease free brush For the regular cleaning of objective lenses and eyepieces of the surgical microscope we recommend the optics cleaning set available from ZEISS 8 1 2 Prevention of fog...

Страница 38: ...paint on the device to become damaged Use a disinfectant based on aldehyde or alcohol The addition of quaternary compounds is acceptable To avoid damaging the surfaces do not use any disinfecting comp...

Страница 39: ...r local ZEISS Service or an authorized partner for performing maintenance activities in due time According to country specific interval requirements Component Procedure Criteria Safety check According...

Страница 40: ...ng locking tabs and brakes securely positioned OPMI Function test Check of optical imaging and illumination of the field of view Focus Function test Play free adjustability of focus Varioskop tube and...

Страница 41: ...stem are performed on schedule and to the stipulated extent The safety checks may only be carried out by the manufacturer or by qualified persons The scope of the safety checks of the system should co...

Страница 42: ...ion adjustment screw on stand over tightened Loosen friction adjustment screw on stand as required Stand wobbles Floor not level Stand base not appropriately positioned Slightly change the stand base...

Страница 43: ...or a damaged file system Format the USB data carrier or replaced it Failure of the Mode Control knob In the event that switching between illumination modes by clicking the Mode Control knob doesn t ta...

Страница 44: ...with a properly connected protective ground conductor Rated voltage 100VAC 240 VAC 50Hz 60Hz Power consumption Max 120 VA Electrical interfaces 1 Power input 100VAC 240 VAC max 5 A 2 Integrated video...

Страница 45: ...20 yoke 2 Straight yoke Height of floor stand floor mount 1735 mm Base of floor stand floor mount Approx 745 x 615 mm floor stand Approx 235 x 235 mm floor mount Maximum permissible load of suspension...

Страница 46: ...Technical specification Instructions for Use System dimensions Ceiling mount Range of H 1261 2176 mm depending on ceiling height Wall mount Floor stand 45 59 305935 3500 000 2 1 2017 12 15...

Страница 47: ...230 200 430 mm Field of view with 12 5x eyepiece 11 3 mm 72 9 mm at a working distance of 200 mm 20 0 mm 128 6 mm at a working distance of 430 mm Tubes Eyepieces 180 tiltable tube f 170mm Foldable tu...

Страница 48: ...ypical Network Interface NA Built in 2 4Ghz Wi Fi router with Access Point WAN port RJ45 for connection to clinic network Network streaming NA RTSP video stream with H 264 encoding Network streaming b...

Страница 49: ...11 7 2 Statement of Class B digital device Part 15 of the FCC Rules Note This equipment has been tested and found to comply with the limits for a Class B digital device pursuant to part 15 of the FCC...

Страница 50: ...cted Consult the dealer or an experienced radio TV technician for help 11 7 3 Conformity of FFC Rules This device complies with Part 15 of the FCC Rules Operation is subject to the two following condi...

Страница 51: ...nger from electromagnetic radiation Electrical devices can influence each other as a result of their electromagnetic radiation The use of non approved components accessories transformers of all types...

Страница 52: ...tage fluctuation flicker as per IEC 61000 3 3 Compliant 11 8 2 Electromagnetic immunity for ME equipment and ME systems The EXTARO 300 is intended for operation in an electromagnetic environment as sp...

Страница 53: ...NOTE UT is the AC supply voltage prior to application of the test level 11 8 3 Electromagnetic immunity for non life supporting ME equipment and ME systems The device EXTARO 300 is intended to be ope...

Страница 54: ...opagation is influenced by absorption and reflection by structures objects and persons a In theory the field strengths of stationary transmitters such as base stations for cell phones and mobile land...

Страница 55: ...put power not listed in the above table the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter with P being the maximum o...

Страница 56: ...C 60601 1 2012 and ANSI AAMI ES60601 1 2005 A2 R2012 A1 Classification according to level of protection against electrical shock Protection class I Electromagnetic compatibility The medical device is...

Страница 57: ...onformity Hereby Carl Zeiss Suzhou Co Ltd declares that the radio equipment type EXTARO 300 is in compliance with Directive 2014 53 EU The full text of the EU declaration of conformity is available at...

Страница 58: ...d waste or communal disposal companies in accordance with the applicable EU guidelines valid at the time the device was placed on the market For detailed information on the disposal of the product ple...

Страница 59: ...rical and electronic devices with their environment EIRP Effective Isotropic Radiated Power FCC Federal Communications Commission HD High Definition providing high resolution IR Infra Red LAN Local Ar...

Страница 60: ...ial Park Suzhou China 215126 Phone 86 512 6287 1388 Fax 86 512 6287 1366 Goeschwitzer Strasse 51 21 07745 Jena Phone 49 36 41 22 03 33 Fax 49 36 41 22 01 12 Email surgical meditec zeiss com Internet w...

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