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OCULUS Corvis ST Скачать руководство пользователя страница 77

21 Appendix

Instruction Manual Corvis® ST (G/72100/XXXX/EN 1019 Rev01)

71 / 80

21.3 Guidance and Manufacturer’

s

Declaration -

Electromagnetic Emmi

sss

ion

s

and Immunity for the Corvi

s

® ST

Guidance and manufacturer´

s

declaration electromagentic emmi

ss

ion

s

IEC 60601-1-2: 2015, ba

s

ed to table 1

The OCULUS Corvis® ST is intended for operation in the electromagnetic environment specified below. The user
of the Corvis® ST should ensure that it is being used in such an environment.

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The Corvis® ST uses RF energy only for its internal functi-
on. Therefore, its RF emissions are very low and are not li-
kely to cause any interference in nearby electronic
equipment.

HF-emissions
CISPR 11

Class B

Harmonics emissions
IEC 61000-3-2

Class A

Voltage fluctuations /
flicker emissions
IEC 61000-3-3

complies

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75
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Содержание Corvis ST

Страница 1: ...OCULUS Corvis ST INSTRUCTION MANUAL Tonometer Pachymeter...

Страница 2: ...this instruction manual before operating the device In particular pay attention to the safety instructions This instruction manual describes the measuring procedure of the Corvis ST Due to ongoing de...

Страница 3: ...al Start Up 17 10 3 Adjustments after an in house transport 18 10 3 1 Device set up 18 10 3 2 Unlock transport safety device 18 10 4 Electrical Connection 19 10 5 Daily operation 21 10 5 1 Switching o...

Страница 4: ...eo function 4 46 13 4 View specific images of the cornea 4 47 14 Perform a measurement with the Corvis ST unit 48 14 1 Change Settings 48 14 2 Entering Patient Data 49 14 2 1 Entering new Patient 50 1...

Страница 5: ...er function or damages 66 20 Technical Data 67 21 Appendix 69 21 1 Correction Calculation of the Tonometrically calculated IOP 69 21 2 Electromagnetic Compatibility 69 21 3 Guidance and Manufacturer s...

Страница 6: ...Table of Contents v v Instruction Manual Corvis ST G 72100 XXXX EN 1019 Rev01...

Страница 7: ...e bill of lading so that a proper claim settlement is possible Keep the packing material Note We reserve the right to change the scope of delivery in line with ongoing technical development Component...

Страница 8: ...use Article number Fragile Disposal in house hold trash is prohib ited Serial number Limit of temperature for transport Applied part Type B Caution Limit of temperature for storage US Pat US patent n...

Страница 9: ...ention All safety related instructions for use of the Corvis ST are given in the Instruction Manual for the unit It is imperative that you read and under stand the whole Instruction Manual before you...

Страница 10: ...version 2 0 2007 measure head from ersion 2 0 2013 The following software versions are used Corvis ST program from version 1 6r2015 Patient Data Management from version 6 09 4 1 1 Graphic symbols used...

Страница 11: ...e 62 Information for set up and connection Do not use the Corvis ST outdoors or in damp rooms and do not store the device there Keep the Corvis ST away from water that may drip splash or spray on it a...

Страница 12: ...via USB Do not use the Corvis ST with wireless technology for example with wireless USB Data responsibility The device itself is not designed to connect with the internet but only with a PC It does n...

Страница 13: ...former Information about the operation of an ME system The Corvis ST and a connected computer form a medical electrical system ME system according to DIN EN 60601 1 If you connect additional devices s...

Страница 14: ...Only authorized persons are allowed to perform the software updates To ensure that it functions correctly and safely we recommend the following Have the Corvis ST checked every two years by our servi...

Страница 15: ...with the requirements of DIN EN ISO 60601 1 20005 section 16 Do not place the multiple socket extension cord on the floor Do not use more than one multiple socket extension cord Plug only the Corvis S...

Страница 16: ...the option for the necessity of re entering the password when exit the screen saver Choose an adequate time setting for starting the screen saver if software session is inactive e g 10 minutes Adequa...

Страница 17: ...non contact Tonometer with the additional function of pachymetry which is a non contact pachymeter The automatic non contact tonometer function is the center of application while the additional Pachym...

Страница 18: ...can cause condensation on the optical components Note Equipment damage due to incorrect transport and improper storage Avoid shocks and vibration Avoid contamination high temperatures and humidity Tr...

Страница 19: ...T G 72100 XXXX EN 1019 Rev01 13 80 9 Device Description 9 1 Overview of Device Components Side view 1 measure head 5 Joystick 2 Chin rest 6 Function keys 3 XY base 7 Display 4 Control knob 8 Printout...

Страница 20: ...Front view 1 Head rest 6 On Off switch 2 Air nozzle window of the slit lamp 7 Control LED 3 Lens protection glass 8 Mains connection 4 LED to illuminate the eye 9 USB port 5 Marking for the eye heigh...

Страница 21: ...cornea in proportion to time The shape of the cornea changes from the normal convex surface to a concave surface This change is optically detected within 140 Scheimpflug images The device calculates...

Страница 22: ...9 Device Description 16 80 Instruction Manual Corvis ST G 72100 XXXX EN 1019 Rev01 Applied parts 1 Head rest 2 Chin rest Abb 9 3 Applied parts 1 2...

Страница 23: ...you in the operation of the Corvis ST Incorrect measurements equipment damage due to incorrect set up Before the first use make sure the installation and connection of the Corvis ST examination area...

Страница 24: ...elow and the head rest to lift it 10 3 1 Device set up Place the Corvis ST on a level surface Place the Corvis ST so that no direct light can effect the measurement Avoid shocks and vibration Avoid co...

Страница 25: ...jacent to or stacked with other equipment verify the correct operation of the Corvis ST Only use the power adapter listed in the list Only use a power cord which meets the requirements of IEC 60227 1...

Страница 26: ...hort period of time Do not use excessive force when connecting the electrical plug Pay attention to the specifications on the nameplate If the electrical plug is damaged contact our service department...

Страница 27: ...e the Corvis ST into the desired position Release the safety stop 2 The safety stop is set You can only move the Corvis ST as far as this position You can move the Corvis ST towards the rear at any ti...

Страница 28: ...T with the On Off Switch 1 Attention Risk of electric shock if the Corvis ST is not completely disconnected from the mains for transport cleaning maintenance disinfection and re pair Turn the Corvis S...

Страница 29: ...gram the USB connection must be enabled in the Settings 2 USB Trans fer of the Corvis ST device the Patient Data Management software For more information see the User Guide 11 1 Using the control unit...

Страница 30: ...tton Control knob 2 Changes the corresponding Parameters Enables the selected parameters Turn the knob to the left or right The selected parameter is highlighted in blue Press the control knob downwar...

Страница 31: ...ch screen to enable the function Buttons on the touch screen You can use the following buttons in Patient Data Management You can start the measurement and edit the patient and examination data via th...

Страница 32: ...Data Management opens automatically If necessary press the Corvis ST icon The Patient Data Management user interface appears If the Windows desktop appears you have to start the Patient Data Manageme...

Страница 33: ...ing data from the USB flash drive Press the button Import The following dialog appears The options for import and export of data are set as defaults in the set tings field see User guide Depending on...

Страница 34: ...e lower part of the dialog To import the data press the Import button 4 The data will then be available in the Patient Data Management software 11 4 1 Enter a new patient You can only start a measurem...

Страница 35: ...elect an existing patient The patient list on the left hand side of the screen displays all previously examined patients in alphabetical order Press the Search button to quickly find the patient you r...

Страница 36: ...0 XXXX EN 1019 Rev01 Extended patient search Extended checkbox Click on the Checkbox Extended The screen displays additional search parameters which for example reference previous examinations Proceed...

Страница 37: ...T sec 12 2 page 32 Start the measurement sec 12 3 page 37 Perform a second measurement sec 14 3 page 52 Save the data sec 12 5 page 38 Complete the measurement sec 12 6 page 39 You can use the patient...

Страница 38: ...ent Make sure that the patient does not put either his hand or any other body part between the measure head and adjusting base Note Incorrect measurements from a dirty air nozzle Before each measureme...

Страница 39: ...ety stop again see sec 10 5 2 page 21 If necessary adjust the height of the chin rest with the buttons In addition you can also adjust the height of the measure head by turning the joystick Turn it cl...

Страница 40: ...is focused on the display If necessary Adjust the height with the buttons The auto tracking function automatically looks for the trigger position Proceed as described in sec 12 3 page 37 If the auto...

Страница 41: ...is bordered by four bars Abb 12 4 Fine Adjustment Example Move the joystick to the right Turn the joystick clockwise Arrow Camera movement Joystick movementaa a If you turn the joystick to its limit t...

Страница 42: ...3 Examinated eye 2 Camera image 4 Buttons Abb 12 6 Measurement procedure 2 4 1 3 Element Function Displaying mode 1 Information about the displaying mode automatically active Camera image 2 Camera im...

Страница 43: ...e measurement Manual measurement Trigger the measurement manually by pressing the joystick button fig 11 1 page 23 Item 4 12 4 Perform a second measurement Position the patient so that his other eye i...

Страница 44: ...pted save If you turn off the Corvis ST while the progress bar is still displayed data will be lost Do not turn off the power until saving is completed e g when the progress bar is complete If you hav...

Страница 45: ...evice After each patient remove one of the paper sheets from the chin rest See also sec 15 4 page 59 Disinfect the head rest and if neccessary the chin rest after each patient sec 15 2 page 58 Attenti...

Страница 46: ...nput boxes for patient data are now enabled and the cursor jumps to the Last name field Change the entries in the individual boxes Press the Save button 12 7 2 Exporting Patient Data For example patie...

Страница 47: ...intervals In case of a loss of data you can reconstruct the data from a previously created backup with the help of this function Since data backup takes several minutes depending on the scope of the d...

Страница 48: ...the button to the right of the Backup directory box 3 In the dialog that appears select the folder to which the data should be backed up Confirm your selection with OK To back up the data press the S...

Страница 49: ...store button 1 All data in the appropriate directory are copied to the Patient Data Management software 12 7 6 Automatic backup In addition to the manually performed backup it is also possible to auto...

Страница 50: ...program the selected examination is loaded in the Corvis ST program If not you may need to load an examination first see sec 11 3 page 26 The most important controls of the Corvis ST program are desc...

Страница 51: ...you can download a new patient examination Click New Patient Quit 13 2 2 Menu item Examination Starting a new examination If an examination is not automatically initiated you can initiate a new examin...

Страница 52: ...creenshots Press the appropriate button For more information refer to the User Guide 13 2 5 Menu item Settings Change settings You can change some of the settings e g contrast and brightness to get a...

Страница 53: ...uction Manual Corvis ST G 72100 XXXX EN 1019 Rev01 47 80 13 4 View specific images of the cornea 4 You can view the images of the cornea at specific times A1 Applanation 1 HC Highest Concavity and A2...

Страница 54: ...page 51 End the measurement sec 14 4 page 52 Re use the patient and examination data sec 14 5 page 53 Buttons and Icons 14 1 Change Settings You can change the default settings for your own individual...

Страница 55: ...with the computer you don not have to enter patient data When you turn on the Corvis ST you see the Patient Data Management first Use Patient Data Management to associate examinations with a patient o...

Страница 56: ...a menu to enter a new patient The following screen appears Use the touch screen as described in sec 11 2 page 25 Enter the patient s last name and confirm with Enter Enter the first name Confirm by pr...

Страница 57: ...ve the new patient data Select Yes The patient s name appears in the list Press the Start button to switch to measure mode sec 12 1 page 31 14 2 2 Select an existing patient Choose a patient whose dat...

Страница 58: ...ltaneously Pachy version Press the Pachy button The corneal thickness along the horizontal sectional plane is measured but without the IOP 14 4 Complete measurement This button is displayed after a me...

Страница 59: ...highlighted in blue Press the Examination button The examination will be deleted 14 5 2 Re using data with the USB flash drive optional If your Corvis ST is not connected to a computer your data is st...

Страница 60: ...al Corvis ST G 72100 XXXX EN 1019 Rev01 Open the cover with the display Pull out the USB flash drive Plug the USB flash drive into your computer Now you can import the data into the Patient Data Manag...

Страница 61: ...into the Corvis ST 15 1 Cleaning Attention Risk of electric shock if the Corvis ST is not completely disconnected from the mains for these jobs Turn the Corvis ST off sec 10 5 4 page 22 Unplug the pow...

Страница 62: ...etc from the patient can get on the head and chin rest Clean these parts before examining the next patient Before and after each measurement wipe off the head and chin rest with a clean cloth for exam...

Страница 63: ...t etc Blow off dust foreign particles etc with a lens blower Afterwards carefully wipe the glass with a cotton swab which you have previously moistened with methanol or pure alcohol Note Damage due to...

Страница 64: ...nt wipes Merz Co company D 60318 Frankfurt Tel 49 69 1503 1 Fax 49 69 596 21 50 E mail merzpr merz de Turn the Corvis ST off sec 10 5 4 page 22 Disinfect the head rest and if neccessary the chin rest...

Страница 65: ...ical measurement testing every 2 years according to MPBtreibV Appendix 2 Tonometer To ensure that it functions correctly and safely we recommend the following Have the Corvis ST checked every two year...

Страница 66: ...N 1019 Rev01 15 5 Insert new printing paper roll Open the cover with the display The following screen appears You can advance and reverse the printer paper by pressing the buttons Printer Feed and Fee...

Страница 67: ...roller and insert the printer roller into the holder 4 Slide the white paper through the white slot from below Make sure the paper 1 is correctly aligned Press the button Printer Feed so that the prin...

Страница 68: ...rly and lock the transport safety device 16 1 Removal Switch off the Corvis ST with the On Off Switch 3 Unplug the power cord Unplug the power cord 2 of the device If necessary disconnect the USB cabl...

Страница 69: ...the cover with the display see fig 16 1 page 62 16 2 Transport and Storage 16 3 Information on Transport and Storage Storage conditions Transport conditions 1 Opening of the transport safety device 2...

Страница 70: ...torage conditions Avoid placing near radiators and moisture Check the Corvis ST for damage every time it has been transported Wait approx 3 4 hours after transport before operating the Corvis ST Extre...

Страница 71: ...you are unable to correct by following the instructions below label the device as out of order and contact our service department or an authorized dealer Fault Possible cause Help No function when th...

Страница 72: ...ral terms and conditions of business and delivery apply as per the date of purchase 19 1 Liability for proper function or damages OCULUS will only accept responsibility for the safety reliability and...

Страница 73: ...ing range 8 5 mm horizontally Pachymeter measuring range 300 to 1200 m Measuring points 576 per image Display resolution 576 x 200 pixels Light source blue LED 470 nm UV free Type of protection agains...

Страница 74: ...00 1060 hPa Power supply 15 V DC 6 A Max power consumption 26 W Mean Well 05150285 Mains connection 100 240 V Frequency 50 60 Hz Max power consumption max 90 W Output 15 V DC Recommended computer spec...

Страница 75: ...ckness from the measured value As the table is imported a linear relationship will be adopted for the va riates It is sufficient to define a start value and an end value with the as sociated correctio...

Страница 76: ...esult in increased emissions or decreased immunity of the other device Do not use the accessories transducers and cables specified by OCULUS with devices other then the Corvis ST To be in compliance w...

Страница 77: ...electromagnetic environment specified below The user of the Corvis ST should ensure that it is being used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emis...

Страница 78: ...pe tition frequency 1 kV for input output lines 2 kV 1 kV Mains power quality should be that of a typical commercial or hospital environment Surge IEC 6100 4 5 1 kV kine s to line s 2 kV line s to ear...

Страница 79: ...ctromagnetic site survey a should be less than the compliance level in each frequency range b Interface may occur in the vicinity of equipment marked with the following symbol Note 1 Note 2 At 80 Hz a...

Страница 80: ...ted maximum output pow er of transmitter W Separation distance according to frequency of transmitter m 150 KHz to 80 Mhz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 2...

Страница 81: ...Appendix Instruction Manual Corvis ST G 72100 XXXX EN 1019 Rev01 75 80 21 4 Description of the Connection Corvis ST Computer PC Laptop Power supply adapter 05150285 Mains connection Cable USB Isolato...

Страница 82: ...on Manual Corvis ST G 72100 XXXX EN 1019 Rev01 21 5 Data sheet Power Supply Adapter 05150285 0 12 3 4 5 6 7 6 8 6 3 1 9 5 5 6 2 0 A B 6 3 C3 0 A 35 C 35 0 A D 6 6 0 2 0 126 0 A E C3 6 0 0 3 10 A 4 5 6...

Страница 83: ...0 0 2 0 0 2 0 32 0 3 2 0 3 1 0 1 2 3 0 1 2 4 5 0 6 7 8 63 9 4 97 3 4 4 4 42 4 8 3 4 4 1 4 A 2 B B 65B B 7 0 C 2 0 D E C 1 F F 2 G 2 C 1 F F 2 G 2 0 3 6 6 1 4 79 0 4 IL IL IL IL H 4 2 4 4 2 4 1 H4 H 4...

Страница 84: ...Appendix 78 80 Instruction Manual Corvis ST G 72100 XXXX EN 1019 Rev01 56 7 8 9 9 9 9 5 9 9 9 5 5 5 57 2 1 HHH 4H H F4 2 1 42 4 1 1 4 6 3 LE 57 I3 5I 42 2 A 989 76 65 5 4 4 N E 3 E 0 G 4 0 ILEI3 8 2 L...

Страница 85: ...21 Appendix Instruction Manual Corvis ST G 72100 XXXX EN 1019 Rev01 79 80...

Страница 86: ...bH M nchholzh user Stra e 29 35582 Wetzlar GERMANY Tel 49 641 2005 0 Fax 49 641 2005 255 E Mail sales oculus de www oculus de USA OCULUS Inc 17721 59th Avenue NE Arlington WA 98223 Tel 1 425 670 9977...

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