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24  Annex

84 / 92

Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)

24.2 Guidance and Manufacturer’

s

 Declaration - Electromagnetic 

Emmi

sss

ion

s

 and Immunity for the Myopia Ma

s

ter® 

Guidance and manufacturer´s declaration electromagentic emmissions
IEC 60601-1-2: 2015, based to table 1

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

Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1

The Myopia Master® uses RF energy only for its internal 
function. Therefore, its RF emissions are very low and are 
not likely 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

Summary of Contents for 68100

Page 1: ...OCULUS Myopia Master INSTRUCTION MANUAL ...

Page 2: ...afety instruc tions This instruction manual describes the measuring procedure how to manage the patient data and the settings in the Myopia Master program Due to ongoing development the diagrams shown may depict minor changes to the actual device delivered If you have any queries or would like additional information about your device do not hesitate to call or send us an email or a fax Our service...

Page 3: ...ervice Purposes 19 9 Operation 20 9 1 Switching On 20 9 2 Switching Off 20 9 3 Daily Operation 20 10 Functions of the Control Pad 21 10 1 Touch Screen 22 10 1 1 Function Keys on the Touch Screen 22 11 Preparing Patients Data 23 11 1 Entering new Patients touch screen 23 11 2 Entering new Patients touch screen deactivated 24 11 2 1 Selecting existing Patients 25 11 2 2 Rename a Patient 26 11 2 3 De...

Page 4: ...2 15 2 Settings 2 54 15 3 Settings 3 56 15 4 Settings 4 57 15 5 Settings 5 59 16 Display Options 60 17 Calculated correction of tonometrically measured IOP 62 17 1 IOP correction based on central corneal thickness 62 17 2 Post LASIK IOP correction 63 17 3 IOP correction based on central corneal thickness and corneal curvature 64 17 4 Performing IOP correction with the Myopia Master 65 17 4 1 Save ...

Page 5: ...sumption of Liability for Functions and Damage 76 22 3 Manufacturer and Service Address 77 23 Technical Data 78 24 Annex 82 24 1 Electromagnetic Compatibility 82 24 2 Guidance and Manufacturer s Declaration Electromagnetic Emmisssions and Immunity for the Myopia Master 84 24 3 Description of the Connection 88 24 4 Data Sheet GSM60B15 P1J 05150725 89 ...

Page 6: ...Table of Contents v v Instruction Manual Myopia Master G 68100 EN Rev04 0820 ...

Page 7: ...vanced with chin and head rest with Scheimpflug camera fully equipped Myopia Master Advanced without chin and head rest with Scheimpflug camera Myopia Master Basic with chin and head rest without Scheimpflug camera Myopia Master Basic without chin and head rest without Scheimpflug camera 68100 68110 68120 68130 Eye shield black 076500001028 Dust protection cover 026010005001 Paper for chin support...

Page 8: ...g Manufacturer Protection class Keep dry Date of manufacturing IP XX Type of protection This way up Conformité européenne Article number Fragile Follow instruction for use Serial number Limit of temperature for transport Disposal in household trash is prohibited Caution Limit of temperature for storage Applied part Type B Do not re use Limit of humidity Medical device Limit of air pressure Example...

Page 9: ...h the Patient Data Management system and all safety related instructions for use of the Myopia Master This manual describes the basic operation and the different features of the Myopia Master versions Software Installation The introduction to the Software Installation describes how to install the Myopia Master software and the associated drivers Additional Symbols and abbreviations on power adapte...

Page 10: ... accident prevention 4 1 1 Pictograms Used in this Manual Warning Identifies a potentially dangerous situation which may cause irreversible injury Caution Identifies a potentially dangerous situation which may cause minor injury or damage to property Note Denotes situations which could result in incorrect findings denotes user instructions and useful or other important information Identifies impor...

Page 11: ...efer to the notes in sec 20 page 74 Instructions for Setup and Connection Do not use or store the Myopia Master in rooms that are humid Keep the Myopia Master away from water that may drip splash or spray on it and make sure that no liquids can get into the Myopia Master Do not place any containers holding liquids in the vicinity of the Myopia Master Only operate the Myopia Master in rooms used fo...

Page 12: ...ot use the Myopia Master with wireless technology for example with wireless USB Data responsibility The device itself is not designed to connect with the internet but only to a PC It does not require the internet to function Do not connect with the internet while using the device It is consid ered misuse If you elect to connect the PC to the internet for other purposes you are responsible for ensu...

Page 13: ...l devices such as for example a printer those devices become part of the ME system Make sure that all devices of the ME system meet the requirements of IEC 60601 1 IEC 60950 1 or 62368 1 Note that an output voltage of maximum 5 5 V DC is supplied by a device connected via USB Instructions for Operation Never operate a damaged Myopia Master Only operate the Myopia Master with the original accessori...

Page 14: ...ly into the laser beam To ensure satisfactory and reliable operation we recommend that you have the Myopia Master checked every two years by our service department or an authorized dealer If an error occurs which you cannot correct label the Myopia Master as being out of order and contact our service department Instructions for Disassembly and Disposal When disconnecting electrical connections pul...

Page 15: ...lies with the requirements of IEC 60601 1 2005 section 16 Do not place the multiple socket outlet on the floor Do not use more than one multiple socket outlet Plug only the Myopia Master and the computer that is being used with the unit if applicable into the multiple socket outlet If you are using a multiple socket outlet it has to be supplied with a isolation transformer If you are using a new c...

Page 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 Adequate time setting should consider duration of examination number of patients time between examinations use of other devices in the examination room several users etc Lock the computer if you are leaving...

Page 17: ...tometer measures the central radii of the cornea The integrated ophthalmic refractometer measures the refractive power of the eye The integrated interferometer measures the axial length of the eye The Myopia Master can be used by physicians opticians and optometrists to support myopia management The Myopia Master may only be used for the purpose described in this instruction manual Heed the safety...

Page 18: ...an 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 Transport the Myopia Master professionally Store the Myopia Master according to the storage conditions Avoid placing near radiators and moisture Note Keep the packing material You can then ship or transpo...

Page 19: ...ual Myopia Master G 68100 EN Rev04 0820 13 92 7 Device Description 7 1 Overview of Device Components 1 Gauge head 4 Control Wheel 7 Function keys 2 Printout slot 5 Sliding plate 3 Display 6 Joystick Fig 7 1 Device components 7 1 6 2 3 4 5 ...

Page 20: ...N Rev04 0820 8 Head rest 11 On Off Switch 14 USB port 9 Marking for the eye height 12 Control LED 15 Chin rest 10 Pachycam camera glass cover 13 Mains connection 16 Measuring ocular Patient eyepiece with Keratometer ring Fig 7 2 Device components 14 13 12 11 8 16 9 10 15 ...

Page 21: ...ows the central radii of the cornea to be determined Pachymeter optional The pachymetry principle uses Scheimpflug images of the cornea which are analysed by a built in computer 600 Absolute data points are evaluated with the Scheimpflug images The measuring range lies on a 4 mm slit through the apex The slit light illuminates a sectional plane from the front surface of the cornea to the back surf...

Page 22: ...7 Device Description 16 92 Instruction Manual Myopia Master G 68100 EN Rev04 0820 Applied parts 1 Head rest 2 Chin rest Fig 7 3 Applied parts 1 2 ...

Page 23: ...ccess That way you can easily disconnect it from the power supply for any repairs or maintenance work Place the Myopia Master on a level surface Place the device so that direct light cannot affect the measurement Make sure the examination is free from light reflections To achieve this darken the examination room 8 1 Electrical Connection Caution Electrical safety hazard Do not use the Myopia Maste...

Page 24: ...g used with the unit if applicable into the multiple socket outlet Connect the device to the power supply using the power cable provided see sec 24 1 page 82 Note Risk of equipment damage due to incorrect connection If you do not connect the Myopia Master properly and the connection is live the unit can be damaged within a short period of time Do not use excessive force when connecting the electri...

Page 25: ...ection of additional items to the IT network disconnecting items from the IT network update of equipment connected to the IT network upgrade of equipment connected to the IT network If your computer is already integrated into an IT network the following information will apply Caution Risk of incorrect measurements equipment damage due to unauthorized personal Ensure that only an expert authorized ...

Page 26: ... shock if the Myopia Master is not completely disconnected from the mains for transport cleaning maintenance disinfection and repair Turn the Myopia Master off Pull the power plug before cleaning When disconnecting electrical connections pull on the respective plug and not on the cable itself 9 3 Daily Operation If you move the Myopia Master to another location you must position the Myopia Master ...

Page 27: ...Activates the selected parameter Turn the knob to the left or to the right The selected parameter is highlighted in blue Press the knob downwards The selected parameter is activated or deactivated Joystick 4 Adjusts the height distance and alignment to the left and to the right Move the joystick up down and to either side turn it Fine Adjustment page 30 Joystick button 1 Manually triggers the meas...

Page 28: ...page 54 In addition to the function keys you can now also use the buttons on the screen for example you can enable the respective button by gently pressing it on the touch screen 10 1 1 Function Keys on the Touch Screen Use these function keys to work with the patient data management system Button Function Button Function Change keyboard Enter Delete character Return to upper line Escape ...

Page 29: ...ore you conduct the measurement 11 1 Entering new Patients touch screen To input a new patient press the button Patient in the patient data menu The following screen appears Use the touch screen as described in sec 10 1 page 22 Enter the patient s last name and first name and confirm In the D o Birth field the keyboard changes to a numeric keypad Enter the date of birth and confirm A confirmation ...

Page 30: ...asuring mode 11 2 Entering new Patients touch screen deactivated To input a new patient press the button Patient in the patient data menu The following screen appears Select each individual letter by turning the control wheel accordingly Confirm each letter by pressing the control wheel Enter the patient s last name Fig 11 2 Patient list Fig 11 3 Touch screen deactivated ...

Page 31: ...tivating the symbols and accordingly Enter the patient s first name and date of birth in the same manner After you have entered the date of birth confirm by pressing Enter You will now be asked whether you want to save the new patient data Select the option Yes The name of the patient appears in the list Press the Measure button to switch to measuring mode 11 2 1 Selecting existing Patients Select...

Page 32: ...t or an Examination If you want to delete a patient or an examination Select the patient in question Press the button To delete a patient Select with the control wheel the button Patient Press the control wheel The data of the patient is deleted To delete an examination Select with the control wheel the button Examination Select the examination that is to be deleted The line for the selected exami...

Page 33: ...printed out together these are also automatically saved together R L and in turn they are also reloaded together If the measurements were not printed out together the examinations are listed individually right left The measurements must then be loaded separately one after the other Generally two measurements can only be displayed together when they belong to a single measuring operation Fig 11 5 L...

Page 34: ...yopia Master A measuring procedure consists of the following steps Selecting a measuring mode Preparing a measurement Performing a measurement Saving data Completing the measurement 12 1 Selecting a Measurement Mode The measuring procedure depends on the selected mode Myopia more information sec 12 3 page 32 AR K more information sec 12 4 page 37 AXL axial length more information sec 12 6 page 41 ...

Page 35: ... disinfected the head rest has been cleaned and disinfected after each ex amination sec 18 page 67 Do not touch the device and the patient simultaneously Ask the patient to place his or her head on the chin and head rest The eye height marking between the chin rest and the headrest should be located roughly at the centerline of the patient s eye Adjust the chin rest In addition you can also adjust...

Page 36: ... in the adjustment window To do this move or turn the joystick in the specified directions Example Turn the joystick counter clockwise When the position has been reached accurately enough a cross appears in the center of the ring that is bordered by four bars The Myopia Master will automatically begin measuring Alternately you can start the measuring procedure manually Manual measurement Initiate ...

Page 37: ...urthermore Eye tracking and Auto release are standardly activated At the bottom of the screen you can see whether measurements have already been taken and saved for the respective eye If the symbol appears at the bottom right or left The right or the left eye has already been measured The respective measurement can be found in the memory Select the appropriate eye to load the examination that was ...

Page 38: ...ps belong to a complete myopia measurement central cornea radii K objective refraction ARK axial length AXL 12 3 1 Myopia Overview Display The measured values of the myopia examination are displayed in the overview display Fig 12 4 Measuring mode 1 Patient and examination data 3 AXL images 2 Refraction values 4 Pachymeter values Fig 12 5 Myopia overview display 4 3 2 1 ...

Page 39: ...of axial length or the refraction The graph displays the axial length measurement values in accordance to the age of the patient The grey lines reflect the percentile curves You can set the risk of the Myopia in the colour bar manually Press the button to change to the risk factors display 1 Patient and examination data 4 Risk assesment 2 Colour for examined eye 5 Measurement values of the patient...

Page 40: ...of myopic parents gender time outdoors per week near work additional to school per day Answer the respective question by adjusting the slider to the corresponding value You can therefore use the control wheel and confirm by pushing Alternatively use the arrow button to the right for increasing or to the left for decreasing the values Press the button to change to the AR K display 1 Patient and exa...

Page 41: ...has a yellow background 7 6 the measuring results are critical repeat the measurement if necessary If the field has a red background 6 repeat the measurement Keratometer Values 3 K1 K2 Horizontal vertical radius of curvature in the center blue flat meridian red steep meridian Pupil Size of pupil Astig Astigmatism of cornea in the center WTW white to white Cornea diameter or iris diameter Q value I...

Page 42: ...rming the measurement the following display appears The axial length values for one or both eyes are shown in the table 2 The corresponding signal to noise ration SNR 3 is listed The axial length with the highest SNR 4 is shown in a single line Furthermore the SNR is shown in a graph 5 12 3 5 Ending the measurements Print and or save the data sec 12 8 page 44 1 Patient and examination data 4 Highe...

Page 43: ...an be measured independently Select the mode AR K The measurement AR K is executed for both eyes The following screen appears Print and or save the data sec 12 8 page 44 Fig 12 10 Measuring mode AR K 1 Patient and examination data 3 Keratometer 2 Refraction values 4 Camera images Fig 12 11 AR K display if both eyes are measured 4 3 2 1 ...

Page 44: ...measurement if necessary If the field has a red background 6 repeat the measurement Keratometer Values 3 K1 K2 Horizontal vertical radius of curvature in the center blue flat meridian red steep meridian Pupil Size of pupil Astig Astigmatism of cornea in the center WTW white to white Cornea diameter or iris diameter Q value If the field has a white background 9 8 the measuring results are good If t...

Page 45: ...tionally Select the mode P AR K If the measurement mode was executed the following overview screen appears for the examination of the right eye Print and or save the data sec 12 8 page 44 Fig 12 12 Measuring mode P AR K 1 Patient and examination data 4 Scheimpflug image 2 Camera image 5 Keratometer values 3 Pachymeter values 6 Refraction values Fig 12 13 P AR K display if both eyes are measured 4 ...

Page 46: ...ted lines Keratometer Values 5 Rh Rv Horizontal vertical radius of curvature in the center blue flat meridian red steep meridian Pupil Size of pupil Astig Astigmatism of cornea in the center WTW white to white Cornea diameter or iris diameter Q value If the field has a white background 9 8 the measuring results are good If the field has a yellow background 7 6 the measuring results are critical re...

Page 47: ...n be measured additionally Select the PARK AXL mode If the measurement mode were executed the following overview screen appears for the examination of the right eye Print and or save the data sec 12 8 page 44 Fig 12 14 Measuring mode PARK AXL 1 Patient and examination data 3 AXL images and values 2 Refraction values 4 Keratometer values Fig 12 15 Overview AXL with images 4 3 2 1 ...

Page 48: ...nd 6 repeat the measurement AXL values 3 The axial length values for one or both eyes are shown The corresponding signal to noise ration SNR is listed Keratometer Values 6 K1 K2 Horizontal vertical radius of curvature in the center blue flat meridian red steep meridian Pupil Size of pupil Astig Astigmatism of cornea in the center WTW white to white Cornea diameter or iris diameter Q value If the f...

Page 49: ...n appears for the examination of the right eye Print and or save the data sec 12 8 page 44 AXL Axial length measurement value The final result of the axial length is calculated just only from all feasible SNR peaks It s display in a single line SNR Signal to noise Ratio of the axial length value Fig 12 16 Measuring mode AXL 1 Patient and examination data 3 SNR values 2 AXL values 4 Graph axial len...

Page 50: ...cedure 44 92 Instruction Manual Myopia Master G 68100 EN Rev04 0820 12 8 Printing and Saving Examinations After performing the measurement of the myopia the following display appears Fig 12 18 Display with print button ...

Page 51: ...nted out each measurement is automatically temporarily saved to the exam nr memory Saving data by Exam no memory page 46 The different measuring processes are outlined briefly in the chapter Chronology of Different Measuring Processes sec 13 page 47 Save the examination retroactively if you did not set up a new patient sec 13 2 page 48 prior to executing the measuring process 12 8 2 Saving an exam...

Page 52: ...ata management If you want to retrieve a measurement again later you will find the examination in the exam nr memory under the exam number that was assigned to it and can thus reload it You can retrieve the measurement at a later time using the number 15 12 9 Complete measurement This button is displayed after a measurement has been conducted Press this button to save the examination data to the p...

Page 53: ...r a new patient after performing the measuring operation sec 13 2 page 48 3 You perform a measuring operation without saving the examination under a patient s name sec 13 3 page 49 13 1 Enter Patient Measure Press the button Patient in the patient data management Create a new patient as described in sec 11 1 page 23 The newly entered patient appears in the list of patients and is highlighted in bl...

Page 54: ...uring operation directly The following screen appears Select Start a new measurement anyway Conduct the measurement sec 12 page 28 When the measuring operation has been completed the overview screen appears fig 12 5 page 32 In the overview screen press the button Save to Patient The Patient List display opens Fig 13 1 Start a new measurement Fig 13 2 Patient list ...

Page 55: ... patient and save the conducted measurement un der that patient s name Exit the character box for entering the patient s data Press the ESC button on the keyboard Select the patient and confirm by pressing the control wheel Alternatively use the button Save to Patient The examination data are saved under the selected patient s name The saved examinations can be viewed again at any time sec 12 8 pa...

Page 56: ...rformed easily and quickly using the reference tool Required materials reference tool provided cleaning agent see sec 18 page 67 Measuring with the reference tool Prerequisite the Myopia Master must be turned on for at least 15 minutes For the reference measurement proceed as follows Remove the cover cap Thoroughly clean the reference tool before saving reference values with the cleaning agent Pla...

Page 57: ...14 Reference Measurement Instruction Manual Myopia Master G 68100 EN Rev04 0820 51 92 The system is now ready for operation Fig 14 2 Example Result on reference tool ...

Page 58: ...hymetry Refraction Keratometry PARK AXL Pachymetry Refraction Keratometry axial length AXL axial length measurement You also activate or deactivate the functions Eye tracking and Auto release here Eye tracking Automatic adjustment of the measuring head in y direction height Auto release Automatic triggering of the measuring operation AR display In Standard mode the calculated mean refraction is di...

Page 59: ...as a radius of curvature in mm or as the curvature equivalent in diopters Step mode Select the increments in which the diopters of the refraction values are to be rounded Vertex distance Set the cornea vertex distance to which the displayed refraction values are to relate Measure details Show AR Activates the refaction display fig 12 8 page 35 Show AXL Activates the axial length display fig 12 9 p...

Page 60: ...time and the date by turning and pressing the rotary knob Display You can adjust the brightness of the display here Startscreen When the option Measure mode is active you start with the measuring operation directly after switch on When the option Pat list is active you start with the patient data management directly after switch on Language Select the on screen language Fig 15 2 Settings 2 ...

Page 61: ...e or deactivate the touch screen function in the Use Touch checkbox In the Kbd Layout field you select the keyboard layout QWERTZ stands for the German keyboard layout QWERTY stands for the American keyboard layout In the field Kbd Mode you select the contact control of the touch screen In Key Down mode the characters are input as soon as you make contact with the touch screen In Key Up mode the c...

Page 62: ...e supported by Myopia Master Status December 2019 Fig 15 5 Parameters for phoropters supported by Myopia Master In the Device ID field you identify the Myopia Master that is connected to a phoropter Assign a Device ID e g when multiple devices are connected to a phoropter Fig 15 4 Settings 3 Manufacturer Phoropter Baud rate Parity Stop bits Phrpt protocol Nidek RT 5100 RT 2100 RT 1200S 9600 uneven...

Page 63: ... Rev04 0820 57 92 15 4 Settings 4 On the Settings 4 screen you can individually configure the printout Print AR Details Print Keratometer Details Fig 15 6 Settings 4 Print AR Details activated Print AR Details activated Print single line K Values activated ...

Page 64: ...printed out Footer in the printout If you want to include your business or office name on the printout Enter the appropriate information in the lines provided for that purpose and activate the checkboxes in front of each line OD OS According to the settings R right and L left is printed out or OD oculus dexter and OS oculus sinister Print AXL Details activated SNR graph activated ...

Page 65: ...15 Settings Instruction Manual Myopia Master G 68100 EN Rev04 0820 59 92 15 5 Settings 5 Fig 15 7 Settings 5 ...

Page 66: ...lay Options In addition to the overview of the measuring results for an eye fig 12 5 page 32 you can also select other display settings To access the available press the Display button repeatedly Examination results for both eyes Refraction and Keratometry Fig 16 1 Standard Right and Left ...

Page 67: ...gression field on the touch screen The device shows you the exact location of the cornea at the selected spot You can move the pointer to the left or to the right on the touch screen with the rotary knob 1 Scheimpflug image 2 Corneal thickness range Measuring range horizontal 4mm section through the apex Fig 16 2 Overview Pachymetry 2 1 ...

Page 68: ...Master This can be done using any of the various correction formulas available for this purpose These formulas are described further below and some are illustrated with diagrams 17 1 IOP correction based on central corneal thickness The correction formulas of Shah and Ehlers as well as the Dresden correction formula are estimates of the true IOP based on measured IOP and corneal thickness Correcti...

Page 69: ...ven by the three formula Fig 17 1 Progression diagram Each formula gives a different way of calculating the IOP correction summand as follows Ehlers IOP change 0 071 545 µm corneal thicknessmeasured Shah IOP change 0 050 550 µm corneal thicknessmeasured Dresden IOP change 0 040 550 µm corneal thicknessmeasured 17 2 Post LASIK IOP correction The Kohlhaas formula estimates the true IOP concerning po...

Page 70: ...ure in calculating the corrected IOP This yields a factor with which the true IOP can be estimated from the measured IOP In contrast to those quoted above this formula includes the measured IOP as a parameter in calculating the corrected IOP It thus involves a larger number of input variables which according to its originators permits a more precise estimate of IOP regardless of corneal thickness ...

Page 71: ...ement sec 12 page 28 The results screen appears for the examined eye The IOP change value is displayed in the IOP change field 1 Depending on the formula which is used the IOP change value is either a summand or a factor Turn the control wheel until the IOP Chg field is activated Press the control wheel The field for entering the tonometrically measured IOP value appears 1 IOP change field Fig 17 ...

Page 72: ...example myopic post LASIK you can select it on the screen of the IOP correction Enter the IOP value by pressing and turning the control wheel Confirm the IOP value with the button Save The corrected IOP value appears 17 4 1 Save the IOP data Store the patient data of the examination fig 12 5 page 32 Printout the data On the printout you can find the following IOP values IOP Table IOP Change IOP Me...

Page 73: ...yopia Master is not completely disconnected from the mains for the cleaning Turn the Myopia Master off sec 9 2 page 20 Pull the power plug before cleaning When disconnecting electrical connections pull on the respective plug and not on the cable itself Do not clean the Myopia Master with aggressive chlorinated abrasive or harsh cleansers Required materials Cleaner for plastic surfaces with anti st...

Page 74: ...ng the head rest and chin rest During the measuring process sweat cosmetics etc from the patient can get on the head and chin rest Clean these parts before examining the next patient Use a lint free damp cloth Do not wipe more difficult spots repeatedly with a dry cloth Instead moisten it with rubbing alcohol 1 Head rest 3 Chin rest 2 Protective glass covers Abb 18 1 Cleaning 2 1 3 ...

Page 75: ...tatic cleaning agent Make sure that no liquid gets into any of the openings of the Myopia Master Wipe off any residue from painted surfaces with the mixture for painted surfaces Cleaning the Touch Screen Clean the touch screen using a dry lint free cloth 18 2 Disinfection Caution Risk of electric shock if the Myopia Master is not completely disconnected from the mains for the disinfection Turn the...

Page 76: ...surface of the device if it is sprayed directly on it Spray the disinfectant solution onto a cleaning cloth do not spray it directly on the device 18 3 Maintenance The Myopia Master is designed so that no special maintenance is necessary For safety reasons we recommend that the illumination and electrical values be checked every two years Please contact OCULUS Service for this Note Incorrect exami...

Page 77: ...rectly into the laser beam 18 4 Attaching Paper to the Chin Rest If you want to attach new chin rest paper follow these instructions Pull the two pins 1 out of the chin rest Put the chin rest paper 2 in such a way that the holes of the paper and the chin rest 3 are aligned Insert the two pins 1 in the chin rest 18 5 Inserting a New Roll of Printer Paper Caution Risk of electric shock if the Myopia...

Page 78: ...r paper Remove the feed roller from the holder and pull out the middle metal pin Push the metal pin into a new feed roller and insert the feed roller into the holder Slide the paper from below through the paper guide Make sure the paper 1 is correctly aligned Press the button Printer Feed so that the printer paper is pulled through the opening Close the opened display unit Fig 18 3 Display for adv...

Page 79: ...he device cause by improper operation Never plug in or unplug the cable or plug while the PC and or the Myopia Master are switched on This could destroy the individual units Error Possible Cause Remedy No function when the On Off Switch is pressed The Myopia Master is not connected to the power supply Power failure or power outlet is not active Plug the power cable into the power outlet or into th...

Page 80: ...iginal packaging 20 2 Transport and Storage Information This device cannot withstand the temperature conditions for storage and transport specified in ISO 15004 1 Storage Transport 20 3 Transport and Storage Caution Risk of equipment damage due to incorrect shipment or from improper storage Avoid shocks vibrations and contamination Avoid high temperatures and humidity Transport the Myopia Master c...

Page 81: ...lacing near heaters and moisture 21 Disposal In accordance with Directive 2012 19 EC of the European Parliament and the Council and in accordance with German law governing the marketing return and environmentally compatible disposal of used electrical and electronic devices such appliances must be recycled and may not be discarded as household waste Dispose the Myopia Master in a compliant manner ...

Page 82: ...ess and Shipping Terms on the date of purchase apply 22 2 Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety reliability and serviceability of the Myopia Master if the unit is used in compliance with the following terms Only use the equipment in conformance with this instruction manual There are no parts either on or inside the Myopia Master that...

Page 83: ...ur Service Department or from our authorized representatives Manufacturer and Service address OCULUS Optikgeräte GmbH Münchholzhäuser Straße 29 35582 Wetzlar GERMANY Tel 49 641 2005 0 Fax 49 641 2005 295 E Mail export oculus de www oculus de USA OCULUS Inc 17721 59th Avenue NE Arlington WA 98223 Tel 1 425 670 9977 Fax 1 425 670 0742 E mail sales oculususa com www oculususa com ...

Page 84: ...0 1 steps Measuring range pupil diameter 1 up to 8 mm in 0 1 steps Auto Position Positioning the height automatically y direction Auto Release Automatic release Measuring range 200 1200 µm Measured points 600 Measuring time approx 1 s Light source blue LED 455 nm UV free Corneal vertex distance VD 0 10 5 12 13 75 15 16 5 mm Sphere 20 22 D VD 12 mm increments 0 01 012 0 25 D Cylinder 10 D VD 12 mm ...

Page 85: ...h 14 40 mm Protection against electric shock Protection class 2 Insulation of applied parts Type Type B Protection against foreign objects contact and water IP20 Temperature 10 35 C Humidity 30 90 Air pressure 800 1060 hPa Ambient temperature 10 55 C Relative humidity 10 95 Air pressure 700 1060 hPa Ambient temperature range 40 70 C Relative humidity range including condensation 10 95 Air pressure...

Page 86: ...3 42 EEC Annex II without section 4 Netzteil GSM60B15 P1J 05150725 AC input 80 264 VAC Frequency 47 63 Hz DC output 15 V DC 4 A 60 W max Fuses Integrated overcurrent shut off Dimensions height x width x depth 266 x 538 x 493 523 mm Weight 12 kg Voltage 15 V DC 4 A Max power consumption 25 W Printer thermal printer Display TFT LCD 5 7 touch screen Interface s USB Contraindications None Noted Lifecy...

Page 87: ...100 EN Rev04 0820 81 92 Classification according to DIN EN 60825 1 2015 and DIN EN 60825 1 2001 The unit contains a Class 1 laser Maximum output of the laser radiation 0 7 mW Single pulse duration Pulse count per examination 510 760 ms 6x Wavelength 880 nm ...

Page 88: ...duced in the consideration of permissible deterioration during or caused by t7he EMC testing without affecting the essential perfor mance criteria Caution The use of accessories transducers and cables not specified by OCULUS for example as replacement parts may result in increased emissions or decreased immunity of the Myopia Master Use only the original accessories transducers and cables specifie...

Page 89: ...a fully equipped 68110 Myopia Master Advanced without chin and head rest with Scheimpflug camera 68120 Myopia Master Basic with chin and head rest without Scheimpflug camera 68130 Myopia Master Basic without chin and head rest without Scheimpflug camera 5200905 Cable EU 1 8 m 5200915 Cable GB optional 1 8 m 5200910 Cable USA optional 1 8 m 5200920 Cable AU optional 1 8 m 5200925 Cable Argentinia o...

Page 90: ... electromagnetic environment specified below The user of the Myopia Master should ensure that it is being used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Myopia Master uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equ...

Page 91: ... 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 61000 4 5 1 kV kine s to line s 2 kV line s to earth 1 kV differential mode 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input ...

Page 92: ...etic site survey a should be less than the compliance level in each frequency range b Interferences may occur in the vicinity of equip ment marked with the following symbol Note 1 Note 2 At 80 Hz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Fi...

Page 93: ...ent Rated 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 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 80 3 80 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estima...

Page 94: ...ex 88 92 Instruction Manual Myopia Master G 68100 EN Rev04 0820 24 3 Description of the Connection Y cable Computer PC Laptop Power supply adapter 05150725 Mains connection 05200600 Myopia Master USB isolator ...

Page 95: ...anual Myopia Master G 68100 EN Rev04 0820 89 92 24 4 Data Sheet GSM60B15 P1J 05150725 0 1 2 3 0 3 1 1 4 1 52 1 67 28 9 7 1 3 1 1 9 52 5 7 1 9 2 6 1 3 A 2 1 B 67 28 C D 1 1 1 1 3 7 8 3 E 60 1 1 1 1 2 1 3 A 7FD 7 92 2 977 C 1 ...

Page 96: ...4 3 2 34 02 34 0 2 34 7 2 8 B 3 1 D 1 G 2 8 G BE 7 H 7 G 0 0 D 2 3 1 1 1 0 1 2 3 455 6 78 9 9 9 9 9 9 9 9 5 5 5 5 5 5 5 5 1 2 6 9 9 7 9 7 9 5 1 6 9 4 7 2 2 4 5 2 2 5 2 2 5 5 A5 4 B 5 A5 4 A 5 5 5 9 7 B C 7 B 1 6 78 5 D E F G H H 1CH H76 B I 5 B 5 J I A 2 3 3 K L L L L 2 L 5 5 J L 5 2 I A 2 3 3 K L 1 6 L ...

Page 97: ...24 Annex Instruction Manual Myopia Master G 68100 EN Rev04 0820 91 92 67 8 9 17A FAL C6 6 6 L J 4 A C A G A 87 76 6 4 0 A M 4 7 B K 2 L 6 6 68 4 455 5 3 5 5 ...

Page 98: ...hholzhäuser Straße 29 35582 Wetzlar GERMANY Tel 49 641 2005 0 Fax 49 641 2005 295 E Mail export oculus de www oculus de USA OCULUS Inc 17721 59th Avenue NE Arlington WA 98223 Tel 1 425 670 9977 Fax 1 425 670 0742 Email sales oculususa com http www oculususa com G 68100 EN LOT ...

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