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22 Annex

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Instruction Manual Myopia Master® (G/68100/EN Rev08)

22

Annex

22.1

Electromagnetic Compatibility

Medical electrical equipment is subject to special precautionary
requirements with respect to EMC, and must be installed and operated
according to the EMC-Instructions contained in the accompanying
paperwork.

No special measures need be observed in respect of OCULUS devices and
systems.

Portable and mobile RF-communications devices can interfere with
electrically operated medical devices.

Produced in the consideration of permissible deterioration during or
caused by t7he EMC testing without affecting the essential
performance 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 specified by
OCULUS.

The use of accessories, transducers and cables specified by OCULUS with
devices other then the Myopia Master® may result 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 Myopia Master®.

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Содержание Myopia Master Basic

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

Страница 2: ......

Страница 3: ...operating the device In particular pay attention to the safety instructions This instruction manual describes the measuring procedure how to manage the patient data and the settings in the Myopia Mas...

Страница 4: ...tart Up 19 8 3 Adjustments after an in house transport 20 8 3 1 Device set up 20 8 3 2 Unlock transport safety device 20 8 4 Electrical Connection 22 9 Operation 24 9 1 Switching On 24 9 2 Switching O...

Страница 5: ...s 5 58 16 Cleaning Disinfection and Maintenance 59 16 1 Cleaning 59 16 2 Disinfection 61 16 3 Maintenance 62 16 4 Attaching Paper to the Chin Rest 63 16 5 Inserting a New Roll of Printer Paper 64 17 T...

Страница 6: ...t chin and head rest not available incl auto refractometer keratometry axial length pachymetry Myopia Master Basic with chin and head rest incl auto refractometer keratometry axial length Myopia Maste...

Страница 7: ...manufacturing IP XX Type of protection This way up Conformit europ enne Article number Fragile Follow instruction for use Serial number Limit of temperature for transport Disposal in household trash i...

Страница 8: ...ily fixed markings on the device Additional Symbols and abbreviations on power adapter Indoor use only Testing center Aquivalent to RoHS Conform to US and Canadian standards Nemkos symbol Chinese Stan...

Страница 9: ...a Master Attention All safety related instructions for use of the Myopia Master are given in the Instruction Manual for the unit It is imperative that you read and understand the whole Instruction Man...

Страница 10: ...s 4 1 1 Pictogram Used in this Manual Attention Identifies a potentially dangerous situation which may cause minor injury or damage to property Note Denotes situations which could result in incorrect...

Страница 11: ...he area designated for carrying out examinations For this reason the device may only be operated by personnel instructed to do so who with appropriate training knowledge and practical experience are a...

Страница 12: ...ion you should let authorized dealer repair the damage Only use a device which is mounted at the lifting table properly Patient environment information Patient environment is the area where patients c...

Страница 13: ...e device at the same time Make sure that the device cannot tip over by leaning against it or sitting on it Do not put the Myopia Master including rechargeable battery or cable down onto devices that p...

Страница 14: ...by IEC 60601 1 If making this connection leads to the leakage current threshold being exceeded protective measures including a circuit breaker must be in place Ensure that connections with non medical...

Страница 15: ...et connection to function User who elect to connect the device coupled computer to the internet or other network for other purposes are responsible for ensuring that it is done so in a controlled mann...

Страница 16: ...ccess to information to their local Healthcare Organization s IT department Precautions To ensure cyber security in order to the usage of the device the following security measures should be considere...

Страница 17: ...he computer to the network If you are using Wi Fi connections nevertheless please ensure the usage of adequate security methods for example WPA2 AES Wi Fi Protected Access Advanced Encryption Standard...

Страница 18: ...the purpose described in this instruction manual Heed the safety instructions listed above Intended medical indication The Myopia Master can be used by physicians opticians and optometrists to suppor...

Страница 19: ...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 Transpo...

Страница 20: ...nual Myopia Master G 68100 EN Rev08 15 84 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...

Страница 21: ...a Master G 68100 EN Rev08 8 Head rest 11 Control LED 14 Chin rest 9 Marking for the eye height 12 Mains connection 15 Measuring ocular Patient eyepiece with Keratometer ring 10 On Off Switch 13 USB po...

Страница 22: ...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...

Страница 23: ...7 Device Description 18 84 Instruction Manual Myopia Master G 68100 EN Rev08 Applied parts 1 Head rest 2 Chin rest Fig 7 3 Applied parts 1 2...

Страница 24: ...irst use make sure the installation and connection of the Myopia Master examination area is completed by our service or by a professional authorized by OCULUS Note Do not expose the Myopia Master to a...

Страница 25: ...ace Place the Myopia Master so that no direct light can effect the measurement Set up the Myopia Master so that the power plug is easy to access That way you can easily disconnect it from the power su...

Страница 26: ...it is locked 1 Press down gently on the transportation safety device and turn it counter clockwise to the unlocked position 2 The spring will push the transport safety device up Close the cover with...

Страница 27: ...nly use a power cord which meets the requirements of IEC 60227 1 type H05VVH2 F type 53 minimum 0 75 m and IEC 60320 1 type C7 If you use a multiple socket outlet to connect the Myopia Master Use a mu...

Страница 28: ...horized dealer to repair the damage Caution Risk of incorrect measurements equipment damage due to unauthorized personal Ensure that only an expert authorized by OCULUS connects the computer updates t...

Страница 29: ...ck 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 dis...

Страница 30: ...vates 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 Joystic...

Страница 31: ...53 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 t...

Страница 32: ...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 descr...

Страница 33: ...1 Preparing Patients Data 28 84 Instruction Manual Myopia Master G 68100 EN Rev08 The name of the patient appears in the list Press the Measure button to switch to measuring mode Fig 11 2 Patient list...

Страница 34: ...ete Line button to delete the whole entry in the field Alternatively you can delete the entered text with the control wheel by selecting the symbol After you have entered the full last name press the...

Страница 35: ...a Management menu press the button Patient Turn the control wheel to get to the desired entry in the list The following screen appears Press the New Exam button to switch to measuring mode 11 2 2 Rena...

Страница 36: ...n 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 con...

Страница 37: ...ted 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...

Страница 38: ...s 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 de...

Страница 39: ...sinfected the head rest has been cleaned and disinfected after each examination sec 16 page 59 Do not touch the device and the patient simultaneously Ask the patient to place his or her head on the ch...

Страница 40: ...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...

Страница 41: ...ermore 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 appear...

Страница 42: ...belong to a complete myopia measurement central cornea radii K objective refraction AR axial length AXL 12 3 1 Myopia Overview Display The measured values of the myopia examination are displayed in th...

Страница 43: ...of the growth curves and the progression i e the development over the time 3 Growth curves If the Growth curves display is selected the graphic shows the measured axial length values depending on the...

Страница 44: ...se between the display of the following measured values Spherical equivalent SEQ Axial length without percentile curves Regardless of the display selected you can manually set the risk of myopia using...

Страница 45: ...yopic 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 w...

Страница 46: ...ring results are good If the field has a yellow background 6 the measuring results are critical repeat the measurement if necessary If the field has a red background 5 repeat the measurement Keratomet...

Страница 47: ...arked in the camera image 12 3 4 Axial length results After performing the measurement the following display appears The axial length values for one or both eyes are shown in the table 2 The correspon...

Страница 48: ...ession 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 kno...

Страница 49: ...ed if you entered a new patient sec 11 1 page 27 prior to starting the measuring process When printed out each measurement is automatically temporarily saved to the exam nr memory Saving data by Exam...

Страница 50: ...you want to save examinations long term use the patient data management If you want to retrieve a measurement again later you will find the examination in the exam nr memory under the exam number tha...

Страница 51: ...ew patient after performing the measuring operation sec 13 2 page 47 3 You perform a measuring operation without saving the examination under a patient s name sec 13 3 page 48 13 1 Enter Patient Measu...

Страница 52: ...g operation directly The following screen appears Select Start a new measurement anyway Conduct the measurement sec 12 page 33 When the measuring operation has been completed the overview screen appea...

Страница 53: ...tient and save the conducted measurement under 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 pressin...

Страница 54: ...rmed easily and quickly using the reference tool Required materials reference tool provided cleaning agent see sec 16 page 59 Measuring with the reference tool Prerequisite the Myopia Master must be t...

Страница 55: ...14 Reference Measurement 50 84 Instruction Manual Myopia Master G 68100 EN Rev08 The system is now ready for operation Fig 14 2 Example Result on reference tool...

Страница 56: ...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 measurin...

Страница 57: ...ncrements 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...

Страница 58: ...just 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...

Страница 59: ...rican 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 mod...

Страница 60: ...tings 3 the display of growth curves can be activated in the lower area Licensing options using the device license Growth Curve Contact your OCULUS contact person to acquire a corresponding licence To...

Страница 61: ...8 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 deacti...

Страница 62: ...ctive subjective measurement are also 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...

Страница 63: ...15 Settings 58 84 Instruction Manual Myopia Master G 68100 EN Rev08 15 5 Settings 5 Fig 15 7 Settings 5...

Страница 64: ...ia Master is not completely disconnected from the mains for the cleaning Turn the Myopia Master off sec 9 2 page 24 Pull the power plug before cleaning When disconnecting electrical connections pull o...

Страница 65: ...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 Protective glass cov...

Страница 66: ...surfaces with the mixture for painted surfaces Cleaning the Touch Screen Clean the touch screen using a dry lint free cloth 16 2 Disinfection Caution Risk of electric shock if the Myopia Master is not...

Страница 67: ...face 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 16 3 Maintenance The Myopia Master is designed so that n...

Страница 68: ...may be exposed to invisible Class 3R 5 mW laser radiation Never open the unit For authorized service personnel only When doing maintenance jobs avoid looking directly into the laser beam 16 4 Attachi...

Страница 69: ...ll back the printer 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...

Страница 70: ...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 N...

Страница 71: ...the original packaging 18 2 Transport and Storage Information This device can withstand the following temperature conditions for storage and transport Storage Transport 18 3 Transport and Storage Caut...

Страница 72: ...the following warranty provisions Prior to and while operating the device it is important that you heed the instruction manual and safety instructions In accordance with legal regulations you are ent...

Страница 73: ...horized persons request a certification of the scope and type of repair and if necessary the changes to the standard values or to the operating range from the service technician This certification mus...

Страница 74: ...mm in 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 m Measu...

Страница 75: ...d parts 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 7...

Страница 76: ...rding to DIN EN 60825 1 2015 and DIN EN 60825 1 2001 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 Displa...

Страница 77: ...ed in the consideration of permissible deterioration during or caused by t7he EMC testing without affecting the essential performance criteria Caution The use of accessories transducers and cables not...

Страница 78: ...ad rest incl auto refractometer keratometry axial length pachymetry 68120 Myopia Master Basic with chin and head rest incl auto refractometer keratometry axial length 68130 Myopia Master Basic without...

Страница 79: ...romagnetic 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 Guidelines RF emis...

Страница 80: ...n 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...

Страница 81: ...ey a should be less than the compliance level in each frequency range b Interferences may occur in the vicinity of equipment marked with the following symbol Note 1 Note 2 At 80 Hz and 800 MHz the hig...

Страница 82: ...Separation distance according to frequency of transmitter m Rated maximum output power of transmitter W 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...

Страница 83: ...78 84 Instruction Manual Myopia Master G 68100 EN Rev08 22 3 Description of the Connection USB mini cable Computer PC Laptop Power supply adapter 05150725 Mains connection 05200600 Myopia Master USB...

Страница 84: ...Manual Myopia Master G 68100 EN Rev08 79 84 22 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...

Страница 85: ...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...

Страница 86: ...22 Annex Instruction Manual Myopia Master G 68100 EN Rev08 81 84 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...

Страница 87: ...MS is to be integrated Licensing required opened ports 3968 TCP 51371 51372 UDP Storage printing data export File and Printer Sharing for Microsoft Networks SMB 3 0 or higher required opened port 445...

Страница 88: ...sks to patients operators or third parties The responsible organization should identify analyze evaluate and control these risks Subsequent changes to the IT Network could introduce new risks and requ...

Страница 89: ...22 Annex 84 84 Instruction Manual Myopia Master G 68100 EN Rev08...

Страница 90: ...holzh 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 Fax 1 42...

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