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OCULUS Keratograph 5M Instruction Manual

System for measuring and analyzing the cornea topography
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OCULUS Keratograph 5M
INSTRUCTION MANUAL
System for measuring and analyzing the cornea topography

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  • Page 1 OCULUS Keratograph 5M INSTRUCTION MANUAL System for measuring and analyzing the cornea topography...
  • Page 2 Foreword Foreword The Keratograph 5M was manufactured and tested under strict quality criteria. To ensure safe operation, it is essential that you use the device correctly. For this reason, you should thoroughly familiarize yourself with the contents of this instruction manual before operating the device.

  • Page 3: Table Of Contents

    10.2 Performing a Reference Measurement ........30 10.3 Loading an Existing Examination............31 10.4 Print Screen.....................31 10.5 Preparing the Examination ...............32 10.6 Start screen .....................34 10.7 Aligning the camera with the joystick ..........34 Instruction Manual Keratograph 5M (G/77000/XXXX/DE – Rev05) 3 / 106...
  • Page 4 18.3 Filling in the “Recommendation” field .........64 18.3.1 Using Text Blocks ...............64 18.3.2 Entering own Texts ............64 18.3.3 Deleting Texts..............64 18.4 Printing the JENVIS Dry Eye Report ..........64 18.5 DEQ OSDI ....................65 4 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/DE – Rev05)
  • Page 5 Keratograph 5M..................97 27.3 Connection Diagram ................ 101 27.4 Data sheet HEMG 49-S240210-7 (05150150)......102 27.5 Instructions for integration into an IT-Network ....104 Instruction Manual Keratograph 5M (G/77000/XXXX/DE – Rev05) 5 / 106...

  • Page 6: Delivery And Deliverables

    Retaining plate (size: 360 mm) 78060  Retaining plate, long (size: 490 mm) 78030  Long support plate adjustable for OCULUS rack wheels 78070  (size 360 – 460 mm) without chin rest 8 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 7 1 Delivery and Deliverables Products and accessories Article number Long support plate adjustable for OCULUS rack wheels 78080  (size 360 – 460 mm) with chin rest We reserve the right to change the scope of delivery in line with ongo- ing technical development.

  • Page 8: Symbols

    Symbols Notes Symbols Notes Permitted temperature range for trans- Permitted temperature range for Transport Storage port storage Keep dry Limit of humidity This way up Limit of air pressure Fragile 10 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 9: Structure Of The Documentation

    Keratograph 5M. Attention All safety-related instructions for use of the Keratograph 5M are given in the Instruction Manual for the unit. It is therefore imperative that you read and understand the whole Instruction Manual before you use the Keratograph 5M.

  • Page 10: Safety Instructions

    For example, in order to open a new examination: Keratograph 5M > Examination > New which means: Select the “Examination” menu from the menu bar.  Select the menu item “New”.  12 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 11: Safety Instructions For Use

    Set up the Keratograph 5M so that the power plug is easy to ac-  cess. That way, you can easily disconnect it from the power supply for any repairs or maintenance work.

  • Page 12: Patient Environment Information

    If you are unable to make a plug connection, check whether the plug fits the socket. If you detect damage to the connection, you should let authorized dealer repair the damage. Only use a Keratograph 5M which is mounted at the lifting table  properly. Patient environment information...

  • Page 13: Information About The Operation Of An Me System

     manual. Instructions for Maintenance The Keratograph 5M is designed so that no special maintenance is nec- essary. To keep the device functioning properly, we recommend per- forming the tasks specified under “maintenance” on a regular basis. If an error occurs which you cannot correct, label the Keratograph 5M as being “out-of-order”...

  • Page 14: Instructions On Electrical Safety

    If you are using a multiple socket extension cord it has to be supplied with a isolation transformer. If you are using a new computer for the Keratograph 5M, you must have the electrical safety checked. Call OCULUS Service for this purpose.

  • Page 15: Cybersecurity Instructions

    Device Security It is the responsibility of the authorized user to ensure that the Keratograph 5M device is not left unlocked, or otherwise unsecured when not in use, to ensure that non-authorized medical, professional, or otherwise unapproved personnel are not exposed to, or gain access to, ePHI.
  • Page 16 Chap. 27.5, page 104 Note For authorized service personnel only: Always use a wired connection to transfer examination data from the unit to the PC. Do not use wireless technologies. 18 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 17: Purpose

    The Keratograph 5M is a measuring device for eye examinations. It measures the surface of the cornea (corneal topography). The Keratograph 5M is thus intended for use in individual contact lens fit- ting. The Keratograph 5M is also intended for use in dry eye screenings.

  • Page 18: Device Description

    6 Device Description Device Description Components Fig. 6-1: Equipment overview of the Keratograph 5M 20 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 19: Functionality

    Note Data misuse OCULUS Optikgeräte GmbH shall not be liable in any form for further use of the data recorded with the Keratograph 5M or for any calcula- tions based thereon. Technical Principle An illumination system with a special reflector illuminates a transparent Placido bowl from the rear which contains a series of concentric rings.
  • Page 20 It displays the measurement results on the monitor as a color map, a graph and as a spatial image. 22 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 21: Set Up And Connection

     The ambient conditions for operation are given in Chap. 26, page Set up the Keratograph 5M so that the power plug is easy to ac-  cess. That way, you can easily disconnect it from the power supply for any repairs or maintenance work.
  • Page 22  Do not use more than one multiple socket extension cord.  Plug only the Keratograph 5M and the computer that is being used  with the unit (if applicable) into the multiple socket extension cord. Use a power socket that has a flawless earth conductor connection.

  • Page 23: Putting Back Into Operation

    Turn the Keratograph 5M off with the on/off switch (OFF position).  Attention Risk of electric shock if the Keratograph 5M is not completely discon- nected from the mains for transport, cleaning, maintenance, disinfection and repair. Pull the power plug before cleaning and maintenance. Take hold of ...

  • Page 24: Using The Wireless Joystick

     To do so, open the hidden icons in the task bar. In the system tray, you should see the icon for the OCULUS wireless joystick. Click it to see the joystick status, e.g. battery charge level. Touch the joystick to activate it.

  • Page 25: Preparing For Measurements

    After you have switched on the computer, it first loads the operating system. If necessary, click on the Keratograph 5M icon  The user interface for the Patient Data Management appears. Fig. 9-1: User interface for Patient Data Management 1 “Functions”...

  • Page 26: Entering A New Patient

    9 Preparing for Measurements To get to the Keratograph 5M program, you must first enter a new pa- tient (8) or select an existing patient from the examination list. For more information on patient data management, refer to the Chap. 20,...

  • Page 27: Extended Patient Search: [Extended] Check Box

    After you have selected your Hecht supplier (which only needs to  be done once) and you have decided on a consultation method, the data, including your personal message, is sent to the “Hecht MailCenter”. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 29 / 106...

  • Page 28: Fundamentals Of Working With The Keratograph

    For detailed information about measurement evaluations, please refer to the User Guide. 10.1 Starting the Keratograph 5M Software You have the following options for starting the Keratograph 5M soft- ware: Select a patient in the Patient Data Management view, and double- ...

  • Page 29: Loading An Existing Examination

    Confirm your selection by clicking [Load examination], or by dou-  ble clicking. The Keratograph 5M program will load the examination you have selected. When performing certain measurements e.g. tear meniscus height mea- surement, you are led directly to the evaluation menu by pressing the [Image] button.

  • Page 30: Preparing The Examination

    Make sure the installation and connection of the “Keratograph 5M“  examination station are completed by our service or by a profes- sional authorized by OCULUS. Let OCULUS or an authorized dealer train you in the operation of  the Keratograph. Recommended for beginners: First practice the entire measurement process a few times using the supplied reference sphere, (Chap.
  • Page 31 If necessary, correct the position of the adjusting base.  Instruct the patient to focus on the red light in the center of the  rings during the entire measurement. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 33 / 106...

  • Page 32: Start Screen

    Position the measuring head in front of the eye so that the ker-  atometry marks are in focus (see figure). Align the camera exactly. Move or rotate the joystick in the direc-  tions indicated. 34 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 33 Rotate the joystick counter-clockwise When the position has been approximately reached, a cross appears in the center of the ring that is bordered by four bars. The Keratograph 5M will automatically begin measuring. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 35 / 106...

  • Page 34: Manual Measurement

    In the menu bar select the “Patient” menu and click on [New Pa-  tient/End]. If necessary, make preparations to examine another patient (see  “10.5 Preparing the Examination” on page 32). 36 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 35: Performing A "Topography" Examination

    11 Performing a “Topography” Examination Performing a “Topography” Examination Start the Keratograph 5M software (see “10.1 Starting the  Keratograph 5M Software” on page 30). In the [Examination] menu, select [New].  The following screen is displayed: Fig. 11-1: Topography examination Position the patient and have them look at the red light in the mid- ...

  • Page 36: Patients Who Are Sensitive To Light: Low Glare With White Flash

    In that case, you will be prompted to manually mark the center of the Placido rings (“Manual measurement” on page 36). 38 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 37 Click with the left mouse button on the center point of the rings  projected on the cornea. The topography of the cornea is then calculated. Fig. 11-3: Pop Up: Manually marking the center of the Placido rings Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 39 / 106...

  • Page 38: Contact Lens Back Side Measurement

    Then screw out the adjusting screw again until the surface of the  water takes on a slightly concave curvature. 40 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 39: Measure The Back Surface Of The Dry Contact Lens

    Adjust the mounting arm so that the optical axes of the contact  lens roughly coincide with those of the keratograph. 12.6 Fully assembled contact lens holder Fig. 12-2: Assembled contact lens holder Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 41 / 106...

  • Page 40: Cl Back Surface

    12 Contact lens back side measurement 12.7 CL Back Surface Start the Keratograph 5M software (see “10.1 Starting the  Keratograph 5M Software” on page 30). In the [Examination] menu, select [New].  Enable the radio button [CL Back ...

  • Page 41: Performing A "Tf Scan" Examination

    Chap. 13.2, page 45  Tear meniscus height, Chap. 13.3, page 46  NIKBUT, Chap. 13.4, page 47  You can find instructions on the magnification changer in Chap. 17.5, page 59 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 43 / 106...

  • Page 42: Examination Of The Lipid Layer

    Fig. 13-2: Lipid Layer Measurement Activate the [Lipid Layer] radio button.  Move the Keratograph 5M in small increments toward the patient’s  eye. Now properly focus the Placido rings. Slightly pull back the camera and focus the lipid layer in the record- ...

  • Page 43: Tf Dynamics Examination

    You can find instructions on the magnification changer in Chap. 17.5, page 59 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 45 / 106...

  • Page 44: Measuring The Tear Meniscus Height

     Press the [Image] button.  You can use the foot switch alternatively, (Chap. 10.10, page 36). You can find instructions on the magnification changer in Chap. 17.5, page 59 46 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 45: Measuring Nikbut

    „Blink 2 times“. Ask the patient to blink twice.  The measurement is performed. Please tell the patient to keep his eye open as long as it is comfort-  able. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 47 / 106...
  • Page 46 13 Performing a “TF Scan” Examination Note The measurement is automatically terminated if the patient blinks, moves strongly, or the tear film significantly breaks up. 48 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 47: Performing An "R Scan" Examination

    Activate the [Bulbar Redness] radio button.  Align the camera so that the grey “disc” covers the iris and .  Press the [Image] button.  Use the foot switch alternatively, (Chap. 10.10, page 36). Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 49 / 106...

  • Page 48: Performing A "Meibo Scan" Examination

    Start the recording of the upper eyelid. To do this, press the [Im-  age] button. Use the foot switch alternatively, (Chap. 10.10, page 36). Repeat the steps for the lower eyelid.  50 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 49: Recording A Single Image

    Position the camera so that the upper or the lower eyelid fits in the  red-framed recording box. Focus on the Meibom glands.  Start the recording. For this, press the [Image] button.  Use the foot switch alternatively, (Chap. 10.10, page 36). Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 51 / 106...

  • Page 50: Performing A "Pupillometry" Examination

    With this function, you continuously examine the pupil size dependent on different glare states. Select the desired measuring program by enabling the corre-  sponding radio button: Pupillogram (page  Asymmetric test (page  Manual (page  52 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 51: Adjustment

    Indicates the status of the ring illumination (Placido system). Red markers “Glare on” Grey markers “Glare off” x axis Measuring time in s y axis Size of pupil in mm Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 53 / 106...

  • Page 52: Pupillogram

    Alternatively, you can end the measurement by pressing the [Stop] but- ton. When the measurement has ended, the Overview screen automatically opens ((Fig. 10-4, page 34)). 54 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 53: Imaging

    Record Fluo Imaging, Chap. 17.1, page 56  Measure near portion height, Chap. 17.2, page 57  Eyelid angle measure, Chap. 17.3, page 58  New recording, Chap. 17.4, page 59  Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 55 / 106...

  • Page 54: Recording A Fluo Image

    The video recordings and single images are saved automatically. Press the [Close] button and you will reach the overview display.  You can find more information in the User Guide. 56 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 55: Near Portion Height Measurement

    (Chap. 10.10, page 36). The image is stored automatically. Press the [Close] button and you will reach the next display. Perform the near part height measurement and evaluation, see User Guide. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 57 / 106...

  • Page 56: Eyelid Angle Measurement

    Use the foot switch alternatively, (Chap. 10.10, page 36). The image is stored automatically and you will reach the next display. Now you can perform the eyelid angle measurement, see User Guide. 58 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 57: New Recording

    “Camera“ groupboxes appear. You can set values for illumination, magnification changer and camera. You can save the settings as a pro- gram. The optimal camera and illumination settings have already been preset for the selectable measuring functions. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 59 / 106...

  • Page 58: Adjust Illumination: [Illumination] Groupbox

    Auto Illumination: You can adjust the illumination with this function, e.g. so as not to overexpose an image. Press the button [Auto Illumination].  You can now adjust the illumination for the entire image capture. 60 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 59: Buttons

    If you press the button, the image program uses the saved settings. If you press the [Delete] button, you delete the image program. You cannot delete the manufacturer “default” settings. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 61 / 106...

  • Page 60: Performing Dry Eye Examinations: Jenvis Dry Eye Report

    3 Result diagram for left eye 8 Camera image for right eye (if available) 4 Camera image for left eye (if available) 9 Patient and examination data 5 Exam types for left eye 62 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 61: Selecting The Exam Type

    Fig. 18-2: JENVIS Dry Eye Report menu bar 1 Patient and Examination Data 4 [Repeat examination] button 2 Color bar for measurement result 5 [Back to report] button 3 Drop down list for measurement result Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 63 / 106...

  • Page 62: Filling In The "Recommendation" Field

    The results of the dry eye examinations will be printed in the JENVIS Dry Eye Report. After printing, the JENVIS Dry Eye Report is in read-only mode. For more detailed information on the printout, refer to the User Guide. 64 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 63: Deq Osdi

    The OSDI value is shown in the assessment field and the diagram. You can also use the McMonnies Questionnaire instead of the DEQ OS- DI. For this, change settings as shown in the User Guide. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 65 / 106...

  • Page 64: Lipcof

    Select the grade or text which corresponds to the result.  Go back to the overview display by pressing the [Back to report]  button. For more information on LIPCOF, refer to the User Guide. 66 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 65: Performing Extended Examinations: Jenvis Pro Dry Eye Report (Optional)

    Report) which contains all results of the tests, the treatment options and extensive glossary, where all examinations are explained. Select in the menu bar “Examination” the entry [New Dry Eye Re-  port] Individualized. Fig. 19-1: Select Dry Eye Report Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 67 / 106...

  • Page 66: Perform The Capture Plan Based On The Worklist

    It is suggested to start for the Tear Meniscus Height with the right eye and switch then to the left eye. For the NIKBUT the software recom- mends to start with the left eye and follow with the right eye. 68 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 67: Additional Supporting Information

    . Fig. 19-4: Additional supporting information 1 Capture element of the examina- 3 Capture advices tion (area of interest) 4 Right eye/left eye 2 Preview Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 69 / 106...

  • Page 68: Adjusting Illumination, Magnification Changer And Camera

     If you press the button, the image program uses the saved settings. If you press the [Delete] button, you delete the image program. You cannot delete the default settings. 70 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 69: Adjust Illumination: [Illumination] Groupbox

    1.0 low aperture, for greater depth of field  1.0 yellow filter, for images taken with fluorescine  If your device is equipped with a wireless joystick, you can use the joy- stick to trigger different images. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 71 / 106...

  • Page 70: Modifying Dry Eye Report Capture Settings: Cog Icon Groupbox

    Screening mode: Click to determine if both eyes or just one eye should be examined in screening mode. If you select “one eye”, the screening will be done on the eye that the Keratograph 5M is currently facing. Capture mode: Click to decide if the software should automatically go on to the next examination step (other eye or next examination) after completing a measurement/image.

  • Page 71: Buttons And Checkboxes

    0/50: Progress bar of the worklist Next: Use these buttons to move on to the next step in the worklist. You are not recording any image or video. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 73 / 106...

  • Page 72: Check Quality Of Images

    He can decide if he/she wants to keep or delete the image. Fig. 19-8: Overview with preview 1 Patient and Examination Data 2 Preview 74 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 73: Printing A Jenvis Pro Dry Eye Report

    The results of the dry eye examinations are shown on the printout of the JENVIS Pro Dry Eye Report. The JENVIS Pro Dry Eye Report includes a glossary of relevant terms for the patient. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 75 / 106...

  • Page 74: Patient Data Management

    Press the [Export] button below the patient list. The following dia-  log is displayed: Fig. 20-1: “Export patient data” dialog 1 Saving destination selection 3 [Cancel] and [Export] buttons 2 [...] button 76 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 75: Import Patient Data

    Note Risk of loss of data due to computer viruses Computer viruses can cause loss of data. Run a virus check before importing data from the USB flash drive.  Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 77 / 106...
  • Page 76 To import the data, press the [Import] button.  The data is then available in the user interface for “Patient Data Management”. 78 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 77: Data Backup

    If you select the option “Changed and new data only”, only the data re- cords that were not saved during a previous backup will be backed up. Press the [...] button to the right of the “Backup directory” field.  Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 79 / 106...

  • Page 78: Restoring Data

    Besides the manually executed backup, there is also the option to carry out a backup when the patient data management user interface is closed. The settings required for this can be made in the “Settings” area, User Guide. 80 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 79: Cleaning, Disinfection And Maintenance

    21 Cleaning, disinfection and maintenance Cleaning, disinfection and maintenance Cleaning of the Keratograph 5M is described in this chapter. Sterilization is not required. Heed the product descriptions and instruction manuals of products  and equipment you use to care for, clean, and disinfect the unit and/or its accessories.

  • Page 80: Cleaning, Disinfection And Maintenance Schedule

    2 years (recommended) values checked by OCULUS Service The Keratograph 5M is designed so that no special maintenance is nec- essary. To keep the device functioning properly, we recommend per- forming the tasks specified under “maintenance” on a regular basis.

  • Page 81: Cleaning The Housing

    Use a lint-free, dry cloth. Make sure that no dust gets into the little holes.  If necessary, you can also carefully clean the Placido bowl with a  barely damp cloth. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 83 / 106...

  • Page 82: Disinfection

    21 Cleaning, disinfection and maintenance 21.3 Disinfection Attention Risk of electric shock if the Keratograph 5M is not completely discon- nected from the mains for these jobs. Turn the Keratograph 5M off, Chap. 8.2, page  Pull the power plug before cleaning. Take hold of the power plug ...

  • Page 83: Reference Measurement

    Reference sphere (r=8.000 mm), provided  Cleaning alcohol  Measuring With The Reference Sphere Prerequisite: the Keratograph 5M has been turned on for at least 15 minutes. For the reference measurement proceed as follows: Thoroughly clean the reference sphere before saving reference val- ...
  • Page 84 The system is now ready for operation. The reference data is stored di- rectly on the device, so that the measuring head is not dependent on a particular computer or laptop. 86 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 85: Troubleshooting

     side of the power adapter is plugged in Software/Hardware problems. Switch off the Keratograph 5M and re- start the computer. Switch on the Keratograph 5M as soon as the patient data management becomes active. When you start the Keratograph 5M program, the message “Load Boot-...

  • Page 86: Transport And Storage

    Observe the transport an storage conditions, refer to “Technical  Data” on page The Keratograph 5M, must be properly dismantled and packed before the device is being transported or stored. After storage and/or transport After transport, allow the Keratograph 5M to rest for approx.

  • Page 87: Disposal

    Electrical and Electronic Equipment, old electrical and electronic equipment must be sent out for recycling and may not be disposed in household trash. Dispose the Keratograph 5M in a compliant manner.  Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 88: Terms Of Guarantee And Servicing

    Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety, reliability and ser- viceability of the Keratograph 5M if the unit is used in compliance with the following terms: Only use the equipment in conformance with this instruction man- ...

  • Page 89: Manufacturer- And Service Address

    Optikgeräte GmbH Münchholzhäuser Str. 35582 Wetzlar GERMANY Phone: 2005-0 Fax: 2005-255 E-mail: sales@oculus.de www.oculus.de USA: OCULUS, Inc. 17721 59th Avenue Arlington WA 98223-1337 Phone: 425-670-9977 Fax: 425-670-0742 E-mail: sales@oculususa.com www.oculususa.com Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 91 / 106...

  • Page 90: Technical Data

    Illumination Color Wavelength Fluo blue 465 nm Ring Illumination infra red 880 nm Meibo infra red 840 nm Fixation 660 nm Glare ring white Tear Film white Ring Illumination white 92 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 91 Relative humidity, including condensation 10 — 95% Air pressure 700 — 1060 hPa Transport Ambient temperature -40°C — +70°C Relative humidity, including condensation 10% — 95% Air pressure 500 hPa — 1060 hPa Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 93 / 106...
  • Page 92 1920 x 1080 Pixel (Full HD) resolution CE in accordance with EC Directive 93/42/EEC for Medical Devices unit Class product. Conformity assessment procedure as per (EU) 93/42/EEC (MDD), Annex II without Section 4 94 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 93: Appendices

    Portable RF communication devices (including peripheral devices such as antenna cables and external antennas) should not be any closer than 30 cm (12 inches) to any part of the Keratograph 5M device. Otherwise, the device performance may be affected. Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 94 Cable with plug, EU Standard 2.5m 05200210 Cable with plug, US Standard 2.5m (110 Volt) 05150150 Power adapter HEMG 49 24 V, 2.1A 70002 Med. secure Isolator + USB Connection acc. 96 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)

  • Page 95: Guidance And Manufacturer´s Declaration Electromagnetic Interference Emission And Interference Immunity Of The Keratograph 5M

    IEC 60601-1-2, based to table 1 The OCULUS Keratograph 5M is intended for operation in the electromagnetic environment specified below. The user of the Keratograph 5M should ensure that it is being used in such an environment. Emissions test Compliance...
  • Page 96 0 degree 0 degree 0% U ; 250/300 0% U ; 250/300 τ τ periods periods Note: U is the a.c. mains voltage prior to application of the test level. τ 98 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 97 If the measured field strength in the location in which the Keratograph 5M is used exceeds the applicable RF compliance level above, the Keratograph 5M should be observed to verify normal operation. If abnormal performance is observed, additional measures may be nec- essary, such as re-orienting or relocating the Keratograph 5M.
  • Page 98 The Keratograph 5M in intended for use in an electromagnetic environment in which radiated RF disturbanc- es are controlled. The customer or the user of the Keratograph 5M can help prevent electromagnetic inter- ference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the com- munications equipment.

  • Page 99: Connection Diagram

    27 Appendices 27.3 Connection Diagram Keratograph 5M Med. secure Isolator + USB Connection acc. 70002 Power adapter (05150150) Computer/PC/laptop Power adapter Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 101 / 106...

  • Page 100: Data Sheet Hemg 49-S240210-7 (05150150)

    (3) The exact obtainable load regulation depends upon the output cord selected and load current. (4) Due to requests in market and advances in technology, specifications subject to change without notice. For the details of safety approval, please consult the factory. 102 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 101 HEMG49-S120400-7 12.0Vdc HEMG49-S120400-8 IEC320-C8(DT8) 12.0Vdc 4.0A HEMG49-S150330-7 IEC320-C14(DT7) 15.0Vdc 3.3A HEMG49-S150330-8 IEC320-C8(DT8) 15.0Vdc 3.3A HEMG49-S240210-7 IEC320-C14(DT7) 24.0Vdc 2.1A IEC320-C8(DT8) 2.1A HEMG49-S240210-8 24.0Vdc MECHANICAL DIMENSIONS: MM [INCHES] WEIGHT: 373.0g (13.2 Oz.) Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 103 / 106...

  • Page 102: Instructions For Integration Into An It-Network

    License handling from local license server to PEMS and vice versa  Storage and data export to local network storage and loading from  local network storage Printout to local printer  104 / 106 Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05)
  • Page 103 Changes to the IT-Network include: changes in IT-Network configuration  connection of additional items to the IT-Network  disconnecting items from the IT-Network  update of equipment connected to the IT-Network  Instruction Manual Keratograph 5M (G/77000/XXXX/EN – Rev05) 105 / 106...
  • Page 104 WW W. OCUL US .D E OCULUS Optikgeräte GmbH Postfach • 35549 Wetzlar • GERMANY Phone +49 641 2005-0 • Fax +49 641 2005-255 E-mail: sales@oculus.de • www.oculus.de...

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