OCULUS Easygraph Instruction Manual

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OCULUS Easygraph

INSTRUCTION MANUAL

Measurement and Evaluation System

for Corneal Topography

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Summary of Contents for OCULUS Easygraph

Page 1 OCULUS Easygraph INSTRUCTION MANUAL Measurement and Evaluation System for Corneal Topography...
Page 2 Instruction manual Easygraph (G/70620/XXXX/EN - Rev02) 2 / 62...
Page 3 Preface The Easygraph 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. Pay attention to the safety...
Page 4: Table Of Contents
9 Perform Measurement................26 Starting the OCULUS Easygraph Software............26 Performing a Reference Measurement ..............27 Loading an Existing Examination................27 Print Screen........................28 Preparing the Examination..................28 9.5.1 Checking the Examination Conditions ..........29 9.5.2 Preliminary Adjustment ................29 Instruction manual Easygraph (G/70620/XXXX/EN - Rev02) 4 / 62...
Page 5 16 Technical Data ..................50 17 Annex...................... 52 17.1 Electromagnetic Compatibility ..................52 17.2 Guidance and Manufacturer’s Declaration - Electromagnetic Emissions and Immunity for the OCULUS Easygraph..53 17.3 Connection-Diagram.....................57 17.4 Data Sheet GEM 181 (05150980) ................58 Instruction manual Easygraph (G/70620/XXXX/EN - Rev02)
Page 6 Instruction manual Easygraph (G/70620/XXXX/EN - Rev02) 6 / 62...
Page 7: Delivery And Deliverables
Have the damages noted on the bill of lading, so that your claim  for damages can be handled properly. For more information regarding shipping and handling, see sec. 13, page Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 7 / 62...
Page 8: Symbols
Article number Disposal in household Serial number trash is prohibited Applied part Type B Medical device Example: UDI number, con- sisting UDI-DI (Device- Identification) UDI-PI (Product Identifier) machine-readable matrix code 8 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 9: On The Packaging
On the Packaging Symbol Description Keep dry This way up Fragile Transport Limit of temperature for transport Storage Limit of temperature for storage Limit of humidity Limit of air pressure Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 9 / 62...
Page 10: Structure Of The Documentation
Software Installation: The introduction to the Software Installa-  tion describes how to install the OCULUS Easygraph software and the associated drivers. If you work with a Floating License Key, please consult the corresponding manual for information on the use of the OCULUS Easygraph within networks.
Page 11: Safety Instructions
4 Safety Instructions Safety Instructions Attention All safety-related instructions for use of the OCULUS Easygraph are given in the Instruction Manual for the unit. It is imperative that you read and understand the whole Instruction Manual before you use the OCULUS Easygraph.
Page 12: Safety Instructions For Use
Set up the OCULUS Easygraph so that the power plug is easy to  access. That way, you can easily disconnect it from the power supply for any repairs or maintenance work.
Page 13: Patient Environment Information
Fig. 4-1: Patient environment Information about the operation of an ME system The OCULUS Easygraph and a connected computer form a medical electrical system (ME system) according to DIN EN 60601-1. If you connect additional devices, such as, for example a printer, those devices become part of the ME system.
Page 14: Instructions For Operation
Only operate the OCULUS Easygraph with the original accessories  supplied by us and only when the unit is in technically perfect condition. Before first use: Let OCULUS or an authorized dealer train you in  the operation of the OCULUS Easygraph. Do not cover the ventilation openings.
Page 15: Electromagnetic Compatibility (Emc) / Cables
If you are using a multiple socket extension chord it has to be supplied with a isolation transformer. If you are using a new computer for the OCULUS Easygraph, you must have the electrical safety checked. Call OCULUS Service for this purpose.
Page 16 Recommendation: Use anti-malware tools with up to date malware definitions. Note Also observe the regulations, instructions and recommendations of your local authorities for information technology security for the protection of critical infrastructures. 16 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 17: Intended Use
The OCULUS Easygraphis to be used in conjunction with the designated examination station or on an examination unit. The OCULUS Easygraph may only be used for the purpose stated in these instructions for use, which includes in particular observing the safety instructions.
Page 18: Device Description
6 Device Description Device Description Device Components Abb. 6-1: Device components OCULUS Easygraph Camera opening Gripping surfaces for better grip Test marks 18 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 19: Oculus Easygraph Functionality
Note Data misuse OCULUS Optikgeräte GmbH shall not be liable in any form for further use of the data recorded with the OCULUS Easygraph or for any calculations based thereon An illumination system with a special reflector illuminates a transparent Placido bowl from the rear which contains a series of concentric rings .
Page 20: Set Up And Connection
Handle the optical device with care.  Set up the OCULUS Easygraph so that the power plug is easy to  access. That way, you can easily disconnect it from the power supply for any repairs or maintenance work.
Page 21 7 Set up and Connection Screw the holder with the knurled screws to the OCULUS  Easygraph. Abb. 7-1: Mounting the holder 1 Holder 2 Knurled screws If required: Take off the cover of the slit lamp receptacle . ...
Page 22: Mounting The Parking Unit
7 Set up and Connection Set the shaft of the Easygraph holder (1) in the receptacle of the slit  lamp (2). Mounting the Parking Unit If the OCULUS Easygraph is not required during an examination, you can use parking unit to "park“ the OCULUS Easygraph temporarily.
Page 23 Note Risk of equipment damage due to incorrect connection If you do not connect the OCULUS Easygraph properly, and the connection is live, the unit can be damaged within a short period of time.
Page 24 7 Set up and Connection Connect the Y cable to the computer/laptop (1) and the power  adapter (2). USB connector for computer/ 2 Connector for power adapter Laptop Abb. 7-6: Connecting y cable 24 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 25: Operation
Operation The Instruction Manual concentrates on how to operate the OCULUS Easygraph. The functional description of the Easygraph software is therefore limited to the respective measuring procedure and to loading existing examinations. For detailed information about measurement evaluations, please refer to the User Guide.
Page 26: Perform Measurement
 examination list to start the OCULUS Easygraph program. Abb. 9-1: Overview example with a topographic examination After selecting a patient: Press the [Easygraph] button to start the  OCULUS Easygraph program. Double-click the selected patient name to start the OCULUS ...
Page 27: Performing A Reference Measurement
 Easygraph" examination station are completed by our service or by a professional authorized by OCULUS. Let OCULUS or an authorized dealer train you in the operation of  the OCULUS Easygraph. Select the menu item [Examination] and click [Load old examinati- ...
Page 28: Print Screen
 Easygraph" examination station are completed by our service or by a professional authorized by OCULUS. Let OCULUS or an authorized dealer train you in the operation of  the OCULUS Easygraph. Recommended for beginners: Practice the entire measurement process a few times using the supplied reference sphere (sec.
Page 29: Checking The Examination Conditions
9 Perform Measurement Align the OCULUS Easygraph parallel with the chin rest  Abb. 9-4: Align Easygraph parallel 9.5.1 Checking the Examination Conditions Make sure that no interfering light gets into the viewer of the  OCULUS Easygraph. If necessary, darken the room.
Page 30 If required: adjust the position with the adjusting mechanism of the  slit lamp. Instruct the patient to focus on the red light in the center of the  rings during the entire measurement. 30 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 31: Starting The Examination
See the User Guide for information about the evaluation of the examinations. Enable the [New Measurement] radio button.  If required: adjust the camera, sec. 9.7, page  Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 31 / 62...
Page 32: Manual Measurement
When the position has been approximately reached, a cross appears in the center of the ring that is bordered by four bars. he OCULUS Easygraph will automatically begin measuring. Note A poor tear film quality or highly irregular corneas can affect the quality of the captured image, or prevent automatic triggering of the measurement from occurring.
Page 33: Marking The Placido Rings Manually
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. Abb. 9-8: Marking the Placido rings manually Note! The topographic measurements will automatically be stored. Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 33 / 62...
Page 34: Ending Of The Measurement
10.6, page 37  Import it, sec. 10.7, page 38  Save it, sec. 10.8, page 39  For more information on Patient Data Management, refer to the User Guide. 34 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 35: Patient Data Management
8 "Patient" group box Abb. 10-1: Patient Data Management user interface To get to the OCULUS Easygraph program, you must first enter a new patient (8) or select an existing patient from the examination list (2). For more information on Patient Data Management, refer to the sec.
Page 36: Entering A New Patient
(bottom right side). 10.4 Extended Patient Search Click on the [Extended] checkbox.  The screen displays additional search parameters which reference previous examinations. Proceed as for the input of a patient name. 36 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 37: Rename Patient Data
Depending on the settings, you may not have to perform all of the following steps (e.g. selection of the directory). Select the "Target" (1) where you would like to export the data.  Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 37 / 62...
Page 38: Importing Patient Data
 Press the [Import] button.  The following dialog appears: 1 Select data source 4 [Import] button 2 [...] button 5 Patient list 3 Previous examinations Abb. 10-6: "Import" dialog 38 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 39: Data Backup
Patient Data Management system. Storage of backup files should always be done on a separate system (for example on a USB flash drive with adequate capacity). Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 39 / 62...
Page 40: Backup Data
Confirm your selection with [OK].  To back up the data, press the [Save] button (5). The previously  selected data will then be backed up to the corresponding folder. 40 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 41: Reconstructing Data
In addition to the manually performed backup, it is also possible to automatically run a backup when exiting the Patient Data Management system. The settings required for this can be made in the "Settings" area, User Guide. Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 41 / 62...
Page 42: Cleaning, Disinfection And Maintenance
 containing, abrasive or sharp cleaning agents. 11.1 Cleaning Attention Risk of electric shock if the OCULUS Easygraph is not completely disconnected from the mains for these jobs. Turn the OCULUS Easygraph off, sec. 8.3, page  Pull the power plug before cleaning. When disconnecting electrical ...
Page 43: Disinfection
 cloth. 11.2 Disinfection Attention Risk of electric shock if the OCULUS Easygraph is not completely disconnected from the mains for these jobs. Turn the OCULUS Easygraph off, sec. 8.3, page  Pull the power plug before cleaning. When disconnecting electrical ...
Page 44: Attaching Paper To The Chin Rest
Required Materials: Reference sphere (r=8,000 mm), provided  Cleaning alcohol  Prerequisite: the OCULUS Easygraph must be turned on for at least 15 minutes. For the reference measurement, proceed as follows: Thoroughly clean the reference sphere before saving reference ...
Page 45 The system is now ready for operation. The reference data is stored directly on the device, so that the measuring head is not dependent on a particular computer or laptop. Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 45 / 62...
Page 46: Troubleshooting
Insert the License Key into the USB- Easygraph program the mes- connector of your computer or the sage appears that the License Floating License Key in the server. Key is not inserted. 46 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 47: Transport And Storage
13 Transport and Storage Transport and Storage The OCULUS Easygraph, must be properly dismantled and packed before being transported or stored. Attention Risk of equipment damage due to incorrect shipment or from improper storage Avoid shocks, vibrations, and contamination. ...
Page 48: Disassembly
Dispose the OCULUS Easygraph in a compliant manner.  48 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 49: Terms Of Warranty And Servicing
Assumption of Liability for Functions and Damage OCULUS will only accept responsibility for the safety, reliability and serviceability of the OCULUS Easygraph if the unit is used in compliance with the following terms: Only use the equipment in conformance with this instruction ...
Page 50: Technical Data
Level of protection against electric shock Type B Level of protection against harmful IP20 penetration of water Software version Patient data management: from version 6.08  OCULUS Easygraph-Software: from version V2.10r 5  50 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 51 16 Technical Data The software version of the patient data management is displayed  on the Settings-General screen page (patient data management). The software version of the OCULUS Easygraph program is  displayed in the [Help] menu, menu item “About...”.. Computer Use a computer which is in conformity with the DIN EN 62368-1 or DIN EN 60950 standard.
Page 52: Annex
Easygraph (slightly image noise on screen) during the examination is permissible because it will not affect the diagnosis, treatment and observation. A short flicker of the illumination of the OCULUS Easygraph during  the examination is permissible because it will not affect the diagnosis, treatment and observation.
Page 53: Guidance And Manufacturer's Declaration - Electromagnetic Emissions And Immunity For The Oculus Easygraph
IEC 60601-1-2: 2015, based to table 1 The OCULUS Easygraph is intended for operation in the electromagnetic environment specified below. The user of the OCULUS Easygraph should ensure that it is being used in such an environment. Emissions test Compliance...
Page 54 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 54 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 55 To assess the electromagnetic environment due to fixed RF transmitters, and electromagnetic site survey should be con- sidered. If the measured field strength in the location in which the OCULUS Easygraph is used exceeds the applicable RF compliance level above, the OCULUS Easygraph should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the OCULUS Easygraph.
Page 56 RF communications equipment and the OCULUS Easygraph, IEC 60601-1-2:2007, table 6 The OCULUS Easygraph in intended for us e in an electromagnetic environment in which radiated RF distur- bances are controlled. The customer or the user of the OCULUS Easygraph can help prevent electromagnetic...
Page 57: Connection-Diagram
17 Annex 17.3 Connection-Diagram Easygraph Y cable 02 7062 00 071 Power supply adapter 05150980 Computer/PC/Laptop Mains connection Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 57 / 62...
Page 58: Data Sheet Gem 181 (05150980)
P1J: Plug for standard model, 2.1 ψ× ψ× 11mm, C+ tuning fork type DC plug type Optional plug type available per request Output voltage Interchangeable AC plug Output wattage Series name File Name:GEM18 -SPEC 2015-05-05 58 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 59 8.The power supply is considered as an independent unit, but the final equipment still need to re-confirm that the whole system complies with the EMC directives. For guidance on how to perform these EMC tests, please refer to “EMI testing of component power supplies.” (as available on http://www.meanwell.com) File Name:GEM18 -SPEC 2015-05-05 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 59 / 62...
Page 60 ID 2.1 x OD 5.5 Outside Inside Plug Assignment Standard plug: P1J OUTPUT CENTER Optional lock type plug: P2S SWITCHCRAFT S761K plug equivalent Installation Manual Please refer to : http://www.meanwell.com/webnet/search/InstallationSearch.html File Name:GEM18 -SPEC 2015-05-05 60 / 62 Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02)
Page 61 17 Annex Instruction manual OCULUS Easygraph (G/70620/XXXX/EN - Rev02) 61 / 62...
Page 62 WW W. OCUL US .D E OCULUS Optikgeräte GmbH Münchholzhäuser Str. 29 • 35582 Wetzlar • GERMANY Phone +49 641 2005-0 • Fax +49 641 2005-255 E-mail: sales@oculus.de • www.oculus.de...

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