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OCULUS Mesotest II INSTRUCTION MANUAL Examination of mesopic vision and glare sensitivity...
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In particular, pay attention to the safety instructions. The Mesotest II is used for testing the mesopic visual acuity of the human eye. Due to ongoing development, the diagrams shown may depict minor changes to the actual device delivered.
Used Graphic Symbols.................4 Safety Instructions for Use ..................4 Intended Use..........................8 Device Description ........................9 Mesotest II Functionality ..................11 Twilight (Mesopic) Vision ..................14 Initial Operation ........................16 Before Initial Operation..................... 16 Information About the Room in which the Device is Set Up ......16 7.2.1...
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Replacing the Fuse ..................72 13.4.3 Change the Lamp at the Panel Illumination........73 14 Troubleshooting........................74 15 Transport and Storage ......................75 15.1 Transport and Storage Information................ 75 15.2 Disassembly and Packing ..................76 iii / v Instruction Manual Mesotest II (G/62800/0715/en)
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17.2 Address of the manufacturer and service department........78 18 Declaration of Conformity..................... 79 19 Technical Data .......................... 80 20 Appendix............................. 82 20.1 Electromagnetic Compatibility................82 20.2 Guidance and Manufacturer’s Declaration - Electromagnetic Emmisssions for the Mesotest II..........83 Instruction Manual Mesotest II (G/62800/0715/en) iv / v...
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/ v Instruction Manual Mesotest II (G/62800/0715/en)
1 Scope of Delivery Scope of Delivery Components Order Number Mesotest II 62800 Mesotest II konkav (minus lenses can be 62801 swung in), with eye occluder Mains cable 05200320 Test block (100 sheets) 62850 Dust protection cover 026010005001 ...
Mesotest II. Software Installation: The introduction to the Software Installation describes how to install the Mesotest II software and the associated drivers. If you work with a floating license key, the respective instruction manual explains how you can use the Mesotest II within a network.
„Settings“ screen within the Patient Data Management (sec. 12.5, page 57). The software version of the Mesotest II programme is shown on the “Change Settings” screen within the Mesotest II programme (fig. 10-11, page 35). Safety Instructions About this Manual ...
Identifies important information about the product and its use, which require special attention. > This symbol denotes menu paths and screen shots. Example for starting an examination: Mesotest II > Examination > Load which means: Select the “Examination” menu from the menu bar. ...
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Keep the Mesotest II away from water that may drip, surge or splash on it, and make sure that no liquids can enter the Mesotest II. Do not place any containers holding liquids in the vicinity of the Mesotest II.
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Abb. 4-1: Patient environment Instrutions to us a ME system The Mesotest II and a connected computer are a medical electrical system (ME system) according to DIN EN 60601-1. If you want to connect further devices, for example a printer, these devices will be part of the ME system.
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Mesotest II checked every two years by our service department or an authorized dealer. If an error occurs which you are unable to correct, label the Mesotest II as “out of order” and contact our service department or an authorized dealer.
Mesotest II functions correctly. Intended Use The Mesotest II is intended for the use described in this Instruction Manual. The Mesotest II is used for testing the mesopic visual acuity of the human eye. Heed the safety instructions listed above. Contraindication...
6 Device Description Device Description Viewer enclosure Yoke spring Device viewer Air vents Housing Fig. 6-1: Front view of the Mesotest II Instruction Manual Mesotest II (G/62800/0715/en) 9 / 86...
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6 Device Description Back of the viewer with grey pane Serial interface port Housing On/Off switch Control pad Nameplate Device plug with fuse holder Fig. 6-2: Back view of the Mesotest II 10 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
The air vents in the enclosure prevent the patient’s glasses or the unit’s viewer glass from fogging. In Germany: The Mesotest II is used for testing mesopic vision and glare contrast sensitivity as required by driver’s license issurance regulations and it meets the requirements of DIN 58220, Part 7.
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6 Device Description Controls You can operate the Mesotest II either via the control pad or via a computer/laptop. Control Pad: The integrated panel illumination allows testing to be done in a darkened room, also see sec. 9.1, page Operation via computer/laptop: You can also operate the Mesotest II via a computer/laptop.
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The visual requirement is deemed to be met when the patient has recognised at least 3 of 5 positions of the Landolt ring (60% criterion). Mark this accordingly on the test sheet. Instruction Manual Mesotest II (G/62800/0715/en) 13 / 86...
Test 7-10: Are used to test mesopic vision with glare. With the examination program „Mesopic vision mono“ (optional with Mesotest II konkav), you can examine mesopic vision monocularly, for the right and for the left eye. It consists of 20 test steps.
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3 out of 5 of the different optotypes presented must be correctly recognised. This means that for the critical contrast levels 1:23 to 1:2.7, at least 5 different optotypes must be presented. Instruction Manual Mesotest II (G/62800/0715/en) 15 / 86...
Do not cover the ventilation openings. Note: Falsified examination results if the room is too bright If you set up the Mesotest II in a bright room, you must occlude the back pane of the viewer with the supplied cover. ...
Place the Mesotest II on a level surface. Set up the Mesotest II 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.
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Do not use more than one multiple socket extension cord. Plug only the Mesotest II and the computer that is being used with the unit (if applicable) into the multiple socket extension cord. Use a socket with a protective earth connection which is fully operating.
The software then installs itself. Switching the Device On and Off Switch the Mesotest II on or off at the On/Off switch at the unit (fig. 7-2, page 18, item If the Mesotest II is connected with a control pad, the unit starts automatically.
8 Before Conducting the Examination Before Conducting the Examination Prepare the Unit for Routine Operation To start the Mesotest II for daily operation, you must: Check the connections, sec. 7.3, page 17 Check whether the viewer is dirty ...
Before the examination, the patient’s eyes need about 5 minutes to adapt to the darkness. When the Mesotest II is set up in a darkened room, this is not a problem. If the unit is set up in a bright room, adaptation of the patient must be done by having him look into the unit for the required length of time prior to starting the examination.
How to test mesopic vision, sec. 9.3, page 26 How to test mesopic vision with glare, sec. 9.4, page 26 Control Pad Mains connection Control pad Fig. 9-1: Control pad 22 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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Turns Fixation Assistance on and off Select an eye for examination (option) Activitates 2nd function (minus lenses) (option) Next patient, or stop current tests andreturn to begin- ning Return to previous test Proceed to next test Instruction Manual Mesotest II (G/62800/0715/en) 23 / 86...
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Landolt ring gap at top right CONTRAST 1: 2 Presented contrast level 1:2 -DPT. R/L/BIN: R Monocular examination of the right eye (option), without minus lens BLEND FIX: (empty) Glare and fixation aids are switched off 24 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
9.2.1 Starting the Examination New start: Switch on the unit. After automatic calibration of the Mesotest II, test no. 1 is presented. After an examination: Press this button. The programme begins with test no. 1 Instruct the patient ...
Conduct the remaining tests, nos. 5 through 8 in the same way as described above, sec. 9.3, page Fill out all of the other required items on the test sheet. 26 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
9 Examination Using the Control Pad 9.4.1 Test for Night Myopia (optional) If your Mesotest II is equipped with minus lenses (Mesotest II konkav), you can conduct these additional examinations. With the minus lenses, you can determine whether the patient suffers from night myopia.
The general use of the examination menu is explained in this chapter. Start the Patient Data Management, sec. 10.3.1, page If necessary, press the [Mesotest II] button to start the Mesotest II programme. Press the button [Examination] (1) to start an examination. Fig. 10-1: Menu “Mesotest II“...
Header with information about the patient and Task bar with the buttons [Back] and [Result], as well “vision aid” selection field. as minus lenses for myopia test (Mesotest II konkav) Optotype display Arrow keys for steps: “back” and “next” Input field “Comment”...
The visual requirement is deemed met when the patient has recognised at least 3 of 5 positions of the Landolt ring (60% criterion). Press this button to present the next optotype. Press this button to display the previous, marked optotype. 30 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
You can swing in minus lenses to determine whether the patient suffers from night myopia. You can only use the myopia test if your Mesotest II has this function (Mesotest II konkav), and the myopia test has been activated in the “Settings” , see sec.
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The selected language will be active after the next start of the Mesotest II programme. Change visual acuity data “Visual acuity levels“ box (fig. 10-7, page 32, item Select the desired setting for the visual acuity data from the drop- down list. 32 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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(fig. 10-7, page 32, item This test is useful for determining whether the patient suffers from night myopia. You can only use this test if your Mesotest II has this function (Mesotest II konkav). Fig. 10-8: The buttons for minus lenses are activated ...
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(fig. 10-7, page 32, item Activate the [Show window fullscreen] checkbox. Activate "Demo" mode This function is for demonstration purposes only, if a Mesotest II is not connected to your laptop/netbook/PC. “Miscellaneous” box (fig. 10-7, page 32, item ...
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You can activate the interface to external office management programmes here. Fig. 10-11: „System“ screen Activate the checkbox [GDT] in the „Export“ box (1). Press the button [...] in the „Export“ box (1). Instruction Manual Mesotest II (G/62800/0715/en) 35 / 86...
A notebook generally has only one port: COM1. A desktop computer generally has two: COM1 and COM2. Save your selection. Switch to the Mesotest II programme Press the [Back] button (fig. 10-7, page 32, item The settings will take effect immediately, except for the language change.
“Patient” box Fig. 10-12: User Interface for Patient Data Management To start the Mesotest II programme, first enter a new patient (8) , or select an existing patient from the list of patients (7). For more information on Patient Data Management, refer to the sec.
To transfer the patient’s name to the patient window, click the entry that you need in the list. This also brings up a list of any previous examinations for that patient in the examination window (bottom right side). 38 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Press the button [End search]. Proceed as for entering a patient name. 10.4 Select and Start Exam If necessary, press the [Mesotest II] button to start the Mesotest II programme. The following dialogue appears: Select a program (2):.
Header with information about the patient and Task bar with the buttons [Back] and [Result], as well “vision aid” selection field. as minus lenses for myopia test (Mesotest II konkav) Optotype display Arrow keys for steps: “back” and “next” Input field “Comment”...
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Conduct test steps 7 through 10 in the same way as described above, sec. , page The visual requirement is deemed met when the patient has recognised at least 3 of 5 positions of the Landolt ring (60% criterion). Instruction Manual Mesotest II (G/62800/0715/en) 41 / 86...
Conduct the Programm "Mesopic vision mono" With the examination program „Mesopic vision mono“ (optional with Mesotest II konkav), you can examine mesopic vision monocularly, for the right and for the left eye, at different contrast levels, with and without glare. It consists of 20 test steps.
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The visual requirement is deemed met when the patient has recognised at least 3 of 5 positions of the Landolt ring (60% criterion). Conduct test steps 13 through 15 in the same way. Instruction Manual Mesotest II (G/62800/0715/en) 43 / 86...
3 of 5 positions of the Landolt ring (60% criterion). 10.4.3 Test for Night Myopia (optional) If your Mesotest II is equipped with minus lenses (Mesotest II, konkav), you can conduct these additional examinations. With the minus lenses, you can determine whether the patient suffers from night myopia.
,I DQ DGGLWLRQDO FRQFDYH OHQV LPSURYHV WKH FRQWUDVW YLVLRQ DQ LQGLFDWLRQ IRU QLJKW P\RSLD LV JLYHQ Header with information about patients Test results „Mesopic vision and glare testing“ when testing was done using a Mesotest II konkav Test results „Mesopic vision and glare testing” Remark Fig.
Press the button [Back] to end the examination. In the dialogue, select whether the data are to be saved or not. You are then returned to the Mesotest II main menu. You can now Start a new examination (sec. 10.4, page 39).
11.3, page 51 11.1 Compilation of a Custom Selection List of Examinations Mesotest II > Settings > Edit programmes Fig. 11-1: Activation of an examination programme This function acts on the display in the selection list for the examination programmes.
Press the [Save] button. The selection list is adapted accordingly. 11.2 Create A New Examination Programme Mesotest II > Settings > Edit programmes Fig. 11-2: List of activated/deactivated examination programmes. Press the [New] button. A new programme appears at the end of the list under the name „noname“.
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You can assign a new name to the examination programme in the field for the “name of the examination programme” (14). To do this, move the cursor into that field and enter the new name. Instruction Manual Mesotest II (G/62800/0715/en) 49 / 86...
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Activate the checkbox for the eye that is to be examined (2). All test steps can be conducted binocularly, or at option monocularly (only possible with device type Mesotest II konkav). The selection is displayed in the list of test steps for the examination programme (13).
11.1, page 11.3 Edit Examination Programme Mesotest II > Settings > Edit programmes Fig. 11-4: List of activated/deactivated examination programmes. You can only edit or delete those examination programmes that were created as user-defined ones.
Press the [Change] button. The input boxes for patient data are now enabled, and the cursor jumps to the "Last name" field. Change the entries in the individual boxes. Press the [Save] button. 52 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
In the dialog that appears, select the folder or the file to which the patient data should be exported. Confirm your selection with [OK] or [Save]. To export the data, press the [Export] button (3). Instruction Manual Mesotest II (G/62800/0715/en) 53 / 86...
Depending on the settings you may not have to perform all the following steps (for example selection of the directory). Select the option (1) which contains the source data ("Folder" or "Single file (U12)"). 54 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
Patient Data Management user interface. Storage of backup files should always be done on a separate system (for example on a USB flash drive with adequate capacity). Instruction Manual Mesotest II (G/62800/0715/en) 55 / 86...
Confirm your selection with [OK]. To import the data, press the [Restore] button (1). All data in the appropriate directory are copied to the Patient Data Management software. 56 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
There are two buttons below and to the left for saving (1) or discard- ing (2) the changes that have been made. All changes are always saved or discarded, and then the screen is closed. Instruction Manual Mesotest II (G/62800/0715/en) 57 / 86...
To be able to carry out entries for the newly defined attributes, proceed as follows: Click with the right mouse button on the patient list and open the associated context menu. 58 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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Attribute "Comment2" in the patient list Fig. 12-7: Custom attribute "Comment" The deselection of attributes in the context menu is done in the same manner. The currently selected attributes are marked with a check. Instruction Manual Mesotest II (G/62800/0715/en) 59 / 86...
You can also select the "load while starting" option (2) for exactly one user. The associated database is loaded by default when the Patient Data Management user interface is started, and is selected accordingly. 60 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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You can also specify settings for devices which are not connected to the computer. Enable the checkbox [Write permission] for the devices that are in fact connected to the computer. Instruction Manual Mesotest II (G/62800/0715/en) 61 / 86...
Select the folder using the folder selection button (2) which should normally be preselected for the automatic export. If the automatic export should be executed, enable the [Enable] checkbox (6). 62 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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In the "Format" drop-down list (5), select whether the default import or export should be done for a folder or a single file (U12). The checkbox „Control unit“ (4) is currently out of function. Instruction Manual Mesotest II (G/62800/0715/en) 63 / 86...
If no email program is installed on the computer, several additional entries must be made here to be able to send emails. Contact your system administrator if you have questions about the individual entries. 64 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
The interface "Default.pat" (3) is used if the Patient Data Management user interface is launched by a third-party program. Add the interface "Default.pat" to the directory of the other program. Select the third-party program's folder as the "in" folder. Instruction Manual Mesotest II (G/62800/0715/en) 65 / 86...
Press the [Config] button (2). A page appears for you to select the type of smartcard reader you are using. Select the [Enable if available] checkbox (1) to enable the smartcard reader. 66 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
This ensures that the database is automatically updated when a patient is created on a computer with the older Patient Data Management V2.x. The "IPad Report" field is currently disabled. Instruction Manual Mesotest II (G/62800/0715/en) 67 / 86...
"Hecht" and "DICOM" tabs "Hecht" and "DICOM" tabs are currently disabled. 13 Cleaning, Disinfection and Maintenance This chapter describes how to clean and disinfect the Mesotest II and how to change the viewer enclosure, the fuses and the panel illumination lamp.
Mild soap solution Cleaning intervals: Wipe the viewer enclosure after each examination, and the housing whenever necessary. Turn the Mesotest II off, sec. 7.5, page Unplug the power cord. When cleaning, use a damp cloth and make sure that no liquid enters the Mesotest II.
13 Cleaning, Disinfection and Maintenance 13.4 Care and Maintenance To ensure satisfactory and reliable operation, we recommend that you Have the Mesotest II checked every two years by our service department or an authorized dealer. Note: Faulty examinations due to damaged equipment If an error occurs that you can not resolve ...
Lay the Mesotest II on its back. Note: Risk of damaging the viewer glass if the unit is put down incorrectly Lay the Mesotest II on its back only. Use the soft cloth as an underlay. Removal: Remove the yoke springs: To do this, take hold of the yoke springs one after the other at ...
Fig. 13-4: Inserting the yoke springs 13.4.2 Replacing the Fuse The Mesotest II has two fuses. These are located in a small fuse box integrated in the mains power plug. You can replace a blown fuse. Note: Function loss due to incorrect fuse ...
You can change a faulty lamp. Note: Risk of functional damage caused by wrong lamp. Use only genuine lamps from Oculus. Order number 016280006004. The bulb is changed together with the plastic holder, which also acts as a glare shield.
Error Possible source Remedy Nothing happens when the pow- The Mesotest II is not connected Plug the power cable into the er switch is turned on to the power supply socket or into the low heat de- vice socket at the Mesotest II.
This device does not keep up with the temperature conditions for storage according to ISO 15004-1. Do not store the Mesotest II under conditions over 50 °C and under -10 °C. In accordance with DIN EN 60601-1, the storage conditions are: Ambient temperature range -10°C to +55°C...
Store the Mesotest II in accordance with the storage conditions. Avoid storing in the vicinity of heaters and moisture. If you want to send the Mesotest II to OCULUS for repair, you can order an empty packaging box from OCULUS Service. That will help prevent po- tential transport damage.
17.1 Liability for proper function or damages OCULUS will only accept responsibility for the safety, reliability and serviceability of the Mesotest II if the unit is used in compliance with the following terms: Use the device in accordance with these instructions and the ...
700 hPa to1060 hPa Transport conditions according to DIN EN 60601-1 Ambient temperature range -40°C to +70°C Relative humidity, including condensation 10% to 95% Air pressure range 500 hPa to 1060 hPa 80 / 86 Instruction Manual Mesotest II (G/62800/0715/en)
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Computer Use a computer which is in conformity with the DIN EN 60950 standard. Recommended computer specifications (for 2 GB RAM, 320 GB optional software) HDD, 1.8 GHz, Windows® 8, 64bit Instruction Manual Mesotest II (G/62800/0715/en) 81 / 86...
Portable and mobile RF-communications devices can interfere with electrically operated medical devices. Minimal performance quality and essential performance criteria A short flicker of the illumination of the Mesotest II during the examination is permissible because it will not affect tthe function- ality described in the intended use.
Guidance and manufacturer´s declaration electromagentic emmissions IEC 60601-1-2, 5.2.2.1, table 1 The OCULUS Mesotest II is intended for operation in the electromagnetic environment specified below. The user of the Mesotest II should ensure that it is being used in such an environment.
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( > 95% dip in U τ τ supply input lines hospital environment. If the user for 0,5 cycle for 0,5 cycle of the Mesotest II requires con- IEC 61000-4-11 tinued operation during power 40 % U ( 60% 40 % U ( 60% τ...
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RF transmitters, and electromagnetic site survey should be considered. If the measured field strength in the location in which the Mesotest II is used exceeds the applicable RF compliance level above, the Mesotest II should be observed to verify normal operation.
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IEC 60601-1-2, 5.2.2.2, table 6 The Mesotest II in intended for us e in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Mesotest II can help prevent electromagnetic interference by main-...
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