Models M700 USB C, CR, M730 Focus and upgrades to Studio 5 User Manual Feb 2014

TABLE OF CONTENTS 1.

MANUAL ORGANISATION... 1

Software Conventions 2.

1

INTRODUCTION ... 3

Variants ...3 Intended Purpose ...3 Standard Accessories...4 Optional accessories ...5 Spare parts ...5 3.

WARRANTY ... 6

4.

IMPORTANT FACTS ... 7

Essential Performance 7 Classification 7 Clinical Results, Accuracy and Age Normals 8 Electrical Safety of System 8 Radiation 8 Electromagnetic Interference 8 Electromagnetic Emissions 12 Side effects 13 Instrument Damage 13 Disposal 13 Symbols and Labels ...13 5.

INSTALLATION ... 16

PC Requirements...16 Perimeter Environment ...16 Software Installation ...17 System Hardware Installation ...17 Medmont Automated Perimeter 17 USB Interface 19 M600 Perimeter Upgrades ...19 Licensing ...20 Registering the Perimeter ...20 PalSet ...23 6.

TESTING A PATIENT ... 24

The Perimeter Test Control Window...24 Preparing the Patient ...25 Express Testing a New Exam ...27 Starting a New Exam ...29 Test Settings 29 Medmont Automated Perimeter

i

Starting the Test 29 Monitoring the Test 30 Changing Test Points during an Exam 30 Pausing a Test 31 Test Point Colours 31 Saving the Completed Test 31 Demonstrating the Test ... 31 Modifying Test Parameters... 32 The Stimulus Parameters Group 33 The Settings Group 34 False Negatives False Positives Fluctuation Measurement Flicker Targets Test Inside NOT SEEN Regions Spatially Adaptive Retest Abnormals

Creating a New Template Defining the Field Saving a User Template Saving a User Template from the Test Window

34 34 34 35 35 36 36

37 38 38 38

Controlling a Test in Progress ... 38 Selecting a Test Template 39 Selecting the Eye 39 Lens Details 39 Setting Prompt to Save 40 Choosing a Slow Response Setting 41 Test Point Colours during Testing 41 Monitoring the Test Progress 41 Test Based on Age Normal HoV Test Based on Previous Exam Re-Testing Points Progressive Analysis

The Test Status Group Percent Complete Monitor Blind Spot Fixation Monitoring Video Fixation Monitoring False Positives Monitor False Negatives Monitor Average response time Monitor Exposure count Monitor Test Elapsed Time Monitor Strategy

Assigning Sounds to Perimeter Events ii

Medmont Automated Perimeter

41 42 42 42

43 43 43 46 48 49 49 50 50 50

50

7.

THE SYSTEM TEST TEMPLATES ... 51

Binocular Single Vision Test ...52 Central Test ...53 Driving Test...53 Binocular Driving Test ...54 Flicker Test ...54 Full Test...55 Glaucoma Test ...55 Macula Test ...55 Neurological Test ...56 Peripheral Test ...56 Quickscan Test (deprecated) ...56 Flash Scan Test ...56 Spatially Adaptive Test ...56 Central 22A Test...57 Central 22 Test ...57 CV% 100 Point Test ...57 8.

THE SYSTEM TEST STRATEGIES ... 58

Stimulus Presentation...58 Fast Threshold Strategy...59 Threshold Strategy ...59 Screening Strategy (deprecated) ...60 Three-Zone Strategy ...60 Fixed Level Strategy ...61 Age Related Strategy ...62 9.

STATISTICAL INDEXES... 63

Age Normal Hill of Vision ...63 Patient Based Hill of Vision ...63 Overall Defect ...64 Pattern Defect...64 Cluster Analysis ...65 Seen Ratio Score ...67 10. ANALYSING AND VIEWING EXAM RESULTS ... 68

Selecting the Exam Results ...68 Retinal Overlay View ...69 Overlay Opacity 71 Setting the Exam View Mode 73 Exam Details View and Editor Moving an Exam to a Different Patient Map View Combination View Medmont Automated Perimeter

73 74 74 75 iii

Compare View

76

Selecting the Map Type and View ... 79 Field Data Visualisations 79 Level Age Normal Deviation Patient HoV Deviation Age Normal Probability Patient HoV Probability Difference from Baseline

79 80 81 82 83 83

Data Visualisation Views

84

Numeric Data View Numeric Grid Data View Plan View Perspective View

84 85 85 85

Setting Image Options ... 87 Cross-Section Tool 88 Moving the Cross-Section

88

Shaded Greyscale Hill of Vision Data Non-Linear Scaling Readout Statistics Numeric Tick Marks Image Options in Other Views Attributes

89 89 89 90 90 91 91 92

Attribute Options Custom Attributes Editing an Attribute Definition Defining a New Attribute

93 94 94 96

Adding Annotations... 97 Text Annotations 98 Callout Annotations 98 Ruler Annotations 98 Shape Annotations 98 Editing and Deleting Annotations ... 99 Saving and Abandoning Changes 100 Zooming and Panning ... 100 Using the Mouse to Pan and Zoom 100 11. REGRESSION ANALYSIS ... 102

Histogram Plots ... 103 The Regression Types... 104 Field Subsets ... 105 Regression Options ... 106 iv

Medmont Automated Perimeter

12. PRINTING THE EXAM RESULTS ... 108

Printing the Current Display ...109 Export a Print Preview to the Clipboard 109 Export a Print Preview to an Image File 109 Printing Multiple Images 110 Printer Settings 111 Threshold Overview Print ... 112 M700 Exam Print Report ... 115 Advanced Print Settings 116 Printing the Patient History ... 117 Regression View Printing... 118 13. EXPORTING THE ANALYSIS ... 120 14. PERIMETER FILTERS ... 121 15. INSTALLING THE DEMONSTRATION DATABASE ... 124 16. POWER ON SELF-TEST... 125 17. GLOSSARY ... 126 Age Normal Hill of Vision 126 Blind Spot 126 Field 126 Fixation Point 126 Offset Fixation Points 126 Strategy 126 Template 126 18. CLEANING, MAINTENANCE AND SERVICE ... 127

Warning: Do not modify this equipment without authorisation of the manufacturer...127 Cleaning ...127 Maintenance ...127 Replacement of fuses 128 Service 128 19. TROUBLESHOOTING ... 131 20. SPECIFICATIONS FOR M700/M730 MODELS ... 132 21. COMPLIANCE ... 134 22. REPRESENTATIVES ... 135

Medmont Automated Perimeter

v

Manual Organisation

1. Manual Organisation This manual is divided into four sections: 1. Introduction and Device description, 2. The installation of the software and the perimeter, 3. The set up for and performance of a test, and the saving and reviewing of the results, and 4. A reference section that elaborates on the introduction given in 2. In discussing the normal interaction between the software and those involved in a particular operation, test or test review, the manual uses the term Clinician to refer to the person operating the equipment, and Patient to refer to the person undergoing the test. The manual describes the M700 USB and M730 USB Automated Perimeter instrument models and software upgrades of all Automated Perimeters to Studio 5. Software Conventions The term Application Button refers to the circular button in the top left of the menu bar. This button can have different icons but is always in the same position on the ribbon bar. When navigating the application button menu we use the following format: Application Button > Import.

When referring to menu selection, the terminology Home > Patient > New means click on the Home ribbon bar tab, then look for the Patient group on the ribbon bar and click on the New icon. This format conforms to the Tab > Group > Action system for identifying menu items in a ribbon bar menu system.

Medmont Automated Perimeter

1

Manual Organisation

A small glossary is included for terminology that originated with Medmont. It also includes some common terms where they apply to Medmont equipment. It is not a glossary of perimetry. Terms that appear in the glossary are underlined in the text.

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Medmont Automated Perimeter

Introduction

2. Introduction The Automated Perimeter software is designed as a component of Medmont’s integrated clinical environment called Medmont Studio. Medmont Studio is an extensible software framework that allows the controlling software for different medical instruments to be fully integrated into a single working environment. See the Medmont Studio documentation for help on installing and using the Studio environment.

Variants The Automated Perimeter may be configured at purchase as a number of optional variants. M700 USB C standard model incl. CCD camera for fixation video monitoring. M700 USB CR, additional Red light perimetry @650nm M730 Focus Max 30 degree field, incl. stray light shroud

Intended Purpose The Medmont Automated Perimeter performs rapid and reliable screening and threshold tests of visual fields, while providing comprehensive control over the test and detailed information on its progress. The clinical applications of visual field testing using the Automated Perimeter can include tests for Glaucoma, Flicker Perimetry, Binocular Testing (including Driving Tests), Neurological Testing, Macula Testing, Peripheral Vision Testing and others. Easily followed instructions enable a clinician to quickly perform accurate visual field tests, as well as providing the ability to easily design custom fields and tests. Testing of the visual field is carried out using the technique of static perimetry, with the stimulus targets being a set of rear illumination Light Emitting Diodes (LEDs). In the text the LEDs are referred to as light points. Testing may select from two fields of different coloured stimuli, one green set and one red set (variant R model).

Medmont Automated Perimeter

3

Introduction

Fixation performance is monitored by the Heijl-Krakau technique, with random stimuli presentations in the blind spot or (optionally) using continuous video tracking of the patient’s iris. The patient's fixation performance is continuously displayed to the clinician both statistically and visually. The Medmont Automated Perimeter shall only be used as described in this manual and only for the intended purpose.

Standard Accessories Medmont Studio 5 package Installation instructions Calibration file on CDR Power cord Spare fuses mains power Spare fuses PCB Patient switch Patient switch holder including fasteners Dust cover Binocular chinrest Eye Occluder Binocular target holder Mounting screws and washers USB cable

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Medmont Automated Perimeter

Introduction

Optional accessories Patient Management Integration Software

Custom

Network licensing

Custom

USB2.0 active extension 5m

PN 1482-242

Medical Isolation transformer 230V 500VA TR2450

PN 0762-279

Medical Isolation transformer 110V 500VA TR1150VAR-UL

PN 1240-279

Spare parts Patient switch Occluder assembly

PN 0472-280 PN 0473-379

Occluder with Target Holder

PN 3044-379

M700 PCB USB Microcontroller

model specific

Lens holder head

PN 0360-370

Dust cover

PN 0471-542

Binocular chinrest

PN 1179-319

Fuse, spare T400mA 250V (pkt 10) Fuse 500mA microfuse

PN 1576 PN 1466-243

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Warranty

3. Warranty This Medmont Automated Perimeter is manufactured with all due care and subjected to stringent testing before leaving the factory. The instrument is guaranteed for 12 months from the date of delivery. During this warranty period Medmont or an authorised agent will repair or replace all defective parts free of charge. Such repairs do not extend the warranty period. The replaced defective parts become the property of Medmont. The warranty does not cover defects due to incorrect handling, installation or setup, unauthorised modifications, non-compliance with the requirements for computer hardware and associated mains powered equipment as specified in this User Manual, loss of the license, loss of income, or service and repair costs for components and associated equipment. Warranty claims are the responsibility of the agent where the instrument was purchased.

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Medmont Automated Perimeter

Important Facts

4. Important Facts This manual does not provide guidance on interpretation of clinical results. The clinician must ensure that he or she has received appropriate medical training in such interpretation. Medmont cannot be held responsible for misdiagnosis of results. Essential Performance Due to the possible effects of external electromagnetic interferences the essential performances of this instrument are:    

Component failures in the Automated Perimeter unit are not permitted Changes in programmable parameters are not permitted Reset to factory defaults are not permitted Errors of a displayed numerical value sufficiently large to affect diagnosis are not permitted

Classification Do not use this instrument other than intended and specified. In accordance with IEC 60601-1 clause 5, the M700 (and variants) Automated Perimeter is classified as

Applied parts to patient

Automated Perimeter unit.

Protection against electric shock

Class I

Warning: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth Degree of protection against electric shock

Type B Applied Part Equipment

Protection against harmful ingress of water

Ordinary (no protection) For indoor use only.

Mode of Operation

Continuous Operation

Oxygen Rich Environment

This instrument is not

Medmont Automated Perimeter

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Important Facts

suitable for use in oxygen rich environment Altitude

<= 4000m

Clinical Results, Accuracy and Age Normals The Automated Perimeter is delivered to the end user quality tested and calibrated as per specifications. While the device has exceptional long-term stability, it is not the responsibility of Medmont to police the accuracy of the device after delivery. The device is calibrated and referenced against the Medmont Age Normal standard displayed as a dB scale. Electrical Safety of System To ensure the safety of the Automated Perimeter system, all associated equipment connected to it must be compliant to EN/IEC60950 and powered by an isolation transformer compliant with medical standard EN/IEC60601-1, UL2601 or CSA22.2#601-1. Any open communication port on the PC must be covered with provided port covers when the device is used in a patient environment. When networking to another computer, either the use of a network device with electrical separation of I/Os or wireless network may be used. Please contact your distributor, as network performance may be affected. Radiation The Automated Perimeter emits radiation in the visual range in the distinct wavelength of 565nm. The levels of intensity of this illumination are below any levels known to be hazardous. Electromagnetic Interference Strong electromagnetic interference from unprotected devices or portable and mobile RF communications equipment or mains disturbances (voltage dips, transient surges) or electrostatic discharge may affect the performance or results of the Automated Perimeter. Avoid using the device while such high interference is present. See Troubleshooting on page 131 for particular effects and solutions. The device is compliant with medical standard 8

Medmont Automated Perimeter

Important Facts

EN/IEC60601-2.

Guidance and manufacturer’s declaration – electromagnetic immunity The M700 USB Automated Perimeter is intended for use in the electromagnetic environment specified below. The customer or the user of the M700 USB Automated Perimeter should assure that it is used in such an environment. IMMUNITY test IEC 60601 Compliance level Electromagnetic test level environment – guidance Electrostatic Floors should be wood, 6 kV contact 6 kV contact discharge (ESD) concrete or 8 kV air 8 kV air IEC 61000-4-2 ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

2 kV for power supply lines 1 kV for input/output lines  1 kV line(s) to line(s)

2 kV for power supply lines N/A

1 kV line(s) to line(s)

2 kV line(s) to earth

2 kV line(s) to earth

<5 % UT (>95 % dip in UT) for 0,5 cycle

<5 % UT (>95 % dip in UT) for 0,5 cycle

40 % UT (60 % dip in UT) for 5 cycles

40 % UT (60 % dip in UT) for 5 cycles

70 % UT (30 % dip in UT) for 25 cycles

70 % UT (30 % dip in UT) for 25 cycles

<5 % UT (>95 % dip in UT) for 5 s 

<5 % UT (>95 % dip in UT) for 5 s

3 A/m

3 A/m

Medmont Automated Perimeter

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the M700 USB Automated Perimeter requires continued operation during power mains interruptions, it is recommended that the [ME EQUIPMENT or ME SYSTEM]

be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical

9

Important Facts commercial or hospital environment. NOTE UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer’s declaration – electromagnetic immunity The M700 USB Automated Perimeter is intended for use in the electromagnetic environment specified below. The customer or the user of the M700 USB Automated Perimeter should assure that it is used in such an environment. IEC 60601 Electromagnetic environment – IMMUNITY test Compliance test level level guidance Portable and mobile RF communications equipment should be used no closer to any part of the M700 USB Automated Perimeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance Conducted RF IEC 61000-4-6

3 Vrms 150 kHz to 80 MHz

3V

√

Radiated RF IEC 61000-4-3

3 V/m 80 MHz to 2,5 GHz

3V/m

√

80 MHz to 800 MHz

√

800 MHz to 2,5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol: a

b

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the M700 USB Automated Perimeter is used exceeds the applicable RF compliance level above, the M700 USB

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Medmont Automated Perimeter

Important Facts Automated Perimeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the M700 USB Automated Perimeter b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances between portable and mobile RF communications equipment and the M700 USB Automated Perimeter The M700 USB Automated Perimeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the M700 USB Automated Perimeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the M700 USB Automated Perimeter as recommended below, according to the maximum output power of the communications equipment. Rated maximum Separation distance according to frequency of transmitter output power of transmitter m W

150 kHz to 80 MHz √

80 MHz to 800 MHz

800 MHz to 2,5 GHz

√

√

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Medmont Automated Perimeter

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Important Facts

Electromagnetic Emissions This device does not emit harmful or undesired electromagnetic emissions. The device is compliant with medical standard EN/IEC60601-2. MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANYING DOCUMENTS. If the M700 USB Automated Perimeter is used in a domestic establishment or connected to the Mains Public Network following warning shall apply: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the M700 USB Automated Perimeter or shielding the location. The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the M700 USB Automated Perimeter. The M700 USB Automated Perimeter should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation in the configuration in which it will be used. Guidance and manufacturer’s declaration – electromagnetic emissions The M700 USB Automated Perimeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Automated Perimeter should assure that it is used in such an environment. Emissions test

RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions

12

Compliance

Group 1

Class A Class A

Electromagnetic environment – guidance The M700 USB Automated Perimeter uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The M700 USB Automated Perimeter is suitable for use in all establishments other than domestic, and may be used in domestic establishments and

Medmont Automated Perimeter

Important Facts IEC 61000-3-2

Voltage fluctuations/ flicker emissions IEC 61000-3-3

Complies

those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the M700 USB Automated Perimeter or shielding the location.

Side effects No undesired side effects to patient or clinician or other persons are known when using this instrument under normal conditions and for the intended purpose. Instrument Damage Never operate instrument in a damaged condition. Contact your distributor to seek advice.

Disposal Some components in the instrument contain lead or polychlorinated biphenyls (PCBs). These substances can be harmful to human health and the environment. Dispose the instrument and all the electronic accessories only through separate collection and not with normal waste. For disposal at the end of the product life cycle, please follow national regulations for disposal and recycling.

Symbols and Labels The following table explains the use of symbols in this manual.

Medmont Automated Perimeter

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Important Facts

Warning: In the event of user error including use error and unforeseen fault condition there may be a serious risk to health or life of patients or operator, or product damage or loss may occur. Caution: In the event of user error or unforeseen fault condition, damage to the device or its performance may occur. Precaution. Safety related instruction: Refer to instruction manual/booklet. Alternating current. Compliance with the EC Directive 93/42 EEC for medical devices. Type B Equipment (degree of electrical safety). The date below this symbol shows the year and month of manufacturing. WEEE mark: Separate collection for electrical and electronic equipment. Device contains dangerous substances; do not dispose with normal waste. Connector socket for patient switch. Type B USB connector for USB cable connection to computer.

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Medmont Automated Perimeter