Zeiss Humphrey Matrix 800 User Manual

Humphrey Matrix

■ Model 800

User Manual

ii

Copyright

© 2011 Carl Zeiss Meditec, Inc. All rights reserved.

Trademarks

FORUM, HFA, Humphrey, and Matrix are either registered trademarks or trademarks of Carl
Zeiss Meditec, Inc. in the United States and/or other countries.

HP and PCL are registered trademarks of Hewlett-Packard Company.

All other trademarks used in this document are the property of their respective owners.

Document Applicability

This document applies to the Humphrey Matrix instrument Model 800, System Software
Version 8.0 or higher, unless superseded.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

(1) Introduction....................................................................................... 1

• Chapter Overview ......................................................................................... 1

• Instrument Overview ....................................................................................1

• Intended Use ................................................................................................2

• Indications for Use........................................................................................ 2

• Humphrey Matrix User Manual..................................................................... 4

• System Hardware.......................................................................................... 5

• Instrument Components..................................................................................... 6

• Underside Connectors................................................................................... 7

• Patient Response Button Connector.................................................................... 8

• Chinrest Module ................................................................................................8

• External Device Equipment......................................................................... 10

• Instrument Installation ............................................................................... 11

• Tips to Avoid Damage.................................................................................11

• Product Compliance.................................................................................... 12

• User Changes to Software or Hardware...................................................... 12

• Protection of Patient Health Information.................................................... 12

• Safety ......................................................................................................... 13

• Electromagnetic Compatibility (EMC) ......................................................... 14

• Symbols and Labels .................................................................................... 17

• Protective Packing Symbols ...............................................................................18

• Product Labels and Serial Number Location.......................................................18

• Instrument Disposition ............................................................................... 19

iii

(2) Setting Up the Instrument .............................................................. 1

• Chapter Overview ......................................................................................... 1

• Unpacking Equipment ..................................................................................1

• Preparation For Use......................................................................................2

• Patient Response Button Connection.................................................................. 2

• USB Keyboard/Track Pad Connection .................................................................. 2

• Chinrest Module ................................................................................................2

• Set Instrument Date and Time ...................................................................... 2

• System Settings ............................................................................................3

• System Settings – General.................................................................................. 4

• System Settings – Testing ................................................................................... 5

• System Settings – Export.................................................................................... 7

• System Settings – Backup .................................................................................. 9

• USB Storage Devices................................................................................... 10

• Selecting a Folder on a USB Storage Device...................................................... 11

• Safely Remove a USB Storage Device.................................................................12

(3) General Operation............................................................................. 1

• Chapter Overview ......................................................................................... 1

• Powering Up the Instrument ........................................................................1

• Powering Down the Instrument.................................................................... 1

• Keyboard and Track Pad Operations ............................................................. 2

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iv

• Screens Overview.......................................................................................... 2

• F1: Main Menu.............................................................................................. 2

• F2: View Patients.......................................................................................... 4

• F3: Recall Tests..............................................................................................5

• F4: File Functions.......................................................................................... 6

• F5: System Settings.......................................................................................7

• F6: Help ........................................................................................................8

(4) Test Results and Reliability Measures............................................ 1

• Chapter Overview ......................................................................................... 1

• Visual Field Tests Summary...........................................................................1

• Screening Tests ............................................................................................. 2

• Threshold Tests .............................................................................................2

• Reliability Measures......................................................................................6

(5) Patient Testing................................................................................... 1

• Chapter Overview ......................................................................................... 1

• Test Set-Up.................................................................................................... 1

• Patient Selection........................................................................................... 1

• MWL - Today’s Patients (Worklist Patients Scheduled for Today)........................... 2

• Worklist Patient Conflicts.................................................................................... 4

• MWL - Custom Query (Search the Worklist)......................................................... 5

• Local Database (Search Local Database or Add New Patient).............................. 7

• OMLocal (OfficeMate Practice Management Software)........................................ 9

• Administering the Test................................................................................ 10

• Patient Correction....................................................................................... 11

• Patient Seating and Position....................................................................... 12

• Explaining the Test Procedure to the Patient .............................................. 12

• Testing ........................................................................................................ 13

(6) Viewing and Printing Tests.............................................................. 1

• Chapter Overview ......................................................................................... 1

• Viewing Test Results .....................................................................................1

• Printing/Saving Test Results.......................................................................... 3

• Saving Tests ....................................................................................................... 3

• Printing Tests .....................................................................................................4

• Moving/Reassigning Tests............................................................................. 5

• Move to Folder ..................................................................................................5

• Reassign Tests.................................................................................................... 6

• Analysis ............................................................................................................. 7

• Sample Tests ................................................................................................. 8

(7) Database Management .................................................................... 1

• Chapter Overview ......................................................................................... 1

• Database Backup.......................................................................................... 1

• Database Import / Merge..............................................................................3

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• Conflict Resolution............................................................................................. 4

• Database Restore .........................................................................................4

• Restore User Settings....................................................................................5

(8) Networking Configuration............................................................... 1

• Chapter Overview ......................................................................................... 1

• Network Capabilities ....................................................................................1

• Risks of Internet Connectivity ....................................................................... 2

• Approved Third Party Hardware and Software..............................................2

• Using the Shared Network Folders ...............................................................2

• Network File Server System Requirements....................................................3

• Configuration to a Pre-existing Office Network............................................4

• Install the Network Cable................................................................................... 4

• Create a Shared Folder on Network File Server.................................................... 4

• Configure Network Settings on the Matrix .........................................................13

• Add Network Shared Folders.............................................................................14

• Selecting a Subfolder in a Network Share ..........................................................17

(9) Printer Configuration ....................................................................... 1

• Chapter Overview ......................................................................................... 1

• Introduction.................................................................................................. 1

• Approved Printers.........................................................................................1

• Printer Safety................................................................................................2

• Installation Overview.................................................................................... 2

• Printer Configuration....................................................................................3

• Connection Overview .........................................................................................3

• Optional USB Printer Installation.................................................................. 3

• Local Printer Power Connections ........................................................................3

• Print Settings................................................................................................ 5

v

(10) Maintenance ...................................................................................... 1

• Chapter Overview ......................................................................................... 1

• Service Information ......................................................................................1

• Technical Assistance Information..................................................................1

• Replacement Parts and Accessories.............................................................. 2

• Troubleshooting Guide..................................................................................3

• Upgrade System............................................................................................5

• Install Software ............................................................................................5

• Help (Including Calibration and Diagnostics) ...............................................7

• Export System Information ................................................................................. 8

• Calibration......................................................................................................... 9

• Diagnostics...................................................................................................... 10

• Logging............................................................................................................12

• Cleaning, Disinfection, and Sterilization..................................................... 14

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vi

(11) Specifications .................................................................................... 1

• Instrument Specifications .............................................................................1

• Chinrest Module Specifications.....................................................................1

• Environmental Specifications........................................................................ 2

• Visual Field Test Specifications......................................................................2

(12) Legal Notices...................................................................................... 1

(A) DICOM Gateway................................................................................. 1

• Chapter Overview ......................................................................................... 1

• Overview....................................................................................................... 1

• Configuration Overview................................................................................2

• DICOM Gateway Configuration.....................................................................3

• Enable DICOM................................................................................................... 3

• Local Application Entity Settings......................................................................... 4

• Remote Application Entities................................................................................ 4

• Advanced DICOM Settings .................................................................................6

• Automatic End of Test Export to a DICOM System........................................7

• Select DICOM as the Default Export Location...................................................... 7

• Select Export as an Automatic End of Test Action................................................ 8

(B) OfficeMate PMS Instructions........................................................... 1

(C) Data Transfer Using a CD.................................................................. 1

• Chapter Overview ......................................................................................... 1

• Compatible Data Transfer Functions.............................................................1

• Data Transfer Instructions............................................................................. 2

(D) Error Codes......................................................................................... 1

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(1) Introduction

Chapter Overview

Topics covered in this chapter:

• Instrument Overview, page 1-1

• Humphrey Matrix User Manual, page 1- 4

• System Hardware, page 1- 5

• External Device Equipment, page 1-1 0

• Instrument Installation, page 1-1 1

• Tips to Avoid Damage, page 1-1 1

• Product Compliance, page 1-12

• User Changes to Software or Hardware, page 1-12

• Safety, page 1-13

• Electromagnetic Compatibility (EMC), page 1-14

• Symbols and Labels, page 1-17

• Instrument Disposition, page 1-19

Introduction

1-1

Instrument Overview

Thank you for purchasing the Humphrey Matrix® Visual Field Instrument, featuring
Frequency Doubling Technology.

The Humphrey Matrix Visual Field Instrument is an innovative, efficient, and compact
automated visual field testing instrument. Years of research and clinical trials of the
patented Frequency Doubling Technology have resulted in an instrument that provides
rapid, clinically validated and user-friendly visual field testing.

Frequency Doubling Technology (FDT)

Frequency Doubling Technology (FDT) isolates a subset of low redundancy, retinal ganglion
cell mechanisms in the magnocellular (M-cell) pathway. These M-cells have large diameter
fibers and comprise only 3% to 5% of all retinal ganglion cells. Damage to these cells, for
example in the glaucoma disease process, is detected by Frequency Doubling Technology.

Key features of the Humphrey Matrix:

• World-class clinical validation by leading researchers in the field

• Statistically significant correlation to the Humphrey Field Analyzer

• Extensive age-normative reference database

• Accurate & reliable supra-threshold screening tests in less than 1 minute per eye

• Full-threshold test results in five minutes per eye

• 24-2, 30-2, 10-2, N-30 and Macula FDT full-threshold tests

• FDT N-30 threshold and screening tests

• Video eye monitoring for patient alignment and fixation monitoring

• Easy to use; no special operator training or certification is needed

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Introduction

• No corrective (trial) lens needed up to +/- 3 diopters; patients can usually wear their
own correction or none at all (see

• No eye patch is needed for the untested eye—it is automatically occluded

• Not affected by normal ambient lighting, so using normal room lighting is possible

• Native generic PCL® 3, PCL 5, and PostScript printer support for local USB printers

• Native generic PCL 3, PCL 5, and PostScript printer support for shared and networked
printers

• Optical drive for data transfer

• Ethernet connector for data transfer

• (Optional) DICOM Gateway for Modality Worklists and image transfer to a DICOM
System

• USB port for data transfer to USB hard drive, USB flash drive, or USB floppy drive

• Storage for more than 1 million patient tests and associated data

• Software upgrade capability for future enhancements

Intended Use

Humphrey Matrix is an AC-powered device intended to determine the extent of the
peripheral visual field of a patient. The device is intended to determine the amount of
visual field loss in a patient, which can then be used to diagnose/track the progression of
glaucoma and other eye diseases.

Patient Correction on page 5-11).

Indications for Use

Humphrey Matrix is an AC-powered device intended to determine the extent of the
peripheral visual field of a patient. The device is intended to determine the amount of
visual field loss in a patient, which can then be used to diagnose/track the progression of
glaucoma and other eye diseases.

Note: These perimetry results are an aid to interpretation, not a diagnosis. The doctor’s
judgment is still the most important element in determining the clinical significance of the
results, including considering the limitations of the statistical package.

Patient Population

The Humphrey Matrix may be used on all adults in need of diagnostic evaluation of the
eye. This includes (but is not limited to) patients with the following disabilities or
challenges:

• Wheelchair user

• Very low or not measurable visual acuity

• Fixation problems

• Deafness

• Large body, but not those above 99th percentile based on anthropomorphic data

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Introduction

There is a general requirement that the patient be able to sit upright and be able to place
their face in the forehead rest of the instrument (with or without supplemental human or
mechanical support).

Part of the Body

The Humphrey Matrix physically interacts with the patient’s forehead and chin. The
patient's hand and fingers (or similar ability) are also required to press the Patient
Response button.

Application

The Humphrey Matrix is designed for continuous use, although it is expected that most
sites operate the instrument for 10 hours or less per day, indoors, within a medical office or
hospital setting. This setting shall have clean air free of soot, vapors from adhesives,
grease, or volatile organic chemicals. Other Operating Environment specifications are given
in

Chapter (11), Specifications. Application related warnings are given in this chapter and

elsewhere.

User Profile

We assume that users are clinicians with professional training or experience in the use of
ophthalmic equipment, and in diagnostic interpretation of the tests. Specific assumptions
regarding the profiles of individuals performing instrument operation or data interpretation
are given below. This manual contains information that will aid in the proper instrument
operation and interpretation of the resultant data.

1-3

Instrument Operation

Demographic

The user should be adult, and at least one of the following:

• Ophthalmologist

• Nurse

• Certified Medical Technician

• Ophthalmic Photographer

• Non-certified Assistant

Occupational Skills

The user should be able to perform all of the following tasks:

• Power on the instrument

• Enter, find, and modify patient identifying data

• Clean surfaces that contact patient

• Instruct the patient

• Align the patient with the instrument

• Select and initiate a test

• Review and save a test or try again

• Generate an analysis report

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Introduction

• Review the analysis report for completeness

• Save, print, or export the analysis report

• Archive data

• Power off the instrument

Data Interpretation

Demogr

aphic

The user should be one of the following:

• Ophthalmologist or other Medical Doctor

• Optometrist or equivalent

Job Requirements

The user should have training and certification in the analysis and treatment of ophthalmic
diseases or other eye-r

elated medical issues as required by governing bodies.

Humphrey Matrix User Manual

Carl Zeiss Meditec designed this User Manual to serve as a detailed usage and reference
guide for the Matrix instrument. The Matrix User Manual instructs you in the procedures
for testing the patient, creating and managing patient records, and reviewing and printing
tests. We assume that users are clinicians or technicians with professional training or
experience in the use of ophthalmic imaging equipment, and in diagnostic interpretation
of the images generated.

Note: This manual provides instructions for System Software Version 8.0 on Model 800.

Note: For the purpose of this manual, a DICOM system, Patient Managment System (PMS),
and Electronic Medical Records (EMR) system are considered the same.

Organization of the Manual

Below are explanations of three symbols used throughout the manual that require special
atten

tion:

WARNING. Failure to follow instructions may result in a hazard that can lead to serious injury.
Instructions may also describe potential serious adverse reactions and safety hazards.

CAUTION. Failure to follow instructions may result in a hazard that may lead to moderate injury or
damage to the equipment or other property.

Note. Important information which should be given special attention.

This introductory chapter (1) provides a system overview and safety information. Chapter

(2) covers setup information. General operation and a screens overview are discussed in

chapter (3). Chapter (4) covers test results and reliability measures. Visual field test
procedures are outlined in chapter (5). Chapter (6) discusses viewing and printings tests.
Database Management is discussed in chapter (7). Chapter (8) discusses network
configuration. See (9) for printer information.

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Introduction

Other chapters and appendices include: (10) Maintenance, (11) Specifications, (12)

Legal Notices, (A) DICOM Gateway, (B) OfficeMate PMS Instructions, and (C)
Data Transfer Using a CD.

Text Conventions

• “Click” means “left-click”.

• Chains of menu or button items are indicated with the use of the “>” symbol between
items. For example, “File > Exit” directs you to select Exit in the File menu.

Selecting buttons

Select buttons and text fields by using the Track Pad on the keyboard. The Track Pad
controls the cursor like a mouse. The left button is used to select items or buttons. Double
tapping the track pad is the same as clicking the left button. The right button is not active
for the Humphrey Matrix software.

The OK button accepts the current screen and any data entered and moves to the next
screen, if applicable. The Cancel button will cancel current activity on the current screen
and return the display to the previous screen, if applicable. Pressing the Esc Key returns the
user to the previous screen. Selecting the Enter Key selects the default button on a screen.

1-5

Electronic User Manual Access

The Matrix User Manual is provided electronically in Adobe® Portable Document Format
(PDF) on the Humphrey Matrix User Documentation CD included in the instrument
accessory kit. You can view the User Manual PDF using any computer. If you do not have
Adobe Reader® installed, go to
Reader.

This User Manual is designed to help you understand the capabilities and operation of the
Humphrey Matrix Visual Field Instrument with Frequency Doubling Technology. This
instrument is designed for use by anyone familiar with the operation as described in this
manual; no special training or qualifications are required. To achieve satisfactory results,
read the User Manual thoroughly before using the instrument. Only appropriately trained
eye care professionals should perform interpretation of the results.

Additional References

Automated Static Perimetry, Second Edition, by Douglas R. Anderson and Vincent Michael
Patella (Mosby, Inc., St. Louis), is recommended for in-depth information and analysis of
visual fields.

www.adobe.com to download and install the free Adobe

System Hardware

With the exception of the keyboard, patient response button, chinrest module, and printer,
the Matrix System integrates all hardware components in a unit, which includes the system
computer and LCD screen display. The illustrations in
on the Model 800. System specifications are in Chapter (11), Specifications.

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Figure 1-1 label hardware elements

1-6

Introduction

Instrument Components

1

2

3

4

7

Figure 1-1 Matrix Model 800 Hardware Components

1. Patient Visor 4. USB Port 7. Patient Response Button

2. Operator Screen 5. Track Pad

3. CD-R/W Drive 6. Keyboard

6

5

and PRB holder

The instrument has a sliding Patient Visor that aids in isolating the eye for testing and
automatically occludes the opposite (untested) eye. A ¾-size keyboard with an integrated
track pad controls the operation of the instrument. A plain paper 8.5” x 11” USB inkjet
printer and a USB printer cable are included with the instrument. The detachable Patient
Response button with holder, two Power Cords (one for the instrument and one for the
printer), two Ethernet cables (one for a printer (in addition to the USB printer cable) and
one for networking), Calibration Cap, and dust cover are also provided.

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Introduction

1-7

1

2

3

Figure 1-2 Instrument – Patient Side

1. Patient Forehead Rest 2. Sliding Patient Visor 3. Power Switch

Underside Connectors

On the underside of the base of the Matrix are the computer ports described below.

Network Connector

The network connector is a standard RJ-45 (10/100 Base T) Ethernet port for connecting to
local ar

ea networks (LANs).

Universal Serial Bus (USB) Connectors

The Universal Serial Bus (USB) is a standard connector for peripheral devices. USB flash
drives, USB disk drives, USB floppy drives, USB keyboards, USB mice, and USB printers can
be connected to these ports (USB 2.0 specification, USB 1.1 compatible). There are two
USB ports on the underside of the base of the Matrix. The USB keyboard and integrated
track pad should be connected to one of the USB ports on the underside of the base of the
instrument. It is recommended to use the other USB port on the underside of the base of

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1-8

Introduction

the instrument for connecting a USB printer. The front USB port should be dedicated to
removable USB storage devices.

CAUTION: Connect ONLY the USB keyboard and integrated track pad supplied with
the instrumen
instrument.

RS-232 Connector

The RS-232 connector (Serial Port) is used by additional software products.

CAUTION: Connect ONLY RS-232 serial compatible computer ports to the computer
interface connector on the bottom of the instrument. Connection of any other
computer port or device to the computer interface connector may damage the
instrument.

Patient Response Button Connector

On the underside of the base of the Matrix is the Patient Response button connector
shown below

t or an approved replacement to a USB port on the bottom of the

.

Patient Response
button connector

Recessed USB Port

Figure 1-3 Patient Response button Connector on the Underside of the Instrument

USB Port

CAUTION: Connect ONLY the Patient Response button supplied with the instrument
or an approved replacement to the connector on the bottom of the instrument.
Connection of any other device to the patient response button connector may
damage the instrument or create an unsafe condition and will void the warranty.

Chinrest Module

The Model 800 includes a chinrest module to place the instrument on. The chinrest
module includes a k

eyboard tray and height-adjustable chinrest. The chinrest has color

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Introduction

markers indicating chin placement for each eye—white marker for left eye and blue
marker for right eye. The knobs on either side adjust the height of the chinrest.

1

2

1-9

3

Figure 1-4 Matrix Model 800 with Chinrest Module

1. Chinrest Height-adjustment knob 3. Blue (right eye) marker

2. Keyboard tray. Observe tray extension limit
marks on both sides of tray (see not below).

4. White (left eye) marker

4

Note: The keyboard tray may extend beyond the table top just up to the extension limit
marks on either side of the tray (Figure 1-4).

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1-10

Introduction

Matrix Instrument Software

Carl Zeiss Meditec pre-installs all software necessary to operate the Matrix System
instrument. Software updates with installation instructions may be provided on CD or on
the Matrix section of our website (

Data Storage

We recommend archiving data to a network file server. For non-networked environments,
an external USB hard drive can be used.

CAUTION: We do not recommend that you use optical disks for long-term data
storage or backup. Use should be limited to data transfer between systems. Take
care to protect these media from damage. We recommend you use hard plastic
cases when transporting and shipping these media. Optical disks are very
susceptible to scratches that could render them unreadable.

External Device Equipment

WARNING: To maintain patient safety, if the instrument is externally
connected to non-medical peripheral devices (i.e. printer, storage devices,
etc.), the complete system must continue to meet the applicable medical
requirements of IEC 60601-1 safety standard. This standard requires the
usage of an Isolation Transformer to power the non-medical peripheral
device if located within 1.5 m from the patient. If the peripheral device is
located outside the patient environment (beyond 1.5 m) and is connected
to the Matrix 800, a separation device must be used or there shall be no
metal to metal connection between the non-medical peripheral device and
the Matrix 800.

www.meditec.zeiss.com/matrix).

The person or the responsible organization connecting additional devices
or reconfiguring the system must evaluate the complete system to ensure
compliance to the applicable IEC 60601-1 requirements. The instrument
operator must not attempt to touch the patient and the peripheral device
simultaneously.

Failure to observe this warning could result in electrical shock to the
patient and/or examiner.

WARNING: Accessory equipment connected to the analog and digital
interfaces must be certified according to the respective IEC standards
(e.g., IEC 60950 for data processing equipment and IEC 60601-1 for medical
equipment).

Printers

See Chapter (9), Printer Configuration for more information.

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Introduction

Isolation Transformer

The Matrix instrument is designed with an integrated Isolation Transformer intended to
power an external printer through the power outlet on the Matrix. Any additional isolation
transformer used to power other peripheral devices must be approved for medical use and
must have a minimum rating that is sufficient for the device(s) being powered. CZM highly
recommends contacting your CZM representative for an isolation transformer qualified for
the Matrix.

Note: Technical support is not provided for accessory devices that have not been qualified
by CZM.

Instrument Installation

Care in Handling

Use extreme care when handling and transporting the Matrix shipping boxes.
The instrument contains fragile components.

Installation Requirements

• The Matrix should operate on a dedicated power outlet. Based on your specification,
we con

figure your Matrix at the factory to use either 100V, 115V, or 230V line voltage.

• An isolation transformer is required when connecting peripheral devices (i.e., printer,
USB stor

age device, etc.) to the USB ports that are plugged into electrical outlets.

1-11

Tips to Avoid Damage

CAUTION: Users are not authorized to dismantle or modify the Matrix hardware.

• Only Carl Zeiss Meditec authorized technicians should disassemble or service this
instrument.

• In case of emergency related to the instrument, unplug the power cord from the wall
outlet and call for service immediately
U.S., call 800-341-6968. Outside the U.S., contact your local CZM distributor.

• This instrument operates according to specifications under standard indoor office

escent) lighting conditions, without exposure to any direct sunlight.

(fluor

• Always select a location for your Matrix that allows easy access for both patient and
technician.

• Always operate the Matrix from a power source as specified. This source should be a
dedicated line. Use of a power sour
life of the unit and may cause damage in addition to improper operation.

• Always route electrical cables with safety as the first concern.

• Always unplug the Matrix before cleaning the plastic body panels or LCD screen. If the

CD or other body panels require more than a dusting, apply a mild cleaner to a soft

L
cloth to clean them.

• Use a UPS (Uninterrupted Power Supply) to protect data from power failures.

• Never lift the Matrix by the patient visor.

. For Carl Zeiss Meditec customer service: In the

ce other than indicated on the unit will shorten the

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Introduction

• Never position the Matrix in direct sunlight or near a direct source of heat.

• Never position the Matrix in a dusty location.

• Never attempt to change any of the batteries in the system. Attempting to change a
battery can cause damage and loss of data.

Product Compliance

Complies with 93/42/EEC Medical Device Directive.

OR

75

+

Complies with US and Canadian medical electrical system safety requirements.

User Changes to Software or Hardware

The Matrix is a medical device. The software and hardware have been designed in
accordance with U.S., European and other international medical device standards
designed to protect clinicians, users and patients from potential harm caused by
mechanical, diagnostic or therapeutic failures.

WARNING: Unauthorized modification of Matrix software or hardware
(including peripher

als) can jeopardize the safety of operators and
patients, the performance of the instrument, and the integrity of patient
data; it also voids the instrument warranty.

CAUTION: It is possible that Matrix functionality may be adversely affected by the
presence, installation, or use of third party software on the same computer. The
user, and not Carl Zeiss Meditec, assumes all risks associated with third party
software.

Protection of Patient Health Information

Note: Health care providers have responsibility for the protection of patient health
information (PHI), both hardcopy and electronic. To protect patient confidentiality of your
exported electr

onic data, the use of encryption is recommended and is the responsibility of

the user.

Note: To protect patient confidentiality of your electronic Matrix data, the Matrix software
is equipped with a built-in, non-configurable screen saver (blank screen) which activates

5 minutes of idle use. When a key is depressed or the trackpad is touched, the screen

after 1
saver is deactivated and the main menu appears.

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Introduction

Safety

Product Safety

This instrument is classified as follows:

• Class I Equipment – Protection against electrical shock.

•

Type BF – Degree of protection against electric shock of applied part (forehead rest
and Patient Response button).

• Ordinary Equipment (IPX0) – Degree of protection against ingress of liquids (none).

• Continuous Operation – Mode of operation.

WARNING: This device contains visual stimuli, including flickering light
and flashing patterns, between 5 and 65 Hz. Medical pr
determine whether this device should be used for patients who may be
photosensitive, including those with epilepsy.

WARNING: To prevent electric shock, the instrument must be plugged into
an earthed ground outlet. Do not remove or disable the ground pin.

CAUTION: Do not use the printer or the instrument with an extension cord or a
power strip (multiple portable socket outlet).

ofessionals need to

1-13

WARNING: Do not open the instrument covers. Opening the instrument
covers could expose you to electrical and optical hazards and will VOID
the warranty.

CAUTION: If a table is available, do not reconfigure system components on the table,
nor add non-system devices or components to the table, nor replace original system
components with substitutes not approved by Carl Zeiss Meditec. Such actions could
result in failure of the table height adjustment mechanism, instability of the table,
tipping and damage to the instrument, and injury to operator and patient.

CAUTION: This instrument may cause ignition of flammable gases or vapors. Do NOT
use in the presence of flammable anesthetics such as nitrous oxide, or in the
presence of pure oxygen.

CAUTION: Avoid tipping. Do not use the instrument on an uneven or sloped surface.
Also, do not roll the instrument table in deep pile carpet or over objects on the floor
such as power cords. Failure to observe these precautions could result in tipping of
the instrument and/or table and resulting injury to operator or patient and damage
to the instrument.

CAUTION: (United States) Federal law restricts this device to sale by or on the order
of a licensed healthcare practitioner.

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Introduction

WARNING: SERVICE or REPAIR to be performed by QUALIFIED,
AUTHORIZED PERSONNEL ONLY. There are NO USER SERVICEABLE PARTS
INSIDE the Humphrey Matrix instrument. Disassembly of the instrument
presents a possible ELECTRICAL SHOCK hazard and will VOID the warranty.
If the unit fails, contact CZM for instructions.

WARNING: REPLACEMENT PARTS and ACCESSORIES – Use only approved
replacement parts and accessories.

CAUTION: The appliance coupler is the main disconnect device of the instrument.
Position the instrument in such a way to have easy access to disconnect the
appliance coupler in case of an emergency.

Electromagnetic Compatibility (EMC)

Note: Essential Performance: To provide accurate visual field measurements.

Note: The Matrix needs to be installed and put into service according to the EMC
information provided herein.

Note: Portable and mobile RF communications equipment can affect medical electrical
equipment.

CAUTION: The use of accessories, transducers and cables other than those specified
may result in increased emissions or decreased immunity of the equipment.

CAUTION: The Matrix should not be used adjacent to or stacked with other
equipment.

CAUTION: DO NOT USE the instrument near other equipment that produces strong
magnetic fields (such as MRI). The video monitor performance may be adversely
affected.

Guidance and manufacturer’s declaration – electromagnetic emissions

The Matrix is intended for use in the electromagnetic environment specified below. The customer or user of the Matrix should assure that it is used in such
an environment.

Emissions Test Compliance Electromagnetic environment - guidance

The Matrix uses RF energy only for its internal

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/

flick

er emissions

IEC 61000-3-3

Group 1

Class B

Class A

Complies

Therefore, its RF emissions are very

function.
low and are not likely to cause any interference
in nearby electronic equipment.

The Matrix is suitable for use in all
establishmen
establishments and those directly connected to
the public low-voltage power supply network
that supplies buildings used for domestic
purposes.

ts, including domestic

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

Introduction

Guidance and manufacturer’s declaration – electromagnetic immunity

The Matrix is intended for use in the electromagnetic environment specified below. The customer or user of the Matrix should assure that it is used in such
an environment.

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment - guidance

Electrostatic Discharge (ESD)

IEC 61000-4-2

Electrical fast transient/burst

IEC 61000-4-4

± 6 kV contact

V air

± 8 k

± 2 kV for power supply lines

± 1 k

V for input/output lines

Surge IEC 61000-4-5 ± 1 kV differential mode

V common mode

± 2 k

<5% U

Voltage dips, short

terruptions, and voltage

in
variations on power supply
input lines. IEC 61000-4-11

40% U

(>95% dip in UT)

T

for 0,5 cycle

(60% dip in UT) for 5

T

cycles

70% U

(30% dip in UT) for

T

25 cycles

<5% U

(95% dip in UT) for

T

5 sec

Power Frequency

3 A/m 3 A/m Power frequency magnetic fields should be at levels

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

Note: U

is the a.c. mains voltage prior to application of the test level.

T

± 6 kV contact

± 8 kV air

± 2 kV for power supply lines

± 1 kV for input/output lines

± 1 kV differential mode

± 2 kV common mode

<5% U

(>95% dip in UT)

T

for 0,5 cycle

40% U

(60% dip in UT) for 5

T

cycles

70% U

(30% dip in UT) for

T

25 cycles

<5% U

(95% dip in UT) for

T

5 sec

Floors should be wood, concrete, or ceramic tile. If
floors are covered with synthetic material, the relative
humidity should be at least 30%.

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
commer

cial or hospital environment. If the user of the
Matrix requires continued operation during power
mains interruptions, it is recommended that the Matrix
be powered from an uninterruptible source.

char

acteristic of a typical location in a typical

commercial or hospital envrionment.

1-15

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

1-16

Introduction

Guidance and manufacturer’s declaration – electromagnetic immunity

The Matrix is intended for use in the electromagnetic environment specified below. The customer or user of the Matrix should assure that it is used in such
an environment.

Immunity Test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Portable and mobile RF communications equipment
should be used no closer to any part of the Matrix,

Conducted RF IEC 61000-4-6 3 Vrms

1

50 kHz to 80 MHz

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to 2,5 GHz

3 V

3 V/m

including cables, than the r
distance calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

d 1.17 P=

d 1.17 P= 80 MHz to 800 MHz

d 2.33 P= 800 MHz to 2,5 GHz

where P is the maximum output power rating of the
tr

ansmitter 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 electr
be less than the compliance level in each frequency

b

range.

Interference may occur in the vicinity of

equipment marked with the following symbol:

ecommended separation

omagnetic site survey,

a

should

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fr
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
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 Matrix is used exceeds the applicable RF compliance level above,
the Matrix should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting
or relocating the Matrix.

b

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

om structures, objects and

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

Introduction

Recommended separation distances between portable and mobile RF communications equipment

and the Matrix

The Matrix is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Matrix
can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the Matrix as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of
tr

ansmitter

W

0,01 0.117 0.117 0.233

0,1 0.370 0.370 0.737

1 1.170 1.170 2.330

10 3.700 3.700 7.368

100 11.700 11.700 23.300

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 fr
transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the higher frequency applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

equency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz

d = 1.17

Separation distance according to frequency of transmitter

m

P d = 1.17 P d = 2.33 P

1-17

~

O I

Symbols and Labels

WARNING

CAUTION

WARNING: Follow instructions for use. Failure to read and follow instructions may result in hazards
that can lead to serious injury. Instructions may also describe potential serious adverse reactions
and safety hazards.

Type BF applied parts: The Patient Forehead Rest and Patient Response button.

Alternating Current

Off On

Manufacturer

Authorized European Community Representative

Serial number

Catalog number / part number

Model number

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

1-18

Introduction

European Conformity

Disposal of the Product within the EU. Do not dispose via domestic waste disposal system or
communal waste disposal facility.

Protective Packing Symbols

The protective packing symbols specify the handling requirements and the transport and
stor

age conditions.

Handling Requirements Transport and Storage Conditions

Fragile, Handle with Care Relative Humidity (0% to 90%, non-condensing)

Keep Dry

This end up Atmospheric Pressure Limits (700 hPa to 1060 hPa)

Temperature (-20 to +60 deg. C)

Product Labels and Serial Number Location

On the lower left side of the instrument as facing the operator is the product label. On the
underside of the base of the instrumen

t is the serial number label.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

Introduction

Instrument Disposition

When it comes time to upgrade the Matrix, please contact Carl Zeiss Meditec to inquire
about trade-in or upgrade values we may offer. Should you not wish to trade in the
instrument, please dispose of it in accordance with local and national electrical and
electronic equipment recycling requirements.

Disposal

This product contains electronic components. At the end of its lifetime, the product should
be disposed of in accordance with the relevant national regulations.

Disposal of the Product within the EU

In accordance with applicable EU guidelines at the time at which the product was brought
into the market, the product specified on the consignment note is not to be disposed of via
the domestic waste disposal system or communal waste disposal facilities.

For further information on disposal of this product, please contact your local dealer or the
manufacturer or its legal successor company. Please read the latest internet information
provided by the manufacturer. Where the product or its components are resold, the seller
must inform the buyer that the product must be disposed of in accordance with the
currently applicable national regulations.

1-19

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

1-20

Introduction

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

Setting Up the Instrument

(2) Setting Up the Instrument

Chapter Overview

Because of its light weight and small size, you can set up your Matrix instrument virtually
anywhere in your office.

• Refer to (9) Printer Configuration and to the information provided in the printer
box for printer setup, use, maintenance and service information.

• Refer to the information provided in the chinrest module box for chinrest module setup.

• Refer to (8) Networking Configuration for networking information and setup.

• Refer to (A) DICOM Gateway if you want to use the DICOM Gateway software.

Topics covered in this chapter:

• Unpacking Equipment, page 2-1

• Preparation For Use , page 2-2

• Set Instrument Date and Time, page 2-2

• System Settings, page 2-3

• System Settings – General, page 2-4

• System Settings – Testing, page 2-5

• System Settings – Export, page 2-7

• System Settings – Backup, page 2-9

• USB Storage Devices, page 2-10

2-1

Unpacking Equipment

Two equipment boxes are shipped stapped together: the smaller box contains the chinrest
and keyboard tray. Unpack the smaller box first.

1. Open the shipping box by carefully cutting the packing tape securing the top flaps of
the box.

2. Lift out the top foam insert. There is an instruction sheet on top that shows how to set
up the chinrest assembly and how to attach the keyboard tray.

3. Pull out the chinrest assembly and place it on the table or surface area where you are
going to put the Matrix instrument. Following the enclosed instructions, attach the
keyboard tray.

Next, unpack the larger box, which contains the Matrix instrument, keyboard and other
items.

1. Open the shipping box by carefully cutting the packing tape securing the top flaps of
the box.

2. Lift out the top foam insert. Note the packing list, instructions, CDs, button and button
holder in the top foam cutouts.

3. Remove the keyboard from the bottom foam insert.

4. Lift the instrument out of the bottom foam insert by grasping the instrument at the
two cutouts provided.

5. Remove the Matrix Visual Field Instrument from the plastic bag.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

2-2

Setting Up the Instrument

6. Set the instrument on the chinrest assembly, as shown on the assembly instruction
sheet.

7. Check the equipment received with the packing list to ensure all parts are included.

Aligning the instrument with your patient is important for good test results. It is
recommended to use the chinrest module with the instrument. A height-adjustable table
and a height-adjustable patient chair are recommended when performing testing. See
instrument specifications – dimensions and weight – in Chapter 11 when considering
tables.

Note: Retain the shipping materials (box and packaging) in the event you ever need to
return the instrument to an authorized service or distribution location.

Preparation For Use

Once you have chosen a location, carefully lay the instrument on its side to prepare the
instrument for use by connecting all of the components.

Patient Response Button Connection

Plug the Patient Response button connector into the small round connector jack towards
the patient end, underneath the base of the unit (at the center) and near the patient
response button symbol. See

Patient Response Button Connector on page 1- 8.

USB Keyboard/Track Pad Connection

While the unit is still on its side, plug the USB keyboard and integrated track pad into one
of the USB ports on the underside of the base of the instrument. See

Chinrest Module

The Matrix Model 800 includes a chinrest module to place the Matrix instrument on
(Figure 1-5). See the installation instruction sheet for more information.

on page 1-7 .

Set Instrument Date and Time

To set the date and time, double-click on the date and time in the lower left corner of the
screen. This will open a window with a calendar and a clock. The arrows next to the year
box and time boxes are used to adjust these values, or type the values directly into the
boxes. Adjust the month by using the arrows to the right of the month or it can be changed
using the month pull down menu. Select the date from the calendar. Select Set Time Zone
to set your time zone. Once the appropriate changes are made select OK to save the
changes. If no changes were made, or to disregard any changes made, select Cancel.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

Setting Up the Instrument

System Settings

System Settings are provided to allow you to customize the operation of the Humphrey
Matrix instrument to meet your preferences and practice needs (see Figure 2-1). The

YSTEM SETTINGS Screen is comprised of eight screens: GENERAL, TESTING, EXPORT, BACKUP,

S

ETWORKING, DICOM GATEWAY, SHARING AND PRINTING. Click on a tab button to see the

N
screen. T
Select Reset Settings to return the first four tab settings — G
B
Screens are backed up with a database backup. To restore only user settings, see Restore

User Settings on page 7-5.

Note: Selecting Reset Settings does not affect NETWORKING,DICOM GATEWAY, SHARING or
P

ESTING and GENERAL factory default system settings are indicated by an asterisk (*).

ENERAL, TESTING, EXPORT and

ACKUP — to the factory default system settings. All user settings on the SYSTEM SETTINGS

RINTER settings .

2-3

Figure 2-1 System Settings – General Screen

The GENERAL, TESTING, , EXPORT, and BACKUP SYSTEM SETTINGS Screens are described below.

ETWORKING and SHARING SYSTEM SETTINGS screens are described in Configure

The N

Network Settings on the Matrix on page 8-13. The DICOM G

ATEWAY SYSTEM SETTINGS

Screen is described in (A) DICOM Gateway. The PRINTING SYSTEM SETTINGS Screen is
described in (9) Printer Configuration.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11

2-4

Setting Up the Instrument

System Settings – General

Date Format: Select the date format preferred from the drop down list. The date format
selected is used everywher

Time Format: Select either 12-Hour or 24-Hour (military) time formats. The time format
selected is used everywher

Tool / Button Tips: Turns popup text descriptions of buttons On or Off.

Language: Select the language used on the instrument. It is necessary to restart the
instrumen

t for the language to take effect.

Contact Information: Enter contact information for printing on the visual field printouts in
the lower right corner
Update to accept a change to the Contact Information.

Issuer of Patient ID: Issuer of Patient ID is a DICOM data field to specify the assigning
authority of the P

atient ID. The Issuer of ID should be a practice-wide identifier which is the
same for all instruments and patient information systems. By default, the Issuer of Patient
ID is “Matrix - SN’, where SN is the serial number of the Matrix. You can enter text in this
field and then select Update to accept the change to the Issuer of Patient ID. Note that this
change will only affect new patients—the current Issuer of Patient ID will not be changed
for patients currently in the local database. To change the Issuer of Patient ID for existing
patients, select V

IEW PATIENTS (F2), select a patient, and then select the Revise Info button

to edit the Issuer of Patient ID field.

e the date is displayed or printed.

e the time is displayed or printed.

. Typical use is to enter information for the practice or doctor. Select

Note: If DICOM Gateway is enabled, editing patient information (or merged into an
existing patient) received from DICOM systems is disabled. Patient edits must be done at
the DICOM system or disable DICOM Gateway to edit patien

t information on the

instrument.

Patient Source: Select the default source of patients on the V

IEW PATIENTS (F2) Screen. See

Patient Selection on page 5-1 for more information.

Humphrey Matrix User Manual 2660021138935 Rev. F 2015-11