OCULUS Easyfield C User manual

OCULUS Easyfield®C/Easyfield®S
INSTRUCTION MANUAL
Examination of the Central Visual Field

i / iii Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
Noteson thisinstruction manual
The Easyfield® was manufactured and tested under strict quality criteria. You have se-
lected a modern and well-engineered product.
To ensure safe operation, it is essential that you use the device correctly. For this reason
you should familiarize yourself thoroughly with the contents of this instruction manual
before operating the device. In particular, pay attention to the safety instructions.
The user guide of the Easyfield® perimeter will provide you with extensive information,
especially about the evaluation programs and displays produced by the examinations.
Due to ongoing development your device might present minor differences compared to
the information contained in this manual.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us an e-mail or a fax. Our service team will gladly assist you.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 13485 and thus has established a high
standard of quality for development, manufacture, quality assurance and service for
our entire product line.

Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) ii / iii
Table of contents
1 Scope of Delivery.........................................................................................................................1
1.1 Software Version ............................................................................................................2
2 Reference numbers on the device ..........................................................................................3
3 Structure of the Documentation ............................................................................................4
4 Safety instructions......................................................................................................................5
4.1 In this handbook.............................................................................................................5
4.1.1 Used pictograms............................................................................................5
4.2 Safety Instructions for Use..........................................................................................6
5 Intended Use.............................................................................................................................. 12
6 Device Description ................................................................................................................... 13
6.1 Operation of the Easyfield®...................................................................................... 14
7 Preliminary steps...................................................................................................................... 16
7.1 Install the software..................................................................................................... 16
7.2 Set-up............................................................................................................................. 16
7.3 Connect .......................................................................................................................... 16
7.4 Setup tasks for Initial Start-Up............................................................................... 19
8 Daily operation ......................................................................................................................... 19
8.1 Switching on Easyfield® ............................................................................................ 19
8.2 Switching off Easyfield® .......................................................................................... 19
9 Patient Data Management .................................................................................................... 20
9.1 Starting Patient Data Management....................................................................... 20
9.1.1 Enter a new patient .................................................................................. 21
9.1.2 Select an existing patient ....................................................................... 21
9.2 Starting the Easyfield® program............................................................................. 22
10 The Easyfield® program.......................................................................................................... 23
11 Measurement Procedure........................................................................................................ 24
11.1 Preparing the Examination....................................................................................... 24
11.1.1 Selecting the Examination program..................................................... 24
11.1.2 Determining the Required Correction.................................................. 24
11.1.3 Inserting the Corrective Lens ................................................................. 26
11.1.4 Preparing the Patient................................................................................ 26
11.1.5 Positioning the patient ............................................................................ 27
11.1.6 Positioning of the pupil ........................................................................... 29
11.1.7 Measuring the Pupil.................................................................................. 29
11.2 Starting the examination.......................................................................................... 29
11.3 Interrupting the Examination .................................................................................. 31
11.4 Ending the Examination ............................................................................................ 32
11.4.1 Saving the Examination Data................................................................. 32
11.5 Performing a re-examination................................................................................... 33

iii / iii Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
12 Working with the Patient Data Management system ...................................................35
12.1 Rename Patient Data..................................................................................................35
12.2 Exporting Patient Data...............................................................................................35
12.3 Importing Patient Data ..............................................................................................36
12.4 Data Backup ..................................................................................................................38
12.4.1 Backup Data.................................................................................................38
12.4.2 Reconstructing Data..................................................................................39
12.4.3 Automatic Backup......................................................................................39
13 Cleaning, disinfection and maintenance ...........................................................................40
13.1 Cleaning..........................................................................................................................40
13.2 Disinfection....................................................................................................................41
13.3 Maintenance .................................................................................................................42
14 Troubleshooting ........................................................................................................................43
15 Transport and storage .............................................................................................................44
15.1 Disassembly and packing...........................................................................................44
15.2 Transport and Storage Information ........................................................................44
16 Disposal .......................................................................................................................................45
17 Terms of Warranty and Servicing ........................................................................................46
17.1 Terms of warranty........................................................................................................46
17.2 Assumption of liability for functions and damage.............................................46
17.3 Manufacturer’s address and service department: ..............................................47
18 Technical Data...........................................................................................................................48
19 Annex...........................................................................................................................................51
19.1 Electromagnetic Compatibility ................................................................................51
19.2 Guidance and Manufacturer’s Declaration -
Electromagnetic Emmisssions and Immunity for the Easyfield® ...................52
19.3 Description of the Connection.................................................................................56
19.4 Data Sheet GSM40B12-P1J (05150805) ..............................................................57

1 Scope of Delivery
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 1 / 60
1 Scope of Delivery
If you find transport damage upon delivery, immediately file a claim
with the transport company.
Have the damages noted on the bill of lading so that your claim for
damages can be handled properly.
Note
We reserve the right to change the scope of delivery in line with ongoing
technical developments.
Product and accessories Order number
Version:
OCULUS Easyfield® C perimeter
(with chin support)
OCULUS-Easyfield® S perimeter
15000
15005
Data medium with software 15110/15120
Dust cover Easyfield® C
Dust cover Easyfield® S
1500011001
6010005001
Hand-held button 56517
Lens holder for inserting trial lenses 1500007000
Eyepatch 44560
Eye shield, translucent 1500008001+002
Instruction Manual
User Guide
Software Installation
GA/15000/XXXX/EN 1219 Rev01
BH/15000/0412/en
SI/50000/xxxx/en
USB cable 05200560
USB FS MED Isolator 015692000010
Power supply GSM40B12-P1J 05150805
Optional Accessories
Compact Laptop Stand 37499
Carrying case for Easyfield® S 56936

1 Scope of Delivery
2 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
1.1 Software Version
This User Manual describes the following versions of the Easyfield®-
Software together with patient data management:
Easyfield®-Software: from Version 3.19
Patient Data Management Version 6.08
☞
The software version for patient data management is displayed on
the "settings" page inside the patient data management.
The software version of the Easyfield®-Program is displayed on the
"settings" page inside the Easyfield®-Program.

2 Reference numberson the device
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 3 / 60
2 Reference numberson the device
More symbols on the device
Graphic symbols on packaging
1 Company logo 10 Power adapter with OCULUS no.
2 Company address 11 Safety symbol
3 Date of manufacturing 12 Protection class protection
4 UDI-Nummer 13 Type B unit
5 Matrix for device identification 14 Disposal in household trash is prohibited
6 CE Conformité Européenne 15 Serial number of the device
7 Degree of protection 16 Reference number
8 Heed Instructions Manual 17 Device name and device number
9 USB FS MED isolator with order no.
Fig. 2-1: Symbols: Example type plate Easyfield® C
12
13
3
17
8
6
7
11
9
15
16 5
4
10
14
12
Applied part type B unit Easyfield® S:
Make sure that the device
cannot tip over by leaning
against it or sitting on it.
keep dry this way up fragile
permitted
temperature range:
transport
permitted
temperature range:
storage
Transport
Storage

3 Structure of the Documentation
4 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
3 Structure of the Documentation
A folder containing a set of documentation is supplied with your
Easyfield® perimeter:
Quick Guide: In this document a checklist of the measurement
procedure is supplied. The document is intended to help you
familiarize with the equipment. The Quick Guide reminds you all
important steps in order to obtain correct results.
Instruction Manual: The design of the unit is described in detail in
this document. The instruction manual also gives you general
information about working with the Patient Data Management
system and all safety-related instructions for use of the Easyfield®
perimeter.
Caution
All safety-related instructions for use of the Easyfield® perimeter are
given in the Instruction Manual for the unit. It is therefore imperative that
you read and understand the whole Instruction Manual before you use
the Easyfield® perimeter.
User Guide: All features of the examination and analysis software
are described in the instruction manual, along with detailed
information about the Patient Data Management system.
Software Installation: The introduction to the Software Installation
describes how to install the Easyfield® perimeter software and the
associated drivers.
If you use a Floating License Key: information on the use of the
Easyfield® within networks.

4 Safety instructions
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 5 / 60
4Safetyinstructions
This chapter contains a summary of the most important safety-related
information.
4.1 In thishandbook
 Carefully read through the Instruction Manual.
 Keep the Instruction Manual, the Quick Guide and the User Guide in
good condition near the unit.
 Observe the legal regulations with regard to accident prevention.
4.1.1 Used pictograms
Warning
Indicates a potentially hazardous situation that may result in irreversible
injury.
Caution
Identifies a potentially dangerous situation which may cause minor injury
or damage to property.
Note
Denotes situations which could result in incorrect findings, denotes user
instructions and useful or other important information.
☞
Identifies important information about the product and its usage, which
require special attention.

4 Safety instructions
6 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
4.2 Safety Instructionsfor Use
Caution
Personal injury or property damage due to improper operation.
 Observe the following safety instructions.
Personal injury or property damage due to equipment modifications
related to safety.
 No modifications may be made to this device without the permission of
the manufacturer.
Instructions to operating personnel
 The e device may only be operated by personnel instructed to do so, who,
with appropriate training, knowledge and practical experience, are able
to ensure proper handling of the device.
Transport and Storage Instructions
Refer to the notes in sec. 15, page 44.
Instructions regarding the set-up and electrical connection
 Do not use or store the Easyfield® in damp rooms and do not store the
unit in such areas.
 Keep the Easyfield® away from water that may drip, surge or splash and
make sure that no liquids can enter the Easyfield® device. Do not place
any containers with liquid either close to or on the Easyfield® device.
 Germany: Only operate the Easyfield® in rooms used for medical
purposes if VDE 0100-710 installation procedures have been observed.
 Do not operate the devices included in the delivery in areas where
explosions may occur, where there are inflammable anesthetics or
volatile substances such as alcohol or petrol nearby.
> This symbol denotes menu paths and screen shots. Example: Call
up a new patient:
 Easyfield® > Examination > New Patient
That is:
 Open the Easyfield® program.
 In the menu list, select the ”Examination“ menu item.
 Click on “New Patient”.

4 Safety instructions
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 7 / 60
 Only use a power cord which meets the requirements of the standards
IEC 60227-1, Type 53, min. 0,75 m² and IEC 60320-1.
 Set up the Easyfield® 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.
 Do not force any plug connections.
If you are unable to make a plug connection, check whether the plug
fits the socket.
If you detect damage to the connection, you should let our service
department or authorized dealer repair the damage.
 Use only the OCULUS USB FS MED isolator (no. 01 56920 00 010) for a
USB connection.

4 Safety instructions
8 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
Patient environment information
Patient environment is the area where patients can come into contact
with any part of a medical electrical equipment (ME equipment) or with
another person being in contact with the ME equipment. In the patient
environment, use devices that conform to IEC 60601-1. If a multiple
power socket is to be used, or if a device is to be used that does not meet
the IEC 60601-1 standard, use an isolating transformer.
Information about the operation of an ME system
The Easyfield® and a connected computer form a medical
electrical system (ME system) according to DIN EN 60601-1. If you
connect additional devices, such as, for example a printer, those devices
become part of the ME system.
 Make sure that all devices of the ME system meet the requirements of
IEC 60601-1 or IEC 60950-1
Fig. 4-1: Patient environment

4 Safety instructions
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 9 / 60
Instructions for operation
 Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Easyfield®.
 Never operate a damaged Easyfield®.
 Only operate the Easyfield® using original accessory parts supplied by us,
and when the device is in technically correct working order.
 Do not touch the patient and the Easyfield® simultaneously.
 Make sure that the device cannot tip over by leaning against it or sitting
on it.
 Do not use the device if you have not understood the Instruction
Manual.
Notes on maintenance
 When cleaning, use a damp cloth and make sure that no liquid enters
the Easyfield®.
 To ensure that it functions correctly and safely we recommend the
following: Have the Easyfield® checked every two years by our service
department or an authorized dealer. If an error occurs which you are
unable to correct, label the Easyfield® as "out of order" and contact our
service department or an authorized dealer.
Instructions on disassembly and disposal
 When disconnecting electrical connections, pull on the respective plug
instead of the cable itself.
 Dispose of the unit in conformance with legal requirements.
Instructions on Electrical Safety
Caution
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Easyfield® with its non-medical electrical equipment (e.g.
data processing equipment) to a medical electrical system must not result in
a patient safety level below that prescribed by DIN EN ISO 60601-1. If making
this connection leads to the leakage current threshold being exceeded,
protective measures including a circuit breaker must be in place.
 Ensure that connections with non-medical devices are made correctly.
 Only use the power adapter listed in the packing list.
 Use only a computer that meets the specifications given in this
instruction manual,
sec. 18, page 48 .

4 Safety instructions
10 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
Caution
Use of a multiple socket extension cord
Risk of personal injury or material damage caused by unsafe multiple
socket extension cord
If you use a multiple socket extension cord to connect the
Easyfield® to the power supply, you must heed the following information:
 Use an extension cord that complies with the requirements of DIN EN
ISO 60601-1: 20005, section 16.
 Do not place the multiple socket extension cord on the floor.
 Do not use more than one multiple socket extension cord.
 Plug only the Easyfield® and the computer that is being used with the
unit (if applicable) into the multiple socket extension cord.
If you are using a multiple socket extension chord it has to be supplied
with a isolation transformer.
If you are using a new computer for the Easyfield®, you must have the
electrical safety checked. Call OCULUS Service for this purpose.
Electromagnetic Compatibility (EMC/Cables)
Risk of personal injury or damage to property due to electromagnetic in-
terference
Portable and mobile RF communications equipment can affect medical
electrical equipment sec. 18, page 48.
 Make sure that portable and mobile RF communications equipment do
not cause interference.
 Recommendation: Maintain a minimum distance of 4 m. If the
distance is shorter, you must ensure that the Easyfield® functions
correctly.
Cybersecurity
☞
Do not use the Easyfield® with wireless technology, for example with
wireless USB
To ensure cyber security in order to the usage of the device, the following
security measures should be considered. Contact your computer
administrator:

4 Safety instructions
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 11 / 60
Precautions for access control of the computer
 Secure the computer with a password (for example at Windows start up).
Choose a complex password: A good password should be at least
eight characters long and are not in the dictionary. In addition to
letters, it should also include numbers and special characters.
Do not choose a name or device name for a password (for example
“Easyfield”).
Change the password regularly.
Do not note the password in an accessible location.
Use different passwords for different users.
Enable the screen saver and use the option for the necessity of re-
entering the password when exit the screen saver.
Choose an adequate time setting for starting the screen saver if
software session is inactive (e.g. 10 minutes). Adequate time setting
should consider duration of examination, number of patients, time
between examinations, use of other devices in the examination
room, several user, etc.
Lock the computer if you are leaving the workstation (shortcut:
‘windows logo key’ + ‘L’).
Precautions if the computer is connected to a LAN or internet network
Prefer wired connections of the computer to the network.
If you are using Wi-Fi connections nevertheless, please ensure the
usage of adequate security methods (for example WPA2/AES – Wi-
Fi Protected Access / Advanced Encryption Standard – with a strong
network key).
The usage of a firewall (software or hardware) is recommended.
Recommendation: Use anti-malware tools with up to date malware
definitions.
Note
Also observe the regulations, notes and recommendations of the
Bundesamt für Sicherheit in der Informationstechnik for the protection of
critical infrastructures.

5 Intended Use
12 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
5 Intended Use
The Easyfield® is intended for the use described in this Instruction
Manual. It is designed for testing the visual field of the human eye.
The Easyfield® offers pre programmed combinations for often needed
examination routines. For example: Screening 24-2, SPARK Quick,
Macula. Custom routines can also be combined and saved as programs.
No other software programs (screen saver, applications, etc.) must run
simultaneously with the examination program in the foreground on the
computer that controls the Easyfield® perimeter.
Only operate the device using original accessory parts supplied by us, and
when the device is in technically correct working order.
 Note the safety instructions listed above.
Contrindication
None known.

6 Device Description
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 13 / 60
6 Device Description
1 Forehead rest 6 Stand support*
2 Eye shield 7 Power On/Off switch
3 Perimeter cone with mounts for correction lens holder 8 Port for external power supply
4 Chin rest* 9 USB port for connection with netbook/PC/laptop
5 Chin rest adjustment knob* 10 Port for connection with hand-held button
Fig. 6-1: Overview Easyfield®
* Easyfield® C only
2
3
1
4
5
6
7
89
10

6 Device Description
14 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
6.1 Operation of the Easyfield®
The OCULUS Easyfield® has been designed for combined use as a
screening unit with all associated options for immediate follow-up
examination of suspicious findings. The most common examination grids
and strategies for the central visual field up to 30° can be accessed.
The Easyfield® offers pre programmed combinations for often needed
examination routines. For example: Screening 24-2, SPARK Quick,
Macula. You can also combine your own routines and then save them as
a program.
The integrated perimeter bowl of the Easyfield® with its 30 cm radius and
a distance-correcting lens meets the Goldmann standard. The unit
complies with the ISO Norm 12866 for perimeters.
The Easyfield® has a grid of 135 test points, including the 30-2 and 24-2
patterns and additional test points in the 10° range (10-2 pattern).
The Easyfield® can be controlled with a netbook, a laptop or a PC.
Perimeter cone: Due to the closed construction it is not necessary to
darken the room for the exam.
Chin rest: The adjustable chin rest ensures increased maximum patient
comfort during the exam.
Corrective lens holder: The corrective lens holder can be easily and
securely suspended from the two mounts.
Software principle:
The Easyfield® operates with two programs acting in concert to process
the supplied values and an analysis program:
Patient Data Management
Use this program to manage the patient data.
Easyfield® program:
This program performs the examination and most of the result
analysis.
TNT program:
This program compares existing exams and provides support in a
progression analysis.
Note
Misuse of data
OCULUS Optikgeräte GmbH can not be held liable in any form for further
use of the data recorded by a Easyfield® and for the evaluations it has
calculated.

6 Device Description
Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01) 15 / 60
Applied parts
1 Chin rest (Easyfield® C only)
2 Hand-held button
3 Forehead rest
Fig. 6-2: Applied parts
1
32

7 Preliminary steps
16 / 60 Instruction Manual Easyfield® (GA/15000/XXXX/EN 1219 Rev01)
7Preliminarysteps
Before the initial operation of the Easyfield® you must first -
Install the software sec. 7.1, page 16
Set up the Easyfield® sec. 7.2, page 16
Connect the Easyfield® sec. 7.3, page 16
Ensure operational readiness, sec. 8.1, page 19
Set up firmware and drivers, sec. 7.4, page 19
Caution
Improper set-up may result in incorrect measurements or equipment
damage
 Before you use the device for the first time, the Easyfield® must be
installed and connected by our service personnel or by an OCULUS-
authorized specialist.
7.1 Install the software
If you are working with a PC or laptop, you must install the Easyfield®
software. The Easyfield® software consists of the following programs
which are installed together.
Patient Data Management
Easyfield® program
TNT program
 Proceed as described in the Software Installation
 After installing the software, restart the PC or laptop.
7.2 Set-up
The Operating Instructions are found in “Ambient operating
requirements” page 49.
 Remove the Easyfield® from the packaging.
 Place the Easyfield® on a level surface.
 Dispose of the packing material in a proper manner.
7.3 Connect
You must connect the Easyfield® to the power supply, and depending on
the configuration, to the netbook, the laptop or PC. Connection and set-
up will be demonstrated using the example of a netbook connection.