OCULUS Binoptometer 4P User manual

OCULUS Binoptometer
®
4P
OCU
L
US
Binoptomete
INSTRUCTION MANUAL
Vision Test Device

i / iii Instruction Manual Binoptometer® 4P (G/59860/1016/en)
Notes on this Instruction Manual
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.
Also read the User Guide Binoptometer 4P. There you will find all information about the
screening programs and testing.
With the Binoptometer 4P you can determine visual acuity, test binocular vision, color
vision, contrast sensitivity and peripheral visual field perception.
You also have the option to test mesopic vision and glare sensitivity.
Due to ongoing development, the diagrams shown may depict minor changes to the
actual device delivered.
If you have any queries or would like additional information about your device, do not
hesitate to call or send us a mail or a fax. Our service team will gladly assist.
OCULUS Optikgeräte GmbH
OCULUS is certified according to DIN EN ISO 13485, setting high standards of quality
for the development, manufacture, quality assurance and service of the entire range of
products.

Table of Contents
Instruction Manual Binoptometer® 4P (G/59860/1016/en) ii / iii
Table of Contents
1 Delivery and Packing List..........................................................................................................1
2 Symbols on the Equipment ......................................................................................................2
3 About this Manual......................................................................................................................3
3.1 Structure of the Documentation................................................................................3
3.2 Software Version ............................................................................................................3
4 Safety Instructions......................................................................................................................4
4.1 About this Manual .........................................................................................................4
4.1.1 Used Graphic Symbols.................................................................................4
4.2 Safety Instructions for Use of the Binoptometer® 4P .........................................5
5 Intended Use.................................................................................................................................9
6 Device Description ................................................................................................................... 10
6.1 Front View .................................................................................................................... 10
6.2 Rear View....................................................................................................................... 10
6.3 Mode of Operation of the Binoptometer® 4P ..................................................... 11
7 First-time Operation................................................................................................................ 11
7.1 Set Up for Initial Use.................................................................................................. 12
7.2 Connecting .................................................................................................................... 13
7.3 Software Installation.................................................................................................. 14
8 Daily Startup.............................................................................................................................. 15
8.1 Setup and Connection for Daily Operation.......................................................... 15
8.2 Clean the Device Viewer............................................................................................ 16
8.3 Use of the External Light Shield.............................................................................. 16
8.4 Turning On..................................................................................................................... 16
9 Conducting an Examination.................................................................................................. 17
9.1 Find the Patient in the Patient Data Management or
Create a New Record.................................................................................................. 17
9.1.1 Starting the Patient Data Management ............................................. 18
9.1.2 Entering a New Patient............................................................................ 19
9.1.3 Selecting an Existing Patient ................................................................. 19
9.2 Change Settings........................................................................................................... 20
9.3 Prepare Patient for the Examination ..................................................................... 28
9.4 Select and Start Exam................................................................................................ 31
9.5 Display and Print Results........................................................................................... 33
9.6 Finishing the Exam...................................................................................................... 33
9.7 Load Existing Examination........................................................................................ 34
9.8 Turning Off .................................................................................................................... 35
10 Exporting Results via the Patient Data Management ................................................... 36
10.1 Exporting Patient Data .............................................................................................. 36
10.2 Importing Patient Data.............................................................................................. 37

Table of Contents
iii / iii Instruction Manual Binoptometer® 4P (G/59860/1016/en)
11 Cleaning, Disinfection and Maintenance .......................................................................... 38
11.1 Cleaning ......................................................................................................................... 38
11.2 Disinfection ................................................................................................................... 39
11.3 Care and Maintenance............................................................................................... 40
11.3.1 Forehead Rest Replacement ................................................................... 40
11.3.2 Replacing the Fuse .................................................................................... 41
12 Transport and Storage ............................................................................................................ 42
12.1 Disassembly and Packing .......................................................................................... 42
12.2 Transport and Storage................................................................................................ 43
13 Disposal....................................................................................................................................... 44
14 Troubleshooting........................................................................................................................ 44
15 Terms of Warranty and Service............................................................................................ 45
15.1 Terms of Warranty ...................................................................................................... 45
15.2 Assumption of Liability for Functions and Damage .......................................... 45
15.3 Manufacturer and Service Address ........................................................................ 46
16 Declaration of Conformity.....................................................................................................47
17 Technical Data .......................................................................................................................... 48
18 Appendix..................................................................................................................................... 50
18.1 Electromagnetic Compatibility................................................................................ 50
18.2 Guidelines and Manufacturer’s Declaration
Electromagnetic interference emissions............................................................... 51
18.3 Description of the Connection................................................................................. 55

1 Delivery and Packing List
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 1 / 55
1 Delivery and Packing List
If transport damage is discovered from the shipment, please file a
complaint with the shipping company immediately.
Component Order number
Binoptometer® 4P with height adjustment 59860
Alternative: Binoptometer® 4P without height adjustment 59862
Accessory kit, consisting of:59871
Dust protection cover 02 59860 00 003
Instruction Manual
User Guide
Software Installation
Patient Instructions
G/59860/.../en
BH/59860/../en
SI/50000/.../en
PA/59860/.../in
Forehead rest (as a replacement) 07 59860 01 007
Disinfectants and cleaning kit, comprising:
Mikrozid sensitive wipes premium
Optical lens and spectacle glass wipes, 10x (double pack)
59869
05490175
05490165
Device connection lead, 2.5 mm, black 05200320
Software module Binoptometer® 4P 59866
USB memory stick with software 59880
USB-cable 80 cm
Alternative: USB-cable 3 m
Alternative: USB-cable 1,8 m
02 59860 00 002
02 59860 00 004
02 59860 00 005
Optional: Tablet-PC
Tablet-PC
59870
05460851
Optional: Netbook „state of the art"
Netbook
Mini Maus black, with cable
Protetection cover for the netbook
59867
05460038
05460582
05460583
Optional: Software for testing the mesopic vision and glare sensitivity
Cover, black
Wash instruction for cover
59863
027070000006
027070000007
Software for eyesight tests suitable for children
incl. Patient Instructions
59885
PA/59887/.../en
Optional: External light shield 59873
Optional: Carrying case for Binoptometer® 4P 59864
Optional: Trolley case with telescopic pull handle 59868
To order: Fuses, 1.25 A, delayed-action 05100170

2 Symbols on the Equipment
2 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
Have the damage confirmed on the bill of lading so that an orderly
handling of the complaint for damages is possible.
Note:
We reserve the right to change the scope of delivery in line with ongoing
technical development.
2 Symbols on the Equipment
Graphic symbols on packaging
1Company logo + address 8Heed Instruction Manual
2Disposal in household trash is
prohibited
9Fuses
3Type B applications only 10 US patent number
4CE 10 Power supply voltage
5Device number 11 Serial number of the device
6Protection class 12 Device name
7Matrix
Fig. 2-1: Figure legend
1
9
5
8
11
2
4
7
12
13
3
10
6
keep dry this way up fragile
permitted
temperature range:
transport
permitted
temperature range:
storage
Transport
Lagerung

3 About this Manual
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 3 / 55
3 About this Manual
3.1 Structure of the Documentation
A folder containing a set of documentation is supplied with your
Binoptometer® 4P:
Instruction Manual: The design of the unit is described in detail in
this document. In the Instruction Manual, you will also find all
safety-related instructions for use of the
Binoptometer® 4P and the examination procedure.
User Guide: The User Guide describes the basic operation of the
Binoptometer® 4P program; all tests are described, how to create an
examination program is explained and more detailed information
about the Patient Data Management system is given.
Software Installation: The introduction to the Software Installation
describes how to install the Binoptometer® 4P software and the
associated drivers.
Patient Instructions: This user guide assists you in your
communication with the patient.
3.2 Software Version
This User Guide describes the following Binoptometer® 4P software
versions and the Patient Data Management:
Binoptometer® 4P software: Version 1.0.4.x
Patient Data Management Version 6.08
☞
Note
The Patient Data Management software version is displayed on the
“Settings” screen in the Patient Data Management (User Guide).
The software version of the Binoptometer® 4P program is shown on
the “Setting” screen within the Binoptometer® 4P program (User
Guide).

4 Safety Instructions
4 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
4SafetyInstructions
This chapter contains a summary of the most important safety-related
information.
4.1 About this Manual
Read the User Instructions and the User Manual carefully.
Keep the User Instructions handy and in the immediate vicinity of
the equipment.
When the device is delivered with a netbook: Read the User
Instructions for the netbook.
Observe the legal requirements for accident prevention.
4.1.1 Used Graphic Symbols
Caution
Denotes a potentially hazardous situation which can easily result in minor
physical injury or property damage.
Note:
Identifies situations which can result in property damage, or denotes
application information and useful or other important information.
☞
Provides more thorough information on the product or its handling which
require more careful attention.

4 Safety Instructions
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 5 / 55
4.2 Safety Instructions for Use of the Binoptometer® 4P
Caution
Personal injury or property damage due to improper operation
Observe the following safety instructions.
Personal injury or property damage due to equipment modifications
which impair safety
No modifications may be made to this device without the permission
of the manufacturer. Only the OCULUS service and authorized
dealers are allowed to modify the device
Instructions for Operating Personnel
Make certain that the Binoptometer® 4P is used exclusively by
personnel that have the training and practical experience to safely
and properly operate the equipment.
Transport and Storage Instructions
Refer to the notes in sec. 12, page 42.
Instructions for Setup and Connection
Do not use or store the Binoptometer® 4P in rooms that are humid.
Keep the Binoptometer® 4P away from water that may drip, surge or
splash on it, and make sure that no liquids can enter the device. Do
not place any containers with liquid either close to or on the
Binoptometer® 4P.
Germany: Only operate the Binoptometer® 4P in rooms used for
medical purposes after they have been set up according to the VDE
Regulations 0100-710.
Do not operate the equipment included in the packing list in
explosive environments, in the presence of combustible narcotic
agents or volatile solvents such as alcohol, benzene, etc.
Set up the Binoptometer® 4P 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 use excessive force when connecting the electrical plug.
If a connection is not possible, check whether the plug fits the jack.
If you find damage to the plug connector, have the damage
corrected by our service department.

4 Safety Instructions
6 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
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.
Fig. 4-1: Patient environment

4 Safety Instructions
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 7 / 55
Information about the operation of an ME system
The Binoptometer® 4P 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.
Instructions for Operation
Never put a damaged Binoptometer® 4P into operation.
Only operate the Binoptometer® 4P using original accessory parts
supplied by us, and when the device is in technically perfect working
order.
Before initial operation: Let OCULUS or an authorized dealer train
you in the operation of the Binoptometer® 4P.
Only operate the equipment after your have read and understood the
User Instructions.
Do not touch the patient and the device at the same time.
Make sure that the device cannot tip over by leaning against it or
sitting on it.
Do not cover the ventilation openings.
Instructions for Maintenance
When cleaning, use a damp cloth and make sure that no liquid enters
the Binoptometer® 4P.
To ensure satisfactory and reliable operation, we recommend that
you have the Binoptometer® 4P checked every two years by our
service department or an authorized dealer. If an error occurs which
you are unable to correct, label the Binoptometer® 4P as "out of
order” and contact our service department or an authorized dealer,
sec. 15, page 45.
Instructions for Disassembly and Disposal
When you disconnect the electrical connections, pull on the
respective connectors, not on the cord.
Dispose of the equipment in compliance with the applicable legal
requirements.

4 Safety Instructions
8 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
Instructions on Electrical Safety
Caution
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Binoptometer® 4P 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.
Use only a computer that meets the specifications given in this
instruction manual, sec. 17, page 48.
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 Binoptometer® 4P
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 Binoptometer® 4P 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 Binoptometer® 4P, 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
interference
Portable and mobile RF communications equipment can affect medical
electrical equipment sec. 18, page 50.
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 Binoptometer® 4P
functions correctly.

5 Intended Use
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 9 / 55
5 Intended Use
The Binoptometer® 4P is intended for the use described in this operating
manual.
The Binoptometer® 4P has the following testing options:
Visual acuity test with Landolt rings, numbers, letters, and similar
Binocular tests (phoria and stereo vision tests)
Color perception test (Ishihara color charts, Velhagen-Broschmann
color charts and Matsubara color charts)
Contrast sensitivity testing under photopic conditions
Mesopic (twilight) vision test with and without glare, in acc. with
DIN 58220 Part 7, DVLA and G25 (optional)
Test for latent hyperopia
Range of accommodation measurement
Peripheral visual field test
Only operate the device using original accessory parts supplied by us,
and when the device is in technically prefect working order.
Heed the safety instructions listed above.
Make sure that the following power supply types are used:
100-230V, 50-60 Hz.
Contraindication
none

6 Device Description
10 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
6 Device Description
6.1 Front View
6.2 Rear View
1) Holder for external light shield
2) Forehead rest
3) Viewing window
4) Knob to adjust the viewing angle
5) Indicator light
6) Netbook/laptop/PC connection
7) Rocker switch for height adjustment (optional)
Fig. 6-1: Front View
8) Handhold
9) Opening for service buttons
10) Ventilation openings
11) Fuse holder
12) Power connection jack
13) On / Off switch
Fig. 6-2: Rear View
1
2
3
4
5
6
7
8
10
11
12
13
9

7 First-time Operation
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 11 / 55
6.3 Mode of Operation of the Binoptometer® 4P
The Binoptometer® 4P is a vision screening instrument that provides a
comprehensive set of tests. The tests are presented on a high-resolution
micro-color display. This technology allows a virtually unlimited
presentation of vision tests.
A precisely calculated, three-element achromatic lens provides an exact
image of the tests. This lens allows vision to be tested irrespective of the
patient’s interpupillary distance.
Function of Some Components
Knob for infinitely adjustable viewing angle (fig. 6-1, page 10, item 4):
The patient can adjust the angle of the test field himself, so that the
vision test can also be conducted with multifocals or varifocals under
physiological conditions. With the adjustment knob, the test field is
moved downward (down-gaze angle).
Viewing window (fig. 6-1, page 10, item 3):The light-protected, yet open
viewer prevents interfering reflections and contributes to a pleasant test
atmosphere.
Rocker switch for height adjustment (optional) (fig. 6-1, page 10,
item 7):The rocker switch for height adjustment allows the patient to
adjust the height him/herself.
Indicator light (fig. 6-1, page 10, item 5):The indicator light shows
whether the Binoptometer® 4P is receiving power.
7 First-time Operation
Before the Binoptometer® 4P is operated for the first time, you must
complete the following actions:
Set up
Connection
If necessary, install the software
After transport or after a long storage period, do not operate the
Binoptometer® 4P for 3-4 hours. In the event of extreme
temperature changes from cold areas to warm rooms, the optical
components can become fogged.
Caution
Risk of incorrect measurements/equipment damage due to improper
setup
Before using the Binoptometer® 4P for the first time, have our
service department or an OCULUS-authorized specialist give you
training.

7 First-time Operation
12 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
7.1 Set Up for Initial Use
The ambient conditions for operation are given in “Ambient Conditions”
page 48.
Remove the Binoptometer® 4P from the packaging. Lift it with the
handhold (fig. 6-2, page 10, item 8).
Place the Binoptometer® 4P on a level surface.
Position the Binoptometer® 4P so that the patient is not affected by
sunlight or artificial light sources.
Avoid reflections from windows, mirrors etc. on the lenses of the
patient and the viewers.
Dispose of the packaging in an environmentally-friendly manner.
Caution
Interruption of the examination due to overheating
If the unit overheats, it shuts itself off and the test results are lost.
Do not cover the ventilation openings.

7 First-time Operation
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 13 / 55
7.2 Connecting
You must connect the Binoptometer® 4P to the mains and, depending on
the version, to the netbook, control unit or laptop / PC.
Caution
Electrical safety hazard
Do not use the Binoptometer® 4P adjacent to or stacked with other
equipment.
If you have to use the Binoptometer® 4P adjacent to or stacked with
other equipment, verify the correct operation of the Binoptometer®
4P.
If you use a power strip to connect the Binoptometer® 4P: Use a
power strip that complies with the requirements of DIN EN 60601-1.
Do not place the multiple socket extension cord on the floor.
Do not use more than one multiple socket extension cord.
Plug only the Binoptometer® 4P and the computer that is being used
with the unit (if applicable) into the multiple socket extension cord.
Use a socket with a protective earth connection which is fully
operating.
Connect the unit to the mains with the supplied power cable.
Make sure that the mains voltage is the same as the voltage
specified on the rating plate.
Set up the Binoptometer® 4P 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.
Note
Risk of equipment damage due to incorrect connection
If you do not connect the Binoptometer® 4P properly, and the connection
is live, the unit can be damaged within a short period of time.
Do not use excessive force when connecting the electrical plug.
Please pay attention to the specifications on the nameplate.
If the electrical plug is damaged, contact our service department or an
authorized dealer to repair the damage.

7 First-time Operation
14 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
Netbook/ Laptop / PC Connection
Connect the Binoptometer® 4P and netbook / laptop / PC with the
appropriate cable.
Make sure that the plug is inserted in the correct position.
Heed the manual of the netbook / laptop / PC.
7.3 Software Installation
Before first use, you must install the Binoptometer® 4P software on your
laptop or PC. Proceed as described in the Software Installation.
It is already installed on the supplied netbook. Prerequisite for the
installation on the PC / laptop, see sec. 17, page 48.
Fig. 7-1: Example: Connect to a netbook

8 Daily Startup
Instruction Manual Binoptometer® 4P (G/59860/1016/en) 15 / 55
8DailyStartup
To start the Binoptometer® 4P for daily operation, you must:
Install and connect the device
Check the device viewer
Turn on the device
Note:
Risk of equipment damage due to incorrect transport
Check the Binoptometer® 4P after each transport and before any
examinations for damage.
Label the damaged Binoptometer® 4P as "out of order”.
Report the damage to the service department.
Use only undamaged Binoptometer® 4P devices.
8.1 Setup and Connection for Daily Operation
The ambient conditions are given in “Ambient Conditions” page 48.
Take the Binoptometer® 4P from the trolley / bag. Lift it with the
handhold (1).
Place the Binoptometer® 4P on a level surface.
Position the Binoptometer® 4P so that the patient is not affected by
sunlight or artificial light sources.
Avoid reflections in the lenses of the patient and viewers, e.g.
through windows or mirrors.
Caution
Interruption of the examination due to overheating
If the unit overheats, it shuts itself off and the test results are lost.
Do not cover the ventilation openings.
Connect the Binoptometer® 4P, sec. 7.2, page 13.
Fig. 8-1: Take out the unit
1

8 Daily Startup
16 / 55 Instruction Manual Binoptometer® 4P (G/59860/1016/en)
8.2 Clean the Device Viewer
Check the device viewer for impurities.
If impurities are found: Clean the viewer glass (1), also see sec. 11.1,
page 38.
8.3 Use of the External Light Shield
You can then still conduct the mesopic (twilight) vision test and glare
sensitivity test, even if you cannot darken the room. You need the external
light shield (optional extra) for this purpose.
Hook the external light shield into place at the holder (1).
Secure the external light shield with the securing tabs (2) at both
sides. The securing tab (2) must fit into the groove (3).
8.4 Turning On
Switch on the Binoptometer® 4P at the On / Off switch.
If the Binoptometer® 4P is connected with a netbook, laptop or PC,
you must start the software.
Fig. 8-2: Check the device viewer
1
1 Holder 3 Groove
2 Securing tab
Fig. 8-3: Use of the external light shield
1
2
3