OCULUS Myopia Master Basic User manual

OCULUS Myopia Master®
®
INSTRUCTION MANUAL

i / v Instruction Manual Myopia Master® (G/68100/EN Rev08)
Notes on this instruction manual
The Myopia Master® has been manufactured and tested according to strict quality
criteria. To ensure safe operation, it is essential that you use the device correctly. For
this reason you should familiarise yourself thoroughly with the contents of this
instruction manual before operating the device. In particular, pay attention to the
safety instructions.
This instruction manual describes the measuring procedure, how to manage the
patient data, and the settings in the Myopia Master®program.
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 an email or a fax. Our service team will gladly
assist.
OCULUS Optikgeräte GmbH
Revision 08
Release: 06.04.2022
Item Number: G/68100/EN

Table of Contents
Instruction Manual Myopia Master® (G/68100/EN Rev08) ii / iii
Table of Contents
Table of Contents ........................................................................................................................ii
1 Scope of Delivery.........................................................................................................................1
2 Graphic Symbols..........................................................................................................................2
3 Structure of the Documentation ............................................................................................4
4 Safety Instructions......................................................................................................................5
4.1 About this Manual .........................................................................................................5
4.1.1 Pictogram Used in this Manual ................................................................5
4.2 Safety Instructions for Use..........................................................................................6
4.3 Cybersecurity Instructions ........................................................................................ 10
5 Intended Use.............................................................................................................................. 13
6 Transport to Installation Location....................................................................................... 14
7 Device Description ................................................................................................................... 15
7.1 Overview of Device Components ............................................................................ 15
7.2 Mode of Operation of the Myopia Master®......................................................... 17
8 Set up and Connection........................................................................................................... 19
8.1 Initial Start-up .............................................................................................................19
8.2 Set-up Jobs for Initial Start-Up .............................................................................. 19
8.3 Adjustments after an in-house transport............................................................. 20
8.3.1 Device set-up.............................................................................................. 20
8.3.2 Unlock transport safety device .............................................................. 20
8.4 Electrical Connection ................................................................................................. 22
9 Operation.................................................................................................................................... 24
9.1 Switching On ................................................................................................................ 24
9.2 Switching Off................................................................................................................24
9.3 Daily Operation ............................................................................................................ 24
10 Functions of the Control Pad................................................................................................ 25
10.1 Touch Screen................................................................................................................. 26
10.1.1 Function Keys on the Touch Screen ..................................................... 26
11 Preparing Patients Data ......................................................................................................... 27
11.1 Entering new Patients (touch screen) ................................................................... 27
11.2 Entering new Patients (touch screen deactivated)............................................ 29
11.2.1 Selecting existing Patients...................................................................... 30
11.2.2 Rename a Patient ...................................................................................... 30
11.2.3 Delete a Patient or an Examination ..................................................... 31
11.2.4 Load an Examination ................................................................................ 32
12 Measuring Procedure .............................................................................................................. 33
12.1 Selecting a Measurement Mode ............................................................................. 33
12.2 Preparing a Measurement......................................................................................... 34
12.3 Myopia measurement and results .......................................................................... 37
12.3.1 Myopia Overview Display ........................................................................ 37
12.3.2 Myopia Results ........................................................................................... 38

Table of Contents
iii / iii Instruction Manual Myopia Master® (G/68100/EN Rev08)
12.3.3 Refraction Results......................................................................................41
12.3.4 Axial length results....................................................................................42
12.3.5 Pachymetry results (optional).................................................................43
12.3.6 Ending the measurements.......................................................................43
12.4 Printing and Saving Examinations..........................................................................44
12.4.1 Printing..........................................................................................................44
12.4.2 Saving an examination.............................................................................45
12.5 Complete measurement .............................................................................................45
13 Chronology of Different Measuring Processes.................................................................46
13.1 Enter Patient + Measure............................................................................................46
13.2 Saving an Examination Retroactively ....................................................................47
13.3 Measuring Without Saving the Patient Data ......................................................48
14 Reference Measurement.........................................................................................................49
15 Settings .......................................................................................................................................51
15.1 Settings 1 .......................................................................................................................51
15.2 Settings 2 .......................................................................................................................53
15.3 Settings 3 .......................................................................................................................55
15.4 Settings 4 .......................................................................................................................56
15.5 Settings 5 .......................................................................................................................58
16 Cleaning, Disinfection and Maintenance .........................................................................59
16.1 Cleaning..........................................................................................................................59
16.2 Disinfection....................................................................................................................61
16.3 Maintenance .................................................................................................................62
16.4 Attaching Paper to the Chin Rest ...........................................................................63
16.5 Inserting a New Roll of Printer Paper ....................................................................64
17 Troubleshooting ........................................................................................................................65
18 Dismantling, Transport and Storage....................................................................................66
18.1 Disassembly ...................................................................................................................66
18.2 Transport and Storage Information ........................................................................66
18.3 Transport and Storage ................................................................................................66
19 Disposal .......................................................................................................................................67
20 Terms of Warranty and Servicing ........................................................................................67
20.1 Terms of Warranty.......................................................................................................67
20.2 Assumption of Liability for Functions and Damage...........................................68
20.3 Manufacturer and Service Address.........................................................................68
21 Technical Data...........................................................................................................................69
22 Annex...........................................................................................................................................72
22.1 Electromagnetic Compatibility ................................................................................72
22.2 Guidance and Manufacturer’s Declaration - Electromagnetic
Emissions and Immunity for the Myopia Master® ............................................74
22.3 Description of the Connection.................................................................................78
22.4 Data Sheet GSM60B15-P1J (05150725) ..............................................................79
22.5 Notes for integration into an IT-Network ............................................................82

1 Scope of Delivery
Instruction Manual Myopia Master® (G/68100/EN Rev08) 1 / 84
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.
Keep the packaging. Keep the packaging in order to ship or transport
the device properly if service or repairs are needed. You will thus
avoid incurring unnecessary damage and costs.
Products and accessories Order number
Version
Myopia Master® Advanced with chin and head rest (not available)
incl. auto-refractometer, keratometry, axial length, pachymetry
Myopia Master® Advanced without chin and head rest (not available)
incl. auto-refractometer, keratometry, axial length, pachymetry
Myopia Master® Basic with chin and head rest
incl. auto-refractometer, keratometry, axial length
Myopia Master® Basic without chin and head rest
incl. auto-refractometer, keratometry, axial length
Myopia Master Optiswiss with chin and head rest (only available via
Optiswiss AG) incl. auto-refractometer, keratometry, axial length
68100
68110
68120
68130
10010728
Eye shield black 076500001028
Dust protection cover 026010005001
Paper for chin support 65313
Printing paper roll (3 rolls) 65311
USB mini cable 05200600
USB FS MED-Isolator 015692000010
Power adapter 05150725
Cable, EU 05200905
Cable, GB (optional) 05200915
Cable, USA (optional) 05200910
Cable, AU (optional) 05200920
Cable, Argentina (optional) 05200925
Testeye 68105
Software-Installation SI/50000/.../en
Instruction Manual G/68100/EN

2 Graphic Symbols
2 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
Note
We reserve the right to change the scope of delivery in line with ongoing
technical development.
2 Graphic Symbols
Symbols equipment Symbols packaging
Manufacturer Protection class Keep dry
Date of
manufacturing
IP XX Type of
protection
This way up
Conformité
européenne
Article number Fragile
Follow instruction
for use
Serial number Limit of temperature for
transport
Disposal in
household trash is
prohibited
Caution Limit of temperature for
storage
Applied part Type B Do not re-use Limit of humidity
Medical device Limit of air pressure
Example: UDI number, consisting UDI-
DI (Device-Identification)
UDI-PI (Product Identifier)
machine-readable matrix code
Transport
Lagerung

2 Graphic Symbols
Instruction Manual Myopia Master® (G/68100/EN Rev08) 3 / 84
There are no temporarily fixed markings on the device.
Additional Symbols and abbreviations on power adapter
Indoor use only Testing center Aquivalent to RoHS
Conform to US and
Canadian standards
Nemkos symbol Chinese Standard
Sign
Meets German
safety requirements
Polarity of
DC connector
Fig. 2-1: Name plate (example)

3 Structure of the Documentation
4 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
3 Structure of the Documentation
A folder containing documentation is supplied with your Myopia Master®:
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
Myopia Master®.
Attention
All safety-related instructions for use of the Myopia Master® are given in
the Instruction Manual for the unit. It is imperative that you read and
understand the whole Instruction Manual before you use the
Myopia Master®.
User Guide: All features of the examination and analysis software
are described in the User Guide, along with detailed information
about the Patient Data Management system.
Software Installation: The introduction to the Software Installation
describes how to install the Myopia Master® software and the
associated drivers.
Manual Floating License Key: Information on the use of the Myopia
Master® within networks.

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev08) 5 / 84
4 Safety Instructions
4.1 About this Manual
Carefully read through the Instruction Manual.
Keep the Instruction Manual in good condition near the device.
Observe the legal regulations with regard to accident prevention.
If standards are named without an issue date, the current version always
applies.
4.1.1 Pictogram Used in this Manual
Attention
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 use which
require special attention.
>This symbol denotes menu paths and screenshots. Example for
starting a new examination:
Myopia Master® > Examination > Scan
which means:
Select the “Examination” menu from the menu bar.
Select the menu item “Scan”.

4 Safety Instructions
6 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
4.2 Safety Instructions for Use
Attention
Personal injury or property damage due to improper operation
Observe the following safety instructions.
Personal injury or property damage due to equipment modifications that
could jeopardize safety
No modifications may be made to this device without the permission
of the manufacturer. Only the OCULUS service are allowed to make
changes or modifications to the device.
Any serious-incident that has occurred in relation to the device should be
reported to the manufacturer ([e-mail]) and the competent
authority of the region in which the user and/or patient is established.
Instructions for Operating Personnel
Make certain that the Myopia Master® is used exclusively in clinics
and by eye specialists and opticians (trained staff etc.). It must be
used in the area designated for carrying out examinations.
For this reason the 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. 18, page 66.
Instructions for Setup and Connection
Only OCULUS or an authorized dealer is allowed to set up and to
connect the Myopia Master®.
Do not use or store the Myopia Master® in rooms that are humid, see
sec. 18, page 66.
Keep the Myopia Master® away from water that may drip, splash or
spray on it, and make sure that no liquids can get into the Myopia
Master®. Do not place any containers holding liquids in the vicinity
of the Myopia Master®.
Germany: Only operate the Myopia Master® in rooms used for
medical purposes after they have been set up according to the VDE
Regulation 0100-710.
Do not operate the devices included in the delivery in areas where
explosions may occur, or in proximity to flammable anesthetics or
volatile substances such as alcohol, benzine or similar products.

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev08) 7 / 84
Set up the Myopia Master® 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 authorized
dealer repair the damage.
Only use a device which is mounted at the lifting table properly.
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.
Attention
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
8 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
Information about the operation of an ME system
The Myopia Master® and a connected computer form a medical electrical
system (ME system) according to IEC 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/IEC 62368-1.
Instructions for Operation
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Myopia Master®.
Never operate a damaged Myopia Master®.
Only operate the Myopia Master® with the original accessories
supplied by us and only when the unit is in technically perfect
condition.
Do not cover the ventilation openings.
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 put the Myopia Master®, including rechargeable battery or
cable, down onto devices that produce heat, heaters (for example
radiators), microwaves or similar.
Only operate the device if you have understood the operating
instructions.
Instructions for Laser Use
Attention
Risk of personal injury or material damage due to invisible laser radiation
The Myopia Master® contains a Class 1 laser according to IEC 60825-1:
2014. It is an encapsulated laser system. When the Myopia Master® cover
is opened, you may be exposed to invisible, Class 3R (5 mW) laser
radiation.
Never open the unit.
For authorized service personnel only: When doing maintenance
jobs, avoid looking directly into the laser beam.
Instructions for Maintenance
In order to retain the high measurement accuracy of the Myopia Master®
OCULUS Optikgeräte GmbH recommends to perform a maintenance
service every two years or after 25000 scans. Additionally to that it is

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev08) 9 / 84
usefull to accomplish a test measurement of the axial length measuring
mode everyday before you start working with the Myopia Master®.
If an error occurs which you cannot correct, label the Myopia Master® as
being “out-of-order” and contact our service department, see sec. 20.3,
page 68.
Instructions for Disassembly and Disposal
When disconnecting electrical connections, pull on the respective
plug and not on the cable itself.
Dispose of the device according to legal regulations.
Instructions on Electrical Safety
Attention
Risk of personal injury or damage to property due to an incorrect level of
safety
Connecting the Myopia Master® 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
IEC 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, page 71.
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
Myopia Master® to the power supply, you must heed the following
information:
Use an extension cord that complies with the requirements of IEC
60601-1, 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 Myopia Master® 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.

4 Safety Instructions
10 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
If you are using a new computer for the Myopia Master®, you must have
the electrical safety checked. Call OCULUS Service for this purpose.
Attention
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. 22, page 72.
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 Myopia Master®
functions correctly.
4.3 Cybersecurity Instructions
☞
The device itself was not designed to connect via a coupled computer to
the internet or other network, or to portable media, as the device does not
require a network or internet connection to function.
User who elect to connect the device coupled computer to the internet or
other network for other purposes are responsible for ensuring that it is
done so in a controlled manner.
Data responsibility:
The device itself is not designed to connect with the internet, but only
with a computer. It does not require the internet to function.
Do not connect with the internet while using the device. It is considered
misuse.
If you elect to connect the computer to the internet for other purposes you
are responsible for ensuring data security.
Device Security
It is the responsibility of the authorized user to ensure that the Myopia
Master® device is not left unlocked, or otherwise unsecured when not in
use, to ensure that non-authorized medical, professional, or otherwise
unapproved personnel are not exposed to, or gain access to, ePHI.
User Responsibility
User names or passwords must not be shared with colleagues or others,
even if they are permitted by law and provider policy to view the same
type of information (e.g. two operators reviewing the same patient
samples).

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev08) 11 / 84
Operators have access to patients’ ePHI and must not take snap-shots,
screenshots or pictures (e.g. using another device) of any information
viewed through the device.
Operators should not enter identifying data into the device. All the data
on the device should be de-identified and relate to the sample id and not
to the patient.
Reporting Device Security or Privacy Breaches
Operators must contact their local IT department and disclose any
suspected or confirmed compromised user accounts, and any other
privacy or security breaches.
Recovering from Compromised Accounts or Devices
When accounts are considered compromised, devices are lost, or
unauthorized access is discovered or suspected, the Healthcare
Organization’s IT network administrators suspend and modify the user
login criteria and issue new login credentials for the user to access their
account securely.
Unavailable Service
Users should report unavailable service or prohibited access to
information to their local Healthcare Organization’s IT department.
Precautions
To ensure cyber security in order to the usage of the device, the
following security measures should be considered. Contact your
computer administrator:
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
“Pentacam”).
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
reentering 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’).

4 Safety Instructions
12 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
Precautions if the computer is connected to a LAN or internet network
If you elect to connect the computer to the LAN or internet, you are
responsible for ensuring data security.
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.
Heed the instructions for integration into an IT-Network sec. 22.5,
page 82
☞
Do not use the Myopia Master® with wireless technology, for example
with wireless USB (connection between device and computer)

5 Intended Use
Instruction Manual Myopia Master® (G/68100/EN Rev08) 13 / 84
5 Intended Use
Attention
Federal law restricts this device to sale by or on the order of a physician.
Indications for Use
The Myopia Master® is designed to photograph the eye and take
Scheimpflug images of the anterior segment to evaluate the thickness of
the cornea. The integrated keratometer measures the central radii of the
cornea. The integrated ophthalmic refractometer measures the refractive
power of the eye. The integrated interferometer measures the axial length
of the eye.
The Myopia Master® may only be used for the purpose described in this
instruction manual.
Heed the safety instructions listed above.
Intended medical indication
The Myopia Master® can be used by physicians, opticians and
optometrists to support myopia management.
Contraindication
none known
Possible side effects
none known
Intended users
Make certain that the Myopia Master® is used exclusively in clinics and
by clinical persons or eye specialists (trained staff etc.).
who can guarantee proper handling due to their knowledge, training
and practical experience.
who have been instructed by OCULUS staff or an authorized dealer
before the initial operation.
Patient group
Children from 3 years up to geriatric patients. No restrictions on weight
and health status. The patient must be awake and able to understand and
see a fixations object.

6 Transport to Installation Location
14 / 84 Instruction Manual Myopia Master® (G/68100/EN Rev08)
6 Transport to Installation Location
The transport and storage conditions see sec. 18, page 66.
Wait approx. 3-4 hours after transport before operating the Myopia
Master®. Extreme temperature changes from cold areas to warm
rooms can cause condensation on the optical components.
Note
Equipment damage due to incorrect transport and improper storage
Avoid shocks and vibration.
Avoid contamination, high temperatures and humidity.
Transport the Myopia Master® professionally.
Store the Myopia Master® according to the storage conditions.
Avoid placing near radiators and moisture.
Note
Keep the packing material. You can then ship or transport the unit
in the proper manner for any servicing or repairs that may arise. You
can thus avoid unnecessary damage and costs.

7 Device Description
Instruction Manual Myopia Master® (G/68100/EN Rev08) 15 / 84
7 Device Description
7.1 Overview of Device Components
1 Gauge head 4 Control Wheel 7 Function keys
2 Printout slot 5 Sliding plate
3 Display 6 Joystick
Fig. 7-1: Device components
7
1
6
2
3
4
5