OCULUS Myopia Master Advanced User manual

OCULUS Myopia Master®
®
INSTRUCTION MANUAL

i / v Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
Noteson thisinstruction manual
The Myopia Master® has been manufactured and tested according to strict quality cri-
teria. 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 instruc-
tions.
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
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 Myopia Master® (G/68100/EN Rev04 0820) ii / v
Table of Contents
1 Scope of Delivery.........................................................................................................................1
2 Graphic Symbols..........................................................................................................................2
3 Structure of the Documentation ............................................................................................3
4 Safety Instructions......................................................................................................................4
4.1 About this Manual .........................................................................................................4
4.1.1 Pictograms Used in this Manual ..............................................................4
4.2 Safety Instructions for Use..........................................................................................5
5 Intended Use.............................................................................................................................. 11
6 Transport to Installation Location....................................................................................... 12
7 Device Description ................................................................................................................... 13
7.1 Overview of Device Components ............................................................................ 13
7.2 Mode of Operation of the Myopia Master®......................................................... 15
8 Set up and Connection........................................................................................................... 17
8.1 Electrical Connection ................................................................................................. 17
8.2 Integrate into IT Network for Service Purposes.................................................. 19
9 Operation.................................................................................................................................... 20
9.1 Switching On ................................................................................................................ 20
9.2 Switching Off................................................................................................................20
9.3 Daily Operation ............................................................................................................ 20
10 Functions of the Control Pad................................................................................................ 21
10.1 Touch Screen................................................................................................................. 22
10.1.1 Function Keys on the Touch Screen ..................................................... 22
11 Preparing Patients Data ......................................................................................................... 23
11.1 Entering new Patients (touch screen) ................................................................... 23
11.2 Entering new Patients (touch screen deactivated)............................................ 24
11.2.1 Selecting existing Patients...................................................................... 25
11.2.2 Rename a Patient ...................................................................................... 26
11.2.3 Delete a Patient or an Examination ..................................................... 26
11.2.4 Load an Examination ................................................................................ 27
12 Measuring Procedure .............................................................................................................. 28
12.1 Selecting a Measurement Mode ............................................................................. 28
12.2 Preparing a Measurement......................................................................................... 29
12.3 Myopia measurement and results .......................................................................... 32
12.3.1 Myopia Overview Display ........................................................................ 32
12.3.2 Myopia Results ........................................................................................... 33
12.3.3 Refraction Results ..................................................................................... 35
12.3.4 Axial length results ................................................................................... 36
12.3.5 Ending the measurements....................................................................... 36

Table of Contents
iii / v Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
12.4 AR + K measurement and results............................................................................37
12.5 P + AR + K measurement and results....................................................................39
12.6 PARK + AXL and results .............................................................................................41
12.7 Axial length and results .............................................................................................43
12.8 Printing and Saving Examinations..........................................................................44
12.8.1 Printing..........................................................................................................45
12.8.2 Saving an examination.............................................................................45
12.9 Complete measurement .............................................................................................46
13 Chronology of Different Measuring Processes.................................................................47
13.1 Enter Patient + Measure............................................................................................47
13.2 Saving an Examination Retroactively ....................................................................48
13.3 Measuring Without Saving the Patient Data ......................................................49
14 Reference Measurement.........................................................................................................50
15 Settings .......................................................................................................................................52
15.1 Settings 1 .......................................................................................................................52
15.2 Settings 2 .......................................................................................................................54
15.3 Settings 3 .......................................................................................................................56
15.4 Settings 4 .......................................................................................................................57
15.5 Settings 5 .......................................................................................................................59
16 Display Options .........................................................................................................................60
17 Calculated correction of tonometrically measured IOP ................................................62
17.1 IOP correction based on central corneal thickness............................................62
17.2 Post-LASIK IOP correction.........................................................................................63
17.3 IOP correction based on central corneal thickness and corneal
curvature ........................................................................................................................64
17.4 Performing IOP correction with the Myopia Master®.......................................65
17.4.1 Save the IOP data.......................................................................................66
18 Cleaning, Disinfection and Maintenance .........................................................................67
18.1 Cleaning..........................................................................................................................67
18.2 Disinfection....................................................................................................................69
18.3 Maintenance .................................................................................................................70
18.4 Attaching Paper to the Chin Rest ...........................................................................71
18.5 Inserting a New Roll of Printer Paper ....................................................................71
19 Troubleshooting ........................................................................................................................73
20 Dismantling, Transport and Storage....................................................................................74
20.1 Disassembly ...................................................................................................................74
20.2 Transport and Storage Information ........................................................................74
20.3 Transport and Storage ................................................................................................74
21 Disposal .......................................................................................................................................75

Table of Contents
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) iv / v
22 Terms of Warranty and Servicing........................................................................................ 76
22.1 Terms of Warranty ...................................................................................................... 76
22.2 Assumption of Liability for Functions and Damage .......................................... 76
22.3 Manufacturer and Service Address ........................................................................ 77
23 Technical Data .......................................................................................................................... 78
24 Annex........................................................................................................................................... 82
24.1 Electromagnetic Compatibility................................................................................ 82
24.2 Guidance and Manufacturer’s Declaration - Electromagnetic
Emmisssions and Immunity for the Myopia Master® ....................................... 84
24.3 Description of the Connection................................................................................. 88
24.4 Data Sheet GSM60B15-P1J (05150725).............................................................. 89

Table of Contents
v / v Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)

1 Scope of Delivery
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 1 / 92
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,
with Scheimpflug camera (fully equipped)
Myopia Master® Advanced, without chin and head rest,
with Scheimpflug camera
Myopia Master® Basic, with chin and head rest,
without Scheimpflug camera
Myopia Master® Basic, without chin and head rest,
without Scheimpflug camera
68100
68110
68120
68130
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 5200905
Cable, GB (optional) 5200915
Cable, USA (optional) 5200910
Cable, AU (optional) 5200920
Cable, Argentinia (optional) 5200925
Testeye 68105
Software-Installation SI/50000/.../en
Instruction Manual G/68100/EN Rev04 0820

2 Graphic Symbols
2 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
Note
We reserve the right to change the scope of delivery in line with ongoing
technical development.
Software versions
The instruction manuals describe the following Software Set version:
1.1r2
2GraphicSymbols
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

3 Structure of the Documentation
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 3 / 92
There are no temporarily fixed markings on the device.
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®.
This manual describes the basic operation and the different features
of the Myopia Master® versions.
Software Installation: The introduction to the Software Installation
describes how to install the Myopia Master® software and the
associated drivers.
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)

4 Safety Instructions
4 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
4SafetyInstructions
4.1 About thisManual
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.
4.1.1 PictogramsUsed in thisManual
Warning
Identifies a potentially dangerous situation which may cause 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 use which re-
quire special attention.

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 5 / 92
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 that
could jeopardize safety
No modifications may be made to this device without the permission
of the manufacturer or authorized dealers.
Instructions for Operating Personnel
Make sure that the Myopia Master® is used only by clinical persons
or eye specialists
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.
Transport and Storage Instructions
Refer to the notes in sec. 20, page 74.
Instructions for Setup and Connection
Do not use or store the Myopia Master® in rooms that are humid.
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®.
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.
Only use a power cord which meets the requirements of IEC 60227-
1, type H05VVH2-F (type 53), minimum 0,75 m² and IEC 60320-1,
type C7.
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.

4 Safety Instructions
6 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
Do not use excessive force when connecting the electrical plug.
If a connection is not possible, check whether the plug fits the socket.
If you find damage to the plug connector, have the damage
corrected by our service department.
Establish an USB connection only with the OCULUS USB FS MED-
Isolator (Nr. 01 56920 00 010).
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Do not use the Myopia Master® with wireless technology, for
example with wireless USB.
Data responsibility: The device itself is not designed to connect with
the internet, but only to a PC. It does not require the internet to
function.
Do not connect with the internet while using the device. It is consid-
ered misuse.
If you elect to connect the PC to the internet for other purposes you
are responsible for ensuring data security.
Only use a Myopia Master® which is mounted 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.

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 7 / 92
In the patient environment, use devices that conform to IEC 60601-1. If
a multiple socket outlet 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 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, IEC 60950-1 or 62368-1.
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Instructions for Operation
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.
Before first use: Let OCULUS or an authorized dealer train you in the
operation of the Myopia Master®.
Only operate the device if you have understood the operating
instructions.
Fig. 4-1: Patient environment

4 Safety Instructions
8 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
Do not put any heavy objects onto the unit or the cables.
Do not put the Myopia Master® down onto devices that produce
heat, heaters (e.g. radiators), microwaves or similar.
Make sure that the device cannot tip over by leaning against it or
sitting on it.
Instructions for Maintenance
Caution
Risk of personal injury or material damage due to invisible laser radiation
The Myopia Master® contains a Class 1 laser according to
DIN EN 60825-1:2015 and DIN EN 60825-1: 2001. 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.
To ensure satisfactory and reliable operation, we recommend that you
have the Myopia Master® checked every two years by our service
department or an authorized dealer. If an error occurs which you cannot
correct, label the Myopia Master® as being "out-of-order" and contact
our service department.
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
Caution
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.

4 Safety Instructions
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 9 / 92
Ensure that connections with non-medical devices are made
correctly.
Only use the power adapter listed in the packing list.
Establish an USB connection only with the OCULUS USB FS MED-
Isolator (Nr. 01 56920 00 010).
Use only a computer that meets the specifications given in this
instruction manual, sec. 23, page 78.
Note that an output voltage of maximum 5.5 V DC is supplied by a
device connected via USB.
Caution
Use of a multiple socket outlet
Risk of personal injury or material damage caused by unsafe multiple
socket outlet
If you use a multiple socket outlet 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: 2005, section 16.
Do not place the multiple socket outlet on the floor.
Do not use more than one multiple socket outlet.
Plug only the Myopia Master® and the computer that is being used
with the unit (if applicable) into the multiple socket outlet.
If you are using a multiple socket outlet it has to be supplied with a
isolation transformer.
If you are using a new computer for the Myopia Master®, 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. 24, page 82.
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 Safety Instructions
10 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
Cybersecurity
☞
Do not use the Myopia Master® 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:
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
“MyopiaMaster”).
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 users, 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
Instruction Manual Myopia Master® (G/68100/EN Rev04 0820) 11 / 92
5 Intended 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® can be used by physicians, opticians and
optometrists to support myopia management.
The Myopia Master® may only be used for the purpose described in this
instruction manual.
Heed the safety instructions listed above.
Contraindications
None known

6 Transport to Installation Location
12 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
6Transport to Installation Location
The transport and storage conditions see sec. 20, page 74.
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 Rev04 0820) 13 / 92
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

7 Device Description
14 / 92 Instruction Manual Myopia Master® (G/68100/EN Rev04 0820)
8 Head rest 11 On/Off Switch 14 USB port
9 Marking for the eye height 12 Control LED 15 Chin rest
10 Pachycam camera glass cover 13 Mains connection 16 Measuring ocular /
Patient eyepiece with Keratometer ring
Fig. 7-2: Device components
14
13 12 11
8
16
9
10
15