MOPTIM easyRef Manual de usuario
1
HandholdAuto Refractometer
easyRef
User Manual
Shenzhen CERTAINN Technology Co., Ltd
Please read the manual carefully before using the device
II
Preface
We appreciate your purchase of our product easyRef Handhold Auto
Refractometer. easyRef Handhold Auto Refractometer mainly used for the preliminary
measurement and screening of human eye diopter, And compared with other Handhold
Auto Refractometer, its biggest advantage is portability and unique inspection method.
This operation instructions manual is designed by Certainn and only applies to
easyRef Handhold Auto Refractometer. It may cause damage or inaccurate inspection
results if it is used in an inappropriate way. This manual is recommended to be used as
reference material for operation and training. The user is supposed to be medical
workers or technicians who have received professional training. In addition, the results
of easyRef Handhold Auto Refractometer is not the prescription for buying glasses, the
final decision shall be made by optometrist or opticians.
III
Catalogue
Chapter1. Important Representation...........................................................................1
1.1 Important Representation....................................................................................1
1.2 Symbol Description...............................................................................................1
1.2.1 Explanation of warning symbols on the instrument....................................1
1.2.2 Position of the product label and serial number..........................................2
1.2.3 Explanation of symbols in the user manual .................................................3
1.3 Security Requirements .........................................................................................3
1.3.1 Safety Notes.....................................................................................................3
1.3.2 Light radiation safety.....................................................................................3
1.3.3 Electromagnetic Compatibility .....................................................................4
1.3.4 Transport and Installation...........................................................................12
1.3.5 Operation Forbiddance................................................................................12
1.3.6 Instructions ...................................................................................................13
Chapter2 .System structures and functions...............................................................14
2.1 Fundamental principle .......................................................................................14
2.2 Product structure and constitution ...................................................................14
2.4 Function...............................................................................................................15
2.5 Intended use.........................................................................................................15
2.6 Contraindications................................................................................................15
Chapter3. Specifications ..............................................................................................15
Chapter4 . Installation and maintenance...................................................................16
4.1 Installation...........................................................................................................16
4.2 Cleaning...............................................................................................................16
4.3 Maintenance and environment conditions........................................................17
4.3.1 Maintenance..................................................................................................17
4.3.2 Environmental Conditions...........................................................................17
Chapter5. The Function and Operation.....................................................................18
5.1 Preparation before inspection............................................................................18
5.2 Inspection steps ...................................................................................................18
5.2.1 Starting up.....................................................................................................18
5.2.2 Switch inspection mode................................................................................19
5.2.3Adjust the posture.........................................................................................19
5.2.4 Start inspect ..................................................................................................19
5.2.5 Choose left eye or right eye..........................................................................20
5.2.6Aim at the pupil ............................................................................................20
IV
5.2.7 Data capture..................................................................................................21
5.2.8 Query the records.........................................................................................21
5.2.9 Print...............................................................................................................21
5.3 System Troubleshooting .....................................................................................22
Chapter6. Battery and charger...................................................................................22
Chapter7. Packing List ................................................................................................23
Chapter8. Service Commitment..................................................................................24
1
Chapter1. Important Representation
1.1 Important Representation
Before using, please read this manual carefully. And please pay more attention to the security
guidance. Other uses of this instrument are illegal.
Only be used and operated strictly according to this user manual.
Only the person authorized by Certainn can maintain the instrument.
Since we will constantly improve our production, Certainn reserves the right to
change the technical specifications without the prior notice.
The model number, manufacturing number, accession designation number, registered
standard, manufacturing year are indicated on nameplate of the instrument.
1.2 Symbol Description
1.2.1 Explanation of warning symbols on the instrument
Caution: consult accompanying documents.
Note: There are important operating and maintenance instructions
found in the manual.
Type B Applied parts.
Medical device
Serial number
batch number
Class 1 laser product
Note: This label indicates that there is a laser nearby, please pay
attention to safety
Class II equipment
European Conformity
2
Manufacturing Date
No Pushing.
Keep Dry
Humidity limitation (10% to 95%, including condensation)
Atmospheric pressure limitation (500 hPa to 1060 hPa)
Note: No Roll over
1.2.2 Position of the product label and serial number
The product label is attached on back cover of the equipment:
This way up
Fragile, Handle with care
Please read the manual prior to any operation.
No Sitting
Temperature limit (-40deg. C to 70 deg. C)
manufacturer
3
1.2.3 Explanation of symbols in the user manual
The symbol warns that violation of operating procedures may cause malfunctions and
personal injury. Violation of the handling procedures will damage the instrument or
accessory equipment!
The part that identifies this symbol in the manual must be executed!
1.3 Security Requirements
1.3.1 Safety Notes
This product complies with the requirements of EU medical device regulations
According to IEC 60601-1-2 :2014 EMC classification，this instrument is categorized as
following:
Class II devices 、(Internal power supply equipment），Handheld ordinary equipment
B type –Degree of protection against electric shock of applicable parts (Forehead pad )
Degree of protection against liquid immersion: IPX0.
Class of operation: Continuous.
1.3.2 Light radiation safety
According to IEC 60825-1 -2014, this instrument is a class 1 laser product.
Operation of the product must be carried out in accordance with the user manual,
unauthorized or disassembly of the instrument may lead to radiation hazards.
When using this product, we should avoid long direct light exposure window
4
which may cause retinal injury.
Please Do not open the instrument enclosure without permission, which may cause
accidental light radiation hazard.
The light source used in this product is the specified accessories. If it needs to be
replaced and returned to the factory for processing, any unauthorized customer service
personnel or agents shall not disassemble the equipment without permission to replace
and repair the light source, otherwise it may cause damage to the instrument and/or
Light radiation hazard.
1.3.3 ElectromagneticCompatibility
Notes:easyRef Handhold Auto Refractometer conforms to IEC60601-1-2:2014 EMC
requirements.
User must install and operate the device based on the provided EMC information.
Portable or mobile RF communication device might influence the performances of
easyRef Handhold Auto Refractometer , please avoid strong electromagnetic disturbance.
Instructions for use：
The ME EQUIPMENT or ME SYSTEM is suitable for healthcare environments and so
on.
Warning：Don’t near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning：Use of this equipment adjacent to or stacked with other equipment should be
avoided because it could result in improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that they are operating normally.
Warning：NOTE The EMISSIONS characteristics of this equipment make it suitable for
use in industrial areas and hospitals
(CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class
B is normally required) this equipment might not offer adequate protection to radio-frequency
communication services. The user might need to take mitigation measures, such as relocating
or re-orienting the equipment.
Warning: Use of accessories, transducers and cables other than those specified or
5
provided by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in improper
operation.”
Warning：Portable RFcommunications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of
the Handhold Auto Refractometer (esayRef ), including cables specified by the manufacturer.
Otherwise, degradation of the performance of this equipment could result.
Warning：Only the power adapter and battery approved by Certainn can be used. In
order to avoid damage to the instrument, please do not change the charging parts
Even if other devices meet the emission requirements of the corresponding national
standards, the easyRef Handhold Auto Refractometer may still be interfered by other devices.
Warning: Do not approach active high-frequency surgical equipment and magnetic
resonance imaging systems in radio-frequency shielded rooms, where the intensity of EMI
disturbances is high.
Warning: Make sure that all electrical accessories connected to the easyRef Handhold
Auto Refractometer must comply with IEC 60601-1,. if in doubt, consult the technical service
department or your local representative
Warning: No unauthorized modification allowed of the ME EQUIPMENT
Caution: Please do not connect a removable storage device to the equipment without
permission, in order to avoid potential computer virus. Computer virus may affect
equipment performance, damage patient database, even void the warranty.
Warning: Any non–medical peripheral devices equipment connected to the interface
ports must be certified according to the respective IEC standards (for example, IEC
60950 for data processing equipment and IEC 60601-1 for medical equipment) Also, all
configurations shall comply with the system standard IEC 60601-1. Any person who
connects or installs accessories to the system has the responsibility to verify the
compliance.
1.3.3.3 ：If any：a list of all cables and maximum lengths of cables (if applicable),
transducers and other ACCESSORIES that are replaceable by the RESPONSIBLE
ORGANIZATION and that are likely to affect compliance of the ME
EQUIPMENT or ME SYSTEM with the requirements of Clause 7
(EMISSIONS) and Clause 8 (IMMUNITY). ACCESSORIES
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