MOPTIM easyRef User manual
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
6
may be specified either generically (e.g. shielded cable, load impedance) or specifically
(e.g. by MANUFACTURER and EQUIPMENT OR TYPE REFERENCE).
If any：the performance of the ME EQUIPMENT or ME SYSTEM that was determined to
be ESSENTIAL
PERFORMANCE and a description of what the OPERATOR can expect if th
e ESSENTIAL
PERFORMANCE is lost or degraded due to EM DISTURBANCES (the define
d term “ESSENTIAL PERFORMANCE” need not be used).
The following cables should be used to meet the requirements of electromagnetic emission
and anti-interference:
No
Cable name
Manufacturers
INPUT
Output
1
switching power
adaptor
Dongguan Shilong Fuhua Electronic Co.,
Ltd.
100-240V~50/60Hz,500m
A
5.0V 2.0A
RF transmitter equipment and system requirements:
No
Types
Launch
frequency
Modulation
type
Frequency
characteristics
Radiated
power
Remark
1
Bluetooth
2402MHz-
2480MHz
FHSS,GFSK,D
PSK,DQPSK
2.4G
≦20dBm
Battery information
No
Types
Moder
Ratings
Remark
1
Rechargeable Li-ion
Battery
PL113565
3.8Vd.c.,3800mAh
EMC（IEC 60601-1-2：2014）
The ME EQUIPMENT or ME SYSTEM is suitable for Professional healthcare
environment and so on.
1. all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE with regard to electromagnetic disturbances for the excepted service life.
2. Guidance and manufacturer’s declaration -electromagnetic emissions and Immunity.
7
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 may be specified either generically
(e.g. shielded cable, load impedance) or specifically (e.g. by MANUFACTURER and
EQUIPMENT OR TYPE REFERENCE).
If any：the performance of the ME EQUIPMENT or ME SYSTEM that was determined to be
ESSENTIAL PERFORMANCE and a description of what the OPERATOR
can expect if the ESSENTIAL PERFORMANCE is lost or degraded due to
EM DISTURBANCES (the defined term “ESSENTIAL PERFORMANCE” need
not be used).
Table 1
Guidance and manufacturer’s declaration - electromagnetic emissions
Emissions test
Compliance
RF emissions
CISPR 11
Group 1
RF emissions
CISPR 11
ClassA
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ flicker
emissions IEC 61000-3-3
Complies
Table 2
Guidance and manufacturer’s declaration - electromagnetic Immunity
Immunity Test
IEC 60601-1-2
Test level
Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ±15 kV air
8
Electrical fast transient/burst
IEC 61000-4-4
Power supply lines：±2 kV
input/output lines：±1 kV
100 kHz repetition frequency
Power supply lines：±2 kV
100 kHz repetition frequency
Surge
IEC 61000-4-5
line(s) to line(s)：±0.5, ±1 kV
line(s) to earth：±0.5, ±1, ±2 kV
line(s) to line(s)：±0.5, ±1 kV
Voltage dips, short interruptions
and voltage variations on power
supply input lines
IEC 61000-4-11
0% 0.5 cycle
At 0º, 45 º, 90 º, 135 º, 180 º,
225 º, 270 ºand 315 º
0% 1 cycle
And
70% 25/30 cycles
Single phase: at 0
0% 300 cycle
0% 0.5 cycle
At 0º, 45 º, 90 º, 135 º, 180 º,
225 º, 270 ºand 315 º
0% 1 cycle
And
70% 25/30 cycles
Single phase: at 0
0% 300 cycle
Power frequency magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Conduced RF
IEC61000-4-6
150KHz to 80MHz：
3Vrms
6Vrms (in ISM bands)
80% Am at 1kHz
150KHz to 80MHz：
3Vrms
6Vrms (in ISM bands)
80% Am at 1kHz
Radiated RF
IEC61000-4-3
3 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
3 V/m
80 MHz –2,7 GHz
80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration - electromagnetic Immunity
Radiated RF
Test
Band
Service
Modulati
Modulatio
Dista
IMMUNIT
IEC61000-4-3
Frequenc
(MHz)
on
n (W)
nce
Y
(Test
y
(m)
TEST
specifications
(MHz)
LEVEL
for
(V/m)
9
ENCLOSURE
PORT
IMMUNITY to
RF wireless
385
380
–390
TETRA
400
Pulse
modulatio
n
18 Hz
1,8
0.3
27
communication
450
380
GMRS
FM
2
0.3
28
s equipment)
–390
460,
±5 kHz
FRS 460
deviation
1 kHz
sine
710
704 –
LTE Band
Pulse
0,2
0.3
9
745
787
13,
modulatio
780
17
n
217 Hz
810
800 –
GSM
Pulse
2
0.3
28
870
960
800/900,
modulatio
TETRA
n
930
800,
18 Hz
iDEN
820,
CDMA
850,
LTE Band
5
1720
1 700 –
GSM
Pulse
2
0.3
28
1845
1 990
1800;
modulatio
CDMA
n
1970
1900;
217 Hz
GSM
1900;
DECT;
LTE Band
1, 3,
4, 25;
UMTS
2450
2 400 –
Bluetooth
Puls
2
0.3
28
2 570
WLAN,
e
802.11
mod
b/g/n,
ulati
RFID
on
10
2450
217
,
Hz
LTE
Band
7
5240
5 100 –
WLAN
Pulse
0,2
0.3
9
5500
5 800
802.11
modulatio
a/n
n
5785
217 Hz
Recommended separation distances between portable and mobile RF communications equipment and
the easyRef handhold auto refractometer
The easyRef handhold auto refractometer is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the easyRef handhold auto
refractometer can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the easyRef handhold auto
refractometer as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2,5 GHz
d = 1.17 P
d = 1.17 P
d = 2.33 P
11
0.01
0.12
0.12
0.23
0.1
0.38
0.38
0.73
1
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the higher frequency applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
12
1.3.4 Transport and Installation
Keep the product upward during transportation.
Caution: The instrument is allowed to be transported by general means of
transportation, but the severe impact, vibration, rain and snow splashing during
transportation shall be prevented. The transportation requirements shall be specified
in the order contract
Do not work in inflammable, explosive and strong electromagnetic interference place!
Only the power adapter and battery recognized by Certainn can be used. In order to
avoid any damage, please do not change the charging parts.
1.3.5 Operation Forbiddance
The operation of easyRef must follow the operating instructions, or it may cause
stoppage and damage.
This instrument may ignite combustible gas or steam. Do not use this instrument in
the environment with combustible and anesthetic gas (for example: nitrous oxide) or
pure oxygen.
Do not disassemble optical system and components unless the operating instructions
indicated.
It is forbidden to refit or add accessories! Only the accessory produced or recognized
by Certainn can be used in this instrument.
If there is any errors, it must be repaired by professionals trained by Certainn
Technology Co., Ltd.. In order to avoid damage, it is forbidden to tear down by
oneself.
Do not use chemical reagent wiping the instrument surface and accessories.
If there is damage or destroy caused by inobservance to the user manual, improper
maintenance, incorrect use and violent collisions reasons beyond we can guarantee,
the user will responsible for these. Please reference the details in the quality
guarantee terms about maintenance, calibration and warranty.
This are not included in the warranty scope: artificial damage, break, thump, bump,
inundation, teardown without authorization or other force majeure reasons.
Please do not put the instrument or battery into water or fire.
13
The battery is an explosive product, please do not try to open the battery, hit or
drop the battery, the internal structure of the battery is not covered by the warranty
Do not attempt to short-circuit the positive (+) and negative (-) batteries. Do not
use the battery on other devices.
Do not use batteries that have leaked, discolored, or have changed appearance
It is forbidden to directly solder anything on the battery
If the battery fluid leaks into your skin, clothing or even your eyes, immediately
wash with plenty of water and then seek medical attention.
Please do not storage the battery in high temperature, inflammable and explosive
environment.
When the equipment reaches the expected life and is scrapped, it should be
disposed of in accordance with local laws and regulations, and it is forbidden to
discard it at will.
To completely disconnect the power, unplug the adapter
1.3.6 Instructions
●When you need to move the instrument elsewhere, please refer to the installation
instructions in the previous section.
●Please ensure the battery power of the instrument, so as not to exhaust the
battery during use and delay the inspection
●When the instrument needs to charge, please follow the safety instructions and
operating methods of this user manual.
●When the patient is next to the instrument, do not perform maintenance or
replace parts, otherwise they may be injured.
14
Chapter2 .System structures and functions
1.1 Fundamental principle
The key technique used in the easyRef Handhold Auto Refractometer is based on principle of
hartmann wave-front sensing .
Light is emitted from the light source system inside the device, and then focuses on the
bottom of the eye through the spectroscope and exit port, then the light is reflected back to the
device,and beam through lens system and received by CCD camera.It is possible to calculate
the diopter of the human eye by detecting the offset between the relative calibration light and
the spot array formed by the light spot of each sub-aperture.
1.2 Product structure and constitution
The product consists of main easyRef hardware and PowerAdapter
1.3 Runtime environment
Operating environment：Android 5.1.1
Host configuration：RK3288、2G+8G
Display screens：1.54" touch screen
Resolution :320*320
15
1.4 Function
As an effective instrument for detecting the refractive power of the human eye, the easyRef
Handhold Auto Refractometer can quickly perform the refractive power detection, which
solves the influence of the medical staff's command and judgment on the test results, making
the test results more objective and reasonable.
1.5 Intended use
Applicable to the preliminary determination of the diopters of adults and infants.
1.6 Contraindications
There are no absolute contraindications.
Chapter3. Specifications
Product Series
easyRef
mode
Infant mode
Adult mode
Spherical power range
-10.0D～+10.0D
Spherical power interval（Cell value）
0.25D
Spherical power tolerance
±0.5D
Cylindrical power range
-5.0D ～+5.0D
Cylindrical power interval（Cell value）
0.25D
Cylindrical power tolerance
±0.5D
Axial range
1°～180°
Axial interval
1°
Axial view tolerance
-3D≤DC＜-0.5D，
0.5D＜DC≤3D，
±5°
DC
＞
3D
，
DC
＜
-3D
±3°
Note: DC represents the cylindrical power
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