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MANUAL REFRACTOMETER

iRef
USER MANUAL
V1.0/September 2020

INTRODUCTION
Thank you for purchasing the MANUAL REFRACTOMETER iRef.

PURPOSE OF THIS MANUAL

This user manual is designed by CERTAINN TECHNOLOGY and only applies to iRef
Manual Refractometer. It may cause damage or inaccurate inspection results if it
is used in an inappropriate way. This user manual is recommended to be used as
reference material for operation and training. Please keep this user Manual
with the instrument for future reference.

REVISION HISTORY
Part Number Rev Approval Description Release Date
V1.0 Xiangsong Dai First issued 2020.09.14

1. No part of this manual may be copied or reprinted, in whole or in part, without

prior written permission.
2. The contents of this manual are subject to change without prior notice and
without legal obligation.

© 2021 SHENZHEN CERTAINN TECHNOLOGY CO., LTD.

ALL RIGHTS RESERVED.

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 CONTENTS
1. IMPORTANT NOTICE ................................................................................................. 4
1.1 Important Notice.............................................................................................. 4
1.2 Symbol Information ......................................................................................... 4
1.2.1 Explanation of Warning Symbols on the Instrument ........................ 4
1.2.2 Explanation of Symbols in the User Manual....................................... 5
1.3 Security Requirements .................................................................................... 6
1.3.1 Safety Classification .............................................................................. 6
2. SYSTEMS STRUCTURES AND FUNCTIONS ............................................................... 8
2.1 Principle ............................................................................................................ 8
2.2 INTENDED USE / INDICATIONS FOR USE ....................................................... 8
2.3 FEATURES.......................................................................................................... 8
2.4 Contraindications............................................................................................. 8
2.5 Product Structures and Functions ................................................................. 8
2.6 Product Appearance Structure Diagram ....................................................... 9
3. TECHNICAL SPECIFICATIONS .................................................................................. 10
3.1 Technical Specifications ................................................................................ 10
3.2 Cybersecurity Instructions ............................................................................ 10
4. ELECTROMAGNETIC COMPATIBILITY ..................................................................... 11
5. INSTALLATION AND MAINTENANCE ...................................................................... 17
5.1 Installation ...................................................................................................... 17
5.2 Maintenance ................................................................................................... 18
5.2.1 Cleaning ................................................................................................ 18
5.2.2 Maintenance ........................................................................................ 18
6. OPERATIONS ............................................................................................................ 20
6.1 Preparations ................................................................................................... 20
6.2 Operations ...................................................................................................... 20
6.2.1 Estimate Refractive Error .................................................................... 20
6.2.2 Evaluate Astigmatism.......................................................................... 21
6.2.3 Estimate Far and Near Vision ............................................................. 22
7. PACKING LIST ........................................................................................................... 23
8. SERVICE COMMITMENT .......................................................................................... 23

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 1. IMPORTANT NOTICE

1.1 Important Notice

Before using, please read this manual carefully, and pay attention to the
security guidance, except for the purposes specified in the user manual,
any other use of this instrument is considered to be illegal.
 Only be used and operated strictly according to this user manual.
 Only the person authorized by CERTAINN can maintain the instrument.
 Due to the continuous improvement of the product, CERTAINN reserves
the right to change the technical specifications without the prior notice.
 The nameplate of the instrument indicates the model number, serial
number and year of manufacture, please provide the product serial
number when you need after-sales service.
 The final interpretation of the user manual is owned by CERTAINN.
 This equipment must be installed and set up by personnel authorized or
trained by the manufacturer and must not be installed or dismantled by
any unauthorized personnel.
 Do not use the appliance in environment with flammable anesthetic gases
mixed with air, oxygen or nitrous oxide, as this may cause an explosion.

1.2 Symbol Information

1.2.1 Explanation of Warning Symbols on the Instrument
Symbol Meaning
Caution: consult accompanying documents.
Note: There are important operating and maintenance instructions
found in the manual.

Type B Applied parts.

Serial number

Batch number

European Conformity

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 Manufacturing Date

Authorised Representative

The device will be put on the European market after August 2021.
The device is not to be disposed via the municipal waste collection
system of any member state of the European Union. It is very
important that customers understand and follow all laws regarding
the proper decontamination and safe disposal of electrical
equipment.
Waste Electrical and Electronic Equipment (WEEE) Recycling
Instructions.
When determined that the device is ready for disposal, it is to be
recycled following the policies and procedures reflecting respective
country’s requirements. Do not dispose of device as general waste.

Switches

Manufacturer

Please read the manual prior to any operation.

1.2.2 Explanation of Symbols in the User Manual

Symbolic warning: Violations of operating procedures may result in
malfunctions and personal injury. Violating the handler can damage
the instrument or accessory device!
The part that identifies this symbol in the manual must be executed!

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 Product label: The equipment is labelled with the product label, as shown
below:

1.3 Security Requirements

1.3.1 Safety Classification
 This product complies with EU medical device regulations.
 According to IEC 60601-1-2: 2014 EMC classification, this instrument is
categorized as following:
 Class I devices - Type of protection against electric shock
 B type - Degree of protection against electric shock of applicable parts
(forehead、Chin rest).
 IPX0 - No special protection from water.
 Continuous - Class of operation.

1.3.2 Transport and Installation

 Keep the product upward during transportation.
 Do not work in inflammable, explosive and strong electromagnetic
interference place!
 Note: The device uses 3 AAA batteries and are not rechargeable.
 The instrument is powered by a built-in power supply and cannot be
externally powered.
 Caution: The instrument is permitted to be transported by general means
of transport, but the severe impact, vibration, rain and snow splashing
during transportation shall be prevented. The transportation
requirements shall be specified in the order contract

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 1.3.3 Operating Instruments
 Before using the instrument, please read the safety requirements section
of the user manual.

1.3.4 Operation Forbiddance
 The operation of iRef Manual refractometer must be used in accordance
with the user manual, and failure to operate as required may cause
stoppage and damage.
 This instrument may cause flammable gases or vapors to ignite. Do not
use this instrument in the case of flammable anesthetic gases (e.g. nitrous
oxide) or pure oxygen.
 Do not disassemble components unless the operating instructions
indicated.
 If there is any error, it must be repaired by professionals trained by
CERTAINN. 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 be responsible for these. Please
reference the details in the quality guarantee terms about maintenance,
calibration, and warranty.
 Do not attempt to short-circuit the positive (+) and negative (-) batteries.
Do not use the battery on other devices.
 The battery is explosive, 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 use batteries that have leaked, discolored, or have changed
appearance.
 If the battery fluid leaks into your skin, clothing or even your eyes,
immediately wash with plenty of water and then seek medical attention.
 This are not included in the warranty scope: artificial damage, broken,
thump, bump, inundation, tear down without authorization or other force
majeure reasons.

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 Please do not storage the battery in high temperature, inflammable, and
explosive environment.
 Please do not put the instrument or battery into water or fire. When the
equipment reaches life expectancy and is scrapped, it should be disposed
of in accordance with local laws and regulations, and it is forbidden to
discard it at will.

2. SYSTEMS STRUCTURES AND FUNCTIONS

2.1 Principle
The manual refractometer is composed of a lens and a removable eye
chart. The testee is required to move the position of the eye chart after
resetting to make the visual target become clearer from blur. Once the
clearest position of the visual target is determined, the testee’s estimated
refractive error can be read from the display screen of the instrument.

2.2 INTENDED USE / INDICATIONS FOR USE

The iRef® provides a quick and convenient solution for primary eye care.
Designed for first evaluation of refractive error, it can be used in any place:
communities, schools, optical stores, and any other places where it is
necessary to make a vision screening.

2.3 FEATURES
This instrument has the following features:
• Estimate refractive error
• Evaluate astigmatism
• Estimate far and near vision
•
2.4 Contraindications
No

2.5 Product Structures and Functions

It is composed of eye chart, dial, occluder, back light, main body and
eyepiece.

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2.6 Product Appearance Structure Diagram

① Eyepiece

② Occluder

③ Screen

④ Power button

⑤ Dial

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 ⑥ Eye chart

3. TECHNICAL SPECIFICATIONS

3.1 Technical Specifications

Sphere range -12D～+6D (step 0.25D)
Battery duration 8 hours
Battery voltage D.C.4.5V
Operating Ambient temperature range: 5 ~ 40℃
Environment Relative humidity: ≤ 80%
Conditions Atmospheric pressure: 86kPa ~ 106kPa
Transport and Ambient temperature range: -20℃ ～ 55℃
storage Relative humidity: ≤ 93％
environment Atmospheric pressure: 86kPa ~ 106kPa
Dimensions (mm) 185 x 47 x 55
Net Weight (g) 195 (batteries not included)

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4. ELECTROMAGNETIC COMPATIBILITY

Notes: The iRef 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 iRef, please avoid strong electromagnetic disturbance.
Instructions for use: The ME EQUIPMENT or ME SYSTEM is suitable for
home environments and so on.
Warning: Do not 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: Use of accessories, transducers and cables other than those

specified or 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 RF communications 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 manual refractometer (iRef),
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 manual refractometer may still be
interfered by other devices.

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Warning: Do not approach active high-frequency surgical equipment and
magnetic resonance imaging systems in radiofrequency shielded rooms,
where the intensity of EMI disturbances is high.

Warning: Make sure that all electrical accessories connected to the manual
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.

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).

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Technical description EMC（IEC 60601-1-2: 2014）
1.all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL
PERFORMANCE regarding electromagnetic disturbances for the excepted
service life.
2. Guidance and manufacturer’s declaration - electromagnetic emissions
and Immunity

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 Group 1
CISPR 11
RF emissions Class A
CISPR 11
Harmonic emissions N/A
IEC 61000-3-2
Voltage fluctuations/ flicker emissions N/A
IEC 61000-3-3

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 Table 2

Guidance and manufacturer’s declaration - electromagnetic Immunity

Immunity Test IEC 60601-1-2 Compliance level

Test level
Electrostatic discharge ±8 kV contact ±8 kV contact
(ESD) ±2 kV, ±4 kV, ±8 kV, ±15 kV air ±2 kV, ±4 kV, ±8 kV, ±15
IEC 61000-4-2 kV air
Electrical fast Power supply lines: ±2 kV
transient/burst input/output lines: ±1 kV N/A
IEC 61000-4-4
Surge line(s) to line(s): ±0.5, ±1 kV
IEC 61000-4-5 line(s) to earth: ±0.5, ±1, ±2 kV N/A
100 kHz repetition frequency
Voltage dips, short 0% 0.5 cycle
interruptions and voltage At 0º, 45 º, 90 º, 135 º, 180 º, 225 º,
variations on power 270 º and 315 º
supply input lines 0% 1 cycle
N/A
IEC 61000-4-11 And
70% 25/30 cycles
Single phase: at 0
0% 300 cycle
Power frequency magnetic 30 A/m 30 A/m
field 50Hz/60Hz 50Hz/60Hz
IEC 61000-4-8
Conduced RF * 150KHz to 80MHz:
IEC61000-4-6 3Vrms
N/A
6Vrms (in ISM bands)
80% Am at 1kHz
Radiated RF 3 V/m 3 V/m
IEC61000-4-3 80 MHz – 2,7 GHz 80 MHz – 2,7 GHz
80 % AM at 1 kHz 80 % AM at 1 kHz
NOTE UT is the a.c. mians voltage prior to application of the test level.
Remark: “*”: Only test for Patient Coupling line.

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 Table 3

Guidance and manufacturer’s declaration - electromagnetic Immunity

equipment)
Radiated RF: IEC61000-4-3 (Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications

Test Band Service Modulation Modulation Distance Immunity

Frequency (MHz) (W) (m) Test Level

(MHz) (V/m)

385 380 –390 TETRA 400 Pulse 1,8 0.3 27

modulation

18 Hz

450 380 –390 GMRS 460, FM ± 5 kHz 2 0.3 28

FRS 460 deviation

1 kHz sine

710 704 – 787 LTE Band 13, 17 Pulse 0,2 0.3 9

745 modulation

780 217 Hz

810 800 – 960 GSM 800/900, Pulse 2 0.3 28

870 TETRA 800, modulation

930 iDEN 820, 18 Hz

CDMA 850,

LTE Band 5

1720 1 700 – GSM 1800; Pulse 2 0.3 28

1845 1 990 CDMA 1900; modulation

1970 GSM 1900; DECT; 217 Hz

LTE Band 1, 3, 4, 25;

UMTS

2450 2 400 – Bluetooth, Pulse 2 0.3 28

2 570 WLAN, modulation

802.11 b/g/n, 217 Hz

RFID 2450,

LTE Band 7

5240 5 100 – WLAN 802.11 Pulse 0,2 0.3 9

5500 5 800 a/n modulation

217 Hz
5785

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 Table 4

Recommended separation distances between portable and mobile RF

communications equipment and the iRef handheld auto refractometer
The iRef handheld auto refractometer is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the iRef handheld auto refractometer can help prevent
electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the iRef
handheld auto refractometer as recommended below, according to the maximum
output power of the communications equipment.
Rated max. Separation distance according to frequency of transmitter
output power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
of transmitter
(W)
d = 1.17 P d = 1.17 P d = 2.33 P
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.

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5. INSTALLATION AND MAINTENANCE

5.1 Installation
 Inspect the packaging materials for visible damage and contact distributor
immediately if there is damage is apparent.
 Take out the instrument and other accessories from the box.
 Battery installation
 This device is powered by 3 pieces of 1.5V AAA batteries. Please follow the steps
below to install the batteries.
Step 1: Remove the silicon cap from the bottom of the device

Step 2: Rotate the battery cover counterclockwise and take out the battery rack.

Step 3: Install the batteries and put the rack back into the device. Close the battery
cover and silicon cap to the original position.

Battery rack

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Battery
Please pay attention to the positive and negative polarity indication of the battery.

Negative side of a battery

+ - goes on the spring

Important Notice
 If it is not in use for a long time, please take off the battery to prevent battery
leakage.
 Please keep the battery out of reach of children. If swallowed by mistake, Seek
medical care immediately.
 Please Discard the used batteries according to local regulations.
 If the instrument is also to be transported safely, we recommend that you use
the original packaging materials to avoid unnecessary damage to the
instrument.

5.2 Maintenance
5.2.1 Cleaning
 Before cleaning, please turn off the power.
 While cleaning the mainframe, do not use the solvents containing acetone or
xylene, and never use abrasive cleaners. Only use common detergent.
 While cleaning, it is forbidden to let any liquid enter the interior of the device.
 Clean with a soft clean wet cloth to the surface of the instrument.

5.2.2 Maintenance
 Please put the instrument back into the special packaging after operation
 Keep the instrument away from heat and strong electromagnetic fields.
 Please keep the instrument clean and maintain it frequently, in case of any
faults, contact the local dealer.
 Only the person authorized by CERTAINN can maintain and repair the
instrument.

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Note: Please do not allow any solution into the machine to avoid damaging the
components. Any internal parts of the instrument must not be disinfected.

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6. OPERATIONS

6.1 Preparations
Step 1: Press the power button until the display is on.
Step 2: Set the device to starting position (+6.00D) by rotating the dial. And now you
are ready to go.

Step 3: To obtain a more accurate result, please relax and close your eyes for a few
minutes before using this device.

6.2 Operations
6.2.1 Estimate Refractive Error
Step 1: Set the device to starting position (+6.00D) by rotating the dial.

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Step 2: Hold the device and look into the eyepiece. Cover the other eye by the occluder
and keep both eyes open.

Step 3: Rotate the dial slowly. Stop immediately when the upper icon becomes clear,
while the lower icon is still blurry.
Step 4: Read the estimated sphere from the screen.

Go back to step 1 and repeat 3 times.

Repeat the process for the other eye.

6.2.2 Evaluate Astigmatism

Step 1: Set the device to starting position (+6.00D) by rotating the dial.
Step 2: Hold the device up to the eye, keeping both eyes open. Ensure that the
occluder covers the other open eye.
Step 3: Rotate the dial slowly in the same direction until the end of dial. Observe the
radial lines during this process.

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• If all lines are equally blurry or sharp like example A: no or little astigmatism.
• If you can see these thicker lines like example B or C: you might have astigmatism.

Repeat the process for the other eye.

6.2.3 Estimate Far and Near Vision

6.2.3.1 Estimate Far Vision
Step 1: Set the device to 0.00D position by rotating the dial.
Step 2: Hold the device and look into the eyepiece. Cover the other eye by the occluder
and keep both eyes open.
Step 3: Test can be done with and without spectacles, to evaluate the corrected and
uncorrected far vision.
Step 4: The value beside the smallest line you can read correctly is the estimated value
of your far vision.

Repeat the process for the other eye.

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6.2.3.2 Estimate Near Vision
Step 1, set the device to -3.0D position by rotating the dial.
Follow the same procedure from step 2 to 4.
Step 2: Follow the same procedure from step 2 to 4 as estimating far vision.

Repeat the process for the other eye

7. PACKING LIST

Item Name Qty

1 Manual Refractometer 1
2 User Manual 1
3 Warranty Card 1

8. SERVICE COMMITMENT

Thank you again for purchasing and using our manual refractometer.

Our company has established a complete and strict quality control system, the
products produced have undergone strict inspection and testing.

Please read this User Manual carefully before using, and operate in strict accordance
with the operating procedures, to avoid any error or damage to the device.

Please feel free to contact us:

 if you have any questions while using the device.

 if there is any malfunction.
 if you have any comments or suggestions on our work.
 If you no longer use our instruments, please dispose of them in accordance with
local laws and regulations.

All employees of our company will welcome your calls with the highest enthusiasm,
answer your questions in the most cordial manner, solve your problems as quickly as
possible, and sincerely accept your criticisms and suggestions.

Thank you for your trust.

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Manufacturer: Shenzhen CERTAINN Technology Co., Ltd
Registration Address: Bldg. 2-C, Zone 2, GOTO Digital Technology Park, No.137 Bulan
Rd., Longgang District, 518112, Shenzhen, PEOPLE’S REPUBLIC OF CHINA

Production Address: Bldg. 2-C, Zone 2, GOTO Digital Technology Park, No.137 Bulan
Rd., Longgang District, 518112, Shenzhen, PEOPLE’S REPUBLIC OF CHINA

Tel: +86-755-84084505
+86-755-84084519
Website: http://www.moptim.com

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