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VX105 User Manual - V1.0

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100% found this document useful (1 vote)
160 views61 pages

VX105 User Manual - V1.0

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 61

VX105

OPERATOR’S MANUAL

Ningbo Ming Sing Optical R&D Co., Ltd


Please read this manual before use
This instrument is manufactured according to the GB9706.1-2007 Medical
electrical equipment General requirements for basic safety and essential performance.
The instrument must be grounded reliably. Please pay attention to the warning labels
on the product and the instructions and review the files coming with the unit to
prevent damage to the operator and other persons, or to other facilities.

ISO 13485 certification—the product design and development, production and


service process of Ningbo Ming Sing Optical R&D Co., Ltd. have passed ISO
13485 certification. The IEC standard is applicable to this manual. Refractive power
showed a reference wavelength of D = 546.07 NM. The material contacting with
customers have been evaluated by ISO10993, and there is no unacceptable risk.

Safety precautions and procedures must be thoroughly understood before using


the equipment. The device complies with ISO 10342 (ophthalmic instruments - eye
refractometer), ISO 10343 (ophthalmic instruments - Keratometer), and ISO 19980
(Ophthalmic instruments - Corneal topograpers) . There are no user-serviceable parts
inside the device except printer paper. If you encounter any problems or have
questions about the instrument, please contact Ningbo Ming Sing Optical R&D Co.,
Ltd customer service department or your authorized distributor.

This manual also serves as a training reference manual. In order to ensure the
best performance of the new machine, it is recommended to carefully read and follow
the steps in this guide. Please keep this manual as a reference for future
communication with other users. If additional copies needed, or any questions about
the instrument, please contact Ningbo Ming Sing Optical R&D Co., Ltd or your
authorized distributor.

The information contained in this manual has been confirmed before publication.
Ningbo Ming Sing Optical R&D Co., Ltd. reserves the right to change the
specification or product contained in this manual without prior notice. Sold products
are not subject to such changes.

Reproduction, retrieval and reprint any chapter of this manual in electronic,


mechanical, or any other means is strictly forbidden without written permission of
Ningbo Ming Sing Optical R&D Co., Ltd.

Manufacturer: Ningbo Ming Sing Optical R&D CO., Ltd


Address: NO.702 North Tiantong road, Ningbo Zhejiang China
Post code: 315000 Tel:0574-87198788/ 87305541 Fax: 0574-87296439
File NO.: q/ms-j514c.11-2021
Revision: A/0 Effective date: 2020-10-13
Table of contents
1.Introduction ..............................................................................................................1
1.1 Product Description ......................................................................................... 2
1.2 Product Features and Use Scope ......................................................................2
1.3 Classification ................................................................................................... 4
1.4 Main performance index ..................................................................................4
1.5 Glossary ........................................................................................................... 5
2. Safety precautions ......................................................................................................7
2.1 Symbols ........................................................................................................... 8
2.2 Before Use ....................................................................................................... 8
2.3 During Use .......................................................................................................9
2.4 After Use ........................................................................................................ 10
2.5 Maintenance and check ..................................................................................11
2.6 Disposal ......................................................................................................... 12
3. Configuration and Functions ................................................................................... 13
3.1 Device configuration ......................................................................................14
3.2 Accessories .....................................................................................................15
3.3 Symbols ......................................................................................................... 16
3.4 Operation Flow .............................................................................................. 18
4. Installation & measurement preparation ..................................................................34
5. Measurement ............................................................................................................36
5.1 Artificial eye measurement ............................................................................ 37
5.2 Patient Measurement ......................................................................................37
5.3 Auto tracing ....................................................................................................39
6. Self-diagnosis and maintenance .............................................................................41
6.1 Troubleshooting ............................................................................................. 42
6.2 Replacing printer paper ..................................................................................42
6.3 Cleaning and disinfection .............................................................................. 43
6.4 Replacing the fuse ..........................................................................................43
6.5 Site Change .................................................................................................... 44
6.6 Preventive inspection and maintenance ......................................................... 44
6.7 Scrap .............................................................................................................. 45
7.Dimensions and Other Specification ..................................................................... 46
7.1 Dimensions and Contraindications ................................................................ 47
7.2 Service life ..................................................................................................... 47
7.3 Disclaimer ......................................................................................................47
7.4 Manufacture date ........................................................................................... 47
8. After-sales service ....................................................................................................48
9.EMC ..........................................................................................................................50
10.Manufacturer Information .......................................................................................56
1.Introduction

1
1.1 Product Description

Product name Multi-function automatic eye diagnoser


Model VX105
Intended use This machine is used to measure human eye refractive status. It
can measure PD, curvature radius of the front surface of corneal,
main meridian axis and corneal distributed curvature.
Structure The device consist of an optical imaging system, a control
system(software version:V2) and a display unit.
Contraindication None
Operating VX105 is a Multi functional eye measurement device. It is
principle integrated with functions including measuring eye refractive,
corneal curvature and corneal topography.
VX105 adopts Shack-hartman technology. It is equipped with
high precision Shack-hartman optical system to measure the
maximum pupil size or the default pupil size specified in device
setting.
There are 24 placido rings for topology measurement to get the
shape of front corneal shape and screen for eye disease such as
keratoconus. The measuring result can show corneal eccentricity
parameter such P and e value after data analyze and calculation.
The multi function automatic eye diagonser is fully automated,
multiple functions can be achieved with one measurement
including auto eye tracing, auto focusing and automatic
measurement.
This manual will introduce to eye doctors and optometrists and
other optometry practitioners how to use, configure and maintain
the VX105 unit.

1.2 Product Features and Use Scope

a) The classification of equipment according to the type of shock proof: class


I, external power supply equipment;
b) The classification of equipment according to the degree of shock proof: B
type;
c) The classification of equipment according to the ability to prevent liquid
entry:not applicable;
d) Application part of the equipment: Chin rest, forehead rest;
e) The type of device power: single phase, network power supply:
100-240V~60/60Hz 105VA;
2
f) Equipment belongs to non AP or APG type;
g) The operation mode: continuous operation;
h) Equipment belongs to impermanent installation equipment.

Transport and storage conditions:


Temperature:-40℃ - +55℃
Humidity:≤80%
Atmospheric pressure:700hPa - 1060hPa (transportation)
500hPa - 1060hPa (storage)
Working condition:
Temperature: 10℃ - 40℃
Humidity: ≤80%
Atmospheric pressure:760hPa - 1060hPa

CAUTION! When the unit is switched on, if without any operations within 5
minutes, it will go into power saving mode automatically. User can press any
button to end power saving mode and go into measurement

Power supply:

Voltage: 100-240V~、50/60Hz

Input power: 150VA

Software operating environment


Model: VX105
Software issuing version:V2
* Processor main frequency:1GHz
* System memory: 4GB
* Memory: 256MB
Network connection:LAN cable
Network safety: Windows Defender (can automatically upgrade with internet)
Data port: TCP/IP, USB2.0 and USB 3.0(transport protocol) ./PDF, XML(storage
format)
3
User access control: Windows account encryption (user ID)/common user(user
type)/ access to the device APP(limits)

Software naming rule:


Software version number includes 3 segments: A,B and C.
Segment A is the main version, indicating major update and upgrade of the software.
Initial value is V1. When there is major upgrade, it will change to V2,V3,V4 for each
major change.
Segment B indicating minor upgrade of the software. Initial version 0, will add 1 each
time there is a minor upgrade of the software.
Segment C is revise version, indicating the corrective upgrade for the software. It
represents the date of the upgrade YYMMDD. Eg, if the software is constructed on
Oct 8, 2012, then it will change to 121008.

1.3 Classification

Model
Auto refraction Keratometry Topography
Function

VX105
Note: means the function is available

1.4 Main performance index

Refraction
Sphere (S) -20.00D to +20.00D (increment 0.01D/0.12D/0.25D, VD=12mm)
Cylindrical(C) -8D to +8D (increment 0.01D/0.12D/0.25D)
Axis(A) 0°to 180°(increment 1°)
VD 0mm/12mm/13.5mm/13.75mm/15mm (optional)
PD 10mm to 85mm (increment 1mm)
Eye relaxation Auto fogging system (landscape chart)
Accuracy Measurement accuracy meets ISO 10342-2010 requirement

Keratometer
Radius range 5.5mm to 10.0mm (increment 0.1mm)
4
Meridian axis 0°to 180°(increment 1°)
Accuracy Measurement accuracy meets ISO 10343-2014 requirement

Topography
Corneal diopter range 33.80D to 61.40D (n=1.3375)
43D measurable zone 0.75mm to 10mm
Measuring rings 24 Placido rings
Measuring dots 6144 dots
Pixels Above 100000
Map analyze Simulate keratometry value, keratoconus screen and peripheral power analyze
Corneal maps Axial map, tangential map, elevation map, refractive map, eye picture and
topo ring correction
Accuracy Measurement accuracy meets YY0787-2012 standard type A requirement
● Electrical equipment safety comply with ISO 15004-1 : 2006 Ophthalmic Instruments
Fundamental requirements and test methods Part 1: General requirements applicable to all
ophthalmic instruments.
● Leaser comply with IEC 60825-1:2014 Safety of laser products Part 1: Equipment classification
and requirements.
● Device comply with IEC60601-Ed.3.1: Medical electrical equipment - Part 1: General
requirements for basic safety and essential electrical safety performance and IEC60601-1-2 Ed
4.0: Medical electrical equipment - Part 1-2: General requirements for safety - Collateral
standard: Electromagnetic compatibility – Requirements and tests.
● The device comply with applicable terms in ISO-15004-1:2006 standards.
● The device optical radiation also comply with requirements in ISO15004-2:2007.

Hardware specification
Printer Thermal printer
Screen 10.1in color LCD touch screen
Memory 100GB (built in memory)
Auto tracing range 102*20*51mm(horizontal, vertical, back and forth )
Measuring method 3D auto tracing
Working distance ≈94mm
Chin rest loading 2.5kg
Chin rest moving
62mm(up and down)
range

1.5 Glossary

Refractive
PD Pupil distance

5
S/C/A Sphere,cylinder, axis
Keratometry
K1,K2 The corneal curvature on perpendicular axis.(K1 is the flat meridian value and
K2 is the most steep meridian corneal keratometry value, namely KF, KS )
AVG The average value of K1 and K2

Topography
Kf, Ks The refractive value on flat and steep meridian
Km The average value of Kf and Ks
Sim K Simulated keratometry, the average keratometery value of the maximum
meridian and the average keratometry value on the meridian vertical to it on the
simulated corneal image’s 6th, 7th and 8th rings
Cyl Cylinder value
Eccentricity chart The eccentricity rate on different pre-set position
Vector chart The vector radius on different pre-set position
Meridians The intersection line on both the corneal surface and the axis of the corneal
topograph
P Shape factory of the cornea (P=1-e2)
e Eccentricity of the cornea. It is used to describe the curvature of the conics,
namely the speed of getting flat or steep after the conics leave the
crest(YY0787-2010.3.2)
Q A factor indicating the asphericity of the cornea (Q=P-I)
SAI Surface asymmetry index, the parameter to reflect the different value between 2
points that are 180°from each other on the corneal surface
DSI Differential Sector Index
SRI Surface Regularity Index
OSI Opposite Sector Index
CSI Center-Surrounded Index
SDP Standard Deviation of corneal Power
IAI Irregular astigmatism index: the average value of the total number of rings on all
cornea meridian after area correction
AA Analyzing area, percentage of the analyzed area on the cornea surface
KPI Keratoconus prediction index
SI Symmetrical index, the difference of the average value for the 2 circle area
centered on the vertical axis
AGV Apex gradient curvature,
AK Apex keratometry, keratometry at cornea apex point
PVA Potential visual ability, presume the eye is normal, by analyzing the cornea
shape to show the ideal corrected vision from function
Es Eccentricity at the oval simulated according to cornea shape at Ks angle
Em Eccentricity at the oval simulated according to cornea shape at Mink angle
Mink Minimum Keratonetry, since the weak meridian (low keratometry) not always
vertical to the strong meridian (high keratometry), Mink is used to show the
minimum keratometry value
6
2. Safety precautions

7
2.1 Symbols
In this manual, signal words are used to designate the degree or level of safety
alerting.
The definitions are as follows.
CAUTION: Indicates a potentially hazardous situation which, if
CAUTION
not avoided, may result in moderate or severe injury.
WARNING: Indicates a potentially hazardous situation which,
if not avoided, may result in mild injury or property damage.
WARNING
Even situations indicated by CAUTION may result in serious injury under certain
conditions.
Safety precautions must be strictly followed at all times.

2.2 Before Use

CAUTION

 This product is Glass 1 leaser product with 3R leaser built in.


 DO NOT try to disassembly or change the deivce.
 There is no operator maintain part on this device. All maintenance and repair
must be conducted by authorized service personnel.

CAUTION

 The safety precautions and operating procedures must be thoroughly understood


prior to operation of the device. Use the device for unintended use may cause
machine malfunction or adverse events.
 Do not open shell and do not touch the interior of the device. This may cause
electric shock or instrument failure.
 Install and use the device in an environment that meets the following conditions.
Temperature:10℃ - 40℃
Humidity:≤80%
Atmospheric pressure:760hPa - 1060hPa
A room with low dust and weak lighting
A location free from vibration and shock
8
------ If the device is not installed and used under above conditions, the
reliability of measured results is impaired, and malfunction may be resulted.
In addition, there is a possibility of injury if the device receives shock and
falls down.
 Avoid storage the device near water, poisonous gas or liquid. The device may
corrode or broken down.
 Avoid installing the device on ventilation path. Changes in temperature may
result in condensation of vapor inside the device or affect measurements.
 Be sure to use the socket meet the device voltage. If the voltage is too low or too
high, the device will not operate. The malfunction of the device may cause fire.
 To avoid electric shock, the device must be connected to supply power with
grounding protection (with grounding sign). Device malfunction or electricity
leakage may cause fire.
 Do not overload the power socket, or it may cause fire.
 Insert the power plug into the socket firmly. Improper connections may cause
fire.
 Never use a power strip or extension cable to supply the device with power. This
may cause failures and fire.
 Do not place heavy objects on the power cord. A damaged power cord may cause
fire or electric shock.
 Switch off the device and disconnect it from power before connecting cables. Or
it may cause device malfunction.
 Make sure to turn off the device, unplug the power cord and the power cable, lock
the head (with a lock sign) when moving the device, to avoid equipment falling
that may cause injury or equipment damage.
 Use special packing to protect the device for transportation. Excessive vibration
or shock can cause malfunction.
 When installing and operating the device follow below EMC instructions in
chapter 9. EMC

2.3 During Use

CAUTION

 When operating the device, the operator and patient should keep hand and body

clean.

 DO NOT touch optical part of the device, or it may affect measurement accuracy.
9
 When the not in use, please turn off the power and cover the device with dust
cover. If the equipment is exposed for a long time, it may collect dust, which will

affect the accuracy.


 Please check the device before the operation. If there is any abnormality, do not

use the it. Using the device under its abnormal conditions may affect the accuracy
of the data, causing unexpected failures, diagnosis errors or hazard.
 Before measuring each patient, clean the chin rest and forehead rest with medical
alcohol. If you use a chin rest paper,please replace a new piece for each patient.

 Keep the measurement window free of fingerprints and dust, or else measurement
accuracy may be decreased substantially.
 In the event of smoke or strange odors, immediately turn off and disconnect the

device from power. After it is certain that the smoke has stopped, contact our
company or your authorized distributor.

 Continuing to use the device under abnormal conditions may cause fire or electric
shock. In case of fire, use a dry powder (ABC) fire extinguisher.

 Never press on the LCD with any hard objects such as a ball-point pen. Keep
magnetic objects away from the LCD.

 Never operate on the LCD screen with wet hand. Water leaking inside of the

device may cause malfunction.


 There may be a few dead or constantly-lit pixels on the LCD. This does not

represent failure of the LCD. It is due to the LCD property.


 Only trained and qualified personnel can operate this instrument, or operate under

their guidance.

2.4 After Use

CAUTION

 If the device is not in use for a long time, unplug the power cord. Dust many
collect moisture that may cause short circuit or fire.
 Occasionally clean the pins of the power plugs with dry cloth. If the dust falls on

10
the tip, it may collect and cause short circuit or fire.
 Do not unplug the power cable violently. It may damage the cable core and
causing electric shock, short circuit or fire.
 Maintain the following environmental conditions during transport and storage of
the device.
Temperature:-40℃ - +55℃
Humidity:≤80%
Atmospheric pressure:700hPa - 1060hPa(transportation)、500hPa -
1060hPa(storage)
A location with low dust
A location not exposed to direct sunlight
 Special packing materials are required to protect the equipment during
transportation. Excessive vibration or shock can cause malfunction.

2.5 Maintenance and check

WARNING

 Do not wipe any part of the DEVICE with solvent or strong cleaning solution.
Otherwise it may be damaged.
 Do not use organic solvents such as paint thinner to clean the outside of the
device. Otherwise it will damage the device surface.
 Avoid touching the optical components of the device to prevent performance
degradation caused by fingerprints or grease stains on the lens set.
 Any repairs and services to this device must be carried out by personnel or
dealers trained by our company. MSOC will provide circuit diagram, spare parts
list, drawing and legend and correction rules or any other necessary material as
per required.
 Adjustments must be made by the technical service personnel of our company or
other authorized personnel.
 The battery (graded with label )of the device must be replaced by the technical
service personnel of our company or other authorized personnel.

11
 When the device needs to be returned to the company for repair or maintenance,
use a clean cloth dipped with alcohol to disinfection the device (especially the
areas where contact with patients).
 When the refraction measurement result is with big difference with the subjective
measurement, please contact MSOC to check if the current device need to be
calibrated for accuracy.

2.6 Disposal

CAUTION
 Follow local governing ordinances and recycling plans regarding disposal or
recycling of device components.
 It is recommended to deal with industrial waste by the designated contractor.
Deal with packaging material in accordance with local laws and regulations.

12
3. Configuration and Functions

13
3.1 Device configuration

Picture 1 VX105 device

NO. Description
Measuring head
1
Movable head to measure human eye
Printer:
2
Print the measurement on a ticket
Power switch:
3
Turn on or turn off the power
Power inlet:
4
For power connection
Forehead rest:
5
Patient forehead leans here
Leaser exit:
6
Window for leaser exit for measurement
Chin rest :
7
Patient chin fixed here during ensnarement
Chin rest up button
8
Press to lift the chin rest button
Chin rest down button
9
Press to lower the chin rest button

14
Chassis
10
Base of the device to fix the measuring head
Power switch:
11
Turn on or turn off the unit
LCD touch screen:
12
Display measurement results. The screen can be tilted.

CAUTION

The device is complied with ISO 15004-2:2007 Ophthalmic instruments —


Fundamental require,emts amd test methods—Part 2: Light hazard protection.

3.2 Accessories

NO. Description
1 Power cord
For device power connection
2 Printing paper
Display measurement result
3 Chin rest paper
Put on the Chin rest during measurement.
4 Chin rest paper fixation pin
To fix the chin rest paper on the chin rest
5 Fuse
To prevent short circuit
6 Operator’s manual
Instructions for use of this device

WARNING

The instrument accessories are provided by our company, and the accessories
of other manufacturers need to be verified and confirmed by MSOC before use.

15
3.3 Symbols

The following symbols are applied to the device.

Need to refer to user manual

Manufacturer

Warning, please read the operator’s manual before operation.

Non ionizing radiation

Type B electric shock protection

Fuse indication

3V CR1220 button battery

Chin rest for patient put chin on during measurement.


Bearing limit:2.5KG

protective grounding

Alternating current

Off position

On position

Chin rest up button

Chin rest down button

Power on/off button

Glass 1 laser product

This side up

Handle with care

Keep away from moisture

16
No stacking

17
3.4 Operation Flow

The design block diagram of the software and user interface is shown in below
picture 2. Through the operating interface, the user can achieve the measurement, data
display, image analysis, and modification of the parameters and functions.

Power on

Start-up screen

Main screen

measuring result Patient screen Configuration screen


screen

Measuring screen

Picture2 Operation screen flow chart

Following is the introduction for several main screens in detail:

3.4.1. Main screen

6
Picture 3 Main screen

18
NO. Description
1 Add:enter patient screen and input patient information
2 Settings: enter settings screen (see part 3.4.5 settings screen)
3 Shutdown button: press to shut down the unit
4 Measure button: press to enter measure screen, the measuring result
will automatically saved as temp file named by automatically
generated ID
5 Patients: press to enter patient list screen, all patients information
will be listed(see part 3.4.2 Patient list)
6 Screen saver: press to show screen saver
NOTE: Current measurement result will show up once the measurement is finished;
enter patient list screen and select one patient to see the patient’s history data.

3.4.2. Patient screen


As shown in picture below:

10

11

12

Picture 4 Patient screen

The function of each button in the screen:


19
NO. Description
1 Add new patient: press to enter info input screen

Modification: open a selected customer info and press this button


2
to modify

3 Delete (patent): delete all selected patient info


Cut: cut the selected patient info, item been cut can be pasted later
4 under designated records (after the selected item have been cut, the
button will change to “Paste”)
5 Delete (record): delete all selected measure record
Load: load in the selected measured result, enter result screen to
6
check measurement data
Patients: list of all patient info saved on the unit (slide to turn to
7
next page)
measuring result: the selected customer’s all measuring result
8
records
Clear: cancel the filter info(first/last name) for searching the
9
patient, return to show all patients info saved on the unit
Screen saver button: the unit go into screen saver mode after
10
pressing this button
11 Settings: Press this button to to into device settings menu
Meausre: Press this button to start a measurement for the selected
12 patient, the result will be saved under the patient’s record
automatically

Note: selected: means an items is highlighted;


Select all: means choosing one or more check box

The screen of editing patient information is as shown in picture 5 below:

20
1

Picture 5 Editing patient information screen

NO. Description
1 Add patient’s name
2 Add patient’s cellphone number
3 Choose patient gender
4 Choose patient birth date
5 Add patient’s e-mail address
6 Cancel editing information
7 Save patient information
8 Save patient information and start a measurement

3.4.3. Measuring screen

21
2 3 4 5 6

13
10
16
14
11

15 12
Picture 6 Measuring screen

NO. Description
1 Return to main screen(see part 3.4.1 main screen)
2 Patient’s name: name of the patient being measured
3 Up arrow: press to move the measuring head up
4 Right arrow: press to move the measuring head to the right
5 Available measurements: slide to choose the intended measurement
6 Choosing the eye to be measured left/right/binocular
Default position for child test: press and the chin rest will lowered to
7
child test position
Default position for adult test: press and the chin rest will be lifted to
8
adult test position
Chin rest up: press to lift the chin rest and patient eye position move
9
up
Chin rest down: press to lower the chin rest and patient eye position
10
move down
Cancel measurement: cancel the measurement and return to the
11
screen before measurement
Cancel/start measurement:start the measurement, during
12
measurement can press this button to pause or skip
13 Right arrow: press to move the measuring head to the right
Camera image: the image captured by the camera, easier for focusing
14
and centering

22
15 Right arrow: press to move the measuring head to the right
The list of measurements to be conducted: display the list of
16 measurements in pre-set order and the progress of current
measurement
Note: when the measurement begins, if patient name is not added, the measurement
result will be autocratically saved under TEMP+NUMBER file name generated by
the device. Operate can change the record to the patient name later in patient
screen(part 3.4.2)

3
4
1
5

Picture 7 Modifying rings on Topography map

NO. Description
The rings on topo map measured by Placido: the number of the rings
1 descending from the outside to the inside, #24 is the ring on the
outside, and the ring in the center is ring#1 .
Selection of the rings: choose number of the ring that need to be
2
modified. The selected ring will become blue.
Erase the selected rings: if erase more than 10% of the rings on the
3 topography map (erase more than 2 rings), it may decrease the
accuracy of the result.
Adding a new ring: select a ring (in blue), keep the topo image clear,
4
the device make a new ring after calculation.
Delete the selected ring automatically: by touching the screen or
5
click on the mouse to delete the selected ring
6 Cancel: cancel all modification have been made

23
Confirm: confirm the modifications and start to calculate for new
7
topo map

3.4.4. Result summary screens


The refraction and keratometry result screen is as shown in below picture 8:

1 2 3 4

10

11
12

13

14

5 6 7
Picture 8 Result summary screen

NO. Description
1 Patient: name or ID of the patient being measured
2 Time: time and date for the measurement
3 PD: pupil distance
4 Left/Right eye: show result of the left eye(L) or the right eye(R)
5 Sum: brief preview of all measurement results
6 Map: sum of maps of all topo measurement
7 Data of all results
8 VD: vertex distance, can be configured
Refraction data of both eyes:sphere, cylinder, axis and pupil. Press
9
this area to show results of several measurements.
10 Map summary of both eyes: briefly show the topo results

24
11 Switch of units: current unit: D/mm
Measure: press to start a measurement under the name of current
12
patient
13 Export: export data or print current result
14 Exit: exit current screen and return to previous screen

The screen for topo measurement result is as shown in picture 9 below:

1 2 3 4 5 6

9
10

7 8

Picture 9 Topo measurement result screen

NO. Description
Color histogram is according to YY0787-2010 appendix B standard
1
(ISO 19980-2012 standard and other options)
2 Map
3 Map type selection
4 Main parameter of the map
5 Switching different views
6 Tools: press to hide/display buttons for different tools
7 Press to apply main values and step value(D) onto the maps
Press to configure default main values and step value(D), and apply
8
onto the map
9 Adjust main values

25
10 Adjust step

The topography maps data screen is as shown in below picture 10

2 5
6

3
4

Picture 10 Data

NO. Description
1 SimK chart: chart for simulated Keratometry values
Menu: choose the data detail to be displayed: eccentricity chart,
2
vector radius and meridian
3 Geometry Table: geometry shape of the cornea
4 Detail data of the item selected in the menu
5 Basic data
6 High index

3.4.5. Settings screen


The topography map high index data(as shown in picture 11) and the definition please
refer to part 1.5.

26
1

Picture 11 Topography map high index data

NO. Description
1 High index: all kind of index for cornea. Refer to glossary in part 1.5

other settings please refer to below picture 12:

1 2 3 4 5

10
8
11
9
12

13

14 15 16 17 18

NO. Description
Setting frequency of clearing temporary data. The temporary data is
1
the patient record saved as “Temp+serial number”

27
2 Default settings
3 Warning beep
4 Password option and setting
5 Screen saver and waiting time
6 Data setting
7 Language
8 Hour setting
9 Minute setting
10 Shutdown
11 Resume factory settings
12 Cancel the changed settings
13 Save the settings
14 General settings
15 Measurement settings
16 Result display settings
17 Export settings
18 Report settings

General settings screen-1:default measurements screen is as shown in below picture


13

Picture 13 Default measurements

NO. Description
28
1 Measurements to be displayed in the list of available measurements

General settings-2: default settings for different measurements,including PD, default


chin rest position, measurement times and beeper(picture 14), child test and adult test
default measure position(picture 15):

4
1
5

2 6

3 7

Picture 14 General settings screen-2

Picture 15 General settings screen-3

NO. Description
1 Default PD position for child test or adult test
2 Default settings for child and adult test

29
3 Setting default patient as “Child” or “Adult”
4 Setting measurement times for refraction
5 Setting measurement times for keratometry
6 Setting the volume of the notification beeper
Setting for DarkField. It is on by default, only be off when measuring
7
artificial eye

The refraction result setting screen is as shown in picture 16 below:

Picture 16 Result setting screen

NO. Description
1 Setting for result increments(step)
2 Default sign for cylinder:+,- or AUTO
3 Default vertex distance

The topography result setting screen is as shown in picture 17 below:

30
1 2

7
8

Picture 17 Topography result setting screen

NO. Description
1 Default map type
2 Default parameter to be displayed
3 Unit
4 Display form of eccentricity
5 Scale for the map
6 Setting step
7 Main values
8 Color plate type

The exporting setting screen is as shown in below picture 18:

31
2 3

Picture 18 Export setting screen

NO. Description
Default export method: the ticket is printed by the built in printer of
the device; report can be printed with external professional printer
1
connected to the device; serial port is to transfer to port or wireless
export.
2 Open control panel
3 Open device management

Report setting screen is as shown in below picture 9:

32
Picture 19 Report setting screen

NO. Description
1 Eyes to show on each report
2 Map type to show on the report
3 Clinic name to show on the report
4 Doctor name to show on the report
5 Custom logo for the report

33
4. Installation &
measurement
preparation

34
4.1.Power cord connection
● Place the device on a flat table.
● Make sure the power switch is turned off. Then connect the power cord with the
power inlet socket on the machine.

4.2.Chin rest paper


● Insert the artificial eye fixing pin into the holes on the Chin rest paper;
● Fix the Chin rest paper onto the Chin rest pad.

4.3.Printer paper
Refer to chapter 6.2.

4.4.Check Parameter Settings


Before measurement, please check each parameter settings carefully. Refer to
chapter 3..4.5.
Before starting measurement, please check the machine
settings with chapter 3.4.5 of this manual to confirm the

CAUTION parameters are correct. Different parameter settings may result in


changes of measurement results.

35
5. Measurement

36
5.1 Artificial eye measurement

1.Turn on the power switch


Connect the power cord and turn on the power. The indicator on the switch
button will light up..
2.Place the artificial eye
Align and adjust artificial eye position to make it as close to the measuring head
as possible.
3. Choosing refraction measurement
In the main screen, enter measuring screen and choose refraction.
4.Measurement position
A. Adjust chin rest height, adjust measuring head position by pressing on the camera
image on the screen to make the artificial eye in the center of the image.
5.Measurement
Press the measure button to start a test.
6. Results
After measurement is finished, it will automatically to to result screen.

5.2 Patient Measurement

1.Switch on the device


Connect the device to power supply and switch power on, the power on indicator
will light up.
2.Long pres on the switch button for 2 second, when hear the “beep”, loosen the
button and wait the machine to finish initialization.
3.Press measure on main screen to enter measure screen, choose measurements
needed.
4.Adjust position
● Let the patient sit on the chair and put their chin on the Chin rest and lean their
forehead on the head rest. Make sure their eye is aligned with the marking line on
the sides of the forehead rest.
37
● Tell the patient to relax and look at the target.
5.Adjust measure position
● Choose “child” or ”adult” according to patient age, automatically adjust chin rest
height. Or press up down button to adjust chin rest position
● Press the eye selection button to choose the eye to be measured.
● Press the arrows in the camera image area on the screen to adjust measuring head
position to make the eye in the center of the image
6.Start measurement
Press the start button to start measurement. During the measurement, tell the
patient not to move their head and open their eye widely to avoid eye lid cover the eye.
When moving to the other eye, press on the screen to adjust measuring head position
to make sure the patient eye is in the center of the image.
7.Results
● When measurement is finished, it will go to result screen automatically. User can
review the sum result, or press each tap at the bottom to check details of each
measurement.
● If the Topography measurement is included, after measurement, it will go to topo
ring modification screen for user to add/erase the rings, press “continue” to go to
the result screen.
If any of the following incidents shall happen, please turn off the power
supply immediately, disconnect the AC power and contact local MSOC
distributor.

WARNING ● If there is smoke, strange smell or noise coming out of the device.
●When liquid or metal objects get inside of the device.
●When the instrument is dropped or appearance is damaged

When the screen saver is on, without any operations for a while, the device
will automatically get to the power saving mode. Press any button to activate

CAUTION the machine from power –saving mode.


● During measuring, keep telling the patient to keep their head steady and
38
stare at the balloon target, or it will influence the result.
● The data measured by this device can not work solely as the basis to
prescribe glasses, it can not replace the diagnose of and optometrist or
lens correcting technology. The result is only for reference manual
refraction.

5.3 Auto tracing


1. If the target eye is not in the measuring range, auto tracing will not work.

Picture 20 Auto tracing will notwork when target eye is out of measuring range

● Ask the patient to sit on the chair, lean forehead on the forehead rest and put chin
on the chin rest.
● Tell the patient to relax the eye and look at the target.
● Choose the eye to start auto measurement. The initial position of the measuring
head is on the left or right. Check the image of they in the camera image area on
the screen. When see the patient’s eye in the area, auto tracing starts.
● When target eye is not in the image capturing area(pupil center not detected), auto
tracing will not work. Press the camera image on the screen to adjust measuring
head position, make the eye position in the center of the camera image, auto
tracing will start work again.
2. Stop measurement

39
Picture 21 Stopping a measurement
● When auto tracing detect that the measurement can not continue, press skip to
move to next measurement.
● After all measurement is finished, adjust siting posture and position and try make
the skipped measurement again.
● If auto tracing not work does not belong to above situations, please contact
MSOC or your local distributor.

40
6. Self-diagnosis and maintenance

41
6.1 Troubleshooting

When there is problem with the device, please try below methods first:
Symptoms Method
·Make sure the power plug is connected to the power
Turning on power switch, the
inlet.
machine has no response.
·Make sure the fuse is installed and not burnt.
The screen stops showing ·The device has entered the screen saver mode. Press
images suddenly any button to return to normal display state.
·There may be an abnormality. Please try to restart
Button failure
the machine.
·Please replace the printer paper
Printing button does not work
Make sure printer paper is installed correctly
Use the chin rest up and down button to adjust
patient head position. If still can not find patient eye,
The image of patient eye is
return to main screen to make the device position
not shown in the screen
re-set (it may be patient eye is too far from the
measuring window)
Enter the topography rings result and modify the
Big noise point on the rings with poor quality
topography measuring result Patient eye is not fully open. Try measure again and
instruct the patient to open their eyes wildly

If you can’t solve the problem according to the table, please contact MSOC or your distributor.

6.2 Replacing printer paper

When a red line appears along the printer paper, please replace the new printer paper.
1 Lift up the printer chamber handle and pull down the cover.
2 Take out the printer paper shaft with the empty paper roll, take off the paper roll.
3 Put on a new roll of printer paper, and make sure the end of the printer is facing
42
up.
4 Put the printer shaft back onto the printer chamber, leave short piece of the printer
out.
5 Push back the printer covers.

6.3 Cleaning and disinfection

Cleaning:
1 Keep the product clean. Don’t use strong volatile solvents, diluent or benzene as
cleaning agent.
② Wipe the product with a soft cloth dipped in soapy water.
③ When wipe the lens and the mirror, firstly blow off the dust on the surface and then
wipe with a soft dry cloth.

Make sure to turn off the device and unplug it from power before cleaning
and disinfecting.
WARNING

●Do not spray liquid into the device, otherwise it will break down the
device.
●Alcohol and acetone are forbidden. Strong solvents can cause damage.

CAUTION ●When cleaning the plastic surface of the device, please use the dedicated,
un-abrasion solvent and soft cloth to clean the top, bottom and side plastic
cover gently.
Disinfection:
① Before measure each patient, the area contacting the patients should be cleaned and
disinfected with medical alcohol (Forehead rest and Chin rest). If you use the Chin
rest paper, replace a new Chin rest paper for each patient.

6.4 Replacing the fuse

1 Turn off the power and unplug the power cord

43
2 Open the fuse cover in the power socket
3 Take the broken fuse
4 Install the new fuse

The VX105 device uses F1AL250V fuse.


WARNIN
G

6.5 Site Change

1 Long press the power button for 2 seconds, or press ‘shutdown’ button from
the main screen to shut down the device;
2 Turn off the power and unplug the power cord.
3 When moving the device, hold the product base and maintain the level.
When moving the product or changing site, make sure to shut down the device
by pressing the on/off button or the shutdown button in the main screen;
If the device need to be packed for location change, the device must be
WARNIN
shutdown by press the “shutdown” button in the main screen for the unit to get
G
into packing mode.

6.6 Preventive inspection and maintenance

6.6.1 Preventative inspection

 Adjust the level of the instrument with a horizontal level. Set the measurement
sphere step to 0.12D. Then measure with -5D artificial eye for 3 tines, the results
should be between -4.75D to -5.25D. If the result does not fall in this range,
please contact MSOC or MSOC distributor for calibration.
 General technical must be in full compliance:
 The device should be installed firmly with no wobble. The chin rest should
move up and down smoothly. The machine should respond accordingly when
certain button is pressed and the measuring head should be flexible to move
forward, backward, left and right.
 The screen should be able to display image clearly.

44
 All optical parts should be clean, un-damaged, and without defects that will
influence light transmission and imaging.
 The digits display should be complete and stable without blinking, the
printed content should be clear and readable.
 Should be able to print the results.
 When there is any non-conformity, must contact MSOC after sales service
department for calibration or repair.

6.6.2 Inspection cycle

 Every 6 month

6.6.3 Maintenance cycle

 The maintenance of this device should be according to part 6.3 of this manual and
do it at least once every month.
(Note: the metrological verification cycle should be according to related regulation )

6.7 Scrap

① The disposal of scrap products and accessories need to comply with the
relevant laws and regulations of local government. The product or lithium
battery scrap, especially lithium batteries may cause pollution to the
CAUTIO environment.
N
② The disposal of waste packaging material shall comply with the relevant
laws and regulations of the local government.

45
7.Dimensions and Other
Specification

46
7.1 Dimensions and Contraindications
Dimension
Body: 496mm×320mm×467490mm
Net weight 20kg
Power: 100-240V~ 50/60Hz,150VA
Contraindication: None

7.2 Service life

8 years

7.3 Disclaimer
The manufacturer shall be responsible for the safety, reliability and performance
of the product if:
(1)Install according to the instruction manual.
(2)Use and maintain according to the instruction manual and service manual.
The manufacturer shall not be held responsible for any
WARNING
problems caused by the alteration of the instrument without
permission. The altered instrument will not be within the scope of
the manufacturer's commitment.

7.4 Manufacture date


See product label

47
8. After-sales service

48
If there are problems during use the machine and still not resolved after
communication with the distributor. Please fill the table according to the following
requirements and submit to the agents of our company.
① Product model:VX105
② Serial number: The number and text recorded on the label
③ Problem Description: A detailed description of the problem

49
9.EMC

50
This unit comply with IEC 60825-1 : 2014 Safety of laser products Part 1:
Equipment classification and requirements.

Must use the cable and accessories provided by this equipment. Cable
information is as follows:
Cable name Length
Power cord 2.1m

 Special precautions for electromagnetic compatibility are required


for this equipment. And must be installed and used in accordance
with the electromagnetic compatibility information specified in
this manual.
WARNING
 Portable and mobile radio frequency communications equipment
may have impact on the device

Basic performance for normal operation:

Name Specific description


Normal
The device can run normally during the test.
operation

 .Except for the power cable(adaptor) which is sold as interior

spare parts, using of non-specified accessories and cables may


increase device or system emit or reduce device immunity to

other interference.
CAUTION
 The equipment or system should not be used or stacked with other
equipment. If it is necessary to be close or stacked, it should be

verified that it can normally operate in its configuration.

Guidance and manufacturer's declaration - electromagnetic emissions


The device is intended for use in the electromagnetic environment specified below.
Customer or user of the device should assure that it is used in such an environment.
Emissions test Compli Electromagnetic environment - guidance
ance
RF emissions Group The device uses RF energy only for its internal
GB 4824 1 function. Therefore, its RF emissions are very low and are
51
not likely to cause any interference in nearby electronic
equipment
RF emissions
Class B
GB 4824
Harmonic
emissions Class A
The equipment is suitable for use in all facilities,
GB 17625.1
including household and public low-voltage power supply
Voltage
network that supplies buildings for domestic purposes.
fluctuations/
Flicker Comply
GB 17625.2

Guidance and manufacturer's declaration - electromagnetic immunity


The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IEC60601 Electromagnetic
Immunity test Compliance level
test level environment - guidance
Floor should be wood,
Electrostatic concrete or ceramic tile. If
Discharge ±6kV contact ±6kV contact floors are covered with
((ESD) ±8kV air ±8kV air synthetic material, the relative
GB/T 17626.2 humidity should be at least
30%.
Electrical fast ±2kV for power Mains power quality should
±2kV for power
transient/burst supply cable be that of a typical
supply cable
GB/T 17626.4 ±1 kV for commercial or hospital
Not applicable
input/output cable environment quality.
Mains power quality
Surge ±1kV Line to line ±1kV Line to line
should be that of a typical
GB/T 17626.5 ±2kV Line to ±2kVLine to
commercial or hospital
ground ground
environment.
< 5% UT,for 0.5 < 5% UT,for 0.5 Mains power quality should
Voltage dips, cycle(> 95% dip cycle(> 95% dip be that of a typical
short in UT) in UT) commercial or hospital
interruptions and 40% UT,for 5 40% UT,for 5 environment. If the user of the
voltage cycles (60% dip in cycles (60% dip device requires continued
variations on UT) in UT) operation during power mains
power supply 70% UT,for 25 70% UT,for 25 interruptions, it is
input lines cycles (30% dip in cycles (30% dip recommended that the device
GB/T 17626.11 UT) in UT) be powered from an
< 5% UT,for 5 < 5% UT,for 5 uninterruptible power supply
sec sec or a battery.

52
(> 95% dip in UT) (> 95% dip in
UT)
Power frequency magnetic
Power frequency fields should be at levels
(50/60Hz) characteristic of a typical
3 A/m 3 A/m
GB/T 17626.8 location in a typical
commercial or hospital
environment.
NOTE:UT is the a.c. mains voltage prior to application of the test level.

Guidance and manufacturer's declaration - electromagnetic immunity


The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IEC60601 Electromagnetic
Immunity test Compliance level
test level environment - guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of the device,
including cables, the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended separation
distance
Radio frequency
emissions 3 V(Effective d =1.2
3 V(Effective
GB/T 17626.6 value)
value) 150kHz-80MHz
150kHz - 80MHz
Radiated RF 3 V/m d =1.2
3 V/m
GB/T 17626.3 80MHZ - 2.5GHZ
80MHz-800MHz

d =2.3
800MHz-2.5GHz

Where P is the maximum


output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in meters (m).
Field strengths from fixed RF
53
transmitters, as determined
by an electromagnetic site
survey, a should be less than
the compliance level in each
frequency range. b
Interference may occur in the
vicinity of equipment marked
with the following symbol:

NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

a.Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the device is used
exceeds the applicable RF compliance level above, the device should be observed to
verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as reorienting or relocating the device.

b.Between the frequency range 150 kHz to 80 MHz, field strengths should be less than 3
V/m.

Recommended separation distances between portable and mobile RF communications


equipment and the device
and the device
The device is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended
below, according to the maximum output power of the communications equipment.
Rated Distance to the transmitter with different emission frequency /m
maximum
150kHz - 80MHz 80MHz - 800MHz 800MHz - 2.5GHz
output power
of transmitter d = 1.2 d = 1.2 d = 2.3
(W)
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

54
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 separation distance for the higher frequency range
applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.

55
10.Manufacturer
Information

56
Manufacturer
Ningbo Ming Sing Optical R&D Co., Ltd.
Address: No. 365 middle Jingu road (west), Panhuo street, Yinzhou District, Ningbo,
Zhejiang province 315104, P.R China
Tel: +86-574-87198788
Fax: +86-574-87296439
Email: [email protected]
Website: www.nbmingsing.com

Aftre sales service provider


Ningbo Ming Sing Optical R&D Co., Ltd.
Address: No. 365 middle Jingu road (west), Panhuo street, Yinzhou District, Ningbo,
Zhejiang province 315104, P.R China
Tel: +86-574-87198788
Fax: +86-574-87296439
Email: [email protected]
Website: www.nbmingsing.com

57

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