LENSHOOKE X1 PRO User manual

Semen Quality Analyzer
X1 PRO
User Manual
Rev.29-0X10801 20200302X1B005

Symbols
Please read this user manual carefully first, to ensure proper use of the product. This user manual is
also available at www.LENSHOOKE.com.
The following icons may appear in the content of this user manual.
The package includes
LensHooke™ X1 PRO
Semen Quality Analyzer
Power Adaptor (for analyzer) User Manual
Semen Quality Analyzer
X1 PRO
User Manual
Rev.29-0X10003 20190909X1D003
Symbol for “The intended use of a prescription IVD product”
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Symbol for “DO NOT REUSE”
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Symbol for “BATCH CODE”
Symbol for “SERIAL NUMBER”
Symbol for “DATE OF MANUFACTURE”
Symbol for “MANUFACTURER”
Symbol for “AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY”
Symbol for “IN VITRO DIAGNOSTIC DEVICE”
Symbol for “TEMPERATURE LIMITATION”
Symbol for “CONSULT INSTRUCTIONS FOR USE”
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CE mark
Symbol for “FOLLOW INSTRUCTIONS FOR USE”

Table of Contents
I.
II.
III.
IV.
V.
VI.
VII.
VIII.
IX.
X.
XI.
XII.
XIII.
XIV.
Introduction
Intended Use
Product Overview
Consumables
Major Functions
Accessories
Getting Started
Cleaning & Maintenance
Error Message
Analyzer Specifications
Reference
Statement
Warnings and Precautions
Warranty
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20
23
25
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(1)
(2)
(3)
(4)
I. Introduction
Sperm concentration (106per ml)
Total motility (PR+NP, %)
Progressive motility (%)
Non-Progressive motility (%)
Sperm morphology (normal forms, %)
pH value
LensHookeTM X1 PRO Semen Quality Analyzer is for in vitro diagnostic only. The user should read this
User Manual first, to get familiar with the device and its proper operation procedure prior to use the
analyzer.
II. Intended use
The LensHookeTM X1 PRO Semen Quality Analyzer used with LensHookeTM Semen Test Cassette is an
optical device for human semen analysis which provides direct and calculated quantitative measure-
ments for:
The LensHookeTM X1 PRO Semen Quality Analyzer does not provide a comprehensive evaluation of a
male’s fertility status.
It is an in-vitro diagnostic system intended for human semen analysis of individuals in healthcare
professional setting to evaluate male fertility.
1

NOTE
Touch Screen
Test Cassette Insert Slot
Power Button
Reset Button
AC Plug
Power Adaptor Plug
Power Adaptor LensHookeTM Semen Test Cassette
III. Product Overview
USB Port : USB 2.0
Reset Button : If the analyzer crashes, please use a pin to press the reset button.
HDMI Port : The analyzer allows a HDMI cable connection to a high definition monitor to review the
images and data.
LensHookeTM X1 PRO Semen Quality Analyzer
Accessories
1
1
2
2
3
4
USB Port
USB Port
HDMI Port
Power Adaptor Port
5
6
7
8
Dongguan Shilong Fuhua Electronic Co., Ltd;
UES12LCP-050200SPA ※Sold separately
2
1
2
3
Top View
Front View Rear View
70.00mm
140.00mm
71.20mm
6 7 84 5

NOTE
Touch Screen Icon
The icons below are functional
HDMI connection icon: This analyzer is connected to monitor by a HDMI port.
USB connection icon: This analyzer is connected to a USB Drive.
Thermal Receipt Printer connection icon: This analyzer is connected to a Thermal Receipt Printer.
Power Adaptor connection icon: This analyzer is connected to a power adaptor.
Battery icon: It shows the battery status.
1
1 2 3 4 5
6
7
8
2
3
4
5
Utilities icon: Functions include:
-Quality Control: To check the quality of the analyzer/device.
-Backup All Records: To backup the data for all results.
-System Update: To update the system.
-About: To get the informations of the analyzer/device.
-Delete All Records: To remove/delete all results.
Settings icon: Functions include:
- WHO Standard: To select WHO edition of 4th or 5th.
- Date & Time: To set up the Date and Time.
- Language: To select the language preference.
- Access Password: To get or change the LAN Password to access the analyzer/device through
network.
- Brightness: To adjust the brightness of the screen.
Recent Tests icon: To review the previous test results.
New Test icon: To start testing.
6
7
8
9
9
3
USB connection icon: If you insert any other USB devices, such as a keyboard, mouse, dongle...etc,
this icon will not appear on the screen.
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IV. Consumables
The consumables for LensHookeTM X1 PRO Semen Quality Analyzer are as below:
The result will be inaccurate, if you DO NOT use a LensHookeTM Semen Test Cassette.
LensHookeTM
X QC Beads (For Semen)
Product picture is for reference only. Actual product may vary.
C-KUPTM Liquefaction Test Cup is for semen sample collection.
LensHookeTM Semen Test Cassette is used to hold semen sample for analysis with the analyzer.
LensHookeTM Cleaning Wipe is used to clean the test cassette insert slot.
LensHookeTM X QC Beads (For Semen) is used for quality control of the analyzer.
LensHookeTM X QC Reticle (For Semen) is used for quality control of the analyzer.
C-KUPTM
Liquefaction Test Cup
4
LensHookeTM
Cleaning Wipe
LensHookeTM
Semen Test Cassette
LensHookeTM
X QC Reticle (For Semen)

5
Turning off the analyzer:
Hold down power button for 10 seconds to directly turn off the analyzer, or you can also push the
power button for 2 seconds until the touch screen shows “Power Off” and select the icon to turn it
off.
2
Insert / Remove the Test Cassette
Insert the Test Cassette:
Insert the cassette into the slot and push it
to the end.
1Remove the Test Cassette:
After the test, remove the test cassette in the
opposite direction of the “arrow”.
2
V. Major Function
LensHookeTM X1 PRO Semen Quality Analyzer
Turn on / off
Turning on the analyzer:
Push the power button down for 2 seconds to turn on the analyzer (as Image 1).
When the touch screen lights up (as Image 2), the analyzer is ready to operate.
1
Charging the battery
When the battery power is low, the “Low Battery” message will show on the screen (Image 3). Use
the power adaptor to charge the battery immediately. The “plug” symbol will appear on the touch
screen (as the of Image 4) during charging. If the “plug” symbol fails to show on the screen,
check to make sure the adaptor is properly connected to the analyzer and socket.
1
Image 1 Image 2
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Low Battery
Device will shut down in 5:00 minutes.
Image 3 Image 4
Analyzer is equipped with a built-in 2500 mA Lithium-ion polymer battery.
The battery can not be removed or changed. If you have battery related problems, please contact us.
If you want to enter power saving mode, please press the power button. If you want to wake up the
analyzer, please press the power button again.
If the device had idled for 10 minutes, the system will automatically enter power saving mode.
* Power Saving Mode: Turns off the touch screen to reduce battery consumption.
For the purpose of extending the built-in Lithium-ion polymer battery life, please keep the adaptor
plugged in even while not using the analyzer.
If the analyzer has not been used for over 3 months, please charge before using.
If the analyzer runs out of battery, the date and time indicator might be reset to the default settings.
Please check and set up the date & time properly (refer to Page 16).
If the warning messages “Battery overheating” or “Battery Temperature is too Low” show on the
screen, the analyzer will shut down automatically within 5 minutes to protect itself. When you see
this warning message, please turn off the analyzer, connect the power adaptor to the analyzer and
resume using after 10 minutes.
NOTE
Prepare the Test Analyzer
1. Please put the analyzer on a flat surface.
2. Check if the analyzer is under the normal operating environment.
3. Check battery status. If the battery is low, connect the power adaptor before testing.
1. Refer to the C-KUPTM Liquefaction Test Cup user manual for details.
2. Refer to the LensHookeTM Semen Test Cassette user manual for details, but also following the
Semen sample collection
indication on the screen.
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7
NOTE
DO NOT exceed 20 characters and symbols for the patient ID#.
If you want to input a letter, please hold the icon for 0.5 to 1 seconds and select the letter. If you
want to input a symbol, please select the “ ” icon to switch the keyboard.
You can also use a barcode scanner to scan the bar or QR code of patient ID#. (Plese refer to page
24 to connect the barcode scanner to the analyzer.)
Please refer to Page 20 in this user manual for refill, if it is the first time you use.
New Test
1
Test the Sample
Step 1. Select the “New Test” icon. Step 2. Please input the patient ID number
and select the “ ” icon to go to
the next step.
Cancel
Select a letter
Please select the Liquefaction Time, Semen Colour, Semen Volume after semen sample is
completely liquefied, and then select “Next” to go to the next step. Select the “OK” icon if
the information you inputed is correct.
Step 3.
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ID # 123-00-0000
ABC
1
DEF
2
GHI
3
JKL
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MNO
5
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STU
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VWX
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YZ
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#+=
A B C a b c
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3
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< 30 min
> 60 min
30 ~ 60 min
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ABC
1
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GHI
3
JKL
4
MNO
5
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6
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7
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#+=

8
Recent Tests
(1) Select the “Recent Tests” icon and then select the record you want to review by patient’s ID.
1
Review the Test Result
NOTE
Refer to the LensHookeTM Semen Test Cassette user manual for details, and following the indica-
tion on the screen to do New Test. If you are familiar with the LensHookeTM Semen Test Cassette
operation, please select “Skip” to do the next step.
Please select and to adjust the semen volume.
(2) The record will appear on the screen. If you want to print out this record, please connect the
printer cable into the analyzer, and select the “” icon. If not, select the “”icon to return
to the previous page.
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N/A
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N/A
N/A
N/A
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111-00-0000
123-00-0000
123-00-1111
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3/15/2017 5:12 PM
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123-00-0000 2019/3/16 5:12 PM
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73
WHO 5th 865 %%%
4% 32.8
M/ml
7.2
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(1) Select “Utilities” and then select the “Quality Control” icon.
1Quality Control
The “Quality Control”, “Backup All Records”, “System Update”, “About” and “Delete All
Records” functions.
(2)Please input the LOT number on the label of the LensHookeTM X QC Beads (For Semen) or
LensHookeTM X QC Reticle (For Semen). Please confirm the LOT number and then select “ ” to
go to the next step.
NOTE
ONLY the icon that turn blue can be selected.
If you want to print the result by Thermal Receipt Printer, please contact your distributor to order
one.
You can also connect the analyzer to the LAN to print the result. (Please refer to page 22 to connect
the analyzer to the LAN.)
If a “ ” symbol appears next to the concentration result, it means that the sample has aggrega-
tion of spermatozoa, sperm crystals, or bubbles that may impact the result. We will suggest you to
note the result or redo the test.
The analyzer will not calculate the pinhead, since it
is not considered a sperm by the clinic as it has no
chromatin. If you want to use our analyzer to exam
for the vasectomy patient, please use the manual
exam method to double confirm.
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1DEF 2GHI 3JKL 4MNO 5
PQR
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STU
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VWX
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YZ
9
0
#+=
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(4)Please follow up the instructions of LensHookeTM X QC Beads (For Semen) or LensHookeTM X QC
Reticle (For Semen) to operate and then insert the cassette into the “Insert Slot”.
Information of X QC Reticle (For Semen)
(3) Please confirm the LOT number and check the information of the screen. If it matches the label
on the LensHookeTM X QC Beads (For Semen) or LensHookeTM X QC Reticle (For Semen), select
“OK” to go to the next step.
Information of X QC Beads (For Semen)
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Reticle
X QC
Level 1
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Rev.32-6QX0004
20180914
LOT
EXP.
Target Value :
pH
CON.
Level 1
Beads (For Semen)
X QC
:
:
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7.2 ± 0.2
25 ± 8 M/ml
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Level 1


Level 1
BeadsX QC
Level 1
Reticle
X QC
GTIN
EXP.
LOT
CON.
(01)04719874740856
(12)240627
(10)19062825081
25±3M/ml

NOTE
11
LensHookeTM X QC Beads (For Semen) exams pH value and concentration.
LensHookeTM X QC Reticle (For Semen) ONLY exams concentration.
If you input the LOT number of LensHookeTM X QC Beads (For Semen) but insert the cassette of
LensHookeTM X QC Reticle (For Semen), the analyzer will show the message as below to warn you,
and vice versa.
If N/A shows on the result screen, it means that the LensHookeTM X QC Beads (For Semen) or
LensHookeTM X QC Reticle (For Semen) is expired. Please use another new one.
X QC Beads X QC Reticle
Result of X QC Beads
(5) After 2-5 minutes, the result will appear on the screen automatically.
Result of X QC Reticle
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2Backup All Records
(1) Prepare a USB Drive in advance. (Capacity : 1GB or more)
(2) Select “Utilities” and then select “Backup All Records”.
(4)
(3) Insert the USB Drive. When the “Backup” icon turns blue, select it to backup the records.
When the records have been backed up to your USB Drive successfully, select the “OK” icon to
return to the previous page.
NOTE
DO NOT remove the USB Drive during back up.
If the memory capacity of analyzer is insufficient, the “Insufficient Storage Available” warning
message will appear on the screen. Please back up all records before you delete them to free up
capacity.
If the memory capacity of the USB Drive is insufficient, please remove the USB Drive and delete the
files using a computer/laptop, or using another USB Drive.
When you backed up the records, you will got the PDF, MP4, and CSV files at the same time.
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3System Update
(1) Prepare the a USB Drive with system update software. (Capacity : 1GB or more)
(Please contact with your local distributor for the system update software).
(2) Select “Utilities” and then select the “System Update” icon.
(3)
(4)
Please connect the device with the power adaptor, and plug the USB Drive with the update file
into the analyzer. Select the ‘‘Update’’ icon to update the system.
Select the ‘‘Restart’’ icon to restart the analyzer and complete the system update. The system
will configure updates automatically, and restart the analyzer when the system update is
completed.
NOTE
Please back up all records before system update.
DO NOT turn off or unplug the device during the update process. Make sure to plug in the power
adaptor and insert the USB Drive with system update file when updating the system.
Rev. 0.9.22
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Rev. 0.9.22
(Rev. 1.3.12)
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(Rev. 1.3.12)
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NOTE
If the ‘‘Update File is Corrupted’’ warning message appears on the screen, it means you did not
download the complete file. Please download the system update file again to the USB Drive and redo
the system update.
If the ‘‘Update Failed’’ warning message appears on the screen, it means the USB Drive for system
update has been removed, please insert the USB Drive with system update file again to redo the
system update.
4About
Select “Utilities” and then select the “About” icon to read about the analyzer’s information.
5Delete All Records
(1) Select “Utilities” and then select the “Delete All Records” icon.
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(3) Select the ‘‘OK’’ icon to return to the previous page.
(2) Select the yellow ‘‘Delete’’ icon to confirm and delete all the records.
WHO Edition
(1) Select “Settings” and then select the “WHO Standard” icon.
1
The “WHO Standard”, “Date & Time”, “Language”, “Access Password”, and “Brightness”
settings.
NOTE
The records cannot be recovered after you delete them. Make sure you want to delete them perma-
nently before selecting the ‘‘Delete’’ icon.
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Date：2019.10.12 - 2019.11.01
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16
(2) Select the preference edition and select “”to return to the previous page.
2Date & Time
(1) Select “Settings” and then select the “Date & Time” icon.
(2) You can select the format of the date by selecting the icon “”or “”, and adjust date &
time by selecting “”or “”.
After setting the Date & time, select the “”icon to return to the previous page.
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17
4Access Password
(1) Select “Settings” and then select the “Access Password” icon.
(2) Select “Admin Password” icon. Switch on “ ” of Admin Password to secure your access.
3Language
(1) Select “Settings” and then select the “Language” icon.
NOTE
The default language is “English”.
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