Arkray SillHa LH-4912 User manual

3
SillHa Oral Wellness Instrument
Contents
Intended Use................................................................................................ 5
Introduction ................................................................................................. 5
Glossary of Symbols .................................................................................. 6
Chapter 1: Overview of SillHa Oral Wellness Instrument ............................... 7
1.1 Overview ............................................................................................... 7
1.1.1 Features ........................................................................................ 7
1.1.2 ARKRAY Customer and Technical Service................................... 7
1.1.3 Specifications: SillHa Oral Wellness Instrument ........................... 8
1.1.4 Measurement Principle.................................................................. 9
1.2 Contents of the Shipping Carton ........................................................ 9
1.3 Instrument Part Names and Functions............................................. 10
1.3.1 Instrument Parts .......................................................................... 10
1.3.2 Instrument Touch-Screen Display ............................................... 11
1.3.3 SillHa Software Screen ............................................................... 14
1.4 Cautions During Instrument Installation and Relocation ............... 15
1.4.1 Install the Instrument ................................................................... 15
1.4.2 Follow These Cautions for Best Results
When Relocating the Instrument: ................................................ 15
1.4.3 Disposal:...................................................................................... 15
1.5 Installation of Software and Connection.......................................... 16
1.5.1 Installing the SillHa Software [Windows Edition] ......................... 16
1.5.2 Installing the SillHa Software [Mac Edition]................................. 18
1.5.3 Connecting the Instrument, PC and Printer................................. 19
1.5.4 Set Initial Settings on Instrument................................................. 19
1.5.5 Automatic Upgrading of the Instrument Software........................ 20
Chapter 2: Measurement.................................................................................. 22
2.1 Cautions During Measurement ......................................................... 22
2.1.1 Handling the Measurement Sample ............................................ 22
2.1.2 Handling the SillHa paper (Test Strip)......................................... 23
2.1.3 Factors Affecting Test Results .................................................... 23
2.2 Preparation for Measurement ........................................................... 24
2.2.1 Recommendations for Patients ................................................... 24
2.2.2 Items Required to Perform Test .................................................. 24
2.3 Performing a Measurement ............................................................... 25
2.3.1 Turn on Instrument and Run Software ........................................ 25
2.3.2 Enter Patient Information on the PC............................................ 27
2.3.3 Prepare Measurement Sample ................................................... 28
2.4 Viewing the Test Results on the PC ................................................. 31
2.5 Creation of the Result Sheet ............................................................. 32
2.5.1 Format and Enter Information ..................................................... 32
2.5.2 Printing the Result Sheet............................................................. 33
2.5.3 Example of Printing a Result Sheet............................................. 34
Contents

4ARKRAY
2.6 At the End of the Day ......................................................................... 36
2.7 Check Measurement .......................................................................... 36
Chapter 3: Auxiliary Operations...................................................................... 40
3.1 List of Auxiliary Operations .............................................................. 40
3.1.1 Auxiliary Operations of the Instrument ........................................ 40
3.1.2 Auxiliary Operations of the SillHa Software................................. 41
3.2 Instrument Settings............................................................................ 43
3.2.1 Setting the Date and Time........................................................... 43
3.2.2 Setting the Digits of the Medical Chart Number .......................... 44
3.2.3 Adjusting the Sound Level and Screen Brightness ..................... 45
3.2.4 Changing the Test Strip Direction ............................................... 46
3.3 History ................................................................................................. 48
3.3.1 Re-transmitting the Most Recent
Measurement Results to the PC ................................................. 48
3.4 Calling the Test Results (Searching)................................................ 49
3.4.1 Searching for Test Results .......................................................... 49
3.4.2 Editing an Uncreated Result Sheet on the PC ............................ 50
3.5 Operations using the Result Data on the PC................................... 51
3.5.1 Exporting the Result Data on the PC .......................................... 51
3.5.2 Importing the Result Data on the PC........................................... 52
3.5.3 Importing the Patient Information ................................................ 53
3.5.4 Creating a List of Result Data ..................................................... 54
3.6 Setting a Comment on the PC........................................................... 55
3.6.1 Registering the Names of the Clinic and Doctor ......................... 55
3.6.2 Creating Potential Causes and Recommendation
for the Result Sheet..................................................................... 56
3.6.3 Creating an Overall Comment..................................................... 57
3.6.4 Upgrading the Instrument Software (As Necessary) ................... 58
Chapter 4: Maintenance of Instrument ........................................................... 60
4.1 Frequency ........................................................................................... 60
4.2 How to Perform Maintenance............................................................ 61
4.2.1 Cleaning the Test Strip Holder .................................................... 61
4.2.2 Cleaning the Reading Unit .......................................................... 63
4.2.3 Adjusting the Driving Speed ........................................................ 64
Chapter 5: Troubleshooting Guide ................................................................. 65
5.1 Instrument Troubleshooting ............................................................. 65
5.1.1 Instrument [Warning] Causes and Remedies.............................. 66
5.1.2 Instrument [Error] Causes and Remedies ................................... 67
5.1.3 Instrument [Trouble] Causes and Remedies............................... 68
5.2 SillHa Software Troubleshooting...................................................... 69
5.2.1 SillHa Software [Warning] Causes and Remedies ...................... 70
5.2.2 SillHa Software [Error] Causes and Remedies ........................... 71
5.2.3 SillHa Software [Trouble] Causes and Remedies ....................... 72
Chapter 6: Index................................................................................................ 73
Contents

5
SillHa Oral Wellness Instrument
Intended Use
SillHa is an oral health assessment instrument, providing information to assess
gum health, tooth health and oral cleanliness. The instrument uses oral rinse
(saliva) samples from individuals to perform this assessment. The instrument is
not intended for diagnosis. It is to be used by dental health care professionals
(such as dentist, hygienist, etc.) to help with patient education on oral wellness.
Introduction
This operating manual contains important information on the functions of SillHa
Oral Wellness System. Read carefully prior to using and retain for future
reference.
This manual provides an overview and the proper procedures for operation and
maintenance. The use of this device by a method or for a purpose other than
those presented herein shall not be guaranteed.
This product conforms to the EMC Standard IEC61326-1:2012(EN61326-1:2013).
Class of emission: CISPR 11 Class A.
NOTE: This instrument has been tested and found to comply with the limits for a
Class A digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference when the
instrument is operated in a commercial environment. This instrument generates,
uses and can radiate radio frequency energy and, if not installed and used in
accordance with the operating manual, may cause harmful interference to radio
communications. Operation of this instrument in a residential area is likely to
cause harmful interference in which case the user will be required to correct the
interference at his own expense.
The electromagnetic environment should be evaluated prior to operation of the
device. Do not use this device in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the proper operation.
© ARKRAY, Inc.
• It is strictly prohibited to copy any part of this operating manual without the
expressed consent of ARKRAY, Inc.
• The information in this operating manual is subject to change without notice.
Intended Use
& Introduction

6ARKRAY
Glossary of Symbols
References obtained from:
• ISO 15223:2016 Medical devices — Symbols to be used with medical device
labels, labelling and information to be supplied
For optimal performance
REFERENCE
Additional explanations that help you make the best use of the instrument and
information on related functions.
Symbol Title of Symbol Description of Symbol Standard
Ref. No.
Temperature limit Indicates the temperature limits to which
the medical device can be safely exposed. 5.3.7
Caution
Indicates the need for the user to consult
the instructions for use for important
cautionary information such as warnings
and precautions that cannot, for a variety of
reasons, be presented on the medical
device itself.
5.4.4
Keep dry Indicates a medical device that needs to be
protected from moisture. 5.3.4
Fragile, handle with
care
Indicates a medical device that can be
broken or damaged if not handled carefully. 5.3.1
Humidity limitation Indicates the range of humidity to which the
medical device can be safely exposed. 5.3.8
Handle with care Indicates handle with care. N/A
Biological risks Indicates that there are potential biological
risks associated with the medical device. 5.4.1
IMPORTANT: Follow the instructions given here to obtain accurate
measurement results.
NOTE: Information useful for preventing damage to the instrument or parts,
and other important information you should keep in mind.
Symbols

7
SillHa Oral Wellness Instrument
1.1 Overview
1.1.1 Features
• Multiple items can be rapidly measured.
With a single measurement taking as little as five minutes, seven analytes
(cariogenic bacteria, acidity, buffer capacity, blood, leukocyte, protein and
ammonia) can be measured simultaneously.
• Simple operation by tapping [Test].
Measurement is performed simply by tapping [Test] and placing the test strip on
the instrument. The measurement results are automatically transmitted to the
PC.
• Easy-to-view graphic display
The test results can be displayed on the PC through easy-to-understand tables
and graphs using the SillHa software.
• Hassle-free daily maintenance
Daily maintenance requires only cleaning of the test strip holder, which can be
removed easily without the use of any tools.
• Equipped with the self-check function
The light volume and driving speed are checked when the instrument starts. If
the measurement cannot be successfully completed, an error message is
shown to notify the user.
1.1.2 ARKRAY Customer and Technical Service
The Troubleshooting Guide is in Chapter 5 for both the instrument and the
software. If you have questions or require technical assistance regarding the use
of SillHa Oral Wellness Instrument and test strips, please contact ARKRAY at
844.559.0842 between the hours of 8 am to 6 pm Central Standard Time.
Return Authorization: All returns must be preapproved by ARKRAY USA before
returning the instrument. Please contact Customer Service at 844.559.0842
between the hours of 8 am to 6 pm Central Standard Time.
For more information on SillHa Oral Wellness System, visit our website at:
www.arkrayusa.com/oral-wellness.
1.1
Chapter 1: Overview of SillHa
Oral Wellness Instrument

8ARKRAY
1.1.3 Specifications: SillHa Oral Wellness Instrument
Windows®is either a registered trademark or trademark of Microsoft Corporation in the U.S.
and/or other countries.
Mac OS is a trademark of Apple Inc., registered in the U.S. and other countries.
Item Description
Name SillHa Oral Wellness Instrument
Configuration Instrument, external PC software (SillHa software),
accessories
Measurement object Oral rinse sample
Test strip type SillHa paper
Measurement item Cariogenic bacteria, acidity, buffer capacity, blood,
leukocyte, protein and ammonia
Measurement wavelength 565 nm, 635 nm, 760 nm
Sample supply Manual dropping
Measurement time Approx. 5 min./measurement sample
Number of measurement samples 1 measurement sample
Warm-up time Maximum 30 seconds
External output USB 1 port
Measurement environment Temperature: 50º – 86ºF (10º – 30ºC);
Humidity: 30 – 60% RH (No condensation)
Storage environment Temperature: 33.8º – 95ºF (1º – 35ºC);
Humidity: 20 – 80% RH (No condensation)
Environment during transport Temperature: 14º – 140ºF (-10º – 60ºC);
Humidity: 20 – 80% (No condensation)
Dimensions 160 (W) x 51 (H) mm
Weight Approx. 430 g (including a rechargeable battery)
Power supply USB (5 VDC, rechargeable battery used)
Power input DC 2.5 w or below
Sound pressure level 80 dB or below
Location of use For indoor use only
Altitude Up to 6500 ft.
Pollution degree 2
Expected life 5 years (According to company data)
The following environment is required for running the SillHa software on the PC.
OS • Windows®7 or later
• MAC OS X (version 10.10 or later)
• May not operate correctly in some usage
enviroments or with some settings.
Processor Intel®Pentium 2, 266 MHz or above
Main memory For Windows®1 GB or above
For Mac OS X: 2 GB or above
HDD/SSD available space 1 GB or above
Resolution VGA (640 x 480) or above
USB USB2.0 5 V 500 mA
1.1.3

9
SillHa Oral Wellness Instrument
1.1.4 Measurement Principle
This instrument measures the oral rinse measurement sample using the dual-
wavelength reflectance method. The change in the color of the test strip after
sample application is measured by the reflectance of light with wavelengths of 565
nm, 635 nm and 760 nm. Then, results are obtained for cariogenic bacteria,
acidity, buffer capacity, blood, leukocyte, protein and ammonia.
1.2 Contents of the Shipping Carton
You will find the following items in the shipping carton. Make sure all of these
items are present inside. If anything is missing or damaged, contact ARKRAY.
Instrument USB cable
USB memory
stick (SillHa
software for
Windows and
Mac OS)
Check strips
•Operating manual (this document) SillHa paper
(test strip kit)
- 30 test strips
- 30 oral rinse
solutions
- SillHa paper
package insert
CAUTION:
Inside the reading unit cover
Do not touch the parts inside the
reading unit cover and the
test strip holder with unprotected
hands. Wear personal protective
equipment to prevent exposure to
pathogenic microorganisms while
placing the test strip, and during
maintenance of these parts.

1.1.4

10 ARKRAY
1.3 Instrument Part Names and Functions
1.3.1 Instrument Parts
No. Name Description
Display/
operator panel
This is a touch panel. Tap the buttons displayed on the screen
to perform operation.
Charge
indicator light
ON (red): Charging, OFF: Not charging
Test strip holder Holder for test strip with measurement sample.
Reading unit
cover
Open this cover to place the test strip.
Power button Press and hold for one second or longer to turn the
instrument ON.
Press and hold for two seconds or longer to turn the
instrument OFF.
USB terminal Connect the USB cable to this USB terminal, and connect the
other end of the cable to the PC. This terminal is used for
communicating with the PC and charging the instrument.






* When the instrument is turned
ON the test strip holder extends
from the instrument.
FRONT
BACK
1.3

11
SillHa Oral Wellness Instrument
1.3.2 Instrument Touch-Screen Display
Top Menu Screen
REFERENCE
•Operation sound: When you tap the button, a “beep” is heard for confirmation.
If the button is disabled, a different sound will be heard, notifying a problem. If
an error occurs, a continuous beep will be heard.
•The backlight turns OFF: If no operation is performed for 5 minutes, the panel
backlight turns OFF to save power. To return to ON, either tap anywhere on the
panel, or press the power button. If no operation is performed for 60 minutes
after the backlight turns OFF, the instrument turns OFF.
No. Name Description
Date/Time Current date and time.
Temperature Temperature of the instrument. It is displayed in the range of
32º – 104ºF (0º – 40°C). When the temperature is below 32°F
(0°C), LO is displayed, and when it exceeds 104°F (40°C), HI
is displayed.
[Test] button Complete the test of the measurement sample (see page 25).
Battery level
indication
Indicates the battery level.
The battery is fully charged.
The battery level has been reduced, but
measurement can be performed.
The battery level has been reduced. The red frame
indicates that the battery is low. Measurement
cannot be performed.
[Setting] button Set the date and time, medical chart number, sound level,
screen brightness and the direction of placing the test strip
(see pages 43 – 46).
[History] button Resend the most recent measurement results to the PC (see
page 48).
[Maint.] button Perform check measurement (see pages 36 – 38), clean the
test strip holder, and adjust the driving speed
(see pages 60 – 64).







1.3.2

12 ARKRAY
Measurement Procedure Screen (on the instrument)
No. Name Description
Procedure
guide
Describes the measurement steps and the time limit.
Medical chart
number
The medical chart number received from the PC is displayed.
[Menu] button Return to the Top menu screen (see page 11).
Status display Displays the progress status from the time [Test] is tapped.
[Start] button This button is enabled when the medical chart number is
received. When disabled, it is grayed out.
IMPORTANT: To obtain accurate measurement results, per-
form the operation according to the operation guide on the
screen and the procedures in “2.3 Performing a Measurement”
on page 25.





Waiting for
Chart No. entry
from the PC
Chart No. is
received from PC
Standby Screen
while preparing
sample
Time left until completion of
measurement mode
Time limit of current procedure
Measurement progress status
(yellow-green)
1.3.2

13
SillHa Oral Wellness Instrument
Setting Screen
No. Name Description
Tab For selection – Date, Digit, Others
Setting value Change the numeric value by tapping the entry field (yellow-
green frame).
[Menu] button Return to the Top menu screen (see page 11).
[↑] button Increase the numeric value by 1.
Entry field Displays numeric value.
[↓] button Decrease the numeric value by 1.
[Delete] button Delete the current numeric value one digit at a time.
[Cancel] button Cancel the entered numeric value and return to the previous
screen.
Numeric buttons Enter a numeric value.
[OK] button Confirm the entered numeric value and return to the previous
screen.









Example:
When the "Year"
is tapped:
Tap the numbers.

1.3.2

14 ARKRAY
1.3.3 SillHa Software Screen
Top Menu Screen
No. Name Description
Date and Time Current date and time.
[Test] button Enter the measurement mode (see pages 22 – 28).
[Call] button Call the past test results (see page 49).
[Data ctrl.]
button
Export or import the result data (see pages 51 and 52).
[Setting] button Register a comment, enter clinic/dr. and maintenance
(see pages 55 – 57).
[–] Minimize the screen.
[X] Exit the SillHa software.







1.3.3

15
SillHa Oral Wellness Instrument
1.4 Cautions During Instrument Installation and
Relocation
1.4.1 Install the Instrument
1.4.2 Follow These Cautions for Best Results When
Relocating the Instrument:
1.4.3 Disposal:
• Where temperature and humidity can be maintained in the following ranges:
- Temperature 68º – 86ºF (20º – 30°C)
- Humidity 30 – 60%
• This instrument can perform a measurement at 50ºF (10°C) or above.
However, when temperature is lower than 68ºF (20°C), cariogenic bacteria
and ammonia results may not be accurate at this temperature.
• In a place without condensation, direct sunlight or wind.
• On a level, vibration free, and sturdy surface.
• If the instrument is not going to be used for long periods of time, disconnect
the USB cable from the instrument to the PC.
• If instrument is moved from environment with temperature variation, allow
at least one hour to adjust to room temperature before a measurement is
taken.
• If an abnormal noise, odor or fumes come from the instrument, disconnect
the USB cable from the device. If it persists after restarting the device,
contact Customer Service at 844.559.0842.
DO NOT:
• Place the instrument within 3 inches of an object on the left and right to
allow for free movement of the strip holder.
• Install the instrument close to magnetic sources.
• Install near places where chemicals are stored, or near equipment that
generates corrosive gas or electrical noise.
• Drop or hit instrument.
• Repair or modify the instrument to prevent damage or injury to a person.
• Allow the instrument to get wet with water as this will result in failure of the
instrument.
• Remove the test strip from inside the instrument to prevent pathogenic
microorganisms from contaminating the areas inside the instrument.
• Press and hold the power button to turn the instrument off, and remove the
USB cable from the instrument.
• Do not subject the instrument to shocks or vibrations during relocation to
prevent damage to the instrument.
• This instrument contains a lithium ion battery that should be removed and
disposed of separately from the instrument following local disposal
guidelines.
1.4

16 ARKRAY
1.5 Installation of Software and Connection
The SillHa software is for receiving measurement results from the instrument and
creating a result sheet.
1.5.1 Installing the SillHa Software [Windows Edition]
Connect the USB memory stick to the USB port of your PC.
Double-click the “Windows_mySaliva~.exe” file in the USB memory. The
Installation Wizard screen appears. Follow instructions in the Wizard to install
the software.
Click [Next].
Read the Terms of Use, and click [I Agree].
Check the installation destination folder name specified under [Destination
folder] (a), and click [Next] (b).
Check the folder name to be added to the Start Menu (a), and click [Next] (b).
• A shortcut will be saved on this folder.
b
Click [Browse...]
to change.
Select the destination
folder, and click [OK].
a
b
Check the
folder name.
Check a box if you
do not want to
create a shortcut.
* You can change
the folder name here.
a
1.5

17
SillHa Oral Wellness Instrument
Select the location for the shortcut, and click [Next].
• Creates a shortcut on desktop.
• Creates a shortcut in Start Menu.
Check the settings on screen, and click [Install]. Click [Back] if you want to
review or change any settings.
• Installation will start.
REFERENCE
If the Microsoft .NET Framework 4 Setup Screen appears:
a. Read the license terms. Check a box next to [I have read and accept the
license terms.], and click [Install]. Installation will start.
b. When [Installation is Complete] appears, click [Finish].
REFERENCE
If the Microsoft SQL Server Compact Setup Screen appears
a. Click [Next].
b. Read the license agreement. Check a box next to [I accept the terms in the
license agreement] and click [Next].
c. Click [Install]. Installation will start.
d. When [Completing the Microsoft SQL Server Compact 4.0 ENU Setup]
appears, click [Finish].
When the completed screen appears, click [Finish].
REFERENCE
When the screen below appears: Click [Restart Now] to restart your PC.
Make sure the shortcut icon on the right has been created on the desktop.
• If you have selected “Do not create
shortcuts” in step , this icon will not be displayed.
Remove the USB memory from the PC.
→Go to “1.5.3. Connecting the Instrument,
PC and Printer” on page 19.
11
1.5.1

18 ARKRAY
1.5.2 Installing the SillHa Software [Mac Edition]
REFERENCE
If the installation has not been properly complete in the procedure below:
Save a copy of “Mac_mySaliva~.pkg” file in the USB memory on the desktop of
your PC, and double-click it. When the Installation screen appears, repeat from
step .
Connect the USB memory to the USB port of your PC.
Double-click the “Mac_mySaliva~.pkg” file in the USB memory.
• The Installation screen appears.
Click [Continue].
Read the License Agreement, and click [Continue].
Click [Agree].
Click [Install] to perform a standard installation.
Enter the [Username] and [Password] (a), and click [Install Software] (b).
• Installation will start.
When the installation complete screen appears, click [Close].
Make sure the shortcut icon below has been created on the desktop.
Remove the USB memory from the PC.
→Go to “1.5.3. Connecting the Instrument, PC and Printer” on page 19.
b
a
1.5.2

19
SillHa Oral Wellness Instrument
1.5.3 Connecting the Instrument, PC and Printer
Use the USB cable provided to connect the instrument to the PC.
• For details on how to connect the printer to the PC (optional), read the
appropriate printer operating manual.
1.5.4 Set Initial Settings on Instrument
Ensure the SillHa software is not running on the PC.
Press and hold the power button.
• Remove your finger when a beep is
heard and the screen lights up.
• The test strip holder extends from the
instrument.
• A beep is heard again and the Top
menu screen is displayed.
Press and hold the power button again,
and remove your finger once the test
strip holder will start moving.
• The test strip holder will retract inside
the instrument.
• The display and instrument power will turn off.
The initial settings are now complete.
PC
Instrument
Printer
USB cable
(accessory)
* SillHa software has
already been installed
Test strip
holder
Power button
1.5.3

20 ARKRAY
1.5.5 Automatic Upgrading of the Instrument Software
If the instrument software version requires upgrading, a message will appear in
the SillHa software screen.
Start the PC software while the PC and instrument are connected with the
USB cable.
Turn on the power of the instrument. If the following screen is displayed on the
PC at this time, go to step and upgrade the software of the instrument.
REFERENCE
If an error or trouble occurred during the upgrade, restart the PC software and
instrument and then perform the procedure again from step .
Turn off the power of the instrument and click [OK] in the PC screen of step .
When the message below is displayed, turn on the power of the instrument
again.
REFERENCE
If the next screen is not displayed in at least 1 minute after turning on the power of
the instrument, check that the USB cable is connected properly and turn the
power of the instrument off and then back on.
1.5.5