BioSieve VIM220H ToxiSmart FIA Reader User Guide
- August 31, 2024
- BioSieve
Table of Contents
VIM220H ToxiSmart FIA Reader
“`html
Product Information
Specifications:
-
Dimensions: 4.90 inches (124.5 mm) x 2.85 inches (72.5 mm) x
1.57 inches (40 mm) -
Weight: 0.36 lbs
Product Usage Instructions:
Installation and Use Conditions:
Installation:
-
Place the Reader on a stable and level surface.
-
The unit is portable and can be moved to a suitable location
for testing. -
Avoid direct sunlight.
Conditions for Use:
Step 1: Press the right button for 3 seconds to turn on the
Reader.
Setting Up Your Reader:
Ensure all components are present and undamaged as per the
Components List provided in the manual.
Operation Instructions:
Refer to the User’s Manual for detailed operation
instructions.
FAQ:
Q: Can the ToxiSmart FIA Reader be used for any type of
diagnostic test?
A: The ToxiSmart FIA Reader is designed for in vitro diagnostic
use only and is intended for clinical specimens.
Q: What should I do if the Reader reports an error
condition?
A: Do not use the Reader if it is reporting an error condition
that cannot be corrected. Contact your Local Distributor or
VivaChek Diagnostics Inc. USA immediately.
“`
ToxiSmart FIA Reader
Dear BioSieveTM ToxiSmart FIA Reader User,
Thank you for choosing the BioSieveTM ToxiSmart FIA Reader! The Reader has the
advantages of easy operation, Robust, reliable results, and simple
maintenance. It can be used widely in many areas, such as hospital, medical
center, clinic, pharmacy, laboratory, etc. This User Manual applies to
BioSieveTM ToxiSmart FIA Reader, it provides detailed descriptions of the
Reader’s characteristics, graphical operation steps and other relevant
information for your convenience. Please read this User Manual carefully
before you use your Reader and keep your User Manual in a safe place, you may
want to refer it in the future.
Thank you again for choosing the BioSieveTM ToxiSmart FIA Reader.
Principle
The BioSieveTM ToxiSmart FIA Reader works with BioSieveTM FIA Test Kit as a
system for measuring the concentration of designated analytes in human
clinical specimens. The Reader is an immunofluorescence detection device that
is based on photoelectric detection principle. With the fluorescence
immunochromatography technology and tiny sample, the Reader gives reliable
result(s) in just a few minutes, which is ideally suitable for professionals
to make quick and correct decision at the point of care. It is intended for
professional use outside the body (in vitro diagnostic use).
Intended Use
BioSieveTM ToxiSmart FIA Reader is a portable fluorescence instrument for in
vitro diagnostic use only. The Reader is designed to perform in vitro
diagnostic tests on clinical specimens. This Reader can be used in a
laboratory or in a point-of-care setting.
i
TABLE OF CONTENTS
1. Understanding Your Reader…………………………………….. 1
Introduction………………………………………………………….. 1 Components List…………………………………………………. 1
Structure…………………………………………………………… 1 Reader Display…………………………………………………… 2 Reader
Use and Precautions………………………………….. 2 Important Safety
Information…………………………………… 2 Electromagnetic Compatibility………………………………. 3
Precautions for Instrument Cybersecurity…………………. 4
2. Installation and Use Conditions……………………………….. 6
Installation………………………………………………………….. 6 Conditions for
Use…………………………………………………….. 6
3. Setting Up your Reader……………………………………………. 7 Setting………………………………………………………… 7
About……………………………………………………………………. 9
4. Operation Instructions……………………………………….. 10
Start………………………………………………………………………… 10 Choose Test Mode……………………………………………………. 10
Standard Test……………………………………………………………. 11 Quick Test…………………………………………………………………11
QC Test……………………………………………………………………. 12 Viewing Your Test
Results……………………………………………12 Turning Off the Reader………………………………………………..13 5.
Maintenance and Precautions………………………………….. 14
Maintenance…………………………………………………………….. 14 Precautions for Reader
Use……………………………………….. 16 6. Technical Information………………………………………………. 17 System
Specifications……………………………………………… 17 Limitations……………………………………………………………….. 18
Index of Symbols………………………………………………………. 19 Warranty…………………………………………………………….. 20
ii
CHAPTER 1: UNDERSTANDING YOUR READER
Introduction
1. Dimensions: 4.90 inches (124.5 mm) x 2.85 inches (72.5 mm) x 1.57 inches
(40 mm) 2. Weight: 0.36 Ibs
Please check whether any component is missing or damaged against the list below after opening the package. Note: If some parts are missing or damaged, please contact your Local Distributor or VivaChek Diagnostics Inc. USA immediately.
Components List
Number
Component
1
BioSieveTM ToxiSmart FIA Reader
2
Type C & USB 2 in 1 cable
3
User’s Manual
4
System quality control test device
5
Bluetooth printer (optional)
Quantity 1 1 1 1 1
Structure
The actual appearance of Reader and accessories may vary with specific model
(Figure 1).
Type-C port
Display
Left Button Slot
(Figure 1)
Right Button
1
Reader Display
Icon
What it means Standard test mode
Quick test mode System Quality Control mode
Memory Bluetooth Battery level
Printer
Reader Use and Precautions
· Keep your Reader in the temperature range of 14°F to 131°F (-10 to 50°C) and
relative humidity range 10 to 90%.
· Reader will shut off by itself after 10 minutes of inactivity. · Do not drop
the Reader or get it wet. If you do drop the Reader or get it wet,
check the Reader by running a quality control test. · Do not use the Reader if
it drops into water or other liquids or if water
splashes on to it. · Use only BioSieveTM FIA Test Kit with your Reader. · Do
not take the Reader apart. Taking the Reader apart will void the
warranty. · Refer to the Caring and Maintenance for details on cleaning the
Reader. · Keep the Reader and accessories parts out of reach of children.
Important Safety Information
· It is for in vitro diagnostic use by professionals only. · Use the
accessories provided by VivaChek with your BioSieveTM
ToxiSmart FIA Reader. Do not use other accessories. · Please read this User’s
Manual carefully before use and keep your User
Manual in a safe place for referring it in the future. · If the Reader emits
peculiar smell, smoke or the liquid flows into the
Reader, please turn off the power immediately and contact with your local
distributor or VivaChek Diagnostics Inc. USA Technical Support. · Please
comply with all the national standards for health and safety. This includes
(but not limited to) protective cover, and gloves when operating and
maintaining the Reader.
2
· If the Reader is used in a manner not specified by the manufacturer, the
protection provided by the Reader will be impaired.
Potential Biohazard All products or objects, which come in contact with
blood/urine/ respiratory secretions, even after cleaning, should be handled as
if capable of transmitting viral disease.
Caution It is for professional use only. Do not use the test kit out of the expiration date. Do not use if the Reader is reporting an error condition that cannot be corrected.
Electromagnetic Compatibility
Caution · Use of accessories, transducers and cables other than those
specified or
provided by the manufacturer could result inincreased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result
in impropeioperation.
Warning · Medical electrical equipment requires special precautions regarding
EMC
and must be installed and operated accordingto these instructions. The device
is to be used in professional healthcare facility environment. · This
equipment has been designed and tested to Group 1 Class B, in a domestic
environment it may cause radio interference, in which case, you may need to
take measures to mitigate the interference. · It is forbidden to use the
equipment near strong radiation source (such as unshielded RF source),
otherwise it may interfere with the normal operation of the equipment.
Electromagnetic emission
Launch test
Compliance
IEC/EN 55011 Conducted emission
IEC/EN 55011 Radiation emission
IEC/EN 61000-3-2 Harmonic emission
IEC/EN 61000-3-3 Voltage fluctuation / flicker emission
Group 1 ClassB
Not applicable Pass
3
Applicable EMC Standards · IEC 61326-1: 2020/ EN61326-1:2021: Electrical
equipment for
measurement, control and laboratory use EMC requirements Part 1: General
requirements. · IEC 61326-2-6: 2020/ EN 61326-2-6: 2021: Electrical equipment
for measurement, control and laboratory use EMC requirements Part 2-6:
Particular requirements In vitro diagnostic (IVD) medical equipmen.
Precautions for Instrument Cybersecurity
The reader uses Bluetooth for wireless communication. It can connect matching
printer and mobile applications. The following measures ensure information
security: · The reader uses the latest Bluetooth protocol version. The new
version
usually includes fixes for security vulnerabilities that existed in previous
versions, improving connection security. · Set a password to protect the
Bluetooth connection. Ensure that communication between devices is encrypted
to prevent unauthorized access and data leakage. · Implement two-way
authentication during data transmission only authenticated reader and BT APP
can transmit data between each other. · The Bluetooth function is disabled by
default when the reader is turned on.
Although the reader has security features, communication security cannot
always be guaranteed. Users should be aware of the following precautions when
using it: · Control Bluetooth visibility: In order to protect personal
privacy, it is
recommended to set the Bluetooth device to the “invisible” state to avoid
unauthorized devices connecting with your device. · Don’t connect unfamiliar
devices at will: only connect devices that you know and trust. Connecting
unfamiliar devices may lead to data leakage or spread of malware. · Avoid
connecting to unsafe public devices: Avoid connecting to unknown or untrusted
public Bluetooth devices, especially in public places such as coffee shops,
libraries or airports. · Turn off Bluetooth after the connection is completed:
When the Bluetooth function is not needed, it should be turned off to prevent
unauthorized access or attacks. · Clear the pairing list regularly: delete the
pairing with the reader you no longer use or trust to reduce security risks. ·
Pay attention to the possible security risks of Bluetooth: Bluetooth signals
can be pierced through the wall, so nearby attackers may eavesdrop or
interfere with your Bluetooth communication. In sensitive environments, it is
better to avoid using Bluetooth devices or take other security measures
4
to protect communication.
RF Exposure Compliance This equipment complies with FCC radiation exposure
limits set forth for an uncontrolled environment. End user must follow the
specific operating instructions for satisfying RF exposure compliance. This
transmitter must not be co-located or operating in conjunction with any other
antenna or transmitter. The portable device is designed to meet the
requirements for exposure to radio waves established by the Federal
Communications Commission (USA). These requirements set a SAR limit of 1.6
W/kg averaged over one gram of tissue. The highest SAR value reported under
this standard during product certification for use when properly worn on the
extremity, with 0 mm separation. SAR compliance for body-worn operating
configurations is limited to the specific configurations tested for this
filing. Body-worn operations are restricted to belt-clips, holsters or similar
accessories that have no metallic component in the assembly and must provide
at least 15mm separation between the device and the body of the user. End-
users must be informed of the body-worn operating requirements for satisfying
RF exposure compliance. The highest reported SAR for body-worn accessory use
conditions is 0.004W/kg.
FCC Regulations This device complies with part 15 of the FCC Rules. Operation
is subject to the following two conditions: · This device may not cause
harmful interference. · This device must accept any interference received,
including interference
that may cause undesired operation. This equipment has been tested and found
to comply with the limits for a Class B digital device, pursuant to part 15 of
the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation. This equipment
generates, uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference.
5
CHAPTER 2: INSTALLATION AND USE CONDITIONS Installation
Please use the Reader under the proper conditions. Step 1: Place the Reader on
a stable and level surface. The unit is portable and can be moved to a
suitable location for testing. Avoid direct sunlight. Step 2: Press the right
button “” for 3 seconds to turn on the Reader.
Use Conditions
Positioning and Placement Requirements (1) The Reader should be placed on a
stable and level surface, and in an indoor environment free of dust, direct
sunlight or corrosive gases. The surface must be able to sustain a weight of
at least 0.36 Ibs (165 g) (2) The Reader should be placed in a well-ventilated
place (without strong vibration source and electromagnetic fields around).
There should be at least 3.93 Inches (10 cm) space around the Reader to ensure
the necessary space for operation and maintenance. Storage and Transport
Conditions (1) Storage Conditions Storage temperature: 14°F ~ 131°F (-10 ~
50°C) Relative humidity: 10 to 90% Atmospheric pressure: 86 to 106 kPa
(2) Transport Conditions Avoid moisture, impact and severe vibration.
6
CHAPTER 3: SETTING UP YOUR READER
Before using the Reader for the first time, you should check and update your
Reader settings.
Setting
Press the right button “” for 3 seconds to turn on the Reader. Press the left
button “” for 3 seconds to enter the “Menu”. Press the right button “” to
select “Setting”, and press the left button “” to enter the interface of
“Setting” (Figure 2).
(Figure 2) Set the Time and Date Press the left button “” to enter the
interface (Figure 3). Press the right button “” to select 24-hour time or
12-hour time format.
(Figure 3) Press the left button “” to enter the 24-hour time format (Figure
4).
(Figure 4) Press the left button “” to adjust the digit. Press the right
button “” to move to the next digit. Repeat the above action until the date
and time setting is completed. Press the left button “” for 3 seconds to keep
the settings. Press the left button “” to enter the 12-hour time format
(Figure 5).
7
(Figure 5) Press the left button “” to adjust the digit. Press the right
button “” to move to the next digit. Repeat the above action until the date
and time setting is completed. Press the left button “” for 3 seconds to keep
the settings. Bluetooth Pinter Connection Press the right button “” to select
“Bluetooth”, and press the left button “” to turn on the Bluetooth (Figure 6).
(Figure 6) Press the right button “” to select “Printer”, and press the left
button “” to connect the printer (Figure 7).
(Figure 7) If the function of Bluetooth and printer is turned on, the
interface will show the icons ” ” and ” ” (Figure 8). When the test is
finished, press the right button “” and the left button “” at the same time to
print the test result.
(Figure 8)
8
About
Press the left button “” to enter the interface (Figure 9). You can check the
serial number of the reader and its software version.
(Figure 9)
9
CHAPTER 4: OPERATION INSTRUCTIONS
Set up your Reader correctly and have all the materials you will need ready
before you begin testing. It includes your BioSieveTM ToxiSmart FIA Reader and
BioSieveTM FIA Test Kit.
Start
Press the right button “” for 3 seconds to turn on the Reader (Figure 10).
(Figure 10)
Choose Test Mode
Standard Test Mode Press the left button “” twice to change the test mode to
standard test. When the test mode is changed successfully, the Reader will
display “S” in the right corner (Figure 11).
(Figure 11) In the standard test mode, you need to insert the test device
immediately after adding the sample, and the Reader will display the test
result when the countdown is finished. Quick Test Mode Press the left button
“” twice to change the test mode to quick test. When the test mode is changed
successfully, the Reader will display “Q” in the right corner (Figure 12).
(Figure 12) In the quick test mode, you need to insert the test device after
the reaction
10
time is completed, and the Reader will display the test result in a few
seconds. System Quality Control Mode Press the left button “” twice to change
the test mode to system quality control test. When the test mode is changed
successfully, the Reader will display “SQC” in the right corner (Figure 13).
(Figure 13)
Standard Test
Step 1: Take the test device out of the foil pouch and place it on a clean,
dust-free and flat surface. Refer to the package insert to add the sample.
Step 2: Insert the test device into the slot immediately. The Reader will
start a countdown (Figure 14)
(Figure 14) Step 3: The Reader will display the test result after the
countdown is finished (Figure 15). Do not remove the test device when testing
is being performed. The count down time is the pre-determined incubation time
of the item you test. Please wait for the pre-determined incubation time for
each test.
(Figure 15)
Quick Test
Step 1: Take the test device out of the foil pouch and place it on a clean,
11
dust-free and flat surface. Step 2: Refer to the package insert to add the
sample wait for the pre-determined incubation time. Step 3: Insert the test
device into the slot after the pre-determined incubation time. The Reader will
display the test result in a few seconds (Figure 16, 17). Do not remove the
test device when testing is being performed.
(Figure 16, 17)
QC Test
Quality Control Test Each lab should use its own standard and procedures for
performance. You should perform a control test: Control test for the following
conditions. (1) Each new lot of test received. (2) Each new shipment. (3) Each
new operator. (4) Monthly to determine that tests are working properly. (5)
Test results seem inaccurate.
System Quality Control Test System quality control by testing the system
quality control test device ensures the normal operation of the circuit and
optical path. Step 1: Insert the SQC test device into the slot. Step 2: The
Reader will display the SQC test result in a few seconds (Figure 18, 19). Do
not remove the SQC test device when testing. If the Reader works normally, the
interface will display “Pass”. Otherwise, it will display “Fail”.
(Figure 18, 19)
Viewing Your Test Results
Press the left button “” for 3 seconds to enter the “Menu”.
12
Test Record Press the left button “” to enter the interface of “Test Record”
(Figure 20).
(Figure 20) Press the “” or “” button to view the previous or next test
results. SQC Record Press the right button “” to select “SQC Record” in the
“Menu” interface. Press the left button “” to enter the interface of “SQC
Record” (Figure 21) to read the detail information.
(Figure 21) Press the “” or “” button to view the previous or next SQC test
results. Print Record Press the right button “”and the left button “” at the
same time to print the current record. Note: Please ensure the functions of
Bluetooth and printer are turned on at first.
Turning Off the Reader
Press the right button “” for 3 seconds to shut down the Reader.
13
CHAPTER 5: MAINTENANCE AND PRECAUTIONS
Maintenance
The Reader includes a rechargeable 3.7 Volt Lithium Ion battery. The battery
will automatically charge while plugged into AC power. The Reader will
automatically switch to battery power when AC power is not available.
Charging Instructions Indications on the Reader displayed for when the Reader
is properly connected, actively charging, and adequately recharged: When the
Reader is properly connected and actively charging, the Reader displays the
battery icon and repeats the charging status from through ,
, . When the Reader is fully charged, the Reader displays the battery icon .
Recommendations for Recharging Battery: The Reader battery may be charged
using one of the following options: · Type C & USB 2 in 1 cable (computer
charging) · Type C & USB 2 in 1 cable with the AC adapter (wall charging)
To optimize battery life, it is recommended to recharge the battery when the
critical battery level (running out of battery) ( ) appears. When using the
USB port on your computer to recharge the battery, be sure the computer is
turned on and not in standby mode. If the Reader is not recharged, try using
another USB port on your computer. Contact seller to confirm whether the AC
adapter meets following specifications before purchasing it: Input: 100-240V~,
50/60Hz, 0.2A Max; Output: 5.0V, 1.0A; Standard ANSI/AAMI ES
Warnings for Recharging Battery: · Do not disassemble the Reader and take
battery out for recharging. · Do not use the Type C & USB 2 in 1 cable, AC
adapter or Reader if it is damaged, discolored or deformed. · Do not put the
Reader on the thermally insulating materials such as clothing, carpet,
blanket, or plastic surface while recharging. · Do not recharge the Reader in
outdoors, sunlight, a wet area or a very hot area. · Do not place the Reader
in environmental temperature above 131°F (50°C), such as outdoors for
recharging to avoid overheating, smoking, and catching fire; the Reader can be
safely recharged at normal indoor temperatures.
Recommended Procedures for Recharging Battery: Step 1): Select a recharging
method from the options below: Option A: Using a Type C & USB 2 in 1 cable by
connecting computer, the
14
computer should be turned on during recharging; Option B: Using a Type C & USB
2 in 1 cable by connecting AC adapter, the AC adapter should meet the
specifications in the section “Recommendations for Recharging Battery” in the
User Manual. Step 2): Check and ensure the contents in the section
“Recommendations for Recharging Battery” are followed. Step 3): Check and
ensure that the applicable contents in the section “Warnings for Recharging
Battery” are followed. Step 4): After connecting the Reader, check that the
main button flashes with green color during recharging. Step 5): Check that
the Reader displays the battery icon and repeats the recharging status from
through , , ; Step 6): Check whether the Reader displays battery icon , this
means that the battery is fully charged. If not, please continue to recharge.
Step 7): Recommend recharging the Reader for three hours. Step 8): Remove the
Type C & USB 2 in 1 cable from the Reader after recharging. Step 9): Your
Reader is now ready to use.
Cleaning
(1) Please keep BioSieveTM ToxiSmart FIA Reader clean. There is no other
special maintenance required.
(2) Do not disassemble the Reader. The internal hardware and software of
BioSieveTM ToxiSmart FIA Reader can only be repaired, replaced or upgraded by
the manufacturer. Please contact your local distributor or Vivachek
Diagnostics inc, USA technical support.
(3) To avoid the possible electrical shock, please turn off and unplug the
cable prior to cleaning. Do not clean the ports on the Reader.
(4) Do not immerse or spray the Reader in liquid.
Maintenance Method
Your BioSieveTM ToxiSmart FIA Reader does not require special maintenance or
cleaning. The purpose of cleaning step is to remove the potential dirt and
dust particles and make sure that the surface is clean for the next
disinfection step. The purpose of disinfection step is to disinfect the
microorganisms on the whole surface of the Reader. External cleaning and
maintenance method: A cloth dampened with 70% alcohol can be used to wipe the
outside of the Reader. Do not use strong bleach (0.5% bleach solution),
because oxidizing substances and solvents may damage the Reader’s parts and
touch screen. Take care to avoid getting liquids, dirt, blood or buffer into
the Reader through the slot or type C port. Wipe the external surfaces only.
Use only CloroxTM Healthcare Bleach
15
Germicidal Wipes (EPA Registration No. 67619-12), which has been approved for
use with the BioSieveTM ToxiSmart FIA Reader.
Maintenance Plan
The meter should be cleaned and disinfected a minimum of once per week.
Precautions for Reader Use
1. Please use the Reader in strict accordance with the User’s Manual provided
by the manufacturer, otherwise, the warranty provided by the Reader will be
void. 2. Reader data preservation and recovery procedures: the Reader can save
the user test records. The test results during the normal use of the user will
be automatically saved to the Reader in the form of records. The Reader can
save up to 999 records. The saved data can be recovered automatically after
power failure and will not be lost.
16
CHAPTER 6: TECHNICAL INFORMATION
System Specifications
Feature
Specification
Principle Dimensions Weight
Fluorescence Immunochromatography
4.90 inches (124.5 mm) x 2.85 inches (72.5 mm) x 1.57 inches (40 mm)
0.36 Ibs (165 g)
Display size
1.54 Inches LCD
Power source Charging current
Rechargeable 3.7 Volt Lithium Ion battery 300mA, Direct current
Operating temperature
50°F ~ 86°F (10 ~ 30°C)
Storage temperature
14°F ~ 131°F (-10 ~ 50°C)
Operating humidity
10 ~ 90% (non-condensing)
Storage humidity
10 ~ 90% (non-condensing)
Atmospheric pressure
86 ~ 106 kPa
Bluetooth
BLE 5.0
Memory
Up to 999 test results
17
Limitations
· Please use the Reader strictly according to the User’s Manual provided by
manufacturer.
· Do not insert anything else into the slot except the test device. · The
tested urine samples are potentially contagious. Please take
protective measures such as wear protective gloves to avoid skin contact with
the urine sample. · The Reader must be disposed of in a safe and compliant
manner. Applicable Federal, State and Local regulatory requirements should be
followed to ensure the Reader is not disposed of as municipal waste. If you
are unsure on the proper methods for disposal, contact a certified waste
management company for guidance. · Dispose the tested samples and materials
carefully. Treat them as if they are infectious materials. Follow proper
precautions and obey all local regulations when disposing them.
18
Index of Symbols
These symbols may appear on the packaging and in the instructions for the
BioSieveTM POCT system.
Symbols
Explanation
Consult instructions for use or consult electronic instructions for use
Manufacturer
Temperature limit
Humidity limitation
Batch code
Catalogue number
Model number
Serial Number
Caution, consult accompanying documents
In vitro diagnostic medical device
Dispose items according to local relevant laws regarding disposal and recycle
Keep away from sunlight and heat
Biological Hazard
19
Warranty
Please complete the warranty card that came with the product and mail it to
your distributor to register your purchase. If the Reader fails to work for
any reason other than obvious abuse within the first three (3) years from
purchase, we will repair or replace it with a new one free of charge. For your
records, also write the purchase date of your product here. Date of purchase:
_____ Note: This warranty applies only
to the Reader in the original purchase, and does not apply to the battery
supplied with the Reader.
20
Warranty Card
Please complete this warranty card to validate your warranty. Mail it within
30 days of purchase to your local distributor. If the Reader does not work for
any reason other than obvious abuse in the first 3 years after purchase, we
will repair or replace it with a new or equivalent Reader free of charge.
Date of purchase
/
/
Reader serial number (e.g. 601A0000001)
Purchased from
Telephone number
Email address
Suggestion/Comments
VivaChek Biotech (Hangzhou) Co., Ltd.
Level 2, Block 2, 146 East Chaofeng Rd.. Yuhang Economy Development Zone,
Hangzhou, 311100, Zhejiang P.R. China