Microgem Sal6830 Manuel utilisateur
User Guide
MicroGEM Sal6830 Point of Care PCR System
For Use with MicroGEM Sal6830 SARS-CoV-2 Saliva Test
For Use under an Emergency Use Authorization Only M0248 Rev4.3
02
WARNINGS AND SAFE USE
03#
1 INTRODUCTION 05#
2MicroGEM Sal6830 Point of Care PCR System AT A GLANCE 09#
3 GETTING STARTED - SETUP 11#
4 SETTINGS MENU 13#
5 RUNNING A TEST 16#
6 EXPORT RESULTS 17#
7 SOFTWARE UPDATES 20#
8 ERRORS AND WARNINGS 21#
9 SYMBOLS 23#
10 ORDERING AND CONTACT INFORMATION 23#
11 WARRANTY 24#
WARNINGS AND SAFE USE
03
The following warnings are to be used as an aid in risk mitigation.
Caution: This product has not been FDA cleared or approved but has been authorized for
emergency use by FDA under an EUA for use by authorized laboratories.
Caution: The emergency use of this product is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and
Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is
revoked sooner.
Caution: Laboratories within the United States and its territories are required to report all results
to the appropriate public health laboratories
Caution: Use only the power supply and adaptor that are provided with the system. The correct
power supply and adaptor are required to maintain the safety and electromagnetic compatibility
of the system. The power supply and adaptor are not serviceable.
Caution: The power supply and adaptor that are provided should only be used with the MicroGEM
Sal6830 Point of Care PCR System.
Hot Surfaces: Do not insert any part of the body into the Test Cartridge slot. Internal components
may be hot.
Hot Surfaces: The Test Cartridge may be hot when removing from the system following a test.
Biological Hazard: This equipment is intended to be used with potentially infectious samples. Use
appropriate PPE when using this equipment and handling samples.
Caution: Always operate the system on a clean, flat, level, and stable surface that is not in direct
sunlight. Do not drop the system. Ensure that air flow to the ventilation openings located on the
front and back of the system is not restricted.
Caution: Never move the system while a test is in progress.
Caution: Follow proper infection control guidelines for handling all specimens and related items.
Properly dispose of all contaminated waste according to federal, state, and local requirements.
WARNINGS AND SAFE USE (Continued)
04
Caution: Do not disassemble or attempt to repair the MicroGEM Sal6830 Point of Care PCR System
as there is a risk of damage to the system. This system does not contain serviceable parts and should
be returned for repair. Disassembling the system will also void the warranty.
Caution: Only operate the system for its intended purpose and in accordance with this User Guide
and warnings. If the system is used in a manner not specified in the User Guide, protection
provided by the equipment will be impaired. This system (including power supply) is designed to
operate within the manufacturer’s specifications. Do not exceed the manufacturer specifications
when in use.
Caution: Position the system with clear access to connectors. Keep connected cables clear of work
areas such that tripping or catching will not pull the unit off its work bench. The main socket outlet
intended for use with the MicroGEM
Sal
6830 Point of Care System power supply should be located
near the system and be readily
accessible. MicroGEM recommends that cables are disconnected
when not in use for an extended period.
Caution: USB interface. If intended for connection to external equipment, please ensure that
interfaces of such equipment are separated from mains by double or reinforced insulation and
present no risk of electrical shock.
Caution: If any assay components are dropped, cracked, found to be damaged or open when
received, DO NOT USE and discard.
Caution: Contamination of the work area with previous positive samples may cause false positive
results. Manage human samples according to standard clinical practices. Clean system and
surrounding surfaces according to instructions provided in Section 1.6, Maintenance & Cleaning.
Caution: To avoid contamination, do not move the MicroGEM Sal6830 Point of Care PCR System
during a run or until all assay components have been removed from the system.
Caution: Always check the expiration date of consumables prior to running a test.
Caution: Keep wireless devices at least 11.81” (30cm) away from the system.
Caution:
The MicroGEM Sal6830 Point of Care PCR System should not be exposed to the
elements, such as sunlight, rain etc.
Caution: Do not dissemble the test cartridge. Dispose the test cartridge when the test is complete.
Treat as human biohazardous material.
1 INTRODUCTION
05
1.1 Intended Use
The MicroGEM Sal6830 Point of Care PCR System is a fluorescence-based detection system for the
automated processing and analysis for use with the MicroGEM Sal6830 SARS-CoV-2 Saliva Test.
This document describes the setup, configuration, and operation of the MicroGEM Sal6830 Point
of Care PCR System.
Caution: Please ensure that the system is operated and used according to the CLIA requirements
of the test.
1.2 Product Description
The MicroGEM Sal6830 Point of Care PCR System, for use with the MicroGEM Sal6830 SARS-CoV-2
Saliva Test, is an integrated sample processing, nucleic acid extraction and amplification system.
Consumables such as the Test Cartridge, Saliva Cup, Cap, and ID barcodes are required to run the
system.
The Test Cartridge and Saliva Cup are pre-loaded with all reagents needed for extraction and
amplification of the target nucleic acid, as well as internal controls to monitor the various assay
steps.
To perform a test, the user deposits a specific amount of sample into the Saliva Cup and places
the cap on the saliva cup. The operator then seals the saliva cup with the locking Cap and inserts it
into the Test Cartridge. The fully assembled Test Cartridge is then inserted into the system ready
for testing. Extraction, amplification, and detection is carried out by the system and results are
automatically displayed on the system screen.
Additional MicroGEM Sal6830 SARS-CoV-2 Saliva Test information and workflows are detailed in
the Instructions for Use (IFU).
1 INTRODUCTION (Continued)
06
1.3 System Specifications
1.3.1 System
Color Touch Screen
3.4 x 6” (86 x 154 mm)
Communications
1x USB port for data export
Data Storage
10,000 test results – 64GB Export via USB
Power Requirements
24V – 180W
Dimensions
15.8” W x 15.7” H X 13.8” D
(403 mm W x 399 mm H x 348 mm D)
Weight
33lb (15 kg)
Operating Environment
Temperature range: 15-30°C (59-86°F)
Humidity range: 20-80% relative humidity
Altitude: 0-6,561.7’ (0-2000 m)
Storage Environment
Temperature range: 15-30°C (59-86°F)
Humidity range: 20-80% relative humidity
1 INTRODUCTION (Continued)
07
1.3 System Specifications (Continued)
1.3.2 24V Power Supply and Adaptor
Rated Input Voltage
100 - 240 VAC
Rated Input Frequency
50/60 Hz
Rated Input Current
2.5-1.3 Amps
Operating Environment
As per system
Storage Environment
As per system
Output Voltage
24V
Output Current
9.2 Amps
1.4 Unpacking
Unpack the MicroGEM Sal6830 Point of Care PCR System, taking care when lifting the
system. There are carrying features at the front and rear of the system for assistance.
Place on a clean, flat, level, and stable surface within reach of an electrical outlet. Place
System in a location where the air vents located in the back of the instrument will not be
blocked, at least 3.94” (10cm) from the nearest wall or blocking surface. Avoid placing the
system in direct sunlight. Inspect for any obvious signs of damage. Report any damage
immediately to MicroGEM technical support at [email protected]. Allow
the system to sit at operating temperature for at least 30 minutes before powering on.
1.5 System Calibration
The MicroGEM Sal6830 Point of Care PCR System is factory calibrated and does not
require any further calibration and verification by the user.
1 INTRODUCTION (Continued)
08
1.6 Maintenance & Cleaning
The MicroGEM Sal6830 Point of Care PCR System is maintenance-free and has no user
serviceable parts. In case of system failure or damage, contact MicroGEM technical
support at [email protected].
MicroGEM recommends that the exterior system surfaces and the surfaces visible
behind the door be cleaned after use.
The system should be cleaned with 70% isopropanol - available in commercial wipes or on
a damp, lint free cloth.
Do not spray or pour solution directly onto system when cleaning. Ensure no excess liquid
is used when cleaning as it may damage the system.
Clean system and surrounding areas immediately after possible patient sample spills or
contamination with 10% bleach on a damp, lint free cloth followed by 70% isopropanol
available in commercial wipes.
Clean barcode reader using 10% bleach on a damp, lint free cloth.
Do not use any other type of cleaner on the barcode reader.
Do not disassemble the system for cleaning.
Do not immerse in water or cleaning solutions.
Do not clean with soap or other solutions except for those listed above.
1.7 Components
The following items are supplied with the MicroGEM Sal6830 Point of Care PCR System:
• Power Supply and Adaptor
• MicroGEM Sal6830 Point of Care PCR System Quick-Start-Card
2 MicroGEM Sal6830 Point of Care PCR System AT A GLANCE
09
MicroGEM Sal6830 Point of Care PCR System, Front View
Door Barcode Scanner
Touch Screen
USB
Connection
Latch
Front Lifting
Feature
Test Cartridge Slot
Airflow Ventilation
Feet
2 MicroGEM Sal6830 Point of Care PCR System AT A GLANCE (Continued)
10
MicroGEM Sal6830 Point of Care PCR System, Rear View
Airflow Ventilation
Power Button Rear Lifting Feature Power Supply
Connection
Table des matières
