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SYSMEX CyFlow Ploidy Analyser - Safety; Intended Use; Prohibited Use; Reasonably Foreseeable Misuse

SYSMEX CyFlow Ploidy Analyser
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3 Safety
CyFlow™ Ploidy Analyser | Operating Manual | October 2021
13
3 Safety
3.1 Intended Use
The CyFlow Ploidy Analyser is equipped with a UV LED 365 nm emission wavelength
and/or a Nd-YAG green laser 532 nm emission line. For fluorescence detection of DAPI
(DAPI-DNA) a blue sensitive PMT is used which analyses fluorescent light between
435 nm and 560 nm. The same detector is used to monitor 532 nm side scattered light
from green laser excitation. Propidium iodide fluorescence (PI-DNA) is detected by a red
sensitive PMT at fluorescence wavelengths above 590 nm. The following versions are
distinguished:
DAPI (REF No.: CY-S-3039_V1)
Particle and cell analysis equipment (flow cytometry system). Electronical device
with a UV LED 365 nm 3 W and one optical parameter for DNA measurements.
PI (REF No.: CY-S-3039_V2)
Particle and cell analysis equipment (flow cytometry system). Electronical device
with a green laser 532 nm 30 mW and two optical parameters for DNA
measurements.
DAPI/PI (REF No.: CY-S-3039_V3)
Particle and cell analysis equipment (flow cytometry system). Electronical device
with a UV LED 365 nm and a green laser 532 nm 30 mW. With two optical
parameters for DNA measurements.
3.2 Prohibited use
Never use the system with organic solvents as this can destroy the fluidic system. Only
use particles with a diameter < 100 μm. It is recommended to use Sysmex Partec
accessories and consumables only.
Do not use in diagnostic procedures. Not for use with biohazardous substances.
3.3 Reasonably foreseeable misuse
Only use this device as a sensitive measuring device.
Do not use as personal computer.
Do not use with chemicals harmful to the device (household sanitisers etc.).
Do not place any objects on top of the device.
3.4 User definition
The device may only be used by personnel properly instructed in its handling. The
manufacturer, authorised distributor or a person authorised by the operator (and trained
by either the manufacturer or an authorised distributor) must provide instruction in
handling the device with the help of this Operating Manual.
The device is aimed at a large spectrum of users, from beginners to experts. In the best
case an expert is around so, if you are a beginner, let her/him help you.
Only adequately trained personnel must be allowed to operate the instrument.

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