COULTER HmX Hematology Analyzer, Справочное руководство

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PN 4237523A 5-1
5 5
LASER SAFETY
5.1 LASER SAFETY PRECAUTIONS
The HmX Hematology Analyzer uses two lasers:
r
A laser bar-code reader
r
A helium neon laser in the diff module (TTM) for analyzing the WBC differential and
Retic counts.
In its design and manufacture of the HmX Hematology Analyzer, Beckman Coulter has
complied with the requirements governing the use and application of a laser as stipulated in
regulatory documents issued by the:
r
U.S. Department of Health and Human Services
r
Center for Devices and Radiological Health (CDRH).
In compliance with these regulatory documents, every measure has been taken to ensure the
health and safety of users and laboratory personnel from the possible dangers of laser use.
5.2 GENERAL LASER SAFETY WARNINGS
Do not attempt to remove the laser or to open it. If removal is required, it must be done only
by your Beckman Coulter Representative.
To ensure your safety, HmX Hematology Analyzer lasers are covered with protective shields
held in place by tamper-proof screws. Do not attempt to remove these shields.
This instrument contains components dangerous to the operator. If any attempt has been
made to defeat a safety feature, or if this instrument fails to perform as listed in this manual,
disconnect power and call your Beckman Coulter Representative.
5.3 WARNING LABELS
CDRH-approved labels are placed near or on those covers that, when removed, might expose
one to laser radiation.
Note: As installed in the Triple Transducer Module (TTM) safety fixture, the laser presents no
radiation hazard to users and complies with 21 CFR 1040.
See Figure 5.1, Figure 5.2, Figure 5.3, and Figure 5.4.
WARNING The laser in the diff module (TTM) can damage both the instrument and your eyes if you do not
use it safely. Follow the instructions and procedures in this manual to safely use the instrument and prevent
damage.
WARNING Use of controls or adjustments, or performance of procedures other than those specified herein
may result in hazardous radiation exposure.