IFU-10891[C] HemaPRO
User
Manual
Page 3 of 33
Congratulations!
You have made an excellent choice for your Lab. Hardy Diagnostics thanks you for the trust you
have placed in our products and services.
This operating manual has been designed to help you gain an understanding of the operation
and application of our HemaPRO Automated Hematology stainer. For optimal utilization of all
functions, we recommend that you thoroughly study this manual prior to beginning operation.
This manual has been prepared as an aid for all operations and user maintenance, which can
be carried out in your facility.
The QuickSlide™ Quality Management System
This product is supplied by Hardy Diagnostics in accordance with its quality management
system, which complies with the U.S. Food and Drug Administration's (FDA's) Quality Systems
Regulation (QSR) and current
Good Manufacturing Practices (cGMP) contained in Title 21 Part
820 of the Code of Federal Regulations (CFR). The company's manufacturing establishments
are registered, and its medical devices are listed with the FDA. In addition,
Hardy
Diagnostics'
quality management system is certified to ISO 13485 for medical devices.
Our devices for the medical laboratory are developed, produced, and distributed according to
the requirements of ISO 13485.
Unpacking and Inspecting
Carefully unpack the HemaPRO and accessories. Check for damage incurred during transit.
Keep all packing material until you are sure the unit operates properly. Any damage to the
shipping box should be reported to the responsible carrier. These instructions must be followed
in order to support your claim.
Set-up assistance for the HemaPRO may be obtained by calling the Technical Service
Department of QuickSlide
TM
at (800) 266-2222 (option 2) during the hours of 8 a.m.to 5 p.m.
Pacific Standard Time, Monday through Friday. Alternatively, you may locate
Unit Installation
(Section 9.0) in this User Manual for quick set-up.
Important
:
Retain
this operating manual
for future use.
© 2016 All Rights Reserved
QuickSlide
TM
800-266-2222 (option, 2)
www.HardyDiagnostics.com
www.QuickSlide.com
