Additional documentation is available from your authorized distributor.
Current additional documentation is listed below:
User Definable Settings
The following operator requirements must be fulfilled before operating
the Medonic M-Series hematology system.
Basic skills in a laboratory environment.
Basic skills in hematology.
Awareness of IVD (EU)/FDA (US) requirements regarding laboratory
equipment.
The operator must read and understand this manual.
Optional accessories
and consumables
Accessories and consumable lists are available from your local
distributor.
Boule Medical AB
Domnarvsgatan 4
SE-16353 Spånga, Sweden
Website: www.medonic.se
Clinical Diagnostic Solutions
1800 NW 65
th
Ave
Plantation, FL 33313 USA
Toll Free: 1-800-453-3328
Direct: 1-954-791-1773
Fax:1-954-791-7118
Website: www.cdsolinc.com
International
standards and
regulations
IVD 98/79/EG
SSEN 61010-2-101 (Low Voltage Directive 2006/95/EC)
EN 61326 (2006) (EMC 2004/108/EC)
2012/19/EU WEEE
Standards harmonized with FDA
February 2016 Article no: 1504472
For information see Appendix B.
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