User's Manual

Page 9 of 38
Sterilized using ethylene
oxide
Single unit pack label & shipping
package
Serial number
Single unit pack label & pump side
label & shipping package
Catalogue Number
Single unit pack label & shipping
package
Authorized representative
in the European
Community
Single unit pack label (ROW)
Sorrel Medical company
logo
Single unit pack label & pump top
label & shipping package
Use by date: YYYY-MM-DD
Single unit pack label & pump side
label
Instructions for use
regarding RF data (includes
a table of relevant
countries with English
language)
Single unit pack label (ROW)
1.4.2 Compliance and Classification
This manual has been written in conjunction with the requirements of the following International Standards:
 IEC 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential
performance
 IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
 IEC 60601-2-24 - Medical Electrical Equipment - Part 2-24: Particular Requirements for Safety of Infusion
Pumps and Controllers. Data presented in the Technical Specification section reflect specific test