x User Manual
only
8
Caution: Federal (USA) law
restricts this device to sale by
or on the order of a physician.
Footnotes
1. EN ISO 15223-1:2016 Medical devices –Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
2. ASTM F 2503 – 13 Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment
3. USB Implementors Forum, Inc. standard icon.
4. IEC TR 60878-3: 2015 Graphical symbols for electrical equipment in medical practice
5. Symbols created by Galil Medical based on the symbols for Helium and Argon in the
Periodic Table of Elements.
6. EN 50419:2006 Marking of electrical and electronic equipment in accordance with article
11(2) of Directive 2002/96/EC (WEEE)
7. ETL Product Listing mark indicates the product is in compliance with North American
product safety standards. Compliance is determined through testing and certication by
Intertek Group plc.
8. USA Code of Federal Regulations 21 CFR Part 801 (§ 801.109(b)(1))
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