Programming Manual
vi Clinician Programming Manual
Terminology
Symbol Details
Title: Fragile, handle with care.
Standard: ISO 15223-1 Reference Number: 5.3.1
1
Description: Indicates a medical device that can be broken or damaged if not handled carefully.
Title: MR Unsafe
Standard: ASTM F 2503-13 Reference Number: 7.3.3
3
Description: An item which poses unacceptable risks to the patient, medical sta, or other persons within the MR
environment.
Title: Non-ionizing Electromagnetic Radiation
Standard: IEC/TR 60878 Reference Number: 5140
4
Description: To indicate generally elevated, potentially hazardous, levels of non-ionizing radiation, or to indicate equipment
or systems, e.g., in the medical electrical area that include RF transmitters or that intentionally apply RF electromagnetic
energy for diagnosis or treatment.
Title: Class II Equipment
Standard: IEC/TR 60878 Reference Number: 5172
4
Description: To identify equipment meeting the safety requirements specied for class II equipment according to IEC 61140.
Title: WEEE Waste of Electrical and Electronic Equipment Symbol for the Marking on EEE
Standard: BS EN 50419:2006
5
Description: Indicates that when end user wishes to discard this product it must be sent to separate collection facilities for
recovery and recycling in the EU.
Title: Type BF Applied Part
Standard: ISO 7000/IEC 60417 Reference Number: 5333
2
Description: To identify a type BF applied part complying with IEC 60601.
ONLY
Title: Rx Only
Standard: 21 CFR Part 801.109 paragraph (b)(1)
Description: Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Title: European Conformity
Standard: 93/42/EEC Annex 12
Description: Indicates manufacturer declaration that the product complies with the essential requirements of the relevant
European health, safety, and environmental protection legislation.
1. 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. ISO 7000:2014 Graphical symbols for use on equipment-Registered symbols
3. ASTM F 2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
4. IEC/TR 60878:2015 Graphical symbols for electrical equipment in medical practice
5. BS EN 50419:2006 Marking of Electrical Equipment in accordance with Article 11(2) of Directive 2012/19/EU (WEEE)
Terminology
is manual and the Clinician Programmer use the following terms interchangeably:
• trial stimulator and External Pulse Generator (EPG)
• implantable stimulator and Implantable Pulse Generator (IPG)
• stimulator to represent both a trial stimulator and an implantable stimulator
• Clinician Programmer to represent the Clinician Programmer Application
0300-000176-001 Rev.2 SCS CP_Mobile.indb 6 7/12/19 9:20 AM