Appendix D: Specifications
55
| SPRINT
®
PNS System – Clinician Instruction for Use [L0090-MAN-000 Rev F]
APPENDIX D
Technical Description and Specifications
Technical Description
The SPRINT PNS System is a neurostimulation system using one or two percutaneous leads and a skin worn
Pulse Generator to deliver low levels of pulsing electrical currents to selected nervous system tissue. The
Pulse Generator has a rechargeable battery incorporating a Lithium Ion polymer cell. The Pulse
Generator is microcontroller based 1 or 2-channel device that delivers biphasic stimulus current waveforms
to percutaneous electrodes controlled by a pushbutton and a Hand-Held Remote controller and clinical
programming tablet computer via Bluetooth (Low Energy) wireless communications.
Specifications
All the components of the SPRINT System are suitable for storage and transportation between
at least
-
20°C (-4°F) and 55°C (131°F). This includes the products in their shipping carton as well as the product as
stored by the clinician or patient between uses.
All* the components of the SPRINT System are suitable for use under the following operating conditions:
– a temperature range of 5°C (41°F) to 40°C (104°F)*;
– a relative humidity range of 15 % to 90 %, non-condensing, with not more than 50 hPa of water
vapor pressure; and
– an atmospheric pressure range of 700 hPa to 1,060 hPa.
None of the components of the SPRINT System are serviceable. There are no user serviceable fuses,
adjustments or components other than the Coin Cell in the Hand-Held Remote. Any suspected
malfunctions should be addressed by the notification of SPR Therapeutics, the return of the suspect
component to SPR Therapeutics, and the replacement by SPR Therapeutics.
*Note: the Clinical Programmer (REF 9630) has an maximum operating temperature of +35°C (95°F)
SPRINT Waterproof Bandage (REF A0009)
Parameter
Specification
Bandage
3M Tegaderm™ + Pad REF 3587
SPRINT MicroLead (with Introducer) (REF 80037)
Parameter
Specification
Stimulating electrode
Length: 1.5 cm
Surface area: 10mm
2
(minimum)
Maximum resistance
150 ohms
Introducer Length
12.5 cm
Sterility
Provided sterile by Ethylene Oxide and non-pyrogenic