Sacral Neuromodulation System Clinician Programmer Manual Model 2501 Clinician Programmer Rx only
Axonics®, Axonics Modulation®, Axonics Modulation Technologies®, Axonics Sacral Neuromodulation System® and r‐SNM® are trademarks of Axonics Modulation Technologies, Inc., registered or pending registration in the U.S. and other countries. Refer to the appropriate clinician manuals for additional information on the Axonics SNM System, including contraindications, warnings, precautions, adverse events, individualization of treatment, patient selection, and implant procedures.
Table of Contents Introduction .............................................................................................................................................6 Purpose of the Trial System Axonics SNM System for Urinary Control ................................................................................................ 7 Indications Precautions Contraindications Precautions ........................................................................................................
Table of Contents Start‐up and General Functions. ............................................................................................................
Table of Contents Home Screen Tools ................................................................................................................................. 60 Clinician Programmer Settings Reports List Troubleshooting. .....................................................................................................................................
Introduction This manual provides information about the Axonics Sacral Neuromodulation (SNM) System Clinician Programmer (CP). The CP can be used during implantation and programming of the following Axonics SNM System components: Axonics Model 1601 Trial Stimulator Axonics Model 1901 PNE Lead Axonics Model 1201 Tined Lead The CP can provide test stimulation during lead implantation and can wirelessly communicate with the Stimulator to check device status and program the device.
Warnings 7
Device Specifications Operating characteristics Power source: Lithium‐ion battery (rechargeable) External power source: Powerbox EMX30 Input Power: 100 – 240 VAC, 47 – 63 Hz, 0.3 ‐ 0.
Device Specifications Shipping and Storage environment The following lists the appropriate temperature, humidity, and pressure condition for shipping and storage of the Axonics CP: Temperature (short term: 3 days): ‐25 oC to 70 oC Temperature (long term): 20 oC to 30 oC Humidity (short term: 3 days): 15% to 95% Humidity (long term): 30% to 85% Pressure (short term: 3 days): 57 kPa to 106 kPa Pressure (long term): 70 kPa to 106 kPa If the CP is stored at temperatures outside of the operating rang
Device Specifications Wireless Communication Radiofrequency telemetry Model: 2501 FCC ID: 2AEEGC IC: 20225‐C Quality of Wireless Service: This device operates in the 401‐406 MHz frequency and the maximum effective radiated power is below the limit of 25 µW ERP/EIRP as specified in EU: EN ETSI 301‐839 and EN ETSI 302‐537 and USA: FCC 47 CFR Part 95; Subpart I. The CP has to be within 1 meter from the Stimulator for successful communication.
Device Specifications conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device. FCC and IC Compliance This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation.
Label Symbols Symbols Description Symbols Description Product Serial Number Pressure limitation Manufacturer Classified by CSA with respect to safety Product Model Number Do not use if package is damaged Authorized representative in the European community The device does not offer protection against water Industry Canada certification number Manufacturing Date IEC 60601‐1/EN60601‐1, Type BF Equipment Non‐ionizing electromagnetic radiation For USA audiences only: IPX0 IC Conformité Européenne (Eu
Axonics Modulation Technologies, Inc. 26 Technology Drive Irvine, CA 92618 (USA) www.axonicsmodulation.com Tel. +1‐949‐396‐6320 Fax +1‐949‐396‐6321 HealthLink Europe Services BV De Tweeling 20‐22 5215 MC ’s‐Hertogenbosch The Netherlands All Rights Reserved. Copyright 2019. Axonics Modulation Technologies, Inc.