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Brand | Abbott |
---|---|
Model | 3599 |
Category | Portable Generator |
Language | English |
Defines the external trial system's purpose and maximum duration of 30 days.
Refers to a separate data sheet for specific indications.
Lists patient conditions where the neurostimulation system should not be used.
Details critical safety warnings for diathermy, gases, electrosurgery, cardiac systems, and MRI.
Covers essential clinician training and appropriate patient selection criteria.
Outlines precautions for single use, liquid exposure, care, and component damage.
Addresses precautions for hospital, home, and occupational environments, including EMI and wireless restrictions.
Lists potential risks like unpleasant sensations, lead migration, and CSF leakage.
Details additional risks such as pain, seroma, allergic response, and battery failure.
Illustrates and labels the key physical features of the EPG and EPG header.
Lists the specific items included in the EPG and EPG header kits.
Provides a high-level summary of the EPG setup and use process.
Detailed instructions for removing and inserting CR2450 batteries into the EPG.
Explains how to monitor the EPG's battery levels via the clinician programmer app.
Guides on establishing wireless communication between the EPG and its controllers.
Describes the meaning of the EPG's various indicator light states.
Instructions for initiating and terminating stimulation using the app or magnet.
Provides general guidance on EPG operation and system compatibility.
Lists trial cable and leads that are compatible with the EPG.
Steps for connecting the multilead trial cable to the EPG stimulator port.
Procedure for safely removing the multilead trial cable from the EPG.
Recommended methods for securing leads and bandaging the lead entry site.
Instructions for placing the EPG into its pouch and securing it to the patient.
How to attach the EPG header to the EPG body securely.
Steps for connecting leads or extensions to the EPG header ports.
Guidance on programming the system using the clinician programmer app.
Tips and precautions for maintaining the EPG's condition and avoiding damage.
Methods for cleaning the EPG using approved materials.
Guidelines for proper storage and safe transportation of the EPG.
Contact information for technical assistance.
Information on ordering replacement parts and accessories.
Details physical specifications like height, width, thickness, weight, and volume.
Lists pulse width, frequency, amplitude, and stimulation output ranges.
Guidance on proper disposal of battery-powered devices.
Statement on compliance with FCC rules for digital devices.
Compliance statement for Canadian radio standards.
Compliance with Canadian ISM device standards.
Details of product identifiers for registration.
Classification as Class B equipment for domestic environments.
Summarizes technical details of the Bluetooth Low Energy implementation.
Details frequency, bandwidth, and channel information for the radio transmitter.
Describes communication quality requirements for Bluetooth LE technology.
Explains how wireless signals are secured and authenticated.
Provides steps to resolve wireless communication problems.
Provides guidance on EMC and essential performance for medical equipment.
Details compliance and guidance for RF emissions in various environments.
Lists immunity test levels and compliance for ESD, transients, surges, and power frequency magnetic fields.
Details radiated RF immunity test levels and recommended separation distances.
Lists test levels and recommended separation distances for proximity fields.
Details RF compliance standards for USA, Canada, and Europe.
Explains common and device-specific symbols.
Defines symbols related to manufacturing, product ID, and compliance.
Explains marks related to NRTL certification and Australian/New Zealand compliance.