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SECTION 1: INTRODUCTION
1.1 Device Overview
WARNING!
Consult a physician before performing a test on patients with clinically diagnosed cancer.
WARNING!
Consult a physician before performing a test on patients who have had previous adverse
reactions to electrotherapy.
CAUTION:
Collection of sweat should be carried out at a time when the patient is clinically stable, well-
hydrated, free of acute illness, and not receiving mineralocorticoids.
CAUTION:
Pilogel discs should be refrigerated at 2 °C to 10 °C. DO NOT FREEZE. Never use discs that have
been frozen or that are cracked.
CAUTION:
This equipment has been designed and tested to CISPR 11 Class A and FCC Part 15 Class A. In a
domestic environment it may cause radio interference, in which case, the operator may need to
take measures to mitigate the interference.
CAUTION:
Only spare parts and accessories supplied or specified by ELITechGroup should be used with this
device, including the battery charging power supply and power cord used for charging the
device. Using non-approved parts may affect the performance and safety features of the device.
If the device is used in a manner not specified by ELITechGroup, the protection provided by the
device may be impaired. If in doubt, contact an ELITechGroup representative.
CAUTION:
The USB connection on the device is intended to be used by authorized personnel. For security
purposes, it is recommended to execute a virus/malware scan on any USB flash drives or
computers prior to making connection. As good practice it is recommended to remove any USB
connection prior to performing iontophoresis on a patient.
Contraindications
• Patients with an implanted device, such as a defibrillator, neurostimulator, pacemaker, or ECG
monitor.
• Patients with a history of epilepsy or seizures.
• Patients who are pregnant.
• Patients that have a known sensitivity or allergy to any ingredient.
• Over damaged, denuded skin or other recent scar tissue.
• Patients with Cardiac Conditions or with suspected heart problems.
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