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SECTION 1: INTRODUCTION
1.1 Device Overview
Using This Manual
This manual provides instructions to install, operate, and maintain the Macroduct® Advanced
Sweat Collection System. The manual is an important part of the product. Read it carefully and
completely before setup and first use of the device. Anyone operating the Macroduct Advanced
Sweat Collection System must be thoroughly familiar with the procedures and cautionary
information detailed in this manual before attempting to use this equipment.
If additional accident prevention and environmental protection requirements exist in the country
of operation, this manual must be supplemented by appropriate instructions to ensure
compliance.
Safety Regulations (Macroduct Advanced Model 3710)
Classification
The Macroduct Advanced Model 3710 is classified as Type BF Medical Equipment, Internally
Powered.
This device has been built and tested in accordance with safety regulations under EN 60601-1 3.1
edition. In order to maintain this condition and ensure safe operation, the operator must observe
all the instructions and warnings contained in this manual. For current information about
applicable standards, please refer to the CE Declaration of Conformity included with the
documents shipped with this device.
NOTE: This equipment complies with the following emission and immunity requirements: EN
60601-1-2 and EN 55022/FCC 47 CFR Part 15.
Specification of Safe Use
Using this device in a manner not specified by ELITechGroup Inc. may impair the safety protection
designed into the device and lead to injury. Do not use where flammable anesthetic is present or
in any oxygen-enriched environment.
WARNING!
Do not use this equipment if it is not functioning properly.
Statement of Environmental Limits
This device is tested for safe operation at 15 °C to 30 °C, relative humidity ≤ 85%, non-condensing,
and atmospheric pressure ≥ 79.5 kPa.
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