Operator's Manual
DS7A - Constant Current Stimulator
Product Intended Usage
The Digitimer DS7A Stimulator is intended for use as shown in the “Indications for Use” section that follows.
It is intended to be used by persons trained in its use. Users are expected to be able to properly operate
the DS7A Stimulator and associated instruments.
The DS7A Stimulator is not intended for use in life support situations, or in situations where improper
operation or failure of the DS7A Stimulator can result in personal injury to user or patient.
Digitimer Limited makes no representation that the design, implementation, testing or manufacture of the
DS7A Stimulator meet more than reasonable standards for use as a medical product.
As stated in the Digitimer Limited Warranty Statement, supplied with each product, “Digitimer Limited
Expressly disclaims all warranties to buyer except the limited warranty set forth therein, including without
limitation to any and all implied warranties of merchantability and fitness for a particular purpose.”
Indications for Use
The Digitimer DS7A and DS7AH are stimulators intended for use during neurological monitoring and
assessment in a clinical environment
They are intended for use by trained personnel either competent to apply appropriate stimuli or under the
supervision and instruction of one who is.
This is from our FDA application for registration of the product.
Digitimer Ltd.
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Copyright © 2014
File Ref: N:\Docs\Company\Manuals\DS7A\Issue-14\DS7A-iss14.odt
Last Revised: February 1, 2017
