Introduction; Notes On Operating Instructions; Intended Use - Atmos Strobo 21 LED Operating Instructions Manual

1.0 Introduction

1.1 Notes on operating instructions

In the following all device versions, as well as all modules and table-top devices are named ATMOS Strobo 21 LED!
These operating instructions contain important notes on how to operate the ATMOS Strobo 21 LED
safely, correctly, and eff ectively. Their reading helps to avoid risks and also to reduce repair costs and
down-times. This increases, among other things, the reliability and service life of the device.
These operating instructions serve not only for new operating personnel to be instructed in its use, but
also for use as a reference manual. Reprints, also in extracts, only with permission in written form by
ATMOS.
These operating instructions must always be kept available near the device.
Care and safety inspections in conjunction with professional execution provide for operational safety
and readiness for use of your ATMOS Strobo 21 LED and are therefore a must besides regular clean-
ing.
Repair work and safety inspections may be carried out only by expert personnel authorized by ATMOS.
By applying only original spare parts you will have the guarantee that operational safety, readiness for
work and the value of your ATMOS Strobo 21 LED will be preserved.
• The product ATMOS Strobo 21 LED bears CE marking CE according to the EC Directive 93/42/EEC
and meets the basic requirements of Annex I of the directive.
• The product ATMOS Strobo 21 LED complies with all applicable requirements of the directive
2011/65/EC restricting the use of certain hazardous substances in electrical and electronic equip-
ment ("RoHS").
• The declaration of conformity and our general standard terms and conditions can be viewed on our
website at www.atmosmed.com.
• The quality management system applied at ATMOS has been certifi ed according to international
standards EN ISO 13485.
• Prior to start-up please peruse chapter 2.0 "For your safety" in order to be prepared for any possible
dangerous situations.
These operating instructions are valid for the following devices:
ATMOS Strobo 21 LED (S 61 Servant vision)
ATMOS Strobo 21 LED

1.2 Intended use

Product name:
Main functions
Intended purpose:
Intended Users / User profi le:
Intended Patient population:
Medical conditions to be diagnosed, treated
or monitored:
Application organ:
Application time:
Application site:
4
REF 531.2050.0
REF 507.4700.0
ATMOS Strobo 21 LED
Recording and analysis of frequency and sound pressure level of a voice.
Appropriate control of a light source. Adjustment of phase shift and pulse width
regulation.
Diagnostics of the anatomy and the movement of the vocal folds.
Doctors and medical specialists
All patients without any restrictions
General examination of the larynx, voice problems
Larynx / vocal folds
< 60 min.
Outpatient medical facilities, e.g., ENT practices, hospital outpatient depart-
ments, medical care centers