4
1.1 Notes on Operating Instructions
1.0 Introduction
These operating instructions contain important notes on how to operate the ATMOS
®
LS 21 LED safely,
correctly and effectively. Their reading helps to avoid risks, and also to reduce repair costs and down-
times. This increases, amongst 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.
• The product ATMOS
®
LS 21 LED bears CE marking CE according to the EC Directive of the council
for medical products 93/42/EEC and meets the basic requirements of Appendix I of the directive.
• The product ATMOS
®
LS 21 LED complies with all applicable requirements of the Directive 2011/65/
EC restricting the use of certain hazardous substances in electrical and electronic equipment
(“RoHS”).
• The declaration of conformity and our general standard terms and conditions can be obtained on our
website at www.atmosmed.com.
•
The quality management system applied at ATMOS has been certified 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.
1.3 Function
The light source ATMOS LS 21 LED is used to connect it
to optical instruments like rigid and flexible endoscopes
respectively laryngoscopes for illumination of throat, nose
and ear.
The anodized aluminium lamp body of the ATMOS
®
LS 21
LED is slender which enables an ergonomic fixation to the
instrument.
There is an adapter sleeve available for adaptation to
current endoscopes which enables the connection of optics
from Storz, Wolf and as per ACMI standard. The optical
instruments with an ATMOS adapter sleeve snap in at the
light source with a ball-shaped quick lock.
The power supply for the light source may either be an
ATMOS power source (power source integrated in the
ENT unit) for LED lamps or the rechargeable LED battery
(please also see HL 21 LED headlight).
The light source has a fix connecting cable with a plug,
which fits both to the rechargeable battery or to the power
supply of the unit.
The light of the 2 Watt LED is beamed into the optical
instrument with a launching lens.
The electrical components (connecting lead and LED) are
installed in the housing and are isolated (4kV). Therefore,
the light source fulfils the requirements for endoscopes
respectively its light sources in accordance with DIN EN
60601-2-18 (labelling as an application part type BF).
1.2 Intended use
Name:
ATMOS
®
LS 21 LED
Main function:
LED light source for optical instruments to illuminate body
openings (ear, nose, throat).
Medical indications / application:
Illumination of body orifices (ear, nose, throat)
Specification of the main function:
Type of light source: LED lamp (high intensity)
Energy source: Rechargeable battery or current source
Application organ:
ENT examination: Ear, nose, throat
OT: For use in the OT by ENT doctors, gynaecologists,
cardiologists, orthopaedics, cosmetic/plastic surgeons,
proctologists
Application time:
ENT: temporary (up to 60 mins)
OT: for a maximum of 4 hours
Application site:
ENT examination: in clinic and practice of ENT doctors
OT: Operating theatre
The light source may only be used by medical trained staff.
Contraindications:
Do not use in explosive areas.
The product is:
Active
Sterility:
Not necessary
Single-use product / reprocessing:
No single use product
