Atmos LS 21 LED Manual de usuario

ATMOS LS 21

LED

Light source

GA1GB.150302.0

2021-06 Index: 16

Operating Instructions

English

Table of contents

1.0 Introduction.........................................................4

1.1 Notes on operating instructions ............................4

1.2 Explanation of pictures and symbols ....................4

1.3 Intended use .........................................................6

1.4 Function ................................................................6

2.0 For your safety....................................................7

3.0 Scope of supply and connection.......................8

4.0 Operation.............................................................9

4.1 Attaching the application part................................9

4.2 Connection possibilities of the light source...........9

4.3 Operation of the optional LED battery.................10

4.3.1 Indication of capacity ..........................................10

4.3.2 Reloading the LED battery..................................10

4.3.3 Maintenance of battery .......................................10

5.0 Cleaning.............................................................11

6.0 Repairs and servicing.......................................12

6.1 Sending in the device..........................................12

7.0 Troubleshooting................................................12

8.0 Accessories.......................................................13

9.0 Technical data ...................................................14

10.0 Disposal.............................................................14

11.0 Notes on EMC....................................................15

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 e󰀨ectively. 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.

• This device bears the CE marking CE in accordance with the European Medical Device Regulation

(MDR) 2017/745.

• The product ATMOS LS 21 LED complies with all applicable requirements of the Directive 2011/65/EU

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 certi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 LS 21 LED 507.4600.0

ATMOS LS 21 LED, warm white 507.4602.0

ATMOS LS 21 LED 541.4300.0

ATMOS LS 21, warm white 541.4400.0

ATMOS LS 21 LED set, white 507.4610.0

ATMOS LS 21 LED set, warm white 507.4615.0

ATMOS LS 21 LED 600.0011.0

1.2 Explanation of pictures and symbols

On devices, type plates and packaging

Consult operating instructions

Warning, pay special attention

This device complies with the relevant re-

quirements of EU regulations.

This device complies with the relevant require-

ments of the Eurasian Economic Union.

Manufacturer

Date of manufacture

Country of manufacture

REF Reference number

SN Serial number

UDI Unique Device Identier of a medical device

MD Medical device

Humidity limitation

700

1060

Atmospheric pressure limitation

Temperature limit

Professional disposal

Keep dry

Fragile, handle with care

1.0 Introduction

Handle with care

Type BF applied part

Connection for lamp to LED battery

Connection for charging power pack with

polarity marking

Test button for battery test

Recyclable

UDI application identier

(1) UDI-DI: Identication of the manufacturer and

the device

(11) Date of manufacture

(21) Serial number

1.4 Function

The device is intended to illuminate natural orices (e.g. ear/nose/ throat) for visual diagnosis.

The product is an electrical product. It contains an LED whose luminous ux is focused on a small diameter output. Here, instru-

ments can be adapted for illumination.

1.3 Intended use

Name: ATMOS LS 21 LED

Main function: LED cold light source for optical instruments.

Intended use / intended purpose: Illumination of natural orices (e.g. ear/nose//throat) for diagnosis.

Intended patient population: All patients without any restrictions

Medical conditions to be diagnosed, treated,

or monitored:

Diagnostic examination of anatomy of all kinds

Application organ: No restrictions (mainly ear, nose, throat)

Application time: < 60 min.

Application site: Outpatient medical facilities, e.g., ENT practices, hospital outpatient depart-

ments, medical care centers

Patient selection criteria: None

Indications: Light source may be used along with other instruments for visual inspection of

anatomy.

Medical contraindications: None

Other contraindications: None

Warnings: None

The product is: Active

Sterility / specic microbial status: Non-sterile

Single-use product / reprocessing: No single-use product. Reprocessing according to instructions for use.

1.0 Introduction

General safety information

Risk of injury! Danger to the device!

• Please make sure that the ATMOS LS 21 LED is used

in an EMC area described in the appendix.

• Please use the ATMOS LS 21 LED light source only in

connection with the rechargeable ATMOS LED battery

or ATMOS current sources.

• Pay also attention to the safety information of the

attached devices/parts as well as to the safety informa-

tion in the following chapters.

• The ATMOS LS 21 LED may be operated only in rooms

used for medical purposes, but not in areas subject to

explosion hazards and in oxygen-rich environments.

• Make sure prior to every application of the equipment

that it is technically safe and in proper condition. Dam-

aged cables must be replaced immediately!

• Pay attention to the correct t of the light source in the

holders.

• Prior to starting up the ATMOS LS 21 LED light source,

read these operating instructions carefully.

• Attention: The light handle gets warmer during applica-

tion.

• ATMOS is not liable for personal injury and damage to

property or malfunctions if:

- no original ATMOS parts are being used

- the advice for use in these operating instructions is

not being observed,

- assembly, new settings, alterations, extensions

and repairs have been carried out by personnel not

authorized by ATMOS.

• Report all serious incidents that have occurred in con-

nection with this product to the manufacturer and your

national competent authority.

• Always make sure that you do not blind patients with

the light source! Watch out that patients do not look

directly into the light source! Never look directly into the

light source!

> EYE INJURY

• There are no warranty claims whatsoever on defects

which arise from the use of third-party accessories or

consumables.

• For cleaning, never use alcohol or alcoholic cleaning

agents. Avoid any contact of the lens with alcohol!

2.0 For your safety

3.0 Scope of supply and connection

Scope of delivery

Operating

Instructions

.....

ATMOS LS

21 LED

Endoscope

adapter Wolf

Danger to the device!

CAUTION!

• If the light source is used with unsuitable adapters, the lens could be badly damaged!

- Use optics only with the supplied and/or optional adapters!

- Make sure the endoscopes with adapter engage in the light source!

4.1 Attaching the application part

4.0 Operation

click

Endoscopes

ATMOS Strobo 21 LED

...

ATMOS LS 21 LED

light source

Endoscopes with light conduct-

ing cable

LED battery

4.2 Connection possibilities of the light source

Adapter Storz

Adapter Wolf

4.3 Operation of the optional LED battery

4.3.1 Indication of capacity

During charging process

Check regularly!

At the end of the battery capacity, the light expires quickly.

• We therefore recommend:

Change or reload battery

Test button

Indication of the

battery capacity

Keep pressed

For 3 s:

Indication of battery capacity

4.3.2 Reloading the LED battery

• Use the primary adapter tting your power supply (Euro/US/UK/Aus).

• During charging, operation of the headlight is not possible!

Connection LED

light source

Connection charging

power pack

4.0 Operation

Constant indication

of the current battery

capacity

Fully charged: when all 5

LEDs expire again

4.3.3 Maintenance of battery

During storage During usage

Do not:

• “Suck it out”! When the capacity indication shows “emp-

ty” (all LEDs are out), do not use the battery any more.

- Recharge immediately! For awless operation, the

battery needs a residue capacity.

• Expose the battery to solar radiation or put it close to

heaters.

- This will reduce the lifespan of the battery.

After approx. 500 charging cycles, the battery is at.

• Get a replacement in time.

Do not: Always do:

• Store discharged over a

longer period of time.

• Do not continuously con-

nect the light handle to the

recharging unit. Over-

charging will destroy the

batteries.

• Store in charged condi-

tion.

• Charge at least all 3

months.

The cooler you store the LED battery, the longer it works.

• Store frost-free!

• Store charged up and cool (e.g. in the fridge).

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