Atmos HL 21 LED Operating Instructions Manual

Please store this document near the device for later use!

Gebrauchsanweisung

ATMOS® HL 21 LED

Operating Instructions

English

2015-05 Index: 09

MedizinTechnik

507.4500.B

507.4507.B

530.4020.B

506.7551.B

507.4760.B

507.4505.B

507.4506.B

2

1.0 Introduction ....................................................................................3

1.1 Notes on operating instructions ........................................................3

1.2 Explanation of symbols ....................................................................4

2.0 Notes on safety ..............................................................................5

3.0 Intended use ................................................................................... 6

4.0 Setting up and starting up ......................................................7 - 10

4.1 Individual components of the headlight ............................................ 7

4.2 Adjustment to head measurement ..............................................8 - 9

4.3 Functionality of rechargeable LED battery ..................................... 10

5.0 Operation ...............................................................................11 - 12

5.1 Variants of the headlight ATMOS® HL 21 LED ............................... 11

5.2 Switching on ................................................................................... 12

5.3 Focusing the headlight ATMOS

®

HL 21 LED ..................................12

6.0 Notes on cleaning and care ........................................................13

6.1 Recommended surface disinfectants ............................................. 13

7.0 Maintenance and servicing .........................................................14

8.0 Trouble-shooting ..........................................................................14

9.0 Accessories, spare parts, consumables ....................................15

10.0 Technical specifi cations .............................................................. 16

11.0 Disposal ........................................................................................17

12.0 Notes on Electromagnetic Compatibility (EMC) ........................18

Table of contents

ATMOS MedizinTechnik GmbH & Co. KG

Ludwig-Kegel-Str. 16 – 79853 Lenzkirch / Germany –

Phone: [phone] - Fax: [phone] (Sales National) – Fax: [phone] (Export)

E-Mail: [e-mail] – www.atmosmed.de

3

1.0 Introduction

1.1 Notes on operating instructions

 These operating instructions are valid for following devices:

• ATMOS

®

HL 21 LED REF 507.4505.0

Examination set

• ATMOS

®

HL 21 LED REF 507.4506.0

OT set

• ATMOS

®

HL 21 LED REF 507.4507.0

Unit set

in connection with the accessories mentioned in chapter 9.0.

 These operating instructions contain important information on how to operate
the ATMOS

®

HL 21 LED safely, correctly and ef ciently.

ALWAYS STORE THESE OPERATING INSTRUCTIONS CLOSE TO THE
DEVICE!

The device’s operating safety and its readiness for use depend not only on your
competence but also on care and maintenance of the ATMOS

®

HL 21 LED.

Regular cleaning and preventive maintenance work is, therefore, essential.

Maintenance and repairs may only be carried out by a skilled person authorised
by ATMOS. Only original spare parts may be used for repairs. This will
guarantee that the safety, readiness for operation and value of your device
will be maintained.

 The ATMOS

®

HL 21 LED bears the CE identi cation symbol CE in accordance with

the EU Medical Devices Directive (MDD) - Directive 93/42/EEC and meets
the basic requirements of Annex I to this Directive.

 The product ATMOS

®

HL 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 used at ATMOS

®

has been certi ed for quality

management in accordance with the relevant international standards.

 These operating instructions correspond to the design of the device and the status
of basic safety engineering standards on going to press.

 Reproduction of these instructions - even in part - only with the written permission
of ATMOS.

Abbreviations / symbols in these operating instructions:

 Identi es a list

• Subdivision of a list/activity. The recommended sequence must be
adhered to in each case!

Important notes!

4

ECO Half performance

O Lamp switched off

POWER Full performance

Test button for battery test

Connection for lamp to rechargeable LED battery

Connection for charging power pack with

identi cation of the polarity

1.2 Explanation of symbols

The following symbols are on the ATMOS® HL 21 LED, on the rechargeable

LED battery or on the charging power pack. Please remember their meaning

.

Symbol
"Pay attention to operating instructions".

This symbol shall draw your attention to the safety information contained in the

operating instructions. It serves as a reference to particular notes which are

important for the application of the headlight.

The CE identi cation symbol shows that this device complies with the appropriate

requirements of the EU guidelines.

Protective insulation, class II equipment

Type B device

SN Serial number

REF Order number

1.0 Introduction

5

2.0 Notes on safety

 Prior to starting up the headlight ATMOS® HL 21 LED, read these operating
instructions carefully.

 ATMOS cannot guarantee perfect functioning neither will it be liable for damage
to people or property if:

• Any non-original ATMOS parts are used.

• The instructions for use contained in these operating instructions are disregarded.

• Assembly, resetting, alterations, extensions and repairs are not carried out
by people authorised by ATMOS.

 No warranty rights shall exist in the event of damage or failure caused by the use of
non-ATMOS accessories or non-ATMOS consumables.

 Please make sure that the ATMOS® HL 21 LED is used in the EMC area described
in the Annex.

 Only use the charging power pack supplied by ATMOS.

 Exclusively use the headlight ATMOS® HL 21 LED in connection with the rechargeable

ATMOS® LED battery or ATMOS® current sources.

 Separation of the charging power pack from the supply is only guaranteed
with the charging power pack being disconnected from the power socket.

 Prior to each application, check the device's functions and its proper condition.
Damaged cables must be replaced immediately!

 During each application, pay attention to proper  t of the headlight ATMOS® HL 21 LED.

 Note: The headlight ATMOS® HL 21 LED is not sterile! This fact might be important

for medical operations.

 Always make sure that you do not shine in patient's eyes resp. that the patient does
not look directly into the light exit as, otherwise,

EYE INJURIES MIGHT BE THE CONSEQUENCE.

 Charging of the LED battery must be checked regularly as the light expires very

fast when the battery gets fl at.

 When the headlight ATMOS® HL 21 LED is applied by several users, regular
cleaning and disinfection is necessary.

 When not in use, switch off the headlight ATMOS® HL 21 LED.

6

3.0 Intended use

Name: ATMOS® HL 21 LED

Main functions: Headlight for medical examination: Illumination of ori ces for the

examination in the ENT  eld.

OT-headlight: Illumination of the operating  eld, natural body ori ces.

Med. indications/ application: Illumination of body ori ces.

Specifi cation of the main function:

Due to the long-life light source with power-white light LED (service

life approx. 50.000h) in combination with a high-end-battery system
the ATMOS® HL 21 LED enables a homogenous illumination of the

examination resp. operating  eld.

Application organ: Ear, nose, throat

Application time: Headlight for medical examination: Temporary application – the

operation and application of the headlight may only be performed by
trained staff.
OT-headlight: For short-term application (max. 4 hours) – the
operation and application of the headlight may only be performed by
trained staff.

Application site: Headlight for medical examination:

Application environment are ENT clinics and practices.

OT-headlight: Application environment are operating rooms.

Contraindications: None

The product is: X active □ not active

Sterility: Not necessary

Single use product / reprocessing:

No single use product

7

4.0 Setting up and starting up

4.1 Individual components of the headlight

 Headlight ATMOS® HL 21 LED
 Different mains plugs for charging power pack (Euro/UK/US/Aus)
 Charging power pack 12 V DC
 Rechargeable LED battery
 Connecting cable; length: 40 cm, 140 cm and 200 cm
 Cable holder on headlight rack
 Adjusting instruments on the headlight rack.

Extent of supply Extent of supply Extent of supply
of Examination Set of OT Set of Unit Set
REF 507.4505.0 REF 507.4506.0 REF 507.4507.0

1 Headlight 1 Headlight 1 Headlight
ATMOS® HL 21 LED ATMOS® HL 21 LED ATMOS® HL 21 LED
1 Charging power pack 1 Charging power pack 1 Cable 200 cm
(Euro/UK/US/Aus) (Euro/UK/US/Aus) 1 Cable clip
1 Rechargeable LED batteries 2 Rechargeable LED batteries
1 Cable 40 cm 1 Cable 40 cm
1 Battery holder 1 Cable 140 cm
1 Cable clip
1 Battery holder

 Prior to dispatch, this ATMOS device was subjected to an extensive functional test and has been carefully

packed.

Nevertheless, please compare the contents of the shipment on completeness immediately upon receipt

(see following extent of supply).

 Please document and report damages in transit immediately. For complaints or return deliveries,

please use enclosed form QD 434.

Fig. 1a + 1b. Single components

 









8

4.2 Adjustment to head measurement

 At  rst, take the headlight rack incl. headlight (,  g. 2) and put it on a table in front of you.

 Adjusting the headlight rack:

Depending on your head measurement, adjust the headlight rack gradually to a comfortable
and correct position by means of the turning knob (,  g. 2).
The level of the headlight rack is adjusted by means of a strap (,  g. 2).

The lower edge of the headlight rack is to be positioned directly above the ears.

Fig. 2. Headlight ATMOS

®

HL 21 LED

 Headlight rack
 Turning knob for adjusting the measurement
 Strap for adjusting the level

The lower edge of the headlight rack is to be positioned directly above the ears.

Prior to  rst operation, pay attention to the safety information in chapter 2.0.

Prior to  rst use of the headlight, charge the LED battery by means of the supplied

charging power pack.

Prior to  rst use of the headlight, charge the LED battery by means of the supplied

charging power pack.

4.0 Setting up and starting up





