Atmos HL 21 LED Unit set Manual de usuario

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

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: +49 7653 689-0 - Fax: +49 7653 689-392 (Sales National) – Fax: +49 7653 689-391 (Export)

E-Mail: [email protected] –www.atmosmed.de

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!

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

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.

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

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

 









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







Fig. 3.

 Cable holder

 Cable clip

 Front pad

 headlight connection

Fig. 4. Connection of

LED battery

4.2 Adjustment to head measurement (contin.)

Take one of the enclosed connecting cables and join it with the headlight connection

(,  g. 3).

Use the short connecting cable if you want to carry the LED battery on the headband.

( g. 8, page 11).

Use the long connecting cable if you want to carry the LED battery in your coat pocket, in your trouser

pocket or on your belt. This cable is also to be used if the headlight is to be

supplied from an ATMOS®current source. If necessary, lead the cable under the front pad

and through the cable holders in the joint of the headlight ATMOS®HL 21 LED.

Use the enclosed cable clip (,  g. 3) to  x the long cable to your clothes.

Join the other end of the connecting cable with the socket on the rechargeable

LED battery ( g. 4) or with the current source in your ATMOS®ENT examination unit.

 Note: By means of its rear cable clip, the rechargeable LED battery can be  xed to your coat pocket, to

your belt or to the battery holder on the headlight ATMOS®HL 21 LED.









4.0 Setting up and starting up

4.3 Functionality of the rechargeable LED battery

4.3.1 Capacity indication

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

very fast when the battery gets ﬂ at. We recommend to change resp. charge

the battery when the capacity is <50%.

As long as the test button (,  g. 5) of the rechargeable LED battery is pressed, the battery capacity is

shown for about 3 seconds (,  g. 5, green LEDs for levels 1 ... 5).

4.3.2 Charging the LED battery

 Use the primary adapter  tting for your power supply (Euro/US/ UK/Aus). See information

enclosed to the charging power pack.

To charge the LED battery, separate it from the headlight ATMOS®HL 21 LED.

Join round connector of the power pack cable with the socket (,  g. 6) on

the LED battery.

During the charging process, the current battery capacity is indicated

(,  g. 5, LEDs for levels 1 ... 5). The battery is fully charged when all 5 LEDs expire again.

During charging, operation of the headlight is impossible!

Fig. 6.

Connecting socket for headlight

 Charging socket on LED battery

 

Fig. 5.

Test button

Indication of battery capacity (green LED)





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

very fast when the battery gets ﬂ at. We recommend to change resp. charge

the battery when the capacity is <50%.

During charging, operation of the headlight is impossible!

4.0 Setting up and starting up

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