Atmos HL 21 LED Unit set User 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: [email protected] –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




9
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

10
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

11
5.0 Operation
5.1 Different variants of the headlight ATMOS®HL 21 LED
Fig. 7: Headlight ATMOS®HL 21 LED with long cable, supply from the LED battery in the
coat pocket or from a suitable ATMOS®current source in an ENT examination unit.
Also pay attention to the respective operating instructions of the ATMOS®ENT
examination unit.
Fig. 8: Headlight ATMOS®HL 21 LED with short cable, LED battery in battery holder on
the headlight.
For removing the battery holder, proceed as follows:
• Use the turning knob to adjust the headlight rack quite tight.
• Remove the centric cover in the turning knob and then take a Philips head
screwdriver to remove the screw.
• Remove the turning knob.
• Remove the battery holder.
• Add the turning knob again. Make sure that the tight adjustment of the headlight rack
has not changed. Otherwise, the headlight rack is to be pushed together again.
• Add screw and cover again.
Fig. 7. Headlight without battery holder Fig. 8. Headlight with battery holder
Also pay attention to the respective operating instructions of the ATMOS
examination unit.

12

Fig. 9. Focusing
Headlight rack
 Focusing ring
5.2 Switching on
Adjust the lateral switch on the LED battery to the desired position:
ECO mode: operation for about 4 hours.
POWER mode: operation for about 2 hours.
5.3 Focusing the headlight
The size of the light spot can be adjusted by turning the focusing ring (,  g. 9).
5.0 Operation

13
6.0 Cleaning
The measures described for cleaning and disinfection are not intended to replace the
regulations applicable for the respective operation!
Always comply on principle with the relevant manufacturer’s information regarding
concentration and material compatibility!
Do not use any:
• Disinfectants containing organic or inorganic acids or bases since these
may cause corrosion damage.
•Disinfectants containing chloramines, phenol derivatives or anionic
tensides since these may cause stress cracks in the plastics used.
When the headlight ATMOS®HL 21 LED is applied by several users, regular
cleaning and disinfection is necessary.
Do not touch the lens in the light object.
Fingerprints can be wiped down with a soft cloth. If necessary, you may use ethanol.
The surfaces can be cleaned with a moist cloth. If necessary, you may use ethanol.
The headlight ATMOS®HL 21 LED cannot be sterilised.
The light body and the rigid headlight rack can be wiped down with a cloth moistened
with a surface disinfectant (see page 14).
The front pad can be cleaned using a brush, clear water and soap. If necessary, you may
use a 70%-ethanol solution. The cleaning agent must not contain tuluol. The front pad
may also be cleaned in the washing machine (30°). Nevertheless, it may not be spin-dried
or be put in the tumbledrier.
5.2 Switching on
Adjust the lateral switch on the LED battery to the desired position:
ECO mode: operation for about 4 hours.
POWER mode: operation for about 2 hours.
5.3 Focusing the headlight
The size of the light spot can be adjusted by turning the focusing ring (,  g. 9).
Always comply on principle with the relevant manufacturer’s information regarding
concentration and material compatibility!
When the headlight ATMOS
cleaning and disinfection is necessary.
Do not touch the lens in the light object.
The measures described for cleaning and disinfection are not intended to replace the
regulations applicable for the respective operation!
6.1 Recommended surface disinfectants
Disinfectant Ingredients (in 100 g) Manufacturer
Incidin®Plus Glucoprotamin 26,0 g Henkel, Düsseldorf
(Application concentrate) Nonionic tensides
Solvents, complexing agents
Dismozon®pur magnesium monoperoxyphthalate 80 g Bode Chemie, Hamburg
(Application concentrate) hexahydrate
End of product 12/2014
Dismozon®plus magnesium monoperoxyphthalate 95,8 g Bode Chemie, Hamburg
(Application concentrate) hexahydrate
Green & Clean SK alkyl-dimethyl-benzyl-ammonium
(Application concentrate) chloride dialkyl-dimethyl-ammonium <1 g Metasys, Rum (Austria)
chloride

14
 Prior to each application, check the device's functions and its proper condition.
Damaged cables must be replaced immediately!
 The headlight ATMOS®HL 21 is low-maintenance. However, the regulations and instructions applying to
the respective  eld of application have to be taken into account.
Maintenance, repairs and period tests may only be carried out by persons who have the appropriate
technical knowledge and are familiar with the product. To carry out these measures the person must
have the necessary test devices and original spare parts.
ATMOS recommends: work should be carried out by an authorized ATMOS-service partner. This ensures
that repairs and testing are carried out professionally, original spare parts are used and warranty claims
remain unaffected.
 Please comply with the country speci c guidelines regarding regular testing especially for the electrical
safety. ATMOS recommends a test every 24 months.
 For repair, this device can be returned to ATMOS.
 Prior to effecting a return shipment, clean and disinfect the device.
 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.
●Rechargeable batteries are wearing parts and therefore excluded from the 2 years‘ product liability!
7.0 Maintenance and servicing
8.0 Trouble-shooting
●Prior to dispatch, the headlight ATMOS®HL 21 LED was subjected to an extensive functional test. If,
nevertheless, a failure should appear, you may possibly clear it yourself if you follow these notes:
Symptom Cause Remedy
No light LED battery is fl at
Cable is not correctly connected
Cable is defective
Charge LED battery
Connect cable
New cable is required
LED battery cannot be charged LED battery is defective
Charging power pack is defective
New LED battery is required
New charging power pack is
required

15
9.0 Accessories, spare parts, consumables
9.1 Accessories
Description REF
Connecting cable for LED battery, 40 cm.................. 507.4542.0
Connecting cable for LED battery, 140 cm................ 507.4541.0
Connecting cable for LED battery, 200 cm................ 507.4545.0
Clip - for xing the cable to clothes .......................... 507.4543.0
9.2 Spare parts
Description REF
Light body complete.................................................. 507.4537.0
Headlight rack........................................................... 507.4530.0
Universal battery quick-charging power pack ........... 011.1199.0
with primary adapters assortment
(Euro/UK/US/Aus)
Cable holder.............................................................. 507.4536.0
9.3 Consumables
Description REF
Replacement LED battery (lithium-ionic)...................507.4510.0
Front pad .................................................................. 507.4535.0
Nape pad.................................................................. 507.4533.0

16
10.0 Technical Data
Issue of Technical Speci cations: 13.05.2015
Charging power pack 100...240 V~ 50/60 Hz; exchangeable primary adapters (Euro/
UK/US/Aus); secondary 12 V DC; 0.8 A via non-medical 1.8 m
cable with DC plug 5.5 x 2.5 mm; protection class II; only for
dry rooms
Rechargeable battery Charging with 12 V DC; approx. 120 min charging time after
complete discharge; automatic switchover battery to compen-
sation charging; capacity indication by 5 LEDs at the touch of
a button and during the charging process; lithium-ionic battery
with 3.7 V nominal voltage and a 1950 mAh capacity; at least
500 charging cycles possible; switch with 2 operating modes
(Power and ECO): 120 min operation with full light performance
and at least 240 min with reduced light performance; weight
approx. 80 g
Light emitter White high-performance LED; Type 5500K; 2 watt; light spot
focusing with a diameter of 25 to 55 mm in 25 cm distance
to the eye
Illuminance 100,000 Lux
Life-span LED max. 50,000 h
Headlight rack Head measurement adjustable from 50...64 cm, level 92...115
mm, weight with emitter: approx. 200 g
Connecting cable 40 cm, 140 cm and 200 cm long
Ambient conditions
• Transport/storage
• Operation
-30 ...+50°C, 5...90 % humidity without condensing,
air pressure 700...1060 hPa
+10...+35°C, 20...80 % humidity without condensing,
air pressure 700...1060 hPa
Period tests Recommended: Testing every 24 months.
Classi cation acc. to Annex IX EEC
directions 93/42/EWG
I
Protection class (EN60601-1) II (charging power pack)
Protection category IP X0
Degree of protection Device / application part: Type B
CE identi cation CE
UMDNS-Code 11-963
GMDN-Code 11963
Canadian Classi cation
Device group:
PNC
Risk Class
Description
Ophthalmology
86KAF
1

17
11.0 Disposal
The headlight ATMOS®HL 21 LED does not contain any hazardous goods.
The LED battery (lithium-ionic) must be disposed of correctly.
Prior to disposal, device and accessories must be de-contaminated.
Make sure that materials are separated carefully.
 Pay attention to country-speci c regulations regarding the disposal.

18
Medical electrical equipment is subject to special precautions with regard to EMC and
must be installed acc. to following EMC notes.
Portable and mobile HF communication facilities can infl uence medical electrical equipment.
The use of other accessories, other converters and cables than stated may lead to an
increased emission or a reduced interference immunity of the equipment or system.
12.0 Notes on EMC
The use of other accessories, other converters and cables than stated may lead to an
increased emission or a reduced interference immunity of the equipment or system.
Guidelines and Manufacturer's Declaration - Emissions
The headlight ATMOS® HL 21 LED is intended for use in the electromagnetic environment speci ed
below. The customer or user of the ATMOS®HL 21 LED should ensure that it is used in such an envi-
ronment.
Emissions Test Compliance Electromagnetic Environment -
Guidance
"RF Emissions
CISPR 11"
Group 1 The headlight ATMOS®HL 21 LED
uses RF energy only for its internal
function. Therefore, its RF emissions
are very low and are not likely to cause
any interference in nearby electronic
equipment.
"RF Emissions
CISPR 11"
Class B The headlight ATMOS®HL 21 LED is
suitable for use in all establishments,
including domestic, and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.
"Harmonics
IEC 61000-3-2"
Inapplicable
"Flicker
IEC 61000-3-3"
Inapplicable
Portable and mobile HF communication facilities can infl uence medical electrical equipment.

19
The device may not be used when being set up directly besides another equipment resp.
when being stacked with other equipment. If, nevertheless, one of these arrangements is
necessary, the device is to be observed to check its intended use.
12.0 Notes on EMC
Guidelines and Manufacturer's Declaration - Immunity
The headlight ATMOS® HL 21 LED is intended for use in the electromagnetic environment speci ed
below. The customer or user of the ATMOS®HL 21 LED should ensure that it is used in such an
environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic
Environment - Guidance
"ESD
IEC 61000-4-2"
± 6 kV Contact
± 8 kV Air
± 6 kV Contact
± 8 kV Air
Floors should be wood,
concrete, or ceramic tile.
If fl oors are synthetic, the
relative humidity should be
at least 30 %.
"EFT
IEC 61000-4-4"
± 2 kV Mains
± 1 kV l/Os
± 2 kV for mains cables
Inapplicable
Mains power quality
should be that of a typical
commercial or hospital
environment.
"Surges
IEC 61000-4-5"
± 1 kV Differential
± 2 kV Common
± 1 kV symmetric
Inapplicable
Mains power quality
should be that of a typical
commercial or hospital
environment.

20
12.0 Notes on EMC
Guidelines and Manufacturer's Declaration - Immunity
The headlight ATMOS® HL 21 LED is intended for use in the electromagnetic environment speci ed
below. The customer or user of the ATMOS®HL 21 LED should ensure that it is used in such an
environment.
Immunity Test IEC 60601-Test Level Compliance Level Electromagnetic
Environment - Guidance
"Voltage Dips/
Dropout
IEC 61000-4-11"
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
(60 % Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
< 5 % UT
(> 95 % Dip of the UT)
for 0.5 Cycle
40 % UT
(60 % Dip of the UT)
for 5 Cycles
70% UT
(30 % Dip of the UT)
for 25 Cycles
< 5 % UT
(>95 % Dip of the UT)
for 5 s
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user of
the ATMOS®HL 21 LED
demands continued function
even in case of interruptions
of the energy supply, it is
recommended to supply the
ATMOS®HL 21 LED from
an uninterruptible current
supply or a battery.
"Power Frequency
50/60 Hz
Magnetic Field
IEC 61000-4-8"
3 A/m Inapplicable Power frequency magnetic
 elds should be that of
a typical commercial or
hospital environment
NOTE UT is the mains alternating current prior to application of the test levels.