Atmos HL 21 LED Operating Instructions Manual
- Type
- Operating Instructions Manual
The Atmos HL 21 LED headlight provides bright, white LED illumination for medical examinations and surgical procedures. With a long-lasting LED bulb (approximately 50,000 hours) and a high-end battery system, the HL 21 LED delivers homogeneous illumination of the examination or surgical field.
The Atmos HL 21 LED headlight provides bright, white LED illumination for medical examinations and surgical procedures. With a long-lasting LED bulb (approximately 50,000 hours) and a high-end battery system, the HL 21 LED delivers homogeneous illumination of the examination or surgical field.
Please store this document near the device for later use!
Gebrauchsanweisung
ATMOS HL 21 LED
Operating Instructions
Englisch
201-04 Index: 0
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 Einzelkomponenten der Stirnleuchte .................................................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 - 14
6.1 Recommended surface disinfectants .................................................14
7.0 Maintenance and servicing .............................................................15
8.0 Trouble-shooting ..............................................................................16
9.0 Accessories, spare parts, consumables ........................................17
10.0 Technical specifi cations ..................................................................18
11.0 Disposal ............................................................................................19
12.0 Annex ................................................................................................20 - 26
12.1 Notes on Electromagnetic Compatibility (EMC) .................................20 - 25
12.2 Declaration of Conformity ...................................................................26
General Standard Terms and Conditions
Table of contents
ATMOS MedizinTechnik GmbH & Co. KG
Ludwig-Kegel-Str. 12, 14-16, 18 – 79853 Lenzkirch / Germany –
Tel: +49 7653 689-0 - Fax: +49 7653 689-392 (Vertrieb Inland) – Fax: +49 7653 689-391 (Export)
E-Mail: [email protected] – www.atmosmed.de
3
1.0 Introduction
1.1 Notes on operating instructions
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 require-ments of Annex I to this Directive.
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 stan-dards 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!
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.
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 Einzelkomponenten der Stirnleuchte .................................................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 - 14
6.1 Recommended surface disinfectants .................................................14
7.0 Maintenance and servicing .............................................................15
8.0 Trouble-shooting ..............................................................................16
9.0 Accessories, spare parts, consumables ........................................17
10.0 Technical specifi cations ..................................................................18
11.0 Disposal ............................................................................................19
12.0 Annex ................................................................................................20 - 26
12.1 Notes on Electromagnetic Compatibility (EMC) .................................20 - 25
12.2 Declaration of Conformity ...................................................................26
General Standard Terms and Conditions
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 at the ATMOS HL 21 LED, at the rechargeable
LED battery or at 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.
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 discon-nected 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 seat 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 direct 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
Description: ATMOS HL 21 LED
Main function: Headlight for medical examination
Illumination of ori ces for the examination in the ENT eld
OT-headlight:
Illumination of the operating eld
Application: For the application on humans
Specifi cation of the
main functions: Due to the long-life light source with power-white light LED
(service life ca. 50,000h) in combination with a high-end-battery
system the ATMOS HL 21 LED enables a homogeneous
illumination of the examination resp. operating eld.
Application organs: Throat / nose / ear
Duration of application: 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 environment: Headlight for medical examination
Application environment are ENT clinics and practices
OT-headlight:
Application environment are operating rooms
Contraindications: None
Sterility: Unnecessary
7
4.0 Setting up and starting up
4.1 Individual components of the headlight
Headlight ATMOS HL 21 LED
Charging power pack 12 V DC
Rechargeable LED battery
Connecting cable; length: 40 cm, 140 cm and 200 cm
Different mains plugs for charging power pack (Euro/UK/US/Aus)
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 Akkuhalterung 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 extents of supply).
Please document and report damages in transit immedia-tely. For complaints or return deliveries, please
use enclosed form QD 434.
Fig. 1. 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 on 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 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.
Pay also 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 toghether again.
• Add screw and cover again.
Fig. 7. Headlight without battery holder
Fig. 8. Headlight with battery holder
Pay also attention to the respective operating instructions of the ATMOS ENT
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.
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 HL 21 LED is applied by several users, regular
regulations applicable for the respective operation!
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.
Do not touch the lens in the light object.
14
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 Bode Chemie, Hamburg
(Application concentrate) hexahydrate 80 g
Green & Clean SK alkyl-dimethyl-benzyl-ammonium
(Application concentrate) chloride dialkyl-dimethyl-ammonium <1 g Metasys, Rum (Austria)
chloride
6.0 Cleaning
15
6.1 Recommended surface disinfectants
Disinfectant Ingredients (in 100 g) Manufacturer
TERRALIN Benzal conium chloride 20,0 g Schülke & Mayr,
(Application concentrate) Phenoxypropanoles 35,0 g Norderstedt
QUATOHEX Didecyl dimethyl Braun, Melsungen
(Application concentratr) ammonium chloride 14,0 g
Benzal conium chloride 10,0 g
Bi-guanidinium acetate 7,5 g
Polymer Biguanid 0,5 g
Active cleaning substances
Incidin Plus Glucoprotamin 26,0 g Ecolab, Düsseldorf
(Application concentratr) nichtionische Tenside
Lösungsmittel, Komplexbildner
Pursept-A Ethanol 38,9 g Merz & Co., Frankfurt/M.
(Disinfectant spray or Glyoxal 0,1 g
disinfectant cloths) QAV 0,05g
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 or opening and repair of the ATMOS HL 21 LED (with exception of the
cleaning work described in these operating instructions) may only be carried out by
ATMOS or a specialist authorised by ATMOS. In this case, attention should be paid to
the protective technical and hygiene measures plus the safety information in chapter 2.0.
For repair, this device can be returned to ATMOS.
Prior to effecting a return shipment, clean and disinfect the device.
7.0 Maintenance and servicing
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 acces-
sories or non-ATMOS consumables.
16
8.0 Trouble-shooting
Symptom
No light
LED battery cannot be charged
Cause
Remedy
LED battery is fl at
Cable is not correctly connected
Cable is defective
LED battery is defective
Charging power pack is defective
Charge LED battery
Connect cable
New cable is required
New LED battery is
required
New charging power
pack is required
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:
17
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
Remedy
18
10.0 Technische Daten
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 compensation
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 watts; light spot
focusing with a diameter of 25 to 55 mm in 25 cm distance to
the eye
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 -30 ...+50°C, 5...90 % humidity without condensing, air pressure
700...1060 hPa
Operation +10...+35°C, 20...80 % humidity without condensing, air pressure
700...1060 hPa
Regular safety Not necessary
technical controls
Classi cation acc. to I
Annex IX EEC directions
93/42/EWG
Protection class II (charging power pack)
(EN60601-1)
Protection category IP X0
Degree of protection Device / application part: Type B
CE identi cation CE
UMDNS-Code 11-963
GMDN-Code 11963
Issue of Technical Spei cations: 29.06.2011
Canadian Classi cation
Device group: Ophthalmology
PNC 86KAF
Risk Class 1
Description
19
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.
20
12.1 Notes on EMC
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 Annex
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.
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Atmos HL 21 LED Operating Instructions Manual
- Type
- Operating Instructions Manual
The Atmos HL 21 LED headlight provides bright, white LED illumination for medical examinations and surgical procedures. With a long-lasting LED bulb (approximately 50,000 hours) and a high-end battery system, the HL 21 LED delivers homogeneous illumination of the examination or surgical field.
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