Ackerman 16-2028 User manual

USER MANUAL
16-2028
LED LIGHTSOURCE

USER MANUAL 16-2028 Rev. 04/2017
These operating instructions contain information that is subject to copyright.
All rights are reserve .
This manual shoul not be photo-copie , uplicate on microfilm or otherwise copie or istribute ,
completely or in part, without the approval of the manufacturer. The manufacturer will appreciate any errors or
anything unclear in this operating manual being pointe out to us by users of our pro ucts.
Due to the continuing progress an evelopment of our pro ucts, we reserve all rights for technical
alterations.
Rev. 04/2017
SERVICE ADDRESS: Ackermann Instrumente GmbH
Eisenbahnstrasse 65-67
78604 Rietheim-Weilheim
Germany
Tel: [phone]
Fax: [phone]
E-Mail: info@ackermanninstrumente. e
Web: www.ackermanninstrumente. e

USER MANUAL 16-2028 Rev. 04/2017
CONTENTS PAGE
1. FOREWORD 4
2. INTRODUCTION 4
3. SAFETY INSTRUCTIONS 4
4. STANDARDS AND REGULATIONS 5
5. INSTALLATION OF THE LIGHTSOURCE 6
6. OPERATION 7
7. DESCRIPTION OF BACK PANEL 7
8. RECOMMENDED DECONTAMINATION PROCEDURE 8
9. AFTER SALES SERVICE AND MAINTANCE 10
10 TROUBLESHOOTING 12
11. TECHNICAL SPECIFICATIONS 13
12. ELECTROMAGNETIC COMPATIBILITY 13
13. SYMBOLS 14
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USER MANUAL 16-2028 Rev. 04/2017
1. FOREWORD
Thank you for the trust you have shown in us by acquiring this evice.
To optimise the use of this evice, it is essential to rea this manual thoroughly an take all the necessary
precautions.
Sentences featuring the symbol are points that require special attention.
Sentences featuring the symbol provi e information.
Our aim was to make the manual more practical to ai installation an use of the evice. We have
therefore provi e references to the presentation page on the insi e cover (for example, in the form of [D1])
to help you visualise the relevant parts of the pro uct more easily.
2. INTRODUCTION
This is an LED light source inten e for use by me ical practitioners when performing surgical or iagnostic
en oscopic proce ures. It has an electronic iris with fibre optic sensing, an automatic thermal protection
system a power level memory as well as an “iris” mo e that allows the user to turn the light off.
Its ease of use, illumination power an precise manual a justment of light intensity make this the perfect
multi isciplinary me ical instrument.
This evice comprises:
• A power cor
• A user manual
• A quick start gui e
Optional accessories:
• Universal light cable
• A apters for universal light cable, source si e (Storz an Olympus) an en oscope si e (Storz, Olympus,
Wolf, S&N, ACMI, Stryker)
We a vise selecting the following iameter of light cable:
Ø = 4.8 mm for en oscopes with iameter >4 mm
Ø = 3.5 mm for en oscopes with iameter >=4 mm
For the Unite States an Cana a, use the Hospital Gra e cor an the connecter that must be fitte
with a Hospital Gra e mains plug.
Fe eral law restricts this evice to sale by or on the or er of a octor.
This equipment will be elivere to you in a carton or a suitcase, which shoul be kept shoul you
nee to transport this equipment.
. SAFETY INSTRUCTIONS
Rea the user’s manual
• Comply with the con itions of use an storage con itions.
• The evice may only be opene by a qualifie technician authorise by the manufacturer.
• Do not insert any metal object into the evice, in or er to avoi any risk of electric shock, fire, shortcircuit
or hazar ous ischarge.
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USER MANUAL 16-2028 Rev. 04/2017
• Do not expose the evice to an excessively humi environment or where it coul be spraye with water.
• Only use the accessories supplie with the evice or optional accessories recommen e by the
manufacturer.
• Do not place any heavy objects on the evice.
• This evice is not sterile.
• If the power cor is amage , imme iately switch off the evice. It is angerous to operate this evice
with a amage cor .
• To isconnect the cor , pull out the plug. Never pull on the cor itself.
• Disconnect the evice from the mains if you o not expect to use it for a few ays or longer.
• Ensure there is sufficient air circulating to prevent overheating insi e the evice: at least 15 cm all
aroun the evice. Do not cover the evice an make sure the feet of the evice are present.
• Do not use corrosive or abrasive pro ucts to clean the evice, but only use the isinfectant liqui s
recommen e in section 8.
• Before using the evice, make sure it oes not have any rough surface, sharp e ges or protuberances
that might cause safety problems.
• The surface temperature can reach 41°C (after a few minutes’ use). Therefore avoi keeping this area
in contact with the patient.
• To avoi any risk of electric shock, this evice shoul only be connecte to an earthe power supply.
• This evice must not be mo ifie without the manufacturer’s authorisation. If the me ical evice is
mo ifie , an inspection an test must be performe to ensure the me ical evice complies with the
safety instructions.
• Before use, check with the manufacturer that your en oscope is compatible with this evice.
• This evice must be use on in ivi uals (patients) capable of un ergoing an en oscopic proce ure.
• Never look irectly at the light aperture or the en of the light cable.
• Do not insert anything other than a light cable into the housing [C1] as this may amage the optical
system.
• The use of cables or accessories other than those specifie may result in increase emissions or
ecrease immunity of the evice.
• After use of the source, when the fibre is being with rawn from its light gui e, the temperature on the
metal coupling of the fibre is very high an can cause burns.
• The light power at the fibre outlet can cause eye amage. Take care when han ling the fibre while the
evice is in use.
• Do not place the istal en of the light cable or the en oscope irectly on the patient or any other
inflammable material (surgical rapes, gauze, etc.) because it may be very hot an may cause burns.
It is a visable to have a secon light source available in the operating theatre, which can be use
as a replacement if performance is seen to be re uce or absent.
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USER MANUAL 16-2028 Rev. 04/2017
This pro uct is fitte with group 1 LEDs in accor ance with stan ar IEC 62471. Do not look irectly
at the light to avoi any risk of eye amage.
4. STANDARDS AND REGULATIONS
4.1 COMPLIANCE
This pro uct was esigne an manufacture by a company which has a certifie quality system. It complies
with the requirements of European Directive 93/42/EEC on me ical evices. It therefore conforms particularly
to the stan ar s of electrical safety (IEC) an electromagnetic compatibility (EMC) a hoc.
4.2 ELECTROMAGNETIC INTERFACE AND ELECTROSTATIC DISCHARGES
Although this pro uct conforms to EMC stan ar s, un er very particular circumstances it may interfere with
other evices, be subject to interference from other evices or an a verse electromagnetic environment.
To avoi these situations it is a visable:
• to ensure the quality of the electrical network (especially the earthing of all appliances an trolleys),
• to istance the evice from electromagnetic sources (e.g. compressor, motor, transformer, HF generator,
etc.).
4.3 MEDICAL DEVICE VIGILANCE
Like any me ical evice, this pro uct is subject to me ical evice vigilance provisions; any serious
malfunction shoul therefore be the subject of a report to the competent authorities an to the manufacturer
as soon as possible an as precisely as possible.
Manufacturer’s contact etails: please refer to the last page of the manual.
4.4 END OF LIFE
This appliance is marke accor ing to the European Directive 2002/96/EEC on Waste Electrical an
Electronic Equipment (WEEE).
By ensuring this pro uct is ispose of correctly, you will help prevent potential negative consequences for
environment an human health, which coul otherwise be cause by inappropriate waste han ling of this
pro uct.
The symbol on the pro uct, or on the ocuments accompanying the pro uct, in icates that this appliance
may not be treate as househol waste. Instea it shall be han e over to the applicable collection point for
recycling of electrical an electronic equipment.
Disposal must be carrie out in accor ance with local environmental regulations for waste isposal. For more
etaile information about treatment, recovery an recycling of this pro uct, please contact your local city
office your househol waste isposal service or the ealer to whom you purchase the pro uct from.
5. INSTALLATION OF THE LIGHTSOURCE
• This me ical evice is inten e for use by a qualifie surgeon uring en oscopic exploratory proce ures. Its
installation oes not require any special training. Please refer to the instructions containe in this manual.
• Place the evice on a stable surface an pick up the various accessories that are essential to its operation.
• If you are using furniture, make sure this is a equately ventilate (at least 15 cm aroun the evice).
• Connect the power cor to the mains socket on the evice [C3].
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USER MANUAL 16-2028 Rev. 04/2017
• Set the switch [S3] to position 1, the evice is then in stan by mo e (the green light [L1] shoul flash an a
logo shoul appear in the isplay [L2]).
• Press the Stan by button [S1] to switch on the evice (the green light is lit an a logo in icating insertion of
a light cable appears in the isplay [L2]). Pressing the Stan by button again will reset the evice to stan by.
• Push the light cable into the aperture provi e [C1]; you shoul hear a click as it engages. A logo in icating
that the evice is in “iris” mo e appears.
• Connect the other en of the light cable to your en oscope. Before setting up an en oscope (or fibroscope)
in front of the camera lens, it is a visable to check the con ition of the en oscope ( istal lens or clean
eyepiece).
• Press the a justment knob [S2] or turn it in or er to release the light.
The light source is fitte as stan ar with an a apter for a Storz-type light cable. A version of this
evice that is compatible with Olympus-type light cables is also available.
If no light cable is connecte to the evice when the latter is switche on, a logo will isplay this
information on the screen. Then you only nee to connect up a light cable in or er to see the “iris”
logo an use the evice.
6. OPERATION
6.1 SETTING THE LIGHT INTENSITY
After insertion of the light cable, a logo in icating the “iris” mo e will be isplaye on the screen [L2]. Pressing
or turning the a justment knob [S2] enables the user to exit this mo e an to release the light. A bar graph
in iquates the level of intensity will then appear [L2]. Turning the a justment knob [S2] clockwise will increase
the light intensity an turning it anti-clockwise will re uce the intensity.
An empty bar graph in icates that the source is completely ea while a full bar graph shows that it is
elivering maximum light intensity.
The LED takes about 10 secon s to stabilise its colour temperature. It is a visable to wait for this
length of time before setting the white balance on the camera.
It is also a visable to o a white balance whenever there is a change of intensity setting.
6.2 POWER LEVEL MEMORY
To put the LED source in “iris” mo e, simply press the a justment knob [S2]. Pressing the same button again
will restore light power to the previous setting. In the same way, if the LED source has been isconnecte
from its power supply it will start up again with the light power of the previous setting.
7. DESCRIPTION OF BACK PANEL
7.1 DESCRIPTION OF VENTS
The vents [A] locate on the back panel of the evice must not be obstructe as this can cause a risk of
overheating.
The light source has an automatic safety evice which stops the lighting function if the internal temperature is
too high. A pictogram in icating whether this safety system is activate will be isplaye on the screen [L2].
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7.2 TRANSFORMER / MAINS SOCKET
The electrical supply to the evice is via an IEC stan ar mains cor provi e with the equipment.
7.3 MAINS SOCKET – FUSES
The electrical supply to the evice is via the power socket locate on the back panel [C3], which must be
connecte to the mains via the mains cor provi e . This socket comprises a fuse flap [F] as well as the main
‘on’ switch [S3].
When replacing a fuse, it is essential to isconnect the pro uct from the mains an use the same type of
fuse. The T in ‘T800mA’ means ‘time elay’. Only use UL/CSA labelle fuses.
7.4 INDICATORS AND SYMBOLS ON BACK PANEL
The in icators an symbols on the back panel of the pro uct i entify it as conforming to the international
stan ar s IEC 60601-1, IEC 60601-2-18, IEC 60417 an EN 980 (see section 13).
8. RECOMMENDED DECONTAMINATION PROCEDURE
The LED source is a non-heat-resistant medical device which will not withstand immersion. It should
therefore be disinfected using a non-woven cloth impregnated with a detergent-disinfectant product.
As decontamination is related to which products, methods and/or tools are chosen, it remains the
sole responsibility of the personnel involved.
This device is not autoclavable.
The existing alkaline solutions for disinfection of certain medical devices are PROHIBITED for
disinfecting this device.
9. AFTER SALES AND MAINTANCE
No special maintenance is require for this evice.
Note: incorrect or faulty use is not covered by the guarantee.
If a problem persists an the pro uct nee s to be returne to our After-Sales Service, please be sure to sen
it to us in its original packaging.
Similarly, you shoul sen us the whole evice (control unit, cables). Please inclu e a small note with your
elivery note, giving etails of the fault encountere .
It is essential to disinfect the equipment before return for repair.
When returning the equipment, check its con ition an note any comments on the elivery note, if necessary.
Please confirm these comments by registere letter to the elivery company within 48 hours. In a situation
where equipment sent by us sustains amage in transit, the cost of repair will be invoice either to the
elivery company if the comments were sent within the ea line, or to the recipient if this has not been one.
In the event of any inci ent, please contact our Customer Service or our nearest sales representative.
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USER MANUAL 16-2028 Rev. 04/2017
10. TROUBLESHOOTING
10.1 NO LIGHT WHEN THE LIGHT IS SWITCHED ON
• Check that the power cor is properly connecte to the electricity supply an to the evice an that the main
switch [S3] on the back of the unit is in the ‘on’ position (“I”).
• Check that the fuses [F] are in goo con ition (only use T800mA - 250V – UL fuses).
10.2 THE SOURCE IS LIT BUT THE FLOW OF LIGHT IS INADEQUATE
• Check that the power cor is properly connecte to the electricity supply an to the evice an that the main
switch [S3] on the back of the unit is in the ‘on’ position (“I”).
• Check that the fuses [F] are in goo con ition (only use T800mA - 250V – UL fuses).
10.3 THE FANS CONTINUE RUNNING AFTER THE LIGHT IS OFF
The light cable is isconnecte .
The light source is fitte with a safety evice which cuts the supply to the LED if the temperature insi e the
evice is too high. A pictogram epicting the status of this safety system will be isplaye on the screen.
Once the temperature has fallen, the source returns to the Stan by position an it can be re-use :
• Check that there is enough space aroun the source to ensure a equate cooling (15 cm all aroun the
evice).
• Check that nothing is obstructing the air vents on the back an un erneath the source
The light source is in “iris mo e”. Press the a justment knob [S2] or turn it in or er to release the light.
If the fault persists an the evice nee s to be returne to our After-Sales Service, please be sure to sen
it to us in its original packaging after the evice has been isinfecte .
10.4 LIGHT APPEARS / DISAPPEARS INTERMITTENTLY
Check that the light cable is fully engage an the connector [C1] is properly screwe in place.
11. TECHNICAL SPECIFICATIONS
Main functions
• LED technology
• Colour temperature: 6500°K
• Typical LED life-time: 50,000 hours
• Compatible light cable: Storz-type or Olympus (optional)
• Electronic iris
• Light intensity a justment: manual
• Anti-glare system with light cable sensor
• Stan by mo e
• Automatic thermal protection system
• Power level memory
• Supply voltage: 100-230VAC / 50 - 60 Hz
• Power consumption: 140 VA
• Dimensions: 300 x 66 x 300 mm
• Weight: 2400 g
Environment
• Operating temperature: +10°C / +40°C
• Operating humi ity: 30% to 75%
• Storage an transport temperature: -+10°C / +40°C
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• Storage an transport humi ity: 20% to 85%
• Operating, storage an transport atmospheric pressure: 800 hPa to 1060 hPa
• Not protecte from vertically falling water (IPXO).
• Not suitable for use in the presence of an inflammable anaesthetic mixture with air, oxygen or nitrous oxi e.
Standards
• Electrical safety class 1, type CF
• Complies with the European Directive 93/42/EEC - Class I
• Complies with the international stan ar s IEC 60601-1; IEC 601-2-18; IEC 60417 an EN 980
• This pro uct is fitte with group 1 LEDs in accor ance with the stan ar IEC 62471. Do not look
irectly into the light to avoi any risk of eye amage.
12. ELECTROMAGNETIC COMPATIBILITY
12.1 GUIDE AND DECLARATION OF THE MANUFACTURER - ELECTROMAGNETIC EMISSIONS
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12.2 GUIDE AND DECLARATION OF THE MANUFACTURER - ELECTROMAGNETIC IMMUNITY
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12.3 GUIDE AND DECLARATION OF THE MANUFACTURER - ELECTROMAGNETIC EMISSIONS
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12.4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF
COMMUNICATION SYSTEMS AND THIS PRODUCT
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1 . SYMBOLS
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