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ACKERMANN 16-2009, User Manual

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ACKERMANN 16-2009 User Manual Download Page 11

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User Manual 16-2009 | Revision 01/20 by   

Ackermann

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 The device is a mobile device, and may be moved using a trolley.

movInG the meDICAl DevICe

There are no known undesirable secondary effects associated with the DUO Full HD (control unit and camera 

head). Please refer to the user manuals for other devices used during surgical endoscopy or diagnostic 

procedures (gynaecology, Laparoscopy, arthroscopy, eNT or spinal endoscopy).

unDesIRABle seConDARy eFFeCts

 The device must only be opened by a competent technician approved by the manufacturer.

 This device must not be modified without the manufacturer’s authorisation. If the medical device is 

     modified, a test and inspection must be carried out to ensure that the medical device satisfies the safety 

     requirements. 

 Only the fuses below the switch at the rear of the device may be replaced. The power should be switched off 

     and the fuses checked and replaced if necessary; only T 1.6 a-250 V UR time-delay fuses should be used 

     (only those marked UL/CSa).

AssemBly AnD DIsAssemBly oF the PRoDuCt 

any serious incident concerning the medical device or its accessories, with the exception of the expected 

secondary effects must be reported to the relevant competent authorities and to the manufacturer as soon as 

possible. generally speaking, the notification period should take into account the seriousness of the incident. 

Consult local applicable regulations.

Manufacturer’s contact details: please see page 18 (CONTaCT) of the manual.

vIGIlAnCe

 This device is not sterile; only the camera and lens may be sterilised.

 When connecting the light cable or camera to the control channel, do not force the connectors, as this may 

      damage them. 

 abide by the proper usage and storage conditions (see chapter 9).

 ensure there is sufficient airflow to prevent any overheating within the device: at least 15 cm clear all round 

      the device. Do not cover it, and ensure that all of the device’s feet are present.

 If the power cord is damaged, immediately switch off the device. It is dangerous to operate this device with 

     a damaged cord.

 after the source has been used, when removing the fibre from its light guide, the temperature of the metal 

     part will be very high and could cause burns.

 The light intensity at the fibre outlet may cause eye damage. Be careful handling it when the device is in use.

PARtICulAR WARnInGs

Summary of Contents for 16-2009

Page 1: ... 20 16 2009 16 2009 Duo Camera The DUO Full HD control unit is a medical device combining a Full HD camera and LeD light source over a single control channel It is designed to provide localilluminationofthepatient sbodyandtocapture images taken by health practitioners qualified in diagnostic procedures or surgical endoscopy procedures ...

Page 2: ...l of the manufacturer The manufacturer will appreciate any errors or anything unclear in this operating manual being pointed out to us by users of our products Due to the continuing progress and development of our products we reserve all rights for technical alterations by Ackermann Instrumente GmbH Rev 01 2020 Foreword 3 Required information 5 Safety instructions 9 Installation of the equipment 1...

Page 3: ...other items liable to mislead the user or patient over the purpose safety and performance of the device Electronic documentation The instructions for use for your device can be provided in electronic format as per request on info ackermanninstrumente deaswell andnotinprintedformat Ifyoudonotgetanyanswerimmediately please be patient our customer service will come back to you asap The electronic use...

Page 4: ...the website regularly to check if there are any downloadable versions of your device s user instructions Users are asked to keep documentation to hand so that it can be consulted when necessary All printed and electronic format documentation relating to your medical device must be kept for the device s entire service life Please retain all original documentation relating to the medical device and ...

Page 5: ...doscope end Ackermann Storz fitting optional Note Any other consumable or accessory not sold by Ackermann will have its own manual Please refer to it before using the product Keep the packaging in case you need to transport the equipment at a later date Indication for use Control unit The DUO Full HD control unit is a medical device combining a Full HD camera and LED light source over a single con...

Page 6: ... in the field and the key medical hygiene principles including cleaning disinfection and sterilisation of MDs The user must wear gloves The user is not the patient The medical device can be used by any adult dental practitioner of any weight age height gender and nationality The user must not be prone to any of the following Visual impairments any vision problems must be corrected by glasses or le...

Page 7: ... of the patient s details such as weight age height gender and nationality Patient population Specific user training No specific training other than initial professional training is required to use this medical software The practitioner is responsible for performing clinical treatments and for dangers that may arise due to a lack of skill and or training The user is the only person who can decide ...

Page 8: ... throughout the entire medical procedure As a highly skilled medical expert the practitioner can immediately detect any problems at the treatment area and react accordingly It is recommended to have a second camera or light source available in the operating theatre for use in the event that a loss or deterioration of functionality is observed in the equipment Product service life Repeated cleaning...

Page 9: ...ed with its accessories or others offered as an option to guarantee maximum safety and performance The use of accessories from other sources could put you and your patients at risk and could damage your medical device Even if the manufacturer or dealer of your accessory claims full compatibility with Ackermann equipment it is advisable to exercise caution with regard to the origin and safety of th...

Page 10: ...o not place the device where it could be splashed with water or in an excessively damp environment Donotusecorrosiveorabrasiveproductstocleanthedevice butonlythedisinfectantliquidsrecommended in the chapter on Cleaning Do not insert anything other than a light cable in the connector provided for that purpose C2 as this may risk the optical system the same applies to the connector designed for the ...

Page 11: ...ous incident concerning the medical device or its accessories with the exception of the expected secondary effects must be reported to the relevant competent authorities and to the manufacturer as soon as possible Generally speaking the notification period should take into account the seriousness of the incident Consult local applicable regulations Manufacturer s contact details please see page 18...

Page 12: ...video outputs HDMI C4 or SDI C6 Connect the other end of the video lead to the monitor video input ConneCtIon The device is fitted with a switch S1 located on the rear of the device The device is switched on by setting this switch to the I position The screen on the device L1 will then come on in standby mode touch the screen to exit standby sWItChInG on Chapter 4 4 1 4 2 Chapter 4 ...

Page 13: ...the control channel C2 The device has two types of connections ackermann Storz by default on the device Olympus provided on the rear of the device D1 ConneCtIon to the CAmeRA heAD AnD lIGht CABle Connect the optics to the optical mount ring on the lens Connect the light cable to the optics ConneCtIon oF the enDosCoPe to the sensoR 4 3 4 4 Chapter 4 ...

Page 14: ...camera and light source are connected to the endoscope film a white surface e g white compress Launch white balance adjustment Via the interface press the button Via the camera head perform a long press of the main button S2 Continue filming the white surface until the screen displays the message AWB OK There is also an indicator light on the device screen White N A Orange AWB in progress Green AW...

Page 15: ...ssfully Red error When the indicator is green you can take a photo by clicking the capture button which will have turned white When the indicator is green you can take a photo by clicking the capture button which will have turned or you can perform a short press of the main button on the camera head Your photo will be saved to your storage system in tiff format Use the focussing ring F1 on the sen...

Page 16: ...er this mode is active Todeactivatethemode pressthe an OSD message represented by F appears on the screen whenever this mode is active buttonagainontheinterface ordouble pressagainonthecamera head button ADjustInG the BRIGhtness To adjust the brightness of the light source you can Press the or buttons on each side of the slider Or drag the slider itself to the left or the right If the buttons are ...

Page 17: ...hen you touch each icon its name will appear on the screen to tell you which function it represents Press the or buttons or move the slider itself to adjust each setting To move from one screen to another press the buttons Once they have been changed you can save your settings by pressing the button You can return the device to your last saved settings or the factory settings if no custom settings...

Page 18: ...formation page so that you can contact our Customer Service team 1 Date Time takes you to a screen where you can adjust the date and time 2 Settings takes you to a screen where you can adjust system settings 3 1 2 3 5 4 1 5 4 SERVICE ADDRESS Ackermann Instrumente GmbH Eisenbahnstr 65 67 78604 Rietheim Weilheim Germany Phone 49 0 7461 966 17 0 Fax 49 0 7461 966 17 70 E Mail info ackermanninstrument...

Page 19: ...press the digits to complete the time If you want to reset this information press the button Settings On this screen you can set The device language FR EN TR DE IT ES AR DK NO NL RU SV JA NL TH CN PL Programming of the camera head buttons S3 and S4 namely Zoom or LED Frequency Frame speed Restore the device to its factory settings 5 4 2 5 4 3 Connect the camera head connector C8 to the control cha...

Page 20: ...n Button s3 AnD s4 settInGs Short press LeD by default or Zoom Short press LeD by default or Zoom long press aWB Short press Photo capture double press Flexible mode shuttInG DoWn the DevICe You are recommended to put the device into standby before switching it off To do that press the button provided for that purpose at the top right of the screen Then operate the switch on the back of the device...

Page 21: ... demineralised water is recommended for the cleaning and rinsing of all devices This device is not autoclavable Always disconnect the device before cleaning Decontaminationislinkedtotheproducts methodsand ortoolsselected itremainsthesoleresponsibility of the personnel concerned After every use Clean any possible splashes of liquid from the control unit removing them with a lightly dampened cloth T...

Page 22: ...r date Any deviation from the recommended cleaning and sterilisation settings must be approved by the user Preparation prior to cleaning Place the devices in containers and allow to soak for a maximum of one hour in a pH neutral pH 6 0 to 8 0 enzymatic cleaning solution Cidezyme 0 8 at room temperature 20 C 2 C 60 F 3 F for 4 minutes or the equivalent diluted to the appropriate concentration in ac...

Page 23: ...nteractions between the material and chemical products arising from different cleaning and sterilisation processes Instructions on cleaning devices Wear protective gloves clothing and a mask during the cleaning of contaminated devices Do not place cameras in an ultrasonic cleaner 1 Immerse the device in a cold circulating water bath for 5 minutes and agitate non rigid components 2 Brush the exteri...

Page 24: ...e instrument trays in the sterilisation chamber These trays are specially designed for hydrogen peroxide vapour sterilisation Use only polypropylene sterilisation packaging and or polyolefine bags approved by the FDA Do not use paper bags or sterilisation envelopes containing wood pulp or cotton Comment The devices judged by Ackermann to be compatible with the STERRAD sterilisation process have be...

Page 25: ...s are specially designed for hydrogen peroxide vapour sterilisation Use only polypropylene sterilisation packaging and polyolefine bags approved by the FDA Do not use paper bags or sterilisation envelopes containing wood pulp or cotton Comment ThedevicesjudgedbyAckermanntobecompatiblewiththeSTERIS sterilisationprocesshavebeenapproved with a minimum of one hundred STERIS cycles Instructions for the...

Page 26: ... solutions containing 0 55 ortho phthalaldehyde e g Cidex OPA a 14 day solution Ackermann does not recommend the use of Cidex PLUS or other glutaraldehyde solutions at room temperature for periods of 28 days for manual high level disinfection because such solutions and agents containhighconcentrationsofsurfactants whichmaydryandcrystalliseondevicesiftheyarenotcarefully rinsed off Solutions contain...

Page 27: ...nn by email info ackermanninstrumente de by telephone 49 0 7461 966 17 0 via a request on the website www ackermanninstrumente de contact html Ackermann will at the request of technical personnel working for the network of approved dealers provide all information required to repair the faulty parts on which they may perform repairs After Sales Service Chapter 7 monitoring 7 1 7 2 Chapter 7 5 Onced...

Page 28: ... USB key Next try a different USB key If the message persists contact the manufacturer LED temperature LED Overheating LED problem Contact the manufacturer The equipment must be disinfected prior to return for repairs When returning the equipment check its condition and note down any anomalies on the shipping form as necessary Confirm those anomalies to the carrier by recorded letter within 48 hou...

Page 29: ...aration distances in this chapter must therefore be strictly observed The use of accessories of transducers and cables other than those specified or sold by Ackermann as replacement parts may have as a consequence an increase of emission or decreased immunity of the medical device and result in inadequate operation Cable length Electromagnetic compatibility Cables and accessories Maximum length Te...

Page 30: ...other devices to check that they are operating normally Electromagnetic emissions The medical device is designed for use in the electromagnetic environment described in the table below The user and or installer must therefore ensure that the medical device is used in the environment described below Emission test Conformity Electromagnetic environment comments Electromagnetic radiation disturbance ...

Page 31: ... 0 5 1 and 2 kV common mode Professional healthcare facility environment and home healthcare environment Magnetic field at rated industrial frequency IEC 61000 4 8 30 A m 30 A m Professional healthcare facility environment and home healthcare environment Voltage dips short interruptions and voltage variations IEC 61000 4 11 0 UT for 0 5 cycles At 0 45 90 135 180 225 270 and 315 0 UT for 1 cycle 70...

Page 32: ...Hz 80 MA at 1 kHz Nearby fields emitted by wireless RF communications devices IEC 61000 4 3 provisional method 9 V m 710 MHz 745 MHz 780 MHZ 5240 MHz 5550 MHz 5785 MHz 27 V m 385 MHz 28 V m 450 MHz 810 MHz 870 MHz 930 MHz 1720 MHz 1845 MHz 1970 MHz 2450 MHz 9 V m 710 MHz 745 MHz 780 MHZ 5240 MHz 5550 MHz 5785 MHz 27 V m 385 MHz 28 V m 450 MHz 810 MHz 870 MHz 930 MHz 1720 MHz 1845 MHz 1970 MHz 2450...

Page 33: ...nce Electrical supply 100 240 Vac 50 60 Hz Electrical power consumption 85 95 VA Two T1 6 A 250 V fuses UL CSA marked only Continuous operation Camera head 1 CMOS Exmor RTMnology 1 2 Full HD sensor 2 programmable buttons Automatic or adjustable electronic shutter 1 50 to 1 100 000 Resolution 1920 x 1080 p Definition 1080 lines Active pixel area 1920 x 1080 Cable length 2 99 metres Dimensions D x H...

Page 34: ...ironment and to human health symbol present on the device or in the accompanying documentation shows that this product cannot under any circumstances be processed as domestic waste It must therefore be disposed of at a waste centre designated for the recycling of electrical and electronic equipment For disposal please comply with current rules concerning waste disposal in the country of installati...

Page 35: ...of standards to which the manufacturers of medical devices must adhere as stated in standard IEC 62366 1 Applicable standards and Failure to comply with the recommendations provided by the manufacturer in this document and those suppliedsubsequentlyinwritten electronicorwhateverotherformwillrenderthewarrantynullandvoid The manufacturer shall be released from any liability including for direct or i...

Page 36: ...he latter is denoted by four figures For medical devices this symbol appears alongside the name and address of the manufacturer Data input and auxiliary output CF type device electronic or electrical equipment marketed aft er 13 08 2005 This symbol indicates that this product must not be processed with domestic waste Please read the user manual Upper and lower temperature limit of the medical devi...

Page 37: ...Page 37 40 User Manual 16 2009 Revision 01 20 by Ackermann L1 C1 C3 C2 S1 C6 I1 C7 C4 C5 D1 S2 F1 C8 S4 S3 ...

Page 38: ...Page 38 40 iNNOVATING TRADITION ...

Page 39: ...Page 39 40 User Manual 16 2009 Revision 01 20 by Ackermann ...

Page 40: ...Page 40 40 iNNOVATING TRADITION www ackermanninstrumente de User Manual 16 2009 Revision 01 20 ...

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