ACKERMANN 16-2009 User manual

ACKERMANN FUSION
Integrated Smart
Integrated Smart
Technology
Technology
User
Manual
16-2009
Ackermann
User Manual 16-2009 | Revision 01/20
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
local illumination of the patient’s body and to capture
images taken by health practitioners qualified
in diagnostic procedures or surgical endoscopy
procedures. «

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INNOVATING TRADITION.
Chapter
4CONTENTS
Chapter
Overview
Chapter
1
Chapter
2
Chapter
3
Chapter
4
Chapter
5
Chapter
6
Chapter
7
Chapter
8
Chapter
9
Chapter
10
Chapter
11
These operating instructions contain information that is subject to copyright.
All rights are reserved.
This manual should not be photo-copied, duplicated on microfilm or otherwise copied or distributed,
completely or in part, without the approval 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 12
Operating principle 14
Disinfection and sterilization 21
After-sales service and routine maintenance 27
Electromagnetic compatibility 29
Technical specifications 33
Disposal and recycling 34
Regulations and standards 35

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User Manual 16-2009 | Revision 01/20 by Ackermann
1.1
1.2
WARNING
!
ASSOCIATED DOCUMENTATION
Thank you for your confidence and for buying this equipment.
It is essential that you familiarise yourself with the contents of this manual. It will help you get the best out of
your equipment and ensure all necessary safeguards are in place.
We have tried to make this manual as straight forward as possible to help with installation and use of the
equipment. In addition, references are provided on page 37 of this manual. They look like this: [D1]. They will
help you view the relevant parts of the product more easily.
Note: UDI numbers: custom products have a dierent UDI from the one shown on the cover of this manual.
You will find it on the product label and labels on the packaging.
In this user manual, Ackermann does not use any text, brand names, pictures, figurative signs or 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.de as well, and not in printed format. If you do not get any answer immediately, please
be patient, our customer service will come back to you asap.
The electronic user instructions are available in PDF format (Portable Document Format). You will need to
have a PDF file read soware installed to read the electronic version of the user instructions. It is important
for you to have read and understood the content of the user instructions relating to the use of your device and
its accessories.
Do not use the device without first familiarising yourself with the instructions for use.
Quick Start
Lens user manual
E-Ifu consulating
The Quick Start document is a simplified summary designed to help you. The only oicial instructions are
the user manuals and the regulatory documents accompanying the medical device.
Chapter
1FOREWORD
Chapter
1

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iNNOVATING TRADITION.
As soon as you receive your device, you are asked to print and download all documents or sections of
documents that you may need to consult in the event of an emergency, if you are unable to connect to the
Internet or if your electronic display device (computer, tablet, etc.) stops working. We recommend that you
visit 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 its accessories for reference at a
later date. When loaning out or selling the medical device, the documentation must be provided with it.
Chapter
1

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User Manual 16-2009 | Revision 01/20 by Ackermann
2.1
2.1.1
2.2
REQUIRED INFORMATION
GENERAL INFORMATION
Note: following notice is only applicable for the United States of America.
United States Federal Law restricts the use of this medical device within its territory to health professionals
who are qualified, fit and certified, or to those under their control.
In the United States and Canada, the “Hospital Grade” power cord provided must be used, and it must be
connected to a “Hospital Grade” power socket.
CONTENTS
This product comprises the following medical devices:
One control channel
One Full HD camera head
One 24mm lens (optional)
One light cable (optional)
And the following accessories:
One USB key with the user manual
One EU or US power cord
One SDI video cable
Two light cable-device adaptors (Ackermann, Olympus and Storz fittings)
Universal light cable adaptors, source end (Ackermann, Storz fitting) and endoscope 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
control channel. It is designed to provide local illumination of the patient’s body and to capture images taken
by health practitioners qualified in diagnostic procedures or surgical endoscopy procedures (gynaecology,
laparoscopy, arthroscopy, ENT, urology or spinal endoscopy).
On the camera side, the DUO Full HD enables the user to relay images to a monitor and capture photos via the
camera head combined with the lens and endoscope.
On the LED light source side, the DUO Full HD has a 23,000 lux light source; this is equivalent to a 180 Watt
Xenon source. Light is sent from the DUO Full HD control unit along the light cable and then to the endoscope,
providing local illumination of the examination site.
Chapter
2
Chapter
2

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iNNOVATING TRADITION.
2.3
2.4
2.4.1
PRINCIPLE OF OPERATION
The lens, light cable (both optional) and camera head are sterilised in accordance with the manufacturer’s
user manual. The control unit is used outside the sterile field, unlike the proximal end of the camera head and
light cable.
A compatible lens is fitted to the DUO Full HD camera head and the light cable is equipped with compatible
adaptors at the two ends. The camera head and light cable are connected to the DUO Full HD control unit. The
other end of the light cable and camera head are connected to the endoscope. It is recommended to use a
sterile, single-use protective cover over the camera head and its cable for the duration of the procedure.
The diagnostic or surgical procedure may now be performed. The cavity is illuminated and video camera
images are displayed on the monitor screen. The images may be stored on a USB key connected to the front
of the DUO Full HD control unit.
USER POPULATION RECOMMENDATIONS
This medical device is intended for use by a skilled and capable surgeon qualified for endoscopy explorations.
This device may also be used by an assistant or nurse under the supervision of the practitioner.
This device is suitable for use in a professional healthcare facility environment.
Users must know and comply with the rules of endoscopy practice in compliance with knowledge acquired
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 lenses.
Infirmity of the upper limbs which could prevent manual manipulation of a hand-held device.
Hearing diiculties that could prevent the user hearing audible alarms depending on medical devices;
Diiculty in memorising or concentrating that could aect the setting of sequences or the performance of
treatment protocols.
USER POPULATION
CAMERA HEAD
The camera head included in the DUO Full HD unit is designed to relay the image captured at the examination
sitetoamonitorviathecontrolchannel.It isdesignedforusebyhealthpractitionersqualified indiagnosticsand
surgical endoscopy procedures (gynaecology, laparoscopy, arthroscopy, ENT, urology or spinal endoscopy).
The practitioner can also control the image settings using three buttons on the camera head: adjust the LED
brightness, or zoom in/out, correct the white balance, move from flexible to rigid mode and vice versa, and
capture photos. The camera head is designed for connection to the DUO Full HD control unit and to a rigid or
flexible endoscope via a lens (endoscope and lens not included). The camera head is equipped with a sterile
protective cover (not included) for the duration of the diagnostic/surgical procedure.
Chapter
2

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User Manual 16-2009 | Revision 01/20 by Ackermann
2.4.2
2.4.3
2.5.1
2.5
2.5.2
2.5.3
APPLIED PARTS
The camera and light cable are deemed to be applied parts within the meaning of the IEC 60601-1 standard.
It is recommended that a sterile disposable protective cover be used on the camera regardless of the chosen
sterilisation procedure and throughout the duration of the surgical procedure.
RECOMMENDED PATIENT POPULATION
This device must be used to support the health practitioner on individuals (patients) who are suitable to
undergo an endoscopy procedure.
This medical device is designed to be used with the following patient populations:
Children
Adolescents
Adults
Elderly persons
This medical device can be used irrespectively 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 soware.
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 whether or not to treat his/her patients.
PATIENT POPULATION RESTRICTION
APPLIED PARTS
The camera and light cable are deemed to be applied parts within the meaning of the IEC 60601-1 standard.
It is recommended that a sterile disposable protective cover be used on the camera regardless of the chosen
sterilisation procedure and throughout the duration of the surgical procedure.
2.6.1
2.6 BASIC SAFETY IN NORMAL USE
The normal usage conditions are as follows:
Storage
Installation
Use
Maintenance
Disposal
NORMAL USAGE CONDITIONS
Chapter
2

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iNNOVATING TRADITION.
2.62.6.2
2.7
BASIC PERFORMANCE
As stated in the applicable safety standard pertaining to electrical medical devices, the manufacturer has
determined that the medical device does not manage basic performance.
The active part, the camera head, is held by the practitioner 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 and sterilisation of the device will result in normal wear to the medical device.
Chapter
2
WARNING
!

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User Manual 16-2009 | Revision 01/20 by Ackermann
3.1 ELECTROMAGNETIC INTERFERENCE AND
ELECTROSTATIC DISCHARGE
3.2 USING ACCESSORIES NOT SUPPLIED BY THE
MANUFACTURER
3.3 CONNECTION AND DISCONNECTION OF ITEMS FROM
THE DEVICE DURING USE
Chapter
3
SAFETY INSTRUCTIONS
Although this product meets standards relating to EMC, it is possible under very specific circumstances that it
may cause interference to other devices, or that it may itself be aected by other devices or an unfavourable
electromagnetic environment.
To avoid such situations, you are recommended:
To ensure the electrical supply network is of good quality (particularly that all devices and trolleys are
earthed);
To keep the device away from sources of electromagnetic interference (e.g. compressor, motor, transformer,
HF generator etc.).
The medical device was designed and developed with its accessories or others oered 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 the product oered. Look out for
warning signs such as a lack of information, information in a foreign language, very attractive prices, suspect
appearance, mediocre quality or premature wear.
In the event of doubt, contact an approved dealer or the Ackermann aer-sales service team.
This includes information relating to the interactions, contraindications and prohibitions known by the
manufacturer on the date on which this document was written.
Parts of the device such as the camera or light cable may be connected and disconnected during use.
We recommend clicking the on/o button on the rear of the device before unplugging it.
Chapter
3

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iNNOVATING TRADITION.
3.4
3.5
3.6
Unplug the device from the mains supply if you have no plans to use if for a few days or longer.
To unplug the power cord, pull on the plug. Never pull on the cord itself.
Prior to each use, make sure the device does not have any rough surfaces, sharp edges or protuberances
which could lead to safety problems.
Check the compatibility of your endoscope with the manufacturer prior to use.
Devices which connect to the inputs/outputs must comply with the IEC 62368-1 standard.
To prevent any errors or delays in diagnosis, you must make sure that the settings on the monitor being
used are optimised for the procedure being performed, such that they will allow a clean, noise-free colour
image to be obtained.
You are recommended to use a sterile single-use protective cover on the camera throughout the procedure.
You are recommended to set up the device on a stable surface to prevent any risk of it falling.
PRECAUTIONS DURING USE
Do not insert metal objects into the device, to avoid any risk of electric shock, fire, short-circuit or hazardous
emissions.
Do not place heavy objects on top of it.
Do not place the device where it could be splashed with water, or in an excessively damp environment.
Do not use corrosive or abrasive products to clean the device, but only the disinfectant liquids recommended
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 camera head [C1].
Never look directly at the light outlet or the end of the light cable when the LED is on.
Do not place the furthest end of the light cable or the endoscope directly on the patientor on any other
flammable material (sheets, gauzes, surgical drapes etc.), as it may be very hot and could result in burns.
Do not obstruct the device’s ventilation openings.
Not suitable for use in the presence of a flammable anaesthetic mixture with air and oxygen or nitrous
oxide.
Do not use in an oxygen-rich environment.
Multiple-socket adaptors or extension leads must not be connected to the electromagnetic system.
RESTRICTIONS
There are no known contraindications 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).
CONTRAINDICATIONS
Chapter
3