Codonics Virtua User manual

Table of Contents
EN - English.............................................................................................................................................................. 22
Documentation Notice ........................................................................................................................................ 22
Overview.............................................................................................................................................................. 22
Specifications....................................................................................................................................................... 22
Product Information............................................................................................................................................ 23
Warnings and Limitations of Use......................................................................................................................... 23
Location of Safety and Compliance Labels...................................................................................................... 23
Voltage Warning.............................................................................................................................................. 24
Laser Warning.................................................................................................................................................. 25
Compliance...................................................................................................................................................... 25
Serial Number, Configuration, Date Code, and Modification Codes............................................................... 25
ESD Caution ..................................................................................................................................................... 26
Fuse Label........................................................................................................................................................ 26
Potential for Radio Frequency Interference on Device Operation.................................................................. 26
Potential for Radio and Television Interference.............................................................................................. 26
Guidance Regarding Electromagnetic Emissions and Immunity..................................................................... 27
Safety Precautions........................................................................................................................................... 29
Location Precautions ....................................................................................................................................... 30
Cleaning Precautions....................................................................................................................................... 30
Media Precautions........................................................................................................................................... 31
Codonics Virtua Medical Image Viewer........................................................................................................... 31
Medical and Patient Information .................................................................................................................... 32
Disposal Requirements.................................................................................................................................... 32
European Disposal Requirements ................................................................................................................... 32
Indications for Use........................................................................................................................................... 32
Additional Warnings........................................................................................................................................ 33
FR - Français............................................................................................................................................................. 34
Documentation Avis ............................................................................................................................................ 34
Aperçu ................................................................................................................................................................. 34
Caractéristiques................................................................................................................................................... 34
Produit Informations ........................................................................................................................................... 35
Mises en garde et Limites de Utilisation ............................................................................................................. 35
Lieu de Sécurité et Conformité Étiquettes ...................................................................................................... 35
Tension Avertissement.................................................................................................................................... 36

Izdelka Informacije ............................................................................................................................................ 329
Opozorila in Omejitve od Uporaba.................................................................................................................... 329
Lokacija od Varnost in Skladnost Nalepke..................................................................................................... 329
Napetost Opozorilo ....................................................................................................................................... 330
Laser Opozorilo.............................................................................................................................................. 331
Skladnost ....................................................................................................................................................... 331
Serijski Številka, Konfiguracija, Datum Koda, in Sprememba Kode............................................................... 331
ESD Previdno ................................................................................................................................................. 332
Varovalka Oznaka .......................................................................................................................................... 332
Potencial za Radio Pogostost Motnje na Naprava Delovanje ....................................................................... 332
Potencial za Radio in Televizija Motnje......................................................................................................... 333
Smernice Glede Elektromagnetni Emisije in Imuniteta................................................................................. 333
Varnost Previdnostni ukrepi.......................................................................................................................... 335
Lokacija Previdnostni ukrepi.......................................................................................................................... 336
Čiščenje Previdnostni ukrepi ......................................................................................................................... 336
Mediji Previdnostni ukrepi ............................................................................................................................ 337
Kodonika Virtua Medicinsko Slika Gledalec .................................................................................................. 337
Medicinsko in Bolnik Informacije .................................................................................................................. 338
Odstranjevanje Zahteve ................................................................................................................................ 338
Evropski Odstranjevanje Zahteve.................................................................................................................. 338
Indikacije za Uporaba .................................................................................................................................... 338
Dodatno Opozorila ........................................................................................................................................ 339
SV - Svenska........................................................................................................................................................... 340
Dokumentation Lägga märke till ....................................................................................................................... 340
Översikt.............................................................................................................................................................. 340
Specifikationer................................................................................................................................................... 340
Produkt Information.......................................................................................................................................... 341
Varningar och Begränsningar av Använda sig av............................................................................................... 341
Plats av Säkerhet och Överensstämmelse Etiketter...................................................................................... 341
Spänning Varning........................................................................................................................................... 342
Laser Varning................................................................................................................................................. 343
Överensstämmelse........................................................................................................................................ 343
Serie Siffra, Konfiguration, Datum Koda, och Modifiering Koder ................................................................. 343
ESD Varning ................................................................................................................................................... 344
Säkring Märka................................................................................................................................................ 344

Potential för Radio Frekvens Interferens på Enhet Drift............................................................................... 344
Potential för Radio och Tv Interferens .......................................................................................................... 345
Vägledning Angående Elektromagnetisk Utsläpp och Immunitet................................................................. 345
Säkerhet Försiktighetsåtgärder ..................................................................................................................... 347
Plats Försiktighetsåtgärder............................................................................................................................ 348
Rengöring Försiktighetsåtgärder................................................................................................................... 348
Media Försiktighetsåtgärder ......................................................................................................................... 349
Codonics Virtua Medicinsk Bild Visare .......................................................................................................... 349
Medicinsk och Patient Information............................................................................................................... 350
Förfogande Krav ............................................................................................................................................ 350
Europeiska Förfogande Krav.......................................................................................................................... 350
Indikationer för Använda sig av..................................................................................................................... 351
Ytterligare Varningar ..................................................................................................................................... 351
TR - Türkçe............................................................................................................................................................. 352
Dokümantasyon Farkına varmak....................................................................................................................... 352
Genel Bakış ........................................................................................................................................................ 352
Teknik Özellikler ................................................................................................................................................ 352
Ürün Bilgi ........................................................................................................................................................... 353
Uyarılar ve Sınırlamalar nın-nin Kullanım.......................................................................................................... 353
yer nın-nin Emniyet ve uyma Etiketler .......................................................................................................... 353
Voltaj Uyarı.................................................................................................................................................... 354
Lazer Uyarı..................................................................................................................................................... 355
uyma.............................................................................................................................................................. 355
Seri Numara, Yapılandırma, Tarih Kod, ve Değişiklik Kodlar ......................................................................... 355
ESD Dikkat...................................................................................................................................................... 356
Sigorta Etiket ................................................................................................................................................. 356
Potansiyel için Radyo Sıklık Girişim açık cihaz Operasyon............................................................................. 356
Potansiyel için Radyo ve Televizyon Girişim.................................................................................................. 357
Rehberlik İle ilgili olarak Elektromanyetik Emisyonlar ve Bağışıklık.............................................................. 357
Emniyet Önlemler.......................................................................................................................................... 359
yer Önlemler.................................................................................................................................................. 360
Temizlik Önlemler.......................................................................................................................................... 360
Medya Önlemler............................................................................................................................................ 361
Kodonik Virtua Tıbbi Resim Görüntüleyen.................................................................................................... 361
Tıbbi ve Hasta Bilgi......................................................................................................................................... 362

Virtua® and Virtua® XR
Medical Disc Publisher
EN - English
Documentation Notice
This document is part of the EU MDR requirements. The Codonics Virtua® Product(s) are Class I medical
devices intended for use by Healthcare Professionals. Product packaging and labeling, including Graphic User
Interface (GUI) for operation are offered in English and meet MDR, Annex I, Chapter III, 23.4, taking account the
training and the knowledge of the potential user.
Web information, Key Specifications, Intended Use, User Manual Appendices, Quick Start Guide and Setup IFU
(Instructions for use) are available in basic translation for Member State Languages. Primary IFU are available in
English.
Overview
The Codonics Virtua Medical Disc Publisher offers exceptional speed, efficiency and ease of use in an automatic
disc recorder. This innovative medical device is a DICOM-compliant network appliance that can concurrently
record and label multiple medical studies onto CD and DVD media. Virtua's compact design features an advanced
embedded processor, robotic disc handling and a user-friendly touch screen interface that optimizes workflow and
productivity. The built-in printer produces brilliant, full-color disc labels that include patient demographics and the
facility’s address and logo for marketing. Customers can create their own custom labels or use Codonics disc
label design service offered exclusively to our customers.
Specifications
Media Inputs: Two 50-disc input bins
Media Output: One 25-disc output bin
Optical Drives: Two CD/ DVD drives
Recordable Formats: CD-R, DVD-R
Label Print Technology: Inkjet
Print Resolution: Up to 4800 dpi
Ink Cartridge: One tri-color cartridge
User Interface: Integrated/detachable 15” LCD touch screen and remote web browser access
Performance:
Virtua: Up to 30 CDs per hour, 15 DVDs per hour (based on a typical clinical study and network configuration)
Virtua XR: Up to 62 CDs per hour, 31 DVDs per hour (based on a typical clinical study and network configuration)
Processor: Intel® Celeron® G3900
Memory: 4 GB
Data Storage: 120 GB
Interface: 10/100Base-T/Gigabit Ethernet (RJ-45)

Network Protocols:
DICOM Store SCP (up to 24 simultaneous connections)
DICOM query/retrieve (optional)
HTTP Web Server (for remote control and configuration)
Smart Drive: USB flash drive for storing configuration data
Power: Universal Input: 100-240VAC, 50/60 Hz, 300VA (rated power)
Dimensions: 26.7“ (67.8 cm) H, 19.2“ (48.6 cm) W, 26.7“ (67.8 cm) L
Weight: 60 lbs. (28 kg.)
Regulatory: Full medical device compliance including Class 2 FDA and Class 1 MDR 2017/745/EU (CE), GMP/QSR,
ISO13485:2016/NS-EN ISO13485:2016, Electrical Safety IEC 60601-1 Ed. 3.1 and EMC/EMI: FCC Class B and IEC
60601-1-2: Ed. 4 for Professional Healthcare Facilities.
Product Information
For technical assistance with the Virtua, call Codonics Technical Support at the following number:
Phone: [phone]
Toll Free: 800.444.1198 (USA only)
Technical Support is available anytime. Technical Support is also available online via email and the Codonics web
site:
Email: [email protected]
Web Site: www.codonics.com
General product information can also be requested by sending email to:
Email: [email protected]om
Please include your postal mailing address and telephone number in the email message. Basic product
information is returned via email unless otherwise requested.
Warnings and Limitations of Use
Location of Safety and Compliance Labels
The following figures show the locations of the imager’s safety and compliance labels.
Location of compliance label at top of Controller

Location of compliance label at rear of Recorder
Location of ESD labels at rear of Controller (Display arm not attached)
Voltage Warning
The exclamation points within an equilateral triangle and person reading a manual symbol are intended to alert
the user to the presence of important operating and maintenance (servicing) instructions in the literature
accompanying this device.
NO USER-SERVICEABLE PARTS INSIDE. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL.
REMOVAL OF LABELS, COVERS, OR ENCASEMENT FASTENERS VOIDS THE WARRANTY.
WARNING Do not modify this equipment without authorization of the manufacturer
THIS APPARATUS MUST BE ELECTRICALLY GROUNDED.
TO PREVENT FIRE OR SHOCK HAZARD, DO NOT EXPOSE THIS IMAGER TO RAIN OR MOISTURE.
WARNING The power cord plug is the main disconnect for the device. The power outlet should be near the
device and be easily accessible.
WARNING Remove the power cord plug from the power outlet to disconnect overall power to the device.
WARNING Grounding reliability can be achieved only when this equipment is connected to an equivalent
receptacle marked “Hospital Only” (that is, “Hospital Grade”).
WARNING To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
WARNING Do not touch a patient while also accessing Virtua internal components that are under the front cover.
EQUIPMENT IS NOT TO BE USED AS A COMPONENT OF A LIFE SUPPORT SYSTEM. Life support devices or
systems are devices or systems that support or sustain life, and whose failure to perform can be reasonably

expected to result in a significant injury or death to a person. A critical component is any component of a life
support device or system whose failure to perform can be reasonably expected to cause the failure of the life
support device or system, or to affect its safety or effectiveness.
Laser Warning
The Codonics Virtua Medical Disc Publisher contains a laser diode in the Recorder unit of a class higher than 1.
To ensure continued safety, do not remove any covers or attempt to gain access to the inside of the product.
Refer all servicing to qualified personnel. The following label appears inside your unit:
CLASS 1 LASER PRODUCT LASER KLASSE 1
Compliance
The Compliance label for the Virtua-2 model, which is affixed to the top of the Controller is shown below. The
power consumption of the Controller and Recorder is indicated by the power switch of each device. The power
consumption of the system is the combined consumption of the Controller and Recorder.
Compliance label for Virtua-2 model
Serial Number, Configuration, Date Code, and Modification Codes
The serial number label is placed onto the compliance label. Serial number labels are also located at the front of
the Recorder and Controller, behind the output bin.
The serial number label includes the following information:
The serial number (SN), which uniquely identifies the unit.
The configuration number (CN), which details the build configuration.
The modifications codes, which are to the right of the CN number and are a series of 20 numbers. When any of
these numbers are blocked out, that identifies a modification that was made to the unit.
The date code in YYYY-MM format below the factory date code symbol.
Serial number label

ESD Caution
Connections to other pieces of equipment are made at the rear of the Codonics Virtua Medical Disc Publisher.
These connectors are marked with a precautionary ESD warning symbol, as shown below. Do not touch any of
the pins of these connectors. When making connections to the device, it is best done while the device is plugged
in but not powered on. ESD may cause erratic behavior of the device when powered on. Should this occur, power
to the device may have to be cycled. It is recommended that all staff involved in making connections to the device
be aware of these ESD precautions.
ESD labels at rear of Controller
Fuse Label
The fuse label is located beneath the Controller rear connector panel.
Fuse label at rear of Controller
Potential for Radio Frequency Interference on Device Operation
Both portable and mobile RF communications equipment can affect medical electrical equipment, including the
Codonics Virtua Medical Disc Publisher. Keep such RF communications equipment out of the immediate area.
Potential for Radio and Television Interference
The Codonics Virtua Medical Disc Publisher generates and uses radio frequency energy, and if not installed and
used properly, that is, in strict accordance with the manufacturer’s instructions, may cause interference to radio
and television reception. Do not change the Display refresh rate, which is set for 75 Hz. The device has been type
tested and found to comply with Class B emission limits for a computing device in accordance with the
specifications in Subpart J of Part 15 of FCC Rules, which are designed to provide reasonable protection against
such interference when operating in a commercial environment. Operation of the equipment in a residential area

is likely to cause interference, in which case the user, at his own expense, will be required to take whatever
measures may be appropriate to correct the interference. If your device does cause interference to radio or
television reception, you are encouraged to try to correct the interference by one or more of the following
measures:
The main difference between this document and the last was that all bulleted lists have had the “List
Bullet” style applied. This is different than the “List Paragraph” style that is applied by default. With this
change bulleted lists are copied over properly.
Reorient the receiving antenna
Relocate the device with respect to the receiver
If necessary, you should consult Codonics Technical Support or an experienced radio/television technician for
additional suggestions. You may find the following booklet prepared by the Federal Communications Commission
helpful: How to Identify and Resolve Radio-TV Interference Problems. This booklet is available from the U.S.
Government Printing Office, Washington, D.C. 20402, Stock No. 004-000-00345-4.
This product is in conformity with the protection requirements of EC Council directive 89/336/EEC on the
approximation of the laws of the Member States relating to electromagnetic compatibility. This product satisfies
the Class B limits of EN55011. A declaration of conformity with the requirements of the Directive has been signed
by the Director of Quality Assurance and Regulatory Affairs.
Guidance Regarding Electromagnetic Emissions and Immunity
Suitable Environments:
The Codonics Virtua Medical Disc Publisher is intended for use in professional healthcare facility environments,
including hospitals and medical clinics.
The Codonics Virtua Medical Disc Publisher has not been evaluated for use near HF surgical equipment. If use
near HF surgical equipment is desired, the user is responsible for verifying proper operation of the Virtua. If
Virtua does not perform correctly in this environment, move the Virtua farther from the source of the
electromagnetic disturbance.
The Codonics Virtua Medical Disc Publisher has not been evaluated for use in emergency medical vehicles.
As a support device, the Codonics Virtua Medical Disc Publisher does not provide essential performance.
WARNING Use of this equipment adjacent to or stacked with other equipment should be avoided because it could
result in improper operation. If such use is necessary, this equipment and the other equipment should be
observed to verify that they are operating normally
WARNING Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.
WARNING Portable RF communications equipment (including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches) to any part of the Virtua, its cables, or accessories.
Otherwise, degradation of the performance of this equipment could result.
Electromagnetic Emissions Standards and Test Levels:

Electromagnetic Immunity Standards and Test Levels:

Safety Precautions
Never connect this device to any outlet or power supply that has a voltage or frequency different than that
specified and set on the rear of the device.
When servicing the device, always power it off using the green soft power button on the Controller front panel,
turn the hard power switches at the rear of the Controller and Recorder to the 0 (off) position, then unplug the
device.
Damage to the power cord may cause fire or shock hazard. When unplugging the power cord, hold it by the plug
only and remove the plug carefully.

If the power cord needs to be replaced, replace it only with another Codonics power cord manufactured
specifically for your power configuration.
If the device is smoking or making unusual sounds, power off and unplug the device immediately.
Do not insert foreign objects of any kind into the device; doing so can constitute a safety hazard and cause
extensive damage.
Do not place any liquid containers on the device. If, for some reason, liquid seeps into the device, power off the
device and unplug the power cord from the source outlet. If used without corrective measures, the device may
be damaged.
Do not use the device near flammable gases.
Location Precautions
The device’s operating ambient temperature range is 15–30ºC (59–86ºF), with a relative humidity of 20%–80%.
If the device is moved quickly from an extremely cold place to a warmer one, condensation is likely to form. Do
not use the device if condensation has formed. Wait until the condensation has evaporated. You can speed up
the evaporation time by moving the device to a drier location.
Ventilation slots and holes are provided on the sides and rear of the device. Place the device on a level, stable
surface and locate it at least 10 cm (4 in.) from walls to ensure proper ventilation.
WARNING: Adequate ventilation is required for proper operation of the device.
Do not place device in a high humidity or high dust area. Airborne dirt particles can cause interference with the
operation of the device. Avoid placing the device in areas where ventilation ducts, open doors, or frequent
passers-by might expose the device and media to high levels of debris.
Do not locate the device in hot-springs areas where hydrogen sulfide and acidic ions are likely to be generated.
Do not locate the device where there are oily fumes and vapors.
Do not locate the device in direct sunlight.
Do not locate device near sources of high RF energy.
Do not locate the device where it might be subject to jarring or vibrations, such as a table or desk in a high-
traffic area. Jarring and vibrations can affect the recording and labeling of discs.
Cleaning Precautions
Many plastic components are used in the device’s construction. Coat flecking and deformation is likely to occur
if the device is wiped with chemical dusters, benzene, thinners, insecticides, or other solvents. Rubber and PVC

materials left in contact with the device for extended times will cause damage. Never use petroleum-based
solutions or abrasive cleaners.”
To clean the device cover, first power off the device using the green soft power button on the Controller front
panel, turn the hard power switches at the rear of the Controller and Recorder to the 0 (off) position, then
unplug the device. Clean the cover with a soft cloth slightly moistened with a mild soap and water solution.
Allow the cover to completely dry before operating the device again.
To clean the Display’s touch screen, use a mild soap and water mixture. Always apply the soap and water
mixture to a clean cloth or towel first and then clean the screen. Liquid applied directly to the Display could
possibly leak inside the device and cause damage.
Do not use alcohol. The touch screen can be damaged if cleaned with alcohol.
Media Precautions
Discs with the word “reject” or a reject icon printed on the label have failed to record properly and should be
destroyed or disposed of to ensure the confidentiality of patient medical information.
Unwanted discs should be destroyed or disposed of to ensure the confidentiality of patient medical information.
Only use Codonics-recommended discs to ensure compatibility with the recording and labeling system of the
device. Contact Codonics Customer Service for a current list of recommended discs and suppliers.
Only use Codonics-recommended ink cartridges to ensure proper operation of the device and proper labeling of
the disc. Contact Codonics Customer Service for a current list of recommended ink cartridges and suppliers.
Never refill ink cartridges as this can cause damage to the mechanism of the device and cause improper labeling
of discs.
Recorded discs should be stored in protective cases or sleeves when not in use to protect from scratches and
contamination that can interfere with data retrieval and label legibility.
Do not subject recorded discs to prolonged exposure to sunlight, ultraviolet light, or extreme heat as this can
interfere with data retrieval and label legibility.
Codonics Virtua Medical Image Viewer
The Codonics Virtua Medical Image Viewer is not intended for diagnostic use. The viewer is provided for
reference use only as a post-diagnostic tool.
Image quality can vary greatly from system to system based on the age, quality, and resolution of the display
device (monitor or LCD display), graphics card, cabling, and ambient light conditions.

Medical and Patient Information
Virtua log files might contain patient information. Use caution when distributing log files.
CD and DVD media are not intended to be used as the only method for archiving medical information. An overall
strategy for archiving medical information that includes CD or DVD media must ensure that multiple copies of
the information be stored at multiple locations. Media quality, handling, and storage conditions are important
factors that must be considered.
Disposal Requirements
Disposal of this product and consumables shall be in accordance with all applicable laws and regulations in effect
at the locality at the time of disposal. For additional information, refer to Appendix A of the User’s Manual,
Hazardous Material Information.
European Disposal Requirements
Codonics imagers and electronic accessory devices are not to be discarded or recycled; rather they are to be
returned to the manufacturer. Contact Codonics directly or by the link provided for the latest information
concerning:
Identification of the country specific Importer/Distributor/Producer
Product return and treatment of our electronic products
Manufacturer: Codonics Incorporated
17991 Englewood Drive
Middleburg Heights, OH 44130 USA
Phone: [phone]
Fax: [phone]
Email: W[email protected]
www.codonics.com
Codonics imagers and electronic accessory devices bearing the following symbol are subject to European
Directive on Waste Electrical and Electronic Equipment (WEEE) 2002/96/EC, amended by Directive
2003/108/EC. The EN 50419 symbol indicates separate collection and return required.
EN 50419 symbol
Indications for Use
Virtua Series devices are intended for digital medical image communication, processing, and storage. Functions
include transfer, “viewing client on CD/DVD” provision, storage, archive, recording, and labeling of CD/DVD
media. When configured, the ability to re-direct all or part of a radiographic study to Codonics Horizon Series

Medical Hardcopy Dry Imagers (Pre-market notification K021054) or other approved 892.2040 medical hardcopy
imager/printer is provided. Typical users of this system are trained professionals, including but not limited to
physicians, nurses, and technicians.
Additional Warnings
WARNING The shipping cartons are heavy. To avoid injury, use two people to unpack and position the
components.
WARNING When removing the Recorder, hold under the front and rear of the device. Do not lift device by the
foam packaging.
WARNING Before placing the Recorder on top of the Controller, make sure your fingers are not under the
Recorder to avoid pinching them.
WARNING Make sure that the voltage supply selection switches are set to the appropriate voltage for the
applicable country.
WARNING To avoid damaging the Display screen, keep the protective cover in place until assembly is complete.
WARNING The power cord plug is the main disconnect for the device. The power outlet should be near the
device and be easily accessible.
WARNING Remove the power cord plug from the power outlet to disconnect overall power to the device.
WARNING Grounding reliability can be achieved only when the equipment is connected to an equivalent
receptacle marked “Hospital Only” (that is, “Hospital Grade”).
WARNING To avoid risk of electrical shock, this equipment must only be connected to a supply main with
protective earth.
WARNING Before powering on the unit, make sure that the Recorder’s pick arm is not holding a disc. If it is,
remove the disc.
WARNING Do not touch the copper area of the cartridge print head.
WARNING The SmartDrive must be inserted for the device to operate. If the SmartDrive is not inserted, the
device can boot up but will not be able to process jobs. A message at the Display will prompt you to insert the
SmartDrive.
WARNING Discs that fail to record properly are either labeled with the word “Reject” or not labeled at all. These
discs should be destroyed to protect the confidentiality of patient data.
WARNING Discs that fail to record properly are either labeled with the word “Reject” or not labeled at all. These
discs should be destroyed to protect the confidentiality of patient data.
WARNING Deleting a job that is in-progress can result in a disc that is either labeled with the word “Reject” or not
labeled at all. These discs should be destroyed to protect the confidentiality of patient data.
WARNING Virtua log files might contain patient information. Use caution when distributing log files.
WARNING Always power off the device and disconnect the device’s power cords before cleaning. Resume
operation only after the surfaces are completely dry.
WARNING Run the Robotic Arm Calibration utility only when requested by Codonics Technical Support
personnel.
WARNING Initiate a remote access connection to Codonics only when requested by Codonics Technical Support
personnel.
WARNING System logs do not have the same user interface appearance and behavior as other screens. These
logs should not be accessed unless requested by Codonics Technical Support personnel.
WARNING Virtua log files might contain patient information. Use caution when distributing log files.
WARNING This device contains lead. Disposal of lead may be regulated due to environmental considerations.
For disposal or recycling information, please contact your local authorities or the Electronics Industry Alliance ().

Virtua® och Virtua® XR
Medicinsk Skiva Utgivare
SV - Svenska
Dokumentation Lägga märke till
Detta dokumentera är del av de EU MDR krav. De Codonics Virtuaprodukt (er) är medicinsk utrustning av klass I
avsedd att användas av vårdpersonal. Produktförpackning och märkning, inklusive grafiskt användargränssnitt
(GUI) för drift erbjuds på engelska och uppfyller MDR, bilaga I, kapitel III, 23.4, med hänsyn till utbildning och
kunskap för den potentiella användaren.
webb information, Nyckel Specifikationer, Avsedd Använda sig av, Användare Manuell Appendices, Snabbt Start
Guide och Uppstart OM DU (Instruktioner för använda sig av) är tillgängliga i grundläggande översättning för
Medlem stat språk. Primary OM DU är tillgängliga i engelsk.
Översikt
De Codonics Virtua Medical Disc Publisher erbjuder exceptionell hastighet, effektivitet och användarvänlighet i en
automatisk skivinspelare. Denna innovativa medicinska enhet är en DICOM-kompatibel nätverksapparat som
samtidigt kan spela in och märka flera medicinska studier på CD- och DVD-media. Virtuas kompakta design har
en avancerad inbäddad processor, hantering av robotskivor och ett användarvänligt pekskärmsgränssnitt som
optimerar arbetsflöde och produktivitet. Den inbyggda skrivaren producerar lysande skivetiketter i fullfärg som
inkluderar patientdemografi och anläggningens adress och logotyp för marknadsföring. Kunder kan skapa egna
egna etiketter eller användaCodonics skiva märka design service erbjuds uteslutande till vår kunder.
Specifikationer
Media Ingångar: Två 50-skiva inmatning soptunnor
Media Produktion: Ett 25-skiva produktion soptunna
Optisk Enheter: Två CD/ dvd enheter
Inspelningsbar Format: CD-R, DVD-R
Märka Skriva ut Teknologi: Bläckstråle
Skriva ut Upplösning: Upp till 4800 dpi
Bläck Patron: Ett trefärgad patron
Användare Gränssnitt: Integrerad / avtagbar 15 ” LCD Rör skärm och avlägsen webb webbläsare tillgång
Prestanda:
Virtua: Upp till 30 CD skivor per timme, 15 DVD-skivor per timme (baserad på a typisk klinisk studie och nätverk
konfiguration)
Virtua XR: Upp till 62 CD skivor per timme, 31 DVD-skivor per timme (baserad på a typisk klinisk studie och
nätverk konfiguration)
Processor: Intel® Celeron® G3900
Minne: 4 GB

Data Lagring: 120 GB
Gränssnitt: 10 / 100Base-T / Gigabit Ethernet (RJ-45)
Nätverk Protokoll:
DICOM Lagra SCP (upp till 24 samtidig anslutningar)
DICOM fråga / hämta (frivillig)
HTTP webb Server (för avlägsen kontrollera och konfiguration)
Smart Kör: USB blixt kör för lagring konfiguration data
Kraft: Universell Inmatning: 100-240VAC, 50/60 Hz, 300VA (betygsatt kraft)
Mått: 26.7“ (67,8 centimeter) H, 19,2 “ (48.6 centimeter) W, 26,7 “ (67,8 centimeter) L
Vikt: 60 kg (28 kg.)
Reglerande: Full medicinsk enhet efterlevnad Inklusive Klass 2 FDA och Klass 1 MDR 2017/745 / EU (CE), GMP /
QSR, ISO13485: 2016 / NS-EN ISO13485: 2016, Elektrisk Säkerhet IEC 60601-1 Ed. 3.1 och EMC / EMI: FCC Klass B
och IEC 60601-1-2: Ed. 4 för Professionell Sjukvård Faciliteter.
Produkt Information
För teknisk bistånd med de Virtua, ring upp Codonics Teknisk Stöd på de följande siffra:
Telefon:[phone]
Vägtull Fri:800.444.1198 (USA endast)
Teknisk Stöd är tillgängliga när som helst. Teknisk Stöd är också tillgängliga uppkopplad via e-post och de
Codonics webb webbplats:
E-post:[e-mail]
webb Webbplats:www.codonics.com
Allmän produkt information burk också vara begärda förbi sändning e-post till:
E-post:[e-mail]
Snälla du omfatta din post utskick adress och telefon siffra i de e-post meddelande. Grundläggande produkt
information är returnerad via e-post såvida inte annat begärda.
Varningar och Begränsningar av Använda sig av
Plats av Säkerhet och Överensstämmelse Etiketter
De följande siffror show de platser av de bilder säkerhet och efterlevnad etiketter.
Plats av efterlevnad märka på topp av Kontroller

Plats av efterlevnad märka på bak- av Inspelare
Plats av ESD etiketter på bak- av Kontroller (Visa ärm inte bifogad)
Spänning Varning
De utrop poäng inom en liksidig triangel och person läsning a manuell symbol är avsedd till varna de användare
till de närvaro av Viktig fungerar och underhåll (underhåll) instruktioner i de litteratur medföljande detta enhet.
NEJ ANVÄNDAR-SERVICEBAR DELAR INUTI. HÄNVISA UNDERHÅLL TILL KVALIFICERAD SERVICE
PERSONAL. BORTTAGNING AV ETIKETTER, TÄCK, ELLER INSLUTNING FÄSTARE TÖMMOR DE GARANTI.
VARNING Do inte ändra detta Utrustning utan tillstånd av de tillverkare
DETTA ANORDNING MÅSTE VARA ELEKTRISKT GRUNDAD.
TILL FÖRHINDRA BRAND ELLER CHOCK FARA, DO INTE ÖVERSIKT DETTA IMAGER TILL REGN ELLER
FUKT.
VARNING De kraft sladd plugg är de huvud koppla ifrån för de enhet. De kraft utlopp skall vara nära de enhet och
vara lätt tillgänglig.
VARNING Ta bort de kraft sladd plugg från de kraft utlopp till koppla ifrån övergripande kraft till de enhet.
VARNING Grundstötning pålitlighet burk vara uppnåtts endast när detta Utrustning är ansluten till en likvärdig
behållare markant "Sjukhus Endast" (det där är, "Sjukhus Kvalitet").
VARNING Till undvika risk av elektrisk chock, detta Utrustning måste endast vara ansluten till a tillförsel elnät
med skyddande jorden.
VARNING Do inte Rör a patient medan också åtkomst Virtua inre komponenter det där är under de främre
omslag.

UTRUSTNING FÅR INTE ANVÄNDAS SOM EN KOMPONENT I ETT LIVSSTÖDSSYSTEM. Livsstödsenheter
eller -system är enheter eller system som stöder eller upprätthåller liv, och vars misslyckande att prestera rimligen
kan förväntas leda till en betydande personskada eller dödsfall. En kritisk komponent är vilken komponent som
helst i en livsuppehållande anordning eller ett system vars misslyckande med prestanda rimligen kan förväntas
orsaka att livsuppehållande anordningen eller systemet misslyckas eller att den påverkar dess säkerhet eller
effektivitet.
Laser Varning
De Codonics Virtua Medical Disc Publisher innehåller en laserdiod i inspelningsenheten i en klass högre än 1. För
att säkerställa fortsatt säkerhet, ta inte bort några skydd eller försök att komma åt insidan av produkten. Överlåt
all service till kvalificerad personal. Följande etikett visas inuti din enhet:
KLASS 1 LASER PRODUKT LASER KLASSE 1
Överensstämmelse
De Överensstämmelse märka för de Virtua-2 modell, som är fäst till de topp av de Kontroller är visad Nedan. De
kraft konsumtion av de Kontroller och Inspelare är anges förbi de kraft växla av varje enhet. De kraft konsumtion
av de systemet är de kombinerad konsumtion av de Kontroller och Inspelare.
Överensstämmelse märka för Virtua-2 modell
Serie Siffra, Konfiguration, Datum Koda, och Modifiering Koder
De serie- siffra märka är placerad till de efterlevnad märka. Serie siffra etiketter är också belägen på de främre av
de Inspelare och Kontroller, Bakom de produktion soptunna.
De serie- siffra märka inkluderar de följande information:
De serie- siffra (SN), som unikt identifierar de enhet.
De konfiguration siffra (CN), som detaljer de bygga konfiguration.
De ändringar koder, som är till de rätt av de CN siffra och är a serier av 20 tal. När några av dessa tal är
blockerad ut, det där identifierar a modifiering det där var gjord till de enhet.
De datum koda i ÅÅÅÅ-MM formatera Nedan de fabrik datum koda symbol.

Serie siffra märka
ESD Varning
Anslutningar till Övrig bitar av Utrustning är gjord på de bak- av de Codonics Virtua Medical Disc-utgivare. Dessa
kontakter är märkta med en försiktighets ESD-varningssymbol, som visas nedan. Rör inte vid någon av stiften på
dessa kontakter. När du ansluter till enheten gör du det bäst när enheten är inkopplad men inte påslagen. ESD
kan orsaka felaktigt beteende hos enheten när den är påslagen. Om detta inträffar kan ström till enheten behöva
cyklas. Det rekommenderas att all personal som arbetar med att ansluta till enheten är medveten om dessa ESD-
försiktighetsåtgärder.
ESD etiketter på bak- av Kontroller
Säkring Märka
De säkring märka är belägen under de Kontroller bak- kontakt panel.
Säkring märka på bak- av Kontroller
Potential för Radio Frekvens Interferens på Enhet Drift