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

ESD Uzmanību ............................................................................................................................................... 244
Drošinātājs Etiķete......................................................................................................................................... 244
Potenciāls priekš Radio Biežums Iejaukšanās ieslēgts Ierīce Darbība........................................................... 244
Potenciāls priekš Radio un Televīzija Iejaukšanās......................................................................................... 245
Norādījumi Attiecībā uz Elektromagnētisks Emisijas un Imunitāte............................................................... 245
Drošība Piesardzības pasākumi ..................................................................................................................... 247
Atrašanās vieta Piesardzības pasākumi......................................................................................................... 248
Tīrīšana Piesardzības pasākumi..................................................................................................................... 249
Mediji Piesardzības pasākumi........................................................................................................................ 249
Kodonika Virtua Medicīniskā Attēls Skatītājs................................................................................................ 249
Medicīniskā un Pacients Informācija............................................................................................................. 250
Iznīcināšana Prasības..................................................................................................................................... 250
Eiropas Iznīcināšana Prasības ........................................................................................................................ 250
Indikācijas priekš Izmantot............................................................................................................................ 251
Papildu Brīdinājumi ....................................................................................................................................... 251
MT - Malti.............................................................................................................................................................. 253
Dokumentazzjoni Avviż ..................................................................................................................................... 253
Ħarsa ġenerali.................................................................................................................................................... 253
Speċifikazzjonijiet .............................................................................................................................................. 253
Prodott Informazzjoni........................................................................................................................................ 254
Twissijiet u Limitazzjonijiet ta ' Uża................................................................................................................... 254
Post ta ' Sigurtà u Konformità Tikketti........................................................................................................... 254
vultaġġ Twissija.............................................................................................................................................. 255
Laser Twissija................................................................................................................................................. 256
Konformità..................................................................................................................................................... 256
Serjali Numru, Konfigurazzjoni, Data Kodiċi, u Modifika Kodiċijiet............................................................... 256
ESD Attenzjoni ............................................................................................................................................... 257
Fjus Tikketta................................................................................................................................................... 257
Potenzjal għal Radju Frekwenza Interferenza fuq Apparat Operazzjoni....................................................... 257
Potenzjal għal Radju u Televiżjoni Interferenza ............................................................................................ 258
Gwida Rigward Elettromanjetiku Emissjonijiet u Immunità ......................................................................... 258
Sigurtà Prekawzjonijiet.................................................................................................................................. 260
Post Prekawzjonijiet ...................................................................................................................................... 261
Tindif Prekawzjonijiet.................................................................................................................................... 261
Midja Prekawzjonijiet.................................................................................................................................... 262

Kodonika Virtwa Mediku Immaġni Telespettatur ......................................................................................... 262
Mediku u Pazjent Informazzjoni.................................................................................................................... 263
Rimi Rekwiżiti ................................................................................................................................................ 263
Ewropew Rimi Rekwiżiti ................................................................................................................................ 263
Indikazzjonijiet għal Uża................................................................................................................................ 263
Addizzjonali Twissijiet.................................................................................................................................... 264
NL - Nederlands..................................................................................................................................................... 265
Documentatie Merk op ..................................................................................................................................... 265
Overzicht............................................................................................................................................................ 265
Specificaties....................................................................................................................................................... 265
Product Informatie ............................................................................................................................................ 266
Waarschuwingen en Beperkingen van Gebruik ................................................................................................ 266
Plaats van Veiligheid en Nakoming Etiketten................................................................................................ 266
Spanning Waarschuwing ............................................................................................................................... 267
Laser Waarschuwing...................................................................................................................................... 268
Nakoming....................................................................................................................................................... 268
Serieel Aantal, Configuratie, Datum Code, en Wijziging Codes .................................................................... 268
ESD Voorzichtigheid....................................................................................................................................... 269
Lont Label ...................................................................................................................................................... 269
Potentieel voor Radio Frequentie Interferentie Aan Apparaat Operatie ..................................................... 270
Potentieel voor Radio en Televisie Interferentie .......................................................................................... 270
De begeleiding Betreffende Elektromagnetisch Uitstoot en Immuniteit...................................................... 270
Veiligheid Voorzorgsmaatregelen ................................................................................................................. 272
Plaats Voorzorgsmaatregelen ....................................................................................................................... 273
Schoonmaak Voorzorgsmaatregelen ............................................................................................................ 274
Media Voorzorgsmaatregelen....................................................................................................................... 274
Codonics Virtua Medisch Beeld Kijker........................................................................................................... 275
Medisch en Geduldig Informatie................................................................................................................... 275
Verwijdering Voorwaarden ........................................................................................................................... 275
Europese Verwijdering Voorwaarden ........................................................................................................... 275
Indicaties voor Gebruik.................................................................................................................................. 276
Extra Waarschuwingen.................................................................................................................................. 276
NO - Norsk ............................................................................................................................................................. 278
Dokumentasjon Legge merke til........................................................................................................................ 278
Oversikt.............................................................................................................................................................. 278

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: WE[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 ().

Virtwa® u Virtua® XR
Mediku Diska Pubblikatur
MT - Malti
Dokumentazzjoni Avviż
Dan dokument huwa parti ta ' il UE MDR rekwiżiti. Il Kodonika Il-Prodott (i) Virtua® huma apparat mediku tal-
Klassi I maħsub għall-użu mill-Professjonisti tal-Kura tas-Saħħa. L-ippakkjar u t-tikkettar tal-prodott, inkluż l-
Interface tal-Utent Grafiku (GUI) għat-tħaddim huma offruti bl-Ingliż u jissodisfaw l-MDR, l-Anness I, il-Kapitolu III,
23.4, filwaqt li jqisu t-taħriġ u l-għarfien tal-utent potenzjali.
Web informazzjoni, Ewlenin Speċifikazzjonijiet, Maħsub Uża, Utent Manwal Appendices, Malajr Ibda Gwida u
Setup IFU (Istruzzjonijiet għal użu) huma disponibbli fi bażiku traduzzjoni għal Membru Stat Lingwi. Primarju IFU
huma disponibbli fi Ingliż.
Ħarsa ġenerali
Il Kodonika Virtua Medical Disc Publisher joffri veloċità eċċezzjonali, effiċjenza u faċilità ta 'użu f'reġistratur tad-
diska awtomatiku. Dan l-apparat mediku innovattiv huwa apparat tan-netwerk konformi mad-DICOM li jista
'jirrekordja u jittikkettja simultanjament studji mediċi multipli fuq midja CD u DVD. Id-disinn kompatt ta ’Virtua fih
proċessur inkorporat avvanzat, immaniġġjar ta’ diski robotiċi u interface touch screen faċli għall-utent li jtejjeb il-
fluss tax-xogħol u l-produttività. L-istampatur inkorporat jipproduċi tikketti ta ’diski brillanti u b’kulur sħiħ li jinkludu
demografija tal-pazjent u l-indirizz u l-logo tal-faċilità għall-kummerċ. Il-klijenti jistgħu joħolqu t-tikketti jew l-użu
tad-dwana tagħhom stessKodonika diska tikketta disinn servizz offruti esklussivament għal tagħna klijenti.
Speċifikazzjonijiet
Midja Inputs: Żewġ 50-diska input bins
Midja Produzzjoni: Waħda 25-diska produzzjoni bin
Ottiku Drives: Żewġ CD / DVD drives
Irrekordjabbli Formati: CD-R, DVD-R
Tikketta Stampa Teknoloġija: Inkjet
Stampa Riżoluzzjoni: Fuq għal 4800 dpi
Linka Skartoċċ: Waħda tri-kulur skartoċċ
Utent Interface: Integrat / li jista 'jinqala' 15 ” LCD tmiss iskrin u remoti web browser aċċess
Prestazzjoni:
Virtwa: Fuq għal 30 CDs kull siegħa, 15 DVDs kull siegħa (ibbażat fuq a tipiku kliniku studju u netwerk
konfigurazzjoni)
Virtwa XR: Fuq għal 62 CDs kull siegħa, 31 DVDs kull siegħa (ibbażat fuq a tipiku kliniku studju u netwerk
konfigurazzjoni)
Proċessur: Intel® Celeron® G3900
Memorja: 4 GB

Dejta Ħażna: 120 GB
Interface: 10 / 100Base-T / Gigabit Ethernet (RJ-45)
Netwerk Protokolli:
DICOM Aħżen SCP (up għal 24 simultanju konnessjonijiet)
DICOM mistoqsija / irkuprata (mhux obbligatorju)
HTTP Web Server (għal remoti kontroll u konfigurazzjoni)
Intelliġenti Issuq: USB flash issuq għal ħażna konfigurazzjoni dejta
Qawwa: Universali Input: 100-240VAC, 50/60 Hz, 300VA (ratata qawwa)
Dimensjonijiet: 26.7“ (67.8 cm) H, 19.2 " (48.6 cm) W, 26.7 " (67.8 cm) L
Piż: 60 lbs. (28 kg.)
Regolatorju: Sħiħ mediku apparat konformità inkluż Klassi 2 FDA u Klassi 1 MDR 2017/745 / UE (CE), GMP / QSR,
ISO13485: 2016 / NS-EN ISO13485: 2016, Elettriku Sigurtà IEC 60601-1 Ed. 3.1 u EMC / EMI: FCC Klassi B u IEC
60601-1-2: Ed. 4 għal Professjonali Kura tas-saħħa Faċilitajiet.
Prodott Informazzjoni
Għal tekniku għajnuna ma ' il Virtwa, sejħa Kodonika Tekniku Appoġġ fi il wara numru:
Telefon:[phone]
Pedaġġ Ħielsa:800.444.1198 (L-ISTATI UNITI biss)
Tekniku Appoġġ huwa disponibbli ghaċ. Tekniku Appoġġ huwa ukoll disponibbli online permezz email u il
Kodonika web sit:
Email:[e-mail]
Web Sit:www.codonics.com
Ġenerali prodott informazzjoni jista ' ukoll tkun mitluba minn tibgħat email lil:
Email:[e-mail]
Jekk jogħġbok jinkludu tiegħek postali posta indirizz u telefon numru fi il email messaġġ. Bażiku prodott
informazzjoni huwa lura permezz email sakemm inkella mitluba.
Twissijiet u Limitazzjonijiet ta ' Uża
Post ta ' Sigurtà u Konformità Tikketti
Il wara figuri juru il postijiet ta ' il tal-imager sigurtà u konformità tikketti.
Post ta ' konformità tikketta fi quċċata ta ' Kontrollur

Post ta ' konformità tikketta fi fuq wara ta ' Reġistratur
Post ta ' ESD tikketti fi fuq wara ta ' Kontrollur (Uri driegħ mhux mehmuża)
vultaġġ Twissija
Il exclamation punti ġewwa an ekwilaterali trijanglu u persuna qari a manwali simbolu huma maħsuba għal twissija
il utent għal il preżenza ta ' importanti joperaw u manutenzjoni (manutenzjoni) istruzzjonijiet fi il letteratura
akkumpanjament dan apparat.
LE SERVIZZABBLI MINN UŻU PARTIJIET ĠEWWA. REFERENZA SERVIZZ LE KWALIFIKAT SERVIZZ
PERSONAL. TNEĦĦIJA OF TIKKETTI, KOPERTURI, JEW KAXXA Qafliet VOIDS IL GARANZIJA.
TWISSIJA Agħmel mhux immodifika dan tagħmir mingħajr awtorizzazzjoni ta ' il manifattur
DAN APPARAT GĦANDU BE ELETTRIKAMENT MALTA.
LE PREVENI NAR JEW XOKK PERIKLU, DO MHUX JESPONU DAN IMMAĠINATUR LE XITA JEW UMDITÀ.
TWISSIJA Il qawwa korda tapp huwa il prinċipali skonnettja għal il apparat. Il qawwa iżbokk għandu tkun qrib il
apparat u tkun faċilment aċċessibbli.
TWISSIJA Neħħi il qawwa korda tapp minn il qawwa iżbokk għal skonnettja ġenerali qawwa għal il apparat.
TWISSIJA L-ert affidabilità jista ' tkun miksuba biss meta dan tagħmir huwa konnessi għal an ekwivalenti ta
reċipjent immarkat “Sptar Biss ” (dak huwa, “Sptar Grad ”).
TWISSIJA Lil evita riskju ta ' elettriku xokk, dan tagħmir għandu biss tkun konnessi għal a provvista mejns ma '
protettiva art.
TWISSIJA Agħmel mhux tmiss a pazjent waqt ukoll aċċess Virtwa intern komponenti dak huma taħt il quddiem
għata.

TAGĦMIR MA JINTUŻAX BĦALA KOMPONENT TA 'SISTEMA TA' SOSTENN TAL-ĦAJJA. Apparat jew sistemi
ta 'appoġġ għall-ħajja huma apparat jew sistemi li jsostnu jew isostnu l-ħajja, u li n-nuqqas tagħhom li jwettaq jista'
jkun raġonevolment mistenni li jirriżulta f'korriment sinifikanti jew mewt lil persuna. Komponent kritiku huwa
kwalunkwe komponent ta ’apparat jew sistema ta’ sostenn tal-ħajja li n-nuqqas li twettaq jista ’jkun raġonevolment
mistenni li jikkawża l-falliment tal-apparat jew tas-sistema ta’ sostenn tal-ħajja, jew li jaffettwa s-sikurezza jew l-
effettività tagħha.
Laser Twissija
Il Kodonika Virtua Medical Disc Publisher fih diode tal-lejżer fl-unità Recorder ta ’klassi ogħla minn 1. Biex tkun
żgurata sigurtà kontinwa, ma tneħħi l-ebda għata jew tipprova tikseb aċċess għal ġewwa tal-prodott. Irreferi l-
manutenzjoni kollha lil persunal ikkwalifikat. It-tikketta li ġejja tidher ġewwa l-unità tiegħek:
KLASSI 1 LASER PRODOTT LASER KLASSE 1
Konformità
Il Konformità tikketta għal il Virtua-2 mudell, liema huwa imwaħħal għal il quċċata ta ' il Kontrollur huwa murija
hawn taħt. Il qawwa konsum ta ' il Kontrollur u Reġistratur huwa indikat minn il qawwa swiċċ ta ' kull wieħed
apparat. Il qawwa konsum ta ' il sistema huwa il magħquda konsum ta ' il Kontrollur u Reġistratur.
Konformità tikketta għal Virtua-2 mudell
Serjali Numru, Konfigurazzjoni, Data Kodiċi, u Modifika Kodiċijiet
Il serjali numru tikketta huwa mqiegħda fuq il konformità tikketta. Serjali numru tikketti huma ukoll jinsabu fi il
quddiem ta ' il Reġistratur u Kontrollur, wara il produzzjoni bin.
Il serjali numru tikketta tinkludi il wara informazzjoni:
Il serjali numru (SN), liema unikament jidentifika il unità.
Il konfigurazzjoni numru (CN), liema dettalji il tibni konfigurazzjoni.
Il modifiki kodiċi, liema huma għal il dritt ta ' il NM numru u huma a serje ta ' 20 numri. Meta kwalunkwe ta ' dawn
numri huma imblukkata barra, dak jidentifika a modifika dak kien magħmula għal il unità.
Il data kodiċi fi SSSS-XX format hawn taħt il fabbrika data kodiċi simbolu.

Serjali numru tikketta
ESD Attenzjoni
Konnessjonijiet għal oħra biċċiet ta ' tagħmir huma magħmula fi il fuq wara ta ' il Kodonika Virtua Medical Disc
Publisher. Dawn il-konnetturi huma mmarkati b'simbolu ta 'twissija ESD ta' prekawzjoni, kif muri hawn taħt.
Tmissx xi pin tal-konnetturi. Meta tagħmel konnessjonijiet mal-apparat, l-aħjar isir waqt li l-apparat ikun imdaħħal
iżda mhux mixgħul. L-ESD jista 'jikkawża imġieba erratika tal-apparat meta jkun mixgħul. Jekk dan iseħħ, l-
enerġija għall-apparat jista 'jkollha tiġi ċiklata. Huwa rrakkomandat li l-impjegati kollha involuti biex jagħmlu
konnessjonijiet mat-tagħmir ikunu konxji ta 'dawn il-prekawzjonijiet ESD.
ESD tikketti fi fuq wara ta ' Kontrollur
Fjus Tikketta
Il fjus tikketta huwa jinsabu taħt il Kontrollur fuq wara konnettur panel.
Fjus tikketta fi fuq wara ta ' Kontrollur
Potenzjal għal Radju Frekwenza Interferenza fuq Apparat Operazzjoni