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

Fjölmiðlar Varúðarráðstafanir ....................................................................................................................... 211
Codonics Virtua Læknisfræðilegt Mynd Áhorfandi ....................................................................................... 211
Læknisfræðilegt og Sjúklingur Upplýsingar ................................................................................................... 211
Förgun Kröfur ................................................................................................................................................ 212
Evrópskt Förgun Kröfur.................................................................................................................................. 212
Ábendingar fyrir Notaðu................................................................................................................................ 212
Viðbót Viðvaranir........................................................................................................................................... 213
IT - Italiano............................................................................................................................................................. 214
Documentazione Avviso.................................................................................................................................... 214
Panoramica........................................................................................................................................................ 214
Specifiche........................................................................................................................................................... 214
Prodotto Informazione...................................................................................................................................... 215
Avvertenze e Limitazioni di Uso ........................................................................................................................ 215
Posizione di Sicurezza e Conformità Etichette .............................................................................................. 215
Voltaggio avvertimento................................................................................................................................. 216
Laser avvertimento........................................................................................................................................ 217
Conformità..................................................................................................................................................... 217
Seriale Numero, Configurazione, Data Codice, e Modifica Codici ................................................................ 217
ESD Attenzione.............................................................................................................................................. 218
Fusibile Etichetta ........................................................................................................................................... 218
Potenziale per Radio Frequenza Interferenza su Dispositivo Operazione .................................................... 218
Potenziale per Radio e Televisione Interferenza........................................................................................... 219
Guida Per quanto riguarda Elettromagnetico Emissioni e Immunità............................................................ 219
Sicurezza Precauzioni .................................................................................................................................... 221
Posizione Precauzioni.................................................................................................................................... 222
Pulizia Precauzioni......................................................................................................................................... 223
Media Precauzioni......................................................................................................................................... 223
Codonics Virtua Medico Immagine Spettatore ............................................................................................. 223
Medico e Paziente Informazione................................................................................................................... 224
Disposizione Requisiti.................................................................................................................................... 224
europeo Disposizione Requisiti ..................................................................................................................... 224
Indicazioni per Uso ........................................................................................................................................ 225
Aggiuntivo Avvertenze................................................................................................................................... 225
LT - lietuvių kalba................................................................................................................................................... 227
Dokumentacija Pastebėti .................................................................................................................................. 227

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.