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

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

Bertaraf Gereksinimler .................................................................................................................................. 362
Avrupalı Bertaraf Gereksinimler.................................................................................................................... 362
Belirteçler için Kullanım................................................................................................................................. 363
Ek Uyarılar...................................................................................................................................................... 363

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