VIDAR Advantage Series Manuel utilisateur
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 2
© Copyright March 2021 by VIDAR Systems Corporation. All rights reserved.
NOTE
The digitizers do not include application specific software (Picture Archiving and Communications [PAC] system,
Teleradiology, Oncology Systems, or Computer Aided Detection [CAD] software). The manufacturer of the application
software will determine specific indications for use. These third-party software packages or complete systems are
approved separately from a regulatory perspective.
The digitizers are marketed as a component to application software development companies, who will incorporate the
digitizer into their respective PACS or Teleradiology, CAD system(s). The software developer is ultimately responsible
for detailing the Contraindications for the PACS System (or Teleradiology software package) or Oncology Systems as
a whole, including the digitizer.
365 Herndon Parkway
Herndon, VA 20170 U.S.A.
Sales: 1-800-471-7070 or
1-800-471-7226
Phone: 1-703-471-7070
Fax: 1-703-471-7665
Internet: www.vidar.com
Technical Support:
1-800-471-7070 or 1-703-471-7070
Emergo Europe
Prinsessegracht 20
2514 AP, The Hague
The Netherlands
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 3
Caution: No operator-serviceable parts inside. Refer servicing to qualified personnel.
Achtung: Gehäuse nicht öffnen. Wartung uno reparatur nur durch eletrofachkräfte.
Attention: Aucune piece ne peut etre remplacee par l’utilisateur. Toute operation de
maintenance doit etre effectuee par une personne qualiee.
Atencion: Acceso interno solo autorizado a personal tecnico cualificado.
Attenzione: Non appire. Rivolgersi a personale qualificado.
Radio Frequency Emissions
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the instruction manual,
may cause harmful interference to radio communications. Operation of this equipment in
a residential area can cause harmful interference, in which case the user will be required
to correct the interference at his or her own expense.
Product compliance testing was conducted using VIDAR shielded cables. Modifications
to the digitizer or the VIDAR shielded cables or the use of cables other than those
available from VIDAR could void the user’s authority to operate the equipment.
Storage/Shipping conditions
Temperature: –18° to +60°C (0° to +140°F)
Relative humidity: 20% to 85%, non-condensing
Atmospheric pressure: 500 to 1060hPa (+18,000 to –1,200ft)
Operating conditions
Temperature: 10°C to 35°C (50°F to 95°F)
Relative humidity: 20% to 85%, non-condensing
Atmospheric pressure: 696 to 1013hPa (10,000 to 0 ft)
Electrical supply
Voltage: 100 to 240 VAC
Current: 0.75 to 1.5 A
Frequency: 50 to 60 Hz
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 4
Safety and compliance information
MEDICAL –GENERAL MEDICAL EQUIPMENT AS TO ELECTRIC SHOCK, FIRE
AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH: CSA CAN/CSA-
C22.2 NO. 60601-1:14, IEC 60601-1:2005+A1:2012) Edition 3.1. ANSI/AAMI
ES60601-1: A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012.
Accessory equipment connected to the analog and digital interfaces must be certified
according to the respective IEC standards (i.e. IEC 60950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore all configurations shall comply
with the system standard IEC 60601-1-1 or IEC 60601-1 Edition 3.1.
Everybody who connects additional equipment to the signal input part or signal output
part configures a medical system, and is therefore responsible that the system complies
with the requirements of IEC 60606-1-1 or IEC 60601-1 Edition 3.1. If in doubt, consult
the technical services department or your local representative.
This product is rated for continuous use.
This product is in the Ordinary Equipment Class. It provides no protection against the ingress of water.
This product is not suitable for use in the presence of flammable anesthetic mixtures with air or with oxygen or
with nitrous oxide.
Class I Medical Device; No Applied Parts. This product provides Class I medical device protection against
electrical shock.
WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with
protective earth.
Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked
“HOSPITAL ONLY” or “HOSPITAL GRADE”.
WARNING: Do not modify this equipment without authorization of the manufacturer.
Do not position the product so that it is difficult access the disconnect switch (power switch) on the back of the
unit.
Mains power may be removed from the product by turning off the power switch on the back of the unit.
Power cords used with this device in North America must be rated by Underwriters Laboratories for hospital use.
Power cords used with this device in Europe must meet the requirements of IEC 227 Designation 53 or IEC 245
Designation 53.
Correct and safe operation of the digitizer requires familiarity with information
that is not marked on the product. The following symbols indicate that the
operator should consult the manual for additional information:
This Class 1 LED device is safe under reasonably foreseeable conditions of
operation.
The LED illumination system consists of 16 Class 1 LEDs, a mirror system to
spread the light, and a diffuser to distribute the light approximately uniformly
across an area of 2.4 sq in (15.5 sq cm). Light from the LED illuminator may be
indirectly observed in the digitizer’s film entry and exit areas.
5RA9
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 5
Contents
DiagnosticPRO®Advantage & DosimetryPRO®Advantage (Red) Installation Guide.....6
Intended Use .............................................................................................................................7
Notice to Users .........................................................................................................................8
Unpack.......................................................................................................................................9
1.Look for Damage ...................................................................................................9
2.Unpack the shipping carton .................................................................................10
3. Unpack the Accessory Box .....................................................................................11
4. Unwrap....................................................................................................................12
5. Identify the Components .........................................................................................13
6. If Anything Is Missing... ...........................................................................................14
7. Activate Your Product Warranty..............................................................................14
Setting Up.........................................................................................................................15
1.Identify Important Features ..................................................................................16
2.Assemble the Digitizer .........................................................................................17
3.Connect the Power Cord......................................................................................22
CAD PRO®Advantage Installation Guide ...........................................................................23
1. Look for Damage ....................................................................................................24
2. Unpack the Shipping Carton ...................................................................................25
3. Unpack the Accessory Box .....................................................................................26
4. Unwrap....................................................................................................................27
5. Identify the Components .........................................................................................29
6. If Anything Is Missing... ...........................................................................................29
7. Activate Your Product Warranty..............................................................................29
Setting Up.........................................................................................................................31
1.Identify Important Features ..................................................................................32
2.Assemble the Digitizer .........................................................................................33
3.Connect the Power Cord......................................................................................36
Device Driver Installation Guide...........................................................................................38
1. Apply Power to the Digitizer....................................................................................39
2. About the VIDAR Drivers ........................................................................................40
3. Install the VIDAR Drivers ........................................................................................40
Appendix: Electromagnetic Guidance .................................................................................47
Appendix: Symbols ...............................................................................................................51
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 6
DiagnosticPRO®Advantage
&
DosimetryPRO®Advantage (Red)
Installation Guide
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 7
Intended Use
VIDAR’s x-ray film digitizers are intended for making digital copies of medical x-ray films.
Note:
The DiagnosticPRO Advantage with ClinicalExpress or other DICOM standard software meet or
exceed ACR and DICOM standards for use of secondary capture images for consultation, review,
and final interpretation. Mammography images captured as DICOM MG are to be used as
reference or comparison only.
The target users of these devices are medical professionals or trained staff for use as secondary
capture images for consultation, review, and final interpretation.
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 8
Notice to Users
In the event of any serious incident occurring in relation to the device please report
to the manufacturer and the competent authority of the Member State in which the
user and/or patient is established.
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 9
Unpack
In this chapter, you will:
Unpack and inspect the digitizer’s parts.
Identify the digitizer’s parts.
1. Look for Damage
Before unpacking the Digitizer, examine the shipping carton for damage.
If the carton is damaged:
Notify the shipper immediately.
Take photographs of the damage.
Send pictures and description of damage to medtech@3dsystems.com.
Notify VIDAR Medical Support at 1-703-471-7070.
19195-001 Rev. J VIDAR Advantage Pro Series Digitizer Installation Guide 10
2. Unpack the shipping carton
IMPORTANT: Save all the packing materials. If you need to
ship the digitizer later, you should repack the digitizer in the
original materials by reversing the procedure described here.
Failure to properly pack, or failure to use VIDAR authorized
shipping materials, will void the product’s warranty, and will
likely result in costly repairs.
Remove items from the shipping carton in the order shown below.
1
Upper foam support
Feeder
Digitizer base
Accessory box
Shipping carton
Leave in box:
lower foam support
2
3
4
Note: For clarity, this
illustration does not show
the plastic bags surrounding
the digitizer and feeder.
Ce manuel convient aux modèles suivants
3
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