VIDAR DiagnosticPRO Edge User manual
Installation guide for
DiagnosticPRO™Edge
Windows 7, 8, & 10
Multi-film feeder
Serial numbers
380,000 to 389,999
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 2
© Copyright by November 2019 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
E-mail: [email protected]
19616-001 Rev. H DiagnosticPRO Edge Film 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 (60°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: 47 to 63 Hz
19616-001 Rev. H DiagnosticPRO Edge Film 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 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 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 to disconnect the product from the mains power supply.
Mains power may be removed from the product by disconnecting the power cable at the rear of the product. The
Mains power may also be disconnected by unplugging the power cord from the external power supply adapter or
unplugging the power cord from the wall outlet.
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 20 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
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 5
Contents
Intended Use .............................................................................................................................6
Notice to Users .........................................................................................................................7
Unpack the digitizer..................................................................................................................8
1.Look for damage...........................................................................................................8
2.Unpack the shipping carton..........................................................................................9
3.Identify the parts. ........................................................................................................12
Standard items............................................................................................................12
Optional items .............................................................................................................13
4.Identify important features..........................................................................................14
Power switch ...............................................................................................................14
Rear panel...................................................................................................................14
5.If anything is missing... ...............................................................................................15
6.Record important information and activate your product warranty.............................15
Assemble the digitizer............................................................................................................16
Place the digitizer on a table .................................................................................................19
Final assembly........................................................................................................................20
Connect the USB cable and power supply........................................................................20
Install the exit tray..............................................................................................................21
Install Device Drivers for Windows 7, 8, and 10..................................................................22
1. Apply Power to the Digitizer and the PC .......................................................................22
About the VIDAR Drivers...................................................................................................23
2. Install the VIDAR Drivers...............................................................................................23
Appendix: Electromagnetic guidance..................................................................................30
Appendix: Symbols ...............................................................................................................34
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 6
Intended Use
The DiagnosticPRO Edge digitizer is used for making digital copies of medical x-ray film, including
printed and radiographic film. The target users of these devices are medical professionals or trained staff
for use as secondary capture images for consultation, review and final interpretation.
The devices are indicated for the digitization of mammography images for review and analysis, but not as
the sole basis for screening or diagnosis.
Note:
The DiagnosticPRO Edge with ClinicalExpress or other DICOM standard
software meets or exceeds ACR and DICOM standards for use of secondary
capture images for consultation, review and final interpretation. Images
captured as DICOM MG are to be used as reference or comparison only, and
not for primary diagnosis.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 7
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.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 8
Unpack the digitizer
In this chapter, you will:
Unpack and inspect the digitizer’s parts.
Identify the digitizer’s parts.
1. Look for damage.
Before unpacking the DiagnosticPRO Edge film 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 [email protected].
Notify VIDAR Medical Support at 1-703-471-7070.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 9
2. Unpack the shipping carton.
IMPORTANT: Save all 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.
a. Remove the accessory box.
b. Lift the digitizer, feeder box and foam end caps—together—out of the shipping
container.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 10
c. Place the group on one foam end cap. Lift off the upper foam end cap.
d. Remove the feeder box from the lower end cap.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 11
e. Remove the digitizer from the lower end cap.
IMPORTANT: Save all 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.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 12
3. Identify the parts.
Check carefully to ensure you received the items listed below.
Standard items
Description (Note: items are not shown to same scale.)
DiagnosticPRO Edge
film digitizer
Multi-film feed tray
Film tray
Power Adapter. Contact
Service Provider or Vidar
Systems Corp for P/N
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 13
continued
Description (Note: items are not shown to same scale.)
Electrical power cord
China Power Cord, P/N 4635
Multi-film feed tray cable, VIDAR part number 4200-001
(if unit has multi-film feed tray)
Quick start guide card
VIDAR DiagnosticPRO Edge Installation CD
USB Cable, VIDAR part number 4618-002
Optional items
Description
Third-party software instructions (not supplied for the market in China)
Lint-free wipes, VIDAR part number 15194 (package of 10)
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 14
4. Identify important features
Look over the digitizer and locate the features shown in this section. You will need to
know where these features are when you assemble and operate the digitizer in later
chapters.
Power switch
The power switch is located on the front of the digitizer.
To turn digitizer ON:
Press and release power switch.
To turn digitizer OFF:
Press and hold for two seconds.
CAUTION: The digitizer power switch is used to disconnect the
24 volts from the external power adapter to the digitizer, and
therefore applies power to and removes power from the digitizer
only. The external power adapter is still a source of electrical
current as long as it is plugged into an electrical outlet.
Rear panel
View the digitizer from the rear to identify the USB port and power connector.
USB port
Power connector
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 15
5. If anything is missing...
6. Record important information and activate your product
warranty.
a. Locate the “Warranty information and
customer survey” form on the DiagnosticPRO
Edge CD.
b. Print the “Warranty information and customer
survey.”
c. In the “Product information” section, record
this information:
Product you are registering:
DiagnosticPRO Edge.
Digitizer serial number.
d. Complete the form.
e. Mail or fax the form to VIDAR Systems Corp.
If your digitizer needs service, this information should be on file at VIDAR.
Contact VIDAR Technical Support if you have any questions
about installing or using your VIDAR film digitizer:
Phone: 1-800-471-SCAN (1-800-471-7226)
1-703-471-7070 outside the U.S.
When you contact VIDAR, you will need to provide:
The unit’s serial number.
Your name, company and contact information.
Where you purchased the digitizer.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 16
Assemble the digitizer
1. Place the digitizer base on a table. Orient the digitizer base with the back toward you.
Notice the two slots on top of the digitizer base.
Slots
2. Orient the film feeder with the back toward you (multi-film feeder is shown; single-film
feeder is similar). You should be able to see the thumbscrew at the bottom rear of the
feeder.
Thumbscrew
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 17
3. Insert the tabs on the bottom of the feeder into the slots on the digitizer base.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 18
4. Tighten the thumbscrew to secure the feeder to the base.
5. Connect the multi-film feeder cable between the feeder and digitizer base as shown
below.
6. Go to “Placing the digitizer on a table,” the next chapter in this manual.
Thumbscrew
Multi-film feeder cable
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 19
Place the digitizer on a table
1. Select a working location for the film digitizer. Consider the following points when
selecting a suitable location:
The digitizer is not intended to be used in a Patient Environment.
The digitizer can only be used on a desk, countertop, table or other physically stable
surface not more than 36" (91cm) high.
SAFETY WARNING
The digitizer must be placed on mechanically secure horizontal
surface, such as a desk or countertop not more than 36" (91cm)
high and with no more than a 5° tilt.
The digitizer must not be placed on the floor.
VIDAR Systems Corp. is not liable for any damages or injuries
to persons or property associated with improper placement or
use of the digitizer.
The digitizer must be within 6 feet (1.8m) of an electrical outlet.
The USB cable must be able to connect to both computer and digitizer.
The digitizer must be away from high traffic areas.
2. Place the digitizer in the location you have selected. Ensure the digitizer is stable (for
example, it should not rock when touched).
3. Go to “Final assembly,” the next chapter in this manual.
19616-001 Rev. H DiagnosticPRO Edge Film Digitizer Installation Guide 20
Final assembly
Connect the USB cable and power supply
CAUTION: Power the digitizer only with the power supply
adapter provided by your Service Provider or Vidar Systems Corp.
1. Connect the USB cable to the USB port on the back of the digitizer. Do not connect the
USB cable to the PC until instructed later.
2. Connect the power adapter’s cable to the power connector on the back of the digitizer.
3. Connect the electrical cord to the power adapter.
4. Place the power adapter, power cable and electrical cord where they will not be a
hazard.
USB port
Power connector
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