Osko Edge Air 1417 Troubleshooting guide

USER & SERVICE
MANUAL
DIGITAL FLAT PANEL X-RAY DETECTOR
▐Edge Air1417 / 1417WCC

Preface
2/ 126 Edge Air 1417 / 1417WCC
Doc. No. : OK-RND-USM005-100 / OK-RND-SVM005-100
Rev. No.: draft
Date : 04.13.2020

Preface
Edge Air 1417 / 1417WCC 3/ 126
Preface
Please note that this information is for proper use and safety of the equipment. The following
symbols may indicate a hazardous situation in which, if not heeded, may result in serious injury
or even death to the user or others, or damage to the equipment.
Used to emphasize essential information.
Be sure to read this information to avoid incorrect operation.
WARNING
Indicates warning and safety instructions. If not adhered to, it could result in death or
serious injury to the user or others.
CAUTION
Indicates a hazardous situation which, if not heeded, may result in minor or moderate
injury to the user or others, or damage to the equipment.
For users in the United States:
United State federal law restricts this equipment to be used by or on the order of a
physician.
Since the X-ray exposure condition can be changed depending on the age, gender and
bone density of the patient, in case of Pediatric, X-ray exposure condition can be changed
by expert’s judge. For further information, please refer to FDA Pediatric X-ray Imaging web
page.
http://www.fda.gov/radiation-
emittingproducts/radiationemittingproductsandprocedures/medicalimaging/ucm298899.htm
For users in other countries:
This equipment is to be used by or on the order of a licensed person under the related laws
for each country.
Need a user language other then English, please contact the seller or the following contact
information.
Intended use:
Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general
radiographic system for human anatomy. It is intended to replace film or screen based
radiographic systems in all general purpose diagnostic procedures. Not to be used for
mammography.
VATECH Global France SARL
51 Quai de Dion Bouton, 92800, Puteaux, France
Tel. [phone], Fax [phone]
OSKO, INC.
8085 NW 90th Street, Miami, Florida, 33166 USA
www.OSKOMEDICAL.com

Contents
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Contents
Preface......................................................................................................................iii
Contents....................................................................................................................iv
PART I. User & Installation Manual 7
1. Safety Information ......................................................................................... 8
1.1 Safety Standard .................................................................................... 8
1.2 Symbols ..............................................................................................12
1.3 Warning ..............................................................................................14
1.4 Caution ...............................................................................................16
1.5 Safety Information ...............................................................................20
1.6 Label and Location of Attachment .........................................................22
1.7 Summary of usability specifications .......................................................22
2. Product Introduction and Specification ...........................................................23
2.1 Product Features..................................................................................23
2.2 Product Components............................................................................24
2.3 Part Names and Functions ....................................................................25
2.4 Part Specifications................................................................................29
2.5 Environmental Requirements ................................................................32
2.6 Dimensions (Unit: mm) ........................................................................33
3. Installation and Calibration ............................................................................37
3.1 Installation ..........................................................................................37
3.2 Calibration...........................................................................................77
4. Usage...........................................................................................................83
4.1 Set Up.................................................................................................83
4.2 Image Acquisition ................................................................................85
4.3 View Images........................................................................................87
4.4 Additional Function...............................................................................89
5. Maintenance...............................................................................................100
5.1 Cleaning............................................................................................100
5.2 Inspection .........................................................................................100
5.3 Replaceable Parts and Instruction of Replacement ...............................101
5.4 Disposal or Recycling..........................................................................102
6. Warranty ....................................................................................................103
6.1Warranty ...........................................................................................103
PART II. Service Manual 105

Contents
Edge Air 1417 / 1417WCC 5/ 126
1. Overview ....................................................................................................106
2. FPD Manager Instruction (IP, SSID Set Up / Firmware, FPGA Update).............107
2.1 Detector IP Address Set Up.................................................................107
2.2 SSID, PSK (Pre-Shared Key) Set Up.....................................................109
2.3 Firmware, FPGA Update......................................................................111
2.4 Set Windows Firewall to use FPD_Manager (For Win 7) ........................113
3. Multi Detector Set Up ..................................................................................115
4. Troubleshooting ..........................................................................................119
4.1 LAN Connection Issue.........................................................................119
4.2 Lost IP Address (Use one of the methods below) .................................121
4.3 Auto Trigger Mode..............................................................................123
Supplement.1 Generator Specification ......................................................................124

Contents
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PART I. User & Installation Manual
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PART I. User & Installation Manual
1. Safety Information...........................................8
2. Product Introduction and Specification........23
3. Installation and Calibration...........................37
4. Usage..............................................................83
5. Maintenance...................................................95
6. Warranty ......................................................103

PART I.User & Installation Manual
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1. Safety Information
1.1 Safety Standard
1.1.1 Medical Device Classification
Item Description
Classification by protection type against Electric Shock Class I or Internally Powered Equipment
Classification according to the degree of protection
against ingress of water IPX66
Mode of operation Continuous electromagnetic
Environment of Use This equipment is not suitable for use in the
presence of flammable anesthetic or oxygen.
IP66 does not mean completely waterproof, so use with caution. If the connector is
contaminated with liquids or foreign substances, clean and dry it sufficiently before use.
If you operate the equipment outside of recommended operating conditions, the
equipment may be damaged. This damage is not covered by warranty.
1.1.2 Regulations
1. Safety and Electromagnetic Compatibility Information
Item Description
IEC/EN/UL 60601-1 Medical electrical equipment
Part 1: General requirements for safety
IEC/EN 60601-1-2 Medical electrical equipment
Part 2: Electromagnetic compatibility-requirements and tests
This equipment has been tested and found to comply with the limits for medical devices in IEC
60601-1-2. These limits are designed to provide reasonable protection against harmful
interference in a typical medical installation.
FCC Interference Statement
This equipment has been tested and generates, uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may cause harmful
interference to radio communications. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and on, the user is
encouraged to correct the interference by one of the following measures: Reorient or relocate
the receiving antenna. Increase the separation between the equipment and receiver. Connect
the equipment into an outlet on a circuit different from which the receiver is connected. Consult
the dealer or an experienced radio/TV technician for help.

PART I. User & Installation Manual
Edge Air 1417 / 1417WCC 9/ 126
2. Radio Frequency compliance
FCC (For USA)
FCC ID: 2ALPQRYRWM001A
•5.15- 5.25 GHz band is restricted to indoor operations only.
•Host device of the approved module shall be marked with the following item:
•Compliance with FCC requirement 15.407(c)
Data transmission is always initiated by software, which is the passed down through the
MAC, through the digital and analog baseband, and finally to the RF chip. Several special
packets are initiated byte MAC. These are the only ways the digital baseband portion will
turn on the RF transmitter, which it then turns off at the end of the packet. Therefore, the
transmitter will be on only while one of the aforementioned packets is being transmitted. In
other words, this device automatically discontinues transmission in case of either absence
of information to transmit or operational failure.
FCC Compliance Statement
This device complies with part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
FCC CAUTION
Any changes or modifications not expressly approved by the party responsible for
compliance could void the user’s authority to operate the equipment. This transmitter must
not be co-located or operated in conjunction with any other antenna or transmitter.
When installing it in a mobile equipment
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment and meets the FCC radio frequency (RF) Exposure Guidelines in Supplement
C to OET65. This equipment has very low levels of RF energy that it deemed to comply
without maximum permissive exposure evaluation (MPE). But it is desirable that it should
be installed and operated keeping the radiator at least 20cm or more away from person’s
body (excluding extremities: hands, wrists, feet and ankles).
When you use the detector with wire mode, the wireless function is automatically off.
•5150-5250 MHz band is restricted to indoor operations only.
IC Notice (For CANADA)
IC: 22586-RWM001A
This Class Adigital apparatus complies with Canadian ICES-003
Host device of the approved module shall be marked with the following item: Contains
Transmitter Module Radio Certification No: 10742B - RWM001A
This device complies with Industry Canada license-exempt RSS standard(s). Operation is
subject to the following two conditions: (1) this device may not cause interference, and (2)
this device must accept any interference, including interference that may cause undesired
operation of the device.

PART I.User & Installation Manual
10 / 126 Edge Air 1417 / 1417WCC
Le present appareilest conforme aux CNR d'Industrie Canada applicables aux
appareilsradioexempts de licence.L'exploitationestautorisee aux deux conditions
suivantes : (1) l'appareil ne doitpasproduire de brouillage, et (2) l'utilisateur de l'appareildoit
accepter tout brouillageradioelectriquesubi, meme si le brouillageest susceptible
d'encompromettre le fonctionnement.
RED Notice (European Union)
The product compliance to the Directive 2014/53/EU as Radio Equipment.
5150-5250 MHz band is restricted to indoor operations only.
3. Electro-Magnetic Compatibility Information
Do not use mobile phones in the vicinity of this device. Use of mobile phones near this
device can cause errors in operation due to electromagnetic wave interference, so such
devices should be turned off in the vicinity of this device.
The use of accessories and cables other than those sold by OSKO Inc. as internal
components, may result in increased emissions or decreased electromagnetic immunity of
this device.
Do not use this device adjacent to or stacked with other devices. If adjacent or stacked use
is necessary, confirm normal operation in the configuration in which this device will be used.
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 Edge
Air 1417 / 1417WCC, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
NOTE: The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment
(for which CISPR 11 class B is normally required) this equipment might not offer adequate
protection to radio-frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.
Cable
Item Length Unit
Link cable (Shielded) 7 m
LAN cable (Shielded) 10 m
Power cord (3-Wire No Shielding) 1.8 m
USB cable (A to B type) 1.8 m
Trigger cable (Rayence I/F Cable) 10 m
Micro USB cable (A to Micro B type) 1 m
Immunity Test Basic EMC standard
or test method Operating mode Test leve/requirement
Mains terminal
disturbance voltage EN 55011 CISPR 11 Wired mode Group1, Class A
Radiated disturbance EN 55011
CISPR 11 Wired & Wireless
mode Group1, Class A