Rayence RY1417WCA User Manual

Release Version 1.0.0

Medical Image Processing Unit

1417WCA

User Manual

All pages of this document contain proprietary and confidential

information of Rayence Corporation and are intended for exclusive use

by Rayence Corporation personnel or customers. Copying, disclosure to

others or other use is prohibited without the express written

authorization from Rayence Corporation. Please report any violations of

requirement to Rayence Corporation.

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Attention

For improvement of product performance, supplementation, or follow-up of information; the

contents of this manual are subject to change without separate prior notice.

Please note that our company has neither responsibility for any accidents nor obligation to

do free repair service for any damage of the equipment due to user's mistake, which resulted

from failure to follow the contents in this manual. Make sure to be familiar with the safety

precautions and usage procedures. Also note that the product may slightly differ from the

contents of this manual depending on specification.

The following marks are used for the effective use of the product in this manual.

Attention, consult accompanying documents.

This is used to emphasize essential information. Be sure to read this information to avoid incorrect operation.

This indicates hazardous situation which, if not heeded, may result in minor or moderate injury to you or others, or may result in machine damage.

This indicates a potentially hazardous situation which, if not heeded, could result in death or serious injury to you or others.

Federal Law restricts this device to sale by or the order of a radiologist or any other practitioners licensed by the law of the state in which that person practices to use or order the use of the device.

Contents

Introduction ........................................................................................ 1

Intended use ...................................................................................... 1

Product features ................................................................................ 2

Product components ......................................................................... 3

Components Description................................................................... 5

Warning .............................................................................................. 8

Caution ............................................................................................. 10

Marking and labeling symbols ........................................................ 12

Notes for Using the Detector ............................................................ 14

Preparing .......................................................................................... 14

Handling ........................................................................................... 15

Handle Assembly ............................................................................. 15

Before Exposure .............................................................................. 17

During Exposure .............................................................................. 17

Limit of Load .................................................................................... 19

Disinfection and Cleaning ............................................................... 20

Others ............................................................................................... 20

Technical Features ........................................................................... 21

Mechanical Features ........................................................................ 21

Electrical Features ........................................................................... 21

Environmental requirement ............................................................. 24

PC Requirements ............................................................................. 25

Installation........................................................................................ 26

General interface ............................................................................. 26

Connection ....................................................................................... 27

IP set up ........................................................................................... 32

Using Web Manager (IP, SSID Change / Upgrade FW) ................... 33

Calibration ........................................................................................ 37

General Principle ............................................................................. 37

Calibration ........................................................................................ 39

Image Acquisition Test ..................................................................... 44

Program setup ................................................................................. 44

Get Image ......................................................................................... 45

View Images ..................................................................................... 46

Operation .......................................................................................... 51

Recommend ..................................................................................... 51

Switching power on / off .................................................................. 51

Storage ............................................................................................. 51

Information ....................................................................................... 52

Safety standard ................................................................................ 52

Electromagnetic Compatibility Information .................................... 54

Radio Frequency compliance.......................................................... 59

Maintenance ..................................................................................... 61

Cleaning ........................................................................................... 61

Inspection ........................................................................................ 62

Disposal or Recycling...................................................................... 63

Appendix ........................................................................................... 64

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Introduction

Overview

The 1417WCA is a wireless digital X-ray flat panel detector that

can generate images of any part of the body. The wireless

LAN((IEEE 802.11a/g/n) communication feature improves the

operability, and high-speed processing. This X-ray imaging

system consists of a scintillator directly coupled to an a-Si TFT

sensor. It makes high-resolution, high-sensitive digital images.

Intended use

For U.S.A.

1417WCA Digital Flat Panel X-Ray Detector is indicated for

digital imaging solution designed for human anatomy including

head, neck, spinal column, arm, leg and peripheral (foot, hand,

wrist, fingers, etc.). It is intended to replace film based

radiographic diagnostic systems and provide a case diagnosis

and treatment planning for physicians and other health care

professionals. Not to be used for mammography.

For European Union

This device provides digital X-ray imaging for diagnosis of

disease, injury, or any applicable health problem. The image is

obtained as the result of imaging X-rays passed through the

human body with an X-ray flat panel detector and importing a

digital signal output from the detector into the image processor.

Product features

 Wi-Fi (802.11a/g/n)

 Based on a-Si TFT active matrix

 Compact (15.9mm thickness) and light weight (Typ. 3.6kg)

 Limiting Resolution : 3.9 lp/mm

 14-bit digital output

 Easy integration

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Photo

Item

Part Name

Quantity

Product components

 Medical Image Processing Unit

Detector SD1417WCA 1

Handle - 1

Battery pack RB37WH 2

Battery charger RC120W 1

Charger adapter PMP120-13-3 1

AGI RA001A 1

Item

Part Name

Length

Quantity

 Cables

Link cable VRH076A 6m 1

PInterface cable

VRH017A 8m 1

USB cable(A to B)

VRH078A 1.8m 1

AC Power cord

VRH018A/019A 1.8m 1

 Installation CD

o Manual

o Detector Library

 Option

o Additional Battery

o Charger for the Car

o Cover Bag

o AP package

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Components Description

The detector is designed to capture radiographic images.

Captured images are transmitted to PC using the wireless/wired connection.

The SparkLAN WPEA-121N 802.11 a/b/g/n half mini PCI-e module is implemented. It supports 2T2R (2 transmit 2 receive) MIMO technology, which delivers throughput up to 300Mbps.

1417WCA (FCC ID: QIIRY1417WCA) in the RF module (FCC ID: PPD-AR5BHB116) does not use DFS band.

The module adopts the latest 802.11n Dual-Band technology (2.4Ghz and 5Ghz). The transmitter of the module is powered by host equipment(Detector). The antennas are 2 printed-dipole antennas.

(1) Detector

1. LED indicator: The LED indicates the state of detector.

i. Green on : Power on.

ii. Blue blinking : Wireless Connection.

iii. Orange on : Low battery.

2. Handle : Hold this handle when carrying the sensor unit. It is

removable.

3. Handle unlock-lever : This is an unlock-lever to remove handle.

4. Link cable connector : This is a connector for Wire communication

and power supplying. Connect the detector to PC and SMPS(not

provided) using Link cable.

5. CFRP(Carbon Fiber Reinforced Plastic) : The part of the patient’s

body to which an image is to be taken should be placed against this

plate.

6. Power button : Power on / Power off switch.

7. Shock sensor : Detector has built-in 4 Shock sensors. It detects

and records impact and mishandling of fragile

8. Battery unlock-lever : This is an unlock-lever to remove battery.

(2) Battery & Charger

1. Battery : Lithium ion battery. The number of times being acquired

image is 600 images(@ cycle time : 15s). The batteries last 2.5

hours and are rechargeable.

2. Charger : Two port cradle type.

3. LED indicator :

i. Orange on : charging

ii. Green on : Charging is completed.

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(3) AGI

1. Trigger connector: This is a connector for synchronization

between detector and generator. Connect the AGI to the generator

using P-interface cable..

2. USB connector: This is a connector for communication between

AGI and PC. Connect the AGI to the PC using USB cable.

Make sure to observe the following right

Warning

Environment of Use and Storage

Follow the specified process of operational instructions written in

this manual for the safety of the users and patients.

Does not use or store the instrument near any flammable

chemicals such as thinner, benzene, etc. Also, this instrument is

not a category AP or APG equipment. If chemicals are spilled or

evaporate, it may result in fire or electric shock through contact

with electric parts inside the instruments. Also, some

disinfectants are flammable. Be sure to take care when using

them.

Connection

Do not connect the instrument with anything other than specified.

Otherwise, it may result in fire or electric shock.

Handling

Always be sure to keep checking the condition of the system and

the patient to ensure they are normal during the use of the

instrument. If any problem is found, take appropriate measures,

such as stopping the operation of the instrument, as required.

Never disassemble or modify the product as it may result in fire

or electric shock. Also, since the instrument incorporates parts

that may cause electric shocks and other hazardous parts,

touching them may cause death or serious injury.

Do not hit or drop the instrument. The instrument may be

damaged if it receives a strong jolt, which may result in fire or

electric shock if the instrument is used without being repaired.

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When Problem Occurs

Should any of the following occur, immediately turn OFF the

power of each instruments, unplug the power supply cord from

the AC outlet, and contact Rayence representative or distributor.

 When there is smoke, odd smell or abnormal sound.

 When liquid has been spilled into the instrument or a metal

object has entered through an opening.

 When the instrument has been dropped and it is damaged.

Maintenance and Inspection

Make sure to observe the following right.

For safety reasons, be sure to turn OFF the power of each

instrument when the inspections indicated in this manual are

going to be performed. Otherwise, it may result in electric shock.

When the instrument is going to be cleaned, be sure to turn OFF

the power of each instrument, and unplug the power supply cord

from the AC outlet.

The instrument must be repaired by a qualified engineer only. If it

is not repaired properly, it may cause fire, electric shock, or

accident.

Caution

Environment of Use and Storage

Do not install the instrument in a location with the conditions

listed below. Otherwise, it may result in failure or malfunction,

cause fire or injury.

 Close to facilities where water is used.

 Where it will be exposed to direct sunlight.

 Close to air-conditioner or ventilation equipment.

 Close to heat source such as a heater.

 Prone to vibration.

 Insecure place.

 Dusty environment.

 Saline or sulfurous environment.

 High temperature or humidity.

 Freezing or condensation.

Do not place the storage case in a location with the conditions

listed below.

 Where the cable of the sensor unit will be strongly pulled

when the sensor unit is put into the case, otherwise, the cable may be damaged, resulting in fire or electric shock.

 Where someone might get their foot caught in the cable of the

sensor unit. Otherwise they could trip over, resulting in injury

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Handling

Do not spill liquid or chemicals onto the instrument or, in cases

where the patient is injured, allow it to become wet with blood or

other body fluids, as doing so may result in fire or electric shock.

In such situation, protect the instrument with disposable covering

as necessary.

Wipe the CFRP plate of the sensor unit with ethanol or

glutaraldehyde solution to disinfect it each time a different patient

uses the instrument, in order to prevent infection.

Turn off the power of each instrument for safety when they are

not going to be used.

Maintenance and Inspection

For safety reasons, be sure to inspect the instrument before

using it. In addition, carry out a regular inspection at least once a

year.

Modifications

Any changes or modifications in construction of this device which

are not expressly approved by the party responsible for

compliance could void the user's authority to operate the

equipment.

Marking and labeling symbols

Symbols Meaning

Caution : “Attention, see instructions for use”

Manufacturer

Date of manufacture

Serial number

WEEE : Waste Electrical and Electronic

Equipment

Authorized representative in the European

Community

CE symbol grants the product compliance to

the European Directive for Medical Devices

93/42/EEC as a class Ⅱa device. Authorized by

Notified Body SGS (code no.:0120) of British

non-ionizing radiation

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Labels

Detector label

Battery label

Notes for Using the Detector

Preparing

Fully charge the battery pack. Charge the battery on the day of

examination or on the previous day.

 Battery slowly discharges even of not in use. The battery

pack may have expired if it discharges immediately after

being fully charged. You can purchase an optional battery

pack to replace an exhausted one.

 Be sure to fully charge the battery before use.

※ The battery charger, RC120W is designed for the

dedicated battery pack.

※ When the detector will not be used for some time, remove

the battery pack.

Attach the battery pack. Align the claw on the battery pack and

the groove on the battery bay. Insert the battery pack fully. Push

down the battery pack. Slide the lock lever toward (lock) side and

lock it.

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Handling

Handle the instrument carefully, as it may be damaged if

something is hit against it, dropped, or receives a strong jolt.

Handle Assembly

※ Insert the handle always in the same direction.

 Handle Assembly

same position with the right picture.

Please confirm lever position. When the

handle is locked, the lever should be

If the

handle is

not locked, the detector can be dropped.

Insert the handle in

the same direction

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Before Exposure

Be sure to check the equipment daily and confirm that it works

properly.

Sudden heating of the room in cold areas will cause

condensation to form on the instrument. In this case, wait until

condensation disappears before performing exposure. If the

instrument is used with condensation formed on it, problems may

occur in the quality of the instrument. When an air-conditioner is

going to be used, be sure to raise/lower the temperature

gradually so that a difference in temperature in the room and in

the instrument does not occur, to prevent forming of

condensation.

During Exposure

Do not use the detector near devices generating a strong

magnetic field. Doing so may produce image noise or artifacts.

Do not apply excessive weight to the sensor unit. Otherwise, the

sensor may be damaged.

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