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Angell-CELV-101C User Manual (EN)

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0% found this document useful (0 votes)
716 views

Angell-CELV-101C User Manual (EN)

Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 37

Edition:V1.

Product register standard No.: YJBZ20212060982


Product registration No.:YJBZ20212060982
Production license No.: YSYJXSCX No. 20051197

Flat Panel Detector


Angell-CELV-101C(17"x14")

User's Manual
Please read this manual before using the product.
Please keep this manual for future references.
Proper usage of the product relies on fully understanding of the manual.

Company Name: SHENZHEN ANGELL TECHNOLOGY CO., LTD.

Head Office Address: Room 408, Building A, Huahan Innovation Park, Langshan Rd,

Nanshan District, Shenzhen, China

Production Address: Building 2, 1st, 2nd and 5th floor of Building 3, Liu Xian Er Rd, No.1,

Xin'an Street, Bao'an District, Shenzhen, China

Marketing Department Tel.: 0755-8601 6630-812 Fax: 0755-2685 9389

Website: http://www.szangell.com

Edition:V1.0

1
Edition:V1.0

INDEX

REMINDER!.......................................................................................................................................4

NOTE:...................................................................................................................................................4

DISCLAIMER.........................................................................................................................................5

GENERAL SAFETY INSTRUCTIONS...................................................................................................... 6

1 INTRODUCTION............................................................................................................................. 18

1.1 WORKING PRINCIPLES.................................................................................................................. 18


1.2 INTENDED USE AND SCOPE OF APPLICATIONS................................................................................... 18
1.3 PRODUCT TYPE........................................................................................................................... 19
1.4 PRODUCT COMPONENTS...............................................................................................................19
1.5 SYSTEM CONNECTION...................................................................................................................19

2 COMPONENT CONNECTORS AND INDICATORS........................................................................... 20

2.1 FP CONNECTOR, INDICATORS AND IMAGE ORIENTATION................................................................... 20


2.2 THE ORIENTATION CORRELATION BETWEEN THE OBJECT ON TOP OF FP AND THE IMAGE IN PC................ 20

3 INSTALLATION AND CONFIGURATION.......................................................................................... 22

3.1 FP AND PC WIRED CONNECTION METHOD.......................................................................................22


3.2 FP AND PC WIRELESS CONNECTION METHOD...................................................................................23
3.3 INSTRUCTIONS OFUSING WIRELESS ROUTER.................................................................................... 23
3.4 PC CONFIGURATIONS................................................................................................................... 24

4 INSTRUCTIONS OF USING TESTUI................................................................................................. 25

4.1 RUNTIME ENVIRONMENT OF TESTUI...............................................................................................25


4.2 FP START-UP.............................................................................................................................. 26
4.3 REGISTRATION AND CONNECTION................................................................................................... 26
4.4 IMAGE ACQUISITION.................................................................................................................... 26
4.5 IMAGE DISPLAY........................................................................................................................... 27
4.6 SYSTEM CONFIGURATION.............................................................................................................. 28
4.7 FP SHUTDOWN........................................................................................................................... 29

5 INSPECTION AND MAINTENANCE................................................................................................ 29

5.1 INSPECTION................................................................................................................................ 29
5.2 CLEANING.................................................................................................................................. 30
5.3 CHANGING BATTERIES.................................................................................................................. 31

6 TRANSPORTATION, MOVEMENT AND STORAGE........................................................................ 32

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6.1 TRANSPORTATION........................................................................................................................ 32
6.2 MOVEMENT............................................................................................................................... 32
6.3 STORAGE....................................................................................................................................32

7 SERVICE INFORMATION.................................................................................................................32

7.1 EXPECTED LIFE TIME.................................................................................................................... 32


7.2 REPAIR.......................................................................................................................................32
7.3 LIMIT ON PRODUCT SPARE PARTS....................................................................................................33

8 SPECIFICATIONS.............................................................................................................................33

8.1 MAIN SPECIFICATIONS.................................................................................................................. 33


8.2 CHARACTERISTIC..........................................................................................................................34

9 COMPONENT................................................................................................................................. 36

10 SIZE...............................................................................................................................................36

11 DICOM 3.0 CONFORMANCE STATEMENT...................................................................................37

12 SERVICE GUIDE............................................................................................................................ 37

12.1 AFTER-SALES SERVICE ADDRESS....................................................................................................37

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Reminder!
This manual is the official documentation for the installation, configuration, operation and

maintenance of the Flat Panel Detector Angell-CELV-101C( 17"x14"). Please read this manual before

using the product.

Note:
1. The product can only be operated by trained, professional medical or engineering personnel.

2. The product must be stored and operated in the specified environment.

3. The product is to be used in connection with the computer and monitor which complies with

GB9706.1 / IEC60601-1 or IEC60950-1 standard.

4. The product can only use the designated medical power adapter and dedicated detector cables.

5. The plug of the power adapter, as a disconnecting device for the network power supply, should

be placed in a position that is easy for the operator to operate.

6. If this equipment is modified, appropriate inspection and testing must be conducted to ensure

continued safe use of the equipment.

7. Devices with E&M emitting capabilities, such as mobile phones, radio transceivers, or remote

controllers may affect the functionality of the product. Therefore it is strongly suggested that

these devices are not used in the same room of the product.

8. Please dispose the device material or components according to the local waste disposal

regulations at the end of the expected service life.

Copyright
 SHENZHEN ANGELL TECHNOLOGY CO., LTD. reserves all rights.

 According to the copyright law,without written permission of SHENZHEN ANGELL

TECHNOLOGY CO., LTD., this manual, in whole or part of, cannot be reproduced.

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Edition:V1.0

Disclaimer
1. Malfunction or damage caused by usage not described by the manual.

2. Malfunction or damage caused by unauthorized modification of any components or circuits of the

product.

3. Malfunction or damage caused by force majeure such as fires, earthquakes, etc.

4. Malfunction or damage caused by using non-dedicated power supplies (voltage, frequency) or

abnormal power supply voltages.

5. Malfunction or damage caused by repairing, re-configuration, or refurbishment by agencies

unauthorized by SHENZHEN ANGELL TECHNOLOGY CO., LTD..

6. X-ray irradiation, image processing, image transferring and data archiving of this product shall

comply with the local regulations of the country or area where the product is installed. The user

takes the responsibility of imaging data confidentiality.

7. The user shall be responsible for any inaccurate treatment of patients caused by inaccurate

diagnosis. ( including loss of image data).

8. SHENZHEN ANGELL TECHNOLOGY CO., LTD. reserves the right to modify the product

specification, configuration, as well as appearance, without notifying the user.

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Edition:V1.0

General Safety Instructions


Please follow the safety instructions in this manual and pay attention to all the warning signs on the

labels. Ignorance of these warnings may result in harmful incidents. Please read through this manual

before using the product.

Safety Classification
Classification of protection against electric shock: Class I.

Classification of the degree of protection against electric shock: Type B.

Applied part: Type B (front part of the flat panel).

Safety Signs

This product, its labels and related documents using the following signs

General Prohibition Sign

Caution

RefertoInstructionManual/Booklet

Manufacturer

CE Mark

Authorized representative in the European Community

Serial Number

Type B Applied Part

Alternating Current

Direct Current

Switch or Switch position

6
Edition:V1.0

Storage Enveironment

General Prohibition Sign


 Do not store the product close to flammable chemicals (such as alcohol). In the incident of chemical

leakage or evaporation, it may cause fire or internal electrical shortage.

 Do not store the product to any equipment that may have liquid or chemical leakage or overflow, which may

cause liquid infiltration into the product and internal electric shortage.

. Caution

 Avoid contact with any sharp object, which may cause damage to housing or paint.

 Avoid moving or holding the product with wet hands or tools, which may cause electric shock.

 Avoid violent impact or dropping of the product. Impact exceeding the limit may cause

unrecoverable damage to the product.

 Storage Temperature: -20℃- 55℃, Relative Humidity: 10%-90%(Non Condensing), Aire Pressure:

700hPa -1060hPa.

Electrical Safety

General Prohibition Sign


 The product must be powered by the dedicated medical power adapter or internal Lithium battery

(in wireless mode). It shall not be powered by other sources, otherwise it may cause fire or electric

shortage.

Caution

 Do not connect more than one product to a same AC outlet, otherwise it may cause fire or electric

shock.

 Do not connect a portable multi-outlet socket into the system, otherwise it may cause fire or electric

shock.

 The power cord plug must be firmly and safely inserted into the network power socket! If the contact fails,

or if a metal object comes into contact with the exposed metal plug, it may cause a fire or electric shock.

 Before unplugging the power plug, make sure that the power switch of the product is in the "off"

(that is, in "○") state! Otherwise, the operator may suffer an electric shock and thereby endanger

life or suffer serious injury.

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 Be sure to hold the plug or connector to disconnect the power cord! If you pull the power cord, the

core wire may be damaged, causing a fire or electric shock.

 Do not occupy the space near the power line plug, so that in case of emergency the power plug can

be unplugged promptly.

 Make sure the power plug and outlet socket are both well grounded. Otherwise it may cause electric

shock.

 The product power supply should have a good indoor grounding socket! Otherwise, it may cause

electric shock or electric shock.

 Do not power on the product when it has condensation to prevent electric shock.

 Turn off the product when it won’t be used for long time.

Installation environment

Caution

 Do not install the product in any of the following places. Otherwise, it may cause product failure,

malfunction, fire or injure.

a) Close to water facilities;

b) Exposed to sunshine;

c) Close to air outlet of air conditioners or fans;

d) Close to heat sources such as a heater;

e) Places where power supply is unstable;

f) Dusty environment;

g) Salty or Acid environment;

h) Places where flammable or corrosive gas exists;

i) Places where temperature or humidity exceeds the limits;

j) Places where it may freeze or condense;

k) Places where there are frequent human-sensible vibrations;

l) On a slope or unstable area;

 The power and communication cables are fairly long. Please place these cables properly to

prevent the cables from being knotted or frequently stamped.

 Non-medical equipments and the accessories of the product, such as the PC, monitor and power

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Edition:V1.0

adapters, shall be placed at least 1.5m from the patient, as the following:

Operation of the product

General Prohibition Sign


 The product shall only be operated by authorized medical professionals or trained operators.

Unauthorized personnel is not allowed to operate the product.

 It is prohibited to disassemble or modify any part of the product. Unauthorized disassembly or

modification may cause fire, electric shock or injure.

 The patient shall not touch any of the buttons or connectors of the product when being used.

Otherwise it might cause unexpected harm.

Caution

Before Exposure

 Do not place any unrelated items on top of the product, which may fall and cause harm. Prevent

metal objects such as a needle or metal fragments, or liquid splashes from infiltrating into the

product. Otherwise it may cause electrical shortage, shock or fire.

 Do not violently impact or drop the product. The product may be damaged from violent impact or

drop. Damage to the external housing of the product may cause electric shock or fire.

 Warming up in a cold and humid environment may cause condensation on the surface of the product. In this

case, the user shall wait until the product reaches thermal equilibrium and the condensation disappears.

Otherwise, the condensation may affect image quality. If any air conditioner is installed in the environment,

please adjust the temperature so that condensation does not appear on the product.

 Do not exceed the weight load limit of the flat panel. Figure 1 shows the maximum limits of weight

load in different conditions.

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a b c

Figure 1

1. Uniformly distributed weight load on the top of the flat panel shall not exceed 135 kg, as shown in

Figure 1a.

2. Local static load, the bearing capacity is on the geometric center of the slab Ø40cm and the back

cover is on a flat surface. Maximum bearing mass: 50kg as shown in Figure 1 b

3. Pressure on the central Ø40cm area while the flat panel is only supported on two sides, shall not

exceed 50 kg, as shown in Figure 1 c.

 Do not bend or twist the flat panel. Otherwise the internal imaging sensor may be damaged. When

placing the flat panel in vertical position, make sure to reliably fasten the flat panel. Otherwise the

flat panel may fall down and cause personnel injury and/or product damage.

During Exposure

 During exposure, the patient being examined shall stay in a fixed pose. Any movement may affect the

final image quality.

 During exposure, do not move or touch any cable of the flat panel to avoid causing image noise,

artifact or even wrong image.

 In the following situations, immediately turn off the power, unplug the power line and contact your

sales representative or manufacturer as soon as possible.

1. When there is smoke, abnormal smell or sound.

2. When there is liquid or metal infiltrating the product.

3. When the product is deformed or damaged.

Cleaning

General Prohibition Sign


 It is prohibited to use flammable liquid such as gasoline or alcohol to clean the product, which may

cause fire.

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Caution

 Generally, the surface of the product does not directly contact patients’ skin. When it does, after

exposure, use a neutral, dry cloth to clean the surface that has contacted the patient.

 Do not spray disinfectant or detergent to the front side of the flat panel.

 Do not use diluents, benzene, acid, alkali, alcohol, etc., which may damage the product surface.

 In case that the patient being examined is injured (with blood or body fluids), it is highly recommended to

use a disposable sterilizing protective cover.

Maintenance and inspection

Caution

 Turn off the power and unplug the power line when the product need to be maintained or inspected.

 Please clean the power line and other cables regularly. Disconnect all the cables, then use a dry cloth to

remove dust and dirt from the cables.

 If the cables accumulates dust or dirt for a long time in a humid environment, the connectors of the cables

may corrode and have contact problem, which causes the product malfunction.

 For safety concerns, all regular inspection in this manual shall be performed after the product is powered off.

Otherwise it may cause electric shock.

Possible risks

Caution

 Over limit weight load, improper connection,violent shock may cause risks such as severe image

artifact or ghost.

 Not calibrating regularly may result in misdiagnosis due to defect pixels or defect lines.

 Improper interface with X-ray equipment may cause functional fault and risks! Loose contact may

cause image quality problems.

 Incorrect relative position between X-ray field and the flat panel may result in error of the exposed

image, or orientation of the image.

 Improper x-ray loading factor may cause unsatisfactory image or harm to the patient. Exposure too

low may result in insufficient image quality; exposure too high may harm the patient being

examined.

 Risk of incorrect X-ray dose. Different patient shall be assigned with different x-ray dose, otherwise

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it may harm the patient.

 Do not change the working principle of the X-ray machine. Otherwise, it will cause image quality

degradation and fail to meet diagnostic requirements.

Electromagnetic compatibility guidelines and manufacturer's declaration

Medical electrical equipment requires special reminders about EMC and should be used according to the

EMC information described below.

This product requires special reminders about electromagnetic compatibility (EMC). Please use it

according to the EMC information described in this manual.

Portable and radio frequency (RF) communication equipment may affect this product.

Do not use this product adjacent to or stacked with other equipment.

Do not use products other than special accessories, otherwise it may increase radiation and reduce

deflection resistance.

Basic performance

The X-ray flat panel detector (4335A) is used in conjunction with the X-ray machine for medical institutions

to perform digital X-ray static imaging of the human body. The basic performance of the product is:

1. Realize the wired communication connection and command transmission between the flat panel

detector and the computer system.

2. Realize the image acquisition of the flat panel detector (actually through the static acquisition of dark

field image verification).

Guidance and manufacturer’sdeclaration–electromagneticemissions-

forallEQUIPMENTandSYSTEMS

Guidance and manufacture’sdeclaration–electromagneticemission


The Angell-CELV-101C Flat Panel Detector is intended foruse in the electromagnetic environment specified below.The

customer or the user of theAngell-CELV-101C Flat Panel Detector should as sure that they are used in suchand environment.

Emissiontest Compliance Electromagneticenvironment–guidance


TheAngell-CELV-101CFlat
PanelDetectoruseRFenergyonlyfor
RFemissions
Group1 itsinternalfunction.Therefore,itsRFemissionsarevery
CISPR11
lowandarenotlikelytocauseanyinterferenceinnearby
electronicequipment.
RFemission TheAngell-CELV-101CFlat PanelDetectorissuitableforuse
CISPR11 ClassB
inallestablishmentsotherthandomesticandthose

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Edition:V1.0

Harmonicemissions
IEC61000-3-2 ClassA

Voltagefluctuations/flicker
emissions Complies
IEC61000-3-3

Guidance and manufacturer’s declaration–electromagnetic immunity–

For all EQUIPMENTandSYSTEMS

Guidance and manufacture’s declaration–electromagnetic immunity

TheAngell-CELV-101C FlatPanelDetectorisintendedforuseintheelectromagnetic environment specifiedbelow.Thecustomer

ortheuserofAngell-CELV-101CFlatPanelDetectorshouldassurethatitisusedinsuchanenvironment.

Electromagneticenvironment-
Immunitytest IEC60601testlevel Compliancelevel
guidance
Electrostaticdischarge :t6kVcontact :t6kVcontact Floorsshouldbewood,concreteor
(ESD) :t8kVair :t8kV air ceramictile.If floorarecovered
IEC61000-4-2 withsyntheticmaterial, therelative
humidityshouldbeatleast30%.
Electricalfast :t2kVforpowersupply :t2kV forpowersupply Mainspowerqualityshouldbethat
transient/burst lines lines ofatypicalcommercialor hospital
IEC61000-4-4 :t1kVforinput/output lines :t1kVfor input/outputlines environment.
Surge :t1kVdifferentialmode :t1kVdifferentialmode Mainspowerqualityshouldbethat
IEC61000-4-5 :t2kVcommonmode :t2kV commonmode ofatypicalcommercialor hospital
environment.
Voltagedips,short <5%UT <5%UT Mainspowerqualityshouldbethat
interruptionsand (>95%dipinUT) (>95%dipinUT) ofatypicalcommercialor hospital
voltagevariationson for0.5cycle for0.5cycle environment.Iftheuserofthe
powersupplyinput 40%UT 40%UT Angell-CELV-101CFlatPanelDetect
lines (60%dip inUT) (60%dipinUT) or requirescontinuedoperation
IEC61000-4-11 for5cycles for 5cycles
duringpowermainsinterruptions,it is
70%UT 70%UT recommendedthat the
(30%dip inUT) (30%dipinUT) Angell-CELV-101C
for25cycles for25cycles
FlatPanelDetectorbepowered
<5%UT <5%UT fromanuninterruptiblepower
(>95%dipinUT) (>95%dipinUT)
supplyorabattery.
for5sec for 5sec
Powerfrequency 3A/m 3A/m Powerfrequencymagneticfields
(50Hz/60Hz)magnetic shouldbeatlevelscharacteristicof
field
IEC61000-4-8 atypicallocationinatypical
commercialorhospital environment.

NOTE UTisthea.c.mainsvoltagepriortoapplicationofthetestlevel.

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Guidance and manufacturer’s declaration–electromagnetic immunity–

For EQUIPMENT andSYSTEMSthatarenotLIFE-SUPPORTING

Guidance and manufacture’sdeclaration–electromagnetic immunity

TheAngell-CELV-101CFlatPanelDetectorisintendedforuseintheelectromagneticenvironmentspecifiedbelow.Thecustomeror

Compliance
theuserofAngell-CELV-101C/FlatPanelDetectorshouldassurethatitisusedinsuchanenvironment.
Immunitytest IEC60601testlevel Electromagneticenvironment-guidance
level
Portable andmobileRFcommunicationsequipment

shouldbeusednoclosertoanypart

oftheAngell-CELV-101C

FlatPanelDetectorincludingcables,thanthe

recommendedseparationdistancecalculatedfrom the

equationapplicable tothe frequencyof the transmitter.

Recommendedseparationdistance 푑=
ConductedRF 3Vrms 3V 3.5
[푉 ] 푝
IEC61000-4-6 150kHzto80MHz 1

3.5
푑=[퐸 ] 푝 80MHzto800MHz 푑 =
Radiated RF 3V/m 3V/m 1

IEC61000-4-3 80MHzto2.5GHz 7
퐸1
푝800MHzto2.5GHz

WherePisthemaximumoutputpowerratingofthe

transmitterinwatts(W)according tothetransmitter

manufactureranddistherecommendedseparation

distanceinmetres(m).

FieldstrengthsfromfixedRFtransmitters,as
a
determinedbyanelectromagneticsitesurvey, shoul
dbelessthanthecompliancelevelineach
b
frequencyrange.
Interferencemayoccur inthe vicinityof equipment
marked withthefollowingsymbol:

NOTE1 At80MHzand800MHz,thehigherfrequencyrangeapplies.

NOTE2 Theseguidelinesmaynotapplyinall situations.Electromagneticpropagationisaffectedbyabsorptionand

reflectionfromstructures,objectsandpeople.
a
Fieldstrengthsfromfixedtransmitters,suchasbasestationsforradio(cellular/cordless)telephonesandland
mobileradios,amateurradio,AMandFMradiobroadcastandTVbroadcastcannotbepredictedtheoreticallywith
accuracy.ToassesstheelectromagneticenvironmentduetofixedRFtransmitters,anelectromagneticsitesurvey
shouldbeconsidered.IfthemeasuredfieldstrengthinthelocationinwhichtheAngell-CELV-101CFlatPanelDetectorisused
exceedstheapplicableRFcompliancelevelabove,theAngell-CELV-101CFlatPanelDetectorshouldbeobservedtoverify
normaloperation.Ifabnormalperformanceisobserved,additionalmeasuresmaybenecessary,suchasreorienting
orrelocating the Angell-CELV-101CFlat PanelDetector.
b
Overthefrequencyrange150kHzto80MHz,fieldstrengthsshouldbelessthan3V/m.

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Recommendedseparationdistancesbetweenportableandmobile
RFcommunicationsequipmentandtheEQUIPMENTorSYSTEM–
forEQUIPMENTorSYSTEMthat arenotLIFE-SUPPORTING
Recommendedseparationdistancesbetween
portableandmobileRFcommunicationsequipmentandtheAngell-CELV-101C Flat Panel Detector

TheAngell-CELV-101CFlatPanelDetectorisintendedfor useinanelectromagneticenvironmentinwhichradiatedRFdisturbances
arecontrolled.ThecustomerortheuseroftheAngell-CELV-101CFlatPanelDetectorcanhelppreventelectromagnetic
interferencebymaintainingaminimumdistancebetweenportableandmobileRFcommunicationsequipment
(transmitters)andtheAngell-CELV-101CFlatPanelDetectorasrecommendedbelow,accordingtothemaximumoutputpowerof
thecommunicationsequipment.

Separationdistanceaccording tofrequency oftransmitter


Ratedmaximumoutput
(m)
poweroftransmitter (W)
150kHzto80MHz 80MHzto800 MHz 800 MHzto2.5GHz
3.5 3.5 7
푑=[ ] 푝 푑=[ ] 푝 푑=[ ] 푝
푉1 퐸1 퐸1
0.01 0.1167 0.1167 0.2333
0.1 0.3689 0.3689 0.7379
lV1
1 1.1667 1.1667 2.3333
10 3.6893 3.6893 7.3786
100 11.6667 11.6667 23.3333
Fortransmittersratedatamaximumoutputpowernotlistedabove,therecommendedseparationdistancedinmetres

(m)canbeestimatedusingtheequationapplicabletothefrequencyofthetransmitter,wherePisthemaximumoutput power rating of


the transmitterin watts(W) according tothe transmitter manufacturer.

NOTE1 At80MHz and800 MHz,theseparation distance for the higher frequency range applies.

NOTE2 These guidelines maynot apply in all situations.Electromagnetic propagation is affectedby absorption and
reflection from structures,objects and people.

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Labels and signs on the product


The front cover of the flat panel detector is the part that might contact patient, type B.

Illustrations of the signs and labels on Angell-CELV-101C

Front type B

Back

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1 Introduction
Angell-CELV-101C Flat Panel Detector (in the following referred to as “FP”) works

with x-ray systems to provide diagnostic imaging for medical facilities.

Features:

 Fast image acquisition.

 High detection efficiency.

 High dynamic range.

 High spatial resolution.

This manual covers the description and instructions of the using Angell-CELV-101C.

1.1 Working Principles

Flat panel detectors consist of scintillation screens and TFT panel. The scintillation

screen converts incoming x-ray energy into visible light photons. The TFT panel converts

light signal to electronic signal. Through charge amplification and A/D conversion, the final

digital x-ray image is acquired.

1.2 Intended use and Scope of Applications

1.2.1 Intended use

The product shall be used together with medical x-ray equipment, for medical

facilities to take digital x-ray images.

The medical x-ray equipment shall have loading time at least 0.5s, and dose at least

50nGy.

After the digital x-ray imaging system installation completes, the system needs to be

tested and verified to ensure safety and functionalities. Installation, operation and

maintenance shall be performed only by trained, authorized personnel.

1.2.2 Scope of Applications

Used for medical digital radiography.

Not for use of mammographic imaging, dental x-ray, computer tomography or

fluoroscopy.

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1.2.3 Applicable Users

For medical facilities, for digital radiology of any human body parts.

1.2.4 Contraindication

Pregnant women, newborns, infants, critically ill patients, shall be treated according

to doctors’ instructions.

1.3 Product Type

Flat Panel Detector

Angell-CELV-101C
Effective Size: Size code

product code

1.4 Product Components

Consisting of a flat panel detector, power adapter, medical detector cable,

cable,Gigabit Ethernet Cable,power cable,lithium battery.

1.5 System connection

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2 Component Connectors and Indicators

2.1 FP Connector, Indicators and Image Orientation

Notes:

①FP Indicators.

Power indicator,Keeps Blue when FP is powered on;Battery low light

POWER flash once every two seconds;Battery error (too hot) flash once per

second;Power off the light is off;

Communication link indicator, Keeps green when FP is link; Flashing


LINK
when acquiring images.

Lit up when FP is powered on or connected to a DC power supply.


READY
Flashing yellow during exposure and data acquisition.

②FP Socket for Detector Cable.

FP is connected to PC through the detector cable and Ethernet cable through this

socket to transmit image data and charge the battery.

2.2 The orientation correlation between the object on top of FP and


the image in PC

The lower left corner of the image corresponds to where the detector cable connector

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is.
FP PC

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3 Installation and Configuration

Angell-CELV-101C has been designed for various applications of digital x-ray imaging. FP

can be connected either through wire or wirelessly. In wireless mode, FP can be

configured as an Access Point to which PC can directly connect, or a Station to connect to

PC with a wireless router (WR). The synchronization between image acquisition and X-ray

exposure can be realized through the internal AED function of FP. There are 3 major

connection configurations for Angell-CELV-101C summarized as the following:

NO. Connection FP WIFI mode Triggermode

(—Wired,…Wireless)

① FP—PC Not Used HST/AED

② FP…PC Access Point HST/AED

③ FP…Router—PC Station HST/AED

3.1 FP and PC wired connection method

The pogo pin port of Detector cable (Figure a) connects to the detector (Figure b).

Ethernet cable (Figure c) and the power adapter cable connects to the other end of the

detector cable (Figure d).Connect the Ethernet cable to the computer and connect the

power line of the adapter to an AC outlet, and press the power switch to turn on the

detector. At this time the detector is powered by the adapter, andthe lithium battery isbeing

charged.

Figure aFigure b Figure c

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Figure d Figure e Figure f

3.2 FP and PC wireless connection method

Directly start the power switch button on the flat-panel detector, the device into

working state, at this time powered by the lithium battery.

3.3 Instructions ofUsing Wireless Router

In the connection configurations ③ ,the product need to connect a wireless router

supporting 802.11ac 2.4Ghz. The following as an example.

3.3.1 Wireless Router Configurations

1. LAN settings

Search for the WIFI with angell_7628_FPD-XXXX (suffix) in the wireless network,

connect WIFI, The password has to be “12345678” ,the IP address of the wireless

network card should be set to automatically get.

2. If unable to connect,manualsettings

Open the browser, enter the IP address:172.16.2.1, and enter the username and

password in the pop-up dialog box, both of which are ADMIN.

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3.Wireless module setting interface


Click "Advanced Settings", "2.4GHZ Wireless" and "General Settings" in turn on
the routing interface, select "1" channel in the column of wireless channel, and click "Apply
Settings".

3.4 PC Configurations

3.4.1 Recommended PC configuration

It is recommended that the User’s PC shall have the following configuration:

Shall comply with the requirements of IEC60601-1 or IEC60950.

Parts Recommended Minimum


CPU I7 4500U or similarCPU and up I3-3110 or similar CPU
Memory 4G DDR high speed memory 1G DDR high speed memory
Hard Drive 1T high speed hard drive 500G high speed hard drive

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Monitor 1920x1080 resolution 1920x1080 resolution


Video Card >1G memory >512M memory
Ethernet Card 1000M 1000M
Wifi Card 802.11n/ac 2.4GHz 802.11n 2.4GHz
Operating System Windows 7/8 32/64 bit Windows7/8 32/64 bit

3.4.2 Configuration of PC’s Ethernet card

For the connection configurations ①,and ③ ,at least one Ethernet card need to be

installed in the PC. The Ethernet card shall be connected to WR’s LAN port or FP, and its

IP shall be set acquired IPAutomatic.

3.4.3 SDK Installation

Please locate the SDK release file SDK_Vx.x.x.zip in the SDK DVD enclosed in the

product package. Unzip the file and copy the folder to PC to use. The SDK release file

includes the following contents:

After installation of SDK, the user can start to use TestUI to connect to FP and

acquire images (Please refer to section 4). The software developers can perform

configuration, command and data acquisition on PZMedical’s product by calling the

functions supplied in the SDK. Please refer to the SDK Interface Manual included

(enclosed in the SDK release file) for detailed software developing instructions.

3.4.4 PC Firewall and Anti-Virus Software Configuration

The firewall or anti-virus software installed on the user’s PC, may keepPZMedical’s

TestUI.exe, or other programs calling PZMedical’s SDK, from accessing the network data

and cause TestUI not functioning properly. The user may need to contact the software

supplier on how to allow certain programs such as TestUI to access the network, or, if

allowed, to turn off the firewall or anti-virus software all together.

4 Instructions of Using TestUI

4.1 Runtime environment of TestUI

Install DXRayDiagnost.exe for application runtime environment and related system

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library files.

4.2 FP Start-up

When FP is powered by a battery or connected to a DC power supply, press down the

power switch for 3 seconds to turn on the FP.After startup, Power light will turn Blue.

4.3 Registration and connection

4.3.1 FP and computer wired connection(FP—PC)

1) Open the DXRay TestUI folder, double click DXRay TestUI.exe to run. From TestUI's

window , After connection is successful, The status of FP is shown in the right down

of the TestUI window , as the following:

4.4 Image Acquisition

After FP is properly opened, user can click on the "Exposure mode" button to

enter the Exposure mode. click on the "FP matrix" button to choose the FP matrix.Then

can Then directly fire x-ray or click on the "Gathering dark figure"buttons in the TestUI to

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get an image.

The image acquisition buttons are shown as the following:

4.5 Image Display

After receiving the image, the image is displayed on the left side. Coordinate and

Pixel value is displayed in the status display bar in the lower left corner. as the following:

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4.6 System Configuration

Select the file under the folder where DXRay TestUI.exe is located, then open the

settings file, ThenopenDetector.Ini with Notepad,The page displays the

default configuration as the following:

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4.7 FP Shutdown

FP in the boot state , press and hold the power switch 3 seconds can enable FP

shutdown. The POWER light and the LINK lightsand the READY lights will turn off.

5 Inspection and maintenance


This equipment can only be maintained by an authorized
Caution
personnel.and not allowed to maintain or repair in use. Improper

repair of replacement of any parts may cause fire, electric shock or

other accidents. For safety purposes, the equipment shall be

inspected before use. In addition, it shall be regularly inspected at

least once a year.

5.1 Inspection

To ensure safe and proper use of this equipment, please inspect it before use.

If any problem is found during the inspection, please follow the instructions in this

chapter.

If the problem still cannot be resolved, please contact SHENZHEN ANGELL

TECHNOLOGY CO., LTD. or authorized distributors.

It is suggested to keep an inspection record (such as the table in this chapter)

5.1.1 Inspection before Use

5.1.1.1 Before turning on the power

Result
Inspection Resolution
Date Date Date
Check if the cable is
Contact PZM or
damaged, check if the cable OK/NG OK/NG OK/NG
Distributors
external surface is broken.
Cables
Reconnect the
Check all the connections OK/NG OK/NG OK/NG connectors and
fasten them.
Check if the surface is
Flat Contact PZM or
damaged and/or connection OK/NG OK/NG OK/NG
Panel Distributors
is loose.

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5.1.1.2 After turning on the power

Result
Inspection Resolution
Date Date Date
Reconnect
Check if the power LED
OK/NG OK/NG OK/NG power cable and
lights up.
detector cable
Take note of
General
Fire x-ray, check if x-ray error message if
exposes correctly and OK/NG OK/NG OK/NG there is any.
image acquired normally Contact PZM or
Distributor.

5.1.2 Regular Inspection

Regular inspection shall be carried out at least once a year. In case of any problem

during the inspection or the user cannot perform the inspection, please contact PZM or

the Distributor.

Result
Inspection Resolution
Date Date Date
Expose x-ray and examine Any problems
the image quality and all OK/NG OK/NG OK/NG contact PZM or
functions. Distributor

5.1.3 Re-Calibration

When the exposure condition has significantly changed (such as change of tube, or

large variation of the distance between flat panel and tube), the flat panel need to be

re-calibrated. Please refer to Section 4.6 for instructions of calibration.

As the product being used for long time, the calibration template may drift and there

may exist new defects. Therefore, the product shall be re-calibrated at least once every 6

months, by PZM or an authorized third party.

5.2 Cleaning

5.2.1 Protection Cover of Flat Panel (Carbon Fiber Plate)

Generally, the surface of the product does not directly contact patients’ .
Caution
When it does, after exposure, use a neutral, dry cloth to clean the

surface that has contacted the patient. In case that the patient being

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examined is injured (with blood or body fluids), it is highly

recommended to use a disposable sterilizing protective cover.

5.2.2 External Housing Surface (Magnesium Alloy)

Turn off the power and unplug the power line before cleaning the
Caution
product. Do not use alcohol, benzene, diluents and any other

flammable detergent, otherwise it may cause fire or electric shock.

If the housing surface is contaminated with dirt, please take the following steps to

clean:

1) Turn off the power of flat panel.

2) Turn off the power of all related equipments.

3) Unplug the power line.

4) Wipe the external surface with a neutral detergent.

Soak a cloth in water-diluted neutral detergent (5%), wring it out and wipe the

exterior surface of the product. It is recommended to clean the product once a

month.

5) Wipe off the neutral detergent.

After cleaning with neutral detergent, make sure to wipe it again with a cloth

soaked in clean water and wringed out.

5.3 Changing Batteries

The product must use the dedicated Lithium battery supplied by PZM,
Caution
Usage of any other battery may cause abnormal temperature rise

and may cause fire or explosion.

If the Lithium battery is not used for a year, it is recommended to

recharge the battery once every half year to prevent battery leakage

and other risks.

The expected life time of the Lithium Battery is 2 years. It is highly

suggested to change the batteries after being used for 2 years.

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6 Transportation, Movement and Storage

6.1 Transportation

Caution This product is a delicate equipment, shall be carefully transported.

6.2 Movement

Pay attention to the product when moving it. Lift and place it gentally.
Caution
The product shall be placed at the bottom of any package

containers. Do not drop the product from height. Do not place the

product in vertical position. Place it in flat position as much as

possible. Do not pile up multiple products in moving. Do not place

any other items on top of the product. Protect the product against

water, rain or snow in movement. The product shall not be placed in

open area, shall be placed in a warehouse. The product packages

shall not be piled up for more than 5 layers.

6.3 Storage

Note that the packaged product shall be stored in a well ventilated


Caution room without corrosive gases or accumulated dust.
Storage Temperature:-20℃ - 55℃

Relative Humidity:10%-90% (non condensing)

Air Pressure:700hPa -1060hPa

Storage Limit: 10 Years

Do not expose the product under sunshine.

7 Service Information

7.1 Expected Life Time

Under normal use and regular inspection and maintenance, the product expect to

have life time of 7 years.

7.2 Repair

Ifit is necessary for the maintenance personnel, MANUFACTURER will provide circuit

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diagrams, component part lists, descriptions, calibration instructions.

If problems cannot be resolved following the instructions of section 5.1, please

contact SHENZHEN ANGELL TECHNOLOGY CO., LTD. or an authorized distributor and

provide the following information:

Product Name, Type: Can be found on the label

Serial Number: Can be found on the label

Problem: Please describe the problem with as much details as possible

7.3 Limit on product spare parts

This product’s key components (components that are necessary to maintain the

product’s functionalities) will be available for two years after the product becomes

obsolete.

8 Specifications

8.1 Main specifications

Flat Panel Detector

X-ray conversion layer CSI / GOS

Active Area ≥(350×95%)×(430×95%)mm

A/D Conversion 16bit

Acquisition Time Wireless:≤7s,wired≤5s

Image preview Time Wireless:≤6s,wired≤5s

Spatial Resolution No attenuation: ≥ 3.5 lp/mm; with

attenuation: ≥2.0 lp/mm

Image Ghost Not seen

Image Artifact Not seen

Image evenness 70KV 10MAS SID=1.8M ≤2.2%

Document Standard DICOM3.0

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Power Supply: Medical power adapter:

Input:100-240VAC,50/60Hz

Output:+19VDC,4.74A

Operation environment Temperature:10℃~30℃

Humidity:30-75%(non-condensing)

Atmospheric pressure:700hPa

-1060hPa

Storage and transport environment Temperature:-20℃ - 55℃

Humidity:10%-90%(non-condensing)

Atmospheric pressure:700hPa

-1060hPa

FP Size 460mm×384mm×15.5mm

FP Weight 3.4kg(with battery)

8.2 Characteristic

8.2.1 MTF

Modulation Transfer Function(MTF)

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8.2.2 DQE

Detective Quantum Efficiency(DQE)

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9 Component
Standard Parts
Flat Panel Detector____________________1

Medical Power Adapter ________________1

Detector Cable ____________________ 1

Gigabit Ethernet Cable_________________ 1

Power cable ______________________1

compact disc________________________1

10 Size
Flat Panel Detector

Unit:mm

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11 DICOM 3.0 conformance Statement


According to the DICOM3.0 standard of medical digital imaging and communication, it
conforms to the consistency of network communication DICOM3.0.

12 Service Guide
SHENZHEN ANGELL TECHNOLOGY CO., LTD. provides comprehensive

installation, commissioning, training, maintenance and other pre-sales and after-sales

service.

12.1 After-sales service address

Manufacturer:SHENZHEN ANGELL TECHNOLOGY CO., LTD.

Address: Room 408, Building A, Huahan Innovation Park, Langshan Rd, Nanshan

District, Shenzhen, China

Tel:0755-8601 6630

Fax:0755-2685 9389

The revision date:2020.11

Version:V1.0

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