DRTECH EVS4343W User manual

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Manual Information
Copyright
Information contained in this manual is confidential and the property of DRTECH Co, Ltd., which is only
provided to the authorized customers of DRTECH Co, Ltd. The purpose of the manual is to assist the users to
comprehensively utilize the product of DRTECH Co, Ltd. All information contained in the manual may not be
altered or distributed without prior written consent of DRTECH Co, Ltd., and may not be disclosed to
unauthorized personnel. Information contained in the manual may be subject to change without prior notice.
Copyright © 2019 DRTECH Co, Ltd. All rights reserved.
To Customers
Thank you for purchasing the DRTECH Radiography EVS4343W / EVS4343WG / EVS3643W / EVS3643G /
EVS 4343WP / EVS 3643WP(hereinafter this Product). This User’s Manual explains how to use the detector,
x-ray interface unit, and other peripheral equipment. Before using this product, be sure to read this manual
thoroughly in order to utilize it more effectively. Also, read the Operation Manual for EVS Calibration and
configuration Software (hereinafter ECali1).
Important information on usage and management of equipment
Only a physician or legally certified operator should use this product.
The equipment should be maintained in a safe and operable condition by maintenance personal.
Use only computers and image display monitors complying with IEC 60601-1 or IEC 60950-1
and under a system configuration complying with IEC 60601-1. For details, consult your sales
representative or local DRTECH dealer.
Use only the dedicated cables. Do not use any cables other than those supplied with this
product.
Disclaimer
In no event shall DRTECH be liable for any damage or loss arising from fire, earthquake, any
action or accident by a third party, any intentional negligent action by users, any trial usage, or
other usage under abnormal conditions.
Roentgenography, image processing, image reading, and image data storage must be
performed in accordance with the laws of the country or region in which the product is being
used. The user is responsible for maintaining privacy of image data.
In no event shall DRTECH be liable for personal physical harm or property damage that is
sustained, under any conditions when the instructions are not followed or the product is misused.
It is the responsibility of attending physicians to provide medical care services. DRTECH will not
be liable for fault diagnosis.

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In no event shall DRTECH be liable for direct or indirect consequential damages arising from the
use or unavailability of this product. DRTECH shall not be liable for loss of image data for any
reason.
In no event shall DRTECH be liable for any damage arising from moving, alteration, inspection
or repair by a person other than authorized service engineers.
Specifications, compositions, and appearance of this product may change without prior notice.
Please contact us if there are any problems while using the product.
DRTECH Co, Ltd.
Customer Support Team
Website: http://www.drtech.co.kr
E-mail: [e-mail]
Tel: [phone]
Fax: [phone]

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Definition of Symbols
Symbols
Description
Non-ionized radiation
The Waste Electrical and Electronic Equipment Regulations indicate separate
collection for electrical and electronic equipment.
Protective Earth (Ground)
Direct Current
Alternating Current
Equipotentiality
Power Off
Power On
Read and understand all instructions and warning labels in the product documentation
before using the equipment. Keep this manual for future reference.
Product contains specific materials that are suitable for recycling.
Should be treated with care because if mistreated it might explode.
Keep away from fire and flames.
Heavy loading is prohibited.
Authorized representative in the European Community
Serial Number
Date of manufacture
Manufacturer
For U.S.A standards
Federal law restricts this device to sale by or on the order of a licensed practitioner
For European Union (EEC Countries)
This mark shows that product is in compliance with the essential requirements and
other relevant provisions of Directive 93/42/EEC and “0120” shows the notified body
number for MDD.

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Table of Contents
MANUAL INFORMATION ........................................................................................................................................ 2
1. SAFETY AND REGULATORY INFORMATION ................................................................................................... 7
1.1 MEDICAL EQUIPMENT SAFETY STANDARDS....................................................................................................................................18
1.1.1 Medical Equipment Classification..................................................................................................................................18
1.1.2 Product Safety Standards ..................................................................................................................................................18
1.2 DECLARATION OF CONFORMITY .......................................................................................................................................................20
1.2.1 Declaration of Conformity for EU Area.......................................................................................................................20
1.2.2 FCC Compliance Statement..............................................................................................................................................22
1.3 LABELS AND MARKINGS ON THE EQUIPMENT ...............................................................................................................................23
1.3.1 Detector.....................................................................................................................................................................................23
1.3.2 Other components ...............................................................................................................................................................25
1.3.2.1 Battery Charger .......................................................................................................................................................................................25
1.3.2.2 Battery pack ..............................................................................................................................................................................................25
1.3.2.3 EVS-WPCS ..................................................................................................................................................................................................25
1.4 PRECAUTIONS REGARDING ELECTROMAGNETIC WAVES.................................................................................................................26
2. DETECTOR SPECIFICATIONS .......................................................................................................................... 28
2.1 MAIN SPECIFICATIONS ........................................................................................................................................................................29
2.1.1 Detector.....................................................................................................................................................................................29
2.1.2 Battery Charger......................................................................................................................................................................34
2.1.3 Battery Package .....................................................................................................................................................................35
2.1.4 EVS-WPCS.................................................................................................................................................................................36
2.2 CHARACTERISTICS................................................................................................................................................................................37
2.3 INTENDED USE.....................................................................................................................................................................................38
3. OPERATING PROCEDURE.................................................................................................................................. 40
3.1 NOTES FOR USING THE EQUIPMENT.................................................................................................................................................40
3.1 SYSTEM CONFIGURATION...................................................................................................................................................................42
3.2 PARTS NAME AND FUNCTIONS.........................................................................................................................................................43
3.1.1 Product Components ..........................................................................................................................................................43
3.1.1.1 Detector Components..........................................................................................................................................................................44
3.1.1.2 EVS-CPDG Components......................................................................................................................................................................45
3.1.1.3 USB C to Lan Gender ...........................................................................................................................................................................46
3.1.1.4 Battery Charger Components........................................................................................................................................................... 47
3.1.1.5 Battery Pack Components..................................................................................................................................................................47
3.1.1.6 Charging Battery Pack..........................................................................................................................................................................47
3.1.1.7 EVS-WPCS Components......................................................................................................................................................................50
3.1.4 Additional Function..............................................................................................................................................................51

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3.1.4.1 AED Mode..................................................................................................................................................................................................51
3.1.4.2 Recommendation of setting AED Sensing Area......................................................................................................................53
3.3 ENVIRONMENTAL REQUIREMENTS ....................................................................................................................................................54
3.3.1 Specifications of Workstation (Minimum and Recommended PC Requirements) .................................54
3.3.2 Recommended Specifications of Grid .........................................................................................................................55
3.3.3 Recommended Exposure Condition.............................................................................................................................55
3.4 BEFORE USING THE DETECTOR...........................................................................................................................................................56
3.5 OPERATING THE DETECTOR ................................................................................................................................................................57
3.5.1 Genral Workflow....................................................................................................................................................................57
3.5.2 Operating the detector ......................................................................................................................................................58
3.5.2.1 Powering on the detector ..................................................................................................................................................................58
3.5.2.2 Register the detector and make connection to the EVS control system ................................................................... 58
3.5.2.3 Conduct examination ...........................................................................................................................................................................59
3.6 POWERING OFF THE DETECTOR .........................................................................................................................................................61
3.7 DETECTOR STATUS LIST .......................................................................................................................................................................61
3.7.1 Detector Status List ..............................................................................................................................................................61
3.7.2 Power Mode Indicator ........................................................................................................................................................62
3.7.3 Signal Strength Indicator...................................................................................................................................................62
3.7.4 Battery Remains Indicator.................................................................................................................................................................63
3.8 ADDITIONAL FUNCTION......................................................................................................................................................................63
3.8.1 Lossless AED/AWC Mode..................................................................................................................................................64
3.8.1.1 Recommendation of setting AED Sensing Area......................................................................................................................66
3.9 PRODUCT INSTALLATION ....................................................................................................................................................................67
3.9.1 Connecting Device .................................................................................................................................................................................... 67
3.9.1.1 Operating AP............................................................................................................................................................................................67
4. TROUBLE SHOOTING......................................................................................................................................... 69
5. MAINTENANCE................................................................................................................................................... 70
5.1 DAILY INSPECTION AND MAINTENANCE .........................................................................................................................................70
5.2 REGULAR INSPECTION AND MAINTENANCE ...................................................................................................................................70
5.3 IRREGULAR INSPECTION AND MAINTENANCE ................................................................................................................................70
6. PACKAGING......................................................................................................................................................... 71
7. REVISION HISTORY............................................................................................................................................ 72

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1. Safety and Regulatory Information
Intended Use
The EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG / EVS 4343WP / EVS 3643WP Digital X-ray
detector is designed as a digital imaging solution, for providing radiographic diagnosis of the human anatomy.
This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic
procedures. This device is not intended for mammography applications.
Safety Notices
Follow the safety instructions in this manual along with the following warning and cautions signs. Ignoring
instructions, warnings, or cautions while handling the product may result in serious injury, accident, or product
damage. To avoid any accident causing personal injury or product damage, be sure to read this manual
carefully before using the product.
Safety Symbols
WARNING
AVERTISSEMENT
This indicates a potentially hazardous situation which may cause serious personal
injury, death or substantial product damage if misused.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer la mort ou des blessures graves.
CAUTION
MISE EN GARDE
This indicates a potentially hazardous situation which may cause minor personal
injury if misused.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer des blessures mineures.
CAUTION
MISE EN GARDE
This indicates a potentially hazardous condition which may cause product damage.
Cette notice est utilisée pour désigner les conditions dans lesquelles une utilisation
incorrecte du produit peut causer des dommages matériels.
PROHIBITED
INTERDICTION
This indicates a prohibited operation.
This indicates an action that must be performed.
IMPORTANT
This indicates important operations and restrictions.
Be sure to check this sign to prevent product damage or malfunction.
This indicates the information about the basic operations of the detector for its
user’s reference. Users are recommended to read this notice.

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Installation and Environment of Use
Installation et environnement d'utilisation
WARNING
AVERTISSEMENT
PROHIBITED
INTERDICTION
Do not operate or store the X-ray detector in or around flammable
chemicals or substances such as alcohol, thinner, benzene, etc.
N'utilisez pas et n’entreposez pas l’appareil à proximité de produits chimiques
inflammables tels que de l'alcool, des diluants, de la benzine, etc.
If chemicals are spilled or evaporated, it may result in fire or electric
shock, caused by their contacts with electric parts inside the detector.
Some disinfectants are also flammable. Be cautious when using them.
Si des produits chimiques sont renversés ou s'évaporent, cela peut provoquer
un incendie ou une électrocution par contact avec des pièces électriques à
l'intérieur de l'appareil. En outre, certains désinfectants sont inflammables.
Assurez-vous de faire attention lorsque vous les utilisez.
Do not connect the detector to any component, other than DRTECH’s
specified components. Doing so may result in fire or electric shock.
Ne connectez pas l'appareil une source d'alimentation autre que celle fournie
avec cet appareil. Cela risque de provoquer un incendie ou un choc électrique.
Do not install the equipment in any of the locations listed below. Doing so
may result in fire, personal injury, or malfunction of the equipment.
N'installez pas l'appareil dans l'un des emplacements énumérés ci-dessous.
Cela pourrait entraîner une défaillance ou un dysfonctionnement de l'appareil,
un incendie ou des blessures.
- Close to fluid or places where fluids is used
Près des installations où l'eau est utilisée
- Where it may be exposed to direct sunlight
à la lumière directe du soleil
- Close to the air outlet of an air-conditioner or ventilation equipment
Près de la sortie d'air d'un climatiseur ou d'un appareil de ventilation
- Close to heat sources such as a heater
Près d'une source de chaleur telle qu'un radiateur
- Where the power supply is unstable
Là où l'alimentation est instable
- In a saline or sulfurous environment
En milieu salin ou sulfureux
- Where temperature or humidity is high
Là où la température ou l'humidité est élevée
- High condensation or extreme cold environment
en cas de gel ou de condensation
- In area prone to vibration
Dans les zones sujettes aux vibrations
- On an incline or in an unstable area
Sur une pente ou dans une zone instable

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Because the equipment cable is long, take care that cables do not become
tangled during use. Also, be careful not to get your feet caught in the
cable.
Otherwise, it may cause a malfunction of the equipment or the injury of the
user due to tripping over the cable.
En raison de la longueur du câble de l’appareil, veillez à ce que les câbles ne
s'emmêlent pas pendant l'utilisation. Veillez également à ne pas vous coincer
les pieds dans le câble.
Sinon, cela risque de provoquer un dysfonctionnement de l'appareil ou des
blessures de l'utilisateur s’il trébuche sur un câble.
Non-medical equipment such as the battery charger, and access point unit
cannot be used in patient’s vicinity.
Les appareils non médicaux tels que le chargeur de batterie et l’unité de point
d’accès ne peuvent pas être utilisés à proximité du patient.
<Patient Vicinity>
<Proximité avec le patient>

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Power Supply
Alimentation électrique
WARNING
AVERTISSEMENT
PROHIBITED
INTERDICTION
Do not operate the detector using any type of power supply other than the
one indicated on the rating label. Otherwise, it may result in fire or electric
shock.
N'utilisez pas l'appareil avec un type d'alimentation autre que celui indiqué sur
l'étiquette. Sinon, cela risque de provoquer un incendie ou un choc électrique
Do not handle the detector with wet hands.
You may experience an electric shock that could result in serious physical
injury or death.
Ne manipulez pas l'appareil avec les mains mouillées.
Vous pourriez subir un choc électrique pouvant entraîner la mort ou des
blessures graves.
Do not place heavy objects such as medical equipments on cables and
cords. Do not pull, bend, bundle, or step on them. These precautions are
required to be followed to prevent cable and cord sheaths from being
peeled. Do not alter the cables and cords. Otherwise, it may damage the
cords which could result in fire or electric shock.
Ne placez pas d'objets lourds tels que des appareils médicaux sur les câbles
d’alimentation, ne tirez pas dessus, ne les pliez pas, ne les regroupez pas et ne
marchez pas dessus pour éviter d'endommager la gaine. Ne les modifiez pas
non plus. Cela risque d’endommager les câbles et provoquer un incendie ou un
choc électrique
Do not supply power to more than one device simultaneously by using the
same AC outlet. Otherwise, it may result in fire or electric shock.
N'alimentez pas plus d'un appareil utilisant la même prise secteur. Cela risque
de provoquer un incendie ou un choc électrique.
Do not turn on the system power when condensation has formed on the
detector. Otherwise, it may result in fire or electric shock.
Ne branchez pas l’alimentation du système lorsque de la condensation s'est
formée sur l'appareil. Cela risque de provoquer un incendie ou un choc
électrique
Do not connect multiple portable socket-outlets or extension cords to the
system. Otherwise, it may result in fire or electric shock.
Ne connectez pas plusieurs prises secteur portables ou rallonges au système.
Cela risque de provoquer un incendie ou un choc électrique.

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Securely plug the power cord into the AC outlet.
Branchez fermement le cordon d'alimentation dans la prise secteur.
If contact failure occurs, or if dust or metal objects come into contact with
the exposed metal prong of the plug, fire or electric shock may result.
En cas de défaillance du contact, ou si de la poussière ou des objets
métalliques entrent en contact avec la broche métallique exposée de la fiche, il
y a risque d’incendie ou de choc électrique.
Be sure to turn OFF the power before connecting or disconnecting the
cords. Otherwise, you may get an electric shock that could result in death
or serious injury.
Assurez-vous que tous les appareils sont hors tension avant de connecter ou de
déconnecter les câbles d’alimentation. Sinon, il y a risque de choc électrique
pouvant entraîner la mort ou des blessures graves.
Be sure to hold the plug or connector when disconnecting the cord. If you
pull the cord, the core wire may be damaged, resulting in fire or electric
shock.
Assurez-vous de tenir la fiche ou le connecteur pour débrancher le câble
d’alimentation. Si vous tirez sur le câble d’alimentation, vous risquez
endommager le fil central et provoquer un incendie ou un choc électrique.
To avoid the risk of electric shock, this equipment must only be connected
to supply mains with protective earth.
Pour éviter tout risque de choc électrique, cet appareil ne doit être branché qu’à
une prise secteur avec terre de protection ».
To make it easy to disconnect the plug at any time, avoid putting any
obstacles near the outlet. Otherwise, it may not be possible to disconnect
the plug in an emergency.
Pour faciliter le débranchement de la fiche à tout moment, évitez de placer des
objets à proximité de la prise secteur. Sinon, il pourrait ne pas être possible de
débrancher la fiche en cas d'urgence.
Be sure to ground the equipment to an indoor grounded connector. Also,
be sure to connect all the earth connections for the system to a common
ground.
Assurez-vous de relier l’appareil à la terre avec un connecteur mis à la masse à
l'intérieur. Assurez-vous également que toutes les mises à la masse du système
sont connectées à une masse commune.
The product has lower breaking capacity type. So do not install at the
building power system prospective short-circuit current exceeding 16 A.
Les produits ont une capacité de coupure plus faible. Donc, ne pas installer
dans le système électrique du bâtiment un courant de court-circuit présumé
supérieur à 16 A
To make it easy to disconnect the plug at any time, avoid putting any obstacles.

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Battery Pack and Charger
WARNING
AVERTISSEMENT
Do not use the battery pack as a power source for equipment other than
EVS 4343W / EVS 4343WG / EVS 3643W / EVS 3643WG detector. Be sure
to use the battery pack dedicated to the EVS 4343W / EVS 4343WG / EVS
3643W / EVS 3643WG detector.
The battery charger is designed for the dedicated battery pack. Do not use
the battery charger other than the dedicated one. Ignoring this may result in
a battery explosion or a battery leak causing fire or electrical shock.
Do not operate the battery charger using any type of power supply, other
than the one indicated on the rating label.
Do not handle the product with wet hands.
Do not use the battery if battery connector is wet or moist.
Do not attempt to disassemble, alter, or apply heat to the product.
Avoid dropping or subjecting the product to severe impacts. To avoid the risk
of injury, do not touch the internal parts of the battery if it has been cracked.
Stop using the battery pack immediately if it emits smoke, a strange smell,
or otherwise behaves abnormally.
Do not let the battery pack and battery charger come into contact with water
or other liquids and do not allow them to get wet.
Do not clean with substances containing organic solvents such as alcohol,
benzene, thinner, or other chemicals. Otherwise, fire or electrical shock may
occur.
Do not allow dirt or metal objects (such as hair pins, clips, staples or keys) to
contact the terminals. Otherwise, battery explosion or leakage of electrolyte
may occur, resulting in fire, injury or pollution of surrounding area. If the
battery leaks and the electrolytes come into contact with your eyes, mouth,
skin or clothing, immediately wash it away with running water and seek
medical attention.
Do not leave, store, or place the product in a location near heat sources, or
in a place subject to direct sunlight, high temperature, high humidity,
excessive dust, or mechanical shock. Otherwise, battery leakage,
overheating or damage to the product may occur, resulting in electrical
shock, burns, injury or fire.
Do not attempt to use a battery pack that has deteriorated. Using a battery
pack that has exceeded its life cycle may lead to overheating, fire or
explosion.
The Lithium ion/polymer battery is recyclable.
Battery slowly discharges even if not in use.
The useful battery life will be expired if it discharges immediately after being
fully charged. You can purchase an optional battery pack to replace an
exhausted one.
The battery pack is a consumable item. If a fully charged battery is
consumed quickly, use a new and fully charged battery pack.
Be sure to charge the battery periodically (once a year) if it is not used for an
extended period of time. The battery pack cannot be charged if it has been
over discharged.

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Before discarding the battery pack, cover the terminals with adhesive tape
or other insulators. Contact with other metal materials may cause fire or
explosion.
Remove battery pack from equipment which is unused for a few minutes to
prevent discharge.
Handling
Manutention
WARNING
PROHIBITED
INTERDICTION
The system, partially or in whole, cannot be modified in any ways without
any written approval from DRTECH.
Le système, partiellement ou intégralement, ne peut être modifié de quelque
manière que ce soit sans l'accord écrit de DRTECH.
No modification of this equipment is allowed.
Aucune modification de cet appareil n'est autorisée
Never dissemble or modify the equipment.
Ignoring this warning may cause fire or electric shock, which may result in
severe personal injury or death by touching the components that cause
electric shock.
Ne jamais démonter ou modifier l'appareil.
Cela risque de provoquer un incendie ou un choc électrique. De plus, étant
donné que l’appareil comprend des pièces susceptibles de provoquer une
décharge électrique ainsi que d’autres pièces dangereuses, leur contact peut
provoquer des blessures graves, voire mortelles.
Do not place any object on top of the equipment.
The object may fall and cause an injury. If metal objects such as needles
or clips fall into the detector or if liquid spills, it may result in fire or
electric shock.
Ne placez rien sur l'appareil.
into he equipment, or if liquid isspilled, if may result in fire or electric shock.
L'objet peut tomber et causer des blessures. Également si des objets
métalliques tels que des aiguilles ou des pinces tombent dans l'appareil, ou si
un liquide y est renversé, cela risque de provoquer un incendie ou un choc
électrique.
Do not hit or drop the equipment.
The product may be damaged if it receives a strong jolt. Using a damaged
detector without repair may result in fire or electric shock.
Ne cognez ni ne laissez tomber l'appareil.
L’appareil peut être endommagé s'il subit une forte secousse, ce qui peut
provoquer un incendie ou un choc électrique si l’appareil est utilisé sans avoir
été réparé.

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Have the patient take a fixed posture and do not let patient touch the parts
unnecessarily.
If a patient touches connectors or switches, it may result in electric shock
or malfunction of the detector.
Demandez au patient de prendre une position figée et ne le laissez pas toucher
des composants.
Si le patient a touché des connecteurs ou des commutateurs, cela risque de
provoquer un choc électrique ou un dysfonctionnement de l'appareil.
Do not spill liquid or chemicals onto the equipment. Especially in cases
that the patient is injured, which requires the equipment to come in
contact with blood or body fluids, protect the equipment with a disposable
cover as necessary.
Ne renversez pas de liquides ni de produits chimiques sur l'appareil ou, dans le
cas où le patient serait blessé, éviter que l’appareil ne soit en contact avec du
sang ou d’autres liquides organiques. Cela risque de provoquer un incendie ou
un choc électrique
Dans une telle situation, protégez l’appareil avec un revêtement jetable, si
nécessaire.
Turn OFF the power to each piece of equipment for safety when not being
used.
Débranchez chaque appareil pour des raisons de sécurité lorsqu'il n'est pas
utilisé.
Handle the equipement carefully.
Manipuler l’appareil avec soin.
Do not submerge the equipement in water.
Ne pas plonger l'appareil dans de l'eau
The internal image sensor may be damaged if something hits against it, or
if it is dropped, or receives a strong jolt.
Le capteur d'image interne peut être endommagé si quelque chose le heurte ou
si il tombe ou subit une forte secousse.
Be sure to use the detector on a flat surface to ensure that the detector is
not bended. Otherwise, the internal image sensor may be damaged. Be
sure to securely hold the detector while using it in upright position.
Otherwise, the detector may fall over, resulting in personal injury, or may

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flip over, resulting in damage to the inner components.
Veillez à utiliser le détecteur sur une surface plane pour ne pas le plier. Sinon, le
capteur d'image interne risque être endommagé. Assurez-vous de tenir
fermement le détecteur lorsque vous l’utilisez en position verticale. Sinon, le
détecteur risque tomber et causer des blessures à l'utilisateur ou au patient, ou
pourrait basculer et endommager le dispositif interne.
Do not place excessive weight on the detector. Otherwise, the internal
image sensor may be damaged.
Ne placez pas un objet lourd sur le détecteur. Sinon, le capteur d'image interne
risque être endommagé.
When a problem occurs
Lorsqu’un problème survient
WARNING
AVERTISSEMENT
If any of the following problems occur, immediately turn OFF the power,
unplug the power cord from the AC outlet, and contact your sales
representative or local DRTECH dealer:
Dans les cas suivants, mettez immédiatement chaque appareil hors tension,
débranchez le câble d'alimentation de la prise secteur et contactez votre
représentant commercial ou votre revendeur DRTECH:
- When smoke, an odd smell or abnormal sound occurs.
Quand il y a de la fumée, une odeur étrange ou un son anormal
- When liquid has been spilled into the detector or foreign metal object has
entered inside the detector.
Lorsque du liquide a été renversé sur l’appareil ou qu'un objet métallique est
entré par une ouverture.
- When the equipment was dropped and damaged.
Lorsque l'appareil est en panne et endommagé.

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Maintenance and Inspection
Entretien et révision
WARNING
AVERTISSEMENT
PROHIBITED
INTERDICTION
When cleaning the detector, be sure to turn OFF the power and unplug the
power cord from the AC outlet. Do not use alcohol, benzene, thinner or
any other flammable cleaning agents. Otherwise, it may result in fire or
electric shock.
Lorsque l’appareil va être nettoyé, assurez-vous de le mettre hors tension et de
débrancher le câble d’alimentation de la prise secteur. N'utilisez jamais d'alcool,
de benzine, de diluant ou tout autre agent de nettoyage inflammable. Sinon,
cela risque de provoquer un incendie ou un choc électrique.
Clean the plug of the power cord periodically by unplugging it from the AC
outlet and removing dust or dirt from the plug. Clean the peripherals and
AC outlet with a dry cloth.
If the cord is kept plugged in for a long time in a dusty, humid or a sooty
place, objects around the plug will attract moisture, and this could cause
insulation failure that may result in a fire.
Nettoyez régulièrement la fiche du câble d’alimentation en la débranchant de la
prise secteur et en retirant la poussière ou les saletés de la fiche, de sa
périphérie et de la prise secteur à l’aide d’un chiffon sec. Si le câble reste
longtemps branché dans un endroit poussiéreux, humide ou couvert de suie, la
poussière autour de la fiche attirera l’humidité, ce qui risque de provoquer une
défaillance de l’isolation pouvant causer un incendie.
For safety reasons, be sure to turn OFF the power when performing the
inspections indicated in this manual. Otherwise, electric shock may occur.
Pour des raisons de sécurité, assurez-vous que tous les appareils sont hors
tension lorsque vous effectuez les révisions indiquées dans ce manuel. Sinon,
cela risque de provoquer des chocs électriques.

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Pediatric Patients
WARNING
AVERTISSEMENT
Health care professionals and hospital administrators take special care in
reducing radiation exposure to pediatric patients by following these steps:
Discuss the rationale for the examination with the patient and/or parent to
ensure a clear understanding of benefits and risks.
Reduce the number of inappropriate referrals (i.e., justify X-ray imaging exams)
by:
determining if the examination is needed to answer a clinical question,
considering alternate exams that use less or no radiation exposure, such as
ultrasound or MRI, if appropriate, and
checking the patient's medical imaging history to avoid duplicate exams.
Use the pediatric protocols or technique charts included as following table:
Table 1. Age categories
NAME
DEFINITION
FDA CODE
NEONATES
NEWBORNS UP TO ONE MONTH
NEO
INFANTS
ONE MONTH TO TWO YEARS
INF
CHILDREN
TWO YEARS TO TWELVE YEARS
CHI
ADOLESCENTS
TWELVE YEARS TO SIXTEEN YEARS
ADO
OTHER
OTHER AGE GROUP STUDIED
OTH
Table 2. Pediatric protocols
Age
categories
NEONATE
S
INFANTS
CHILDREN
ADOLES
CENTS
OTHER
Collimati
on size
Protec
-tion
Bodypart
kVp
mA
s
kVp
mAs
kVp
mA
s
kVp
mA
s
kVp
mAs
Skull AP
60
10
70
10
75
12
70
16
70
20
8 x 10
or 10 x 12
chest,
abdomen
Skull LAT
60
10
65
10
70
10
70
16
70
20
8 x 10
or 10 x 12
chest,
abdomen
Chest PA
70
1
90
2
90
2
90
4
90
4
10 x 12
or 14 x 14
abdomen,
gonadal
Chest LAT
80
2
90
2.5
95
2.5
100
4
100
4
10 x 12
or 14 x 14
abdomen,
gonadal
Abdomen
50
4
60
6.3
70
6.3
75
20
75
25
10 x 12
or 14 x 14
tyroid,
gonadal
Pelvis
50
4
60
6.3
70
6.3
75
20
75
25
10 x 12
or 14 x 14
gonadal
Please refer to the FDA website for details on pediatric information.
http://www.fda.gov/Radiation-
EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298
899.htm

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1.1 Medical Equipment Safety Standards
1.1.1 Medical Equipment Classification
Type of protection
against electrical shock
Class I ME Equipment
Degree of protection
against electrical shock
Type B Applied Parts
(Applied Part: Detector panel)
Degree of protection
against ingress of water
IP54
Mode of operation
Continuous Operation
Flammable anesthetics
Not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide
1.1.2 Product Safety Standards
USA and Canada
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance
IEC 60601-1-2 Ed.4: 2014
Medical electrical equipment-Part 1-2:Collateral
standard: Electromagnetic compatibility-Requirements and
tests
European Union
IEC 60601-1:2005 + C1:2006 + C2:2007
+ A1:2012
Medical electrical equipment –Part1 : General requirements
for Safety
EN 60601-1-2:2015
Medical electrical equipment–Part 1-2 : Collateral standard:
Electromagnetic compatibility-Requirements and tests
IEC 60601-1-6 : 2010 + A1:2013
Medical electrical equipment –Part 1-6: General requirements
for basic safety and essential performance –Collateral
standard: Usability
IEC 62304:2006 + A1:2015
Medical device software–Software life cycle processes

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IEC 62366:2007 + A1:2014
Medical device –Application of usability engineering to
medical devices
EN ISO 14971:2012
Medical device –Application of risk management to medical
devices

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1.2 Declaration of Conformity
1.2.1 Declaration of Conformity for EU Area