(Manual) Ecoview9plus
(Manual) Ecoview9plus
Ecoview9 Plus
[Installation, Operation and Service Manual]
ECORAY Co.,LTD
3F Urbanlight B/S, 630, Eonju-ro, Gangnam-gu, Seoul, KOREA 135-832
Factory at 621-17, dochun-dong, Gwangsan-gu, Gwangju, KOREA
Tel)+82 70 7510 3400
Email to [email protected]
Ecoview9 Plus Installation, Operation and Service Manual
- Table of Contents -
3. Safety …………………………………………….………… 13
3.1 Safety instructions
3.2 General details
3.3 Electrical shock or explosion safety
3.4 Radiation safety
3.5 Radiation protection
3.6 EMC
3.7 Product disposal
6. Installation …………………………………………….………… 33
6.1 Introduction
6.2 Site conditions
6.3 Electricity required
6.4 Preparations before start
6.5 Unpack
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9. Maintenance …………………………………………….………… 99
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Chapter 1
Introduction
[Ecoview9 Plus]
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1. Manual Introduction
1.1 Introduction
This manual describes on how to install Ecoview9 Plus, repair and how to efficiently
manage and maintain the system.
Copyrights of this manual is reserved only to EcoRay Co. Ltd., and is prohibited to copy and
use it without the approval of EcoRay Co. Ltd.
1.2 Contents
The images in the manual are only example and can be different from the actual product. In
addition, the manual explains only about the system for the equipment with all possible
accessories applied and it may not include explanation for the different system
configurations of the equipment you selected.
It is recommendable to read and understand the manual before using the equipment and
keep the manual where can be easily found to avoid losing or damage it.
1.3 Service
Contact information to request technical support or purchase accessories
EcoRay Co. Ltd.
TEL: (+82)-70 7510 3400
FAX: (+82)-70 8630 3420
e-mail: [email protected]
Homepage: www.ecoray.kr
1.5 Responsibility
√ EcoRay Co. LTd., is responsible for the safe maintenance, repair or modification of the
equipment only performed by the authorized personnel.
√ EcoRay Co. Ltd., will be not responsible for any defects and damages caused by the
ignorance of the safe maintenance regulations or disuse of the system.
√ EcoRay Co. Ltd., must be assure that the equipment have been installed and managed
only by the trained and qualified personnel.
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Chapter 2
Product Introduction
[Ecoview9 Plus]
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2. Production Introduction
2.1 Introduction
Ecoview9 Plus uses X-ray radiation for patient image diagnosis and is composed basically of
X-ray generator, tube support, patient table, upright stand, collimator, and hand switch for
exposure.
2.4 Features
Ecoview9 Plus can be used in the operating room, the emergency room and for other clinical
purposes with the following features.
√ Having stable X-ray output with a high frequency inverter type, produces low voltage
ripple.
√ Has self-diagnostic processor that detects malfunction of the equipment.
√ Is operated by dual filament.
√ Is operated by dual anode stator.
√ The tube Filament current is protected and controlled by processor.
√ Has protective system to prevent X-ray tube overheating.
√ The high voltage is constant and stable controlled by high voltage feedback circuit that
provides safe and stable reproducible dose[CV].
2.5 Warnings
Human exposure to ionizing radiation must be always medically justified. Especially
pregnant women, children and teenagers.
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2.6 Options
This manual describes the equipment with all features included. Therefore, it may not be
included explanations depending of selected features.
2.7 Training
After the installation of the system, EcoRay Co. Ltd, engineers or representative/dealer of
EcoRay Co. Ltd., will offer training of the equipment to the expected user.
If you have any additional questions or information you can reach to the personnel via the
contact information indicated in the manual.
2.8 Regulations
√ The Ecoview9 Plus is a radioactive equipment, must be used in accordance with
regulations and be sure to read and understand the regulations to radiation before
use.
2.9 Category
The system as an electrical medical equipment is classified as below.
√ IEC 60601-1
√ IEC 60601-2
√ IEC 60601-1-3
√ IEC 60601-1-6
√ IEC 60601-2-28
√ IEC 60601-2-54
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Item Details
Age All ages
Weight No restrictions
√ Pregnant women excluded
Health status
√ Patients with implanted pacemakers or cardiac shocker excluded.
Country Multiple
Item Details
Sex No restrictions
Country No restrictions
Fault tolerance Must have no disabilities and corrected visual acuity of 0.7 or higher.
Height of 140cm or more
Other
By looking the equipment in advance, stability can be verified
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2.14 Symbols
European
Manufacturers European representative
representative
Date of
Product date of manufacture
manufacture
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2.15 Labels
The labels indicate product name, model, power environment, production date, manufacturer,
manufacturer address, product identification number, etc and are located as follows.
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Chapter 3
Safety
[EcoView 9 Plus]
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3. Safety
3.1 Safety instructions
This manual does not include all safety measures required for each special operating conditions
or safety measures operation for each medical equipment.
However, it contains instructions that must be followed to ensure the safety of the operator and
patient and prevention of property damage.
Such guidelines are highlighted as follows:
▶ DANGER
Indicates a hazardous situation which could result in death or serious injury if the mark
instructions are not followed.
▶ WARNING
Indicates a hazardous situation which could result in death or serious injury if is not avoided.
▶ CAUTION
Indicates a hazardous situation could result in minor or moderate injury if is not avoided.
▶ NOTE
Above display is simply informative. Add a hint or description to provide useful information for
the operator and patient.
▶ WARNING
In order to operate the system as intended, be familiar with the contents of this manual.
Read and understand this manual before operating the system.
Is important to comply with all safety instructions and warnings.
▶ WARNING
The user is responsible for the operation and maintenance of the medical equipment.
▶ WARNING
Unauthorized modifications and changes of the equipment can lead to dangerous consequences.
Changes or corrections of the equipment must be performed after EcoRay Co. Ltd., approval.
▶ WARNING
Do not connect or install uncertified devices to the equipment.
Devices or external devices must be installed by qualified service engineer authorized by the
manufacturer.
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Operation
The EcoView 9 Plus is a radiation imaging equipment, must be operated by users trained or with
qualified license and with permission.
▶ WARNING
Do not operate the equipment if flammable gas is present.
If operated when flammable gas is present, there is risk of fire and explosion.
▶ WARNING
Do not use disinfectant sprays that are flammable or explosive. Disinfectant sprays can be a
cause that harms life, cause serious injuries and damage the equipment.
▶ WARNING
In order to avoid electric shock risk, the protective ground must be connected to the system.
▶ WARNING
Even using the intended radiation dose, there is critical influence of high risk in the process.
▶ WARNING
Only operators who are trained must use the equipment.
▶ WARNING
Must follow with radiation regulations of the country where the equipment is installed.
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▶ WARNING
When the hand switch is not being used, place it to its assigned place.
Patient protection
To minimize radiation exposure to the patient, long focal distance of exposure must be
maintained.
3.6 EMC
The EcoView 9 Plus as a medical equipment, special precautions, service and installation must be
done in accordance with EMC guidelines.
The EcoView 9 Plus, by EMC tests does not have to receive interference of portable and mobile
RF communications systems.
▶ WARNING
Using a non specified device can interfere with the equipment electromagnetic emissions.
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Chapter 4
System configuration
[Ecoview9 Plus]
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4. Product Configurations
4.1 Product Configuration
Ecoview9 Plus is X-Ray diagnostic imaging system which it uses radiation to diagnose
patients that it comprises with generator, tube support device, patient table, upright stand,
and collimator.
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3
3 Tube Support Unit Maintain position of X-ray tube (left & right, back & forth, rotation)
4 Table Bucky The device where a patient can lay on for examinations.
5 Stand Bucky The device can take images from patient’s standing position.
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4 HVT Tank Controlled by generator and firing up High Voltage to X-ray tube.
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Rear view
13 MIO Board port Connecting port between Mio board and OP console
14 Hand switch port Connecting port between Hand Switch and OP console
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Overview
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Overview
1 Table top The plate where a patient can lay down for X-ray examination
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Overview
1 Stand holder A patient can hold this bar for Lateral Exam
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4.2.7 Collimator
Overview
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Overview
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Chapter 5
Specifications
[Ecoview9 Plus]
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5 System specifications
5.1 Dimension & weight
▶ CAUTION
Following info can be changed by different Revision or/and additional options.
5.1.1 Generator
■ Size (Unit: ㎝ ±10%)
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5.2.4 Collimator
Type Manual
Inherent Filtration 1.2 mmAl
Maximum Tube voltage 150kVp
Maximum X-ray Field 46 x 46 ㎝ at SID 100 ㎝
LUX 160Lux
Lamp timer Approx. 30sec (Push button type)
Power voltage AC/DC24V
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Movement (Up & Down) 400~1600mm (between the center of detector and floor)
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Chapter 6
Installation
[Ecoview9 Plus]
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6.1 Introduction
This chapter explains how to unpack the unit from the box and install correctly at site so please read
carefully and follow the instruction accordingly. Before you start, please check all the inner box
items and compare it with given list.
▶ WARNING
The site safety circumstances must be strictly fulfilled the required conditions, otherwise the
device and installation activity can be harmful or to be a cause of trouble.
The device has been designed and produced under high level safety standard and it requires well
trained personnel or technicians strictly for usage to preserve operators and patients from any
possible X-ray radiation overdose.
All related personnel should obtained required license with permission before its use. Additionally
they must keep the regulation of self-protection with accessories and protection kits wear.
▶ WARNING
Any physical damage found during unpack, please contact the local distributor or manufacturer
about the details then proceed the installation under the confirmation about it.
▶ WARNING
If cable connections or alliances are not correct, or there is any cable damage found during the
installation procedures, please do not power on the unit and contact the local distributor or
manufacturer to make report for appropriate action against it.
▶ WARNING
This manual contents must be read and studied enough by installation personnel before start.
Operating conditions
√ Ambient temperature range 10 C to 40 C (50 F to 104 F)
√ Relative humidity range 30% to 75%, non-condensing
√ Atmospheric pressure range 700 hPa to 1060 hPa
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Required tools
Please be prepared with following tools
√ Hand tools and normal servicing tools. (Ex, screw drivers, rench drivers etc)
√ Digital water level
√ Rotation laser
√ Hammer drill
√ Nipper
√ Pliers
√ Multi tester
√ Leakage current tester for measurements according to IEC 60601-1
√ Protective ground wire tester for measurements according to IEC 60601-1
√ Assorted cable ties
√ Lift
√ Oscilloscope
6.5 Unpack
6.6.1 Check installation space correctly and confirm the cable route and each part position.
■ Conduits.
■ Space requirements. (Unit: mm)
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▶ WARNING
For the Floor rail, the horizontal and vertical balance is very important once the tube stand is well
installed. Check entire level of floor rail from left end to right end, rear & front side.. please verify the
balance status by using balance bubble kit.
If this balance is not perfect, the tube stand would not work properly and this will affect to image
quality directly.
■ Check vertical & horizontal balance by the measurement kit. (please see the photo) – please
put something below the bottom side of rail in order to make correct balance.
■ Once the balance is O.K, install tube stand on the floor rail and assemble the tube &
collimator.. Then check the balance again on tube itself.
■ When all the rest parts are installed correctly, put anchor bolt holes and fix the rail with
Wedge Anchor bolts.
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Stand
Bolted
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■ Put X-ray tube on Tube York – at this time, please insert weight balance plates into behind of
Tube Stand.
Open the rear cover of Stand, put weight balance plates to make perfect balance for Tube arm.
The weight is increasing when you put X-ray tube and collimator.
Attention : the weight balance plates are very heavy, so please be careful when you
handle the plates. And the plate should not escape from the lack.
Once the weight balance work is correct, please close the rear cover.
■ Assemble the collimator and Tube head side wiring.
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AC1
No.3: P703 in Handle Bar PCB goes to P907 on Stand Lock board.
No.4: P601 in Handle Bar goes to Angle sensor.
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■ Lock cabling
● Locker are Up/ Down, Front/Rear, Left/Right, Column Rotation, Tube Rotation Lock.
● Please pay your attention to the Lock board location – see below photo.
Lock Board
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3 2 1
No.1: Connection between AC3 (Handle Bar Power) and P914 on Stand Lock Board.
No.2: Connection between P910 on Lock board and Front/Rear Lock.
No.3: Connection between P913 in Stand Lock Board and Tube Rotation Lock.
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Connecting Hole
No.1: Connection between P911 on Stand Lock Board and Left/Right Lock.
No.2: Connection between P915 on Stand Lock Board and Up/ Down Lock.
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Temperature Switch.
● Tube Anode side is consist of following points (see below photo).
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▶ WARNING
Table top should be flat with perfect balance at both of longitudinal way and transverse way.
Otherwise table top will be sleepy and not giving correct imaging.
6.8.1 Installation
■ Move the device the desired position.
■ By using bubble balance kit, please make longitudinal and transverse balance.
■ When the balance is good, fix the position with anchor bolts. Before you do this, make sure
if table center and Bucky Stand (Wall bucky) center should be match.
■ Fix the device with Wedge Anchor bolt.
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▶ WARNING
Stand Bucky is also necessary to keep vertical and horizontal balance. This is important for patient
positioning and image quality.
6.9.1 Installation
■ Carry the device to the right position.
■ Make the horizontal & vertical balance.
■ When the balance is good, fix the position with anchor bolts. Before you do this, make sure if
table center and Bucky Stand (Wall bucky) center should be match.
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▶ WARNING
The long ceiling rail goes to ceiling side – and ceiling frame of the room must hold the long rail
hard enough. This is one of most important points in ceiling rail installation. If inside ceiling
frame is not strong enough, it would be a cause of ceiling unit falling down or crash.. this can be a
serious disaster with safety issue.
▶ WARNING
Ceiling device must work correctly with perfect balance – horizontal & vertical – rear side and front
side / left end to right end as well. Incorrect balance will bring malfunction of tube stand travel or
affect to image quality after all.
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■ And dismantle the rail to make separate rail frames of 1,2,3 and 4 like below photo.
1 2
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▶ NOTE
The bolts would not join tight at this time since the rail distance should be adjusted.
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■ The long rails are joined to ceiling frame (see below photo)
■ Once the stopper is installed, then measure the distance between 2 long rails. (see below
photo)
* when 2 side distance is same, you can join the bolts tight enough.
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■ If there is any deviation, just adjust it by moving short rail bearing plate position.
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■ Install Short rail (lower rail) into Long rail (upper rail) – insert the bearing into the slot.
■ When you insert the rail, please pay your attention to Main bearing (bigger one, upper side)
and Guide bearing (lower side smaller one).
Guide bearing
Main bearing
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■ Cover close.
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NOTICE : This ceiling unit is very heavy (over 150kg), so you need a specialized lift or 5+
people to lift it up together.
Be careful not to have any safety issue – possible to meet accident during the lift because
the unit must be installed at overhead height..!!!
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Lock Free
Lock
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■ At Lockfree condition, you can scroll the column down to appropriated height for tube
assembly.
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■ Remove upper Yoke – this will be installed again with Tube later.
■ If balance needs to be adjusted, please unscrew the side bolts and shift the holder for perfect
balance. (and join the bolts tight when the balance it good)
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■ When the balance is good, put Tube on the position and cover the upper Yoke then join the
tube angle fixing bolts.
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■ Check the collimator components like bolts and plates. (please see the photo below).
Collimator
Fixing bolts
Al Filter Collimator
Ring
bracket
■ Before collimator module installation, please put AL filter first and bracket then insert
collimator ring with screws.
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6.10.5 Cablings
■ Tube handle bar side cable connections.
● The locations
Hand Switch
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● Connection check
4-Way Bucky Table
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Female Connector
■ Check and prepare for communication cable, magnetic lock cables well like the photo below.
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Make correct wire position on anode side. (the location of each wire is important!!)
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Column rotation
Lock switch port
Tube rotation
Lock switch port
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To Generator
GC Board
To Console SUB
Connector
● Handle Bar Cabling and Tube anode cabling and its order.
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Lock
PCB
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■ BAND connection
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Chapter 7
[Ecoview9 Plus]
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● When the boot-up is over and the system is ready with following screen display.
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Chapter 8
[Ecoview9 Plus]
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8.1 Generator
Power Input
● Main power input
√ Main power will be engaged through the main circuit breaker in the room.
√ When the proper AC power connected to the generator, check Power standby Lamp
on the console; the light should be ON (yellow) with appropriate power input.
√ In case there is no light or different color on the field, just check the input power
status or connections.
Power ON
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√ When the error occurs, press ‘Reset’ button to make CPU refresh and continue to
use it. If error is still alive even you make Reset, it would be a sign to require
technical service / treatment to the system.
√ To make sure about the error, please turn off the unit and ON again to check if the
same error is coming or not.
Power OFF
● Main power off.
√ Shut the main circuit breaker down.
√ Power Lamp (and On/Off lamp) on OP console will be OFF.
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Large Focus
Small Focus
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Reset button
● This button refreshes CPU from error code display. Once an error does not disappear
with Reset, you should contact for technical service.
Reset button
● mA adjustment
√ mA value is adjustable at mA field and moves from 10 to 800mA what displays on
LCD window.
● Time adjustment
√ When the function is selected at Time, adjust it by up/down keys (from 1msec to 6
sec) and it is displayed on LCD window.
● mAs adjustment.
√ Select at mAs and adjust it (displayed on LCD window)
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Body part
Exposure direction
√ The adjusted data could be saved into the microprocessor by value storage key, if it
is required. The original data is not changed in case you don’t save new data.
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Sensor selection
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● X-ray exposure setting values (kV, mA, Time) can be changed, if necessary.
● Chamber selection
√ Once AEC is selected, chose Bucky location.
√ AEC chamber position will be automatically fixed by Bucky location as below.
√ Bucky1 [Chamber1]
● X-Ray exposure
√ When every value and setting is finished, you can make X-ray exposure right away.
Once exposure is done, total exposure time will be displayed in Time field.
● mAs Overload
√ mAs = mA x sec and the alert lamp is on when mAs value is over 500mAs. X-ray
can’t be used with this mal on. mAs value should be decreased to use it gain. (mA
down or Time reduce or mAs value decrease)
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● Ready indication
√ Once you press Ready key, the indication is ON about a sec later.
● X-Ray indication
√ Ready stage is OK, you make an exposure of X-ray through a Hand Switch or OP
console. X-ray indication lamp is ON as long as X-ray is being exposure. – X-ray will
be performed upon time setting of operation.
√ When X-ray exposure is over, OP console produce ‘beep’ sound to alert that X-ray
exposure is being exposure.
● Ready switch
√ When X-ray output setting is done, please press it. This will make machine to be
ready for X-ray exposure.
√ Once the unit is got ready, the Ready lamp is ON.
● X-Ray switch
√ Press down to Exposure status at Ready position.
√ Beep sound will continue during X-ray exposure and hold the X-ray switch until the
X-ray exposure is completely done. Then release the switch.
.
X-Ray button
Ready button
X-ray exposure time is decided by OP console operation, and users should hold the
X-ray switch as long as X-ray exposure is completed. Otherwise, unit will produce
error code.
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4 Lock for left & right Free for longitudinal way move. (press it to release)
5 Rotation Lock button Press it when the tube needs to be turned (release it to be locked)
7 Transverse Lock button Free for transverse way travel (tube back and forth)
8 X-ray parameter display kV, mA, mAs are engaged from Generator
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When the angle display and actual angle is not matching, it is necessary to make calibration for
correct display. (Calibrate and save the new data)
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● And the icon will turn to Green color and Calibration mode will be displayed right away.
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■ Angle calibration
● 0˚ position setup
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(5) And current display value will be adjusted. (any number will be turned to 0)
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Chapter 9
Maintenance
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9 Maintenance
To ensure satisfactory operation, Ecoview9 Plus requires periodic planned maintenance and
routine user checks. These are essential to keep the equipment operating safely, effectively and
reliably. Planned maintenance may only be carried out by qualified and authorized service
technicians. In this context, qualified means those qualified to work on this type of medical
electrical equipment in the jurisdiction in which the equipment is being used, and authorized
means those authorized by the user of the equipment. Ecoview9 Plus is able to provide a full
planned maintenance and repair service on either a call basis or a contract basis.
Maintenance Schedule
Check the following functions or perform the following maintenance work at the specified time
intervals:`
Working Check X-ray exposed or not when push the “X-ray” button. ○
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An Overview
The purpose of this Periodic Maintenance is to assure continued safe performance of the
X-Ray generator, to increase serviceability, to reduce the cost (save time, repairs, etc.)
and to assure the safety (personal risk).
The following checks and maintenance procedures, together with the suggested intervals,
are the manufacturer’s recommendation for the most effective periodic maintenance
schedule for this generator.
If X-ray system is out of order, contact local distributor or manufacturer ask service.
General cleaning
● External surfaces cleaning
√ Clean external covers and surface frequently (without cloth).
√ If chemical is present on the surface, clean it quickly to protect rust.
√ Use dry clothe when cleaning the surface.
√ Do not use cleaners or solvents of any kind.
√ If external surface is scratched, touch up if need.
Never attempt to clean or handle any part of the X-Ray generator when it is turn on.
Switch off the generator main disconnect before cleaning or inspecting.
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Cable check
● Check that all electrical connections are firm and secure and that all cable clamps and
strain relief are in place.
● Also check that connectors do not have exposed wires and check cable Sheaths for
wear and fraying.
Console check
● Check hand switch wiring condition.
● Check correct operation of console switches, displays and indicators by performing the
following test:
● Check console standby lamp lighting with yellow.
● Push the “Power On” button of console and supply electric power to generator.
● After system checking, changed normal mode to use or not.
● Check all switches working condition.
● Set over X-ray exposure value and check “Over Load” message display or not.
● Check “Ready” and “X-Ray” switches working condition.
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Chapter 10
Troubleshooting
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10 Troubleshooting
Scope
Ecoview9 Plus observes x-ray generator state in real time with circuit, if x-ray generator
troubled, display trouble message to the console. Troubles set with error code to be
understood more easily by Operator or engineer.
Tools
Essential tools and testers are as below. And if needs other tools or tester should be prepared by
trouble states.
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Consist of part
Connect (P805)
Fuse (F801)
Connect (P803)
Connect (P802)
Connect (P804)
Relay (RLY802)
L.Volt(VR801),C.Volt(VR802)
Test Point (TP802,803,804,805)
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Variable Resistor(VR702)
Consist of part
Variable Resistor(VR701)
Diode(D707,709)
Test Point(TP106)
Connector(P706)
Test Point(TP105)
Variable Resistor(VR901)
Test Point(TP109)
Test Point(TP111)
Connector(P702)
Connector(P901)
LED(D906,911,912 Fuse(F901)
)
Variable Resistor(VR902)
Temperature Relay
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IGBT Device signal and Protection circuit error (Check ECO-XR5-FnD Board)
Consist of part
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● Check wiring condition of ECO-XR5-FnD Board and check IGBT_OCP trouble when IGBT Device
signal and protection circuit troubles. And check procedures are as follows.
Displayed on console
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Consist of part
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Chapter 11
Circuit diagram
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11 Circuit diagram
11.1 System Block Diagram
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