ROLENCE ENTERPRISE XR-01 User manual

S-19-01-1500-U0001 V 1.5
Portable X-ray System
XR-01
USER’S MANUAL
Rolence Enterprise, Inc.
No.18-3, Lane 231, Pu Chung Rd., Chungli, Taoyuan 32083, Taiwan
TEL: [phone]; FAX: [phone],
www.rolence.com.tw; [email protected]

Table of Contents
2
S-19-01-1500-U0001 V1.5
I.
CERTIFICATE OF WARRANTY ..............................................................4
1.1
Range and terms for warranty ............................................................... 4
1.2
Requirements on After service call ........................................................4
1.3
Development Policy...............................................................................4
II.
GETTING STARTED.................................................................................. 5
2.1. Intended Use ........................................................................................ 5
2.2
Principle of Operation ............................................................................ 5
2.3
Compliance ........................................................................................... 5
2.4
Cleaning ................................................................................................ 6
2.5
Symbols ................................................................................................ 7
III.
SAFETY. ................................................................................................8
3.1
Electrical Safety..................................................................................... 8
3.2
Electrical Fire......................................................................................... 9
3.3
Electromagnetic Compatibility Statement .............................................. 9
3.4
Radiation Safety .................................................................................. 10
3.5
Storage and Transportation Environment ............................................ 13
IV.
PRECAUTION......................................................................................14
4.1 Radiation Safety Precaution ................................................................14
4.2
Caution when user starts to use .......................................................... 15
4.3
Checking Before Operating .................................................................15
4.4
System Malfunction ............................................................................. 15
4.5
Inspection............................................................................................ 15
Table of Contents

Table of Contents
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S-19-01-1500-U0001 V1.5
V.
COMPOSITION.....................................................................................16
5.1
Composition ........................................................................................ 16
5.2
AC/DC adaptor for recharging.............................................................. 16
5.3
Battery................................................................................................. 17
VI.
EXPLANATION OF EACH PART .............................................................19
6.1
Main Dislpay and Control Panel........................................................... 20
VII.
OPERATION.......................................................................................21
7.1
Power On ............................................................................................ 21
7.2
Adjustment of Exposure time............................................................... 22
7.3
Exposure ............................................................................................. 24
7.4
Battery recharging and operation time................................................. 25
7.5
Periodic Check .................................................................................... 25
VIII.
Maintenance plan..............................................................................26
8.1 Daily Maintenance ............................................................................... 26
8.2 Battery Maintenance............................................................................ 26
8.3 Annual Maintenance............................................................................ 26
8.4 Calibration Check ................................................................................ 26
8.5 Maintenance Log sheet……………………………………………………..27
IX.
HELP MESSAGE...............................................................................28
9.1 Error Code........................................................................................... 28
X.
DISPOSAL........................................................................................................... 29
XI.
TECHNICAL DATA............................................................................................ 29
11.1 Basic Technical Specifications ........................................................... 29
11.2 X-Ray Tube Specifications and Characteristics .................................32
11.3 Wiring Diagram.................................................................................. 36
11.4 EMC Test Report………………………………………….……………….37

Certificate of Warranty
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S-19-01-1500-U0001 V1.5
I.
CERTIFICATE OF WARRANTY
1.1
Range and terms for warranty
Rolence guarantee this product without any expense for the malfunction or
disorders occurred under standard transportation and operation within 1year
from installation.
1.2
Requirements on After service call
When the malfunction or disorder appeared, stop operating and check again
the related article of this “User’s Manual”.
Before your calling, please put off this equipment and check for the model
name, serial No. and purchasing date.
Rolence Is not responsible for indirect harm.
Rolence cannot warrant for defect or harm after warranty period.
1.3
Development Policy
Rolence pursues a policy of continual product development. Although
every effort is made to produce up-to-date product documentation this
manual should not be regarded as an infallible guide to current
specifications. We reserve the right to make changes without prior notice.

Getting Started
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S-19-01-1500-U0001 V1.5
II.
GETTING STARTED
2.1
Intended Use
The XR-01 Portable X-Ray System is intended to be used by trained dentists
and dental technicians as an extraoral x-ray source for producing diagnostic
x-ray images using intraoral image receptors. Its use is intended for both
adult and child subjects
2.2
Principle of Operation
Rolence Portable X-Ray system XR-01 is designed for use in radiography to
find hidden dental structures, malignant or benign masses, bone loss,
cavities and other areas of dental diagnosis. The controlled x-ray beam
penetrates oral structures at different levels, which depending on varying
anatomical densities, and then exposures onto image receiver such as film or
digital sensor to form a radiography image.
2.3
Compliance
The owner/operator is responsible for verifying continued compliance
exposure rates, leakage radiation, alignment of the useful beam, and the
calibration of kVp and mAs. Annual verification by a qualified service
technician may be required by federal law. Compliance with applicable
statutory and regulatory requirements is the responsibility of the
owner/operator. Consult local, state, and/or federal agencies regarding
specific requirements and regulations applicable to the use of this type of
medical electronic equipment.
Caution: U.S. Federal law restricts this device to sale by or on the order of a
physician or other licensed practitioner.
CAUTION!

Getting Started
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S-19-01-1500-U0001 V1.5
2.4
Cleaning
Ensure the adaptor is unplugged before attempting to clean. To make sure
that power is off while cleaning. Use a non-alcohol based disinfectant only -
wipes or a cloth dampened with liquid or spray. The system is not designed
to be subjected to any kind of sterilization procedure and not designed to be
used to sterilize anything else.
Do not modify this equipment without authorization of the manufacturer.
WARNING
!

Getting Started
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S-19-01-1500-U0001 V1.5
2.5
Symbols
Symbols used in this publication and used mark on the equipment have the
following meanings.
Symbols Description Symbols Description
X-Ray Source Assembly, Electrical Shock
Emitting Hazard
Warning;
Radioactive material High Voltage
or ionizing radiation
Consult Accompanying Attention,
Documents Consult Accompanying
Documents
Consult Accompanying WEEE Mark
Documents
Type B Applied Part
WARNING
Warning is given in situations and circumstances in which a serious hazard
for the patient or user can be happened.
CAUTION
Cautions are given in situations or circumstances in which the equipment
can possibly be damaged, or a threat of minor personal injury can be
happened.
NOTE
Notes are given in situations requiring special attention to operate this
equipment.

Safety
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S-19-01-1500-U0001 V1.5
III.
SAFETY
3.1
Electrical Safety
Observe the following safety procedures to avoid electric shock or serious
injury to operators and patients and to avoid system malfunction.
●
Under no circumstance should the safety interlocks in the system be
bypassed, jumped, or otherwise disabled.
●
Under no circumstance should the system or assembly covers be removed
by anyone other than a Rolence trained service representative.
●
Do not place food or beverage containers on any part of the equipment.
They can trip over and introduce conductive substances into the electrical
circuitry.
Electrical circuits inside the equipment use voltages which are capable of
causing serious injury or death from electric shock.
To avoid this hazard, operators should never remove any of the cabinet
covers.
WARNING
!
This system is not waterproof. Water, soap, or ot
her liquids, if allowed to drip
into the equipment, can cause electrical short circuits leading to electric
shock and fire hazards. If liquids should accidentally spill into the system
electronics, do not connect the power cord to a supply connection or tu
rn the
system on until the liquids have dried or evaporated completely.
WARNING
!

Safety
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S-19-01-1500-U0001 V1.5
3.2
Electrical Fire
The user should develop an emergency procedure for the area in which the
system is used that includes the following safety measures:
●
Turn the system off and unplug the main power cable from the outlet.
●
Evacuate everyone from the area.
●
Call for help.
●
Use only a fire extinguisher of a type approved for electrical fires.
3.3
Electromagnetic Compatibility Statement
This generating equipment, used and related to radio frequency energy, if not
installed and used in accordance with the instructions, may cause harmful
interference to other devices in the vicinity. However, there is no guarantee
that interference will not occur in particular installation. If this equipment does
cause harmful interference to other device, which can be determined by
turning the equipment off and on, the user is encouraged to try to correct the
interference by on or more of the following measures.
●
Reorient or relocate the receiving device.
●
Increase the separation between the equipment.
●
Connect the equipment into an outlet on a circuit different from that to
which the other device(s) are connected.
Consult the manufacturer or field service technician for help.
The use of the wrong type of fire extinguisher presents electrical shock and
burn hazards. To avoid these hazards, a fire extinguisher which has been
approved by the approp
riate local, state, and federal codes must be available
in the room where the equipment is being used.
CAUTION!

Safety
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S-19-01-1500-U0001 V1.5
3.4
Radiation Safety
3.4.1
General
This X-Ray tube assembly produces ionizing radiation when energized.
Hence, when, used, it can be better that the authorized operators wear
X-ray Protective devices like X-Ray protective apron, glove or thyroid cover,
etc.
It is imperative that the owner designates areas suitable for safe operation
and service of the system and operator ensure that it is used only in these
designated areas.
It is the responsibility of the owner to ensure that all personnel wear
protective clothing and radiation monitoring devices while using this system.
This x-ray unit may be dangerous to patient and operator unless safe
exposure values are used and correct operating procedures are observed.
WARNING
!
The beam limiting device(Collimator cone) is lined with Pb because of
leakage radiation.
NOTE !

Safety
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S-19-01-1500-U0001 V1.5
3.4.2
Handheld
Rolence XR-01 Portable X-Ray can be used handheld equipment; it is convenient
for use anytime anywhere.
3.4.3
Significant zones of occupancy
Please establish significant zone of occupancy as following and puts
individual defense tool such as apron in this area and face in radiography.

Safety
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S-19-01-1500-U0001 V1.5
3.4.4
Leakage and Scatter Measurement Information
Annual Occupation Dose Limits
Type Occupational Dose Limit
Total effective dose equivalent 50 mSv
Lens of the eye 150 mSv
Skin 500 mSv
Hands and feet 500 mSv
 Specified in 10 CFR 20.1201 and 10 CFR 20.1208
Leakage
The inherent shielding of XR-01 was sufficient to eliminate leakage radiation.
The measurement was performed at 10 mm from the device surface at 9
points as follows: (Unit: mGy/hour)
According to FDA guidance “Radiation Safety Considerations for X-Ray
Equipment Designed for Hand-Held Use” and IEC 60601-1-3 standard,
leakage radiation shall not exceed 0.88 mGy/hour and 0.25 mGy/hour
respectively. All shipped XR-01 have been inspected strictly with leakage
limit 0.04 mGy/hour, which is 6.25 times than IEC regulations.
Scatter
The vertical and horizontal significant zone have been established by
internal design verification. The estimated annual dose to operators who stay
in safety zone is approximately 1 mSv if maximum exposure time is assigned
for each exposure.
0.028
0.001
0.012
0.023
0.0021
0.028
0.027
0.027
0.027

Safety
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S-19-01-1500-U0001 V1.5
3.5
Storage and Transportation Environment
Avoid the following environments for storage or transportation;
●
Where the equipment is exposed to water vapor.
●
Where the equipment is exposed to direct sunlight.
●
Where the equipment is exposed to dust.
●
Where the equipment is exposed to high humidity.
●
Where there is a ventilation problem.
●
Where the equipment is exposed to a salty atmosphere.
●
Where the equipment is exposed to chemicals or gas.
For normal operation, you must keep away from the place with a Strong
vibration and maintain the following range of temperature and humidity.
Usable range of temperature and Relative humidity
●
Temperature : -5°C ~ 40°C
●
Humidity : 30% ~ 75% RH
●
Atmosphere : 700 ~ 1060hPa
●
For storage and transportation condition, you must maintain the following
range of temperature and humidity and atmosphere.
●
Temperature : -10°C ~ 70°C
●
Humidity : 10% ~ 90% RH
●
Atmosphere : 500 ~ 1060hPa

Precaution
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S-19-01-1500-U0001 V1.5
IV.
PRECAUTION
4.1
Radiation Safety Precaution
4.1.1
Before operation, make sure User’s Manual and maintenance schedules are
observed. X-ray must only be operated by trained personnel in a controlled
setting otherwise X-ray may be dangerous to patient, operator or ancillary
people.
4.1.2
Pregnant women are generally advised to avoid X-rays to minimize the
chances of causing any harm to the fetus unless necessary.
4.1.3
Personal exposure monitoring device and radiation protection equipment
must be provided to operators. Maximum permissible whole-body or partial-
body radiation dose of operator in accordance with local regulations shall be
established. The record shall be checked before each operation.
4.1.4
Backscatter shield is designed to protect operators from scatter radiation.
Make sure to install backscatter shield properly by following step before
operation.
a) Check the backscatter shield and collimator before each operation. Do
not operate if any of them is broken.
b) Keep Backscatter shield on the outer side of the collimator cone as close
as possible to the patient.
c) Operator stays within the significant zone of occupancy. (see 3.4.3 for
more details)
The system should be used only by personnel possessing relevant
qualifications, including adequate training in radiation protection.
NOTE !
Read carefully the following this manual.
NOTE !
Radiation safety training requirements vary from country to country. Please
consult with your local Radiation/Health authority for more details.
NOTE !

Precaution
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S-19-01-1500-U0001 V1.5
4.1.5
Never stand in the direct line of the primary X-ray beam. If patient needs
assist, give caregiver personal protective equipment such as an apron to
wear or to stand behind a barrier.
4.1.6
For reducing radiation exposure to operator and help ensure stability while
taking radiographic images, the use of a tripod is recommended as possible.
4.2
Caution when user starts to use
1.
Before Operating, read carefully the User’s Manual and follow direction
while setting.
2.
Before Operation, check accessories.
3.
Before turning Power on, check whether battery should be fully charge.
4.3
Checking Before Operating
1.
Observe carefully on the whole system and the patient.
2.
When there is problem with the system or the patient, keep the patient in
safety, stop operating the system and make relevant disposition.
4.4
System Malfunction
Observe carefully on the whole system and the patient. When there is problem
with the system or the patient, keep the patient in safety, stop operating the
system and make relevant disposition. In case of malfunction, do not attempt
to operate the system until it has been checked out by a qualified service
technician.
4.5
Inspection
1.
Make inspection for system and part periodically.
2.
In case it is used after quite a long time of recess, confirm its status from
an expert of this equipment or manufacturer.
3.
Wash periodically with neutral detergent very carefully.
4.
Do not use erosive detergent of fluid.
Remove the power cord before using, XR-01 is not functional while charging.
NOTE !

Composition
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S-19-01-1500-U0001 V1.5
V.
COMPOSITION
5.1
Composition
This system is composed of main body and accessories as follows.
Main
-
XR-01 Portable X-Ray
-
Beam limiting Device
Accessories
-
AC/DC Adaptor
-
Power Cord
-
Hand Switch
-
Carrying Box
- Back Scatter Shield (Optional)
5.2
AC/DC Adaptor
-
Model Name : GSM60A24-P1J
-
Manufacturer : Mean Well Enterprises Co., Ltd.
- Rated Input : 100-240Vac, 50-60Hz, 1.4-0.7A
-
Rated output : 24Vdc/2.5A, 60W MAX
Recharge with the recharge unit supplied by Rolence.
Use it only for the XR-01, otherwise it may occur malfunction or disorder.
WARNING
!

Composition
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5.3
Battery
-
Model Name : 7S1PXRP001(Li-Polymer Type)
-
Manufacturer : Rolence Enterprise Inc.
-
Voltage : 25.2Vdc
-
Capacity : 2900mAh
- Recharge Battery -
Use the battery supplied by Rolence.
The user is responsible for any malfunction from usage with another battery.
WARNING
!
Assemble Power Cord and
adapter then charge directly

Composition
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S-19-01-1500-U0001 V1.5
1.
Assemble Power Cord and Adapter then charge directly.
2.
If powered, the LED indicator light on with green.
3.
The LED indicator shows orange light if recharging.
4.
The LED indicator shows green light if recharge complete.

Explanation of each part
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S-19-01-1500-U0001 V1.5
VI.
EXPLANATION OF EACH PART
X-ray
Exposure
B
utton
Main Display and
Control Panel
Beam Limiting
Device
Power ON/OFF
Switch
Hand Switch
Connector
Battery Cover

Explanation of each part
20
S-19-01-1500-U0001 V1.5
6.1
Main Display and Control Panel
1. Power Indicator Light: Light on when power on.
2. Main Display: Display current exposure time or error code when error
happens.
3. Battery Status: Display the remaining battery power. Low battery when all 4
blocks disappear.
4. Exposure Time Setting: Manually adjust the exposure time, press "up" button
to increase, "down" button to decrease. (0.01sec / step)
5. Quick Setting Button For Patient:
Use the default time setting for each kind of patient.
6. Quick Setting Button For Tooth:
Use the default time setting for each kind of tooth.
7. Quick Setting Button For Image Sensor:
Use the default time setting for each kind of image sensor.
Battery Status
Ready Button and
Indicator Light
Main Display
Power
Indicator Light
Exposure
Warning Light
Exposure Time
Setting
Patient: Child
Patient:
Adult
Quick Setting
Button
For Patient
Quick Setting
Button
For Tooth
Quick Setting
Button
For Image Sensor
Tooth: Anterior
Tooth: Posterior
Tooth: Bite Wings
Image Sensor:
Phosphor Plate
Image Sensor:
Digital Sensor
Image Sensor:
Film