Sri PXS-710D User manual

PXS-710D
Podiatry X-Ray Source
(Bi-Directional Operation)
Installation/Operation Manual
(Revision 0, S/N 501 …)
Source-Ray, Inc.
50 Fleetwood Ct., Ronkonkoma, NY 11779
631-244-8200, 631- 244-7464 (Fax)

REVISION CONTROL
Rev Description Initiated
By Date Approved By Date
0 Initial Release Steven L. 11/15/18 R. Manez 11/16/18

PXS-710D TABLE OF CONTENTS
1
SECTION PAGE
I GENERAL INFORMATION
1.1 Introduction 7
1.2 Description 7
1.3 Important Notice 7
1.4 Responsibilities 9
1.5 Electromagnetic Compatibility Warnings & Declarations 10
1.6 Compliance Notice 15
1.7 Safety Standards 15
1.8 Electrical Specifications 16
1.9 X-ray Tube Characteristics 18
1.10 X-ray Collimator 23
1.11 Mechanical Specification 23
1.12 Equipment Classification 25
II INSTALLATION AND CALIBRATION
2.1 Un-Packaging 28
2.2 Assembly 30
2.3 Electrical Connections 32
2.4 Calibration Set-Up 33
2.5 Tube Potential (kVp) & Beam Current (mA) 33
2.6 mAs 43
2.7 Beam Alignment 44
III UNIT OPERATION
3.1 Controls and Indicators (Control Panel) 45
3.2 Source Base 49
3.3 Operating Procedure (Generator/Control Assembly) 54
3.4 Faults 55
3.5 Procedure 56
IV THEORY OF OPERATION
4.1 Source Overview 60
4.2 Generator/Control Assembly 60
4.3 OpalRad Generator Communications 62
V UNIT MAINTENANCE PAGE
5.1 Introduction 66
5.2 Recommended Intervals 66
5.3 Ordering Information 67
5.4 Maintenance Procedure 67
5.5 Warm-Up Procedure 67

PXS-710D TABLE OF CONTENTS
2
LIST OFFIGURES
FIGURE DESCRIPTION PAGE
1.1 Tube Characteristics 20
1.2 X-Ray Tube Ratings Chart 21
1.3 X-ray Tube Anode Cooling Chart 22
1.4 X-ray Head Heating Chart 22
1.5 X-ray Head Cooling Chart 22
1.6 Collimator Front View 24
1.7 Collimator Side View 24
1.8 Focal Spot Location 25
1.9 Source Dimensions 26
1.10 Zone Of Occupancy 27
2.1 Anchor Points 30
2.2 Handrail Assembly 31
2.3 View Menu 36
2.4 Password Dialog Box 37
2.5 Calibration Menu 37
2.6 Calibration Wizard 38
2.7 Settings Confirmation 39
2.8 Settings Saved Confirmation 40
2.9 Application Exit 40
2.10 Calibration Mode Selection 41
2.11 Calibration Mode Utility 42
2.12 Ready Indicator 42
2.13 X-ray Indicator 43
3.1 Generator/Control Connector Description 47
3.2 Optional Remote Control Panel Description 47
3.3 Control Panel Description 48
3.4 Hand Switch Assembly 48
3.5 Source Front View 50
3.6 Source Side View (0° Head Tilt) 51
3.7 Source Side View (15° Head Tilt) 51
3.8 Source Base (Rear Control Panel) 53
3.9 Source Base (Side Control Panel) 53
3.18 OpalRad Ready Time Display 60

PXS-710D TABLE OF CONTENTS
3
LIST OF TABLES
TABLE DESCRIPTION PAGE
1.1 Emissions & Immunity Chart 13
3.1 mAs Increments Chart 48
3.2 Technique Chart 57
4.1 Approved 3rd Party Control Software 62
4.2 RS-232 Pin Out 63
4.3 Generator OpalRad Communications 65
5.1 Maintenance Checklist (Every 6 Months) 68
5.2 Displayed Fault Conditions 69
LIST OFSCHEMATICS
SCHEMATIC DESCRIPTION PAGE
5.1 Base Wiring Diagram 70
5.2 Generator Wiring Diagram 71

PXS-710D TABLE OF CONTENTS
4
L IST O F S YMBOLS
SYMBOL DESCRIPTION
Exposure Switch
Type “B” Applied Part
Protective Earth
Caution
Pinch Point, Keep Hands Clear
Warning- Electric Shock Hazard, Keep Hands Clear
Refer to Instruction Manual
Operator’s Manual; Operating Instructions
Only Prescription Use (Part 21 CFR 801 Subpart D)

PXS-710D TABLE OF CONTENTS
5
LABELS
LABEL “A” LABEL “B”
LABEL “C” LABEL “D”
LABEL “I”
LABEL “E” LABEL “F”
LABEL “H”
LABEL “G”
LABEL “J”

PXS-710D TABLE OF CONTENTS
6
L ABEL L OCATIONS
C
D
E
G
B
A
F
I
“J”&“H”
located
insideofbase
LABEL “K”
“K”located
insideofbase
“K”located
insideofbase
L
LABEL “L”

PXS-710D Section 1
7
GENERAL INFORMATION
1.1 INTRODUCTION
This manual is divided into five sections and contains the following information:
Section I describes general information. Section II contains installation and
calibration procedures. Section III contains operating procedures and technique
guides. Section IV discusses theory of operation and Section V contains
maintenance procedures and recommended intervals.
1.2 DESCRIPTION
The PXS-710D Podiatry X-Ray source is designed and manufactured by Source-
Ray, Inc. It provides a high quality radiographic capability in a small lightweight
format. The source consists of the following major assemblies:
X-Ray Generator/ Tube Housing
X-Ray Remote Control Module (Optional)
Podiatry Support Platform
1.3 IMPORTANT NOTICE
The equipment manufactured by Source-Ray, Inc. and covered in this manual
will function properly when operated, maintained, and repaired in accordance
with the instructions in this manual. Source-Ray, Inc. does not assume
responsibility for any malfunctioning of this equipment resulting from
improper operation, maintenance, repair, or modification of its components.
Keep this Operating Manual with the machine at all times and periodically
review Important Notice’s and the Operating & Safety Instructions.
This manual should be carefully studied prior to use of the Podiatry X-ray
Source and the instructions within should be always followed to assure safe
continued usage.
The contents of this manual should be thoroughly read and understood prior
to attempting to put this X-Ray Source into operation.

PXS-710D Section 1
8
1.3 CONTINUED:
This equipment sold is to be used exclusively by or under the prescribed
direction of a person who is licensed by law to operate equipment of this
nature.
The PXS-710D contains no user serviceable parts.
Only qualified and authorized personal shall operate this source. In this
context, qualified means those legally permitted to operate this equipment in
the jurisdiction in which the equipment is being used, and authorized means
those authorized by the authority controlling the use of the equipment. Full
use must be made of all radiation protection features, devices, sources,
procedures, and accessories.
Zone of Occupancy: During X-ray exposure personnel should be located in
a safe distance outside the X-ray field, governed by the regulations and
requirements of every state.
Any procedure involving taking x-ray exposures must comply with federal and
local regulations. X-ray can be harmful unless proper precaution and safety
procedures are adhered to.
Trained personnel operating this unit should be familiar with the
Recommendations of the International Commission on Radiological
Protection, contained in Annals of the ICRP with the applicable National
Standards and should have been trained in the use of the equipment. The
operator should use the largest possible focal post to skin distance in order to
keep the absorbed dose as low as reasonably achievable.
This X-ray source may be dangerous to patient and operator unless safe
exposure factors, operating instructions and maintenance schedules are
observed.
This source is designed to take x-rays of the lower extremities (foot and
ankle). Do not jump or bounce on the foot rest area. Do not lift the unit by
the Patient Assist Handles. Handles are meant for additional patient assist
only.

PXS-710D Section 1
9
1.3 CONTINUED:
The boom arm presents a pinch hazard. Keep hands clear when in use.
1.4 RESPONSIBILITIES
To operate X-ray equipment it is required by state/country that the operator
will be trained personnel. The operator must be familiar with safety
requirements for operating the X-ray generator.
It is the responsibility of the operator to ensure the safety of the patient
during exposure via proper positioning of the x-ray source.
This equipment can be hazardous to both patient and operator unless
established safe exposure factors, operating instructions, and maintenance
schedules are observed. Source-Ray, Inc. disclaims all responsibility from any
injury resulting from improper application of this equipment.
Ensure that all personnel authorized to use the unit are aware of the danger
of excessive exposure to X-ray radiation.
The unit herein described is sold with the understanding that the
manufacturer, its agents and representatives are NOT liable for injury or
damage which may result from over-exposure of patients or personnel to X-
ray radiation.
The manufacturer does not accept any responsibility for over-exposure of
patients or personnel to X-ray radiation generated by this unit which is a
result of poor operating techniques or procedures.
The manufacturer of this unit does not assume any responsibility for any
equipment that has not been serviced and maintained in accordance with the
manufacturer instructions or which has been modified or tampered with in
any way.
It is the responsibility of the operator to ensure the safety of the patient while
the X-ray unit is in operation by visual observation, proper patient positioning
and use of the devices that are intended to prevent patient injury.

PXS-710D Section 1
10
1.4 CONTINUED:
The unit has been designed to be used and installed on a flat surface as a
fixed unit that stays in place with no wheels.
It is the responsibility of the operator to always watch all parts of the unit to
verify that there is neither interference nor possibility of collision with the
patient or with other equipment.
Responsible organizations (e.g. X-ray System Integrators) combining
imaging components or accessories with the PXS-710D are required to insure
the resulting system meets the requirements of ANSI/AAME ES 60601-1 and
the standards identified in section 1.7.
Maximum Permissible Dose (MPD): Make sure that the X-ray generator
is set in working position with the reference axis (X-ray beam) pointing to the
reception area. The operator shall use the largest possible focal spot to skin
distance in order to keep the absorbed dose as low as reasonably achievable.
Trained personnel operating this unit should be familiar with the
Recommendations of the International Commission on Radiological
Protection, contained in Annals Number 60 of the ICRP with the applicable
National Standards and should have been trained in use of the equipment.
1.5 ELECTROMAGNETIC COMPATIBILITY WARNINGS & DECLARATIONS
1.5.1 INSTRUCTIONS FOR USE
[ENVIRONMENTS]
The PXS-710D is intended for use in a Professional Health Care Facility.
The PXS-710D may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take mitigation
measures, such as additional shielding or relocating or re-orienting the
equipment.

PXS-710D Section 1
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1.5.1 CONTINUED:
[ESSENTIAL PERFORMANCE]
The ME Equipment, PXS-710D, shall be able to perform its Essential
Performance and remain safe. The following degradation associated with
Essential Performance shall not be allowed:
Expose Loading Parameters KV, mA, Time and mAs set on the
operator control panel (OCP) shall not be different than actual output
of X-Ray generator KV, mA and mAs, Time. (Within tolerance of each
loading parameter)
Reproducibility and Linearity of radiation output shall meet IEC
60601-2-54 requirement.
The X-ray Generator shall protect the X-Ray tube exceeding its safety
limits required by tube manufacture.
With customer supplied Digital Imaging Panels: Performance of the
PXS-710D shall provide image quality acceptable for medical
diagnostic. The PXS-710D is designed to power one Digital Imaging
Panel at a time.
“WARNING: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating
normally.”

PXS-710D Section 1
12
1.5.1 CONTINUED:
[LIST OF CABLES AND LENGTHS]
DESCRIPTION P/N LENGTH
AC Power Cable 560021 12ft
Exposure Switch 910007 12ft
“WARNING: Use of accessories, transducers and cables other than those
specified or provided by the manufacturer of this equipment could result
in increased electromagnetic emissions or decreased electromagnetic
immunity of this equipment and result in improper operation.”
“WARNING: Portable RF communications equipment (including
peripherals such as antenna cables and external antennas) should be
used no closer than 30 cm (12 inches) to any part of the PXS-710D,
including cables specified by the manufacturer. Otherwise, degradation
of the performance of this equipment could result.”
NOTE: The EMISSIONS characteristics of this equipment make it suitable
for use in industrial areas and hospitals (CISPR 11 class A). If it is used
in a residential environment (for which CISPR 11 class B is normally
required) this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take
mitigation measures, such as relocating or re-orienting the equipment.

PXS-710D Section 1
13
TABLE 1.1
EMISSIONS & IMMUNITY CHART
Emissions and Immunity Test Standards Compliance
Emissions test Compliance Immunity Test Level
(Professional Health Care Facility)
RF emissions
CISPR 11 Group 1
Conducted Emissions
Frequency
Range
Group 1, Class A
Limit [dBuV]
Quasi Peak Average
0.15 to 0.50 79.0 66.0
0.50 to 5.00 73.0 60.0
5.00 to 30.0 73.0 60.0
The lower limit applies at all transition frequencies.
Radiated Emissions
Frequency
Range
Group 1, Class A
Quasi-Peak Limit [dBuv/M]
10.0 Meters 3.0 Meters
30 to 230
MHz 40 50
230 MHz to
1 GHz 47 57
RF emissions
CISPR 11 Class A
Harmonic emissions
IEC 61000-3-2 Complies
Harmonic Order
N
Maximum Permissible
Harmonic Current
A
Odd Harmonics
3 2.30
5 1.14
7 0.77
9 0.40
11 0.33
13 0.21
15 ≤n ≤39 0.15 * (15/n)
Even Harmonics
2 1.08
4 0.43
6 0.30
8 ≤n ≤40 0.23 * (8/n)
Voltage
fluctuations/flicker
emissions
IEC 61000-3-3
Complies
The limits shown below were used to determine compliance to the requirements of
IEC 61000-3-3.
The value of Pst shall not be greater than 1.0;
The value of Plt shall not be greater than 0.65;
The value of d(t) during a voltage change shall not exceed 3.3% for more
than 500ms;
The relative steady-state voltage change, dc, shall not exceed 3.3%;
The maximum relative voltage change dmax shall not exceed;
o4% without additional conditions;
o6% for equipment which is;
Switched manually, or
Switched automatically more frequently than twice per day, and also
has either a delayed restart (the delay being not less than a few tens
of seconds), or manual restart, after a power supply interruption

PXS-710D Section 1
14
o7% for equipment which is;
Attended whilst in use (for example: hair dryers, vacuum cleaners,
kitchen equipment such as mixers, garden equipment such as lawn
mowers, portable tools such as electric drills), or
Switched on automatically, or is intended to be switched on
manually, no more than twice per day, and also has either a delayed
restart (the delay being not less than a few tens of seconds) or
manual restart, after a power supply interruption
Pst and Plt requirements were not applied to voltage changes caused by manual
switching.
The limits were not applied to voltage changes associated with emergency switching
or emergency interruptions.
Electrostatic Discharge
IEC 61000-4-2 Complies +/- 8.0 kV, contact +/- 2 kV, +/- 4 kV, +/- 8 kV, +/- 15 kV, Air
Radiated Immunity
IEC 61000-4-3 Complies
3 V/m 3 V/m
80 to 1000 MHz 1.0 to 2.7 GHz
80 % AM at 1kHz
Electrical Fast
Transient/Burst, Power
Ports,
I/O Ports
IEC 61000-4-4
Complies
Power Ports: +/- 0.5 kV, +/- 1.0 kV, +/- 2.0 kV
IO Ports: +/- 0.25 kV, +/- 0.5 kV, +/- 1.0 kV
100 Hz repetition frequency
Surge Immunity
IEC 61000-4-5 Complies +/- 0.5 kV, +/- 1.0 kV Differential Mode +/- 0.5 kV, +/- 1.0 kV, +/- 2.0 kV Common Mode
Conducted Immunity
Power Ports, I/O Ports
IEC 61000-4-6
Complies
Power Ports:
3 Vrms
0.15 to 80 MHz
6 Vrms in ISM test bands: 6.765 to 6.795, 13.553 to 13.567, 26.957 to
27.283, 40.660 to 40.700 MHz
1 kHz, 80%, AM
IO Ports:
3 Vrms
0.15 to 80 MHz
1 kHz, 80%, AM
Magnetic Immunity
IEC 61000-4-8 Complies 30 A/M RMS 50 Hz
Voltage Dips,
Interrupts and
Variations
IEC 61000-4-11
Complies
0 % Ut 0.5 cycle (Variations)
At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315°
0 %t, 1 cycle (Variations)
And
70 % Ut, 25 cycles
Single Phase at 0°
0 % Ut, 250 cycles (Interrupts)

PXS-710D Section 1
15
1.6 COMPLIANCE NOTICE
The Source-Ray PXS-710D you have purchased has been designed,
manufactured, and calibrated to comply with the governing Federal Regulations
21 CFR Subchapter J. The maintenance schedules included are crucial to the
continued reliability of this equipment with respect to regulatory compliance.
CLASS I – INTERMITTENT MODE
PXS-710D SOURCE CONSISTING OF:
X-Ray Generator/ Tube Housing (PXS-710D-G)
Base Assembly
Remote Control Module (Optional)
INDICATION FOR USE:
The model PXS-710D Podiatry X-Ray source is intended for General Purpose
Radiographic exams utilizing film, computed radiography, or direct digital flat
panels. Not for mammographic use. Rx Only. Imaging Equipment is
Provided/Integrated by the end User.
SPECIFIED RANGE OF COMPLIANCE:
Tube Current: 10 mA
Tube Voltage: 40 - 70 kVp
Milliampere-second: 0.1 – 20 mAs
1.7 SAFETY STANDARDS
The Source-Ray PXS-710D you have purchased has been designed,
manufactured, and calibrated to meet the following safety standards;
Podiatry X-ray source with radiation protection in accordance with IEC 60601-
1-3:2008.
Podiatry X-ray source for radiography in accordance with IEC 60601-2-
54:2009.
X-ray tube assembly in accordance with IEC 60601-2-28:2010.

PXS-710D Section 1
16
1.8 ELECTRICAL SPECIFICATIONS
MILLIAMPERES
Milliamperes will not deviate from the selected value by more than + 5% within
the operating line voltage range and within the specified range of line voltage
regulation.
KILOVOLTS
Kilovoltage will not deviate from the selected value by more than + 5% of full
scale
MAS
MAS will not deviate from the selected value more than + 8% or 0.2 mAs
whichever is greater within a range of 0.10 – 20 mAs.
MAXIMUM RATING
10 mA at 70 kVp DC
kVp Range Max Time mA Max mAs
40 –70 2.00 Sec. 10.0 20.0
LINE VOLTAGE REGULATION
5% maximum as measured at the x-ray control panel at maximum rated output.
INPUT ELECTRICAL RATING
For 115V Installation:
Line Voltage Range: 115VAC, 60 Hz
Momentary Max Line Current: 13 A, @ 70kVp and 10mA
Long Term Max Line Current: 2 A, @ Standby
Mains Resistance: Measured at the line input connector, not to
exceed 0.88Ω

PXS-710D Section 1
17
1.8 CONTINUED:
NOMINAL ELECTRIC POWER
700 W, Constant potential derived from a high frequency inverter source,
Regulated for both kVp and mA.
MAX OUTPUT POWER
Instantaneous: 700W (70kV @ 10 mA)
DUTY CYCLE (AUTOMATIC)
3.3% (ie.. X-ray Exposure 1 second ON, 30 seconds OFF)
MINIMUM PERMANENT FILTRATION
1.8 mm of aluminum equivalent at 70 kVp
REFERENCE CURRENT TIME PRODUCT (Power On Defaults)
Beam Current: 10 mA
Tube Potential: 60 kVp
mAs Setting: 1.60 mAs
LEAKAGE TECHNIQUE FACTORS
Testing is performed at 70 kVp and 10 mA, 10 mAs exposure.
COOLING CURVES
Automatic inhibit circuits provide a delay between exposures proportional to the
exposure time. This delay is sufficient to allow proper tube cooling. The delay
between exposures varies between 2 seconds and 60 seconds depending on the
exposure time.

PXS-710D Section 1
18
1.8 CONTINUED:
ENVIRONMENTAL
OPERATING:
Temperature: 40°F - 90°F (5°C - 32°C)
Pressure: 70 kPa – 106 kPa
Humidity: 30% - 90% (Non-Condensing)
STORAGE:
Temperature: 30°F - 110°F (-1°C - 43°C)
Pressure: 70 kPa – 106 kPa
Humidity: 30% - 90% (Non-Condensing)
1.9 X-RAY TUBE CHARACTERISTICS
X-RAY TUBE TYPE
Superior SXR-90-15-0.5
ENVELOPE
Hard glass, Borosilicate 0.085 thick.
ANODE MATERIAL
Tungsten target, copper plated and vacuum cast in copper.
TARGET ANGLE
15 Degree
FOCAL SPOT
0.5 mm nominal as per N.E.M.A. XR-5.
CATHODE
Tungsten filament, line focus.