OEC Compact Series Operating and maintenance manual

Compact / Series 7600
Mobile Imaging System
Installation Procedure
Part Number: 00-879039-03
April 1997
OEC Medical Systems, Inc.
384 Wright Brothers Drive
Salt Lake City, UT. 84116
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Compact / Series 7600 Installation Procedureii
This manual contains descriptions, instructions and
procedures that apply to the Compact / Series 7600 Mobile
Digital Imaging System only.
Refer to the Installation Report/Checklist P/N 00-879038-03
when installing a 7600 system.
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Compact / Series 7600 Installation Procedure iii
Revision History
Rev Dash Date Change Description
Rev 1 -01 December 1995 Initial Engineering Release
Rev A -01 December 1995 Manufacturing Release
Rev B -02 July 1996 Added power supply tolerances, kV tracking
specifications, and resolution specifications
Rev C -03 April 1997 Add Series 7600 installation procedures
Rev D -03 November 1998 Drawing change only
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Compact / Series 7600 Installation Procedureiv
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Compact / Series 7600 Installation Procedure v
TABLE OF CONTENTS
Introduction................................................................................................................... 1
Responsibility.............................................................................................................................1
Safety Procedures......................................................................................................................1
Explosion Hazard...................................................................................................................................... 1
Electrical Safety......................................................................................................................................... 2
Accident Reporting.................................................................................................................................... 3
Unauthorized Modifications....................................................................................................................... 3
System Specifications.................................................................................................. 4
Technical Specifications............................................................................................................................ 4
System Classification .................................................................................................................4
Connector Output Power............................................................................................................4
C-Arm........................................................................................................................................................ 4
Input Power................................................................................................................................5
X-ray Source Assembly..............................................................................................................6
Fluoroscopy............................................................................................................................................... 6
Pulsed Fluorography Mode....................................................................................................................... 6
Radiography.............................................................................................................................................. 7
Accuracy ................................................................................................................................................... 7
Video Signal.............................................................................................................................................. 7
Dimensions ............................................................................................................................................... 8
Tube Data And Rating Charts.....................................................................................................8
General Tube Data.................................................................................................................................... 8
X-ray Generator Information.......................................................................................................9
Unpacking and Inspection ......................................................................................... 10
Remove Protective Shipping Material.......................................................................................10
De-pallet the System (Compact)...............................................................................................10
De-pallet the System (Series)...................................................................................................10
C-Arm...................................................................................................................................................... 10
Workstation............................................................................................................................................. 10
Installation................................................................................................................... 11
Site Requirements....................................................................................................................11
Installation Kit Contents............................................................................................................11
Cover Removal.........................................................................................................................12
C-Arm:..................................................................................................................................................... 12
Workstation:............................................................................................................................................ 12
Mechanical Checks ..................................................................................................................12
Inspection and Setup................................................................................................................12
Line Voltage Compatibility Check.............................................................................................13
Isolation Transformer Wiring.....................................................................................................13
Power ON System....................................................................................................................13
System Power Supply Voltages................................................................................................14
Measure Line Voltage Regulation.............................................................................................14
System Operational Verification ...............................................................................................15
Generator................................................................................................................................................ 15
Workstation............................................................................................................................................. 18
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Compact / Series 7600 Installation Procedurevi
Thermal Printer / Multiformat Camera........................................................................20
Fluoroscopic Image Tests.........................................................................................................21
Radiographic Beam Alignment Test..........................................................................................21
Setup....................................................................................................................................................... 21
Beam Alignment Verification................................................................................................................... 21
Complete Paper Work...............................................................................................................22
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Compact / Series 7600 Installation Procedure 1
Introduction
This manual describes the installation of the Compact / Series 7600 system
and a definition of the responsibilities and instructions for reporting, safety,
unpacking, moving and verifying system operation.
Responsibility
The customer must provide the labor and equipment necessary to unload the
system from the transport vehicle and move it to the final location. It is the
customer’s responsibility to obtain all permits necessary to meet all
requirements of state and local codes, regulations and ordinances with respect
to the installation and operation of the system.
A qualified service technician should perform the following:
•Installation Report/Checklist (00-879038-03).Safety procedures should be
in effect at all times during the installation process. By law, complete
reports within 15 days from the date of assembly (installation).
•Return the assembler's copy of the Report of Assembly of Diagnostic X-ray
(FDA form 2579), the Beam Alignment Radiographs (films), and the
Installation Report/Checklist to OEC Medical Systems, Inc., Attention:
Technical Support, in the stamped, manila envelope provided in the Field
Service Documentation Package.
•Distribute the various remaining copies of the Report of Assembly of
Diagnostic X-ray (FDA form 2579), following the documentation instructions
included in the Field Service Documentation Package.
•The OEC Medical Systems, Inc. Representative MUST sign the last page of
the Installation Report and Checklist, verifying Field Service acceptance of
the unit. If, for any reason, the installation remains incomplete, notify the
Hospital that the system is not yet ready for use.
Safety Procedures
Under no circumstances should the safety interlocks in the system be
bypassed, jumped or otherwise disabled. Never operate or store the system in
a location where conductive fluids such as water, saline solution, etc., can spill
on any part of the equipment unless you cover the system with a protective
waterproof draping.
NOTE: All OEC Medical Systems, Inc. systems comply with International
Electrotechnical Commission safety standard IEC-601. Do not connect any
external device to the system that does not meet the requirements of IEC-601.
Only devices provided by or approved by OEC Medical Systems, Inc. should be
connected to the system.
Explosion Hazard
Never operate the system in the presence of flammable anesthetics or other
flammable or explosive liquids, vapors, or gases. Vapors and gases can ignite
by electrical arcs that can occur during the normal operation of switches, circuit
breakers, push-buttons and other circuit components.
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Compact / Series 7600 Installation Procedure2
If flammable substances are present before you apply system power, do not
plug in or turn on the system.
If you detect flammable substances after the system has been turned on, do
not touch any of the controls, switches, knobs or cables. Evacuate all personnel
immediately, then ventilate the room to clear the air of the flammable vapor or
gas. Remove any volatile liquids that are producing flammable vapors to a safe
storage area.
Electrical Safety
Electrical circuits inside the equipment use voltages that are capable of causing
serious injury or death from electrical shock.
WARNINGS: This equipment contains high power electrical components and only
personnel familiar with the circuitry and its operation should provide
service. Some components may maintain a charge with the power cord
disconnected.
Observe safety precautions when measuring high voltage electronics.
Steps within this procedure produce x-rays. Use appropriate precautions.
Areas where hazardous voltages exist include:
Transformers - 100 - 240 volts
Video Monitors - 100 - 240 volts and High AC/DC Voltages
Image Intensifier - 50,000 volts
Generator - 110,00 volts
•Observe the following precautions when you remove system covers:
•Observe the two person rule when working near lethal voltages. A person
who is familiar with the emergency power removal procedure must be in
attendance. This person must remain clear of the machine and be prepared
to turn it off in an emergency.
•Be familiar with the components being serviced and the locations of
hazardous voltages in the assembly where you work.
•High voltage cables and capacitors can retain a charge even when you
remove all power from the system. Avoid touching these unless you are
certain the charge has dissipated to ground.
•Some high energy capacitors in the system should be shorted to ground
through an adequate resistance to avoid a burn hazard.
•A protective earth ground stud, located on the bottom left side of the
system base, and marked with the international symbol shown below on the
left. It also has a distinctly colored decal at the base of the stud as shown
below on the right.
el
Grn
PROTECTIVE EARTH SMBOL PROTECTIVE EARTH STUD
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Compact / Series 7600 Installation Procedure 3
Accident Reporting
The Medical Device Reporting Regulation, 21 CFR Part 803, requires that the
manufacturers of medical devices submit a report to the appropriate federal
agency containing specific information in the event of an accident resulting in
death or serious injury during the use or service of its medical devices. (In the
following paragraphs, labeling definitions include all instructional and
procedural text contained in the Operator's Guide and Periodic Maintenance
Procedures.)
A report is not necessary if:
•The potential for death or the type of serious injury that may result
appears in the labeling for the system.
•The malfunction and the routine service, repair, or maintenance in-
structions to correct the problems appear in the labeling for the system.
•The malfunction has occurred at or below its expected rate of frequency
and severity.
•The malfunction does not lead the manufacturer to undertake a remedial
action involving any other systems.
For OEC Medical Systems, Inc. to meet these reporting requirements, all users
of these systems, operators, and service technicians, must provide the QA
Manager of OEC Medical Systems, Inc. with the following information regarding
all reportable events as soon as possible:
1. Identify the model and the serial number.
2. Describe the event. Include whether any serious injury or death occurred,
the number of personnel injured, and any publication title and dates of any
articles in the scientific or medical literature describing the reported event.
3. Identify the person who is submitting the information, include their address,
to OEC Medical Systems, Inc.
4. Indicate whether additional information will be submitted, and if so, when.
5. Indicate whether the event being reported has occurred with greater
frequency or severity than is indicated in the labeling for the system, or is
unusual for this type of system.
Unauthorized Modifications
Unauthorized changes or modifications to any part of the system could have
hazardous consequences. Changes or modifications are forbidden unless
specifically authorized by OEC Medical Systems, Inc.
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Compact / Series 7600 Installation Procedure4
System Specifications
Technical Specifications
The policy of OEC Medical Systems, Inc. is one of continual product
development and improvement. For this reason, OEC Medical Systems, Inc.
reserves the right to change the operating characteristics and specifications of
newer products at any time, without prior notice, and without incurring any
obligation relating to previously manufactured items.
The specifications list limited to general performance and physical data.
Specifications of optional equipment provided by other manufacturers in the
applicable manuals provided with those options.
OEC Medical Systems, Inc. will make available, on request, circuit diagrams,
component part lists, descriptions, calibration instructions, or other information
that will assist properly trained and qualified technicians to repair those parts of
the system which are designated as repairable.
System Classification
Class I (as defined by IEC 601-1)
Type B
Ordinary protection against ingress of water
Non AP (Non-anesthetic proof)
Continuous operation
Connector Output Power
C-Arm
Footswitch: 15 VAC 30 milliamp current source
Handswitch: 15 VAC 30 milliamp current source
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Compact / Series 7600 Installation Procedure 5
Input Power
NOTE: The system operating voltage is changeable. If the operating voltage requires
changing, the change may only be accomplished by an OEC Medical Systems,
Inc. field service technician, or by qualified technical service personnel.
Line Frequency: 60/50 Hz
Single Phase:
110V ~ Standby (long-time) 5 A,
*Maximum (momentary) 25 A.
230V ~ Standby (long-time) 2 A,
*Maximum (momentary) 15 A.
*Maximum (Momentary) rating is for maximum radiographic exposure and
limited to 4 seconds.
Resistance of Mains 0.6 ohms/230 ~
0.3 ohms/110 ~
Technique Factors at Maximum Line Current Condition:
Peak current demand is independent of technique load factors.
Line Regulation (Percentage):
15% at maximum radiographic exposure. Also, under no conditions should the
loaded voltage fall below 100 VAC, measured on the secondary of the isolation
transformer.
Maximum Continuous Power Dissipation:
4,253 BTUs. Figure based on a maximum real power value of 1,245 watts.
NOTE: Line regulation based on measurements made at the input (primary winding) of the
isolation transformer under standby conditions and at maximum radiographic
exposure by the following equation:
Line regulation = 100 (Vn - Vl)/Vl
Where Vn = no load voltage (standby)
Vl = loaded voltage (maximum radiographic exposure).
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Compact / Series 7600 Installation Procedure6
X-ray Source Assembly
Type Fixed anode type
Focal Spot Dual, 0.6 mm and 1.5 mm
Total Filtration >3 mm minimum aluminum equivalent
Anode Heat
Storage Capacity 76,000 HU
Leakage
Technique Factors 110 kVp and 3.0 mA
Voltage Rating 110 kVp maximum
Fluoroscopy
Focal Spot Size 0.6 mm
High Voltage Range 36 kVp to 110 kVp, with manual adjustment
available.
Current Range Standard 3 mA maximum
Dense Anatomy 6 mA maximum continuous
Snapshot 8 mA
Duty Cycle: 110 kVp @ 6 mA maximum continuous
Collimation Nominal diameter iris circle for 9/6 inch system
6 inches (15.2 cm), 9 inches (22.8 cm)
Iris collimation is continuously adjustable to
less than 5 x 5 cm, measured at the SID.
Slot collimation is continuously variable and
rotatable.
Pulsed Fluorography Mode
Focal Spot 0.6 mm
kVp Range 36 kVp-110 kVp
mA Range 0.2 - 8.0 mA
Pulse Rate 1 pulse per second.
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Compact / Series 7600 Installation Procedure 7
Radiography
1.5mm Focal Spot High voltage range: 36 kVp to 110 kVp
Tube current 20 mA fixed.
Timer Duration of radiography can be manually set
from 0.1sec to 4.0 sec with an internal electronic
timer.
Duty Cycle 110 kVp @ 20 mA maximum for 4.0 seconds.
Collimation Nominal diameter iris circle for standard 9-inch
(22.8cm) system, continuously adjustable to less
than 5 x 5 cm, measured at the SID. A continuously
variable and rotatable slot collimator is
also standard.
Film Cassette Standard: 10 x 12 x 5/8-inch nominal.
Holder Metric: 24cm x 30cm
Accuracy
kVp: + 10%
mA: + 10%
Timer: + 10%
Video Signal
Composite video, EIA RS170A 60 Hz, 525 line, [International CCIR 50 Hz, 625
line] 1 Vp-p
Single "C" mounted FastScan flicker-free monitor
30cm (12 inch) Standard
44cm (17 inch) Optional
20 MHz bandwidth
Workstation
Dual Monitors 44cm (17”)
Fastscan, flicker-free monitor (100Hz) with anti reflection filter
Image Rotation: 360 degrees
400 Image Memory wih last image hold
X-Ray “ON”indicator lamp
Patient annotation keyboard and control panel for system operation
Integrated thermal printer (option)
Integrated multiformat camera 2-on-1 or 1-on-1 (option)
Environmental and Transport Requirements
Ambient Operating: 10 to 35 degrees C
Temperature
Extended 0 to 40 degrees C
Storage and
Transportation
Short-term -10 to 55 degrees C
Storage and
Transportation
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Compact / Series 7600 Installation Procedure8
Stability Positive stability on grades up to 10 degrees when in
transport position and on grades up to 8 degrees in any position
of normal use.
Altitude 8,000 ft. (2438 meters) maximum
Humidity Operating: 20 to 80%, non-condensing
Storage and transport: 10%-90%, condensing
Shock and Vibration 1G at 5-200 Hz for 2 hours
Dimensions
C-Arm Non-bracketed numbers are for the 17.8 cm/7-inch I.I.
Numbers in brackets are for the 23 cm/9-inch I.I.
Focus to top of generator housing: 205mm maximum
w/o skinspacer.
SID: 930 mm (37 inches) [905 mm]
Free Space: 705 mm [680 mm]
Central Beam to C-Arm: 660 mm (26 inches)
C-Arm orbital motion: 115 degrees (25 degree overspan)
C-Arm Rotation: +225 degrees
C-Arm vertical motion: 420 mm.
C-Arm horizontal motion: 190 mm.
C-Arm Wig-wag: +10 degrees
Length: 1630 mm
Height: 1690 mm
Width: 780 mm
Weight: 245 Kg.
Workstation Length: 560mm
Width: 660mm
Height: 1665
Weight: 140kg
Tube Data And Rating Charts
General Tube Data
Maximum 110 kVp.
Rated Tube
Potential
Leakage 110 kV at 3.0 mA. This is also the maximum continuous
Technique rating of the X-ray tube housing assembly. 110 kV at 3.0
Factors mA are the leakage technique factors used for the
diagnostic source assembly.
Total >3.0 mm minimum aluminum equivalent.
Filtration
Anode Heat 76,000 HU
Storage
Anode 330 HU/second maximum. Refer to the Thermal
Maximum Characteristics curves in this section.
Cooling Rate
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Compact / Series 7600 Installation Procedure 9
X-ray Generator Information
The X-ray Generator in the Compact / Series 7600 complies with IEC 601-2-
7/1987 and CSA 22.2 #601.2.7. The following information provided in
accordance with these standards.
Reference: 601-2-7 Clause 6.8.2
1. Maximum mA @ Nominal kVp
Standard Fluoro 3 mA @ 110 kVp
Dense Anatomy Fluoro 6 mA @ 110 kVp
Pulsed Fluoro 3 mA @ 110 kVp
Snapshot Fluoro 8 mA @ 110 kVp
Film Mode 20 mA @ 110 kVp
2. Maximum kVp @ Maximum mA (See 1 above)
3. Maximum Output Power
Snapshot (Fluorography) 0.88 kW @ 110 kVp, 8 mA
Film Mode 2.2 kW @ 110 kVp, 20 mA
4. Nominal Output Power for 0.1 Second Exposure
Film Mode 2.0 kW @ 100 kVp, 20 mA
5. Reference mAs @ 50% of Nominal Output Power
Film Mode 2.0 mAs @ 55 kVp
(20 mA, 0.1 second)
6. (Not Applicable)
7. (Not Applicable)
8. Nominal Shortest Exposure Time
Film Mode 0.1 second
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Compact / Series 7600 Installation Procedure10
Unpacking and Inspection
The customer should inspect the shipping containers and exposed system
components for any apparent damage prior to unpacking. Unpack any shipping
containers that appear damaged with the carrier's agent present. The customer
should ensure that all equipment specified in the purchase order has been
delivered.
If any part of the shipment shows damage or parts are missing, immediately
notify the carrier and the nearest OEC Medical Systems, Inc. regional service
office. Retain the shipping container and packing material for the carrier's
inspection.
Use the Installation Report/Checklist for reporting shipping damage to the
equipment. Indicate the location of damage on the drawing view or views as
appropriate and describe parts lost or damaged in shipment.
Remove Protective Shipping Material
1. Remove the banding from the shipping carton(s).
2. Remove the cardboard cap(s) and lift the cardboard from the top of the
unit(s). Discard the cardboard.
3. Remove the tape and packaging.
De-pallet the System (Compact)
1. Remove the three u-shaped metal brackets that hold the system to the
pallet.
2. Remove the tape or banding that attaches the x-ray tube to the metal
brace on the front of the pallet.
3. Carefully lift the system and remove the three rubber-covered shipping
blocks from underneath the system.
4. Carefully roll the system off the pallet using the ramp supplied with the
system.
5. Attach the monitor to the system using the supplied hardware.
De-pallet the System (Series)
C-Arm
1. Remove the four metal brackets securing the wheels and C to the pallet.
2. Carefully lift the system and remove the three rubber-covered shipping
blocks from underneath the system.
3. Carefully roll the system off the pallet. Be careful not to damage the cable
pushers.
Workstation
1. Remove the four turnbuckles.
2. Remove the four eyebolts from underneath the workstation.
3. Carefully roll the workstation off of the pallet.
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Compact / Series 7600 Installation Procedure 11
Installation
As you perform the steps in this procedure check them off on the Installation
Report/Checklist P/N 00-879038-02.
Additional information needed for operating the Compact / Series 7600 found
in the Operator Guide’s.
Site Requirements
There are three major considerations for installing a system. They are:
1. Electrical power requirements
2. Environmental conditions
3. Safety precautions.
The system requires an input power source capable of providing nominal
voltage inputs of:
115 VAC @ 15 Amps
230 VAC @ 8 Amps
The site must meet the line voltage regulation requirements as described in the
Installation Report/Checklist.
The customer is responsible for preparing the building, equipment, environment
and services required to install and operate the system.
Installation Kit Contents
Verify that the following materials arrived in the 7600 Installation Kit
(00-879040-01). Note any shortages on the Checklist.
•Beam Film Labels
•FDA Form 2579
•FSP-10 Installation Paperwork Requirements SOP
•Installation Procedure (This Document)
•Installation Report/Checklist P/N 00-879038-03
•Manual Response Form
•Various Envelopes
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Compact / Series 7600 Installation Procedure12
Cover Removal
C-Arm
Rear Cover
1.Unplug the system power cord from the AC power receptacle.
2. Remove the two screws located on the lower front section of the rear cover
and the screw located on each side of the cover.
3.Move the cover toward the floor. (This will release the top tab restraints.)
4.Pull the cover away from the system.
5. Remove the ground wire.
Workstation
Rear Cover
1. Remove the ten screws securing the rear cover. Six along the sides and
four around the power cord plate.
2. Pull the cover back away from the system.
3. Remove the ground wire.
Mechanical Checks
In the steps below, check for ease of movement without excessive play.
1. Check the Locking Pedals of the system for proper operation. Lock the
system in place by pressing the locking pedals down completely (Compact
/ Series).
2. Check the Wig Wag movement of the system from side to side. Verify
proper operation of the wig wag lock.
3. Check the Cross Arm movement of the system. Verify proper operation of
the cross arm lock.
4. Check the Flip Flop movement of the system and integrity of the Pivot
Point. Check proper action of the pivot lock.
5. Check the Radial Movement of the system and verify there is adequate
resistance to stop the C-Arm when the brake is applied.
6. Check the Steering Handle of the C-Arm for proper operation.
Inspection and Setup
1. Verify or mount the skin spacer as directed by state regulation.
2. Inspect the AC power cable and interconnect cable for proper strain relief.
Inspect the power cable assembly and interconnect cable assembly for any
shipping damage. Look for any signs of damage or abrasion to the cable
jacket and inspect each plug for loose pins.
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Compact / Series 7600 Installation Procedure 13
Line Voltage Compatibility Check
Check the line voltage in each room where the equipment operates. Do not
assume the line voltage will be constant throughout the hospital.
Verify voltage compatibility in all hospital rooms where this machine will
operate. If a particular room is unavailable, write "NK" in the location, voltage
and plug compatibility blanks on the checklist. A room is not plug compatible
when the plug requires an adapter. Notify the hospital if any rooms are not
voltage compatible.
Isolation Transformer Wiring
1. The isolation transformer(s) of the Compact / Series 7600 reside in the
lower left portion of the generator cabinet. And in the lower rear section of
the workstation (Series).
2. Directly above the generator isolation transformer and in the lower rear of
the workstation is the isolation transformer terminal block. The isolation
transformer(s) have input taps for 90, 100, 110, and 120V.
3. Unplug the system from the wall receptacle and measure the AC voltage at
the wall receptacle. Move the brown wire on the isolation transformer
terminal blocks to the appropriate input tap.
Power ON System
1. Plug the AC power cord into the system and then the wall receptacle
(Compact).
2. Connect the interconnect cable between the generator and the workstation
(Series).
3. Plug the AC power cord into the wall receptacle (Series).
4. Turn the system on by pressing the green START button on the control
panel (Compact / Series) or workstation (Series).
5. The system will display the OEC test pattern on the monitors when the
system has initialized.
6. Verify that the elapsed time indicator operates on the generator.
NOTE: The elapsed time indicator will increment every 6 minutes or 1/10th of an hour.
If the indicator is not running initiate repairs before continuing the installation.
7. Verify that the cooling fan operates (Series).
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Compact / Series 7600 Installation Procedure14
System Power Supply Voltages
1. The power supplies reside in a perforated metal enclosure on the left side
of the generator cabinet. There are two separate power supplies
(Compact) and one (Series) in the enclosure.
2. Locate the output voltage wire bundle coming from the top power supply
(NG1). This wire bundle exits the enclosure on the left side and has a 15-
pin connector on the end of the bundle. The 15-pin connector designation
is P1. Measure the voltages listed below and record them on the
Installation Checklist.
GND To Ad
j
ust Volta
g
e Tolerance
P1-2 P1-
5
N
o
t A
djus
t
ab
l
e
+
5
V
±0.5V
P1-2 P1-4 Not Ad
j
ustable +24V ±1V
P1-2 P1-1 R39 +16V ±1V
3. Locate the output voltage wire bundle coming from the bottom power
supply (NG2) (Compact). This wire bundle exits the enclosure on the left
side and has a 9-pin connector on the end of the bundle. The 9-pin
connector designation is P2. Measure the voltages listed below and record
them on the Installation Checklist.
GND To Ad
j
ust Volta
g
e Tolerance
P2-2 P2-1 R
39
+
5
V
±0.5V
P2-2 P2-4 Not Ad
j
ustable +12V ±1V
P2-2 P2-5 Not Ad
j
ustable -12V ±1V
Measure Line Voltage Regulation
1. Measure the AC line voltage at the wall receptacle.
NOTE: In the next step the voltage measured at the wall receptacle will drop
immediately after the exposure terminates. Read the meter at this time.
2. Measure the line voltage at the wall receptacle again while making a
radiographic exposure (80 mAs @ 110 kVp).
3. Calculate the percentage line voltage regulation using the following formula
and record the results on the Installation Report/Checklist.
100 X Vn - Vl
Vl where: Vn = No load voltage Vl = Max load voltage
4. If the results above do not fall within the range of 0 to 15 percent, inform
the hospital that an in-house wiring problem exists. (This problem results in
a violation of a provision of the Federal Performance Standards 21 CFR
1020.30)
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An Independent C-Arm Service Provider. This PDF provided for research / historical purposes only.