G6P1133Wireless Dosimetry

- 1 - OPERATING INSTRUCTIONS Radio Frequency – In-Vivo Dosimeter "rf-IVD" Model 1133 NOTICE: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC ID: G6P1133 INF OR MAT ION T O USE R: Ca utio n, a ny cha nges or modificatio ns not expressly approved by Sun Nuclear Corporation could void the user's authority to operate this equipment. Display Firmware: 0100 Turtle Firmware: 0100 Base/Pod Firmware: 0100 October 18, 2000 DESIGNED AND MANUFACTURED BY SUN NUCLEAR CORPORATION MELBOURNE, FL USA 321-259-6862 http://www.sunnuclear.com - 2 - 1. INTRODUCTION .................................................................................................................................................................. 3 SPECIFICATIONS................................................................................................................................................................... 3 Diode Detector Inputs .......................................................................................................................................................... 3 Component Definitions, size and weight .............................................................................................................................. 3 Power.................................................................................................................................................................................... 4 Display Module .................................................................................................................................................................... 4 Detector Pod/Base Station ................................................................................................................................................... 4 Turtle .................................................................................................................................................................................... 5 D ESCRIPTION :............................................................................................................................................................................ 5 Display Module Front Panel................................................................................................................................................ 5 LCD Display ......................................................................................................................................................................... 6 Available Keys and LEDs ..................................................................................................................................................... 6 2. DISPLAY AND DETECTOR POD OPERATION ............................................................................................................. 7 A. S ETUP ................................................................................................................................................................................... 7 B. P OWER O N ............................................................................................................................................................................ 7 C. M EAS U REMEN T O PERATION ................................................................................................................................................. 7 1. General ............................................................................................................................................................................. 7 2. Starting the display: ......................................................................................................................................................... 8 3. Display the splash screen:................................................................................................................................................ 8 4. Finding the components: Turtle, Base Station and Measurement Pod ............................................................................ 8 5. Background collection screen: ....................................................................................................................................... 10 6. Dose collection screen or Main Screen: ........................................................................................................................ 10 7. Wireless measurements and Hard-wired measurements................................................................................................ 12 D. M EN U O PERATION .............................................................................................................................................................. 12 1. Select System .................................................................................................................................................................. 12 2. Check Battery ................................................................................................................................................................. 13 3. Display Adjust ................................................................................................................................................................ 13 4. Set Time/Date ................................................................................................................................................................. 15 5. View software version .................................................................................................................................................... 15 6. Dose Calibration ......................................................................…

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5 the start of the next RFA1 ON sequence should be set to sample the narrowest RF data pulse at least 10 times. Otherwise, significant edge jitter will be added to the detected data pulse. ASH Transceiver Block Diagram Figure 2 is the general block diagram of the ASH transceiver. Please refer to Figure 2 for the following discussions. Antenna Port The only external RF components needed for the transceiver are the antenna and its matching components. Antennas presenting an impedance in the range of 35 to 72 ohms resistive can be satisfacto - rily matched to the RFIO pin with a series matching coil and a shunt matching/ESD protection coil. Other antenna impedances can be matched using two or three components. For some impedances, two inductors and capacitor will be required. A DC path from RFIO to ground is required for ESD protection. Receiver Chain The output of the SAW filter drives amplifier RFA1. This amplifier in - cludes provisions for detecting the onset of saturation (AGC Set), and for switching between 35 dB of gain and 5 dB of gain (Gain Se - lect). AGC Set is an input to the AGC Control function, and Gain Se - lect is the AGC Control function output. ON/OFF control to RFA1 (and RFA2) is generated by the Pulse Generator & RF Amp Bias function. The output of RFA1 drives the SAW delay line, which has a nominal delay of 0.5 μs. The second amplifier, RFA2, provides 51 dB of gain below satura - tion. The output of RFA2 drives a full-wave detector with 19 dB of threshold gain. The onset of saturation in each section of RFA2 is detected and summed to provide a logarithmic response. This is added to the output of the full-wave detector to produce an overall detector response that is square law for low signal levels, and tran - sitions into a log response for high signal levels. This combination provides excellent threshold sensitivity and more than 70 dB of detector dynamic range. In combination with the 30 dB of AGC range in RFA1, more than 100 dB of receiver dynamic range is achieved. The detector output drives a gyrator filter. The filter provides a three-pole, 0.05 degree equiripple low-pass response with excellent group delay flatness and minimal pulse ringing. The 3 dB bandwidth of the filter can be set from 4.5 kHz to 1.8 MHz with an external re- sistor. The filter is followed by a base-band amplifier which boosts the de- tected signal to the BBOUT pin. When the receiver RF amplifiers are operating at a 50%-50% duty cycle, the BBOUT signal changes about 10 mV/dB, with a peak-to-peak signal level of up to 685 mV. For lower duty cycles, the mV/dB slope and peak-to-peak signal level are proportionately less. The detected signal is riding on a 1.1 Vdc level that varies somewhat with supply voltage, tempera - ture, etc. BBOUT is coupled to the CMPIN pin or to an external data recovery process (DSP, etc.) by a series capacitor. The correct value of the series capacitor depends on data rate, data run length, and other factors as discussed in theASH Transceiver Designer’s Guide. When an external data recovery process is used with AGC, BBOUT must be coupled to the external data recovery process and CMPIN by separate series coupling capacitors. The AGC reset function is driven by the signal applied to CMPIN. When the transceiver is placed in power-down (sleep) or in a trans - mit mode, the output impedance of BBOUT becomes very high. This feature helps preserve the charge on the coupling capacitor to mini - mize data slicer stabilization time when the transceiver switches back to the receive mode. Data Slicers The CMPIN pin drives two data slicers, which convert the analog signal from BBOUT back into a digital stream. The best data slicer choice depends on the system operating parameters. Data slicer DS1 is a capacitively-coupled comparator with provisions for an ad - justable threshold. DS1 provides the best performance at low Transceiver Block Diagram RFA1RFA2 TXA1TXA2 SAW Delay Line SAW CR Filter Log Antenna RFIO Tuning/ESD Detector Low-Pass Filter BB AGC Control Peak Detector Pulse Generator & RF Amp Bias LPFADJ PRATE PWIDTH RXDATA TXMOD CN TRL1 CN TRL0 AGCCAP R REF THLD2THLD1 Modulation & Bias Control Power Down Control Gain Select AGC Set AGC Reset Threshold Control BBOUT DS2 DS1 AND dB Below Peak Thld RefThld PKDET Ref AGC C BBO C PKD R LPF C AGC R PR R PW R TH2 R TH1 R TXM 20 8 17 18 14 15 3 9 56 4 7 13 1112 VCC1: Pin 2 VCC2: Pin 16 GND1: Pin 1 GND2: Pin 10 GND3: Pin 19 RREF: Pin 11 CMPIN: Pin 6 TX IN Tuning Figure 2 1 ® TR1000 916.50 MHz Hybrid Transceiver The TR1000 hybrid transceiver is ideal for short-range wireless data applications where robust operation, small size, low power consumption and low cost are required. The TR1000 employs RFM’s amplifier-sequenced hybrid (ASH) architecture to achieve this unique blend of character- istics. All critical RF functions are contained in the hybrid, simplifying and speeding design-in. The receiver section of the TR1000 is sensitive and stable. A wide dynamic range log detector, in combination with digital AGC and a compound data slicer, provide robust performance in the presence of on-channel interference or noise. Two stages of SAW filtering provide excellent re - ceiver out-of-band rejection. The transmitter includes provisions for both on-off keyed (OOK) and amplitude-shift keyed (ASK) modulation. The transmitter employs SAW filtering to suppress output harmonics, facilitating compliance with FCC 15.249 and similar regulations. RatingValueUnits Power Supply and All Input/Output Pins-0.3 to +4.0V Non-Operating Case Temperature-50 to +100 o C Soldering Temperature (10 seconds)230 o C CharacteristicSymNotesMinimumTypicalMaximumUnits Operating Frequencyf O 916.30916.70MHz Modulation TypeOOK Data Rate2.4kbps Receiver Performance (OOK @ 2.4 kbps) Input Current, 3 Vdc SupplyI R 1.8mA Input Signal for 10 -4 BER, 25°C 1-98dBm Rejection, ±30 MHzR REJ 55dB Transmitter Performance (OOK @ 2.4 kbps) Peak Input Current, 3 Vdc SupplyI TP 12mA Peak O…

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Bottom view. The label is metalized mylar of a type that we have been using for approximately 10 years for serial numbers on our products. They have proven very durable and it is located between the rubber feet where it will not be abraded.

- - 1 FCC ID LABEL/LOCATION Page 2 of this document is the front cover of The Model 1133 RF-IVD instruction manual with the appropriate labeling. Page 3 is a picture of the unit with the FCC ID label attached. The label is a metallized mylar label that has an adhesive that gets progressively stronger over time. It is positioned on the bottom of the unit between the rubber feet so that it is not subject to abrasive damage in normal use. This label is of a type that we have been using for years to put serial numbers on our products. They have proven very durable. - - 2 OPERATING INSTRUCTIONS Radio Frequency – In-Vivo Dosimeter "rf-IVD" Model 1133 NOTICE: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC ID: G6P1133 INF OR MAT ION T O USE R: Ca utio n, a ny cha nges or modificatio ns not e xpressly approved by Sun Nuclear Corporation could void the user's authority to operate this equipment. Display Firmware: 0100 Turtle Firmware: 0100 Base/Pod Firmware: 0100 October 14, 2000 DESIGNED AND MANUFACTURED BY SUN NUCLEAR CORPORATION MELBOURNE, FL USA 321-259-6862 http://www.sunnuclear.com - - 3

RF-IVD, MODEL 1133, INTERNAL PHOTOGRAPHS FIGURE 1 Base Station/Diode Pod Assembly The assembly shown in Figure 1 consists of four Printed Circuit Board (PCB) assemblies. The lower board is the electrometer board. When it is used as a Diode Pod, it converts the current from the radiation detection diodes to digital values for transmission back to the Base Station. When it is used as a Base Station, it receives data from a Diode Pod and relays it to an Operator Module or a Personal Computer via a cable. The board being held in position by the pliers is a battery pack consisting of three “AAA” NiMH batteries. The third board is the RF transceiver. The fourth is the antenna mounting pad (Not visible). The first three boards slide into grooves in the extruded aluminum case. The picture shows them in their approximate positions. Refer to the following assembly drawing for a more detailed representation of the unit as assemblied. FIGURE 2A Top of Electrometer Assembly FIGURE 2B Bottom of Electrometer Assembly FIGURE 3A Top of RF Transceiver Assembly FIGURE 3B Bottom of RF Transceiver Assembly FIGURE 4A Antenna Mounting Pad, Top FIGURE 4B Antenna Mounting Pad, Bottom

OPERATIONAL DESCRIPTION Radio Frequency – In-Vivo Dosimeter "rf-IVD" Model 1133 DESIGNED AND MANUFACTURED BY SUN NUCLEAR CORPORATION MELBOURNE, FL USA 321-259-6862 http://www.sunnuclear.com 1.0 Product Operational Overview The Sun Nuclear Model 1133 rf-IVD (or wireless IVD) is a system that measures the radiation output of a radioactive substance such as a Co-60 source or a linear accelerator, during the treatment of a patient. Because the radioactive source is located near the middle of the treatment room an RF link makes the movement of personnel, patients and equipment around it safer, i.e. no cables to trip over and no cables to roll carts over. The system consists of 4 components: Display Module (user interface), Turtle (Communication Hub), Base Station (rf transmitter and receiver), and Detector Pod (rf transmitter and receiver). The Base Station and Detector Pod are identical and are interchangeable through system setup. The diode radiation detectors are connected to the Detector Pod through coaxial BNC connectors. The radiation therapist connects the radiation detectors (diodes) to the Detector Pod and then positions them on the patient in order to measure the radiation from the accelerator. At this time, the patient is on the treatment couch of the accelerator, already positioned for treatment. The detector pod is battery operated and is positioned within 3 to 10 feet of the beam entrance to the patient. Also at this time, the beam is not on and the rf-IVD is not making a dose measurement. The therapist then leaves the treatment room that is shielded with approximately 3 feet of concrete and a heavy interlocked door. The patient is restrained on the couch because the treatment plan requires position accuracy to within millimeters, therefore no movement is allowed. Dose measurement is then remotely started on the rf-IVD from the Display Module in the control room and the accelerator beam turned on. A treatment fraction generally lasts for ½ minute or so. When the beam turns off, the rf-IVD is stopped and the dose value is displayed. The rf-IVD display value is recorded or printed on an accessory printer. The therapist then enters the room and removes the detector from the patient. The recorded rf-IVD measurement is a QA test that verifies the dose output during treatment from the radiation machine. The actual treatment plan is calculated in the Treatment Planning Computer (TPC – not part of the rf-IVD) which uses dosimetry data acquired from a NIST traceable calibrated ion chamber and 3D water phantom. The plan output should also include the "expected" dose at the point of the IVD detector placement. Then the measured IVD dose and the expected TPC dose can be compared for verification. If the expected dose is not verified, the measured dose should not be used to adjust future treatments. Instead, an investigation should be conducted as to why the error occurred. The IVD is calibrated at the institution using the NIST traceable calibrated ion chamber as a standard, the same standard that is used to calibrate the accelerator and the TPC. Therefore, the IVD offers a closed loop QA test of the implementation of the plan. 2.0 RF Transceiver The RF Transceiver is a completely self-contained hybrid in a 7mm X 10mm, surface-mount, 20-terminal metal can. It operates at 916.5 MHz, +/- 0.2 MHz. The modulation is On/Off Keyed. We are using a baud rate of 4630 bits/sec. The following Acrobat PDF document is the manufacturer’s specification for the hybrid that we are using. Double-click on the icon below to review the manufacturer’s specification. Acrobat Document This hybrid is mounted on a two-sided circuit board with a bottom ground plane and a top copper poured ground plane around all of the circuit traces and component mounting pads. There is an 8-pin connector that connects the transceiver to the microcontroller based electrometer board beneath the transceiver’s printed circuit board . The transceiver gets its power, control and data thru the connector from the electrometer board. The transceiver’s power supply Voltage is 3.0V. The power is filtered to keep noise from the electrometer board from getting on the RF output. The two control lines place the transceiver in either transmit mode, receive mode or “Off” mode. There is one transmit line for data to the transceiver and one receive line for data from the transceiver. The RF output track on the printed circuit board from the transceiver hybrid is impedance matched to a 50 Ohm coaxial cable connector. The other end of the coaxial cable is plugged into another 50 Ohm connector that is soldered to the antenna mounting pad. The antenna mounting pad has a “Reverse SMA” connector that is not readily available to the consumer. The ¼ wave helical whip antenna mounts to the “Reverse SMA” connector. The case is an aluminum extrusion with metal end panels. The system has been tested to meet section 15.249 of Part 15. We are not measuring a patient biometric, i.e. a physical parameter of a human being. We are measuring radiation coming from a radioactive isotope or a particle accelerator. A patient does not have to be present for this equipment to be used. 3.0 Location of Intended Use The radio frequency communication is only performed in the treatment vault of a hospital, clinic or university. The treatment vault is a shielded room having solid high density steel reinforced concrete walls and ceiling, typically 3 feet thick. The door is an 8 inch thick steel and boron polycarbonate laminate. The treatment vault must be well shielded to protect personnel from very high energy x-rays (20 MV) and is built on the ground floor of the institution. The shielding to prevent high-energy x-rays from leaving the room also prevents RF energy from entering or leaving the room. Refer to the following System Block Diagram.

284 West Drive, Suite B Melbourne, FL 32904 RUBICOM SYSTEMS, INC. SEPTEMBER 2000 Rubicom Systems, Inc. THIS REPORT SHALL NOT BE REPRODUCED EXCEPT IN FULL WITHOUT THE WRITTEN APPROVAL OF THE TESTING LABORATORY FCC TEST RECORD FOR THE SUN NUCLEAR CORPORATION RF-IVD WIRELESS DOSIMETRY SYSTEM JA-1755-2 1 FCC EMISSIONS REPORT FOR THE SUN NUCLEAR CORPORATION rf-IVD  WIRELESS DOSIMETRY SYSTEM Prepared by: ________________________________________________ Joseph G. Barbee Tested by: ________________________________________________ Alex Belardinelli Performed by:Performed for: RUBICOM SYSTEMS, INC.SUN NUCLEAR CORPORATION 284 West Drive, Suite B425-A Pineda Co urt Melbourne, Florida 32904Melbourne, Florida 32940 Completed:September 7, 2000 JA-1755-2 2 TABLE OF CONTENTS ParagraphTitle Page ABST RACT ............................................................................................................. 3 1.0INTRODUCTION ..................................................................................................... 4 1.1Purpose ................................................................................................................... 4 1.2Requirements .......................................................................................................... 4 1.3Unit Under Test Description .................................................................................... 4 1.4Summary of Results ................................................................................................ 5 2.0APPLICABLE DOCUMENTS ................................................................................. 6 3.0TEST SITE DESCRIPTION .................................................................................... 7 3.1Enviro nmental Conditio ns ....................................................................................... 7 4.0TEST INSTRUMENTATION ................................................................................... 8 5.0TEST SAMPLE SETUP AND CONFIGURATIONS ............................................... 9 Figure 5.0-1 ............................................................................................................. 9 6.0PROCEDURES AND RESULTS .......................................................................... 12 6.1Power Line Co nducted Results............................................................................. 12 6.2Radiated Emissions Results ................................................................................. 12 6.3Procedures ............................................................................................................ 12 6.3.1 Pretest ....................................................................................................... 12 6.3.2 Official Quasi-Peak, Peak and Average Scans ........................................ 12 6.3.3 Quasi-Peak Ambient (EUT Off/Support Equipment On) .......................... 13 6.3.4 Normalized EUT Scan (EUT and Support On) ......................................... 13 Data Sheets 6.1-1 - 6.1-2 ............................................................................... 14 - 15 Data Sheets 6.3.1-1 - 6.3.1-8......................................................................... 16 - 23 Data Sheets 6.3.2-1 - 6.3.2-14....................................................................... 24 - 37 Data Sheets 6.3.3-1 - 6.3.3-14....................................................................... 38 - 51 ATTACHMENT A .............................................................................................................. 52 JA-1755-2 3 ABST RACT This report presents test results of the emanations found emitting from the Sun Nuclear Corporation rf-IVD  Wireless Dosimetry System, referred to hereafter as the system, and the comparison of these emissions to the FCC rules stated in 47 CFR, Part 15, Subpart C, specifically 15.249, 15.205, 15.207 and 15.209. This testing was performed on a 3-meter open area test site at Rubicom Systems, Inc. (RSI). The testing was performed for Sun Nuclear Corporation under purchase order 13504. The report is o n file at RSI under JA number 1755. The results of this test effort indicate compliance of the system to the FCC requirements when configured as described in Paragraph 5.0. JA-1755-2 4 1.0INRODUCTION 1.1Purpose The purpose of this report is to present the results of testing a Sun Nuclear rf-IVD  to the FCC requirements of 15.249, 15.205, 15.207 and 15.209. 1.2Requirements The test requirements for emissions are as follows: RADIATED 15.209 Frequency (MHz) Distance (Meters) Field Strength dBμV 20 Log 3 Meter dBμV/ m 30 - 88310040 88 - 216315043.5 216 - 960320046 Above 960350054 RADIATED 15.249 Intentional Radiator 916MHz Field Strength of Fundamental - 50 Millivolts/Meter = 94dB μ V/m Field Strength of Harmonics - 500 μ Volts/Meter = 54dB μ V/m (Avg.) CONDUCTED 15.207 Frequency (MHz) Limits dBμV Quasi-Peak .45 - 3048 1.3Unit Under Test Description The rf-IVD  Wireless Dosimetry System is used for verification of patient radiation dosage. The rf-IVD  eliminates the wires between the treatment co uch and the user interface at the co nsole. The data is transferred via a RF link to the remote display or computer. The transmitter frequency is 916MHz. Attachment A presents a detailed description of the system. JA-1755-2 5 1.4Summary of Results Power line conducted data is presented in Data Sheets 6.1-1 and 6.1.2. No signals were measured within 18dB of the requirement. Only the transmit frequency was found in the radiated scans and found to be within the requirements. No harmonics were detected above the receiving system in average or peak detectors. JA-1755-2 6 2.0APPLICABLE DOCUMENTS The following documents form a part of this report to the extent expressed he rei n: ANSI C63.4-1992 FCC Characteristics of Open Field Test Sites Bulletin OET 55, October 1989 Code of Federal Regulations - 47 Part 15 (October 1998) JA-1755-2 7 3.0TEST S…

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DATA SHEET 6.1-1 DATA SHEET 6.1-2 DATA 6.3.1-1 DATA SHEET 6.3.1-2 DATA SHEET 6.3.1-3 DATA SHEET 6.3.1-4 DATA SHEET 6.3.1-5 DATA SHEET 6.3.1-6 DATA SHEET 6.3.1-7 DATA SHEET 6.3.1-8 DATA SHEET 6.3.2-1 DATA SHEET 6.3.2-2 DATA SHEET 6.3.2-3 DATA SHEET 6.3.2-4 DATA SHEET 6.3.2-5 DATA SHEET 6.3.2-6 DATA SHEET 6.3.2-7 DATA SHEET 6.3.2-8 DATA SHEET 6.3.2-9

DATA SHEET 6.3.2-10 DATA SHEET 6.3.2-11 DATA SHEET 6.3.2-12 DATA SHEET 6.3.2-13 DATA SHEET 6.3.2-14 DATA SHEET 6.3.3-1 DATA SHEET 6.3.3-2 DATA SHEET 6.3.3-3 DATA SHEET 6.3.3-4 DATA SHEET 6.3.3-5 DATA SHEET 6.3.3-6 DATA SHEET 6.3.3-7 DATA SHEET 6.3.3-8 DATA SHEET 6.3.3-9 DATA SHEET 6.3.3-10 DATA SHEET 6.3.3-11 DATA SHEET 6.3.3-12 DATA SHEET 6.3.3-13 DATA SHEET 6.3.3-14

JA-1755-2 1 ATTACHMENT A JA-1755-2 2 JA-1755-2 3 JA-1755-2 4 JA-1755-2 5 JA-1755-2 1

TEST SAMPLE SETUP CONFIGURATION WIRING DIAGRAM The rf-IVD was co nfigured as presented below. Power to the power supplies can be from 100-240 VAC, 47-63Hz. The switching supplies automatically adapt. The test were performed at 220VAC. All I/O ports were loaded with the typical cabling that wo uld be used in a regular setup. The system was setup using a RF link between the detector pod and base station. A dosage simulator was attached to one input o n the detector pod. The remaining two inputs had nuclear radiatio n detection diodes attached. Photos one and two present the conducted and radiated setup. Dosage Sim ulator IVD Base Station SIT Thermal Pr inter Model DPU-414 S/N: 1033061A Astrodyne Model SPU15A-1-1 Power Supply Astrodyne Model SPU15A-4 Power Supply RF IVD Turtle IVD Keypad Approx. 20' Cable 220 VAC 220 VAC +15 VDC +15 VDC Enclosure Wall 6 VDC IVD Detector Pod PHOTO 1 PHOTO 2