PFG-TD312Blood Pressure Cuff Inflator

D. E. Hokanson, Inc. 12840 N. E. 21st Place Bellevue, WA 98005, USA Phone (800)999-8251 (425)882-1689 FAX (425)881-1636 TD312 RF LINK Calculating Cuff Inflator Manual Serial No. ___________________ Copyright 2000, DEH#86437.DOC 2 TD312 Calculating Cuff Inflator General description The TD312 Calculating Cuff Inflator is a uniquely designed powerful cuff inflator with an electronic memory and calculator. It will increase the accuracy of your blood pressure measurements and save you time in measuring segmental limb pressures and calculating pressure indices. The unit can inflate a vascular cuff to over 300 mmHg. Inflation and deflation are controlled by a single thumbwheel. There are 12 memory registers in the TD312 which can store pressures from multiple sites. The memory buttons are numbered and coded with letters corresponding to various pressure sites, i. e. LUT = Left Upper Thigh. Once stored, the pressure measurements will remain until changed by the user; values are not deleted from memory when the unit is turned off. Two versions of the TD312 provide a computer interface. The Data Link version connects to a computer interface with a cable at the top of the instrument. The RF Link version has no connector on top and sends its data directly by radio to a receiver attached to the computer interface. The unit is powered by ten rechargeable AA nickel-cadmium batteries and will inflate approximately 350 ankle cuffs on one battery charge. Short form operating instructions A symbolic form of operating instructions (as pictured below) appears on the bottom of the instrument. After you learn how to use the instrument, these will serve as a helpful reminder how to perform various functions. 3 TD312 Specifications Inflate Rate 100 mmHg in 4 seconds with an applied SC10 cuff. Inflations per Battery Charge Up to 350 inflations of an SC10 cuff up to 160 mmHg. Deflate Rate Continuously variable from 0 to 50 mmHg/sec with an SC10 cuff. Output Pressure 0 to 350 mmHg. Memories Twelve selectable memory locations. Memory is continuous, i.e., it is not lost when the instrument turns off. Calculator The value of any memory cell can be divided by that of any other for calculating pressure ratios like the ankle/brachial index. Power Ten rechargeable AA nickel cadmium batteries. A wall mounted charging unit will recharge the batteries in 14 hours. Computer Interface Serial RS232, 9600 Baud. Data is transferred each time the Store button is pressed. The RF Link version transmits the data through a 418 MHz radio transmitter in the unit at 4800 baud. Size 10 cm X 28 cm X 4 cm (4 X 11 X 1.5 inches). Weight 1.0 Kg (2.2 lb.). TD312 User Instructions Automatic Zero When the instrument is first turned on, the display will automatically be set to zero. Sometimes, due to temperature change, the display may drift by 1 or 2 mmHg. If the drift is in the negative direction the unit will automatically re-zero itself when zero pressure is reached. If the drift is positive and the display shows a small value even when no cuff is connected, the user can reset the zero (see instructions under Additional Controls.) Error Message An error message of 999 will flash on the display accompanied by a series of beeping tones if the drift of the pressure sensor is perceived by the instrument to be 3 or more mmHg negative. The instrument can be reset by restarting it, but if the error signal continues the instrument is out of calibration and should be returned for repair and calibration. 4 Inflating a Cuff Cuffs should always be applied snugly prior to inflation. This will help minimize movement of the cuff when it is inflated and will also shorten the inflation time since less air will be required to reach the desired pressure. The connector furnished with the TD312 is a standard male Luer slip fitting. Slip the connector into the mating female connector on the cuff with a slight twisting motion. Push the thumbwheel forward against the stop to inflate the cuff. This will turn on the instrument and start the air compressor. The unit will remain on for a period of 5 minutes after the compressor runs or any button has been pressed; then it will automatically turn off to save power. The compressor will run while the thumbwheel is pushed forward until a pressure of approximately 310 mmHg is reached. The maximum value can vary somewhat depending on the size of the cuff because the compressor coasts to a halt. If the maximum pressure is reached the unit cannot be restarted until the pressure drops to approximately 200 mmHg. During inflation the display will show the approximate pressure, and it may be necessary to add or release air to reach a precise pressure value. Data Storage The display of the TD312 has two modes, CUFF MODE and MEMORY MODE . In Cuff Mode the display shows the pressure in the cuff to the nearest mmHg. Memory Mode is indicated by a small arrow in the upper left hand corner of the display. In Memory Mode the display shows the contents of the memory registers or the results of calculations. The MEM- CUFF button will toggle the display between the two modes. Starting the unit will automatically reset the display to Cuff Mode to show the pressure in the cuff. In order to store a pressure in one of the memory registers it is necessary to press two buttons. First you must select the memory register in which you wish to store the pressure. This may be done prior to (or after) inflating the cuff. Pressing the STORE button will store whatever pressure is displayed at the moment in the chosen memory register. Data Trnasmission Pressing the STORE button automatically transmits the pressure data through the data port (Data Link version) or via the RF Link. The pressure is recorded by the NIVP3 computer program. A cable or TD312 Receiver is required to input the data into the computer interface for the NIVP3 software. When the TD312 Receiver is used it receives its power from the computer interface box. It does not need to be turned on…

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December 12, 2000 Testing Lab: The model TD312 transmits 4 bytes whenever the "Store" key is pressed. Before the bytes are transmitted, they are inverted. A high level into the transmitter initiates a burst. A low level keeps the transmitter off. Therefore, the worst-case "on" time corresponds to the maximum number of zeros contained in the transmitted bytes. The first two bytes are "id" bytes: hex 48 followed by hex 85. The third byte is the high byte of the data. The worst-case format of this byte is hex 80. The fourth byte is the low byte of the data. Worst-case for this byte is hex 00. The bytes are transmitted at 4800 Baud, which is 208us / bit. There are four low "start" bits, which are transmitted as highs. Therefore, the worst-case number of zeroes is 30. This gives a duty cycle of 6.24%. These calculations are outlined below. Byte Hex Binary Number of 0's First id byte: 48 0100 1000 6 Second id byte 85 1000 0101 5 First data byte 80 1000 0000 7 Second data byte 00 0000 0000 8 Start bits 4 Total 30 (30 X 0.208ms X 100) / 100ms) = 6.24% Thank you, Mark VanSteenkiste Assoc. Engineer 524-882-1689 [email protected]

2 TD312 Calculating Cuff Inflator General description The TD312 Calculating Cuff Inflator is a uniquely designed powerful cuff inflator with an electronic memory and calculator. It will increase the accuracy of your blood pressure measurements and save you time in measuring segmental limb pressures and calculating pressure indices. The unit can inflate a vascular cuff to over 300 mmHg. Inflation and deflation are controlled by a single thumbwheel. There are 12 memory registers in the TD312 which can store pressures from multiple sites. The memory buttons are numbered and coded with letters corresponding to various pressure sites, i. e. LUT = Left Upper Thigh. Once stored, the pressure measurements will remain until changed by the user; values are not deleted from memory when the unit is turned off. Two versions of the TD312 provide a computer interface. The Data Link version connects to a computer interface with a cable at the top of the instrument. The RF Link version has no connector on top and sends its data directly by radio to a receiver attached to the computer interface. The unit is powered by ten rechargeable AA nickel-cadmium batteries and will inflate approximately 350 ankle cuffs on one battery charge. Short form operating instructions A symbolic form of operating instructions (as pictured below) appears on the bottom of the instrument. After you learn how to use the instrument, these will serve as a helpful reminder how to perform various functions.

FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 1 of 16 FCC PART 15, SUBPART B and C TEST METHOD: ANSI C63.4-1992 TEST REPORT for BLOOD PRESSURE CUFF INFLATOR Model: TD312 Prepared for D.E. HOKANSON, INC. 12840 NE 21ST PLACE BELLEVUE, WASHINGTON 98005 COMPATIBLE ELECTRONICS INC. 114 OLINDA DRIVE BREA, CALIFORNIA 92823 (714) 579-0500 DATE: JANUARY 12, 2001 REPORT APPENDICES TOTAL BODY A B C D E PAGES 16 2 2 12 18 2 52 This report shall not be reproduced except in full, without the written approval of Compatible Electronics. FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 2 of 16 TABLE OF CONTENTS Section / Title PAGE GENERAL REPORT SUMMARY 4 SUMMARY OF TEST RESULTS 4 1. PURPOSE 5 2. ADMINISTRATIVE DATA 6 2.1 Location of Testing 6 2.2 Traceability Statement 6 2.3 Cognizant Personnel 6 2.4 Date Test Sample was Received 6 2.5 Disposition of the Test Sample 6 2.6 Abbreviations and Acronyms 6 3. APPLICABLE DOCUMENTS 7 4. Description of Test Configuration 8 4.1 Description of Test Configuration - EMI 8 4.1.1 Cable Construction and Termination 9 5. LISTS OF EUT, ACCESSORIES AND TEST EQUIPMENT 10 5.1 EUT and Accessory List 10 5.2 EMI Test Equipment 11 6. TEST SITE DESCRIPTION 12 6.1 Test Facility Description 12 6.2 EUT Mounting, Bonding and Grounding 12 7. Test Procedures 13 7.1 Radiated Emissions (Spurious and Harmonics) Test 13 7.2 Bandwidth of the Fundamental 15 8. CONCLUSIONS 16 FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 3 of 16 LIST OF APPENDICES APPENDIX TITLE A Modifications to the EUT B Additional Models Covered Under This Report C Diagrams, Charts and Photos • Test Setup Diagrams • Radiated Emissions Photos • Antenna and Effective Gain Factors D Data Sheets E Laboratory Recognitions LIST OF FIGURES FIGURE TITLE 1 Conducted Emissions Test Setup 2 Plot Map And Layout of Test Site FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 4 of 16 GENERAL REPORT SUMMARY This electromagnetic emission test report is generated by Compatible Electronics Inc., which is an independent testing and consulting firm. The test report is based on testing performed by Compatible Electronics personnel according to the measurement procedures described in the test specifications given below and in the "Test Procedures" section of this report. The measurement data and conclusions appearing herein relate only to the sample tested and this report may not be reproduced in any form unless done so in full without the written permission of Compatible Electronics. This report must not be used to claim product endorsement by NVLAP or any other agency of the U.S. Government. Device Tested: Blood Pressure Cuff Inflator Model: TD312 S/N: N/A Product Description: See Expository Statement. Modifications: The EUT was not modified during the testing. Manufacturer: D.E. Hankinson, Inc. 12840 NE 21st Place Bellevue, Washington 98005 Test Date: January 11, 2001 Test Specifications : EMI requirements CFR Title 47, Part 15 Subpart B and C, Sections 15.205, 15.209, and 15.231 Test Procedure: ANSI C63.4: 1992 Test Deviations: The test procedure was not deviated from during the testing. SUMMARY OF TEST RESULTS TEST DESCRIPTION RESULTS 1 Conducted RF Emissions, 450 kHz - 30 MHz Complies with the Class B limits of CFR Title 47, Part 15, Subpart B 2 Radiated RF Emissions, 10 kHz - 4200 MHz Complies with the limits of CFR Title 47, Part 15, Subpart C, sections 15.205, 15.209, and 15.231 FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 5 of 16 1. PURPOSE This document is a qualification test report based on the Electromagnetic Interference (EMI) tests performed on the Blood Pressure Cuff Inflator Model: TD312. The EMI measurements were performed according to the measurement procedure described in ANSI C63.4: 1992. The tests were performed in order to determine whether the electromagnetic emissions from the equipment under test, referred to as EUT hereafter, are within the specification limits defined by CFR Title 47, Part 15, Subpart B and C, sections 15.205, 15.209, and 15.231. FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 6 of 16 2. ADMINISTRATIVE DATA 2.1 Location of Testing The EMI tests described herein were performed at the test facility of Compatible Electronics, 114 Olinda Drive, Brea, California 92823. 2.2 Traceability Statement The calibration certificates of all test equipment used during the test are on file at the location of the test. The calibration is traceable to the National Institute of Standards and Technology (NIST) . 2.3 Cognizant Personnel D.E. Hokanson, Inc. D.E. Hokanson President Mark VanSteenkiste Associate Engineer Compatible Electronics Inc. Kyle Fujimoto Test Engineer Scott McCutchan Lab Manager 2.4 Date Test Sample was Received The test sample was received on January 11, 2001 2.5 Disposition of the Test Sample The test sample has not been returned to D.E. Hokanson, Inc. as of January 12, 2001. 2.6 Abbreviations and Acronyms The following abbreviations and acronyms may be used in this document. RF Radio Frequency EMI Electromagnetic Interference EUT Equipment Under Test P/N Part Number S/N Serial Number HP Hewlett Packard ITE Information Technology Equipment CML Corrected Meter Limit LISN Line Impedance Stabilization Network FCC ID: PFG-TD312 Report No.: B10111D1 114 OLINDA DRIVE, BREA, CALIFORNIA 92823 PHONE: (714) 579-0500 FAX: (714) 579-1850 Page 7 of 16 3. APPLICABLE DOCUMENTS The following documents are referenced or used in the preparation of this EMI Test Report. SPEC TITLE CFR Title 47, Subpart C FCC Rules – Radio frequency devices (inclu…

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