Page 1 01/24/14 Instructions for Use P/N 5651 Page 2 Page
Contents
1. Expiratory pressure recording and display Respiratory effort Breathing Cue metronome Heart rate via electrocardiography ECG Non invasive blood pressure from optional external device The HRV Acquire does not make a diagnosis or indicate by itself that any disease state exists The HRV Acquire is not designed for vital signs monitoring or self monitoring of patients Contraindications None Warnings and Cautions Warning PACEMAKER PATIENTS Rate meters may continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias Do not rely entirely upon rate meter keep pacemaker patients under close surveillance See this manual for disclosure of the pacemaker pulse rejection capability of this instrument Warning Not defibrillation proof Disconnect from patient prior to defibrillation Warning The medical equipment should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the medical equipment should be observed to verify normal operation in the configuration in which it will be used Warning The conductive parts of Electrodes and associated connectors for applied parts including the Neutral electrode should not contact other conductive parts including earth Page 4 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Warni2. Low PA Autonomic nervous system function J Clin Neurophysiol 1993 10 1 14 27 Low PA Testing the autonomic nervous system Semin Neurol 2003 23 4 407 421 Low PA Opfer Gehrking TL Textor SC et al Postural tachycardia syndrome POTS Neurology 1995 45 4 suppl 5 S19 S25 Schrezenmaier C Gehrking JA hines SM et al Evaluation of orthostatic hypotension relationship of a new self report instrument to laboratory based measures Mayo Clin Proc 2005 80 3 330 334 Suarez GA Opfer Gehrking TL Offord KP et al The Autonomic Symptom Profile a new instrument to assess autonomic symptoms Neurology 1999 52 3 523 528 Vogel ER Sandroni P Low PA Blood pressure recovery from Valsalva maneuver in patients with autonomic failure Neurology 2005 65 10 153301537 Goldstein DS Smith L The NDRF handbook for patients with dysautonomias New York Futura Media Services 2002 Freeman R Pure Autonomic failure In Robertson D Biaggioni eds Disorders of the autonomic nervous system Luxembourg Harwood Academic Publishers 1995 83 106 Freeman R Autonomic peripheral neuropathy Lancet 2005 365 9466 1259 1270 Troubleshooting Problem Possible Cause Correction Check ECG Error Poor patient connection Perform skin prep and or adjust electrode placement Flat line ECG signal Temporary corruption of USB End any test that may be running connection to computer Power the HRV Acquire off for 15 seconds then tur
3. a H RV Acquire Heart Rate Variability Acquisition 01 24 14 Instructions for Use P N 5651 WR Medical Electronics Co Copyright information This manual copyright 2010 2014 by WR Medical Electronics Co All rights reserved No part of this manual may be reproduced in any form by any means graphic electronic or mechanical including photocopying recording taping or any information storage and retrieval system without the written permission or WR Medical Electronics Co HRV Acquire item number 5650 For more information contact WR Medical Electronics Co 1700 Gervais Avenue Maplewood MN 55109 USA Phone 651 604 8400 Phone toll free within the United States and Canada 800 635 1312 Fax 651 604 8499 Fax toll free within the United States and Canada 800 990 9733 E mail neuro wrmed com Web Site www wrmed com Comments or Questions We appreciate receiving any suggestions comments or questions that would help us to improve this manual Please forward comments to the address above Page 2 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Contents OVENI EWN en SRD E RR NR RS Rc RS RR DR ene vece ee 4 Eare ANOS ate tcc E RIO QUERO RISO JE E RR OR SRD RE DRT RIR 4 Ge aides ae i c ssa assassina E A Ra ain EE E E eer er ee 4 Mannes ana Cautions assa ren Doctor ade T AGO aa ne eee 4
4. SPO WIZ AION es sea aneeeceoeaqnenaisanatmasenceandacte E E E E E Gaceananataraqncasicetesceaqess 5 A NOIS 1116 o Sp DR RD No o ER eee ERR aa RS RR RR eee 5 System Classification IEC601 1 EN 60601 1 ccccccseeseeeesceeeeeeseeeeuseseeueeeesseueeesssueueeesseeeeesseueenses 6 Operating Transportation and Storage ivicciissasecicdcnacdsacsevavisvedaawetntesdanstessarasaddwsedsvnstwned inuneasddsnedbapeceusedateediseders 6 Electromagnetic Compatibility siscissccassccnvsteadcaesadecscontwabadonnssecadansdeensondsuwsdevadnsaniie a aaral 6 Satety and Information SymbDOlS wacosmncoesinct oases daseneancuncetonevavecsasscosietonnanaucnvonsninaseuesrcuressnecetaeuenssersesenantinsaesseniees 10 EEC MC PECE IDON ornan T E A 10 A O o Se ese E RR seen E EE E O E ER RR A E A E 11 ECO PECI O a EAE E EE E E E E 11 R Wave Detection Specifications sssssssesssesssrrssersrrrsrersrrrsrerssrrsrresrrsrresersrroserssrrorersstrseersetrsrerseersrerseeeseeo 12 Pacemaker PULE Recusa anos sao na ssa IEn REN AE NANREN 12 Pressure Onor operi CIONS en a O E si Ca asas 12 Anos MPU ONON l aT E EE TNA 12 Responsibility ofthe Suppliers st add Gi dn a ad iecdeunpe nee 12 Preventative Maintenance and Cleaning cccssccsscccsseceneccsecceneceneeseneeeseeeseeeeneceeeeeeecseneeeseeseneeaeeseeeseneegaeees 13 OWE ConnCeLONS quesosmame seen an sce E T AEE EA qui aj O uaE aaa EE E E NE 14 Operation ol tne HRV ACOUGO ses aaa se G Dis O 15 Equipment Setup a
5. Valsalva Expiratory Pressure Expected Actual Correction 0 0 mmHg 1 3 1 3 0 0 mmHg 1 3 1 3 Calibrate Chest Expansion Expected Actual Correction Zero 0 02 0 02 Restore Save Factory Data Cancel Calibrations Completed calibration sample The selection of Save Calibration will write the new constants into non volatile memory The factory data will not be over written Calibrate Warranty WR Medical standard 1 year warranty from date of purchase for main device Cords and Cables are 90 days If additional warranty is needed please contact the sales department for additional information Service and Repair Procedures Service and technical questions are welcome No readjustments or modifications are to be made by anyone other than persons authorized by WR Medical Electronics Because of the specialized circuitry of this instrument and the need for special test instruments we recommend that it be returned to the manufacturer for necessary servicing To send in a unit for service please ship by insured method and signify that it is USA made if sending from outside the USA Page 28 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Suggested Readings Goldstein DS The autonomic nervous system in health and disease New York Marcel Dekker Inc 2001
6. the user on the HRV Acquire should assure that it is used in such an environment IEC 60601 test level Compliance level Electromagnetic environment guidance Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply lines IEC 61000 4 11 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1kV line s to line s 2 kV line s to earth lt 5 Ut gt 95 dip in Ut For 0 5 cycle 40 Ut gt 60 dip in Ut For 5 cycles 70 Ut 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1kV line s to line s 2 kV line s to earth lt 5 Ut gt 95 dip in Ut For 0 5 cycle 40 Ut gt 60 dip in Ut For 5 cycles 70 Ut Page 7 WR Medical Electronics Co e 1700 Gervais Avenue e Phone 800 635 1312 e Fax 651 604 8499 e Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the HRV Acquire requi
7. UMENTS CAUTION Portable and mobile RF communication devices can affect MEDICAL ELECTRICAL EQUIPMENT Page 6 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co CAUTION The Power Conditioner HRV Acquire amp computer and monitor may require reset after an EMI event This is considered a normal and safe condition of the operation of the HRV Acquire device Guidance and manufacturer s declaration Electromagnetic emissions The HRV Acquire is intended for use in the electromagnetic environment specified below The customer or the user on the HRV mae T should assure that it is used in such an environment Compliance Electromagnetic environment guidance The HRV Acquire uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to cause any interference in nearby electronic equipment CISPR 11 IEC 61000 2 3 Harmonic emissions emissions CISPR 11 establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies The HRV Acquire is suitable for use in all buildings used for domestic purposes IEC 61000 3 3 Guidance and manufacturer s declaration Electromagnetic immunity The HRV Acquire is intended for use in the electromagnetic environment specified below The customer or
8. Use of accessories and cables other than those specified with the exception of transducers and cables sold by WR Medical Electronics for the HRV Acquire as replacement parts for internal components may result in increased emissions or decreased immunity of the equipment System Classification IEC601 1 EN 60601 1 Degree of protection against moisture ingress IEC529 IPXO Ordinary Degree of protection in the presence of a flammable Not protected unsuitable anesthetic mixture with air or with oxygen or with nitrous oxide Mode of operation Continuous Valsalva and Chest Expansion Type of protection against electric shock Type BF v ECG Type of protection against electric shock Type CF Operating Transportation and Storage After exposure to transport and storage extremes allow the system to acclimatize before operating The system should not be subject to transport and storage extremes for an extended period of time Operating Temperature Range 20 C to 25 5 C Operating Relative Humidity 20 to 55 non condensing Transport and Storage Temperature 10 C to 50 C Transport and Storage Relative Humidity 0 90 non condensing Electromagnetic Compatibility This device is independently tested to comply with IEC 60601 1 2 2004 CAUTION MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in the ACCOMPANING DOC
9. ails Rest for 5 minutes Start the second set Note Keep recording on WR TestWorks throughout the entire test even while the patient is resting between sets When complete stop the recording Select the test analysis icon at the bottom of the screen then the HRDB R R icon ee the second Heart Follow the instructions in the dialogue box to analysis the test Page 22 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co To see the entire test on screen this will be necessary in order to select the area to be analyzed zoom out by using the magnifier button Analyze the first set and press the save icon 7 amp E 3 53 Zoom out again select the second set and analyze it The composite report button on the bottom of the screen 3 icon from the left will put both analyses on test result on the one report Note Remove the chest bellows after maneuver as it is no longer needed and may be uncomfortable for the patient For further detail please see the WR TestWorks Software User s Guide Sample Protocol for Valsalva maneuver Performing Valsalva using the HRV Acquire and WR TestWorks Software Several items affect the Valsalva Recording These must be considered by the technician and controlled in order to maintain standardization and consistency between test subjects or for repeated t
10. d com WR Medical Electronics Co Sample Protocol for Performing Tilt Protocol for performing Tilt using the HRV Acquire and WR TestWorks Software Several items affect the Tilt Recording These must be considered by the technician and controlled in order to maintain standardization and consistency between test subjects or for repeated tests on the same patient WARNING Physician attendance required Instructions 1 Have the patient come in relaxed and comfortable with an empty bladder Patient should lay down for a minimum of 5minutes prior to starting the test 2 Attach the ECG electrodes white on right black on left red is reference You may want to prepare the skin with an alcohol wipe NuPrep or other standard ECG preparation If you are getting a lot of artifact remove the pads prepare the skin and then start again with fresh pads Two sites for electrode placement are Figure 2 The interscapular area just medial to the tip of the scapula The supraclavicular areas Reference electrode site is not critical Front Back Figure 3 3 OPTIONAL Connect beat to beat blood pressure device in accordance with manufactures manual 4 Turnonthe HRV Acquire and the WR TestWorks software 5 Select the patient name or add new patient and the Tilt test E Begin recording Note Only a small heart will be displayed during this test no other indications are displayed 6 Explain the procedure to the s
11. ests on the same patient Instructions 1 Have the patient come in relaxed and comfortable with an empty bladder Patient should lay down for a minimum of 5 minutes prior to starting the test 2 Attach the ECG electrodes white on right black on left red is reference You may want to prepare the skin with an alcohol wipe NuPrep or other standard ECG preparation If you are getting a lot of artifact remove the pads prepare the skin and then start again with fresh pads Two sites for electrode placement are Figure 2 The interscapular area just medial to the tip of the scapula The supraclavicular areas Reference electrode site is not critical Page 23 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Front Back Figure 2 3 OPTIONAL Connect beat to beat blood pressure device in accordance with manufactures manual 4 Turn on the HRV Acquire and the WR TestWorks software 5 Select the patient name or add new patient and the Valsalva test he Begin recording Note The count down timer will automatically start when 30mmhg is crossed 6 Explain the procedure to the subject We are going to be testing your autonomic nerves This test is quite simple We will ask you to exhale into the mouthpiece and cause the light bar to move upwards to the 40mmhg line and continue blowing for 15 sec
12. g for the first time Connect Power Supply Connect Analog input from Blood Pressure Device optional See WR TestWorks for configuration Power device On ui AUN Note If the ECG is not connected to the patient the screen will display a yellow message Check ECG B WR TestWorks Default File Edit view Patient Test Device Heart Rate Deep Breathing Utilities Window Help p alsa a gella aded vejo je je aa A Heart Rate Deep Breathing Blais Jack M O Systoic EH Mm O Mean BP ES MO Diastolic EH M 0 0 Rate ECC EM eatsiMin mmHg B M a a Am 00 00 00 10 00 20 00 30 00 40 00 50 01 00 2000 O Frimn ES tp _ 00 00 00 10 00 20 00 30 00 40 01 00 0 0 Arterial BP ES 0 0 cc EM 0 0 Chest Exp ES mmHg molts x50 00 00 00 01 00 03 00 04 00 06 00 08 00 09 Check to see that the cable and electrodes are connected properly Suggested Patient Preparation for all test modes Page 20 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co No food coffee nicotine alcohol for 8 hrs No anticholinergics e g antidepressants antihistamines OTC cold remedies florinef diuretics sympathomimetics or parasympathomimetics for 48hrs No alpha or beta antagonists for 24 48hrs No analgesics compressive clothing Sample Protocol HRDB Heart Rate Deep Breathing Performing HRDB using
13. les should be carefully coiled when not in use to prevent tangling or breaking Inspect cables before using to detect any At the end of service consult local regulations for disposal of system parts Page 13 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Power Connections The HRV Acquire computer and monitor are to be powered by the Power conditioner at all times When power cycling the HRV after turning the unit Off wait 15 seconds before turning the unit back On Power connection diagram Wall receptacle LR LA HRY Power Conditioner sL A a um BIBIB Secondary ground T O A Ground terminal Secondary wire connection Q VGA Remove one of the monitor s receptacle standoffs 3 16 from the rear panel Place the standoffs threads through the ring E terminal and reattach Connect the other ring terminal to the ground terminal on the rear panel of the power conditioner Warning Do not remove or bypass the ground prong on any plug or disable any safety feature Page 14 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Operation of the HRV Acquire System Components Display Pole Clamp do not place ona pole with IV ECG solutions o
14. libration WR TestWorks Analog Mux ADC Expected Actual 0 500 Y Setup the analog BP device to output its calibration signal Press OK when device is setup core Calibrate Valsalva Pressure Entry Pressurize the valsalva input to approximately 45 mmHg Arterial Blood Pressure Enter the exact pressure value then press OK Expected Actual Correction Exact Pressure fo 200 mmHg Cancel Calibrate Valsalva Pressure Entry Correction Tle mm 2 048 V Tle O mmHg Pressurize the valsalva input to approximately 5 mmHg Enter the exact pressure value then press OK Exact Pressure fo Cancel Calibrate WR TestWorks Valsalva Expiratory Pressure Expected Actual Correction Tle Chest Expansion Expected Actual Zero Restore Factory Data Cancel Disconnect chest expansion bellows or open purge valve Press OK when ready Calbat o cm Correction mr E Page 27 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co HRY Acquire Calibration Analog Mux ADC Expected Actual Correction 0 500 V 0 500 0 000 2 048 2 048 0 000 Calibrate Arterial Blood Pressure Expected Actual Correction 200 mmHg 201 0 1 0 0 mmHg 0 2 0 2 Calibrate
15. n power back on Page 29 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com
16. nd Connection to WR TestWorks Software ccccccecccsseceseceeesseneceseetenseeeeeeuseeneeeeeens 19 Sample Protocol HRDB Heart Rate Deep Breathing e crereeeere crer cerran renan ceran renas reranrenaao 21 Sample Protocol for Valsalva maneuver ccceecccseccesscecseceeeucecaeccauececeececsuceseecteneceeeecessucessnecesneceseeseseneenees 23 Sample Protocol for Performing TIE cssassassaisa as sadisosi asas dnAd sedia batisianarEa GE ninar ia suada ssa isbn ad aih den na insana 25 WM UM q LO ce E cent RAD RR ND RR RN nou on E E RR RA UR RR DR 28 DONVICO eee es ee sa Ce nbs Sun ads ES a aaa ee ere cr E Ena ee ee re ere 28 Suee Ted RE AOS auras en ae A Rs a eee 29 TROUDIESNOO LINE sans trio LOS a A E Rd ada 29 Page 3 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Overview The HRV Acquire will be used in research labs and clinics along with WR TestWorks to support autonomic testing with clinical evaluation of physiologic parameters The HRV s display of ECG is only a signal quality indicator not considered a monitor with ECG waveform display capability The HRV is applied to determine changes in heart rate under defined test conditions Indications The Heart Rate Variability HRV Acquire device is intended to record and indicate the following parameters during autonomic testing maneuvers
17. ng Be aware of any safety hazard due to the summation of Leakage currents when several items of equipment are interconnected Caution Do not use this device in the presence of HF electrosurgical instruments Caution Line isolation monitor transients may resemble actual cardiac waveforms Do not allow electrode cables to run parallel with or cross any power cord Caution Federal law restricts this device to sale by or on the order of a physician Caution This device is to be operated only by trained personnel under the direction of a physician Caution The HRV Acquire is not explosion proof and should not be used in the presence of explosive gases Caution Carefully route patient cables to reduce the possibility of patient entanglement or strangulation Caution The HRV will remember operator settings and patient data if an interruption of supply mains exceeds 30 seconds Sterilization Not required Accessories WR Part No Cable length T 5651 Instructions for Use o ooo o 479 W0 81013 Valsalva bugle o oo o o 5048 ECG cable lead wires 3 046 5180 Electrodes Silver Silver chloride o oo 5560 Power Conditioner SSS oo oo o Note The HRV Acquire outputs the heart rate to the WR TestWorks software via the USB interface Page 5 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co WARNING
18. oftware when running the selected test See the WR TestWorks manual for additional information on performing tests All modes combine the ECG signal and external signals Optional Beat to Beat Blood Pressure device must be FDA approved to output via USB connection to the host computer HRDB This mode displays a moving cadence of LEDs of 5 seconds up 5 seconds down This is a visual reference or cue for the patient to breathe along with Valsalva This mode displays a target equal to 40mmhg and moving bar referenced to the patient bugle input This is for patient feedback to exert a consistent effort during the maneuver ECG This mode displays a heart and is used to record ECG during other maneuvers such as tilt or standing tests ECG Specifications Defibrillator Protection none See Warnings and Cautions Patient Cable 6 pin AAMI Standard WR PN 5047 5048 Patient Lead LII RA LA LL Frequency Response 0 2 to 100Hz Response time lt 8 seconds Patient Electrodes Silver Silver chloride Recommended No alarms are provided NOTE The HRV Acquire is not intended for use with pacing devices Page 11 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co R Wave Detection Specifications Range 15 to 300 bpm Accuracy 2 Resolution 1 bpm Sensitivity 300 uV peak Response time lt 8 sec
19. onds Tall T Wave Rejection Rejects T waves lt R wave Pacemaker Pulse Rejection Width 0 1 ms to 2 ms 2 mV to 700 mV Overshoot 4 ms to 100 ms and not greater than 2 mV Detector disabling none provided Pressure Sensor Specifications Chest expansion 0 5 to 5 0 psi O 5psi of ambient Valsalva O to 2 psi Analog Input optional DB15 Input Signal for blood pressure O to 5vdc Signal will be filtered with a 250Hz 25Hz first order low pass filter Responsibility of the Supplier WR Medical Electronics Co accepts responsibility for the affects of safety reliability and performance of the equipment only if Assembly operation extensions readjustments modifications and repairs are conducted by persons authorized by WR Medical Electronics Co The electrical installation of the room complies with local regulations The equipment is used in accordance with the Instructions for Use Page 12 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Preventative Maintenance and Cleaning Inspect the device and cables before using to detect any damage or damage to cables Clean the device when necessary by using a dry cloth For stubborn stains a lightly dampened cloth and a mild detergent may be used Be sure to completely dry the unit before returning to service Do not immerse unit or any cables Cab
20. onds After a 5 minute rest we will ask you to repeat the test with another effort It is important to try and reach 40mmhg and hold it as steady as possible Do not hold your breath at any time We will have you try it so you can see how it feels 7 Position the HRV Acquire display so that the patient has full unobstructed view of the front 8 Give the patient a practice test 9 Let the subject rest 2 minutes after the practice 10 Start the first set Press the Mark key Cl OS A OA green triangle in WR TestWorks to signify the beginning of the test Press the Mark key again when completed 11 Rest for 5 minutes 12 Start the second set NOTE Keep recording on WR TestWorks throughout the entire test even while the patient is resting between sets NOTE It is important to continue recording at least 30 seconds after the maneuver When complete stop the recording Select the test analysis icon at the bottom of the 9 screen then the Val R R icon YALS the second Heart Follow the instructions in the dialogue box to analysis the test To see the entire test on screen this will be necessary in order to select the area to be analyzed zoom out by using the magnifier button Analyze both sets at the same time For further detail please see the WR TestWorks Software User s Guide Page 24 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrme
21. r other liquids Front View Chest Valsalva Bellows On Off See section HD15 Analog Input Optional Beat To Beat Blood Pressure only See section 26 Rear View Power Accessories Page 15 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Valsalva Bugle WRH479 W0 81013 HUB amp tubing WR 5812 Chest Expansion Bellows WR 5582 la ECG Lead set WR 5047 5048 Page 16 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Analog Input Cable WR 5052 USB Cable A to B WR 5053 Power supply WRH5051 Page 17 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Accessories Page 18 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Equipment Setup and Connection to WR TestWorks Software See WR TestWorks User Manual Installing the HRV Acquire device driver Insert the WR TestWorks CD ROM Disk in the drive and connect the USB cable to install the driver The following dialog boxes will be presented It i
22. res continued operation during power interruptions it is recommended that the HRV Acquire be powered from an uninterruptible power supply Maplewood MN 55109 USA Web www wrmed com WR Medical Electronics Co gt 30 dip in Ut gt 30 dip in Ut For 25 cycles For 25 cycles lt 5 Ut lt 5 Ut gt 95 dip in Ut gt 95 dip in Ut For5s For5s Power frequency Power supply magnetic fields 50 60 Hz should be at levels Magnetic field characteristic of a typical IEC 61000 4 8 location in a typical commercial or hospital environment NOTE Ut is the a c mains voltage prior to application of the test level Guidance and manufacturer s declaration Electromagnetic immunity The HRV Acquire is intended for use in the electromagnetic environment specified below The customer or the user on the HRV Acquire should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used to closer to any part of the HRV Acquire including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms d 1 2 Vp IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 1 2 Vp 80 MHz to 800 MHz d 2 3 Vp 800 MHZ to 2 5 GHz Where p is the maxim
23. s Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Safety and Information Symbols This device is to be independently tested to comply with UL 60601 1 Unit meets or exceeds the specifications for the AAMI EC13 2002 Standard Latex Statement The accessory chest bellows WR 5582 contains latex Direct skin contact should be avoided and should be applied over snug fitting clothing for all patients Attention consult accompanying documents Type CF Applied part F type patient contact part isolated from other parts of the equipment such that patient leakage currents cannot exceed allowed limits in NORMAL and SINGLE FAULT CONDITION Power On Power OFF Class Il Equipment for Medical Grade power supply Type BF Applied part for Valsalva and Chest Bellows inputs Direct current power for HRV Acquire ai o o Consult Operating Instructions Page 10 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Technical Specifications Size 10 25 x 6 57 x 1 26 inches 26 x 16 7 x 3 2 cm Weight 2 lbs 700 g 100 240 VAC 50 60HZ 1A desktop power supply Provides 5VDC 4A maximum to the HRV Center positive Leakage Current lt 100 uA at normal condition Modes All modes are selected by the WR TestWorks s
24. s not necessary to be connected to a network to install the driver and No not this time can be checked The device must be powered on during this installation Found New Hardware Wizard Welcome to the Found New Hardware Wizard Windows will search for current and updated software by looking on your computer on the hardware installation CD or on the Windows Update Web site with your permission Read our privacy policy Can Windows connect to Windows Update to search for software Yes this time only Yes now and every time connect a device No not this time Click Next to continue Found New Hardware Wizard This wizard helps you install software for HRY Acquire If your hardware came with an installation CD lt 4 or floppy disk insert it now What do you want the wizard to do Install the software automatically Recommended Install from a list or specific location Advanced Click Next to continue Page 19 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co Found New Hardware Wizard Completing the Found New Hardware Wizard The wizard has finished installing the software for e USBxpress Device Click Finish to close the wizard Finish 1 Connect the USB found on rear panel to computer running WR TestWorks a NOTE See above if connectin
25. the HRV Acquire and WR TestWorks Software Several items affect Heart Rate Deep Breathing HRDB These must be considered by the technician and controlled in order to maintain standardization and consistency between test subjects or for repeated tests on the same patient Instructions 1 Have the patient come in relaxed and comfortable with an empty bladder Patient should lay down for a minimum of 5minutes prior to starting the test 2 Attach the ECG electrodes white on right black on left red is reference You may want to prepare the skin with an alcohol wipe NuPrep or other standard ECG preparation If you are getting a lot of artifact remove the pads prepare the skin and then start again with fresh pads Two sites for electrode placement are figure 1 e The interscapular area just medial to the tip of the scapula e The supraclavicular areas e Reference electrode site is not critical Front Back Figure 1 3 Attach the patient bellows around the patient just below breast line Have the patient exhale make themselves small to set the zero point for testing and connect the bellows to the HRV Acquire device Page 21 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co 4 10 11 12 13 14 15 OPTIONAL Connect beat to beat blood pressure device in accordance with manufact
26. ture It is recommended that periodic Yearly verification be performed as with any electronic equipment To perform this verification the following equipment will be needed NOTE The manufacture calibration constants are stored in non volatile memory within the device and can always be restored 1 Pressure gauge mmHg Valsalva and Chest Expansion Use an accurate digital manometer whose calibrations are traceable to NIST standards The manometer should have a positive and negative input 2 or less in accuracy 2 Arterial Blood pressure device outputting square wave signal Arterial Blood pressure Only non invasive blood pressure monitors that output a 0 5VDC reflecting 0 500mmHg in WR TestWorks calibration signal can be used Within WR TestWorks gt Device gt Cardiac gt Calibrate 8 WR TestWorks Default File Edit view Patient Test Analysis ee Utilities Window Help B 9 Configure ast 4 lastro ast4 lastro ast4 lastro ast HRDE QSweat dl Calibrate CA gt SE Iv 2 Test Explorer Manual QST gt Sniff Magnitude gt The following dialog box will be displayed Follow the dialog messages to perform the calibration The Analog Mux ADC calibrate is an internal voltage measurement not requiring any external connection Page 26 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co HRY Acquire Ca
27. ubject We are going to be testing your autonomic nerves This test is quite simple You will be tilted up to 80 and your ECG and blood pressure will be recorded For approx 10 minutes then you will be titled back down to 0 You may feel that you are somewhat upside down this feeling will go away after awhile If you feel dizzy or uncomfortable at any time during this procedure please speak up Page 25 WR Medical Electronics Co e 1700 Gervais Avenue e Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co 7 Start the tilt by depressing the up button on the tilt table control until 80 as noted on green triangle in WR TestWorks to signify the up of the tilt 8 Continue recording for 10 minutes 9 End the tilt by depressing the down button on the tilt table control until 0 as noted on green triangle in WR TestWorks to signify the down of the tilt 10 Record for 5 minutes When complete stop the recording Select the test analysis icon at the bottom of the 9 screen then the Tilt icon TILT Follow the instructions in the dialogue box to analysis the test To see the entire test on screen this will be necessary in order to select the area to be analyzed zoom out by using the magnifier button a For further detail please see the WR TestWorks Software User s Guide Calibration The HRV Acquire is calibrated at the manufac
28. uch as re orienting or relocating the HRV Acquire b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the HRV Acquire The HRV Acquire is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the HRV Acquire can help prevent electromagnetic interference by maintaining a minimum distance between mobile and portable RF communications equipment transmitters and the HRV Acquire as recommended below according to the maximum output power of the communication equipment Do Separation distance according to frequency of transmitter m Rated maximum output 150 kHz to 80 MHz 80 MHz to 800 MHz 800MHz to 2 5 GHz power of UE d 1 2 Vp d 1 2 Vp d 2 3 Vp For RR rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where p is the maximum output power rating of the transmitter in watts W according to the manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 9 WR Medical Electronic
29. um output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strength from fixed RF transmitters as determined by an electromagnetic site survey should be less than the Page 8 WR Medical Electronics Co e 1700 Gervais Avenue Maplewood MN 55109 USA Phone 800 635 1312 e Fax 651 604 8499 e Web www wrmed com WR Medical Electronics Co compliance level in each frequency range P Interference may occur in the vicinity of equipment marked with the following symbol o NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radios AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the HRV Acquire is used exceeds the applicable RF compliance level above the HRV Acquire should be observed to verify operation If abnormal performance is observed additional measures may be necessary s
30. ures manual Turn on the HRV Acquire and the WRTestWorks software Select the patient name or add new patient and select the HRDB test iconHRDB Begin recording o a Ti icon starts and stops the LED cadence Explain the procedure to the subject We are going to be testing your autonomic nerves This test is quite simple We will ask you to breathe deeply at the same rate as the oscillating bar or to breathe in and out according to my hand movements for a total of 8 breaths After a 5 minute rest we will ask you to repeat the test with another 8 breaths It is important to breathe as deeply as possible You can breathe in through your nose and out through your mouth if that is comfortable for you Do not hold your breath at any time but use a full 5 seconds for breathing in and a full 5 seconds for breathing out We will have you try it for 2 breaths so you can see how it feels Position the HRV Acquire display so that the patient has full unobstructed view of the front Give the patient a practice test The practice should be only two breaths Let the subject rest 2 minutes after the practice Start the first set Press the metronome Ti in WR TestWorks to signify the beginning of the test Press the metronome Ti key again when the set is completed a NOTE if respiration cycles in the configuration is set to a specific number the mark and cadence will automatically stop See the WR TestWorks software user manual for det
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