Instructions for Use
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01/24/14 Instructions for Use P/N 5651
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: [email protected] 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 • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Contents Overview: ... 4 Indications: ... 4 Contraindications: ... 4 Warnings and Cautions ... 4 Sterilization: ... 5 Accessories ... 5 System Classification (IEC601--1 / EN 60601--1) ... 6 Operating, Transportation and Storage ... 6 Electromagnetic Compatibility ... 6 Safety and Information Symbols ... 10 Technical Specifications ... 10 Modes ... 11 ECG Specifications ... 11 R--Wave Detection Specifications ... 12 Pacemaker Pulse Rejection ... 12 Pressure Sensor Specifications ... 12 Analog Input (optional) ... 12 Responsibility of the Supplier ... 12 Preventative Maintenance and Cleaning ... 13 Power Connections ... 14 Operation of the HRV Acquire ... 15 Equipment Setup and Connection to WR TestWorks™ Software ... 19 Sample Protocol HRDB (Heart Rate Deep Breathing) ... 21 Sample Protocol for Valsalva maneuver ... 23 Sample Protocol for Performing Tilt ... 25 Warranty ... 28 Service ... 28 Suggested Readings ... 29 Troubleshooting ... 29 Page | 3 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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: - 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 • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Warning: 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
5051 5651 5052 5582 5812 479--W0--81013 5047 5048 5180 5560 5053
Medical Grade Desktop Power supply; +5VDC Instructions for Use Optional BP cable Chest Expansion bellows (see latex statement in section 10) Valsalva Hub and tubing Valsalva bugle ECG, Three lead patient cable ECG cable lead wires, 3 Electrodes, Silver--Silver chloride Power Conditioner USB cable, Computer should be USB 2.0 capable
Cable length In meters 2.5 -- 2.5 3 3 -- 2.8 0.46 -- -- 2.5
Note: The HRV Acquire outputs the heart rate to the WR TestWorks software via the USB interface.
Page | 5 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
WARNING: 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) Degree of protection in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide Mode of operation Valsalva and Chest Expansion Type of protection against electric shock: Type BF ECG Type of protection against electric shock: Type CF
IPX0 -- Ordinary Not protected (unsuitable)
Continuous
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 DOCUMENTS. CAUTION: Portable and mobile RF communication devices can affect MEDICAL ELECTRICAL EQUIPMENT. Page | 6 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
CAUTION: The Power Conditioner, HRV Acquire, & 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 Acquire should assure that it is used in such an environment. Emissions test RF emissions CISPR 11
Compliance Group 1
RF emissions CISPR 11 Harmonic emissions IEC 61000--2--3 Harmonic emissions IEC 61000--3--3
Class B
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. The HRV Acquire is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-- voltage power supply network that supplies buildings used for domestic purposes.
Class B Complies
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 Electrostatic discharge ± 6 kV contact ± 6 kV contact Floors should be wood, (ESD) concrete or ceramic tile. If ± 8 kV air ± 8 kV air floors are covered with IEC 61000--4--2 synthetic material, the relative humidity should be at least 30%. Electrical fast ± 2 kV for power supply ± 2 kV for power supply Mains power quality should be transient/burst lines lines that of a typical commercial or ± 1 kV for input/output lines ± 1 kV for input/output hospital environment. IEC 61000--4--4 lines Surge ± 1kV line(s) to line(s) ± 1kV line(s) to line(s) Mains power quality should be that of a typical commercial or IEC 61000--4--5 ± 2 kV line(s) to earth ± 2 kV line(s) to earth hospital environment. Voltage dips, short <5% Ut <5% Ut Mains power quality should be interruptions and voltage (>95% dip in Ut) (>95% dip in Ut) that of a typical commercial or variations on power supply For 0.5 cycle For 0.5 cycle hospital environment. If the lines user of the HRV Acquire 40% Ut 40% Ut requires continued operation IEC 61000--4--11 (>60% dip in Ut) (>60% dip in Ut) during power interruptions, it For 5 cycles For 5 cycles is recommended that the HRV Acquire be powered from an 70% Ut 70% Ut uninterruptible power supply.
Page | 7 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Power frequency (50/60 Hz) Magnetic field IEC 61000--4--8
(>30% dip in Ut) For 25 cycles <5% Ut (>95% dip in Ut) For 5 s 3 A/m
(>30% dip in Ut) For 25 cycles <5% Ut (>95% dip in Ut) For 5 s na
Power supply magnetic fields should be at levels characteristic of a typical 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 Conducted RF IEC 61000--4--6 Radiated RF IEC 61000--4--3
IEC 60601 test level 3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz
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.
3 Vrms 3 V/m
Recommended separation distance: d = 1.2 √p d = 1.2 √p 80 MHz to 800 MHz d = 2.3 √p 800 MHZ to 2.5 GHz Where p is the maximum 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 a, should be less than the
Page | 8 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
compliance level in each frequency range b. Interference may occur in the vicinity of equipment marked with the following symbol:
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. a 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, such 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. 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 transmitter W d = 1.2 √p d = 1.2 √p d = 2.3 √p 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.79 3.79 7.27 100 12.0 12.0 23.0 For transmitters 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 Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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.
I O
Power On
Power OFF
Class II Equipment for Medical Grade power supply
Type BF Applied part – for Valsalva and Chest Bellows inputs
Direct current power for HRV Acquire
Consult Operating Instructions
Page | 10 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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: <100 µA at normal condition
Modes All modes are selected by the WR TestWorks™ software 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: ≤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 • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
R--Wave Detection Specifications Range: 15 to 300 bpm Accuracy: ±2% Resolution: 1 bpm Sensitivity: 300 µV peak Response time: < 8 seconds Tall T Wave Rejection: Rejects T waves < 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 ± 0.5psi of ambient Valsalva: 0 to 2 psi
Analog Input (optional) DB15 Input Signal for blood pressure: 0 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 • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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. Cables 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 • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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:
Secondary wire connection:
Warning: Do not remove or bypass the ground prong on any plug, or disable any safety feature.
Page | 14 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Operation of the HRV Acquire System Components
Display LED’s
Pole Clamp – do not place on a pole with IV solutions or other liquids
ECG Connector Front View
Valsalva Connection
Chest Bellows
On/Off. See section 20.
Power Input
Rear View USB Connector
HD15 Analog Input -- Optional Beat--To--Beat Blood Pressure only. See section 26.
Accessories Page | 15 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Valsalva Bugle WR#479--W0--81013 -- HUB & tubing WR#5812
Chest Expansion Bellows WR#5582
ECG Lead set WR# 5047/5048
Page | 16 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Analog Input Cable WR#5052
USB Cable (A to B) WR#5053
Power supply WR#5051
Page | 17 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
Accessories
Page | 18 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
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 is 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.
Page | 19 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com
1. Connect the USB found on rear panel to computer running WR TestWorks™ a. NOTE: See above if connecting for the first time. 2. Connect Power Supply 3. Connect Analog input from Blood Pressure Device, optional. 4. See WR TestWorks™ for configuration. 5. Power device On. Note: If the ECG is not connected to the patient the screen will display a yellow message “Check ECG”
Check to see that the cable and electrodes are connected properly. Suggested Patient Preparation for all test modes. Page | 20 WR Medical Electronics Co • 1700 Gervais Avenue • Maplewood, MN 55109 USA Phone: 800--635--1312 • Fax: 651--604--8499 • Web: www.wrmed.com