Q-Sweat User Guide Jan 2014

WR

WR Medical Electronics Co.

This manual copyright © 2001-2014 by WR Medical Electronics Co. All rights reserved. No part of this manual may be reproduced in any form by any means-graphic, digital, electronic, or mechanical, including photocopying, recording, taping, or any information storage and retrieval system-without the written permission of WR Medical Electronics Co. WR TestWorks and Q-Sweat are trademarks of WR Medical Electronics Co. Q-Sweat Patent No. 6.269.265 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: 800-635-1312 • FAX: 651-604-8499 • E-mail: [email protected] • Web site: www.wrmed.com

Comments or Questions? We would appreciate receiving any suggestions, comments, or questions that would help us to improve this manual. Please forward comments to the address above.

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Contents Indications and Contraindications...4 Warnings and Cautions...4 Safety Information...5 SYSTEM DESCRIPTION

7

Background...8 Overview ...9 Components... 9

SYSTEM OPERATION

13

Overview...14 Operating Parameters... 14 Basic Test Procedure... 14

CALIBRATION AND MAINTENANCE

15

Calibration...16 Maintenance...16 Service and Technical Support...16 Technical Specifications...17 REFERENCES AND SUGGESTED READINGS

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WR Medical Electronics Co.

INDICATIONS AND CONTRAINDICATIONS Indications: •

The Q-Sweat™ Quantitative Sweat Measurement System is designed to measure the sweat output of the skin of humans. This device does not make a diagnosis or indicate by itself that any disease state exists.

Contraindications: •

Do not conduct the Q-Sweat test on fragile skin.

WARNINGS AND CAUTIONS Cautions: • • • • •

This device is restricted to sale by or on the order of a physician. This device is to be operated only by trained personnel under the direction of a physician. Subjects to be tested must be examined by a physician before testing. Do not use the device on any person when any covers of any equipment have been removed. This device is to be serviced only by WR Medical Electronics Co. If servicing is done by any party other than WR Medical Electronics Co., the product warranty and/or safety or quality certifications could become invalid. Contact the factory for repair advice before attempting to repair.

Warnings: •

None. See Contraindications.

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SAFETY INFORMATION System Classification (IEC601-1/EN60601-1)

• Type of protection against electric shock: Type BF • Degree of protection against electric shock: Class I • Degree of protection against moisture ingress (IEC529): Ordinary IPX0 • Degree of protection in the presence of a flammable anesthetic mixture with air or with oxygen or with nitrous oxide: Not protected (unsuitable)

• Mode of operation: Continuous • Sterilization/disinfections: Not suitable System Supply Mains Rating

• Supply Voltage: 100 to 240 VAC • Supply Power: 80 Watts • Supply Frequency: 50/60Hz • Protection 2 x F0.8A (5x20mm IEC127)

Environmental Ratings

• Operating • Temperature: 20°C to 25.6°C (68-78°F) • Relative Humidity: 20% to 55% • Transport and Storage • Temperature: -14°C to 122°C • Relative Humidity: 0% to 90% (non-condensing) • Atmospheric Pressure: 300 hPa to 1060 hPa

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 longer than 15 weeks.

Preventive Maintenance and Cleaning • •

Clean the unit when necessary by using a dry cloth. For stubborn stains, a lightly dampened cloth and a mild detergent may be used. Do not immerse the unit. Do not immerse the measurement capsules or hoses. Wipe the capsule ends with alcohol or disinfectant if desired. Ensure surfaces are dry prior to attaching to patient or storing.

Responsibility of the Supplier WR Medical Electronics Co. accepts responsibility for the effects of safety, reliability, and performance of the equipment only if: • Assembly operations, extensions, readjustments, modifications, or repairs are carried out 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 system manual.

Electromagnetic Compatibility The system has been independently tested and found to comply with IEC601-1-2/ EN60601-1-2.

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WR Medical Electronics Co.

Safety and Information Symbols Symbols that appear on the equipment have the following meanings;

Attention, consult accompanying documents

Type BF 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 On – Power connection to supply mains

Off – Power disconnection for supply mains

Replace fuselinks as marked

250V F.8A 5x20mm

Consult Operating Manual

Environmental Protection Main Unit and Consumables • At the end of service consult local regulations for disposal.

Technical Description WR Medical Electronics Co. will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information which will assist an appropriately qualified technical personnel to repair or service the equipment.

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SYSTEM DESCRIPTION

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WR Medical Electronics Co.

BACKGROUND The Q-Sweat quantitative sweat measurement system accurately measures moisture from the skin. Results are given in nanoliters/minute (rate) and microliters (total volume). Dr. Phillip Low of Rochester, Minnesota has published several papers on sweat measurement in humans. In his articles are normative values based on age and gender.

Suggested Reading Laboratory Evaluation of Autonomic Function, Clinical Autonomic Disorders, 2nd Edition, 1997 Lippincott-Raven Publishers, Philadelphia, Chapter 15, pages 179-209 Low, Phillip A,; Mathias, Christopher J. “Quantitation of Autonomic Impairment”, Peripheral Neuropathy, 4th Edition, Dyck, PJ; Thomas, PK, editors, Elsevier Saunders Inc, Chapter 44, pgs 1103-1133:2005 Low, Phillip A. “Laboratory Evaluation of Autonomic Function”, Clinical Autonomic Disorders: Evaluation and Management, 2nd Edition, Low, PA, editor, Lippincott-Raven, Chapter 15, pgs 179-209:1997 Low, Phillip A.; Zimmerman, IR, “Development of an Autonomic Laboratory”, Clinical Autonomic Disorders: Evaluation and Management, 2nd Edition, Low, PA, editor, Lippincott-Raven, Chapter 29, pgs 383-390:1997 American Academy of Neurology, “Assessment: Clinical Autonomic Testing”, Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology, Published in Neurology, 1996;46:873-880

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WR Medical Electronics Co.

OVERVIEW The Q-Sweat uses room air drawn across a desiccant to pick up moisture from the skin. This moisture is evaporated inside a measurement capsule where it is transported by airflow to temperature and humidity sensors, and a measurement of moisture is made.

Components The Q-Sweat system consists of several components. Your particular configuration may or may not have the exact items as described. • • • • • • •

4-Channel Q-Sweat Main Unit Measurement capsules (4 large resting sweat measurement capsules, and 4 small evoked measurement capsules) Personal Computer, laptop or desktop WR TestWorks application software Desiccant cylinder Parking fixture USB 2.0 cable, Type A-B connectors

4-Channel Q-Sweat Main unit The Q-Sweat main unit contains an internal power supply, air pump, airflow regulator, voltage-sensitive proportioning orifice valve (VSO), mass air flow sensors, output air connections, input air connections, and either a USB interface or an analog interface (NIDAQ). The Q-Sweat Main Unit communicates through the interface to a computer with WR TestWorks software.

Measurement capsules Measurement capsules are provided in 2 sizes: • •

Evoked (0.787 sq cm measurement area) Resting (5.06 sq cm measurement area)

The capsule is a component of a hose assembly, which consists of the measurement capsule (patient interface end), an 8’ long hose, and connectors which attach to the front of the Q-Sweat Main Unit. The Measurement capsules attach to patients’ skin with silicone straps.

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Measurement Capsules

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WR Medical Electronics Co.

Personal computer Minimum Requirements: • Pentium 4 1.5 GHz with Windows XP Pro (w/SP2) • 512 MB RAM • 30GB Hard Drive • 1 PCMCIA or PCI card slots (if performing cardiovagal studies with the IVY Biomedical ECG, BMEYE Nexfin, Colin Pilot, Finometer, Finapres or • Portapres. • CD-RW or DVD-RW Optical Drive • 1024 x 768 resolution 17” monitor • 3 USB 2.0 Type A connections

WR TestWorks Application software The application software was written by WR Medical and is called WR TestWorks. WR TestWorks consists of a main framework with application submodules. The available submodules include software for the following acquisition devices: • Q-Sweat Main Unit • CASE IV QST System, manufactured by WR Medical Electronics Co. • IVY Biomedical ECG Monitors, Model 3000 and 101 • BMEYE Nexfin • Finapres Medical Systems (FMS) devices, such as the Finometer, Finometer Pro, Finmeter Midi, and Portapres The WR TestWorks main framework includes the patient database, tests performed, patient demographics, report generation options, user and study set up, and several other features which are described in detail in the WR TestWorks Software User Guide.

Desiccant Cylinder A refillable desiccant cylinder is used to dry room air. To attach the cylinder, remove the screws on the side of the unit and position the brackets in place. Replacement desiccant, in a convenient 5 lb glass jar, can be purchased directly from WR Medical Electronics Co. Use P/N 5598 when ordering. The Q-Sweat device has a built-in sensor that indicates when desiccant needs to be replaced. A warning in WR TestWorks software will alert you to replace the desiccant. The life of the desiccant can be extended by running the unit only during its 15 minute warmup period and during patient testing. Do not leave the unit running overnight. Note that desiccant is blue when it is new, and turns pink as it becomes used (humidified).

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WR Medical Electronics Co.

Parking Fixture The Parking Fixture is located along the side of the Q-Sweat Main Unit. When not in use the measurement capsules should be placed on the parking fixture. This keeps the measurement capsules dry by limiting their exposure to room air. When the measurement capsules are on the parking chamber and the hoses are connected to the front panel of the Main Unit, air will be flowing through the hoses and desiccant as long as the Main Unit is turned on. If any of the connections are broken the air supply will be shut off.

Optional Outputs The Q-Sweat system may include analog and digital outputs for customer laboratory research. Output signals are not enabled unless requested. Please contact WR Medical Electronics Co. sales department for information and pricing.

Power Light (USB version only) A bicolor LED on the front panel of the Q-Sweat main unit gives information as to the operational status of the system. Steady green Flashing green Steady amber Flashing amber Light off

unit is running and is in use unit is ready for patient testing warming up POST error (contact WR Medical) Main Unit is not running or powered off

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WR Medical Electronics Co.

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SYSTEM OPERATION

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WR Medical Electronics Co.

Operating Parameters For most accurate measurements, the Q-Sweat™ device should be used in the following conditions and ranges: • • • •

The room in which the test is conducted should be at comfortable room temperatures (70 to 72 degrees F.), with no air vents or ceiling fans blowing on the patient. The unit requires a 15-20 minute warm-up prior to use. The operating ambient humidity should be less than 90 percent non-condensing. The technician must have a basic working knowledge of how to use the Q-Sweat.™

Basic Test Procedure 1. Perform a visual check of your equipment. If damage is found, do not use the device. Contact WR Medical Electronics Co. for service and repair instructions. • Examine your desiccant source to be sure it is fresh, indicated by a blue color. Desiccant that is pink is used. Replace desiccant if necessary. 2. Turn the unit on at least 15 minutes prior to patient testing. 3. Unused testing sites can be turned of in the WR TestWorks software (Q-Sweat>Test setup, then un-check the unused sites) prior to starting patient testing. 4. Enter the patient demographics into the software (Patient>New) or highlight an existing patient name. Select the sweat test as indicated by the blue water drop icon. 5. Choose the recording site, and prepare patient skin according to protocol. Do not use on broken or inflamed skin. Typical recording sites are: • the medial forearm (75 percent of the distance from the ulnar epicondyle to the piciform bone), • the proximal leg (lateral aspect, 5 cm. distal to the fibular head), • the distal leg (medial aspect, 5 cm. proximal to the medial malleolus), • the proximal foot (on a flat surface over the extensor digitorum brevis muscle). 6. Attach the recording capsules to the selected skin locations, and start a recording. All sites that are actively recording should say ON. If the message AIR LEAK occurs, there is a leak in the air flow. Be sure your hose connectors on the front panel are firmly attached and that the measurement capsule is firmly affixed to the patient. If the DESICCANT warning light is on stop the recording and turn the main unit off from the toggle switch on the back of the unit. Check your desiccant to be sure if it is usable (blue in color). If your desiccant is in good condition, you may need to warm up the unit for an additional 5-10 minutes in order for the desiccant warning to disappear. 7. Once the recording is complete, stop the recording in the software by pressing the STOP sign. Remove the measurement chambers from the patient and place them back on the parking chamber. 8. Follow the steps in the WR TestWorks Software User’s Guide for saving, discarding, or analyzing the data.

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Skin capsule affixed to arm

CALIBRATION AND MAINTENANCE

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WR Medical Electronics Co.

CALIBRATION At WR Medical, each individual sensor is calibrated to a physical standard using a traceable measurement system (temperature, flow in and out, and fractional RH). The Q-Sweat™ device and its matched sensors are then validated using a 5 microliter test with a calibrated Hamilton micro-pipette and a special test fixture. For calibration verification at site, a known quantity of water many be placed in the parking fixture capsule and then evaporated and totalized by the system. The totalized amount may be compared to the known quantity placed in the fixture capsule.

MAINTENANCE The Q-Sweat does not require regular maintenance. Visually examine the equipment and look for damage or changes. Hose assemblies should be examined for nicks, cuts, or other sources of leaks.

SERVICE AND TECHNICAL SUPPORT CAUTION: •

•

This device is to be serviced only by WR Medical Electronics Co. If servicing is done by any party other than WR Medical Electronics Co., the product warranty and/or safety or quality certifications could become invalid. Contact WR for advice before returning for repair. No readjustments or modifications are to made by anyone other than persons authorized by WR Medical Electronics.

Prior to returning the Q-sweat unit for repair, please contact the Technical Support/Help Desk for a Return Authorization Number.

For questions regarding the Q-Sweat device or the WR TestWorks software, please contact: Technical Support/Help Desk WR Medical Electronics Co., 1700 Gervais Avenue, Maplewood, MN 55109 USA Phone: 651-604-8400 or toll-free: 800-635-1312) Fax: 651-604-8499 E-mail: [email protected] Web: www.wrmed.com Please have your serial number and module license key(s) available, which are found on the license sheet shipped with the product. The Help Desk staff is available during normal business hours (8:00 am to 4:30 pm, Central Standard Time).

For questions regarding the computer, printer, or any other hardware or software not made by WR Medical, including the Windows operating system, you may need to contact the manufacturer directly. Page | 16

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TECHNICAL SPECIFICATIONS FOR ACCURATE OPERATION* Environment: Power requirement: Power consumption: Physical dimensions: Weight: Operating Temperature:

100-240 VAC 50/60 Hz Max. 40VA (.33 amperes at 120 VAC) (.167 amperes at 240 VAC) 16.0”w x 7.25”h x 13.0”d (406.0 x 184.0 x 330.0 cm) 10.0 kg (22.0 lbs) 68 to 78 degrees F. (20 to 25.6 degrees C.)

Minimum PC requirements: OS: Memory: Display: Storage: I/O Interface:

Windows XP 512 MB minimum RAM 1024 x 768 resolution 17” monitor 30+ GB Hard Disk CD-RW or DVD-RW Optical Drive 2 USB 2.0 connectors

Software description: Operating system: Application software: Integrated features:

Windows XP WR TestWorks Patient browser and database Test browser and database Report generator and data export utility Real-time rate and volume display (with event markers)

Sweat output measurement: Number of channels: Measurement method: Measurement area: Dry air flow rate:

4 direct vapor pressure calculation .787 square centimeters/5.06 square centimeters 60 SCCM

Volume calculations: Range: Accuracy: Repeatability: Sensitivity:

0-1000 nanoliters ± 5 percent ± 5 percent 0.1 nanoliters

Rate calculations: Range: Accuracy: Repeatability: Sensitivity:

0-1000 nanoliters per minute ± 5 percent ± 5 percent 0.1 nanoliters per minute

Features:

Integral dry air source

Benefits:

No special gasses needed to operate the system Easy to interface to personal computers Convenient to operate

*These specifications describe tolerances for accurate operation of the Q-Sweat™ device, and may not match the safety specifications.

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WR Medical Electronics Co.

REFERENCE Low, PA. “Laboratory Evaluation of Autonomic Function,” in Clinical Autonomic Disorders: Evaluation and Management, 2nd Edition, Low, PA, editor. Lippincott-Raven, 1997, Chapter 15, pages 179-208.

Low, PA; Mathias, CJ. “Quantitation of Autonomic Impairment,” in Peripheral Neuropathy: 4th Edition, Dyck, PJ; Thomas, PK, editors. Elsevier Saunders Inc., 2005, Chapter 44, pages 1103-1134.

Low, PA; Zimmerman, IR. “Development of an Autonomic Laboratory,” in Clinical Autonomic Disorders: Evaluation and Management, 2nd Edition, Low, PA, editor. Lippincott-Raven, 1997, Chapter 29, pages 383-390.

American Academy of Neurology. “Assessment: Clinical Autonomic Testing,” Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology, 1996. Published in Neurology 1996;46:873-880.

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