MEDEIA QMEDICAL (HW10) · 4 medeia Designed for clinicians by clinicians For a FREE Demonstration...

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medeia Designed for clinicians by clinicians

For a FREE Demonstration Call: +1 800 433 4609 www.medeia.com, www.sudocheck.com [email protected]

MEDEIA QMEDICAL (HW10) STEP BY STEP INSTRUCTIONS

Autonomic Function Testing (ANS)

ECG Assessment

Arterial Vascular Assessment

Pulse Wave Velocity

Ankle Brachial Indices (ABI)

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CONTENTS

Device Parts and Accessories ......................................................................................................................................... 4

PC Software Setup ......................................................................................................................................................... 7

Safety Information ......................................................................................................................................................... 8

Physician`s Responsibility .......................................................................................................................................... 8

Contraindications: ..................................................................................................................................................... 8

Warnings .................................................................................................................................................................... 8

Cautions: .................................................................................................................................................................. 10

Notes: ...................................................................................................................................................................... 12

Limitations of Noninvasive Vascular Tests: ............................................................................................................. 12

Safety of Ultrasound Doppler (If Available): ............................................................................................................ 12

Maintenance and Cleaning .......................................................................................................................................... 14

Cleaning Precautions: .............................................................................................................................................. 14

Cleaning and Disinfection: ....................................................................................................................................... 14

Maintenance: ........................................................................................................................................................... 14

Customer Service ..................................................................................................................................................... 14

Autonomic (ANS) Function Testing .............................................................................................................................. 16

Test Description ....................................................................................................................................................... 16

Test Time ............................................................................................................................................................. 16

Report Parameters: ............................................................................................................................................. 16

Autonomic Function Testing Contradictions ........................................................................................................... 16

Persons with Following Conditions Cannot Be Tested ........................................................................................ 17

Valsalva maneuver Procedure should not be performed on persons ................................................................. 17

Additional Procedural Notes ................................................................................................................................ 17

Preparation Before Procedural Test Session ........................................................................................................... 18

Patient Setup ........................................................................................................................................................... 19

1) Check for Contraindications ............................................................................................................................ 19

2) Attach ECG Electrodes (#1) .............................................................................................................................. 19

3) Attach PPG/SpO2 Plethysmograph sensor ...................................................................................................... 21

4) Attach Blood Pressure cuffs ............................................................................................................................. 22

5) Patient Positioning: ......................................................................................................................................... 23

6) Check the signal quality ................................................................................................................................... 23

7) Instructions for the Test Administrator ........................................................................................................... 24

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Start a new Measurement ....................................................................................................................................... 25

Arterial Vascular Assessment ...................................................................................................................................... 28

Patient Setup ........................................................................................................................................................... 30

1) Check for Contraindications ............................................................................................................................ 30

2) Attach ECG Electrodes (#1) .............................................................................................................................. 30

3) Attach PPG/SpO2 Plethysmograph sensor ...................................................................................................... 32

4) Attach Blood Pressure cuffs ............................................................................................................................. 33

5) Patient Positioning: ......................................................................................................................................... 34

6) Check the signal quality ................................................................................................................................... 34

Start a new Measurement ....................................................................................................................................... 35

Description of Product and Controls ....................................................................................................................... 37

Description of the Device .................................................................................................................................... 37

Description ........................................................................................................................................................... 37

Product Overview .................................................................................................................................................... 38

Doppler Overview (if available) ........................................................................................................................... 39

Ankle Brachial Index Chart (ABI) .......................................................................................................................... 39

Toe Brachial Index or TBI ..................................................................................................................................... 40

Segmental Pressures ............................................................................................................................................ 40

Photo Plethysmography ...................................................................................................................................... 40

Pulse Volume (PV) Arterial .................................................................................................................................. 40

Peak Velocity ....................................................................................................................................................... 41

Error Messages ............................................................................................................................................................ 42

Print patient report ...................................................................................................................................................... 43

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DEVICE PARTS AND ACCESSORIES

The main connectors are located on the front panels of the QMedical device. The display provides you with: ‐ A power switch that, when turned on, indicates this with an “on” light on the front panel. ‐ 2 PPG/SpO2 connectors. ‐ Doppler probe connector, with frequencies of 4MHz, and 8MHz (if available). ‐ A connector for 2 or 4 air NIBP tubes. ‐ ECG connector. Each QMedical device displays 2 connectors at the back panel. One is the power supply, and another one a USB connector to connect the QMedical via USB cable to the host computer. The QMedical device works with any 5V (positive center) medical power supply once connected. All other supportive device components, such as keyboard, mouse, printer, and USB connect directly to the host PC computer.

1) 12 Leads or 3 Leads ECG Electrode Cable 3 Leads ECG Cable (3 wires)

12 Leads ECG Cable (10 wires)

Autonomic (ANS) Function Testing require using 3 Leads ECG Cable only. Using the 12 Leads ECG measurement during the ANS test is optional. The system can use only one (3 Leads ECG or 12 Leads ECG) Cable at the time.

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2) Reusable Finger/Toe Photoplethysmography (PPG/SpO2) Sensor 1 (PPG1 ‐ short cable)

3) Reusable Finger/Toe Photoplethysmography (PPG/SpO2) Sensor 2 (PPG2 ‐ long cable)

The both PPG1 and PPG2 sensor are the same. The only difference is that the PPG2 cable is longer.

4) Doppler Bi‐Directional, Continuous‐Wave (CW) Probe (4MHz or 8MHz) (optional)

The doppler probe is optional and not available in all product packages. Doppler probe is available only for HW10‐B4‐D version. There are two doppler probes 4MHz and 8MHz. The system can use only one doppler probes at the time.

5) Non‐Invasive Blood Pressure Sensor 1 (NIBP1)

6) Non‐Invasive Blood Pressure Sensor 2 (NIBP2)

There are two Blood Pressure NIBP sensors. For HW10‐B4‐D device version there are 4 Blood Pressure NIBP sensors. Connect to each NIBP sensors appropriate cuff size depend of the patient evaluation area. There are 4 different cuff sizes are available: Size S ‐ small adult, Range 17‐26 cm Size M ‐ medium adult, Range 24‐32 cm Size L ‐ large adult, Range 32‐42 cm Size XL – extra‐large adult, Range 42‐56 cm

7) Event Button or Blood Pressure Relief button

8) LED Indicator: Green – Device is powered on and ready for use; Blinking Blue – Device is measuring (Doppler probe is ON), LED is blinking with the patient Heart Rate.

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9) Power Supply: +5V, 1.6A

10) Device On/Off Button

11) Reusable USB Communication cable: USB 2.0 Cable Male A/B 6Ft

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PC SOFTWARE SETUP

1) At the PC software home screen meny click “SETTINGS” (you may click on the tab or on the setting box).

2) Under the “HARDWARE” tab make sure “HW10” is chosen as the “Hardware Type” option. 3) Make sure the Device sub type is “BP2” selected. For HW10‐B4‐D device version make sure the Device sub type is “BP4‐D” selected. Keep all other options as it is shown on the screenshot. 4) Make sure you connect the device cables properly. ‐ Connect USB cable (#11) at the back on the device box to one of the laptop USB ports. ‐ Connect Power Supply (#9) to the power outlet and to the device box at the back. ‐ Turn on (#10) the device box at the back. 5) Press “Check Connection” button. A pop‐up will appear if the connection to the device is good. 6) Press “Save” button at the top right corner. You are now ready to hook the patient and start a new measurement.

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SAFETY INFORMATION

PHYSICIAN`S RESPONSIBILITY

The QMedical System is provided for the exclusive use of qualified physicians or personnel under their direct supervision. The numerical and graphical results and any interpretation derived from a recording must be examined with respect to the patient`s overall clinical condition. Patient preparation and the general recorded data quality, which could affect the report data accuracy, must also be taken into account. It is the responsibility of the physician to make the diagnosis or to obtain expert opinion on the results, and to institute correct treatment if indicated. FEDERAL LAW IN THE USA RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

CONTRAINDICATIONS:

WARNING! This device is for use only on intact skin. WARNING! This device is not intended for use with HF surgical equipment. WARNING! This device is not intended for fetal use. WARNING! The ultrasound doppler probes (if available) are not to be used on or near the eyes. Use the doppler only for Peripheral Vessel assessment. WARNING! The system should not be used for patients under 14 years of age.

WARNINGS

WARNING! The QMedical is for use by qualified personnel only. Read the User’s Manual before use. WARNING! Carefully route all cables and tubing to reduce the possibility of patient entanglement or strangulation. WARNING! Do not allow the patient to operate any portion of the equipment. Patient should not be in contact with the equipment main box and controls. Operator should be the entire time of measurement procedure with the patient. WARNING! Do not place the equipment in any position that would allow it to roll, fall, or collide with a user or patient. WARNING! Do not use equipment that is damaged or malfunctioning. Seek appropriate service when needed. Inspect equipment regularly for signs of damage. Use alternate equipment if needed. WARNING! Confirm the setting of the PC real‐time clock prior to saving patient data. WARNING! Any equipment connected to the USB data port must be configured to comply with IEC 60601‐1. By connecting additional equipment to the USB data port, the user is configuring a medical system and the user is responsible for ensuring the overall system compliance. Connected equipment must be certified to the applicable IEC standard (i.e. IEC 60950 for data processing equipment, IEC 60601‐1 for medical equipment). Contact the technical service department for more information. WARNIN! Do not use the patient lead wires with combination with other system or device rather than QMedical (HW10). WARNING! Do not use the patient lead wires and do not connect a patient before you check if QMedical (HW10) system is assembled correctly and all the lead wires cables are connected properly to the QMedical (HW10) box.

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WARNING! No modification of this equipment is allowed. Do not connect other equipments and cables not part of that equipment. WARNING! Preventing electric shock • Never touch the computer power supply with wet hands. • Do not use an extension cable and multiple outlets. This also applies for the USB connection on the supplementary touchscreen display notebook/computer. • Make sure that the separately provided notebook/computer power cable is not crimped and cannot be damaged by sharp edges. • Do not operate the device above a height of 3000 m. WARNING! Patient hazard, Preventing injuries and infections • Prepare the device hygienically after each measurement. • Ensure that the patient does not have any contagious diseases. • Ensure that the positioning of the device is steady. WARNING! Patient hazard, Use of measured results The QMedical is not a diagnostic device. The device assists the attending physician with creating a diagnosis. • For the creation of a precise diagnosis and for the initiation of therapies, in addition to the use of the QMedical, careful examinations must be conducted by the attending physician and the results of these taken into consideration. • The responsibility for diagnoses and the therapies derived from them lies with the attending physician. • No modification of this equipment is allowed. WARNING! Servicing is to be carried out by qualified personnel only. WARNING! Do not use this unit in areas where there is any danger of explosion or the presence of flammable gases such as anaesthetic agents. WARNING! This product is not designed for sterile use. WARNING! This product is not designed for outdoor use. WARNING! Do not, under any circumstances, immerse the unit or cable assemblies in liquid. WARNING! Do not use high temperature sterilization processes (such as autoclaving). Do not use e‐beam or gamma radiation sterilization. WARNING! This unit is CF classified according to IEC EN 60601‐1. This means that the patient connection is fully isolated and defibrillation protected. Medeia can only guarantee protection against defibrillation voltage however, when the original Medeia patient cable is used. WARNING! Do not touch the casing during defibrillation. WARNING! If the patient cable should become defective after defibrillation, lead off will be displayed. WARNING! When disconnecting the device from the power line, remove the plug from the wall outlet first, before disconnecting the cable from the device. Otherwise there is a risk of coming in contact with line voltage by inadvertently introducing metal parts in the sockets of the power cord.

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WARNING! The mains plug must be connected to an appropriate power supply with grounded‐to‐earth wire. WARNING! EXPLOSION HAZARD — The device is not designed for use in areas of medically used rooms where an explosion hazard may occur. An explos ion hazard may result from the use of flammable anesthetics, skin cleansing agents and disinfectants. WARNING! EQUIPMENT FAILURE — Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all peripheral devices operated in the vicinity of the recorder comply with the relevant EMC requirements. X‐ray equipment, MRI devices, radio systems (cellular telephones) etc. are possible sources of interference as they may emit higher levels of electromagnetic radiation. Keep the recorder away from these devices and verify the recorder performance before use. WARNING! SUFFOCATION HAZARD — Dispose of the packaging material, observing the applicable waste‐control regulations. Keep the packaging material out of children's reach. WARNING! A PC connected to the QMedical should meet the requirements of EN 60601. If it doesn't, it must be set up outside the patient environment. If the PC fulfills the requirements of EN 60950, it must be set up within the medically used area. WARNING! Prolonged, excessive, or incorrect use of the QMedical may lead to tissue injury, venous pooling, and impairment of circulation in the arm of the patient. WARNING! The blood pressure cuff should not be used on the same arm as an IV or any other medical equipment that relies on the circulatory system distal to the cuff WARNING! Too frequent measurements can cause injury to the PATIENT due to blood flow interference WARNING! SpO2 sensors and equipment need to be calibrated and verified by Medeia Support Team before use in combination. Only use SpO2 sensors provided and approved by Medeia. Possible patient injury can result. WARNING! The effect that misapplication of a PULSE OXIMETER PROBE with excessive pressure for prolonged periods can induce pressure injury. WARNING! Excessive cuff pressure for prolonged periods can induce pressure injury. The blood pressure cuff over a wound, mastectomy, intravascular access, arterio‐venous shunt or therapy, as this can cause further injury. The blood pressure cuff can temporarily cause loss of function of simultaneously used monitoring on the same limb. Continuous CUFF pressure due to connection tubing kinking can cause Blood flow interference and resulting harmful injury to the PATIENT. WARNING! Pregnant women and pre‐eclamptic should only measure their own blood pressure in consultation with their doctor.

CAUTIONS:

CAUTION! Do not plug the probe cables into a telephone system, computer, or any equipment other than the QMedical. CAUTION! Read the Maintenance and Cleaning Section of this manual before cleaning.

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CAUTION! Federal law restricts this device to sale by or on the order of a licensed practitioner. CAUTION! Do not drop or mishandle the QMedical main unit, probes, hand controller or other accessories. Damage may occur. CAUTION! Switch the unit off before cleaning and disconnect from the mains. CAUTION! Inspect the Doppler probe (if available) for any cracks before start the system and use in fluids. CAUTION! Use only accessories and other parts recommended or supplied by Medeia. Use of other than recommended or supplied parts may result in injury inaccurate information and / or damage to the unit. CAUTION! It must be ensured that neither the patient nor the electrodes (including the neutral electrode) come into contact with other persons or conducting objects (even if these are earthed). CAUTION! There is no danger when using the ECG unit for a pacemaker patient or with simultaneous use of other electrical stimulation equipment. However, the stimulation units should only be used at a sufficient distance from the electrodes. In case of doubt, the patient should be disconnected from the recorder. CAUTION! If several units are coupled there is a danger of summation of leakage currents. When operating several devices for medical and non‐medical application do not use any extension cables or distribution boxes for the connection. CAUTION! Do not disassemble the unit or arm cuff. CAUTION! Use only the approved arm cuff for this unit. Use of other arm cuffs may result in incorrect measurement results. Use the cuff best feet to the patient. CAUTION! Make sure that the air tube is not wrapped around other parts of your body when taking measurements at night. This could result in injury when the air pressure in the air tube is increased. CAUTION! Do not leave the cuff wrapped on the arm if taking measurements during the night. This could result in injury. CAUTION! Do not inflate the arm cuff over 299 mmHg. CAUTION! Avoid compressing or restricting the coiled tubing, which may restrict inflation or deflation of the cuff and cause mechanical failure of the tubing. CAUTION! Significant physical damage to the QMedical could result in inaccurate results or even injury. CAUTION! Exercise care when moving the QMedical to avoid the risk that dropping it could cause an injury. CAUTION! Not for Continuous Monitoring. No Alarm for SpO2. No Alarm for ECG. No Alarm for Pulse Rate. CAUTION! Do not place the device very close to the wall, to make sure the device power switch and connector can be easy accessible. CAUTION! The Doppler (if available) is ON during entire measurements period. You can turn off the Doppler by unplugging from the device or by terminating the measurement procedure. The Doppler is may be on ON when the equipment is switched ON.

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NOTES:

NOTES: Do not use solvent cleaners. NOTES: This unit complies with EMC regulations for medical products which affords protection against emissions and electrical interference. However special care must be exercised when the unit is used with high frequency equipment. NOTES: Before using the unit, ensure that an introduction regarding the unit functions and the safety precautions has been provided by a product representative. NOTES: The information in this manual only applies to QMedical version HW10. It does not apply to earlier versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. The information in this manual is subject to change without notice. NOTES: Medeia shall not be liable for technical or editorial omissions made herein, nor for incidental or consequential damages resulting from the furnishing, performance, or use of this guide. NOTES: All illustrations in this manual are provided as examples only. They may not necessarily reflect your monitoring setup or data displayed on your monitor. In this manual, all names appearing in examples and illustrations are fictitious. The use of any real person’s name is purely coincidental. NOTES: PULSE OXIMETER MONITORS, the PULSE OXIMETER PROBE(S) and in this device has been VALIDATED and tested for compliance with ISO 80601‐2‐61:2011 International Standard. NOTES: After interruption of Supply Mains exceeding 1s the device will be restarted and the measurement procedure need to be manually started. NOTE: Make sure before start operating with the equipment and after equipment is installed the proper validation procedure need to be process. Please referrer to “System Level Test Protocol Acceptance Testing” document for instructions.

LIMITATIONS OF NONINVASIVE VASCULAR TESTS:

In Current Noninvasive Vascular Diagnosis (Chapter 13, Page 208), Ali F. AbuRahma and Edward B. Diethrich note the following limitations of arterial leg Doppler examinations. •Falsely high segmental pressure readings in areas with calcified arteries •Artificially elevated high‐thigh pressure in very large or obese patients •Difficult interpretation of segmental pressures in patients with multilevel occlusive disease •Difficulty in interpretation of high‐thigh readings •False‐negative results in patients with mild vascular occlusive disease who have normal resting ankle pressures

SAFETY OF ULTRASOUND DOPPLER (IF AVAILABLE):

The QMedical probes were designed to be safe and effective. However, the risk from some hazards cannot be eliminated completely. Instead, they are reduced to a level that is As Low As Reasonably Achievable (ALARA).

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Prudent use of this device in accordance with the principle of ALARA includes minimizing the duration of the patient’s exposure to ultrasound to the extent practical. Prudent Use and Clinical Safety Approved by the American Institute of Ultrasound – April 2012 Diagnostic ultrasound has been in use since the late 1950s. Given its known benefits and recognized efficacy for medical diagnosis, including use during human pregnancy, the American Institute of Ultrasound in Medicine herein addresses the clinical safety of such use: No independently confirmed adverse effects caused by exposure from present diagnostic ultrasound instruments have been reported in human patients in the absence of contrast agents. Biological effects (such as localized pulmonary bleeding) have been reported in mammalian systems at diagnostically relevant exposures but the clinical significance of such effects is not yet known. Ultrasound should be used by qualified health professionals to provide medical benefit to the patient. Ultrasound exposures during examinations should be as low as reasonably achievable (ALARA). Safety in Training and Research Approved by the American Institute of Ultrasound ‐ April 2012 Diagnostic ultrasound has been in use since the late 1950s. There are no confirmed adverse biological effects on patients resulting from this usage. Although no hazard has been identified that would preclude the prudent and conservative use of diagnostic ultrasound in education and research, experience from normal diagnostic practice may or may not be relevant to extended exposure times and altered exposure conditions. It is therefore considered appropriate to make the following recommendation: When examinations are carried out for purposes of training or research, ultrasound exposures should be as low as reasonably achievable (ALARA) within the goals of the study/training. In addition, the subject should be informed of the anticipated exposure conditions and how these compare with normal diagnostic practice. Repetitive and prolonged exposures on a single subject should be justified and consistent with prudent and conservative use. Prudent Use Approved May 1999 The AIUM advocates the responsible use of diagnostic ultrasound. The AIUM strongly discourages the non‐medical use of ultrasound for psychosocial or entertainment purposes. The use of either two‐dimensional (2D) or three‐dimensional (3D) ultrasound to only view the fetus, obtain apicture of the fetus or determine the fetal gender without a medical indication is inappropriate and contrary to responsible medical practice. Although there are no confirmed biological effects on patients caused by exposures from present diagnostic ultrasound instruments, the possibility exists that such biological effects may be identified in the future. Thus ultrasound should be used in a prudent manner to provide medical benefit to the patient.

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MAINTENANCE AND CLEANING

CLEANING PRECAUTIONS:

WARNING: The QMedical is not designed for liquid immersion. Do not soak or drop the probes or main unit in liquids. Do not use solvent cleaners. Use only the recommended spray or wipe cleaners and disinfectants (see “Cleaning and Disinfection” below). WARNING: The QMedical is not designed for sterilization processes such as autoclaving or irradiation. WARNING: The QMedical is not intended for use on open skin. If there is evidence of open wound contamination, disinfect the probes before using again as described below.

CLEANING AND DISINFECTION:

Excess gel should be wiped off the Pulse oximetry probe sensors and ultrasound doppler probes (if available) after every examination. Probes should be cleaned with a cloth dampened by warm water or with pre‐saturated isopropyl alcohol wipes or spray. Be sure to clean carefully along any seams, but do not allow liquids to enter the unit through connectors or speaker grill. To disinfect the unit, cables, cuffs, use commercially available spray or wipe disinfectants that are registered with the U.S. Environmental Protection Agency (EPA). Follow the instructions provided with the disinfectant and be sure to wipe the unit dry when finished. QMedical users should wash hands and change gloves after every exam. Refer to local and hospital policies regarding cleaning and disinfection. Store the unit in a clean area free of dust and debris. Follow the temperature and humidity storage requirements as specified in this manual.

MAINTENANCE:

A qualified technician must verify the accuracy of the pressure readout annually. Return the unit to Medeia for calibration if needed. See this manual for applicable pressure specifications. Periodically ‐‐ not less than annually ‐‐ inspect the main unit and probes for signs of cracks or breakage. Inspect cables, tubing, and connectors for signs of wear or failure. Inspect labels for damage. The user should discontinue use of the unit or probes if any loss of housing integrity is detected. In order to preserve, protect and improve the quality of the environment, protect human health and utilize natural resources prudently and rationally – do not dispose of waste electrical or electronic equipment (WEEE) as unsorted municipal waste. Contact local WEEE disposal sites or Medeia to dispose of equipment.

CUSTOMER SERVICE

The Customer Service staff at Medeia Inc encourages you to contact them for product assistance If you have questions please send them by email to [email protected] or +1 800 433 4609 for a prompt response.

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Medeia Inc. makes no claim that its products treat or heal. Medeia’s products are designed to measure and monitor physiological change. Professionals should work within the scope of their licenses and/or certifications when interpreting or applying data derived from Medeia’s products. CAUTION: U.S. Federal law restricts this device from being sold by or on the recommendation of a physician. NOTICE: The operator of this device should read and gain a thorough understanding of this manual before use. NOTICE: Please check the Theory Document to better understand the result reports and scientific background; this document only explains how to operate the system and software.

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AUTONOMIC (ANS) FUNCTION TESTING

TEST DESCRIPTION

TEST TIME

Total Test Time: 8min and 30 seconds Resting Test (4 minutes) ‐ The patient will relax and breathe normally Deep Breathing (1 minute) ‐ The patient will take full (not over exaggerated) breaths, 5 seconds in and 5 seconds out. Valsalva (1 minute) ‐ The patient will take a full breath in, HOLD it and the computer will state when to push the breath out. Standing Tilt (2 minutes) ‐ The patient will need to be sat upright, the computer will prompt you when to do this. Patient will relax and breathe normally.

REPORT PARAMETERS:

Cardiac Autonomic Function Testing (ANS): Heart rate variability Analysis and Cardiac Autonomic Reflex Tests (Autonomic Tonus, Autonomic Balance, Valsalva Ratio, Deep Breathing Reflex, E/I Ratio, K30/15 Ratio and Beat to Beat Systolic blood pressure response difference while standing or tilt). Artery Assessment: Endothelial Dysfunction, Pulse Wave Velocity, Peripheral Augmentation Index, Central Aortic Systolic Pressure, Right Ankle Brachial Indices (ABI) and Right Toe Brachial Index (TBI), PPG, PVR, PTT. The system performs Artery Vascular Assessment in parallel during Autonomic Function Testing. For “HW10‐B4‐D” device version only also Left Ankle Brachial Indices (ABI) and Left Toe Brachial Index (TBI) are available. Otherwise “Segmental Vascular Assessment” test need to be performed separately. ECG Assessment: 3 or 12 Leads ECG Assessment, Ventricular Extrasystoles (PVC), Atrial Extrasystoles (PAC), QT Variability Overall Health Level Assessment: Accumulative Mental Stress Index, Accumulative Physical Stress Index, Overall Health Level

AUTONOMIC FUNCTION TESTING CONTRADICTIONS

The system should not be used for patients under 14 years of age. The system is not effective for patients with pacemaker. The system may not be effective for patients with paroxysmal atrial fibrillations and multiple premature beats. Erratic and/or non‐rhythmic heartbeats and/or excessive electromagnetic noise may cause inaccurate results. The system should not be used during fibrillation. For the results to be valid, the patient should fast for two hours prior to the examination and avoid smoking, taking insulin, caffeine or over‐the‐counter medications. The patient should not exercise on the day before the test.

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PERSONS WITH FOLLOWING CONDITIONS CANNOT BE TESTED

• Any one with erratic, accelerated or mechanically controlled irregular heart rhythms • Individuals with insufficient peripheral circulation, acute cases of low blood pressure or low temperature • Arterial fibrillation/flutter • Atrio‐ventricular block • Individuals who are unable to comprehend or follow simple instructions • In case of anticipated pregnancy • Individuals who use a pacemaker • Undergoing procedures with proliferative retinopathy and a systolic Blood pressure of 160mm Hg or higher • Anyone who had laser treatment for retinopathy within the past three months

VALSALVA MANEUVER PROCEDURE SHOULD NOT BE PERFORMED ON PERSONS

Undergoing procedures with proliferative retinopathy and a systolic Blood pressure of 160mmHg or higher; Who have had laser treatment for retinopathy within the past three months; Valsalva maneuver impedes the return of venous blood to the heart and thus should not be performed on persons with severe coronary heart disease, persons who have had a recent heart attack or moderate‐to‐severe reduction in blood volume. Because of the possible risks, Valsalva maneuver should be performed in an environment where emergency equipment is accessible. The test ”Valsalva maneuver combined with deep breathing“ is targeted to reveal changes from normal breathing to deep breathing and compare these two stages.

ADDITIONAL PROCEDURAL NOTES

The QMEDICAL system should not be installed and operated in a damp, wet, dusty, sterile or noisy environment; Only standardized and recommended ECG electrodes should be used to maintain signal output integrity; During the procedure the system should be kept at a distance of about two (2) yards from the person tested; if necessary use a standard ”USB“ extension cable; The test environment should be quiet, gently illuminated and maintain a constant temperature; Noise and disturbance of all types should be kept away from the testing environment. During the procedure the person being tested should avoid speaking or physical body movements that are not related to the procedure; The test administrator should focus and guide the person being tested throughout the entire process as prompted by the program in the test progression screen; Blood pressure values of the person being tested can be obtained and entered in the procedure records before and after the test procedure; Dedicated computer should be used for testing measurements and storage so that other software installations do not interfere with the procedure and the device‘s performance;

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Please avoid all other electrical/electronic devices (other than the QMEDICAL system (computer and printer)) from sharing the power‐source socket; it is also advised that no other electrical/electronic device is allowed to operate while the test is in progress (in the same testing room). HRV analysis is known as a cardiac rhythm fluctuation study that involves the autonomic function – the testing of the autonomic nervous system balance. This procedure has been accepted by the medical community to assess cardiac autonomic function non‐invasively; to explore patho‐physiological mechanisms of heart disease; to evaluate treatment protocols and therapy options; and to predict long‐term prognosis.

PREPARATION BEFORE PROCEDURAL TEST SESSION

While waiting for this procedure to begin patients should be asked to relax. The person undergoing the procedure should be seated in a comfortable chair, preferably with arm rests but without wheels or rollers, throughout the entire procedure; The procedure candidate may be asked to empty his/her bladder prior to testing; Before the electrodes are attached, the skin of the examined person must be sanitized using standard alcohol wipes. A poor signal quality may result if the electro‐conductivity between the electrodes and the skin is not secure. In such cases, the electrodes should be replaced with new ones (use only standardized and recommended electrodes to guarantee signal integrity). WARNING: Changing the patient’s position (e.g. supine, sitting, stretching, talking, sudden movements, etc.) during the test unless indicated by test protocol may affect the accuracy of the QMEDICAL measurements. WARNING: For best recording results, electrical noise should be minimized by placing the patient away from electrical equipment or other sources of electromagnetic interference. The recording must be performed in a comfortable, relaxed sitting position with limiting body movements. If patient feels tired after coming to the examination room, allow him/her to have a 10‐ to 15‐minute rest before beginning the testing. It is important to eliminate any factors that can cause emotional stress. There is no need to provide specific training to patients on how to be tested. However, it is important to brief the patient on what is entailed in the test and how the test will unfold. This will help to lower any anxiety felt by the patient and his/her alertness levels, and establish a good rapport with the test administrator.

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PATIENT SETUP

1) CHECK FOR CONTRAINDICATIONS

(See Previous Pages)

2) ATTACH ECG ELECTRODES (#1)

a) Perform Good Skin Preparation The build‐up of skin oils and residues increases the resistance to the conduction of the electrical signal. Therefore, it is crucial to prepare the skin properly. Ideal skin preparation should follow the steps below: • Shave or clip hair if present. This allows for better electrode contact and reduces patch removal pain. Shaving may increase skin irritation under the electrode. • Rub vigorously with a gauze pad. Five to 10 strokes can effectively decrease the electrical resistance with minimal reddening of the skin. This will ensure that the heart’s electrical signals can travel to the electrodes. • Rub the skin with either isopropyl alcohol or soap and water to remove skin oils. Soap and water can minimize skin irritation. Let skin dry thoroughly. This will allow for better electrode‐to‐skin contact, as the adhesive base on the electrode will then grip the skin. b) Check the Electrodes Check the electrode gel to make sure it is fresh and moist. The electrode gel greatly affects the transmission of signals from the skin to the electrode. A dry electrode with inadequate conducting gel will not work properly since it reduces the conduction of the ECG signal. In most instances, electrode gel dry‐out is simply a result of incorrect storage. Electrodes are packaged in metal foil pouches to prevent gel evaporation, therefore it is important to remember the following: • Use electrodes prior to their expiration date. • Do not remove the electrodes from their pouch until they are ready to be used. • Do not place electrodes in open bins or drawers. If a pouch is already open, place it in a zip lock bag to preserve moisture and prevent evaporation. • Avoid warm storage areas. Do not use different brands of electrodes during a test. Resistance varies from brand to brand, and the signal is best when an equal signal comes from all of the electrodes. In fact, using electrodes of dissimilar composition can actually prevent an ECG trace. Pre‐gelled silver/silver chloride electrodes are recommended.

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(R) ‐ Red, place on right side just below right clavicle bone. (N) ‐ Black, place on left side below left clavicle bone. (L) ‐ Yellow, place on left side just below last rib cage.

Make sure patient has a Normal ECG

Normal ECG Rhythm

Abnormal ECG Signals

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3) ATTACH PPG/SPO2 PLETHYSMOGRAPH SENSOR

• Place short plethysmography (PPG1) (#2) on the left index finger (Nail facing up). • Place long plethysmography (PPG2) (#3) on the right foot, second toe (Nail facing up). Use this 3rd toe only as an alternate option if 2nd toe is too big. Do NOT use the big toe.

PPG1 PPG2 Make sure patient has a Normal Pulse Wave Curve

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4) ATTACH BLOOD PRESSURE CUFFS

Using the Blood Pressure Unit ‐ use the small cuff NIBP1 (#5) for the right arm and the big cuff NIBP2 (#6) for the right leg. ‐ Insert the air plug into the air jack ‐ Check the following before wrapping the cuff. a) The bladder is securely installed in the cuff. b) The bladder is not twisted inside the cuff. ‐ Inspect the cuff for overall condition and physical integrity, e.g. tear and wrap the cuff, the bladder and tubing. ‐ Put your arm/leg through the cuff loop ‐ Position the arm/leg correctly. The bottom edge of the cuff should be 1 to 2 cm above the elbow. Notes: When you take a measurement on the right arm, air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube. Notes: The blood pressure can differ between the right arm and the left arm, and therefore also the measured blood pressure values can be different. If the values between the two arms differ substantially, please check with your physician which arm to use for your measurement. Note: Blood pressure monitoring is especially useful for patients with poorly controlled hypertension. Note: The blood pressure measurement does not result in prolonged impairment of the circulation of the blood of the Patient. Cuff wrapping guide The Cuff Wrapping Guide is a unique feature that indicates if the cuff is not wrapped tightly enough around the arm. Even when the is displayed, a blood pressure reading will be taken. Note: This reading is NOT reliable due to the incorrect wrapping of the cuff. Please wrap the cuff again, taking care to wrap it correctly and take the measurement again. When the is displayed, the cuff is correctly wrapped tightly enough on the arm and the reading is accurate and reliable. Troubleshooting The reading not available. ‐ Arm cuff not applied correctly. Apply the arm cuff correctly. ‐ Movement or talking during measurement. Remain still and do not talk during measurement. ‐ Clothing is interfering with the arm cuff. Remove any clothing interfering with the arm cuff. Arm cuff pressure does not rise. ‐ The air tube is not securely connected into the main unit. Make sure that the air tube is connected securely. ‐ Air is leaking from the arm cuff. Replace the arm cuff with a new one. Arm cuff deflates too soon. ‐ The arm cuff is loose. Apply the cuff correctly so that it is firmly wrapped around the arm. If you get a message before the test. “The software cannot connect to the Blood Pressure device. Please check connection settings.”. Please check if the power cable is connected to the device and power outlet. Otherwise the Blood pressure cuff will not inflate.

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5) PATIENT POSITIONING:

• No body movements, only those directed. No talking, no chewing gum. • Sitting Position: Confirm that the patient’s hands are placed flat on the patient’s thigh, with no body movements. • Supine Position: confirm patient’s hands are flat by patient’s side, with no body movements. • Standing Position: Confirm that the patient’s hands are on their side touching the side of their leg during the entire standing procedure.

6) CHECK THE SIGNAL QUALITY

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7) INSTRUCTIONS FOR THE TEST ADMINISTRATOR

The person undergoing the procedure should be asked to relax while explaining the purpose and usefulness of the test; Contraindications: Persons with following conditions cannot be tested: • Anyone with erratic, accelerated or mechanically‐controlled irregular heart rhythms; • Arterial fibrillation/flutter; • Atrio‐ventricular block; • Individuals who are unable to comprehend or follow simple instructions; • Individuals who are pregnant or suspect they might be pregnant; • If a Person undergoing the procedure has a pacemaker, it should not be active during the test; Autonomic Balance Test: Valsalva Maneuver Procedure Should not be performed on a person undergoing procedures with proliferate retinopathy and a systolic Blood pressure of 160mmHg or higher; anyone who had laser treatment for retinopathy within the past three months; Sometimes a double signal may appear. Two heartbeats will be registered – the R‐prong is registered, immediately followed by the T‐wave, which also resembles an R‐prong. This means that the electrodes are placed on an area with too strong a signal and the position of the electrodes must be changed. The distance between the electrodes must be increased or placed even further down the thorax. In the case of actual pathological heartbeat disorders, a poor quality signal cannot be avoided. The pulse must be controlled palpatorically or ausculatorically. This ensure the extrasystoles are easily found – the pulse is obviously irregular. If more than one extrasystole corresponds to ten cardiointervals, it is impossible to conduct precise HRV analysis tests. In such cases, only the number of the extrasystoles is assessed. The best time for test procedure is from 8 a.m. to 2 p.m. Autonomic Balance Test Administration – Supplement

TIME INVOLVED EVENT TEST DESCRIPTION AND PURPOSE

3.30 or 4:30 MINUTES (INCLUDES 30 SECONDS OF RELAXATION BEFORE NEXT PHASE)

RESTING BASELINE SITTING POSITION

CARDIORESPIRATORY COUPLING AND AUTONOMIC BALANCE ‐ (SYMPATHETIC AND PARASYMPATHETIC TONE), STRESS ANALYSIS

1.00 MINUTE (EXTRA 30 SECS ALLOWED FOR RELAXATION BEFORE NEXT PHASE)

PACED BREATHING

BAROFLEX SENSITIVITY

1 or 1.30 MINUTES (EXTRA 30 SECONDS ALLOWED FOR RELAXATION BEFORE NEXT PHASE)

VALSALVA MANEUVER

SYMPATHETIC VASOCONSTRICTION REFLEX

2 or 5.00 MINUTES (STANDING, STANDING TO SITTING AND REPETITION STARTS AFTER FIRST 2 MINUTES OF STANDING PHASE)

STANDING, STANDING and SITTING

ORTHOSTATIC TEST, CARDIOVASCULAR REFLEX, FITNESS ANALYSIS

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START A NEW MEASUREMENT

Select “New Measurement” from the menu or from the big Icon.

Select “Autonomic Balance Analysis ‐ ANS”. Press “OK” Button to continue.

Select ANS “Full Test”. Select “Tilt Table” if applicable. Press “Continue” Button.

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Fill the patient questioner if applicable and press “Continue” Button.

Select Existing patient from the list or create a new one.

Fill the patient Profile. First Name, Last Name, Gender, Birthdate, Weight and Hight are mandatory fields.

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Make sure the signal is good for all 3 channels: ECG, PPG1, PPG2. Press Start Button when all 3 channels have good signal quality. During the test procedure, the person being tested should avoid any speaking or physical body movements that are not related to the procedure; Otherwise the test results can be compromised. Follow the test instruction on the screen. Note: After the 4th minute during the test the software in background will perform ECG event extrasystoles and artifact detection. If the total number of patient irregular heartbeats is more than 8% the test will be terminated at the middle and only ECG and PWV analyses report will be available. It is contraindications patients with high number of irregular heartbeats to perform Autonomic Function Testing (ANS). The ANS test result for such patients can be compromised.

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ARTERIAL VASCULAR ASSESSMENT

There are 5 different Arterial Vascular Assessment tests: Arterial Vascular Assessment during Autonomic (ANS) Function Test If you perform “Autonomic (ANS) Function Testing” the Arterial Vascular Assessment on full Right side will be performed in parallel. The “HW10‐B4‐D” has 4 NIBP Blood Pressure sensors. If you have “HW10‐B4‐D” device version also full Left side evaluation will be available. The “HW10‐B2” has two NIBP Blood Pressure sensors. It allows only one side (Right side) evaluation at the time. If Left side evaluation requeue, a separate Arterial Vascular Assessment Left side evaluation can be performed. One Side Segmental PWV & ABI Analysis It is also included during ANS test, but it can be performed also separately. Patient setup is the same as the ANS Test. The only difference is that the PPG1 (#2) sensor need to be placed on the Right index finger instead of the Left. The total test time is 3 minute. Two Side Segmental PWV & ABI Analysis Patient setup is the same as the ANS Test. The only difference is that the PPG1 (#2) sensor need to be placed on the Right index finger instead of the Left. The total test time is 4 minute. The system will request after second minute to move all patient sensors from the Right Side to the Left Side. In that way, the system will able to perform evaluation on the both side using only two BP cuff. If you have “HW10‐B4‐D” device version this test will performed only for two minutes’ time frame. Exercise Segmental PWV & ABI Analysis Patient setup is the same as the ANS Test. The only difference is that the PPG1 (#2) sensor need to be placed on the Right index finger instead of the Left. The total test time is 7 minute. 2 minutes – Resting PWV & ABI Analysis 3 minutes – Exercise Bike or Some Squads 2 minutes – Post Exercise PWV & ABI Analysis

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Peripheral Arterial Tone Assessment (PAT) The QMedical System utilizes PAT technology to measure endothelium‐mediated changes in vascular tone. PAT technology uses a simple and noninvasive finger probe or biosensor. The fingertip biosensor non‐invasively measures finger arterial pulsatile volume changes by collecting the PAT signal. The fingertip biosensors apply a consistent sub‐diastolic pressure to the fingertip. This manner of probing the fingertip relieves arterial wall tension which produces a greater dynamic range of PAT signal, prevents distal venous blood pooling and prevents the biosensor from shifting or releasing from the finger. Next, a standard blood pressure cuff is placed onto the patient’s non‐dominant arm. To control for simultaneous non‐endothelial dependent changes in vascular tone, measurements are also taken from the contra‐lateral arm. As the cuff tightens, it induces a downstream hyperemic response, which causes a 5‐minute arterial occlusion. Once the cuff is removed, the sudden flood of blood causes an endothelium‐dependent Flow Mediated Dilatation (FMD). This dilation (Reactive Hyperemia) is marked by an increase in the PAT Signal amplitude. This fluctuation is captured and processed by the Endothelial System. All of the PAT signal data is collected then analyzed using digital signal processing algorithms. The resultant information is processed then expressed in a simple format to the physician using dedicated, advanced software. The program calculates the Endothelial Index by creating a post‐occlusion to pre‐occlusion ratio. PAT results can be classified into the following categories: PAT Score of 2.1 or higher: This low reading indicates a correspondingly low risk for heart disease. The endothelium is functioning properly, offering maximum protection and maintaining a healthy heart. This levels is referred to as GREEN LEVEL PAT. PAT Score of between 1.68 and 2: This moderate reading indicates that some lifestyle changes may be necessary. The endothelial function is acceptable and there are no current health risks, however, preventative steps may be necessary to prevent endothelial dysfunction and descending into the Red Level. Lifestyle changes such as reducing cholesterol, managing stress, quitting smoking, lowering blood pressure and losing weight may be recommended to avoid or postpone heart disease. This PAT reading is referred to as YELLOW LEVEL PAT. PAT Score of 1.67 or lower: A reading of 1.67 or below indicates the need for urgent medical attention. This measure is referred to as RED LEVEL PAT. Doppler Vascular Assessment It is only available for “HW10‐B4‐D” device version. There is a separate User’s manual document which describe in detail the Doppler Vascular Assessment.

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PATIENT SETUP

1) CHECK FOR CONTRAINDICATIONS

(See Previous Pages)

2) ATTACH ECG ELECTRODES (#1)

a) Perform Good Skin Preparation The build‐up of skin oils and residues increases the resistance to the conduction of the electrical signal. Therefore, it is crucial to prepare the skin properly. Ideal skin preparation should follow the steps below: • Shave or clip hair if present. This allows for better electrode contact and reduces patch removal pain. Shaving may increase skin irritation under the electrode. • Rub vigorously with a gauze pad. Five to 10 strokes can effectively decrease the electrical resistance with minimal reddening of the skin. This will ensure that the heart’s electrical signals can travel to the electrodes. • Rub the skin with either isopropyl alcohol or soap and water to remove skin oils. Soap and water can minimize skin irritation. Let skin dry thoroughly. This will allow for better electrode‐to‐skin contact, as the adhesive base on the electrode will then grip the skin. b) Check the Electrodes Check the electrode gel to make sure it is fresh and moist. The electrode gel greatly affects the transmission of signals from the skin to the electrode. A dry electrode with inadequate conducting gel will not work properly since it reduces the conduction of the ECG signal. In most instances, electrode gel dry‐out is simply a result of incorrect storage. Electrodes are packaged in metal foil pouches to prevent gel evaporation, therefore it is important to remember the following: • Use electrodes prior to their expiration date. • Do not remove the electrodes from their pouch until they are ready to be used. • Do not place electrodes in open bins or drawers. If a pouch is already open, place it in a zip lock bag to preserve moisture and prevent evaporation. • Avoid warm storage areas. Do not use different brands of electrodes during a test. Resistance varies from brand to brand, and the signal is best when an equal signal comes from all of the electrodes. In fact, using electrodes of dissimilar composition can actually prevent an ECG trace. Pre‐gelled silver/silver chloride electrodes are recommended.

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(R) ‐ Red, place on right side just below right clavicle bone. (N) ‐ Black, place on left side below left clavicle bone. (L) ‐ Yellow, place on left side just below last rib cage.

Make sure patient has a Normal ECG

Normal ECG Rhythm

Abnormal ECG Signals

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3) ATTACH PPG/SPO2 PLETHYSMOGRAPH SENSOR

• Place short plethysmography (PPG1) (#2) on the right index finger (Nail facing up). • Place long plethysmography (PPG2) (#3) on the right foot, second toe (Nail facing up). Use this 3rd toe only as an alternate option if 2nd toe is too big. Do NOT use the big toe.

PPG1 PPG2 Make sure patient has a Normal Pulse Wave Curve

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4) ATTACH BLOOD PRESSURE CUFFS

Using the Blood Pressure Unit ‐ use a small cuff to NIBP1 (#5) for the right arm and a big cuff to NIBP2 (#6) for the right leg. ‐ for “HW10‐B4‐D” device also use a small cuff to NIBP4 for the left arm and a big cuff NIBP3 for the left leg. ‐ Insert the air plug into the air jack ‐ Check the following before wrapping the cuff. a) The bladder is securely installed in the cuff. b) The bladder is not twisted inside the cuff. ‐ Inspect the cuff for overall condition and physical integrity, e.g. tear and wrap the cuff, the bladder and tubing. ‐ Put your arm/leg through the cuff loop ‐ Position the arm/leg correctly. The bottom edge of the cuff should be 1 to 2 cm above the elbow. Notes: When you take a measurement on the right arm, air tube will be at the side of your elbow. Be careful not to rest your arm on the air tube. Notes: The blood pressure can differ between the right arm and the left arm, and therefore also the measured blood pressure values can be different. If the values between the two arms differ substantially, please check with your physician which arm to use for your measurement. Note: Blood pressure monitoring is especially useful for patients with poorly controlled hypertension. Note: The blood pressure measurement does not result in prolonged impairment of the circulation of the blood of the Patient. Cuff wrapping guide The Cuff Wrapping Guide is a unique feature that indicates if the cuff is not wrapped tightly enough around the arm. Even when the is displayed, a blood pressure reading will be taken. Note: This reading is NOT reliable due to the incorrect wrapping of the cuff. Please wrap the cuff again, taking care to wrap it correctly and take the measurement again. When the is displayed, the cuff is correctly wrapped tightly enough on the arm and the reading is accurate and reliable. Troubleshooting The reading not available. ‐ Arm cuff not applied correctly. Apply the arm cuff correctly. ‐ Movement or talking during measurement. Remain still and do not talk during measurement. ‐ Clothing is interfering with the arm cuff. Remove any clothing interfering with the arm cuff. Arm cuff pressure does not rise. ‐ The air tube is not securely connected into the main unit. Make sure that the air tube is connected securely. ‐ Air is leaking from the arm cuff. Replace the arm cuff with a new one. Arm cuff deflates too soon. ‐ The arm cuff is loose. Apply the cuff correctly so that it is firmly wrapped around the arm. If you get a message before the test. “The software cannot connect to the Blood Pressure device. Please check connection settings.”. Please check if the power cable is connected to the device and power outlet. Otherwise the Blood pressure cuff will not inflate.

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5) PATIENT POSITIONING:

• No body movements, only those directed. No talking, no chewing gum. • Sitting Position: Confirm that the patient’s hands are placed flat on the patient’s thigh, with no body movements. • Supine Position: confirm patient’s hands are flat by patient’s side, with no body movements. • Standing Position: Confirm that the patient’s hands are on their side touching the side of their leg during the entire standing procedure.

6) CHECK THE SIGNAL QUALITY

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START A NEW MEASUREMENT

Select “New Measurement” from the menu or from the big Icon.

Select “Arterial Vascular Assessment”. Press “OK” Button to continue.

Select the desired assessment type. Press “Continue” Button.

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Fill the patient questioner if applicable and press “Continue” Button.

Select Existing patient from the list or create a new one.

Fill the patient Profile. First Name, Last Name, Gender, Birthdate, Weight and Hight are mandatory fields.

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DESCRIPTION OF PRODUCT AND CONTROLS

DESCRIPTION OF THE DEVICE

The QMedical is a diagnostic device used to aid the clinician in obtaining systolic pressure values at the arms, legs and feet. The device will provide a bi‐directional Doppler (if available) for detecting presence or absence of blood flow, and will control the inflation and deflation of a pressure cuff under direction of the user. Three additional modalities, Pulse Cuff Recording (PCR), Photoplethysmography (PPG) and Electrocardiography (ECG), will provide additional information for the clinician. PCR will be used as a plethysmograph to obtain alternative blood flow waveforms, the PPG will be used primarily to obtain toe pressures and ECG will be used to obtain the heart rate. The unit will calculate Ankle Brachial Index (ABI), Toe Brachial Index (TBI) or segmental values once the clinician has accepted or entered the appropriate pressure values. Waveforms, pressure values, and index results can be printed directly from the notebook or uploaded using QMedical report generating software and an external user supplied PC via a USB port. The unit run from an external power supply.

DESCRIPTION

The QMedical system is non‐invasive peripheral vascular diagnostic system. The QMedical is a complete peripheral vascular system that supports 2 independent pressure channels, 2 PPG/SpO2 sensors, and 2 Doppler frequencies (if available). Some of the main features include patient details and patient database management; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols; measurement site configuration; export in various formats; backup features; restoring backup data; online help options; and review stations. Also the standard signal control options and signal display options, as well as measurement calculations. The quantitative measurements and the main measurement of the QMedical is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal (if available) in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure. Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure. If Doppler is available the standard main Doppler parameters that are calculated, include: Mean, representing the time‐average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; P, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity ‐ minimal diastolic velocity) /

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mean velocity; RI, representing the Pourcelot Resistance Index, calculated based on the peak envelope as (peak systolic velocity ‐ minimal diastolic velocity) / peak systolic velocity; S/D, representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute. Additional parameters that are displayed are related to the specialty tests. During exercise stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous refluxc testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre‐dorsi flexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation. The QMedical complies with Class A EMC requirements. Therefore, the QMedical 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.

PRODUCT OVERVIEW

The QMedical concept provides a full‐featured ABI/vascular system to aid the diagnosis of peripheral arterial disease (P.A.D.). It is fast, efficient, meets reimbursement criteria, and offers 3 modalities for obtaining systolic pressures and ankle waveforms. To retrieve ankle waveforms that are required for reimbursement, either pulse volume recording (PVR) or a bi‐directional Doppler probe (if available) can be utilized. The system comes with a total of 2 pressure cuffs, and step‐by‐step exam instructions are supported by graphic waveform display. The process of performing exams is accelerated through automatic cuff inflation and deflation and automatic indices calculation. The QMedical accommodates both standard and custom protocols, and includes PC download software to accommodate interface with various Electronic Medical Record (EMR) systems. Features: Retrieves two pressures at each ankle site (PT and DP) Exam is customized by automated segmental studies Automatic calculations for ABI, TBI and segmental Automatic cuff inflation and deflation system Graphic waveform display with step‐by‐step instructions Seated ABI can be carried out for mobility impaired patients Bi‐Directional Doppler probe (8MHz / 5MHz) (if available) 2 or 4 blood pressure cuffs PVR waveform modality & PPG probe to obtain toe and limb pressures ECG and Pulse Transmission Time Ankle Brachial Index Ankle and Arm Systolic Pressures Automatic ABI Calculation Automatic Selection of Arm Pressure (higher of the two) Configurable for one or two Ankle Pressures

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Toe Brachial Index Arm and Toe Systolic Pressures Automatic TBI Calculation Automatic Selection of Arm Pressure (higher of the two) Seated ABI Ankle and Arm Systolic Pressures Automatic Hydrostatic Correction and ABI Calculation Automatic Selection of Arm Pressure (higher of the two) Configurable for one or two Ankle Pressures Segmental Studies Arm and 5 Lower Limb Systolic Pressures Automatic Index Calculation Automatic Selection of Arm Pressure (higher of the two) Ability to customize study by selecting the number and location of arterial sites Waveforms Bi‐Directional Doppler Pulse Volume Recording (PVR) Photoplethysmography (PPG)

DOPPLER OVERVIEW (IF AVAILABLE)

To draw out arterial pulses, the Doppler component pertaining to non‐invasive arterial studies uses a high frequency sound wave. What is defined as a normal audible sound wave, is a clear sounding wave which, in harmony with the sinus rhythm of the cardiac systolic beat, repeats itself on a regular basis. The appearance of quick beats or pauses can be indicators of bi‐ or trigeminy or other cardiac arrhythmias. The performance of a peripheral Doppler Study by a podiatrist could be the first time that signs of a cardiac arrhythmia are discovered and diagnosed. In such a case, the patient should as soon as possible be referred back to his or her primary care physician or cardiologist, as high pitched Doppler sounds are generally suggestive of a more proximal stenosis. Should they appear in concurrence with very high arterial pressure, this is suggestive of an arterial wall calcification.

ANKLE BRACHIAL INDEX CHART (ABI)

ABI is calculated by ankle systolic pressure/brachial systolic pressure. Above 0.96‐Normal 0.71‐0.96‐Mild Obstruction. 0.31‐0.70‐Moderate Obstruction 0.00‐0.30‐Severe Obstruction It is important to note that vessel calcification can cause an above normal ABI and suggest a false elevation of the lower extremity pressure. Abnormal blood flow and volume can be determined by the analysis of the arterial wave form with further information made available through PV Arterial and PPG.

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TOE BRACHIAL INDEX OR TBI

The toe systolic pressure (measured with either a PPG or Doppler) divided by the brachial systolic pressure provides you with the TBI. Above 0.75‐Normal 0.66 ‐ 0.75‐Acceptable Borderline 0.00 ‐ 0.66‐Abnormal Range A possible indicator of the healing probability in a diabetic foot ulcer is a toe pressure of greater than 30 mmHg, while poor perfusion is suggestive with a PPG waveform showing slow recovery.

SEGMENTAL PRESSURES

Any pressure difference between two adjacent levels of less than 20 mmHg is considered within normal limits. Any pressure difference between two adjacent levels exceeding 20 mmHg is considered abnormal. Further analysis of waveform variations will assist the examiner in determining the level of obstruction. Treadmill or reactive hyperemia studies (analysis of how long it takes for flow to resume to normal after cuff deflation) will assist in determining the extent of obstruction.

PHOTO PLETHYSMOGRAPHY

Photoplethysmography (PPG) is based on the determination of the optical properties of a selected skin area. For this purpose, non‐visible infrared light is emitted into the skin. More or less light is absorbed and determinations about the measurement of the reflected light can be made, using the optical properties of tissue and depending on the blood volume changes.

PULSE VOLUME (PV) ARTERIAL

PV Arterial is useful in detecting arterial occlusive conditions in the lower extremities solely through analysis of waveform patterns. This method is sufficiently sensitive even for distal digital studies, and is useful in patients in whom vessel wall calcification prevents accurate Doppler signal processing and occlusion‐cuff pressure measurements. They typical appearances of a normal PV Arterial are characterized by: Rapid upstroke during systole with a sharp peak at maximum amplitude. A more gradual down stroke following peak amplitude. A dicrotic notch midway in the down slope. The dicrotic notch is a particularly prominent feature of PV waveforms obtained from arm arteries. After the dicrotic notch, the pattern curves or bows toward the baseline. The first sign of abnormality is the absence of the dicrotic notch. Distal to more significant occlusions, the slope of both the ascending and descending segments of the trace decreases and rounding of the systolic peak is noted. As the obstruction increases, the waveforms will become level.

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PEAK VELOCITY

Femoral = 29.8 cm/sec to 51.6 cm/sec Posterior Tibial = 6 cm/sec to 26 cm/sec Dorsal Pedal = 11.1 cm/sec to 22/5 cm/sec Normal peak is 30± 10 Abnormalities in the peak velocity may be indicative of stenosis and occlusion. In early stages of stenosis and occlusion, the peak velocity distal to the occlusion may actually increase. Therefore, any significant abnormality should be noted and compared with other components of the non‐invasive study prior to drawing any conclusions. System Parameters:

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ERROR MESSAGES

1/0,"Software has not been registered." Offline version: The software has not been registered before or the previous software registration has been expire. The registration expire every one year. The user need to register the software using the Serial Number and Client Code previously provided. 1/0, "The maximum number of measurement has been reached. Please re‐register the application again." Offline version: The previous software registration has been expire. The registration expire every one year. The user need to register the software using the Serial Number and Client Code previously provided. Online version: The user need to add more find to his account. The user need login to his account and add more funds. Or to contact his account supervisor. 2/0, "The software cannot connect to the hardware. Please check connection settings." ‐ Please check is the hardware is properly plugged in to the PC. ‐ Please check the hardware configuration settings in the software. Check is the hardware type and check the connection options. ‐ For some older HW6 and for Win XP and for some Win Vista the hardware drivers need to be instilled manually. Please check the user manual how to install hardware drivers. ‐ For Win XP the hardware drivers need to be installed separately for each USB port. 200/0 "The Data is too short." There are too many artifacts or the electrodes are not connected properly or the patient was moving. This error message can appear at the end of the test measurement or after the 4min from test beginning. 101/0 "Computer is not receiving response from the hardware or connection time out. Check the hardware is plugged in properly." The hardware has been unplugged during the measurement or the USB cable connection is unstable. Please make sure the hardware cable USB connection is good all the time and the device is powered. "Data Input Error Message" The hardware has been unplugged during the measurement or the USB cable connection is unstable. Please make sure the hardware cable USB connection is good all the time. "Data Processing Error" This error appear when previously collected measurement is opened for analysis and measurement has too many artifacts or electrodes are not connected properly or the patient has been moving. The measurement need to be redone properly again. "Signal is Bad" The input resistance measurement is not in the expected range. The results possibly compromised. “The software cannot connect to the Blood Pressure device. Please check connection settings.” Please check if the power cable is connected to the device and power outlet. Otherwise the Blood pressure cuff will not be inflated.

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PRINT PATIENT REPORT

The QMedical software provides the download of examination results from the QMedical and explanatory patient data; it permits for added clinician interpretation and comments and saves and prints patient examination reports. WARNING: Only trained personnel, familiar with the manufacturer supplied labeling and the manual, shall operate the QMedical and QMedical software. WARNING: The QMedical software does not provide an examination results analysis. Before further procedures are carried out, patient results should be considering with patient history. CAUTION: Run regular virus checking software and system diagnostics to ensure proper operation of the user supplied external hardware. CAUTION: As with all electronic devices, back up the system frequently to ensure integrity of data on the user supplied external hardware.

Follow the instructions on the screen.

MEDEIA QMEDICAL (HW10) · 4 medeia Designed for clinicians by clinicians For a FREE Demonstration...

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