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SENSIBLE MEDICAL ReDS System V2.6 User Manual

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ReDS™ System
Healthcare Provider
User Manual
ReDS
™
System
V2.6
RA-56029 Rev. B
January 2019

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Summary of Contents for SENSIBLE MEDICAL ReDS System V2.6

  • Page 1 ReDS™ System Healthcare Provider User Manual ReDS ™ System V2.6 RA-56029 Rev. B January 2019...
  • Page 2 This user manual describes how to use the ReDS™ System to monitor the fluid status of patients. This manual describes the ReDS System V2.6. It applies to healthcare providers (HCPs) who are using the device to monitor patients in single or in multiple patient mode...

  • Page 3: Table Of Contents

    Table Of Content Table of Contents About This Manual ..................... 2 Table of Figures ....................4 Legal Notice ......................6 Support and Contact Information ..............6 Conventions Used in This Manual ..............7 Important Safeguards ..................8 1 Introducing the ReDS System ..............11 Overview ............................

  • Page 4: About This Manual

    Table Of Content Positioning the front sensor ......................41 Adjusting the height of the back sensor ..................42 Adjust Back Center Strip ........................44 Reading Ruler Value .......................... 47 Verification Screen ..........................49 Reading Patient Chest Size ....................... 51 3 Taking a Measurement ................52 Taking a Measurement –...
  • Page 5 Table Of Content Administrative User .......................... 77 SensiCloud Troubleshooting ......................79 5 Troubleshooting ..................80 A Labeling ....................... 82 System Labels............................ 82 Labeling Symbols ..........................83 B Handling ...................... 84 Storage .............................. 84 Cleaning ............................. 84 Maintaining ............................84 Packing instructions ......................... 85 C Technical Information .................

  • Page 6: Table Of Figures

    Table of Figures Table of Figures Figure 1: Front of Bedside Console, Tabletop Mounting ....................13 Figure 2: Back of Bedside Console, Tabletop Mounting ....................13 Figure 3: Bedside Console, Cart Mounting ......................... 14 Figure 4: Connecting Cellular Modem ..........................15 Figure 5: Sensor Vest Front View ............................
  • Page 7 Table of Figures Figure 43: Measurement Results ............................59 Figure 44: Measurement Ended ............................61 Figure 45: Patient History Screen ............................61 Figure 46: Patient List ................................64 Figure 47: My Account Screen .............................66 Figure 48: Login Screen.................................67 Figure 49: Enrolling a New Patient ............................68 Figure 50: Editing Patient Details ............................69 Figure 51: Suspending a patient ............................70 Figure 52: Archiving a patient ..............................72...

  • Page 8: Legal Notice

    Legal Notice Copyright © 2017 Sensible Medical Innovations Ltd. All rights reserved. All intellectual property rights in this publication are owned by Sensible Medical Innovations Ltd. and protected by applicable copyright laws and international treaty provisions. Sensible Medical Innovations Ltd. retains all rights not expressly granted. No part of this publication may be reproduced in any form whatsoever or used to make any derivative work without prior written approval by Sensible Medical Innovations Ltd.

  • Page 9: Conventions Used In This Manual

    The WEEE symbol indicates that this system contains electrical and electronic components which must be collected and disposed of separately. Never dispose of electrical and electronic waste in general municipal waste. Collect and dispose of separately. Make use of the return and collection systems and components available to you, or use your local recycling program.

  • Page 10: Important Safeguards

    Important Safeguards Important Safeguards To ensure proper and dependable usage of the ReDS System, read all the instructions provided in this user manual before using the ReDS System. WARNINGS! 1. The ReDS System should only be operated in accordance with the manufacturer's instructions, as specified in this user manual.
  • Page 11 Cautions CAUTIONS: 1. Do not operate the ReDS System without proper training. For additional information, and in case additional training is needed, contact support. 2. In case of user discomfort, abort the operation of this system by using the console or by unfastening and removing the sensor vest. 3.
  • Page 12 Cautions CAUTIONS Continued 14. In the following cases remove the sensor vest, turn off the system, disconnect the power supply and contact support: Recurring device malfunction message Device is not responding A measurement that does not stop automatically within four (4) minutes of starting.

  • Page 13: Introducing The Reds System

    Introducing the ReDS System Introducing the ReDS System This chapter introduces the ReDS System and describes its components. Overview The ReDS System is a non-invasive device consisting of a Bedside Console connected to a wearable vest that is used for the measurement of lung fluid. A measurement session lasts 90 seconds.

  • Page 14: Patient Population

    Introducing the ReDS System NOTE: This User Manual, pertaining to ReDS System V2.6 GAS0056, include instructions for use applicable to a subset of ReDS system indicated users, i.e. – Health Care Providers Patient Population The system is suitable for: Patients over 21 years of age.

  • Page 15: Figure 1: Front Of Bedside Console, Tabletop Mounting

    Introducing the ReDS System ON/OFF Button Figure 1: Front of Bedside Console, Tabletop Mounting NOTE: Note that the Bedside Console contains a battery that enables it to stay ON and perform some functions without being connected to a power outlet. However in order to perform measurements and update patient info, the Console must be connected to a power outlet.

  • Page 16: Figure 3: Bedside Console, Cart Mounting

    Introducing the ReDS System Figure 3: Bedside Console, Cart Mounting Wireless Connectivity If the SensiCloud portal option is included with the system, a cellular USB modem is provided with the device. This modem enables the transmission of measurement results data to a secured cloud server for healthcare provider review.

  • Page 17: Figure 4: Connecting Cellular Modem

    Introducing the ReDS System CAUTIONS: Do not connect devices to this system’s USB port, except as instructed in this manual. Do not connect any unauthorized USB devices to the USB port. Please consult with your institution's IT/bioengineering department to get guidance on which USB devices are authorized, and how to use them.

  • Page 18: Sensor Vest

    Introducing the ReDS System Sensor Vest The right inside of the sensor vest has two sensors, one in the front and one in the back, for measuring lung fluid content. The measurement information is transferred to the Bedside Console via a cable from the sensor vest. The following describes the components of the sensor vest.

  • Page 19: Figure 6: Fastening Flaps And Fastening Strap Back View

    Introducing the ReDS System Shoulder Fastening Flap Fastening Strap Left Fastening Flap Right Fastening Flap Figure 6: Fastening Flaps and Fastening Strap Back View Back Center Strip The back Center Strip is used to position the sensor vest properly on the patient’s body during the adjustment process.

  • Page 20: Figure 9: Positioning Reference Points

    Introducing the ReDS System Two Positioning Reference Points Two circular reference points help position the sensor vest on the patient’s body. The top one is to be positioned just below the patient’s suprasternal (Jugular) notch, and the bottom one rests below on the patient's breastbone (sternum). Positioning Reference Points...

  • Page 21: Sensicloud ™ Portal

    Introducing the ReDS System Chest Size Ruler The Chest Size ruler is used to measure the chest size when the sensor vest is worn by the patient. Chest Size Ruler Figure 11: Chest Size Measurement Ruler You may refer to the Reading Patient Chest Size section on page 51 for a description of this procedure.

  • Page 22: Figure 12: Sensicloud Components

    Introducing the ReDS System Figure 12: SensiCloud Components The following are the main functions available in SensiCloud: Enrolling patients in the SensiCloud Portal, which associates them with the healthcare provider using the system Performing technical and administrative tasks by Sensible service team for supporting healthcare provider’s work.

  • Page 23: Setting Up Reds System

    Setting Up ReDS System Setting Up ReDS System This chapter describes how to adjust the sensor vest to fit a specific patient and other general setup procedures that must be performed one time prior to using the ReDS System. CAUTIONS: To ensure proper and dependable usage of the ReDS System, read all the instructions provided in this user manual before using the ReDS System.

  • Page 24: Step 2: Adjusting The Bedside Console

    Setting Up ReDS System Figure 13: Bedside Console VESA Mounting Plate Step 2: Adjusting the Bedside Console The tilt of the console display can be adjusted. For Cart configuration, use the lever on its back. To adjust the tilt of the Bedside Console (Cart configuration) display: Turn the black lever on the cart’s back clockwise to release the console’s hinge.
  • Page 25 Setting Up ReDS System To set up communication: Connect the cellular modem (or the wireless adaptor if using Wi-Fi) to the back of the console. Use the white straps to secure in place. The cellular modem is provided within the ReDS System package. See System Settings on page 29 for more details CAUTION: The use of USB accessories other than those specified may result in increased...

  • Page 26: Patient Setup

    Setting Up ReDS System Patient Setup This section describes how a healthcare provider should adjust the sensor vest. Each sensor vest must be adjusted for a specific patient before it is used to measure that patient. The sensor vest adjustment procedure need be performed for each patient. After the sensor vest is adjusted for a specific patient, it should be repeated for all his/her future measurements.

  • Page 27: Step 1: Preparing The Patient

    Setting Up ReDS System Step 1 Preparing the Patient Step 2 Powering Up Step 3 Setting Up a New Patient Adjusting the Sensor Vest Step 4 Taking a measurement Step 5 Step 1: Preparing the Patient To prepare the patient: o Make sure the patient is dressed in plain light clothing.

  • Page 28: Step 2: Powering Up

    Setting Up ReDS System Step 2: Powering Up WARNING! This system should not be operated if there is any visible physical damage to any of its parts (Sensor Vest, Bedside Console, power supply or cables), such as cracks, breaks, tears and so on. The ReDS System should not be used in the vicinity of RF emitters such as magnetic resonance imaging (MRI) machines, computed tomography (CT) machines, RF diathermy devices, RFID devices and electromagnetic security...

  • Page 29: Figure 14: Start Screen

    Setting Up ReDS System displayed, as shown below: Figure 14: Start Screen System is ready for use only when “System Status: Ready” is displayed.

  • Page 30: Figure 15: Screensaver

    Setting Up ReDS System NOTE: The system should remain plugged into the power outlet. The console has a screen saver. When the screen saver is displayed, simply tap the screen to redisplay. When the screen is completely black (OFF), then power on the ReDS System, as described above Figure 15: Screensaver If the system is unplugged or if power is down, the following message displays on...

  • Page 31: System Settings

    Setting Up ReDS System System Settings The System Settings screen enables you to configure the ReDS System. To set up the ReDS System: In the Start screen (see figure 14 on page 27), click the cogwheel icon on the bottom left. The following screen displays: Tap to turn Tap to turn transmission...
  • Page 32 Setting Up ReDS System NOTE: In order to allow successful transmission of all data, do not disconnect the system from the power outlet until the system displays a notification that the transmission has ended. Disconnecting during data transmission aborts the process and requires the data to be sent again.
  • Page 33 Setting Up ReDS System Similarly, if using WiFi, a standard WiFi strength indicator is displayed. Additionally, the blinking blue LED on the USB adapter is another indication of a good signal and working connection. Use ‘Communication Test’ in the ‘System Setting’ screen to test cellular or WiFi connectivity. Manual Data Transmission Upload to cloud button in the Start Screen, is the system’s feature allowing the transmission of measurement results from the system to SensiCloud (when the SensiCloud service is...

  • Page 34: Step 3: Setting Up A New Patient

    Setting Up ReDS System Step 3: Setting Up a New Patient A new patient must be set up as described below when using the system on a patient for the first time. Note, if the patient has been measured previously you should use his existing record.

  • Page 35: Figure 18: Patient List Screen

    Setting Up ReDS System To select a patient: In the Start screen (see Figure 14), tap Start. The following screen displays: Figure 18: Patient List Screen...

  • Page 36: Figure 19: Adding New Patient

    Setting Up ReDS System This screen lists all patients currently defined in the system. If the patient already appears in the list, tap his/her patient row to select that patient and then proceed to Step 5- adjusting the Sensor Vest. NOTE: You can type in part of the patient’s name or ID to filter the patient list.

  • Page 37: Figure 20: Patient Details Screen

    Setting Up ReDS System Fill out the Patient information: patient ID, Name, Date Of Birth, Height, Weight & Scoliosis. Tap Next Figure 20: Patient Details Screen A keyboard will pop up on the screen, where needed. Use it to make your entries. NOTE: When working in Anonymous mode, the Patient Name, Patient ID # and Date of Birth fields do not appear.

  • Page 38: Step 4: Adjusting The Sensor Vest

    Setting Up ReDS System Step 4: Adjusting the Sensor Vest Adjusting the sensor vest involves the following: Loosening the flaps and the Fastening Strap. Positioning the front of the sensor vest. Setting the back piece height. Centering the back piece. Tightening the side flaps and fastening the strap.
  • Page 39 Setting Up ReDS System CAUTIONS: When considering whether to use the ReDS System, take the following patient-related considerations into account: 1. Physical deformities in the thorax area that may prevent application or correct adjustment of the sensor vest. 2. Recent surgery in the torso area. 3.

  • Page 40: Figure 21: Pop Up Shows After Completing Patient Details

    Setting Up ReDS System Instruct the patient to remain still for the duration of the measurement procedure. In the Patient Details screen, tap Next or Skip instructions. The following popup window displays: Figure 21: Pop up shows after completing Patient Details The popup window indicates which Height Marker to choose during the vest adjustment and whether to align or shift the center strip, based on the patient’s anatomy.

  • Page 41: Figure 22: Positioning Front Sensor Screen

    Setting Up ReDS System Figure 22: Positioning Front Sensor Screen Loosen the flaps in order to prepare the sensor vest for adjustment: Open the Right Fastening Flap and then reattach it to its maximum opening position, as shown below: Figure 23: Opening the Right Fastening Flap...

  • Page 42: Figure 24: Opening The Left Fastening Flap

    Setting Up ReDS System Open the Left Fastening Flap and reattach it to its maximum opening position, as shown below: Figure 24: Opening the Left Fastening Flap Open the fastening shoulder flap and then reattach it to its maximum opening position, as shown below: Create a large opening for the right arm.

  • Page 43: Positioning The Front Sensor

    Setting Up ReDS System NOTES: When adjusting the vest, a standing posture is preferable. If a standing posture is not possible, then have the patient sit upright in a chair with no backrest or a bed with his/her feet on the floor. Adjustment should be done while the patient's shoulders are relaxed and the patient is upright.

  • Page 44: Adjusting The Height Of The Back Sensor

    Setting Up ReDS System Close the buckle Ask the patient to hold the sensor vest steady in its current position and close the buckle with the left-side flap. Have the patient hold the closed buckle and verify that it is centered on his/her sternum.

  • Page 45: Figure 29: Using The Back Center Strip To Position The Sensor Vest

    Setting Up ReDS System NOTE: The wizard will indicates which Height Marker to choose during the vest adjustment, based on the personal details that were entered in the Patient Details screen. For shorter patients of height up to and including 165 cm (5' 5"): The lower, S labeled height marker on the Back Center Strip (Figure 29) covers the C7 vertebra.

  • Page 46: Adjust Back Center Strip

    Setting Up ReDS System Tap Next to continue. Adjust Back Center Strip Figure 30: Adjust the Back Center Strip While the patient is holding the front buckle steady on the sternum, carefully center the back of the sensor vest by aligning the lower end of the Back Center Strip with the patient’s spine.

  • Page 47: Figure 31: Tightening The Left Fastening Flap

    Setting Up ReDS System While holding the sensor vest back piece flat against the body with one hand, use your other hand to attach the Left Fastening Flap. Place one of your hands on the back piece. Pull the Left Fastening Flap using your other hand.

  • Page 48: Figure 33: Shifting The Center Back Strip

    Setting Up ReDS System NOTE: Patients with scoliosis- While the patient is holding the front buckle steady on the sternum, carefully shift center strip about a finger width to the right of the spine. Figure 33: Shifting the Center Back Strip To verify, use your fingers to feel the spinal column in the lower part of the vest near the center strip.

  • Page 49: Reading Ruler Value

    Setting Up ReDS System Reading Ruler Value Figure 34: Reading the Ruler Value Read the patient’s chest size, as described in the Reading Patient Chest Size section on page 51. In the chest size ruler field, enter the value If the chest size value is less than 10 (in new and existing patients), a re-adjustment popup may show: Figure 35: Re adjustment Pop-up Repeat steps 1-4, but this time do it while shifting the center strip about a finger width to the...

  • Page 50: Figure 36: Shifting The Center Back Strip

    Setting Up ReDS System right of the spine, as shown on the Screen: Figure 36: Shifting the Center Back Strip Tap Next to continue. In the chest size ruler field, enter the value read in the chest size ruler. NOTE: The vest adjustment supports ruler chest dimension values of 2cm to 25cm.

  • Page 51: Verification Screen

    Setting Up ReDS System Verification Screen Figure 37: Verification Screen While the patient is upright, verify that the sensor vest is positioned properly, as described below: Make sure that the sensor vest fits snugly, but is not uncomfortably tight. Verify that the back of the vest is properly positioned, as follows: The correct height marker is placed over the C7 vertebra (Figure 29).

  • Page 52: Figure 38: Verifying Front Sensor's Position

    Setting Up ReDS System Verify that the front of the vest is properly positioned, as follows: The upper Positioning Reference Point is in place (Figure 29). The Front Sensor is entirely below the clavicle bone, such that the upper edge of the sensor is not touching it.

  • Page 53: Reading Patient Chest Size

    Setting Up ReDS System NOTE: You can move directly to the Verification screen from the Patient Details screen (see Figure 20), and skip the intermediate steps in the wizard. To do so, tap the Skip Instructions button in the Patient Details screen. Then, enter or verify patient values in the Verification screen.

  • Page 54: Taking A Measurement

    Taking a Measurement Taking a Measurement This chapter describes how to measure a patient using the ReDS System. This chapter assumes that a sensor vest has already been adjusted for the patient to be measured, as described in Chapter 2, Setting Up ReDS System on page 21. CAUTIONS: To use the ReDS System correctly and dependably read all instructions in this user manual before using it.

  • Page 55: Taking A Measurement - Workflow

    Taking a Measurement At least once a week, perform a thorough visual inspection of the device: a. Detach the 3 flaps of the vest b. Inspect the garment of the vest for any tears or opening of seams (both internal and external sides) c.

  • Page 56: Step 1: Preparing The Patient

    Taking a Measurement Step 1: Preparing the Patient To prepare the patient: Make sure the patient is dressed in plain light clothing. Avoid using over a bra. CAUTION: To ensure high quality measurements, use the device over plain, light clothing such as a t-shirt or an undershirt.

  • Page 57: Step 2: Putting On The Sensor Vest

    Taking a Measurement The system should remain plugged into the power outlet. The console has a screen saver. When the screen saver is displayed, simply tap the screen to redisplay. When the screen is completely black (off), then power on the ReDS System, as described above.

  • Page 58: Step 3: Positioning The Patient

    Taking a Measurement Pick up the sensor vest, slide the patient's right arm through the armhole and put the vest on the shoulder as close as possible to the neck, as shown below: Figure 39: Inserting the Right Arm into the Armhole Follow the wizard on the screen for proper vest adjustment.

  • Page 59: Step 4: Taking A Measurement

    Taking a Measurement Ensure that the Front Sensor is entirely below the clavicle bone, such that the upper edge of the sensor is not touching it. Use your hand to feel both the upper edge of the front sensor and the patient's clavicle, as shown below: Figure 40: Verifying that the Front Sensor is Not Touching the Clavicle Bone NOTE: If the patient's position requires correcting, ask the patient to sit back up, re-position and...

  • Page 60: Figure 42: Measurement Progress Screen

    Taking a Measurement Tap the screen to start the actual measurement process. The following screen is displayed while the red chest sensor inflates: Figure 42: Measurement Progress Screen NOTE: If needed, tap the abort button on the screen to stop the measuring process. Wait while the measurement is performed.

  • Page 61: Unsuccessful Measurement

    Taking a Measurement Wait until the measurement process ends automatically and the red chest sensor deflates. After a successful measurement the following screen is displayed. Figure 43: Measurement Results Remove the sensor vest. Place the sensor vest next to the Bedside Console or in the auxiliary basket if using a cart.

  • Page 62: Step 5: Reviewing Measurement Results

    Taking a Measurement If this is the first time that the sensor vest is being used after it was adjusted, then repeated unsuccessful measurements may indicate that the sensor vest was not fitted properly. In this case, re-adjust the sensor vest by following the wizard’s instructions on the device. You can also follow the instructions in Chapter 2, Setting Up ReDS system on page 21 and then re-run the measurement process described in this chapter.

  • Page 63: Reviewing Historical Measurements

    Taking a Measurement Figure 44: Measurement Ended Reviewing historical measurements: Figure 45: Patient History Screen The fluid content parameter is displayed in Ohm ( ) units. When viewing fluid content by Ohm units, the display range is 177 (low fluid content) to 70 (high fluid content).

  • Page 64: Step 6: Shutting Down The Reds System

    Taking a Measurement The results may also be displayed in percent units (%), representing the volume of fluid in the lung out of the total lung volume. The display range for the fluid content parameter is 15% (low fluid content) to 60% (high fluid content). The normal lung fluid content ranges roughly from 20% to 35%.

  • Page 65: The Sensicloud™ Portal (Availble Only For Single Patient Monitoring)

    The SensiCloud Portal The SensiCloud™ Portal (availble only for single patient monitoring) This chapter describes how to use of the SensiCloud Portal to monitor, record and review the thoracic fluid status of your monitored patients. This chapter contains the following sections: SensiCloud Overview, page 63 below, describes the main functions of the SensiCloud Portal.

  • Page 66: Connecting Over The Internet

    The SensiCloud Portal Connecting over the Internet All SensiCloud Portal users should use an active internet connection and one of the following (or newer) browser versions: Internet Explorer 11, Chrome 35 or Firefox 30. You may contact support for technical compatibility and assistance. SensiCloud Main Screens The following are the three main screens of the SensiCloud Portal: Patient List...

  • Page 67: Patient Graph View

    The SensiCloud Portal Patient Graph View The Patient Graph View displays the patient’s historical readings in a graphical or tabular view. This view enables you to adjust thresholds that trigger notifications and to acknowledge received notifications. Time stamped notes may be recorded for general purposes. Figure 50: Patient Graph View...

  • Page 68: My Account

    The SensiCloud Portal My Account The My Account screen enables you to enter your details and to define your notification message preferences This defines the timing and type of automatic messages sent to you. Messages are sent once a day, if your predefined notification threshold for one or more of the monitored patients is exceeded.

  • Page 69: Using The Sensicloud

    The SensiCloud Portal Using the SensiCloud This chapter describes how you can manage and track your patient's fluid readings using the SensiCloud System. NOTE In cases where the SensiCloud™ service is unavailable, a healthcare provider may contact the patient to inquire about his/her fluid readings. When using the SensiCloud Portal, it is recommended to assess the patient's measurements at the same time each day, preferably in the late morning after most patients have completed their lung fluids measurements.

  • Page 70: Figure 49: Enrolling A New Patient

    The SensiCloud Portal Figure 49: Enrolling a New Patient Fill in the patient information. Fields highlighted by an asterisk (*) are mandatory. In the Device Serial Number field, enter the serial number of the ReDS System used to measure this patient. The serial number of the ReDS System is written on the back of the Bedside Console.

  • Page 71: Editing Patient Details

    The SensiCloud Portal CAUTION: Verify successful setup and connectivity by performing a test measurement and viewing the results under the patient's graph view in the SensiCloud. For more information about how to view measurement results in SensiCloud, refer to the Using the SensiCloud section on page 67.

  • Page 72: Suspending A Patient

    The SensiCloud Portal Suspending a Patient Suspending a patient is useful where you need to pause monitoring of a patient for a limited time. NOTE Suspending a patient will disable reminder notification messages to that patient. If a reading is received for a suspended patient, the system automatically changes the status for this patient back to Active.

  • Page 73: Archiving A Patient

    The SensiCloud Portal NOTE To change a patient back to active, repeat the above steps. Archiving a Patient Archiving a patient may be used for archiving the data for patients who are no longer being monitored. Doing so will remove him/her from the active patient list, and will disable all notifications related to that patient.

  • Page 74: Figure 52: Archiving A Patient

    The SensiCloud Portal To Archive a Patient: Log in to the SensiCloud, as described above. The Patient List screen is displayed. Select the patient whom you wish to archive by clicking either the View link in right most column or the patient ID. Click the View Patient Details button on the upper right corner of the screen.

  • Page 75: Viewing The Patients List

    The SensiCloud Portal Viewing the Patients List After login or completion of a New Patient Enrollment (as described above), the Patient List is displayed showing all active patients. Figure 53: Patient List – Default Sort By default the table is sorted as follows: Patients that have both missed readings notifications and active fluid parameter notifications are displayed at the top of the list.

  • Page 76: Reviewing The Patient Graph View

    The SensiCloud Portal Reviewing the Patient Graph View NOTE In cases where the SensiCloud™ service is unavailable, a healthcare provider may contact the patient to inquire about his/her fluid readings. The Patient View screen displays the current and historical readings in a graphical or tabular view.

  • Page 77: Setting The Lung Fluid Threshold Per Patient

    The SensiCloud Portal Figure 54: Patient Graph View Setting the Lung Fluid Threshold per Patient To set the lung fluid thresholds for a patient: Click either the View link in the right most column of each patient row or the patient ID to access Patient Graph View.

  • Page 78: Viewing And Acknowledging Notifications

    The SensiCloud Portal CAUTION: The healthcare provider should review patient data as needed, irrespective of the notification functionality provided by the SensiCloud Portal. NOTE For convenient follow up, every threshold change for a patient automatically generates a time-stamped note that contains the information about the change. This note will be shown both in the notes list on the bottom of the page as well as in the plot area according to the time and date in which the change was made.

  • Page 79: Administrative User

    The SensiCloud Portal Administrative User The cloud portal also provides functionality for centrally monitoring system use, monitoring patient compliance and performing system administration tasks. These functions may be used by healthcare providers or by administrative users supporting the healthcare providers' workflow.

  • Page 80: Figure 57: Patient View

    The SensiCloud Portal The list is sorted first by site, enabling the administrative user to easily review a selected site's patients. Within each site, the list is then sorted by physician and for each physician, the patients are displayed according to the default sort described in 'Viewing the Patients List' on page 77.

  • Page 81: Sensicloud Troubleshooting

    The SensiCloud Portal Additionally, notes recorded by administrative users for the viewed patient are shown below the table. My Account "My Account" screen enables the administrative user to provide and edit his personal details. SensiCloud Troubleshooting The following describes how to troubleshoot various system problems. If a problem cannot be solved contact support.

  • Page 82: Troubleshooting

    Troubleshooting Troubleshooting This chapter describes how to troubleshoot various system problems. If a problem cannot be solved, contact support. Table 1: Troubleshooting Problem Potential Causes Action Required System is Make sure the power supply is properly No power plugged into a working outlet. Press the unresponsive System is off ON/OFF button.
  • Page 83 Troubleshooting Problem Potential Causes Action Required Message displayed: Technical malfunctions 1. Press and hold the ON/OFF button "System for five seconds, release it and then Malfunction" press it again. The system restarts. 2. If the malfunction persists, stop using the system and contact support. Message displayed: USB Cellular modem is not Connect your USB cellular modem to...

  • Page 84: A Labeling

    Labeling Labeling This appendix shows the label that is attached to the ReDS and describes the symbols that appear on them. Note that the labels shown here are for reference only. System Labels Figure 58: System Identification Labels Samples...

  • Page 85: Labeling Symbols

    Labeling Labeling Symbols Table 2: Labeling Symbols Symbol Description Symbol Description Fluid Status Manufacturer Intended Purpose Monitor commercial logo ReDS System Product Commercial Name Non-ionizing radiation UDI (Unique Device V2.6 Model ID Identifier) Federal law restricts this device to sale by or on the Catalog number order of a physician Follow instructions for use...

  • Page 86: B Handling

    The screen should be cleaned using a standard computer screen-cleaning solution. Maintaining No user maintenance is required for the ReDS System. This device must only be serviced by Sensible Medical Innovations Ltd. qualified personnel. There are no user-serviceable parts inside the ReDS System. Contact support in case of battery malfunction.

  • Page 87: Packing Instructions

    Handling Packing instructions...

  • Page 88: C Technical Information

    Technical Information Technical Information This appendix provides ReDS System technical specifications and other technical information. Technical Specifications Table 3: Technical Specifications Electrical Requirements 100–240 VAC, 50/60 Hz 0.75 A @ 100 VAC 0.35 A @ 240 VAC Sensor Electromagnetic Information Operating Frequency 0.95-2 GHz Frequency Band...
  • Page 89 Technical Information Bedside Console Height 10.83 inches ± 10% Tabletop Sensor Vest Materials, Internal PL - PU FR Coating Sensor Vest Materials, External 100% PL Display Parameters Fluid Content Display Range -177 , 15%–60% Accuracy ± 7% Cellular Wireless Connectivity Cellular Connectivity Options GSM, GPRS, EDGE, HSPA, UMTS, LTE, CDMA 700, 800, 850, 900, 1700, 1800, 1900, 2100 or...

  • Page 90: Classification And Standards

    FCC Compliance Statements FCC Part 15.21 Statement Changes or modifications not expressly approved by Sensible Medical Innovations Ltd. could void the user’s authority to operate the equipment. FCC Receivers and Class B Digital Statement This device complies with FCC Rules Part 15. Operation is subject to two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference that may be received or that may cause undesired operation.

  • Page 91: Guidance And Manufacturer's Declaration-Electromagnetic Immunity And Emissions

    Consult the manufacturer, distributor or an experienced radio/TV technician for help. Guidance and Manufacturer’s Declaration— Electromagnetic Immunity and Emissions The ReDS System V2.6 is intended for use in the electromagnetic environment described below. The user of the system should ensure that it is used in such an environment. NOTES:...
  • Page 92 Technical Information Table 5: Electromagnetic Emissions for All ME Equipment and ME Systems Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions CISPR The ReDS System uses RF energy only for its Group 1 internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby ReDS System...
  • Page 93 Technical Information Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance Electrical fast 2 kV for power supply lines Mains power transient/burst, quality should 100 kHz repetition freq. 2 kV for power supply lines IEC 61000-4-4 be that of a 100 kHz repetition freq.
  • Page 94 Technical Information Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance Voltage dips, For 0.5 cycles: For 0.5 cycles: Mains power short quality should 0% U (> 95% dip in U 0% U (> 95% dip in U interruptions be that of a and voltage typical...
  • Page 95 Technical Information Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance Power 30 A/m 30 A/m Power frequency frequency (50/60 Hz) magnetic fields magnetic field, should be at IEC 61000-4-8 levels characteristic of a typical location in a typical commercial or hospital environment.
  • Page 96 Technical Information Immunity Test IEC 60601 Compliance Electromagnetic Environment Level Level Guidance Conducted RF, 3 Vrms ] = 6 Vrms Recommended separation distance: IEC 61000-4-6 150 kHz to 80 150 kHz to 80 d = 0.6 P 6 Vrms in ISM bands between 150 kHz to 80 80 % AM at 1...
  • Page 97 Technical Information Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 98 Technical Information Table 8: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the ReDS System for Non-life-supporting ME Equipment and ME Systems Rated Maximum Separation Distance According to Frequency of Transmitter (in Meters) Output Power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,500 GHz Transmitter (in...
  • Page 99 Sensible Medical Innovations Ltd. Meir Ariel 6, Netanya 4059300 Israel Federal law restricts this device to sale by or on the order of a physician...

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