reds™ system healthcare provider user manual hcp_fina… · the reds system should only be...

ReDS™ SystemHealthcare Provider

User Manual

ReDS™ SystemV2.6

RA-56029 Rev. B January 2019

About this Manual

About This ManualThis user manual describes how to use the ReDS™ System to monitor the fluid status ofpatients.

This manual describes the ReDS System V2.6. It applies to healthcare providers (HCPs) who areusing the device to monitor patients in single or in multiple patient mode

This manual contains the following chapters:Chapter 1, Introducing the ReDS System, page 11, introduces the ReDS System anddescribes it components.Chapter 2, Setting Up, page 21, describes how to adjust the sensor vest to fit a specificpatient and other general setup procedures that must be performed once beforestarting to use the ReDS System.Chapter 3, Taking a Measurement, page 52, describes how to measure a patient usingthe ReDS System.Chapter 4, The SensiCloud™ Portal, page 63, describes how to use of the SensiCloudPortal to monitor the thoracic fluid status of patients.Chapter 5, Troubleshooting, page 80, describes how to troubleshoot various systemproblems. This information is provided in order to allow you to solve simple problems.If a problem cannot be solved, please contact support.Appendix A, Labeling, page 82, shows the labels that are attached to the ReDS Systemcomponents and describes the symbols that appear on them.Appendix B, Handling, page 84, describes how to install, store, clean and maintain theReDS System.Appendix C, Technical Information, page 86, provides ReDS System technicalspecifications and other technical information.

Table Of Content

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Table of ContentsAbout 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 ...................................................................... 11Overview ........................................................................................................................................... 11Indications for use ............................................................................................................................ 11Patient Population ............................................................................................................................ 12Contraindications ............................................................................................................................. 12System Components ........................................................................................................................ 12Bedside Console ............................................................................................................................... 12Sensor Vest ....................................................................................................................................... 16SensiCloud™ Portal ............................................................................................................................ 19

2 Setting Up ReDS System .............................................................................. 21General Setup ................................................................................................................................... 21Step 1: Assembling the Cart ............................................................................................................. 21Step 2: Adjusting the Bedside Console ........................................................................................... 22Step 3, Setting Up Communication ................................................................................................. 22Patient Setup .................................................................................................................................... 24Patient Setup Workflow ................................................................................................................... 24Step 1: Preparing the Patient .......................................................................................................... 25Step 2: Powering Up ......................................................................................................................... 26System Settings ................................................................................................................................. 29Step 3: Setting Up a New Patient .................................................................................................... 32Selecting the Patient ........................................................................................................................ 32Step 4: Adjusting the Sensor Vest ................................................................................................... 36Vest Adjustment Workflow ............................................................................................................. 36

Table Of Content

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Positioning the front sensor ............................................................................................................. 41Adjusting the height of the back sensor .......................................................................................... 42Adjust Back Center Strip ................................................................................................................... 44Reading Ruler Value .......................................................................................................................... 47Verification Screen ............................................................................................................................ 49Reading Patient Chest Size ............................................................................................................... 51

3 Taking a Measurement ................................................................................ 52Taking a Measurement – Workflow ................................................................................................ 53Step 1: Preparing the Patient ........................................................................................................... 54Powering Up ...................................................................................................................................... 54Step 2: Putting On the Sensor Vest .................................................................................................. 55Step 3: Positioning the Patient ......................................................................................................... 56Step 4: Taking a Measurement ........................................................................................................ 57Unsuccessful Measurement ............................................................................................................. 59Step 5: Reviewing Measurement Results ........................................................................................ 60Reviewing historical measurements: ............................................................................................... 61Step 6: Shutting Down the ReDS System* ...................................................................................... 62

4 The SensiCloud™ Portal (availble only for single patient monitoring)........ 63SensiCloud Overview ........................................................................................................................ 63Connecting over the Internet ........................................................................................................... 64SensiCloud Main Screens .................................................................................................................. 64Patient List ......................................................................................................................................... 64Patient Graph View ........................................................................................................................... 65My Account........................................................................................................................................ 66Using the SensiCloud ........................................................................................................................ 67SensiCloud Portal Login .................................................................................................................... 67Enrolling a New Patient using the SensiCloud ................................................................................ 67Editing Patient Details....................................................................................................................... 69Suspending a Patient ........................................................................................................................ 70Archiving a Patient ............................................................................................................................ 71Viewing the Patients List .................................................................................................................. 73Reviewing the Patient Graph View .................................................................................................. 74Setting the Lung Fluid Threshold per Patient.................................................................................. 75Viewing and Acknowledging Notifications ...................................................................................... 76

Table Of Content

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Administrative User .......................................................................................................................... 77SensiCloud Troubleshooting ............................................................................................................ 79

5 Troubleshooting .......................................................................................... 80

A Labeling ....................................................................................................... 82System Labels.................................................................................................................................... 82Labeling Symbols .............................................................................................................................. 83

B Handling ...................................................................................................... 84Storage .............................................................................................................................................. 84Cleaning ............................................................................................................................................. 84Maintaining ....................................................................................................................................... 84Packing instructions ......................................................................................................................... 85

C Technical Information ................................................................................. 86Technical Specifications ................................................................................................................... 86Classification and Standards ............................................................................................................ 88FCC Compliance Statements ............................................................................................................ 88Guidance and Manufacturer’s Declaration— Electromagnetic Immunity and Emissions .......... 89

Table of Figures

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Table of FiguresFigure 1: Front of Bedside Console, Tabletop Mounting ................................................................................................... 13Figure 2: Back of Bedside Console, Tabletop Mounting .................................................................................................... 13Figure 3: Bedside Console, Cart Mounting ......................................................................................................................... 14Figure 4: Connecting Cellular Modem ................................................................................................................................. 15Figure 5: Sensor Vest Front View ......................................................................................................................................... 16Figure 6: Fastening Flaps and Fastening Strap Back View ................................................................................................. 17Figure 7: Back Center Strip ................................................................................................................................................... 17Figure 8: Back Center Strip Height Indicators.................................................................................................................. 17Figure 9: Positioning Reference Points ............................................................................................................................... 18Figure 10: Chest and Back Sensors ...................................................................................................................................... 18Figure 11: Chest Size Measurement Ruler .......................................................................................................................... 19Figure 12: SensiCloud Components ..................................................................................................................................... 20Figure 13: Bedside Console VESA Mounting Plate ............................................................................................................. 22Figure 14: Start Screen ......................................................................................................................................................... 27Figure 15: Screensaver ......................................................................................................................................................... 28Figure 16: Battery Icon when device is not connected to power...................................................................................... 28Figure 17: System Settings Screen ....................................................................................................................................... 29Figure 18: Patient List Screen............................................................................................................................................... 33Figure 19: Adding New Patient ............................................................................................................................................ 34Figure 20: Patient Details Screen ......................................................................................................................................... 35Figure 21: Pop up shows after completing Patient Details ................................................................................................ 38Figure 22: Positioning Front Sensor Screen ........................................................................................................................ 39Figure 23: Opening the Right Fastening Flap ...................................................................................................................... 39Figure 24: Opening the Left Fastening Flap ........................................................................................................................ 40Figure 25: Opening the Fastening Shoulder Flap................................................................................................................ 40Figure 26: Positioning the Front Sensor .............................................................................................................................. 41Figure 27: Positioning the Sensor Vest During Adjustment ............................................................................................... 41Figure 28: Set back Height.................................................................................................................................................... 42Figure 29: Using the Back Center Strip to Position the Sensor Vest ................................................................................. 43Figure 30: Centering the Back of the Sensor Vest .............................................................................................................. 44Figure 31: Tightening the Left Fastening Flap ..................................................................................................................... 45Figure 32: Tightening the Right Fastening Flap .................................................................................................................. 45Figure 33: Shifting the Center Back Strip ............................................................................................................................ 46Figure 34: Reading the Ruler Value ..................................................................................................................................... 47Figure 35: Re adjustment Pop-up ........................................................................................................................................ 47Figure 36: Shifting the Center Back Strip ............................................................................................................................ 48Figure 37: Verification Screen .............................................................................................................................................. 49Figure 38: Verifying Front Sensor's Position ....................................................................................................................... 50Figure 39: Inserting the Right Arm into the Armhole ......................................................................................................... 56Figure 40: Verifying that the Front Sensor is Not Touching the Clavicle Bone................................................................. 57Figure 41: Start Measuring Screen ...................................................................................................................................... 57Figure 42: Measurement Progress Screen .......................................................................................................................... 58

Table of Figures

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Figure 43: Measurement Results .........................................................................................................................................59Figure 44: Measurement Ended ..........................................................................................................................................61Figure 45: Patient History Screen ........................................................................................................................................61Figure 46: Patient List ...........................................................................................................................................................64Figure 47: My Account Screen .............................................................................................................................................66Figure 48: Login Screen.........................................................................................................................................................67Figure 49: Enrolling a New Patient ......................................................................................................................................68Figure 50: Editing Patient Details .........................................................................................................................................69Figure 51: Suspending a patient ..........................................................................................................................................70Figure 52: Archiving a patient ..............................................................................................................................................72Figure 53: Patient List – Default Sort ...................................................................................................................................73Figure 54: Patient Graph View .............................................................................................................................................75Figure 55: Patient Graph View .............................................................................................................................................76Figure 56: Patients List - Administrative User View............................................................................................................77Figure 57: Patient View.........................................................................................................................................................78Figure 58: System Identification Labels Samples ................................................................................................................82

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Legal NoticeCopyright © 2017 Sensible Medical Innovations Ltd. All rights reserved.All intellectual property rights in this publication are owned by Sensible Medical InnovationsLtd. and protected by applicable copyright laws and international treaty provisions. SensibleMedical Innovations Ltd. retains all rights not expressly granted. No part of this publication maybe reproduced in any form whatsoever or used to make any derivative work without priorwritten approval by Sensible Medical Innovations Ltd.Sensible Medical Innovations Ltd. reserves the right to revise this publication, and/or makeimprovements or changes in the product(s) and/or the program(s) described in thisdocumentation at any time without prior notice. The information in this document is providedin good faith, but without any representation or warranty whatsoever, whether it is accurate,or complete or otherwise, and on express understanding that Sensible Medical Innovations Ltd.shall have no liability whatsoever to other parties in any way arising from or relating to theinformation or its use.Any software described in this publication is furnished under a license agreement.All other trademarks are the property of their respective owners. Other company and brandproducts and service names are trademarks or registered trademarks of their respectiveholders.

Document Number: RA-56029 Revision B

Release Date: January 2019

Configuration: U GAS0056Device SW Version: 1.8SensiCloud™ SW Version: 1.3

Federal law restricts this device to sale by or on the order of a physician

Support and Contact Information Sensible Medical Innovations Ltd. Meir Ariel 6, Netanya, 4059300, Israel Website: www.sensible-medical.com Email: [email protected]

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The WEEE symbol indicates that this system contains electrical andelectronic components which must be collected and disposed ofseparately.Never dispose of electrical and electronic waste in general municipalwaste. Collect and dispose of separately.Make use of the return and collection systems and components availableto you, or use your local recycling program. Contact your local authority orplace of purchase to find out what options are available.Electrical and electronic equipment contain hazardous substances which,when disposed of incorrectly, may leak into the ground. This cancontribute to soil and water pollution which is hazardous to human healthand endangers wildlife.It is essential that customers look to recycle electrical and electronicwaste to avoid it going to landfill sites or incineration without treatment.

Conventions Used in This ManualWARNING!Warnings indicate conditions or practices that could result in death or seriousinjury. It may also describe potential serious adverse reactions and safety hazards.

CAUTION:Caution indications relate to conditions or practices that are potentially hazardousthat may result in minor or moderate injury to the user or damage to theequipment or other property. Caution indications may also be used to indicatepractices that are necessary for the effective use of the device.

NOTE:Notes provide additional important information.

Important Safeguards

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Important SafeguardsTo ensure proper and dependable usage of the ReDS System, read all the instructionsprovided 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.2. Keep this system away from heat or open flame.3. Do not use this system in an explosive environment or in the presence of

flammable anesthetics or gases.4. Do not use this system in oxygen-rich environments.5. Do not connect other devices to this system’s USB port, except as instructed in

this manual, as this may compromise electrical safety.6. 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 ascracks, breaks, tears and so on.

7. No modification of this equipment is allowed.8. 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 securitysystems such as metal detectors, as this may result in increased electromagneticinterference to the ReDS System.To avoid possible interference from such hospital environment emitters, theReDS System should not be used in the vicinity of, or during proceduresinvolving devices which deliver energy. In addition, avoid using RFID devices(such as asset or patient tracking RFID devices) in proximity to the device whiletaking a reading.

9. In case you are using a single device for multiple patients, use the Sensicloudonly for device level readings back up.

Cautions

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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. Federal law (USA) restricts this device to sale by or on the order of a physician.4. The sensor vest should be individually adjusted for the measured patient as

described in Chapter 2, Setting Up on page 21.5. To ensure high quality measurements, the patient should wear light clothing,

such as a t-shirt or an undershirt. Metal elements under the sensors should beavoided, such as jewelry. Avoid using the device over a bra.

6. Pay attention to the sensor vest cable in order to avoid entanglement,strangulation or pulling the Bedside Console.

7. When using the table stand mount, place the Bedside Console on a flat andstable surface to prevent tipping and falling.

8. The basket on the cart is designed to carry weight of up to 3 Kg (6.5 pounds).Do not overload it, as this may make the device unstable.

9. Avoid exposing the system to liquids, as this may cause damage to the device.10. This system should only be serviced by qualified personnel.11. Remove the vest before performing defibrillation to avoid system damage or

ineffective defibrillation therapy.12. The ReDS System fluid reading is intended to be used as an adjunct parameter

to standard clinical assessment methods.13. When considering using the ReDS System, take the following patient-related

considerations into account:Physical deformities in the thorax area that may prevent application orcorrect adjustment of the sensor vest.Recent surgery in the torso area.Surgical wounds, healing tissue or recent skin grafts or flaps on the thorax.Burns, open wounds or skin infections on the thorax.Osteoporosis or osteomyelitis of the ribs.Complaints of chest-wall pain.

Cautions

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CAUTIONS Continued14. In the following cases remove the sensor vest, turn off the system, disconnect the

power supply and contact support:Recurring device malfunction messageDevice is not respondingA measurement that does not stop automatically within four (4) minutes ofstarting.

15. When connecting the USB modem, to reduce risk of damage to the system, donot touch the system's USB port as identified by the following label:

16. The use of USB accessories other than those specified may result in increasedelectromagnetic interference or decreased electromagnetic immunity of theReDS System.

17. The ReDS System should not be used adjacent to, or stacked with, otherelectronic equipment. See Table 7 and Table 8 for minimal separation distances.

18. To ensure accurate measurements make sure to read and enter the chest sizeruler value accurately.

19. The system is intended for indoor use and storage, avoid exposing to high or lowtemperatures, humidity and pressure conditions (See Section C TechnicalSpecifications) as this may cause system malfunctions. To avoid patient mix up,when it is not the first time the patient is being measured, make sure you areselecting the correct patient from the list, according to the unique patient IDand/or other patient details.

20. Stop using the device if there is a reason to suspect that it has beencontaminated.

21. Make sure to use the vest with proper disposable infection control garments toprotect patients.

22. Do not connect devices to this system’s USB port, except as instructed in thismanual.

23. Do not connect any unauthorized USB devices to the USB port. Please consultwith your institution's IT/bioengineering department to get guidance on whichUSB devices are authorized, and how to use them.

Introducing the ReDS System

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1 Introducing the ReDSSystem

This chapter introduces the ReDS System and describes its components.

OverviewThe ReDS System is a non-invasive device consisting of a Bedside Console connected to awearable vest that is used for the measurement of lung fluid. A measurement session lasts 90seconds. Measurement results in percent units (%) or in impedance units ( Ohms),representing the volume of fluid in the lung out of the total lung volume.

ReDS system configuration described in this manual (Configuration: U GAS0056) may be usedby a healthcare provider to obtain readings for either single or multiple patients. Each time thedevice is used, it must be set up and properly positioned on the patient to be measured.

Measurement results are optionally transmitted via a cellular or Wi-Fi data link to a securedcloud based portal, SensiCloud™, for physician review.

Indications for useReDS System is intended for use by qualified healthcare practitioners and by patients, underthe direction of a physician, in hospitals, hospital-type facilities and home environments, forthe non-invasive monitoring and management of patients with fluid management problems ina variety of medically accepted clinical applications.

ReDS System is indicated for patients:

With fluid management problems

Taking diuretic medication

Living with heart failure

Recovering from Coronary Artery Disease related event


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NOTE:This User Manual, pertaining to ReDS System V2.6 GAS0056, include instructions foruse applicable to a subset of ReDS system indicated users, i.e. – Health Care Providers

Patient PopulationThe system is suitable for:

Patients over 21 years of age.

Male and female patients of height between 155 cm (5' 1'') to 195 cm (6' 5'') with a bodymass index of 22 to 36.

Patients within the height range having a BMI of 36 to 38 can use the system if their chestsize ruler value (as measured by the vest) is 4 or more.

ContraindicationsThe ReDS System is not appropriate for patients with rib fractures, with or without flail chest.

System ComponentsThe ReDS System consists of the following components:

Bedside Console (with optional Tabletop or Cart mounting), page 13

Sensor Vest, page 16

SensiCloud, page 20, is a software application intended for storage and display of fluid contentmeasurements collected automatically from the ReDS System.

Bedside ConsoleThe following describes the components of the Bedside Console.


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Figure 1: Front of Bedside Console, Tabletop Mounting

NOTE:Note that the Bedside Console contains a battery that enables it to stay ON andperform some functions without being connected to a power outlet. However inorder to perform measurements and update patient info, the Console must beconnected to a power outlet.

The back of the console may be mounted to a stand for positioning it upright on a tabletop, asshown below:

Figure 2: Back of Bedside Console, Tabletop Mounting

ON/OFF Button

USB Port

Tilting Hinge

ON/OFF Button


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Figure 3: Bedside Console, Cart Mounting

Wireless ConnectivityIf the SensiCloud portal option is included with the system, a cellular USB modem is providedwith the device. This modem enables the transmission of measurement results data to asecured cloud server for healthcare provider review. Cellular technologies supported are thestandard technologies provided by US carriers for data communications including: GSM, GPRS,EDGE, HSPA, UMTS, LTE and CDMA. Depending on the technology available, the modemtransmits in one of the following frequency bands: 700, 750, 800, 850, 900, 1700, 1800, 1900,2100 or 3500 Mhz. The modem complies with FCC Class B limits. The provided modem iseither the Sierra Wireless U308 SHOCKWAVE USB Modem FCC ID: N7NU309 or otherequivalent qualified modem.

Alternatively, a Wi-Fi solution for connectivity is also available in cases of cellular coverageproblems. Wi-Fi technology supported will be one or more of the 802.11 technologies IEEE802.11b/g/n and the operating frequency band will be either 2.4Ghz or 5Ghz. The Wi-Fiadapter complies with FCC Class B limits. The Wi-Fi adapter to be provided is CISCO LinksysAE2500 Wireless-N USB Adapter or other equivalent adapter. If needed, a router may also beprovided. For further information regarding Wi-Fi option please contact support

NOTE:The option to transmit readings to the cloud server can be disabled using theTransmission to Cloud setting, as described on page 28.


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CAUTIONS:Do not connect devices to this system’s USB port, except as instructed in thismanual.Do not connect any unauthorized USB devices to the USB port. Please consultwith your institution's IT/bioengineering department to get guidance on whichUSB devices are authorized, and how to use them.

NOTE:Avoid using the device in places where the use of cellular devices is prohibited.You may use it in such places if the USB cellular modem is not connected.

Figure 4: Connecting Cellular Modem*This componant might look somewhat different depending on your local cellular provider


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Sensor VestThe right inside of the sensor vest has two sensors, one in the front and one in the back, formeasuring lung fluid content. The measurement information is transferred to the BedsideConsole via a cable from the sensor vest.

The following describes the components of the sensor vest.

Figure 5: Sensor Vest Front View

Sensor Vest Fastening Flaps and Fastening StrapThe sensor vest has three adjustable fastening flaps (that enable the sensor vest to fit snugglyon the patient), and one fastening strap, as follows:

Right Flap: This flap closes around the patient’s right rib cage.

Left Flap: This flap closes around the patient’s left rib cage.

Shoulder Flap: This flap closes around the patient's shoulder.

Fastening Strap: This strap is used during the adjustment procedure for tightening thesensor vest on the patient's body.

Fastening Buckle


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Figure 6: Fastening Flaps and Fastening Strap Back View

Back Center StripThe back Center Strip is used to position the sensor vest properly on the patient’s body duringthe adjustment process.

Figure 7: Back Center Strip

Figure 8: Back Center Strip Height Indicators

Right Fastening Flap

Shoulder Fastening Flap

Fastening Strap

Left Fastening Flap

Back Center Strip

Two Height Indicatorsfor Distance Measuring


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Two Positioning Reference PointsTwo circular reference points help position the sensor vest on the patient’s body. The top oneis to be positioned just below the patient’s suprasternal (Jugular) notch, and the bottom onerests below on the patient's breastbone (sternum).

Figure 9: Positioning Reference Points

Sensor Vest Inside ViewThe following shows the sensors embedded inside the sensor vest.

Figure 10: Chest and Back Sensors

Chest Red Sensor: This sensor inflates during measurement for better contact with thepatient’s upper-right chest through the clothing.

Back White Sensor: This sensor is positioned on the upper-right part of the patient's back

PositioningReference

Points

Back Sensor

Chest Sensor


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Chest Size RulerThe Chest Size ruler is used to measure the chest size when the sensor vest is worn by thepatient.

Figure 11: Chest Size Measurement Ruler

You may refer to the Reading Patient Chest Size section on page 51 for a description of thisprocedure.

SensiCloud™ PortalSensiCloud is an optional software application intended for storage and display of fluid contentmeasurements collected automatically from ReDS System devices.

The data from the ReDS System is automatically transmitted via a cellular or WiFi dataconnection to the SensiCloud secure server for healthcare provider review.

SensiCloud ComponentsThe SensiCloud consists of a secured cloud-based server hosting the system database and theSensiCloud Portal application.

Chest Size Ruler


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Figure 12: SensiCloud Components

The following are the main functions available in SensiCloud:

Enrolling patients in the SensiCloud Portal, which associates them with the healthcareprovider using the system

Performing technical and administrative tasks by Sensible service team for supportinghealthcare provider’s work.

Available for single patient per device use only:

Providing a graphical/tabular view of all available fluid readings of his/herassociated patients.

Setting up lung fluid level thresholds and receiving automatic system notifications(via email and/or text messages) triggered by those user-defined thresholds

Monitoring patients' compliance via missed daily readings indicators.

Enabling automatic measurement reminder notifications to patient.

Setting Up ReDS System

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2 Setting Up ReDS SystemThis chapter describes how to adjust the sensor vest to fit a specific patient and other generalsetup 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 instructionsprovided in this user manual before using the ReDS System.Do not operate the ReDS System without proper training. For additional information,contact support.

General SetupThe following steps need only be performed once before using the ReDS System for the firsttime.

Step 1: Assembling the CartThis step is optional. If no cart is needed, skip to Step 2 on page 22.

To assemble the cart:o Assemble the cart stand wheels, basket and handle according to the assembly

instructions provided in the cart box, with the handle being positioned at adistance of 1 cm from the top of the pole, and the basket positioned 78cm abovefloor, both facing backwards (opposite to the VESA mounting plate).

o Mount the Bedside Console on the VESA mounting plate, shown below. Use theprovided screws and a standard Phillips screwdriver.


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Figure 13: Bedside Console VESA Mounting Plate

Step 2: Adjusting the Bedside ConsoleThe 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:1 Turn the black lever on the cart’s back clockwise to release the console’s hinge.

2 Tilt the console to the angle that suits you.

3 Turn the lever counter-clockwise to lock the Bedside Console in position.

NOTE:Lifting the black lever allows it to turn without releasing or locking the console'shinge.

To adjust the tilt of the Bedside Console (Tabletop configuration) display: Tilt the screen gently to the angle that suits you.

CAUTION:Place the Bedside Console on a flat and stable surface to prevent tipping andfalling.

Step 3, Setting Up CommunicationThis step is optional. If the ReDS System is to be used in a Standalone mode, (meaning withoutthe SensiCloud™) skip this step.


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To set up communication:

Connect the cellular modem (or the wireless adaptor if using Wi-Fi) to the back of theconsole. Use the white straps to secure in place. The cellular modem is providedwithin 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 increasedelectromagnetic interference or decreased electromagnetic immunity of the ReDS System.

NOTE:

A Wi-Fi solution for connectivity is available in cases of cellular coverage problems and is notprovided within the ReDS System package.

For further information regarding Wi-Fi option please contact support.

For additional information about communication troubleshooting, you may refer to Chapter 5,Troubleshooting on page 80.

NOTE:‘Transmission to cloud’ is ON by default to allow for cellular communication to theSensiCloud. If Wi-Fi is used, “Wi-Fi” should be selected accodingly. It should be turned OFFwhen neither cellular communication nor Wi-Fi are available or if no communication isrequired. Contact support for more information.


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Patient SetupThis section describes how a healthcare provider should adjust the sensor vest. Each sensorvest 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 sensorvest is adjusted for a specific patient, it should be repeated for all his/her futuremeasurements.

CAUTION:When using the device with multiple patients make sure to use the vest with properdisposable infection control garments to protect patients.

If the sensor vest adjustment is modified for any reason, the adjustment procedure must berepeated in its entirety.

CAUTION:Each sensor vest adjustment is only intended to be used by the patient for whom itwas set up.

Patient Setup WorkflowThe following provides an overview of the steps for setting up a sensor vest for a new patientand a reference to the sections of this user manual that provide detailed instructions.


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Step 1

Step 2

Step 3

Step 4

Step 5

Step 1: Preparing the Patient

To prepare the patient:o Make sure the patient is dressed in plain light clothing.

o Avoid using over a bra.

CAUTION:To ensure high quality measurements, use the device over plain, light clothing suchas a t-shirt or an undershirt. Metal elements under the sensors should be avoided,such as jewelry. Avoid using device over a bra.

Powering Up

Preparing the Patient

Setting Up a New Patient

Adjusting the Sensor Vest

Taking a measurement


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Step 2: Powering UpWARNING!

This system should not be operated if there is any visible physical damage toany of its parts (Sensor Vest, Bedside Console, power supply or cables), suchas cracks, breaks, tears and so on.

The ReDS System should not be used in the vicinity of RF emitters such asmagnetic resonance imaging (MRI) machines, computed tomography (CT)machines, RF diathermy devices, RFID devices and electromagnetic securitysystems such as metal detectors, as this may result in increasedelectromagnetic interference to the ReDS System.

To avoid possible interference from such hospital environment emitters, theReDS System should not be used in the vicinity of, or during proceduresinvolving devices which deliver energy. In addition, avoid using RFID devices(such as asset or patient tracking RFID devices) in proximity to the devicewhile taking a reading.

To power up the ReDS System:1 Plug in the Power Supply to a standard power outlet. The blue LED (light) in the

upper left corner, next to the ON/OFF power button icon lights up (Figure 1).

2 Briefly press the blue ON/OFF button on the top left of the console (Figure 1) topower on the console. Wait one minute, the console’s start screen is then


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displayed, as shown below:

Figure 14: Start Screen

System is ready for use only when “System Status: Ready” is displayed.


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NOTE:The system should remain plugged into the power outlet.

The console has a screen saver. When the screen saver is displayed, simply tap thescreen to redisplay. When the screen is completely black (OFF), then power on theReDS System, as described above

Figure 15: Screensaver

If the system is unplugged or if power is down, the following message displays onthe screen: Power cord is unplugged

A Battery Icon will appear on the bottom left corner and System Status will showsame massage until system is plugged in.

Figure 16: Battery Icon when device is not connected to power


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System SettingsThe System Settings screen enables you to configure the ReDS System.

To set up the ReDS System:

1 In the Start screen (see figure 14 on page 27), click the cogwheel icon on thebottom left. The following screen displays:

Figure 17: System Settings Screen

2 Use the options in this screen, as follows:Time Zone: Select your correct time zone (the default time zone is CST).Transmission to Cloud: The device enables easy synchronization of results andother data to the cloud (via either cellular/WiFi communication). When thisfeature is enabled, measurement results are automatically transmitted to thecloud.

Tap to turntransmissionoff

Tap to turntransmissionon and selectthe method


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NOTE:In order to allow successful transmission of all data, do not disconnect the system from thepower 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 sentagain.

NOTE:Transmission to cloud is ON by default to allow for cellular communication to the cloud. IfWiFi is used, Wifi should be selected accordingly (page 22, Setting Up Communication)) . Itshould be turned OFF when neither cellular communication nor WiFi are available or if nocommunication is required (Standalone). If needed, you may contact support for moreinformation.

Communication Test button: If the system is set up to communicate via acellular or WiFi connection, then tapping this button verifies the connection. Asuccess or failure message displays.Height Units: The system can be set to either the Imperial or Metric System.Select in for Inches or cm for Centimeters.Weight Units: The system can be set to either the Imperial or Metric System.Select lb for Pounds or kg for Kilograms.Fluid parameter display units: choose between Percentage and Ohm units todisplay the fluid content.

NOTE:Click Save to return to the Start screen.

Signal Strength IndicatorThe cellular signal strength received by the device's USB cellular modem is indicated on theStart screen in the form of a cellular signal bars indicator. Use the indicator to troubleshootcellular coverage issues.


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Similarly, if using WiFi, a standard WiFi strength indicator is displayed. Additionally, theblinking blue LED on the USB adapter is another indication of a good signal and workingconnection.

Use ‘Communication Test’ in the ‘System Setting’ screen to test cellular or WiFi connectivity.

Manual Data TransmissionUpload to cloud button in the Start Screen, is the system’s feature allowing the transmissionof measurement results from the system to SensiCloud (when the SensiCloud service isavailable)

Use manual data transmission to initiate a transmission of pending measurement data. Whenmanual transmission of pending measurement data is required, the following indicator isdisplayed in bottom left corner on the main screen

To transmit pending data:1. Plug in the system power supply to a standard outlet.

2. On the Start screen, press Upload to Cloud button.

3. The following icon will appear on the bottom of the screen indicating data is beingtransmitted:

4. Once all data will transmit successfully to SensiCloud, the cloud icons willdisappear from the bottom of the screen.


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Step 3: Setting Up a New PatientA new patient must be set up as described below when using the system on a patient for thefirst time. Note, if the patient has been measured previously you should use his existingrecord. Thus you should always search for the patient before creating a new record.

Selecting the PatientAfter a patient record has been created, it will be displayed in the patient list in subsequentmeasurements sessions. To select the patient to be measured, you should first check whetherthat patient already exists in the patient list. If he/she does not, then you must create a patientrecord for that patient (refer to Setting Up a New Patient).

NOTE:When working in Anonymous mode, select a patient from the list according to the uniquePatient ID number.

CAUTION:To avoid patient mix ups, make sure that you select the correct patient, according to theunique patient ID and/or other patient details.


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To select a patient:

1 In the Start screen (see Figure 14), tap Start. The following screen displays:

Figure 18: Patient List Screen


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This screen lists all patients currently defined in the system. If the patient already appears inthe list, tap his/her patient row to select that patient and then proceed to Step 5- adjusting theSensor Vest.

If the patient does not appear in the list, click the New Patient button and refer to Step 3-Setting up a New Patient.

To set up a new patient:

1 In the Start screen (see Figure 14), tap Start New Patient

Figure 19: Adding New Patient

NOTE:You can type in part of the patient’s name or ID to filter the patient list.When working in Anonymous mode, the Patient Name, Patient ID and Date of Birthfields are not applicable.


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2 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 ofBirth fields do not appear. Patient Number field is shown to define the patient.

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 theSkip Instructions button in the Patient Details screen. Then, enter and verifypatient values in the Verification screen.

3 If patient record has been created previously, skip to the next step.


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Step 4: Adjusting the Sensor VestAdjusting 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.

Performing verification steps.

Follow the procedure below for complete details.

Vest Adjustment WorkflowThe following provides an overview of the steps for adjusting a sensor vest for a patient and areference to the sections of this user manual that provide detailed instructions.

Taking a measurement

Choosing the correct height marker

Loosen the straps and position the front

Center strip and alignment with spine

Verification


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The procedure for placing and positioning the Sensor Vest on the patient and taking ameasurement uses a guided wizard.

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 theSkip Instructions button in the Patient Details screen. Then, enter and verifypatient values in the Verification screen.

CAUTIONS:When considering whether to use the ReDS System, take the following patient-relatedconsiderations 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. Surgical wounds, healing tissue or recent skin grafts or flaps on the thorax.4. Burns, open wounds or skin infections on the thorax.Pay attention to the sensor vest cable in order to avoid entanglement, strangulationor pulling the Bedside Console.


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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 windowdisplays:

Figure 21: Pop up shows after completing Patient Details

The popup window indicates which Height Marker to choose during the vest adjustment andwhether to align or shift the center strip, based on the patient’s anatomy. The personal detailsthat were entered in the Patient Details screen, or the settings from the previousmeasurement session are used for this purpose.

Tap Done.


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Figure 22: Positioning Front Sensor Screen

Loosen the flaps in order to prepare the sensor vest for adjustment:1 Open the Right Fastening Flap and then reattach it to its maximum opening

position, as shown below:

Figure 23: Opening the Right Fastening Flap


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2 Open the Left Fastening Flap and reattach it to its maximum opening position, as shownbelow:

Figure 24: Opening the Left Fastening Flap

3 Open the fastening shoulder flap and then reattach it to its maximum opening position, asshown below:

Figure 25: Opening the Fastening Shoulder Flap

Apply the sensor vest on the patient:

CAUTION:When using the device with multiple patients make sure to use the vest with properdisposable infection control garments to protect patients.

Create a large openingfor the right arm.


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NOTES:When adjusting the vest, a standing posture is preferable. If a standing posture is notpossible, then have the patient sit upright in a chair with no backrest or a bed withhis/her feet on the floor.Adjustment should be done while the patient's shoulders are relaxed and the patient isupright.

Positioning the front sensor1 Put the sensor vest on the patient's shoulder so that the red sensor is positioned on the front-right side of the chest.

Figure 26: Positioning the Front Sensor

2 Place the sensor vest so that the Positioning Reference Points are vertical and aligned withthe sternum. The upper Positioning Reference Point (Figure 27) is just below the patient’ssuprasternal (Jugular) notch and the bottom Positioning Reference Point rests below thepatient’s breastbone (sternum), as shown below:

Figure 27: Positioning the Sensor Vest During Adjustment

Position the RedSensor on the FrontRight Side of the Chest

Hold theVest for

Positioning

Positioning theReference Points


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Close the buckleAsk the patient to hold the sensor vest steady in its current position and close the bucklewith the left-side flap. Have the patient hold the closed buckle and verify that it is centeredon his/her sternum.

Tap Next to continue.

Adjusting the height of the back sensor

Figure 28: Set back Height

Stand behind the patient and center the back center strip over the spine.

Then adjust the back height to cover C7 vertebra (as guided by the wizard).


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NOTE:

The wizard will indicates which Height Marker to choose during the vest adjustment, basedon 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 labeledheight marker on the Back Center Strip (Figure 29) covers the C7 vertebra.For taller patients of height greater than 165 cm (5' 5"): The higher, T labeled heightmarker on the Back Center Strip (Figure 29) covers the C7 vertebra.

NOTE:When adjusting the flap, make sure that the patient's shoulders are relaxed and that thepatient is upright.

Figure 29: Using the Back Center Strip to Position the Sensor Vest

NOTE:To locate the C7 Vertebra:

While the patient's head is tilted forwards and downwards, use two fingers to feel forthe most prominent vertebra. That vertebra is the C7 vertebra.

Position the height indicator marker against the C7 vertebra, and make sure that theheight indicator is kept in position when the patient raises his/her head

Tighten the shoulder flap to secure the correct height.

Position theappropriate marker on the C7

vertebra Use one of the twoheight markers


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Adjust Back Center Strip

Figure 30: Adjust the Back Center Strip

1 While the patient is holding the front buckle steady on the sternum, carefully center theback of the sensor vest by aligning the lower end of the Back Center Strip with thepatient’s spine. To verify, use your fingers to feel the spinal column in the lower part of thevest near the back sensor. Once centered, hold the back piece in place.

Figure 30: Centering the Back of the Sensor Vest

Align the lower end of theBack Center Strip with thepatient's spine.

Use your fingers to feel thatthe spine is just below this

area of the Back Center Strip.


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2 While holding the sensor vest back piece flat against the body with one hand, use yourother hand to attach the Left Fastening Flap.

Figure 31: Tightening the Left Fastening Flap

3 While holding the sensor vest back piece flat against the body with one hand, use yourother hand to tighten the Right Fastening Flap around the patient’s chest so that it fitssnugly, but is not uncomfortably tight. For patient comfort, make sure that the side flaps(left and right flaps) are not pressed up too tightly into the armpit.

Figure 32: Tightening the Right Fastening Flap

4 Verify that the back center strip is still centered on the patient’s spinal column (as in step6). If necessary, make minor adjustments to the side (right/left) straps.

Place one of yourhands on the backpiece.

Pull the Left FasteningFlap using your other

hand.

Pull the Right FasteningFlap using your righthand.

Place your left hand onthe back piece.


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NOTE:

Patients with scoliosis- While the patient is holding the front buckle steady on thesternum, 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 vestnear the center strip. Once positioned, hold the back piece in place and continueto step 2-4.

NOTE:

The wizard will indicates whether to align or shift the center strip during the vestadjustment, based on the personal details that were entered in the Patient Detailsscreen or the settings in the previous measurement.



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Reading Ruler Value

Figure 34: Reading the Ruler Value

Read the patient’s chest size, as described in the Reading Patient Chest Size section onpage 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 popupmay 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


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right of the spine, as shown on the Screen:

Figure 36: Shifting the Center Back Strip


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. Pleasedo not use the ReDS System if the measured ruler values exceed this range. Foradditional information, you may contact support.

If center strip was already shifted due to scoliosis, there’s no need to shift it more.


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Verification Screen

Figure 37: Verification Screen

While the patient is upright, verify that the sensor vest is positioned properly, as describedbelow:

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).The lower end of the back center strip is as instructed by the wizard: alignedwith the spinal column of the patient or is shifted a finger width to the right ofthe spine.The vest lies flat against the body with no creases or folds.


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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 thesensor is not touching it.

Figure 38: Verifying Front Sensor's Position

NOTE:In some cases, due to patient’s anatomy, you will be instructed by Support tochange the vest fitting and change manually the parameters in the verificationscreen

Instruct the patient to lie back in a reclined position, either lying close to supine or sitting,in an adjustable bed, a reclining chair, or on a regular bed supported by pillows.

Make sure the patient does not roll or slide against the bed or chair when getting intoposition.Verify again that the front of the vest is properly positioned, as described above.If necessary, correct the adjustment and the adjustment parameters on the screenaccording to the following:

o If the Front Sensor is touching the clavicle bone when the patient is lying back,repeat the entire adjustment procedure. This time, place the upper PositioningReference Point roughly 2 – 3 cm lower.

o If the vest back piece is too low or too high, repeat the back height adjusting step.o If the position of the vest’s back center strip needs to be adjusted relative to the

spine (to the left or right), have the patient hold the front piece in place, releaseone flap and tighten the opposite flap until it is in place. If this is not sufficient forcentering, use the shoulder flap to shift the back piece right or left relative to thefront chest piece.

After any readjustment, repeat the verification step and make sure the adjustment is correct.


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NOTE:You can move directly to the Verification screen from the Patient Details screen (seeFigure 20), and skip the intermediate steps in the wizard. To do so, tap the SkipInstructions button in the Patient Details screen. Then, enter or verify patientvalues in the Verification screen.

Reading Patient Chest SizeThis procedure uses the vest’s integrated Chest Size ruler.

Figure 40: Chest Size Measurement Ruler

To read the patient’s chest size:Look at which number the vertical red line crosses the Chest Size ruler. Note for example inthe shown picture the chest size is 5.5 (the red line has cleared the 5th rectangle and anadditional half of the 6th box). Choose the closest whole number marker or half box marker(i.e no need for higher accuracy than 0.5).

CAUTION:To ensure accurate measurements make sure to read and enter the chest sizeruler value accurately.

Vertical Red Line

Taking a Measurement

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3 Taking a MeasurementThis 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 bemeasured, 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 usermanual before using it.Each sensor vest is adjusted for a specific patient. Do not use the sensor vest for anypatient other than the one for which it was adjusted, as this may result in low qualitymeasurements.When using the device with multiple patients make sure to use the vest with properdisposable infection control garments to protect patients.

1. A new patient must be set up as described in chapter 2- Setting ReDS system page 21when using the system on the patient for the first time.

NOTE:if the patient has been measured previously you should use his/her existingrecord. Thus you should always search for the patient before creating a newrecord.

2. Before setting up the vest and before applying it to take a measurement (‘Setting Up’process described in chapter 2, and to the ‘Taking a Measurement’ process described inthis chapter), apply a protective garment over the patient’s upper body (e.g. disposablejacket, isolating gown, cape, or any other disposable garment that is cleared for clinical usein infection control) so that it separates it from the vest. After the vest is applied over thepatient, apply an additional protective layer so that it covers the front of the vest frompotential excretions (saliva, mucus etc.)

3. Dispose the used infection protective garments after use.


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At least once a week, perform a thorough visual inspection of the device:

a. Detach the 3 flaps of the vestb. Inspect the garment of the vest for any tears or opening of seams (both internal

and external sides)c. Inspect the Bedside Console, Power Supply and the Cables (power cable and vest

cable) for any visible physical damage (cracks, breaks)

WARNING!

This system should not be operated if there is any visible physical damage to any ofits parts (Sensor Vest, Bedside Console, power supply or cables), such as cracks,breaks, tears and so on.

Taking a Measurement – WorkflowThe following provides an overview of the steps for taking a measurement using the sensorvest and a reference to the section of this user manual that provides detailed instructions.

Step 1

Step 2

Step 3

Step 4

Step 5

Step 6

Preparing the Patient

Putting On the Sensor Vest

Positioning the Patient


Reviewing Measurement Results

Shutting Down the ReDS


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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 suchas a t-shirt or an undershirt. Metal elements under the sensors should be avoided,such as jewelry. Avoid using device over a bra.

Powering UpWARNING!

This system should not be operated if there is any visible physical damage to anyof its parts (Sensor Vest, Bedside Console, power supply or cables), such ascracks, breaks, tears and so on.The ReDS System should not be used in the vicinity of RF emitters such asmagnetic resonance imaging (MRI) machines, computed tomography (CT)machines, RF diathermy devices, RFID devices and electromagnetic securitysystems such as metal detectors, as this may result in increased electromagneticinterference to the ReDS System.

To avoid possible interference from such hospital environment emitters, theReDS System should not be used in the vicinity of, or during proceduresinvolving devices which deliver energy. In addition, avoid using RFID devices(such as asset or patient tracking RFID devices) in proximity to the devicewhile taking a reading.

To power up the ReDS System:

1 Plug in the Power Supply to a standard power outlet. NOTE:


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The system should remain plugged into the power outlet. The console has a screensaver. 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, asdescribed above.If the system is unplugged or if power is down, the following message will bedisplayed on the screen: “Power cord disconnected”

2 Press the ON/OFF button on the top left of the console to power on the console.Within one minute the following screen is displayed, as shown below:

3 The system is ready to take measurements once System Status is Ready.

4 Tap on Start and choose the patient from the patient’s list

Step 2: Putting On the Sensor Vest

To put the sensor vest on: CAUTION:When using the device with multiple patients make sure to use the vest with properdisposable infection control garments to protect patients.


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1 Pick up the sensor vest, slide the patient's right arm through the armhole and put the veston the shoulder as close as possible to the neck, as shown below:

Figure 39: Inserting the Right Arm into the Armhole

2 Follow the wizard on the screen for proper vest adjustment.

Step 3: Positioning the PatientPosition the patient as described below, and make sure the patient does not move, talk, drink,or use a cell phone while taking a measurement.

To position the patient:1 Instruct the patient to lie back in a reclined position, close to supine, in an adjustable bed,

a reclining chair, or on a regular bed supported by pillows.

2 The patient should recline backwards into position and avoid rolling or sliding against thebed or chair while getting into position, as this may shift the vest’s position.

3 Ensure that the patient is leaning back so that the back sensor is pressed against his/herback.

4 Ensure that the patient's arms are resting at his/her sides.


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5 Ensure that the Front Sensor is entirely below the clavicle bone, such that the upper edgeof the sensor is not touching it. Use your hand to feel both the upper edge of the frontsensor 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 andthen recline back.

Step 4: Taking a MeasurementThe following screen is displayed:

Figure 41: Start Measuring Screen

NOTE:If the screen is not displayed, the screen saver may be active. Simply tap the screen toredisplay the screen above. If the screen is completely black (off), then power on theReDS System by pressing the ON/OFF button, as described in the Step 2, Powering Upsection on page 26.


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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. The red chest sensor in the front will start toinflate. The measurement takes 90 seconds.

NOTE:The patient should not move, talk, drink, or use a cell phone during this time, as this mayresult in low quality measurement.

If a technical failure occurs, the measurement terminates immediately and a relevantmessage is displayed. Try again. You may refer to Chapter 5, Troubleshooting on page80. Contact support if a problem persists.If the patient is uncomfortable, remove the sensor vest at any time to abort themeasurement procedure.


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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. This completes the measurement session.

Refer to the Step 5, Reviewing Measurement Results section on 57 for a description of theresults.

Unsuccessful MeasurementIf the measurement was not successful, then the following message is displayed:Low Quality

Verify that the instructions in this chapter were followed correctly. It is recommended to checkthat the back sensor is pressed against the back, and that the patient does not move or talkduring the measurement process. For additional information you may refer to Chapter 5,Troubleshooting on page 80.

Re-run the measurement process by taping on Redo button.


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

If the problem occurs three times in a row, remove the sensor vest and contact support.

Step 5: Reviewing Measurement ResultsAfter a successful measurement process, the following is displayed on the Bedside Consolescreen:

NOTE:

If the measurement was not successful, then the following message is displayed:Low Quality

You may refer to page 59 for more information.

If the measurement was successful and if you are using the SensiCloud, the results aretransmitted at this stage. After a successful transmission, the following message isdisplayed: Your measurement was transmitted successfully. In any case of transmissionfailure, a message will be shown on screen saver and the results will be saved on thedevice until transmitted successfully.

Regardless to transmission, the result will be saved on the device in Patient’s Historyrecord.

For additional information regarding data transmission, you may refer to Chapter 5,Troubleshooting on page 80.


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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 Ohmunits, the display range is 177 (low fluid content) to 70 (high fluid content). The normallung fluid content ranges roughly from 150 to 105 .


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The results may also be displayed in percent units (%), representing the volume of fluid in thelung 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 roughlyfrom 20% to 35%.

CAUTION:The ReDS System fluid reading is intended to be used as an adjunct parameter tostandard clinical assessment methods

Step 6: Shutting Down the ReDS System**Perform the following only when the ReDS System is not going to be used for some time.

To shut down the ReDS System:

1 Briefly push the ON/OFF button and wait for the shutdown process to complete.

2 Unplug the Bedside Console from the power outlet.

3 Store the sensor vest, as described in the Storage section on page 84.

The SensiCloud Portal

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4 The SensiCloud™ Portal(availble only for single patient monitoring)

This chapter describes how to use of the SensiCloud Portal to monitor, record and review thethoracic 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.

SensiCloud Main Screens, page 64, describes the three main screens of the SensiCloud Portal.

Using the SensiCloud Portal, page 67, describes how to manage and track your patients usingthe SensiCloud Portal.

SensiCloud Troubleshooting, page 79, describes how to troubleshoot various SensiCloudPortal problems.

SensiCloud OverviewThe SensiCloud enables quick and easy access to your patients' data through a simple userinterface. The SensiCloud provides the following functions:

Enrolling patients in the SensiCloud Portal.

Pairing a specific ReDS System device (by serial number) to a patient in the system toenable collection of measurements.

Providing healthcare providers with a graphical or tabular view of all the available fluidreadings of their associated patients.

Setting up lung fluid level thresholds and receiving automatic system notifications (viaemail and/or text messages) triggered by those user-defined thresholds.

Enabling physician acknowledgement of notifications.

Monitoring patients' compliance via missed daily readings indicators.

Enabling automatic measurement reminder notifications to patients.

Recording of textual time-stamped notes per patient.


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Connecting over the InternetAll 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 contactsupport for technical compatibility and assistance.

SensiCloud Main ScreensThe following are the three main screens of the SensiCloud Portal:

Patient ListThe Patient List enables a physician or healthcare provider to display a concentrated tabularview of all patients. For each patient this screen shows the last measurement value andgraphical indicators of threshold parameter-related notifications and missed readings(indicating the number of days since a reading has been successfully received).

Figure 46: Patient List

For additional details and historical readings, you can click the View link in the right mostcolumn on each line or on the patient ID to display the Patient Graph View, described below.


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Patient Graph ViewThe 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 acknowledgereceived notifications. Time stamped notes may be recorded for general purposes.

Figure 50: Patient Graph View


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My AccountThe My Account screen enables you to enter your details and to define your notificationmessage 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 themonitored patients is exceeded. The notification message reminds you to log into the system,and may be chosen to be received in the form of email, text message or both, and also may bedisabled completely or during weekends and federal holidays.

Figure 47: My Account Screen


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Using the SensiCloudThis chapter describes how you can manage and track your patient's fluid readings using theSensiCloud System.

NOTEIn cases where the SensiCloud™ service is unavailable, a healthcare provider maycontact the patient to inquire about his/her fluid readings.When using the SensiCloud Portal, it is recommended to assess the patient'smeasurements at the same time each day, preferably in the late morning aftermost patients have completed their lung fluids measurements.

SensiCloud Portal LoginLog in using your personal user name and password

Figure 48: Login Screen

Enrolling a New Patient using the SensiCloud

To set up a new patient using the SensiCloud:In the Patient List screen, which is displayed after log in, press the Add New Patient button,the New Patient screen is displayed:


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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 tomeasure this patient. The serial number of the ReDS System is written on the back of theBedside Console.

Enter the patient's primary and secondary phone numbers in the Phone Number fields.

Set reminder notifications ON/OFF for the patient. If ON, Voice or text messages can beselected. The primary phone number will be used for sending automatic measurementreminder messages to the patient (please use the appropriate international prefix number,press on the icon for proper phone number formats).

Make sure all information is correct and tap the Save button.

The new patient record is then created and displayed in the Patient List.

CAUTION:Verify that the patient is assigned to the correct physician and that the phonenumber provided for contact is also correct. This can be easily done by viewing thePatient Details screen, which can be accessed from the Patient Graph View.


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CAUTION:Verify successful setup and connectivity by performing a test measurement andviewing the results under the patient's graph view in the SensiCloud. For moreinformation about how to view measurement results in SensiCloud, refer to theUsing the SensiCloud section on page 67.

Editing Patient Details

To edit patient details:1 Log in to the SensiCloud, as described above. The Patient List screen is then

displayed.

2 Select the patient whom you wish to edit by clicking either the View link in theright most column or the patient ID.

3 Click the View Patient Details button on the right corner of the screen. ThePatient Details screen is displayed:

Figure 50: Editing Patient Details

4 Edit the information and when done click the Save button


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Suspending a PatientSuspending a patient is useful where you need to pause monitoring of a patient for a limitedtime.

NOTESuspending a patient will disable reminder notification messages to that patient.If a reading is received for a suspended patient, the system automaticallychanges the status for this patient back to Active.Suspended patients will be displayed in the Active Patient List in Gray.

To suspend a patient:

1 Log in to the SensiCloud, as described above. The Patient List screen is displayed.

2 Select the patient whom you wish to suspend by clicking either the View link in rightmost column or the patient ID.

3 Click the View Patient Details button on the upper right corner of the screen. ThePatient Details screen is displayed:

Figure 51: Suspending a patient

4 Click the (change) button located next to the ‘Status’

5 Click ‘OK’ to confirm or ‘Cancel’.

6 Tap Save.


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NOTETo change a patient back to active, repeat the above steps.

Archiving a PatientArchiving a patient may be used for archiving the data for patients who are no longer beingmonitored. Doing so will remove him/her from the active patient list, and will disable allnotifications related to that patient. ‘Archived’ patients' data is displayed in the ‘ArchivedPatients’ list in the Patient List screen. Archived patients are not visible to AdministrativeUsers.

NOTE

Archiving a patient will disable reminder notification messages to that patient.


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To Archive a Patient:

1 Log in to the SensiCloud, as described above. The Patient List screen is displayed.

2 Select the patient whom you wish to archive by clicking either the View link in rightmost column or the patient ID.

3 Click the View Patient Details button on the upper right corner of the screen. ThePatient Details screen is displayed:

Figure 52: Archiving a patient

4 Click the Archive Patient button located at the bottom

5 Click Yes, Archive Patient to confirm or No, go back to patient screen to cancel.

6 Tap Save.

NOTETo change a patient back to active, repeat the above steps, this time the buttonwill change its name to ‘Mark as Enrolled’. You will need to provide the deviceserial number.


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Viewing the Patients ListAfter login or completion of a New Patient Enrollment (as described above), the Patient List isdisplayed 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 parameternotifications are displayed at the top of the list.

This is followed by patients that have active fluid parameter notifications.

This is followed by patients that have missed reading notifications.

This is followed by patients that had a fluid parameter notification which wasacknowledged but their last reading result still exceeds the predefined thresholds.

This is followed by the rest of the patients, meaning patients with no fluid parameternotifications and no missed readings.

Cl

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