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SENSIBLE MEDICAL ReDS System V2.6, User Manual

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SENSIBLE MEDICAL ReDS System V2.6 User Manual Download Page 93

Technical Information

91

Immunity Test IEC 60601 Level

Compliance Level

Electromagnetic

Environment
Guidance

Electrical fast
transient/burst,
IEC 61000-4-4

2 kV for power supply lines
100 kHz repetition freq.

2 kV for power supply lines
100 kHz repetition freq.

Mains power
quality should
be that of a
typical
commercial or
hospital
environment.

Surge,
IEC 61000-4-5

0.5 & 1kV

0.5 & 1kV

Mains power
quality should
be that of a
typical
commercial or
hospital
environment.

Summary of Contents for ReDS System V2.6

Page 1: ...ReDS System Healthcare Provider User Manual ReDS System V2 6 RA 56029 Rev B January 2019...

Page 2: ...se the ReDS System Chapter 3 Taking a Measurement page 52 describes how to measure a patient using the ReDS System Chapter 4 The SensiCloud Portal page 63 describes how to use of the SensiCloud Portal...

Page 3: ...ndications 12 System Components 12 Bedside Console 12 Sensor Vest 16 SensiCloud Portal 19 2 Setting Up ReDS System 21 General Setup 21 Step 1 Assembling the Cart 21 Step 2 Adjusting the Bedside Consol...

Page 4: ...eviewing Measurement Results 60 Reviewing historical measurements 61 Step 6 Shutting Down the ReDS System 62 4 The SensiCloud Portal availble only for single patient monitoring 63 SensiCloud Overview...

Page 5: ...stem Labels 82 Labeling Symbols 83 B Handling 84 Storage 84 Cleaning 84 Maintaining 84 Packing instructions 85 C Technical Information 86 Technical Specifications 86 Classification and Standards 88 FC...

Page 6: ...en 35 Figure 21 Pop up shows after completing Patient Details 38 Figure 22 Positioning Front Sensor Screen 39 Figure 23 Opening the Right Fastening Flap 39 Figure 24 Opening the Left Fastening Flap 40...

Page 7: ...ogin 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 Figure 53 Patient List Default Sort 73 Figur...

Page 8: ...t is provided in 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 sha...

Page 9: ...to soil and water pollution which is hazardous to human health and endangers wildlife It is essential that customers look to recycle electrical and electronic waste to avoid it going to landfill site...

Page 10: ...al damage to any of its parts Sensor Vest Bedside Console Power Supply or cables such as cracks breaks tears and so on 7 No modification of this equipment is allowed 8 The ReDS System should not be us...

Page 11: ...stand mount place the Bedside Console on a flat and stable 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 th...

Page 12: ...measurements make sure to read and enter the chest size ruler value accurately 19 The system is intended for indoor use and storage avoid exposing to high or low temperatures humidity and pressure co...

Page 13: ...ther single or multiple patients Each time the device 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 W...

Page 14: ...having a BMI of 36 to 38 can use the system if their chest size ruler value as measured by the vest is 4 or more Contraindications The ReDS System is not appropriate for patients with rib fractures w...

Page 15: ...ome 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 The back of the console may be...

Page 16: ...e modem complies with FCC Class B limits The provided modem is either the Sierra Wireless U308 SHOCKWAVE USB Modem FCC ID N7NU309 or other equivalent qualified modem Alternatively a Wi Fi solution for...

Page 17: ...h your institution s IT bioengineering department to get guidance on which USB devices are authorized and how to use them NOTE Avoid using the device in places where the use of cellular devices is pro...

Page 18: ...r Vest Front View Sensor Vest Fastening Flaps and Fastening Strap The sensor vest has three adjustable fastening flaps that enable the sensor vest to fit snuggly on the patient and one fastening strap...

Page 19: ...Strip is used to position the sensor vest properly on the patient s body during the adjustment process Figure 7 Back Center Strip Figure 8 Back Center Strip Height Indicators Right Fastening Flap Sho...

Page 20: ...patient s breastbone sternum Figure 9 Positioning Reference Points Sensor Vest Inside View The following shows the sensors embedded inside the sensor vest Figure 10 Chest and Back Sensors Chest Red S...

Page 21: ...Cloud Portal SensiCloud is an optional software application intended for storage and display of fluid content measurements collected automatically from ReDS System devices The data from the ReDS Syste...

Page 22: ...service team for supporting healthcare provider s work Available for single patient per device use only Providing a graphical tabular view of all available fluid readings of his her associated patien...

Page 23: ...tact support General Setup The following steps need only be performed once before using the ReDS System for the first time Step 1 Assembling the Cart This step is optional If no cart is needed skip to...

Page 24: ...le 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 s hing...

Page 25: ...he ReDS System NOTE A Wi Fi solution for connectivity is available in cases of cellular coverage problems and is not provided within the ReDS System package For further information regarding Wi Fi opt...

Page 26: ...ure measurements CAUTION When using the device with multiple patients make sure to use the vest with proper disposable infection control garments to protect patients If the sensor vest adjustment is m...

Page 27: ...ht clothing o 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 Metal elements under the sensors should be...

Page 28: ...sed electromagnetic interference to the ReDS System To avoid possible interference from such hospital environment emitters the ReDS System should not be used in the vicinity of or during procedures in...

Page 29: ...Setting Up ReDS System 27 displayed as shown below Figure 14 Start Screen System is ready for use only when System Status Ready is displayed...

Page 30: ...reen 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 the screen Power co...

Page 31: ...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 synchron...

Page 32: ...ct support for more information Communication Test button If the system is set up to communicate via a cellular or WiFi connection then tapping this button verifies the connection A success or failure...

Page 33: ...from the system to SensiCloud when the SensiCloud service is available Use manual data transmission to initiate a transmission of pending measurement data When manual transmission of pending measureme...

Page 34: ...been created it will be displayed in the patient list in subsequent measurements sessions To select the patient to be measured you should first check whether that patient already exists in the patien...

Page 35: ...Setting Up ReDS System 33 To select a patient 1 In the Start screen see Figure 14 tap Start The following screen displays Figure 18 Patient List Screen...

Page 36: ...nsor 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...

Page 37: ...the Patient Name Patient ID and Date of Birth 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 sc...

Page 38: ...side flaps and fastening the strap Performing verification steps Follow the procedure below for complete details Vest Adjustment Workflow The following provides an overview of the steps for adjusting...

Page 39: ...ter and verify patient values in the Verification screen CAUTIONS When considering whether to use the ReDS System take the following patient related considerations into account 1 Physical deformities...

Page 40: ...indow 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 stri...

Page 41: ...itioning 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 Fig...

Page 42: ...the fastening shoulder flap and then reattach it to its maximum opening position as shown below Figure 25 Opening the Fastening Shoulder Flap Apply the sensor vest on the patient CAUTION When using th...

Page 43: ...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...

Page 44: ...he left side flap Have the patient hold the closed buckle and verify that it is centered on his her sternum Tap Next to continue Adjusting the height of the back sensor Figure 28 Set back Height Stand...

Page 45: ...ers the C7 vertebra NOTE When adjusting the flap make sure that the patient s shoulders are relaxed and that the patient is upright Figure 29 Using the Back Center Strip to Position the Sensor Vest NO...

Page 46: ...aligning the lower end of the Back Center Strip with the patient s spine To verify use your fingers to feel the spinal column in the lower part of the vest near the back sensor Once centered hold the...

Page 47: ...so that it fits snugly 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 Rig...

Page 48: ...Back Strip To verify use your fingers to feel the spinal column in the lower part of the vest near the center strip Once positioned hold the back piece in place and continue to step 2 4 NOTE The wizar...

Page 49: ...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 Fig...

Page 50: ...ler field enter the value read in the chest size ruler NOTE The vest adjustment supports ruler chest dimension values of 2cm to 25cm Please do not use the ReDS System if the measured ruler values exce...

Page 51: ...its 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 bac...

Page 52: ...o position 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 screen according to the following...

Page 53: ...ses 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 exam...

Page 54: ...patient must be set up as described in chapter 2 Setting ReDS system page 21 when using the system on the patient for the first time NOTE if the patient has been measured previously you should use hi...

Page 55: ...tem 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 Taking a Measurement Wor...

Page 56: ...s 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 dev...

Page 57: ...be displayed 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...

Page 58: ...ent 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 rec...

Page 59: ...ing the Clavicle Bone NOTE If the patient s position requires correcting ask the patient to sit back up re position and then recline back Step 4 Taking a Measurement The following screen is displayed...

Page 60: ...hest sensor in the front will start to inflate The measurement takes 90 seconds NOTE The patient should not move talk drink or use a cell phone during this time as this may result in low quality measu...

Page 61: ...er to the Step 5 Reviewing Measurement Results section on 57 for a description of the results Unsuccessful Measurement If the measurement was not successful then the following message is displayed Low...

Page 62: ...urement process the following is displayed on the Bedside Console screen NOTE If the measurement was not successful then the following message is displayed Low Quality You may refer to page 59 for mor...

Page 63: ...l 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 flui...

Page 64: ...from 20 to 35 CAUTION The ReDS System fluid reading is intended to be used as an adjunct parameter to standard clinical assessment methods Step 6 Shutting Down the ReDS System Perform the following o...

Page 65: ...oblems SensiCloud Overview The SensiCloud enables quick and easy access to your patients data through a simple user interface The SensiCloud provides the following functions Enrolling patients in the...

Page 66: ...ortal Patient List The Patient List enables a physician or healthcare provider to display a concentrated tabular view of all patients For each patient this screen shows the last measurement value and...

Page 67: ...splays 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 not...

Page 68: ...ic 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 The notification message reminds you to log into th...

Page 69: ...e 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 Se...

Page 70: ...r the patient If ON Voice or text messages can be selected The primary phone number will be used for sending automatic measurement reminder messages to the patient please use the appropriate internati...

Page 71: ...ud 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...

Page 72: ...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 pati...

Page 73: ...re no longer being monitored Doing so will remove him her from the active patient list and will disable all notifications related to that patient Archived patients data is displayed in the Archived Pa...

Page 74: ...iew Patient Details button on the upper right corner of the screen The Patient Details screen is displayed Figure 52 Archiving a patient 4 Click the Archive Patient button located at the bottom 5 Clic...

Page 75: ...arameter notification which was acknowledged but their last reading result still exceeds the predefined thresholds This is followed by the rest of the patients meaning patients with no fluid parameter...

Page 76: ...click and drag anywhere on the plot area to pan to your region of interest You can record textual time stamped notes per patient All your recorded notes will be displayed in a chronological order in a...

Page 77: ...d value textbox The center of the range is indicated graphically by a green zone In the event that a reading is received and it is higher than the upper threshold OR lower than the lower threshold a n...

Page 78: ...e and date in which the change was made Viewing and Acknowledging Notifications As described in the My Account section above notification will appear in the Patient List and in the Patient Graph View...

Page 79: ...ications indicator The cloud portal also presents the administrative user with two additional indicators The Physician Support Tasks indicator shows up when the attending physician has not acknowledge...

Page 80: ...lable contact information Patient View Pressing either the View button or the patient ID of each patient on the list will show the patient view screen In this screen all patient measurements are shown...

Page 81: ...Problem Potential Causes Action Required SensiCloud Portal is inaccessible SensiCloud server failure communication problems Wait a few minutes and try again If the problem persists contact support Un...

Page 82: ...ty 1 Patient slid or rolled on the bed or chair while lying back and the vest has moved 2 Vest was applied over multiple layers of clothing or thick clothing 3 Sensor vest positioning reference points...

Page 83: ...the console position to improve cellular reception Use the signal reception indicator available on screen to verify that the minimal quality of service is available indicated by at least two bars Wi...

Page 84: ...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 Identifi...

Page 85: ...vices Keep away from sunlight Direct Current Degree of protection against electric shock Type BF LBL0315 Rev A Label number and revision Waste of electrical and electronic equipment IP22 Protected aga...

Page 86: ...wer cable by wrapping them around the Bedside Console When using the Cart configuration use the utility basket to store the sensor vest the power supply and their cables Cleaning If soiled or if clean...

Page 87: ...Handling 85 Packing instructions...

Page 88: ...35 A 240 VAC Sensor Electromagnetic Information Operating Frequency 0 95 2 GHz Frequency Band 0 95 2 GHz Type of Modulation Stepped CW Type of Modulating Signal NA Frequency of Modulating Signal NA Ef...

Page 89: ...imal signal strength of two bars in the cellular signal strength indicator Effective Radiated Power 20dBm 34 dBm 0 1 Watt 2 5 Watt FCC Compliant Yes Class B Wi Fi Wireless Connectivity Protocol option...

Page 90: ...ree of Protection Against the Presence of Flammable Anesthetic Mixtures Not for use with flammable anesthetics FCC Compliance Statements FCC Part 15 21 Statement Changes or modifications not expressly...

Page 91: ...eorient or relocate the system Increase the separation between the system and receiver Connect the system into an outlet on a circuit different from that to which the receiver is connected Consult the...

Page 92: ...stablishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Harmonic Emissions IEC 61...

Page 93: ...ient burst IEC 61000 4 4 2 kV for power supply lines 100 kHz repetition freq 2 kV for power supply lines 100 kHz repetition freq Mains power quality should be that of a typical commercial or hospital...

Page 94: ...UT For 25 cycles 70 UT 30 dip in UT For 25 cycles 0 UT 95 dip in UT For 0 5 cycles 0 UT 95 dip in UT at 0 45 90 135 180 225v 270 and 315 For 1 cycles 0 UT 95 dip in UT For 25 cycles 70 UT 30 dip in UT...

Page 95: ...pical commercial or hospital environment NOTE UT is the AC mains voltage prior to application of the test level Table 7 Electromagnetic Immunity Immunity Test IEC 60601 Level Compliance Level Electrom...

Page 96: ...ms 150 kHz to 80 MHz Recommended separation distance d 0 6 P Radiated RF IEC 61000 4 3 10 V m 80 MHz to 2 7 GHz E1 10 V m Recommended separation distance d 1 2 P 80 800 MHz range d 2 3 P 800 2 500 MHz...

Page 97: ...d additional measures may be necessary such as re orienting or relocating the ReDS System b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m NOTES At 80 MHz and 80...

Page 98: ...a minimum distance between portable and mobile RF communications equipment transmitters and the ReDS System as recommended below according to the maximum output power of the communications equipment 0...

Page 99: ...Federal law restricts this device to sale by or on the order of a physician Sensible Medical Innovations Ltd Meir Ariel 6 Netanya 4059300 Israel...

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