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VITALSV20
User Manual
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Vitalerter VITALSV20 User Manual

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Vitalerter LTD
User Manual
Vitalerter System
VTS-TEC-007 Rev 1 ENG
Table of Contents
1.1. Intended Use ................................................................................................................................. 5
1.2. Indications for Use ........................................................................................................................ 5
1.3. Contraindications .......................................................................................................................... 5
2.1. General Safety Guidelines ............................................................................................................. 6
2.2. General Hazards ............................................................................................................................ 7
2.2.1. Electrical Safety ..................................................................................................................... 7
2.2.2. EMC ....................................................................................................................................... 7
2.2.3. Electrical Fire ......................................................................................................................... 8
2.2.4. WIFI and Bluetooth Communication .................................................................................... 8
3.1. The Vitals Sensor ........................................................................................................................... 9
3.2. The Integrated Care Management System (Cloud) .................................................................... 10
4.1. Vitals Product Supply .................................................................................................................. 10
4.2. Vitals sensor Labels ..................................................................................................................... 11
4.2.1. Vitals sensor Labels Legend ................................................................................................ 11
4.3. Unpacking ................................................................................................................................... 12
4.4. Installation .................................................................................................................................. 12
4.4.1. Mounting ............................................................................................................................. 12
4.4.2. Power Supply ...................................................................................................................... 14
4.4.3. Sensor Indications ............................................................................................................... 14
4.4.3.1. Power .............................................................................................................................. 14
4.4.3.2. Communication ............................................................................................................... 14
4.4.3.3. Sensor .............................................................................................................................. 15
4.5. Calibration ................................................................................................................................... 15
4.6. Servicing ...................................................................................................................................... 15
5.1. Access to Vitalerter Cloud via Web Browser .............................................................................. 16
5.2. Residents ..................................................................................................................................... 17
5.2.1. Add Resident ....................................................................................................................... 17
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5.2.2. Patient Profile ..................................................................................................................... 17
5.2.3. Monitor Setting Configuration ............................................................................................ 18
5.2.4. Devices ................................................................................................................................ 20
5.3. Existing Resident ......................................................................................................................... 21
5.3.1. Dismissing Resident ............................................................................................................ 21
5.4. Dashboard ................................................................................................................................... 22
5.4.1. Status .................................................................................................................................. 23
5.4.2. Alerts ................................................................................................................................... 23
5.4.3. Monitors .............................................................................................................................. 24
5.4.4. Map ..................................................................................................................................... 24
5.5. Trend Analysis Reports ............................................................................................................... 25
5.5.1. Alerts ................................................................................................................................... 25
5.5.2. Vitals .................................................................................................................................... 28
5.5.2.1. Sleep ................................................................................................................................ 28
5.5.2.2. Move ............................................................................................................................... 29
5.5.2.3. Relax ................................................................................................................................ 29
5.5.2.4. Heart Rate ....................................................................................................................... 30
5.5.2.5. Respiratory Rate .............................................................................................................. 31
5.5.2.6. Heart Rate Variability ...................................................................................................... 31
5.5.2.7. Stroke Volume ................................................................................................................. 32
5.5.2.8. Multiple parameter Viewing ........................................................................................... 32
5.5.2.9. Report Export .................................................................................................................. 33
5.6. Access to Vitalerter Integrated Management Care System via Android .................................... 34
5.6.1. Accessing the application ........................................................................................................ 34
6.1. Vitals Unit .................................................................................................................................... 36
6.2. Electrical ...................................................................................................................................... 36
6.3. Operating, Storage and Transportation Conditions ........................................................................ 36
6.4. Wireless Communications /Radio ............................................................................................... 36
6.5. Heart Rate ................................................................................................................................... 36
6.6. Respiration ...................................................................................................................................... 36
6.7. Compliances ................................................................................................................................ 37
6.8. Communication risk mitigation ................................................................................................... 39
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6.8.1. Risk Analysis Summary ........................................................................................................... 39
6.8.2. Residual Risks .......................................................................................................................... 39
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1. Introduction
The Vitalerter system includes a contact free medical device and integrated care management system
intended to provide continuous measurement and monitoring of patient vitals heart rate, respiration
rate and body motion for preventive care analysis while patient is at rest or during sleep.
The Vitalerter system continuously acquires patient vital signs data by the Vitals sensor unit. This data is
transmitted at real time to the integrated care management system where the data is analyzed and
relayed to a central display station or mobile application.
The Vitals sensor is mounted on a bed or a wheel chair and continuously monitoring the patient.
The Integrated care management system presents the monitored data at real time and alerts for fall
prevention, pressure ulcers prevention, warning signs in situations of irregular breathing and heart rate
incidents.
The Vitalerter system is used in hospital facilities, nursing homes, rehabilitation centers and by
authorized private caregivers.
1.1. Intended Use
The Vitalerter System is intended for continuous measurement of Heart rate (HR), Respiration
rate (RR) and movement, in an automatic contact-less manner, in hospital or nursing home
setting to proactively provide preventive care information.
The Vitalerter system is not intended to permanently store any type of data. The Vitalerter
System is not intended to provide automated treatment decisions or as a substitute for
professional healthcare judgment. All patient medical diagnosis and treatment are to be
performed under direct supervision and oversight of an appropriate health care professional.
1.2. Indications for Use
The Vitalerter system is indicated for residents that require continuous monitoring in a hospital,
nursing facility, rehabilitation center or by authorized private caregiver.
1.3. Contraindications
o Patients that require monitoring for life sustaining or life supporting purpose. o An Magnetic Resonance (MR) environment
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2. Safety
2.1. General Safety Guidelines
Please read and adhere to all warnings, cautions and notes listed here and in the associated sections throughout this manual.
Warning statements alert the user to conditions or practices that could result in injury to a person, or serious adverse events associated with the use or misuse of the Vitalerter System.
Caution statements alert the user to conditions or practices that could result in problems with the Vitalerter System.
Read the instructions in this manual before using the device
The Vitalerter system installation shall be performed according to the instructions in this manual.
|Rx Only Prescription Use Only
Caution
o The Vitals sensor can be damaged internally if dropped. Avoid dropping and rough
handling by proper assembly and placement in an area that is least exposed to
mechanical damage.
o The Vitals sensor operating environment is recommended for indoors only to provide
least amount of interference.
o Safe decommissioning of the device is required. Sorted disposal of battery according to
local regulation or contact local distributor.
o The Vitals sensor is not intended to permanently store any type of data. o The Vitals sensor is protected against dripping water (IP21). o Do not expose the Vitalerter Vitals sensor to a wet environment.
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Electrical Medical Equipment Classification
Equipment Classification
Class 1, Internally and continuously powered
Equipment Type
Fixed, Stationary
o Do not attempt to self-install the Vitals sensor on another bed or chair. All units must be
installed by authorized Vitalerter representatives.
o The Vitalerter system is not intended to provide automated treatment decisions or as a
substitute for professional healthcare judgment.
o All patient medical diagnosis and treatment are to be used under direct supervision and
oversight of an appropriate health care professional
o The Vitals sensor is intended for individual patient, sharing touching or moving bed
should be avoided during measurements.
2.2. General Hazards
2.2.1. Electrical Safety
The Vitals sensor has been tested for product safety and is in conformance with IEC/EN
60601-1
Only equipment specified in this manual and complying with requirements of EN60601-
1 should be connected to the system
2.2.2. EMC
The Vitals sensor is in compliance with EMC IEC 60601-1-2 . This standard is designed to
provide reasonable protection against harmful interference in a typical medical
installation.
However, because of the proliferation of radio-frequency transmitting equipment and
other sources of electrical noise in healthcare and other environments, it is possible that
high levels of such interference due to close proximity or strength of a source might
disrupt the performance of this device. Medical electrical equipment needs special
precautions regarding EMC, and all equipment must be installed by qualified service
personnel.
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Emission Test Compliance
IEC 60601-1-2 2007 3rd Edition
FCC Part 15 Subpart B
EN 301 489-1 V2.1.1:2017 EN 301 489-17 V3.1.1:2017
2.2.3. Electrical Fire
Caution
Avoid placing liquids or food on the Vitals sensor. Do not allow conductive fluids
to leak into the active circuit components of the sensor as this may cause a short circuit,
which could result in an electrical fire. In such an event, only fire extinguishers approved
for use on electrical fires should be used. The sensor is not intended for use in the
presence of flammable mixtures.
Warning
Do not attempt to connect or power the Vitals sensor with a power adapter and cable other than the ones provided with the device.
2.2.4. WIFI and Bluetooth Communication
All wireless devices are susceptible to radiofrequency interference that can disrupt connectivity. During such interference the Vitals sensor continues to monitor, however relay of information will be halted until the connectivity is restored. A clinician or nurse must always be in direct view of the central display of patient status. If the status appears as blank refer to troubleshooting.
If excessive disconnections are observed please inform your facility administrator to investigate and correct. Always consult with Vitalerter representative before performing any changes to the network. These changes can compromise the communication required for the delivery of status and alerts to the clinicians.
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3. System Description
The Vitalerter system consists of:
3.1. The Vitals Sensor
The Vitals sensor containing high sensitivity sensor programmed to sense the patient vitals and
motion. Vitals and motion data are collected and transmitted to the cloud and displayed on the
integrated care management system. The Vitals sensor contains no display of information.
Figure 1 Vitals Unit Image
The Vitals sensor is powered by:
o Power adapter
The Vitals sensor contains a power adapter and cable supplied with the unit that is
connected to the vitals via USB-C. Make sure that the system is always plugged in to the
electrical outlet during routine operation.
Figure 2 Vitals Power
o Battery
The Vitals sensor contains a lithium polymer rechargeable battery that provides power
in case the unit is unplugged from the electrical outlet, or in case of a power shortage.
The battery is not intended to be replaced by the operator. In standard operating mode,
the battery is designed to allow approximately 30 hours of operation.
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Quantity
Description
1
Vitals Unit
1
Power adapter
1
Power cord
1
User Manual
In case the battery no longer maintains the necessary charge, it must be serviced by an
authorized Vitalerter representative.
3.2. The Integrated Care Management System (Cloud)
The cloud receives the data from the sensor and analyzes and creates the information presented
in real time to the user as it is monitored and displayed in a visual form for appropriate caregiver
to directly view patient vitals status and alerts.
4. System Installation and Setup
4.1. Vitals Product Supply
Vitals sensor is supplied in a protective packaging and in bulk to the facility. An individual unit
contains the following components:
Table 1 Product Supply Information
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Vitals v2.0
SN
Rx Only
Input: 5V@1A Warning:
Vitalerter LTD 2 Ha-Yarden Airport City 70199 Israel
Consult
FCC ID: 2ANR2-VITALSV20
EU Rep:
Caution Warning
Consult Accompanying Documents
Manufacturer
Rx Only
Caution: Federal Law prohibits sale by physician order only Fragile
Keep Dry Sorted Disposal
4.2. Vitals sensor Labels
Table 2 System Labels
4.2.1. Vitals sensor Labels Legend
The following explanation of the symbols that appear on the outer packaging and labels of the Vitals sensor.
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4.3. Unpacking
representative.
4.4. Installation
The Vitalerter representative performs:
4.4.1. Mounting
The Vitals sensor should be unpacked and installed only by a Vitalerter authorized
a) The mounting of unit to the residents’ bed/chair (4.4.1) b) The initial powering of the unit (4.4.2)
The Vitals sensor may be installed on a bed or a wheelchair.
Patient is to be instructed to lay with upper body in the direction of the USB to
allow ideal quality of measurements.
When mounting to bedside the USB Port should be situated in the direction of patient
head as follows:
o The device can be mounted by zip tie or double side Velcro.
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Figure 3 Mounting to Bed
o Carefully route cables and connections to reduce the possibility of tripping,
entanglement or strangulation. This will be done by addition of zip tie to assure
securement of cables.
o Install in area that is least likely to be exposed to spillage or ingress of liquids. This
can damage the functioning of the device.
o Avoid mechanical damage to device (falling, rough handling) by installing in area
that is least likely exposed rough handling. Shaking or falling of device can damage
the device internal circuits
of liquids can damage the functioning of the device.
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Figure 4 Vitals Mounted to Chair
Avoid assembly under chair for patients with bladder control problems. Ingress
Inform caretaker of and where the device is assembled.
4.4.2. Power Supply
Use only the power adapter provided in the Vitalerter package. Power supply is
necessary for the Vitals sensor performance. The Vitalerter representative will connect
the power adapter to the Vitals sensor and to the electrical outlet. At this point the
sensor is ON.
4.4.3. Sensor Indications
The unit contains the following LED indication:
4.4.3.1. Power
The green LED will be continuously on when the power adapter is connected. When the power adapter is disconnected and the Vitals sensor is running on batter the green LED will bling every 1 sound.
4.4.3.2. Communication
The yellow LED will indicate the communication status: If the LED is constantly on or off there is a problem with the communication. If the LED is blinking the communications is good.
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4.4.3.3. Sensor
4.5. Calibration
System Calibration is performed upon device installation.
The orange LED will constantly be on when the sensor is OK.
4.6. Servicing
In case the Vitalerter Vitals does not operate properly, contact your local distributor or customer service at the address provided ahead.
Please refer to the troubleshooting section 7.
o Only Vitalerter technicians are authorized to service the device. o Do not attempt to service the device on your own. o Servicing of device will not be performed while in use.
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5. Vitalerter Integrated Care Management System
The Vitalerter integrated care management system is operated by users that have read and understood the user manual and are authorized to care for the patient either by profession (a nurse or a physician) or by training (a private caretaker).
5.1. Access to Vitalerter Cloud via Web Browser
Access to the Vitalerter cloud is made possible through the link, user name and password that are provided.
Figure 5 Vitalerter Sign in Screen
Signing out of the system is performed by clicking the “Sign Out” button that is located at the top right corner and appears when clicking on the username.
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authorized users.
5.2. Residents
5.2.1. Add Resident
The user will add resident by clicking from the “Residents” button at the left side menu. User will be routed to create a patient profile, configure the parameters to be monitored and adding device to the patient.
To prevent settings from being inadvertently changed provide password only to
5.2.2. Patient Profile
A screen for creating patient profile including name, age, gender, room and bed is presented. Enter patient information and click save (see image ahead).
Figure 6 Screen: Patient Profile
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Patient information may be edited by returning to the “Residents” tab and selecting the
patient and selecting “Edit”.
5.2.3. Monitor Setting Configuration
The following window allows the user to choose the patient alerts:
Heart Rate Respiratory Rate Fall Prevention Pressure Ulcer
Each option can be turned ON or OFF to activate or deactivate the alert notifications.
Alert settings are configured by clicking on “Edit” at the bottom left of each parameter.
Figure 7 Screen: Monitor Settings
Alert settings can be configured for the following parameters:
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5.2.3.1. Heart Rate
Figure 8 HR Configuration
5.2.3.2. Respiratory Rate
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Figure 9 RR Configuration
5.2.3.3. Pressure Ulcer
Figure 10 Pressure Ulcer Protocol Configuration
5.2.3.4. Fall Prevention
For alert settings to take effect, click “save”.
5.2.4. Devices
The User will select the device assigned to the patient by adding the device from the “Devices” tab.
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Figure 11 Fall Prevention Configuration
Figure 12 Device Adding
5.3. Existing Resident
The following is an example of an existing resident.
The image below presents the “residents menu” with an existing resident. Information consists of patient name, room and bed and the parameters monitored. By clicking on the “monitors”
icons the user can configure the threshold values.
Figure 13 Screen: Residents
5.3.1. Dismissing Resident
When the resident is released, the “active” box should be unchecked this will stop the monitoring of the said patient. If patient is admitted again, monitoring is resumed by checking the active box .
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All Okay
Color code green indicating that patient parameters measured are all within defined threshold and no alerts at the moment
Take Care
Color code mustard is an alert for patient care
Urgent
Color code red, alerts that the defined thresholds are exceeded
Fall Prevention
1
2
Pressure Ulcer Prevention
1
2 3
Respiration Rate
1
Heart Rate
1
5.4. Dashboard
The system utilizes color codes that appear on the various screens to indicate the level of alerts. The following color codes are displayed alongside the data presented on the dashboard and are an additional visual indication of patient status
Figure 14 Status Color codes
The system presents alert icons as follows:
Figure 15 Legend of Alerts
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Through the dashboard tab the user can view the patient data monitored that is continuously measured and presented at the central station (nurses station) by selecting from the various tabs available on the dashboard as follows:
5.4.1. Status
Viewing the current status of all patients including if they are in or out of bed or if there is an alert. Alert level is indicated by a color code. The following figure depicts the status of patients in bed, out of bed and in motion.
Figure 16 Dashboard: Status
5.4.2. Alerts
Viewing of all the alerts that are set off by the system. The user can view the alert, the time of the alert and the length of time that has elapsed since the alert. Click “Done” after handling the alert.
If “Done” is not selected within an hour then the alert is canceled.
Figure 17 Dashboard: Alerts
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5.4.3. Monitors
Viewing of measured parameters in real time of each patient including in or out of bed status, movement, relaxation, HR and RR. The limits defined for the vitals appear aside the actual measurements and each patient appears with a color code indicating alerts if any.
Figure 18 Dashboard: Monitors
5.4.4. Map
Presents view of all resident rooms and their color-coded status
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Figure 19 Dashboard: Map
5.5. Trend Analysis Reports
By selecting “Reports” option, the user is presented with a menu from which they may select to view “Alerts” or “Vitals” reports.
The “Reports” option provides the user with the ability to reviewed the data measured and
analyzed for over a period of up to one month.
5.5.1. Alerts
The Alerts provides the user with a list of all patients, the type and the total amount of alerts that occurred indicated by an image from the Vital Alerts legend accompanied by the number of alerts.
The following figure presents several residents, the alerts that occurred over a period of a week and the total amount of times the alerts occurred for each resident.
For instance, resident observed in room 407 had 111 alerts for fall prevention
represented by the image over a period of a week.
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Selecting +details will also provide the detail of every alert, the date and time the alert occurred.
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Figure 20 Alerts Trend Analysis Reports
The user can choose to survey the alert trends over a time span of up to a month by selecting from the hours, days, month.
The “Handled after” recordings are available only for alerts that were deactivated by selecting “Done”
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5.5.2. Vitals
The Vitals tab, selected from the “Reports” menu allows the user to view trends in the
parameters (Vitals) monitored.
Start by selecting the patient/resident for whom the trends report is requested.
Figure 21 Vitals Trend Analysis Reports
5.5.2.1. Sleep
Selection of “Sleep” below the graph, presents the sleeping pattern of the patient including, “in” and “out “of bed and change of posture. The following
report presents the sleeping patterns for patient 401A over the period 0f 48 hours. By placing the cursor over the graph, the user can follow the date, time and hour that the patient is in or out of bed.
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Figure 22 Trend Report Sleep
5.5.2.2. Move
Selection of “Move” presents the user with information on patient activity, patient self-movement. This activity is rated against four scales of activity,
presented to the right of the graph. “Move”, is the lowest on the activity scale identifying that the patient moved in bed. “Turn”, identifies patient turning in bed. “Active”, identifies patient increase in movement strength. “Effort” is the
highest on the activity scaled and considered more strenuous activity. By placing the cursor over the graph, the user can follow the date, time and hour that the patient is active.
Figure 23 Trend Report Move
5.5.2.3. Relax
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Selection of “Relax” presents the user with information on patient state of relaxation. This parameter is rated against a scale from “Rest” being that the
patient is fully rested with high rest, normal rest and low rest in between and before “Stress” indicating restlessness. By placing the cursor over the graph, the user can follow the date, time and hour that the patient is at rest.
Figure 24 Trend Report Relax
5.5.2.4. Heart Rate
Selection of “HR” presents the user with measures of patient Heart Rate (BPM).
By placing the cursor over the graph, the user can follow the date, time and actual reading of the heart rate.
Figure 25 Trend Report Heart Rate
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5.5.2.5. Respiratory Rate
Selection of “RR” presents the user with measures of patient Respiratory Rate (RPM).
By placing the cursor over the graph, the user can follow the date, time and actual reading of the Respiratory rate.
Figure 26 Trend Report Respiratory Rate
5.5.2.6. Heart Rate Variability
Selection of “HRV” presents the user with measures of patient Heart Rate Variability.
By placing the cursor over the graph, the user can follow the date, time and actual reading of the HRV.
Figure 27 Trend Report Heart Rate Variation
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5.5.2.7. Stroke Volume
Selection of “SV” presents the user with measures of patient Stroke Volume. By placing the cursor over the graph, the user can follow the date, time and actual reading of the stroke.
Figure 28 Trend Report Stroke Volume
5.5.2.8. Multiple parameter Viewing
User may select more than one parameter for viewing of trends at the same time. The figure below presents the values measure for HR and RR.
Figure 29 Trend Report Multiple parameters
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5.5.2.9. Report Export
Figure 30Report Export
The reports may be exported as different formats from the system.
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5.6. Access to Vitalerter Integrated Management Care System via Android
5.6.1. Accessing the application
5.6.1.1. Install the Vitalerter application via Google store.
5.6.1.2. Locate the Vitalerter icon (application) and download to your mobile device:
5.6.1.3. When opening the application, following choice of your domain according to the
instructions provided with unit, the following welcome window will appear:
5.6.1.4. Type the user name and password provided.
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5.6.1.5. Display of the Dashboard main menu will appear, presenting the Status, Alerts
and Monitoring as such:
5.6.1.6. After Login, the app will remain open even if it is closed on the screen.
5.6.1.7. To Exit, you need to sign out as follows:
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Dimensions
84x41x25 mm (WxLxD)
Weight
80 g
Materials
ABS +Polycarbonate
Power Supply
5V@900 mA
Power Connector
USB-C
Battery
Li-Po 1800mAh
Battery Life
33 hours
Operations
Storage and Transportation
Temperature
5-40 °C | 41-104 °F
0-50 °C | 32-122 °F
Humidity
10% - 95% non-condensing
10% - 95% non-condensing
Atmospheric pressure
540 – 1060 mBar
540 – 1060 mBar
Frequency
2.4GHz
Protocol
Wi-Fi, BLE
Modulation
Security
Power Output (max)
Wi-Fi: 18dBm, BLE: 4dBm
Wi-Fi Alliance Compliant
Display Range
BPM
Accuracy Range
BPM
Accuracy
Time to alert
Display Range
BR/MIN
Accuracy Range
Accuracy
Time to alert
6. Specifications
This section provides specifications regarding measurement ranges, accuracy levels and environmental
operating conditions for the Vitals System.
6.1. Vitals Unit
6.2. Electrical
6.3. Operating, Storage and Transportation Conditions
6.4. Wireless Communications /Radio
6.5. Heart Rate
6.6. Respiration
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6.7. Compliances
FCC Compliance Statement
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in residential installations. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio and television reception.
However, there is no guarantee that interference will not occur in a particular installation. If this device does cause such interference, which can be verified by turning the device off and on, the user is encouraged to eliminate the interference by one or more of the following measures:
– Re-orient or re-locate the receiving antenna.
– Increase the distance between the device and the receiver.
– Connect the device to an outlet on a circuit different from the one that supplies power
to the receiver.
– Consult the dealer or an experienced radio/TV technician.
WARNING! Changes or modifications to this unit not expressly approved by the party responsible for compliance
could void the user’s authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference.
(2) This device must accept any interference received, including interference that may cause undesired operation.
A distance of at least 8cm. between the equipment and all persons should be maintained during the operation of the equipment.
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Emissions Test
Compliance
Avoiding Electromagnetic Interference
RF Emissions
RF Emissions CISPR 11
Class B Passed
Voltage Fluctuations IEC 61000-3-3:2013
Pass
Immunity Test
IEC 60601-1-2
Test Level
Compliance Level
Electrostatic Discharge (ESD) IEC 61000-4-2
±6 kV contact ±8 kV air
±6 kV contact ±8 kV air
Electrical fast transient/burst IEC 61000-4-4
±2 kV for power supply lines ±1 kV for signal lines
±2 kV for power supply lines ±1 kV for signal lines
Surge IEC61000-4-5
±1 kV differential mode ±2 kV common mode
±1 kV differential mode ±2 kV common mode
Voltage dips short
Power Frequency
Immunity Test
IEC 60601-1-2 Test Level
Compliance Level
Conducted RF IEC 61000-4-6
3 VRMS 80%A.M. by 1kHz
3 VRMS 80%A.M. by 1kHz
Radiated RF IEC 61000-4-3
ELECTROMAGNETIC EMISSIONS:
The Vitals sensor is suitable for use in the electromagnetic environment specified in the table below. Ensure that the sensor is used in such an environment.
ELECTROMAGNETIC IMMUNITY:
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RECOMMENDED SEPARATION DISTANCE
6.8. Communication risk mitigation
The Vitals System utilizes the Responsible Organization’s network to communicate between the Vitals unit and the Integrated care management system (cloud). The Vitals unit is configured to the responsible organization access point and physiological data that originates from the Vitals Sensor is processed and transmitted through WIFI to the router through LAN and from the router to the cloud through the internet. Any malfunction in one of the computing interfaces described above can prevent data and alerts from be delivered to the display unit. Therefore, reliability of the network is essential in ensuring the Vitals system intended use.
6.8.1. Risk Analysis Summary
The user may at their discretion consider the following residual risks that may interfere with the Vitals system intended use. The end effect of these residual risks may require the user to resort to manual spot check monitoring in the following situations described below.
6.8.2. Residual Risks
In facilities where uninterrupted power supply is not available (i.e generators),
during power shortage the server may be down. The sensor will continue to monitor as it has a battery backup.
Other RF radiating devices (such as high powered RFID readers and Bluetooth
devices) that are in close proximity with the Vitals System may interfere with the wireless communications. During such interference, the Vitals sensor continues to monitor but the data does not reach the integrated management system and will not be displayed during this time. If wireless communication is affected when using the Vitals unit in close proximity with another RF radiating device, move the other device away from the Vitals or discontinue use of the other device under physician’s orders only.
Loss of connectivity, Low internet Quality, network or WIFI failure will influence the
Vitals systems ability to display data required to monitor patient data and alerts. Management of this risk is the responsibility of the Responsible Organization for the IT Network.
For the time span above where the Vitals system is not active alternate monitoring
and measuring methods are considered at the discretion and responsibility of the facility.
This risk is minimized with the following mitigations: Vitalerter Responsibilities
• Vitalerter network assessment prior to installation.
• Vitalerter verification that the Responsible Organization network meets the Vitals
System connectivity requirements at the time of installation.
• Hand over protocol with all settings/configurations as installed and configured
(Training)
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Problem
Possible Cause
Solution
Patient NA
No power (depleted battery, no
connection of power adapter)
Call Technical Support
Patient NA
No communication, connectivity
lost
Call Technical Support
Unit Fail
Not applicable
Unit replacement
Patient in bed -no reading
The system takes at least a minute
for readings to proceed
Readings should proceed
Responsible Organization Responsibilities
• Conduct a risk assessment of the IT Network prior to installation and mitigate
technical risk.
• Maintain backup and emergency power resources for Vitals System network components.
• Maintain network configuration post installation of the Vitals System.
• Notify Vitalerter prior to modifications to the network, including any
configurations changes that could potentially compromise the IT Network as verified at the initial installation of the Vitals System. For support contact Vitalerter representative directly or through your distributor.
Perform a risk assessment and verification before implementing a change or
7. Maintenance
NA
modification to the IT infrastructure. Changes to IT network configurations can
compromise Vitals units configured to the server
8. Troubleshooting
Table 3 Vitalerter Vitals System Troubleshooting
8.1. Technical Support
Email: support@vitalerter.com
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EU Representative:
Vitalerter:
2 Ha-Yarden St. Airport City 7019900 Israel Website: www.vitalerter .com
9. EU Representative and Contact Information
Contact Vitalerter:
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