EarlySense InSight AME-01350-US User manual

EarlySense Modular
Bedside Unit User Guide
ALL-IN-ONE • SAFETY • VITALS
EarlySense InSightTM
0344

2
Important Notice
Revised: November 2018
SW ver. supported by this document: 1.1.8-1 and up
HW ver. Supported by this document: Models AME-01350-US/US-F
Document Number: MK-3702-IS-US Revision 2
Copyright 2018 EarlySense Ltd. All rights reserved worldwide. This user guide is proprietary to EarlySense Ltd.
Unauthorized use, disclosure or reproduction is prohibited.
EarlySense Ltd. assumes no responsibility for errors that may appear in this user guide. EarlySense Ltd. reserves
the right to make changes without notice to this user guide and the products described herein.
Contact and Support Information
You may contact EarlySense at:
Israel
EarlySense Ltd. (Manufacturer)
7 Derech Ze’ev Jabotinsky
Ramat Gan 5252007, Israel
Phone: [phone]
Fax: [phone]
USA Office
800 West Cummings Park, Suite 6400
Woburn, Massachusetts 01801
USA
Phone: [phone]
Fax: [phone]
Email: [email protected]
www.earlysense.com

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Intended Use
The EarlySense InSight System is intended for continuous measurement of Respiratory Rate, Heart
Rate and Movement in an automatic contact-less manner, in hospital or clinical setting. The
system is indicated for use in children, adolescents and adults. The operation of the EarlySense
has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and
resting condition.
NOTE
Definition of Age for Children: Children aged 2 and above.
About This User Guide
This user guide describes how to operate the EarlySense InSight:
•Please read this user guide thoroughly before operating the system. If any part of this user
guide is not clear, you may contact EarlySense Customer Support for clarification.
•This user guide does not replace the EarlySense InSight users’training course.
•This manual provides the information necessary to setup the contact free Sensing Unit and
basic operation of the EarlySense InSight Device that is placed at the patient’s bedside in a
safe and efficient manner. For user interface explanations, please refer to the Remote
Control and Display (RCD) Unit manual. For information on InSight Cradle, please refer to
EarlySense InSight Cradle User Manuals.
•This user guide must always be located near the EarlySense System so that all personnel
operating the EarlySense System are aware of its location and can locate it easily.
This user guide contains the following chapters:
•Chapter 1, Introduction, page 15, introduces the EarlySense InSight and its components.
•Chapter 2, Set UP,page 24, describes how to operate the InSight and the information that it
provides.
Conventions
The following conventions are used throughout this user guide:
WARNING
A warning indicates precautions and instructions, which if not followed, may
result in serious bodily injury or death.
CAUTION
A caution indicates instructions or cautionary notes, which if not followed,
may result in damage to the equipment or to the quality of measurements.
NOTE
Notes contain helpful information and tips.

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Table of Contents
Important Notice .................................................................................................................................. 2
Contact and Support Information ...................................................................................................... 2
Intended Use......................................................................................................................................... 3
About This User Guide.......................................................................................................................... 3
Table of Contents ................................................................................................................................. 4
List of Figures ......................................................................................................................................... 5
Safety ..................................................................................................................................................... 6
Supplying Sensors............................................................................................................................... 12
Introduction ................................................................................................................. 15
1.1 What Is the EarlySense InSight System?................................................................................... 15
1.2 System Components.................................................................................................................. 16
1.2.1 Sensing Units......................................................................................................................................... 17
1.2.2 Sensing Unit Extension Cable............................................................................................................ 17
1.2.3 InSight Device...................................................................................................................................... 18
1.2.4 EarlySense InSight Device Controls and Indicators....................................................................... 19
1.3 InSight Device Specifications ................................................................................................... 20
Physical Characteristics .................................................................................................................................. 20
1.4 Additional Specifications .......................................................................................................... 21
1.4.1 System Performance –Sensing Unit................................................................................................. 21
Set UP............................................................................................................................ 24
2.1 Positioning the InSight Device and Bed Sensing Unit............................................................. 24
2.2 Positioning the Chair Sensing Unit on a chair ......................................................................... 25
2.3 Visual and Audial Alerts ............................................................................................................ 26
2.4 Electrical Failure ......................................................................................................................... 26
2.5 After Electrical Power is restored.............................................................................................. 27
2.6 Clinical Alert ............................................................................................................................... 27
2.7 Technical alerts .......................................................................................................................... 27
2.8 Maintenance and cleaning...................................................................................................... 27
2.8.1 Cleaning and disinfecting the InSight Device............................................................................... 28
2.8.2 Cleaning and disinfecting the Sensing Unit ................................................................................... 28
2.9 Troubleshooting .......................................................................................................................... 28
Appendix A: ................................................................................................................ 29
Manufacturer declaration.......................................................................................... 29
A.1 Overview ..................................................................................................................................... 29
Appendix B: ................................................................................................................. 34
FCC Compliance Standard Statement ..................................................................... 34

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List of Figures
Figure 1: EarlySense InSight Components..................................................................................................................... 16
Figure 2: Chair Sensing Unit- a cushion with a sensor incorporated inside............................................................. 17
Figure 3: InSight Device Indicators and Keys ............................................................................................................... 18
Figure 4: InSight Device- Side View................................................................................................................................ 19
Figure 5: Positioning the Sensing Unit and the InSight Device .................................................................................. 24
Figure 6: Example of Chair Sensing Unit attached to a chair ................................................................................... 25

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Safety
General Safety Guidelines
WARNING
US Federal Law restricts this system for sale by or on the order of a Physician.
The data acquired by the EarlySense InSight System should be interpreted only by a
Healthcare Professional.
WARNING
All changes made on an InSight Unit via remote control should only be performed by a
healthcare professional.
WARNING
The installation of the remote view software on the portable device (tablet or PC) should
be performed only by qualified service personnel authorized by EarlySense Ltd. in
cooperation with the Enterprise IT department.
•This manual, accessory direction for use and all precautionary information and specifications should be
read before use.
•Handle the InSight System with care. Do not drop, knock or shake the InSight System. Rough handling
can damage the internal circuit boards.
•The system is intended for indoor operation only.
•A damaged System should not be disposed of as unsorted municipal waste. Contact your local
distributor for Device disposal.
•Changes or modifications not expressly approved by EarlySense Ltd. could affect the safety or
effectiveness of the EarlySense InSight System and void the system's warranty.
•The EarlySense Insight Sensing Units (the under the mattress Sensing Unit, the “chair” Sensing Unit) should
be connected and used only with the EarlySense InSight Device.
•The EarlySense InSight Device is classified as IP20 Device (provides protection against access to
hazardous parts and is not protected against water, should be kept dry).
•The Sensing Unit is continuously operated solid object protected and splash-proof accessory (IP24).
•Do not use a damaged system. Use of damaged components might result in malfunctioning of the
system.
•The EarlySense InSight Device should be installed and serviced only by qualified service personnel
authorized by EarlySense Ltd. Technical diagrams and descriptions will be available to authorized and
qualified personnel. Prospective short-circuit current of installation shall not exceed 35A.
WARNING
The installation of the remote view software on the portable device (tablet or PC) should
be performed only by qualified service personnel authorized by EarlySense Ltd. in
cooperation and authorization of the Institution IT department.

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WARNING
All changes made on an InSight Unit via remote control should only be performed by an
authorized healthcare professional.
Defibrillation
The system is Defibrillation Proof with Type BF applied part.
Electromagnetic Compatibility
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical
equipment and/or systems. 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 system. Medical electrical equipment needs special precautions regarding EMC and all
equipment must be installed by qualified service personnel. See Appendix A: Manufacturer’s Declaration
tables for specific information regarding the system’s compliance with IEC 60601-1-2.
InSight is intended to be used in professional healthcare facility environment and in home healthcare
environment. The electromagnetic compatibility testing was performed according to the worst case
scenario, which is home healthcare environment. The detailed explanation of the performed tests and the
recommended precautions as for the electromagnetic interference between the EarlySense System and
other RF equipment can be found in Appendix A page 28, Manufacturer’s Declaration.
Wireless Communication
The system incorporates an off-the-shelf certified Wi-Fi (802.11b/g/n) communication Module (complies with
FCC part 15).
For proper wireless communication, maximum operating distance between InSight device and router should
be up to 18 m, the minimal separation distance between InSight and other wireless interfering devices should
be not less than 20 cm (8 inch).
This device complies with FCC/ISED radiation exposure limits set forth for an uncontrolled environment and
meets the FCC radio frequency (RF) Exposure Guidelines and RSS‐102 of the ISED radio frequency (RF)
Exposure rules. This transmitter must not be co-located or operating in conjunction with any other antenna or
transmitter
Electrical Fire
Avoid splashing liquids on any part of the system, keep it dry. Do not allow conductive fluids to leak into the
active circuit components of the system 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 system is
not intended for use in the presence of flammable mixtures.
Classification
The EarlySense InSight Device is an internally, continuously powered ordinary non-transit operable portable
equipment with type BF applied part. The EarlySense InSight Device is classified as IP20 device, provides
protection against access to hazardous parts. The Device is not protected against water, and should be
kept dry. Sensing Unit is a continuously operated solid object protected and splash-proof accessory (IP24)).
Only equipment specified in this manual and complying with requirements of IEC 60601 should be connected
to the system. The system complies with IEC 60601-1 and IEC 60601-1-2.

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Electrical Shock
The EarlySense InSight Device contains no user serviceable parts. Do not open the Device's covers.
The EarlySense InSight Device is not waterproof. Keep the InSight Device dry to avoid electrical shock or
malfunction.
Contraindications for Use
The EarlySense InSight System is contraindicated for use in:
•Patients whose proper positioning cannot be achieved or maintained.
•Patients who do not meet the weight limits tested or specified.
•Situations where a dry environment cannot be ensured.
•An MR environment.
•An explosive atmosphere.
Warning and Cautions
•EarlySense InSight System should be installed and serviced only by qualified service personnel authorized
by EarlySense.
•Mounting the InSight Device to the Power Socket should be performed while exercising utmost caution.
DO NOT place the InSight Device over the patient’s head to avoid safety related conditions.
•If no readings are received from the InSight Device, check that it is fully inserted into the Power Socket.
•Mounting the InSight Device to the Power socket should be performed by mechanical experts of the
institution (e.g. Biomed/Engineering) to make sure they are safely attached. EarlySense Ltd is not
responsible for any harm or damage related to the wrongful placement of the InSight Device.
•The connection of the InSight Devices and the Remote Control and Display (RCD) Unit to the LAN /WLAN
should be performed only by qualified personnel, authorized by EarlySense Ltd. in cooperation with the
Biomedical/ IT Engineering Departments of the hospital.
•Configuration of the LAN/WLAN for correct communication between the RCD and the InSight Devices
requires the support of hospital's Biomedical / IT Engineering Department, as well as an authorized
EarlySense Representative to ensure correct definitions and final testing of the complete system and
proper communication between the InSight Devices and the RCD Unit.
•The data acquired by EarlySense InSight System should be interpreted only by a Healthcare Practitioner.
•In the event that the EarlySense InSight System does not operate properly, contact EarlySense Inc.
Support Services: [phone].
•Never open the InSight Device's housing as this may damage the system. Refer all servicing to an
Authorized Technician.
•Only equipment specified in this manual and complying with requirements of IEC 60601 should be
connected to the system.
•EarlySense Chair Sensing Unit should not be used adjacent to or stacked with other equipment and if
adjacent or stacked use is necessary, the EarlySense Chair Sensing Unit should be observed to verify
normal operation in the configuration in which it will be used.
•Measurements may be affected by cable lengths. Do not shorten or extend the lengths.
•The use of accessories, transducers and cables other than those specified by the system’s specifications
could result in increased emissions or decreased immunity.
•Changes or modifications not expressly approved by EarlySense Ltd. could affect the safety or
effectiveness of the EarlySense InSight System and void the system's warranty.

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•The system should be operated within a temperature range of 5-40°C (41-104F). The non-condensing
relative humidity conditions allowed for Sensing Units are 30-95% and 15-93% for the Insight Device,
atmospheric pressure: 700-1060 hPa for the whole system including Sensing Units.
•Do not use a damaged system. The use of damaged components might result in the malfunctioning of
the system.
•Avoid splashing liquids on any part of the system. Do not allow conductive fluids to leak into the active
circuit components of the system as this may cause a short circuit, which could result in an electrical fire.
In this event, only fire extinguishers approved for use on electrical fires should be used. Care should be
taken when an EarlySense Sensing Unit is placed under the mattress for patients with poor bladder
function or control, including small children.
•Do not share the bed with another person or pet during the EarlySense InSight System recording session.
Sharing the bed could affect the effectiveness of the system and the accuracy of the measurements.
•Avoid using heating blankets. Use of heating blankets could affect the safety or effectiveness of the
EarlySense InSight System and void the system's warranty.
•Do not use the EarlySense InSight System for patients who weigh more than 200 kg (440 Pounds). Usage
of the system for such patients might result in malfunction of the Sensing Unit
•The patient should not have direct contact with the Sensing Unit. A mattress, pad or mattress cover
should always be placed as a barrier between the Sensing Unit of the EarlySense InSight System and the
patient. Patients should be frequently checked to ensure direct contact does not occur.
•If used by multiple patients, the Chair Sensing Unit should be covered by clean bed sheet to prevent
cross-contamination of the users.
•Careful oversight should be provided when EarlySense InSight System is used with children.
•False alerts may occur in some situations. The alert must be identified and understood. The cause(s) of
the false alerts must be addressed whenever possible to eliminate the possibility of repeated false alerts
and alert fatigue which might result in a failure to respond to an actual alert situation.
•All wireless systems are prone to intermittent signal dropout. Make sure that the patient only has
conditions which can tolerate intermittent monitoring interruptions. The InSight Device is the alerting
monitor. Alert delays were measured between the InSight Device and RCD and the same alert from the
RCD to the InSight Device. Delays are less than 10 total seconds, not including any hold-off settings set
by the clinical facility. However, network speeds vary and the system’s performance may vary,
depending on the speed of clinical facility network.
•Alert limit settings are patient- or facility-specific. The clinician must set and verify on the RCD Unit that
alert limits are appropriate for each patient. Failure to set alert limits properly can lead to false alerts or
failure to alert. Alerting will only work properly if set up properly.
•The usage of EarlySense InSight System on the bed or chair, close to any adjacent source of vibration,
might influence the accuracy of the system's measurements or create periodic interferences with the
measurements.
•The InSight System does not support life & nurses are required to continue their standard practice The
EarlySense InSight System is not intended for monitoring high risk situations where ECG monitoring is
required. The most reliable method of patient monitoring combines close personal surveillance with
correct operation of the monitoring equipment.
•It is strongly recommended that the InSight Unit be installed with redundant power supplies.
•External wireless alerting devices as used by the hospital should be used as secondary to the alerts as
provided by the EarlySense system.
•When utilizing EarlySense CDS as the Remote Control and display device (RCD), configuring the possibility
to remotely access the CDS via tablets or other portable devices should be performed by EarlySense
authorized technicians and requires authorization from the facility’s IT/Biomed for network setup.
•EarlySense InSight should not be used adjacent to or stacked with other equipment and if adjacent or
stacked use is necessary, the InSight System should be observed to verify normal operation.

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•Portable RF communications equipment, including antennas, such as mobile phones, Walkie-Talkie,
mobile radios, etc. should not be used closer than 30 cm (12 inches) to any part of EarlySense System,
including its cables, as it can negatively affect its performance
WARNING
Due to the small size of the system’s label it can be read only from the intended position
of the user - from the user’s hand.
WARNING
Configuring the possibility to remotely access the bedside via tablets, computers or other
portable devices should be performed by EarlySense authorized technicians, and
requires authorization from the hospital IT/Biomedical department for network setup.
WARNING
All wireless systems are prone to intermittent signal dropout due to communication lost.
Make sure that the patient only has conditions that can tolerate intermittent monitoring
interruptions. Do not pause or turn off an alert remotely if patient safety might be
compromised.
WARNINGS
Patient harm risk. Do not pause or turn off an audible alert remotely if patient safety may
be compromised. Do not adjust a patient's alert limits as a way to silence an alarm.
Remote monitoring is not a substitution for frequent patient assessment by attending
clinicians, or a substitute for the alerting that occurs at the patient monitor.
Alerts and other events can go unnoticed if clinical personnel are not present at the
bedside or if interruptions occur in power, network connections or Monitoring Units
operation.
Explanation of System Labels
The following provide a description of the graphical symbols which appear on the EarlySense InSight System
components and package.
Table 1: System Label Description
Warning
Caution
Consult accompanying documents
Defibrillation proof, type BF applied part
Fragile, handle with care
Keep dry

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Indoor operation only
Class II equipment (double insulated electrical
Device, does not require a safety connection to
electrical earth)
Non-ionizing Electromagnetic Radiation
IP24
Solid object protected and splash-proof accessory
IP20
Solid object protected
Sorted disposal
Manufactured by:
Date of manufacture:
MR Unsafe- Keep away from magnetic resonance
imaging (MRI) equipment
Rx Only
US Federal Law restricts this Device to sale by or on
the order of a physician.
Temperature Range
Relative Humidity
Atmosphere Pressure

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Compliance with Standards
The EarlySense InSight System was tested and found to be in compliance with the following standards:
Standard
#
Medical Electrical Equipment –Part 1: General Requirements for Basic Safety
and Essential Performance
IEC 60601-
1:2005+CORR.1:2—
6+CORR
2:2007+A1:2012
Medical electrical equipment Part 1-6
General requirements for safety - Collateral Standard: Usability
IEC 60601-1-6:2010
+ A1:2013
Medical Electrical Equipment - Part 1: General Requirements for Basic Safety
and Essential Performance; Electromagnetic Compatibility -Requirements and
Tests
IEC 60601-1-2:2014
(Fourth edition)
and 2007+I-SH
01:2010 (third
edition)
Electromagnetic compatibility
and Radio Spectrum Matters (ERM);
Electromagnetic Compatibility (EMC)
standard for radio equipment and services
EN 301 489-1
V1.9.2:11;
EN 301 489-7
V1.3.1:05;
EN 301 489-17
V2.2.1:12
This equipment complies with IEC 60601-1-2 for electromagnetic compatibility for medical electrical
equipment and/or systems, ESD Air Discharge was tested to ± 2kV, ± 4kV, ± 8kV only.
See Appendix A for Manufacturer’s declaration and tables for specific information regarding compliance
with IEC 60601-1-2.
Supplying InSight Unit
The EarlySense InSight Device is shipped in a protective package. The Device should be unpacked and
installed only by an authorized EarlySense Technician.
The EarlySense InSight Device can only be operated by connecting to a Cradle. The Cradle is suppled
separately. For further explanation refer to EarlySense Cradle User Guide.
Supplying Sensors
The EarlySense Bed Sensing Units are supplied in a separate package. Each Sensing Unit is isolated to ensure
safe transport.
The EarlySense InSight System may also be provided with optional Chair Sensing Unit/s.
The EarlySense InSight System should be unpacked and installed only by an authorized EarlySense Technician.

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Terms, Abbreviations and Definitions
Table 2: Terms, Abbreviations and Definitions
Term/Abbreviation
Definitions
°C
Degrees Centigrade
F
Degrees Fahrenheit
AC
Alternating Current
AM
Ante Meridiem (L) –Before Noon
BF
Type BF applied part –medical device classification
BPAP
Bi-level Positive Airway Pressure
BPM
The number of heartbeats per unit of time (beats per minute)
Br./min
Breaths per minute
Braden Score
A scale for predicting pressure sore risk
CPAP
Continuous Positive Airway Pressure
CSV
Comma Separated Values (text file format)
ECG
Electrocardiography
EMC
ElectroMagnetic Compatibility
F
Female
FCC
Federal Communications Commission
FDA
US Food and Drug Administration
HIS
Hospital Information System
HR
Heart Rate
ID
Identification number
IEC
International Electrotechnical Commission
IFU
Instructions For Use
IP24
Solid object protected and splash-proof accessory
IT
Information Technology
Kg
Kilogram = 2.2 pounds weight
kHz
Kilohertz
LAN
Local Area Network
LED
Light Emitting Diode
M
Male
MHz
Megahertz
MR
Magnetic Resonance
MRI
Magnetic Resonance Imaging
MRN
Medical Record Number
OEM
Original Equipment Manufacturer
PDF
Portable Document Format
PIN
Personal Identification Number
PM
Post Meridiem (L) –After Noon
RCD UNIT
Remote Control and Display Device which can be EarlySense Central Display
Station (CDS) or other regulatory-approved central monitoring station
Q
Turn Interval
RR
Respiratory Rate
RF
Radio Frequency
Wi-Fi
Local area wireless technology

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Blank page for double-sided printing

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Introduction
This chapter introduces the EarlySense InSight and its components.
1.1 What Is the EarlySense InSight System?
The EarlySense InSight System developed by EarlySense Ltd. is designed for continuous and
contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body
motion; monitors patient movement and can notify users when the patient exits the bed. The
device can communicate numerical data on Heart Rate, Respiratory Rate and Movement. The
System can notify the Remote Control and Display (RCD) Unit when Heart or Respiratory Rates
averaged over time, passes above or below predefined limits.
Setting, viewing and adjusting the parameters of the InSight is managed by the Remote Control
and Display (RCD) Unit that can communicate with the InSight device according to its
predefined standard communication protocol.
Providing contact-free, passive monitoring capabilities, with no need for patient activation, the
EarlySense InSight System enables continuous monitoring of patients in hospitals or clinical
settings. The InSight Device has no display. The display of patients’ measurements, as well as the
individual setting is only available with the EarlySense CDS System or other regulatory-approved1
central monitoring station (i.e. Remote Control and Display - RCD Unit) that complies with the
minimum requirement specifications for the central monitoring station (See RCD Unit's
documents). For detailed information of using InSight with EarlySense CDS, please see EarlySense
CDS User Manual.
The basic System includes a Sensing Unit which is placed beneath the bed mattress or between
the mattress and a mattress pad/cover, a Chair Sensing Unit, a Cradle and an InSight Device
itself which processes the information detected by the Sensing Unit and sends it to the Remote
Control and Display (RCD) Unit. Monitoring of the patient may begin automatically as soon as
the sensor under the mattress detects bed entry. The data acquired by the System is continuously
logged into the InSight Device that is placed at the patient’s bedside. The data provided by the
System is intended to aid in the evaluation process of a patient's clinical status and should be
interpreted only by a Healthcare Practitioner.
The InSight device will communicate with the Remote Control and Display (RCD) Unit via LAN or
Wi-Fi communication protocol.
NOTE
The EarlySense InSight System has not been studied on any specific patient group,
nor has it been studied as a diagnostic tool for any specific disease or medical
condition. It is meant only as an adjunctive tool for measuring Respiratory Rate,
Heart Rate and Movement.
1The regulatory approval depends upon the geographic area of usage of the system- CE approval is
needed for European countries, FDA clearance for the USA market, etc.
1

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1.2 System Components
The system consists of a Sensing Unit, a Cradle and InSight Device, connected by a cable.
Figure 1: EarlySense InSight Components
1. InSight Device
3.Bed Sensing Unit (to be
placed under the mattress
2.InSight
Cradle

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1.2.1 Sensing Units
Bed Sensing Unit
The Bed Sensing Unit is placed under the mattress (See Positioning the InSight Device and Sensing
page 24) and detects physiological and motion signals generated by the patient. A solid base
plate is designed to be fixed to the bed’s frame for convenience during placement.
Chair Sensing Unit (Optional)
The Sensor is inserted into a cushion so that it is not in contact with the patient. The cushion can
be placed on a chair and is able to detect the patient’s Heart Rate, Respiratory Rate, and
Motion while seated.
Only one Sensigs device can be connected to the EarlySense InSight Device, either
the Bed Sensing Unit or the Chair Sensing Unit
If using an accessory switch (provided by Earlysense), Both Sensing units can be connected to
the InSight Device together.
Figure 2: Chair Sensing Unit- a cushion with a sensor incorporated inside
1.2.2 Sensing Unit Extension Cable
An optional extension cable for the Sensing Unit is available, if required.
NOTE
Use total length of extension cable which should not exceed 12 meters (39.36 ft.).
Sensor Cable
Chair Sensor
EarlySense Cushion
(Sensor included
inside)

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1.2.3 InSight Device
The display of patients’ measurements, as well as the individual setting is only available on the
Remote Control and Display (RCD) Device. For more elaborated explanation and user interface
details, please refer to the Remote Control and Display (RCD) Unit's User Manual.
Figure 3: InSight Device Indicators and Keys
NOTE
The EarlySense InSight System has not been studied on any specific patient group,
nor has it been studied as a diagnostic tool for any specific disease or medical
condition. It is meant as an adjunctive tool only for measuring Respiratory Rate,
Heart Rate and Movement.
NOTE
Sorted Disposal
Do not discard this product. Contact your local authorized representative for
additional information for collection and recovery programs available for this
product and for appropriate facilities for recovery and recycling.
Operational
Buttons
Front Panel
Power
indication LED
Communication with RCD
Alert LED
Cradle Lock Bar
Cradle Release
Button

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1.2.4 EarlySense InSight Device Controls and Indicators
The InSight Device contains the following controls and indicators:
1. Operational Buttons- located at the side panel, and can be configured to fulfill various
functions
2. LEDs -
A. Alert LED- indicates either a technical or a clinical active alert at this InSight
Device. Further information regarding Clinical Alerts can be found in “Clinical
Alerts” section on page 27
B. Communication LED - indicates if communication with external control and
display device is intact or not. Orange when connected and OFF when
disconnected
C. Power indication - confirms that the InSight Device is plugged to the power
socket. Green when connected and OFF when disconnected.
3. Responding to an Active Alert key- is made by pressing on the InSight Device (the entire
exterior shell operates as a button).
Figure 4: InSight Device- Side View
Sensing Unit
Connector
Network
Connector