EarlySense INSIGHT User Manual

EarlySense Modular

0344

EarlySense InSight

Bedside Unit

User Guide

ALL-IN-ONE • SAFETY • VITALS

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

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: +972-3-752-2330 Fax: +972-3-752-2340

USA Office

800 West Cummings Park, Suite 6400

Woburn, Massachusetts 01801

USA

Phone: +1-781-373-3228 Fax: +1-781-373-2367

Email: support.usa@earlysense.com

www.earlysense.com

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.

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

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

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

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.

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: (781) 373-3228.

• 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.

• 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.

• 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

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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