Welch Allyn EarlySense System 1.0 User Manual
Doc. No. MK600
SUBJECT: EarlySense User Guide – USA (FDA) version
REV. REVISION DESCRIPTION ECO
DATE NAME
NO.
7
8
9 Software ver. 3.0.13 ECO-11-21 June 2011 Shiraz
10 Clarifying “children” definition, updated
11 Change name of device to EarlySense
NAME
Added the need that cable of sensor to be
connected from back of the bed. – for
safety purposes
Changed pictured and changed labels,
class A EMC
cleaning and disinfection procedure and
changing “EverOn” to “EarlySense
System”
(Labels with the new “EarlySense” logo)
ECO-11-12
ECO-12-01 Dec 2011 Shiraz / Dalia / Aya
ECO-12-13 April 2012 Shiraz
Feb. 2, 2011
April 2011
Dalia Argaman
Dalia
DATE SIGNATURE
Written by: Shiraz Levkovich
Appr. Marketing Maayan Wenderow
Appr. Product
Roman Karasik
manager
Appr. Clinic., Regul. Dalia Argaman
Appr. QA Asaf Grosgold
EarlySense Ltd.
12 Tzvi St., Ramat Gan, Israel
Proprietary and Confidential
CONFIDENTIALITY NOTICE
This document contains valuable trade secrets and confidential information of EarlySense Ltd.
Nothing herein may be copied, reproduced or distributed in any form or any medium, or
disclosed to any third party in any manner, without prior written authorization of EarlySense.
The EarlySense System
(EarlySense Model 1.0 - Equivalent to model EverOn 1.0)
User Guide
i
EarlySense Ltd.
EarlySense 1.0
User Guide
Revised April, 2012
SW Version: 3.0.13
Document Num. MK-600 Revision Ver. 11
COPYRIGHT 2011 EARLYSENSE LTD. ALL RIGHTS RESERVED WORLDWIDE THIS MANUAL IS
PROPRIETARY TO EARLYSENSE LTD. UNAUTHORIZED USE, DISCLOSURE OR REPRODUCTION IS
PROHIBITED
EARLYSENSE TECHNOLOGIES ASSUMES NO RESPONSIBILITY FOR ERRORS THAT MAY OCCUR IN
THIS MANUAL. EARLYSENSE LTD RESERVES THE RIGHT TO MAKE CHANGES WITHOUT NOTICE
TO THIS EVERON MANUAL, ALSO REFERRED TO AS “THE EARLYSENSE SYSTEM”,AND THE
PRODUCTS DESCRIBED HEREIN.
Contact EarlySense at:
European Representative
MedNet GmbH
Borkstrasse 10
48163 Münster, Germany
Phone +49 251 322660
Fax +49 251 3226622
EarlySense Ltd.
Israel
EarlySense Ltd.
12 Tzvi St.,
Ramat Gan 52504, Israel
Web-site: www.earlysense.com
USA
EarlySense Inc.
135 Beaver Street,
Suite 211, Waltham, MA 02452
Phone: (781) 373 3228
E Mail: support@earlysense.com
Support Telephone:
East Coast - (617) 800-6668
West Coast - (818) 370-7748
Web-site: www.earlysense.com
Table of Contents
1 Introduction ....................................................................................................................... 1
The EarlySense System Bedside Monitor ........................................................................................... 1
About This Manual ............................................................................................................................... 2
Manual Conventions ............................................................................................................................ 2
Menus Screens and dialog boxes ............................................................................................................. 2
Warnings, Cautions and Notes ................................................................................................................. 3
Terms ................................................................................................................................................... 3
2 Safety ................................................................................................................................. 4
General Safety Guidelines ................................................................................................................... 4
General Hazards .................................................................................................................................. 4
Electrical Shock ........................................................................................................................................ 5
Defibrillation .............................................................................................................................................. 5
Electric Magnetic Interference .................................................................................................................. 5
WiFi Communication ................................................................................................................................. 5
Electrical Fire ............................................................................................................................................ 5
Classification ........................................................................................................................................ 5
Intended Use ........................................................................................................................................ 6
Contraindications for Use ..................................................................................................................... 6
Warnings and Cautions ........................................................................................................................ 6
System Labels...................................................................................................................................... 9
Bedside Unit Label.................................................................................................................................... 9
Sensing Unit Label.................................................................................................................................. 10
System Packaging Label ........................................................................................................................ 10
Explanation of System Labels ................................................................................................................ 11
Compliance with Standards ............................................................................................................... 12
How the Bedside Unit is supplied ...................................................................................................... 12
3 System Description ........................................................................................................ 13
System Components .......................................................................................................................... 13
Sensor .................................................................................................................................................... 13
Sensor Extension Cable ......................................................................................................................... 13
Bedside Unit Controls and Indicators ...................................................................................................... 14
Battery ............................................................................................................................................. 16
The EarlySense System’s User Interface and Screens ..................................................................... 17
User Interface ......................................................................................................................................... 17
System Messages and Alerts ........................................................................................................... 18
Screens .................................................................................................................................................. 18
Setting the volume level of the bedside unit (page 32).............................................................................. 21
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4 System Operation ........................................................................................................... 22
Overview ............................................................................................................................................ 22
Positioning the Bedside and Sensing Units ....................................................................................... 23
Turning the System On/Off ................................................................................................................ 24
Electrical Failure................................................................................................................................. 24
After Electrical Power is Restored .......................................................................................................... 26
Patient Information (Admit/Discharge) ............................................................................................... 26
Admitting a Patient.................................................................................................................................. 26
Discharging a Patient / Ending a Patient Monitoring Session ("Discharge") ........................................... 31
Pausing a Patient Monitoring Session ............................................................................................... 32
Setting the General Volume ............................................................................................................... 33
Alerts .................................................................................................................................................. 34
Alerts Table ............................................................................................................................................ 35
Multiple Alerts ................................................................................................................................ 36
Alert Triggers .......................................................................................................................................... 37
Alerting Parameters......................................................................................................................... 37
Modifying Alert Thresholds ..................................................................................................................... 38
Audible and Visual Alert Notification ....................................................................................................... 39
Blue Alerts .............................................................................................................................................. 39
Suspending Red and Yellow Alerts......................................................................................................... 40
Disabling and Enabling Alerts ................................................................................................................. 40
Alerts Setup ............................................................................................................................................ 42
Setting Individual Alert Volume and Tone ..................................................................................... 42
Silencing Alerts ............................................................................................................................... 43
Bed Exit .............................................................................................................................................. 43
Configuring the Bed Exit Alert ................................................................................................................. 44
Setting Bed Exit Sensitivity ............................................................................................................ 44
Patient Turn ........................................................................................................................................ 45
Setting the Patient Turn Interval ............................................................................................................. 45
Starting the Patient Turn Counter ........................................................................................................... 45
Documenting Patient Turn and Resetting Counter ................................................................................. 46
Air Mattress ............................................................................................................................................ 47
Patient Movement .............................................................................................................................. 48
Low Patient Movement Alert ................................................................................................................... 48
Patient Motion Detection ......................................................................................................................... 49
Recording and Viewing Events .......................................................................................................... 50
Manually Recording an Event ................................................................................................................. 50
Trends ................................................................................................................................................ 51
Trends Graph ......................................................................................................................................... 51
Alert Symbols ................................................................................................................................. 54
Event Symbols ................................................................................................................................ 55
Setting the Time Scale .................................................................................................................... 56
Analysis .................................................................................................................................................. 56
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Settings .............................................................................................................................................. 57
Brightness ............................................................................................................................................... 57
Choosing a Language ............................................................................................................................. 57
Maintenance ........................................................................................................................................... 58
Reports ............................................................................................................................................... 59
Generating Reports (Data Retrieval) ...................................................................................................... 59
Downloading Patient Data and Reports .................................................................................................. 59
5 Specifications, Maintenance and Troubleshooting ...................................................... 63
Specifications ..................................................................................................................................... 63
Physical Characteristics .......................................................................................................................... 63
Performance ........................................................................................................................................... 64
Electrical ................................................................................................................................................. 64
Operating Conditions .............................................................................................................................. 64
Storage and Transportation Conditions .................................................................................................. 64
Maintenance and Cleaning ................................................................................................................ 65
Cleaning and Disinfection of the Bedside Unit ........................................................................................ 65
Cleaning and Disinfection of the Sensing Unit ........................................................................................ 65
Troubleshooting ................................................................................................................................. 66
6 European Representative and Contact Information ..................................................... 67
iv
1 Introduction
The EarlySense System Bedside Monitor
The EarlySense System (also known as EverOn) is designed for continuous and contact-
free measurement of respiration rate and heart rate when the patient is lying in bed. In
addition the system tracks body motion and monitors patient movement and can notify
users upon patient bed exit .The system displays numerical heart rate, respiration rate and
movement level and graphical data of trends of these parameters.
The system's design allows the operator to adjust the settings of the threshold parameters
and notifies the caregiver when heart or respiration rate averaged over time, passes above
or below predefined limits. The system also allows the health practitioner to document
the changes in the patient's position in bed by recording the event. The system then
verifies the change in position and logs the information. The system also provides an
option to notify the health care practitioner if a specific amount of time has passed since
the nurse last changed the patient's position. The users can decide to activate or deactivate
these notifications.
Providing contact-free, passive monitoring capabilities, with no need for patient
activation or involvement, the EarlySense System enables continuous monitoring of
patients in home, hospital or clinical settings. The data acquired by the System is
continuously logged in a Bedside Unit, thus, when using the System at home, the data
may be later presented, in a time stamped format, for off-line health care practitioner
analysis.
The system includes a Sensing Unit that is placed beneath the bed mattress or between
the mattress and a mattress pad or mattress cover, and a Bedside Unit which sets the
system options and displays the collected data. Monitoring of the patient begins
automatically as soon as the patient enters the bed. The data acquired by the system is
continuously logged in the Bedside unit, thus allowing the data to be presented, in a time
stamped format. The data provided by the system is intended to aid in the evaluation
process of a patient's clinical status and should be interpreted by a health care practitioner
only.
1
Note
The EarlySense System has not been studied on any specific patient
group, neither has it been studied as a diagnostic tool of any
specific disease or medical condition. It is meant as an adjunctive
tool only for measuring respiratory rate, heart rate and movement
rate.
About This Manual
This manual provides the information necessary to operate the EarlySense system in a
safe and efficient manner. Please read the manual thoroughly and understand its contents
before operating the system. If any part of this manual is not clear, contact EarlySense
Customer Support for clarifications.
The manual is intended to serve as an accompanying document to the EarlySense system.
It is not intended to replace the users training course.
This manual should always accompany the unit, and all personnel operating the unit must
be aware of its location.
Manual Conventions
The following manual conventions are used throughout the manual.
Menus Screens and dialog boxes
The names of menus, screens and dialog boxes are presented in bold
2
Warnings, Cautions and Notes
Warnings, Cautions and Notes are used throughout this manual:
Terms
HR Heart Rate
RR Respiratory Rate
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 a damage to the equipment or to the quality
of measurements
Note
Notes contain helpful information and tips
3
2 Safety
General Safety Guidelines
Warning
• Handle the Bedside Unit with care. Do not drop, knock, or shake the Bedside
• The System is intended for indoor operation only.
• A damaged system should not be disposed of as unsorted municipal waste.
• Changes or modifications not expressly approved by EarlySense Ltd. could affect
• The EarlySense Sensing Unit should be used only with the EarlySense Bedside
• The EarlySense Bedside Unit is continuously operated equipment with water-
US Federal Law restricts this device to sale by or on
the order of a physician.
The data acquired by the EarlySense System should
be interpreted by a health care professional only.
Unit. Rough handling can damage the internal circuit boards.
Contact your local distributor for unit disposal.
the safety or effectiveness of the EarlySense System and void the system's
warranty.
Unit, and the EarlySense Bedside Unit should be connected only to the
EarlySense Sensing Unit.
proof splash sensor (IPX4).
General Hazards
• Do not use a damaged System. Use of damaged components might result in
malfunctioning of the System.
•
The EarlySense System should be installed and serviced only by qualified service
personnel, authorized by EarlySense Ltd
4
.
Electrical Shock
The system contains no user serviceable parts. Do not open the system covers.
The Bedside Unit is not waterproof. Keep the Bedside Unit dry to avoid electrical shock
or malfunction.
Defibrillation
The system is Defibrillation proof Type BF applied part.
Electric Magnetic Interference
This equipment complies with IEC EN 60601-1-2:2001 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 device. Medical electrical equipment needs special
precautions regarding EMC, and all equipment must be installed by qualified service
personnel.
WiFi Communication
The system incorporates an off-the-shelf certified Wifi communication card (complies
with FCC part 15)
Electrical Fire
Avoid placing liquids or food 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 such an event, only fire extinguishers approved
for use on electrical fires should be used. The device is not intended for use in the
presence of flammable mixtures.
Classification
Mode 1: The unit is classified as Class I
5
Mode 2: The unit is internally powered, continuously powered, ordinary portable
equipment with applied part (IPX4).
Only equipment specified in this manual and complying with requirements of EN60601
should be connected to the system
The system complies with IEC 60601-1, IEC 60601-1-2 and IEC60601-1-4 EMC class A
device.
Intended Use
The EarlySense system is intended for continuous measurement of respiration rate, heart
rate and movement, in an automatic contact-less manner, at home, hospital or clinic
setting. The system is indicated for use in children, adolescents and adults. The operation
of the EarlySense System 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
Contraindications for Use
The EarlySense System is contraindicated for use in:
• Patients in whom 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 or in the presence of flammable anesthetics or gases
Warnings and Cautions
• The EarlySense System should be installed and serviced only by qualified service
personnel, authorized by EarlySense Ltd.
• Mounting bed-side unit to the wall should be performed while exercising out-
most caution. DO NOT place the bed-side unit over patient’s head, to avoid
safety related conditions.
6
• Mounting of bed-side unit to the wall should be performed by mechanical experts
of the institution (e.g., Biomed/ engineering), to make sure safe attachment.
EarlySense is not responsible for any harm or damage related to wrongful
placement of the bed-side unit
• Implementation of the nurse call connector option provided in The EarlySense
Bedside Monitor requires coordination between the hospital and EarlySense. Do
not implement this option without consulting with, and receiving approval from,
the hospital administration.
• The data acquired by The EarlySense System should be interpreted only by a
health care practitioner.
• In the event that the EarlySense System does not operate properly, contact
EarlySense Ltd. customer support: (617) 800-6668 (for the east coast) or (818)
370-7748 (for the west coast).
• Never open the Bedside Unit 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
EN60601 might be connected to the system.
• Measurements may be affected by cable lengths. Shorten or extend the lengths
only according to the manual’s direction.
• Changes or modifications not expressly approved by EarlySense Ltd. could affect
the safety or effectiveness of the EarlySense System and void the System's
warranty.
• The System should be operated within a temperature range of 10-35°C (50-95 °F)
for the Bedside Unit, and 5-40°C (41-104 °F) for the Sensing Unit, and within a
relative humidity of 30-80%, non condensing.
• Do not use a damaged System. Use of damaged components might result in
malfunctioning of the System.
• Avoid placing liquids or food 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 for patients with poor bladder functioning or control, including small
children, when an EarlySense sensor is placed under their mattress.
7
• Do not share the bed with another person or pet during EarlySense 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 System and void the System's warranty.
• Do not use the EarlySense 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 a direct contact with the Sensing Unit. A mattress,
mattress pad or mattress cover should be always placed as a barrier between the
Sensing Unit of the EarlySense System and the patient. Patients should be
frequently checked to insure direct contact does not occur.
• Careful oversight should be provided when the EarlySense System is used with
children.
• As with all medical equipment, carefully route cables and connections to reduce
the possibility of tripping, entanglement or strangulation.
• Do not create sharp bends in the cable, as this may tear or break the shielding.
Warning
The EarlySense 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.
!
Caution: US Federal Law restricts this device to sale by or on the order of a
physician.
8
System Labels
Bedside Unit Label
Incorporates WiFi module
FCC ID: PD9WM3B2200BG
Figure 1: Bedside Unit Label
9
Sensing Unit Label
System Packaging Label
Figure 2: Sensing Unit Label
Figure 3: Packaging Label
10
Explanation of System Labels
The following provides a description of the graphical symbols that appear on the
EarlySense System components and package.
!
Caution/Warning
Consult Accompanying documents
Defibrillation proof, type BF, IPX4 applied part
Fragile, handle with care
Keep dry
Indoor operation only
Sorted disposal
11
Compliance with Standards
The EarlySense System was tested and found to be in compliance with the following
standards:
1.
2.
Medical electrical equipment- general requirements
for safety. Part 1: General Requirements for Safety
Medical Electrical Equipment - Part 1: General
Requirements for Safety; Electromagnetic
Compatibility -- Requirements and Tests
STANDARD
How the Bedside Unit is supplied
#
IEC 60601-8
(2006)
EN/IEC 60601-1-2
(2005)
The EarlySense System is shipped in a protective package containing the following
components:
• 1 Control Unit (Bedside unit)
• 1 Sensor
The System should be unpacked and installed only by an authorized EarlySense
technician.
12
3 System Description
System Components
The system consists of a Sensing Unit and a Bedside Unit connected by a cable.
1
1.Bedside Unit
2. Sensor
Figure 4: The EarlySense System Components
Sensor
The Sensor is placed under the mattress (See Positioning the Bedside and Sensing Unit,
page 23) and detects a signal generated by the patient's breathing, heartbeat and motion.
The sensor’s cable, which should be connected to the bedside unit, is three-meter long.
Sensor Extension Cable
Only if required, an optional two-meter extension cable for the sensor is available.
Note
2
Use only one extension cable per sensor.
13
Bedside Unit
The Bedside Unit shows system status, displays the heart rate, respiration rate, movement
level, patient turns and bed exit data, and allows system configuration.
1
1. Alert indicator key that can be
2
3
pressed as a response to an active
alert
2. On/Off
3. Suspend alerts for 15 minutes
5
Figure 5: Bedside Unit Indicators and Keys
Bedside Unit Controls and Indicators
The Bedside Unit contains the following controls and indicators:
1. Alert indicator key - the light will flash red in case of red alerts (e.g. heart rate,
respiration rate and bed exit), yellow in case of yellow alerts (movement and patient turn
reminder) and blue in case of technical alerts. While an alert is active, alert light key can
be pressed to respond to the alert.
4
4. Download reports
5. Speaker/ buzzer
2. ON-OFF button. Use the button to switch the bedside unit ON or OFF.
3. 15 min Suspend Key – Pressing it will disable the red and yellow alerts for 15 minutes.
No red or yellow alert will be given by the EarlySense System during the next 15
14
minutes after this action! Alert symbols on the screen will turn into a Timer (see Figure
6) to notify of this temporary suspension mode. Pressing the Suspend key button again
turns the alerts back on. Blue alerts cannot be suspended under any circumstances.
Figure 6: Suspension Timer
4. Download Reports Key – password will be required
1. USB Connector
2. Nurse Call Connector
1
3. Sensor Connector
4. Network Connector
2
4
Other connectors (for future use) are
clearly labeled as not in use.
3
Figure 7: Bedside Unit - Side View
15
Battery
Note
The nurse call in the EarlySense System is a UL1069 compliant
nurse call relay closure connector – Supplementary Device
The EarlySense bedside unit can interface with the existing nurse
call systems found in the hospital., though the actual connection to
the nurse call system requires the support of the Hospital
Biomedical Engineering department
The system is internally powered by a lithium polymer rechargeable battery that provides
power in case of a power failure (See Electrical Failure, page 24). The battery is not
intended to be replaced by the operator. In standard operating mode, the battery is
designed to allow approximately 30 minutes of operation while the unit is unplugged
from the Electrical Outlet, or in case of power failure.
The battery is automatically recharged by the system. In case the battery no longer
maintains the necessary charge, it must be replaced by an EarlySense authorized
technician. Contact EarlySense technical support.
Note
The system batteries will function when the system is unplugged. In
order to maintain the batteries adequately charged, make sure that
the system is always plugged in to the Electrical outlet during
routine operation.
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
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