Doc. No. MK600 SUBJECT: EarlySense User Guide – USA (FDA) version REV. REVISION DESCRIPTION 7 Added the need that cable of sensor to be connected from back of the bed. – for safety purposes 8 ECO NO. DATE NAME Feb. 2, 2011 Dalia Argaman April 2011 ECO-11-12 Dalia Changed pictured and changed labels, class A EMC 9 10 11 Software ver. 3.0.
The EarlySense System (EarlySense Model 1.0 - Equivalent to model EverOn 1.
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.
Table of Contents 1 Introduction ....................................................................................................................... 1 The EarlySense System Bedside Monitor ........................................................................................... 1 About This Manual ............................................................................................................................... 2 Manual Conventions .........................................................
4 System Operation ........................................................................................................... 22 Overview ............................................................................................................................................ 22 Positioning the Bedside and Sensing Units ....................................................................................... 23 Turning the System On/Off .....................................................................
Settings .............................................................................................................................................. 57 Brightness ............................................................................................................................................... 57 Choosing a Language............................................................................................................................. 57 Maintenance .......................................
1 Introduction The EarlySense System Bedside Monitor The EarlySense System (also known as EverOn) is designed for continuous and contactfree 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.
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.
Warnings, Cautions and Notes Warnings, Cautions and Notes are used throughout this manual: 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 Terms HR Heart Rate RR Respiratory Rate 3
2 Safety General Safety Guidelines Warning 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. • Handle the Bedside Unit with care. Do not drop, knock, or shake the Bedside Unit. 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.
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.
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.
• 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 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).
System Labels Bedside Unit Label Incorporates WiFi module FCC ID: PD9WM3B2200BG Figure 1: Bedside Unit Label 9
Sensing Unit Label Figure 2: Sensing Unit Label System Packaging 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.
Compliance with Standards The EarlySense System was tested and found to be in compliance with the following standards: STANDARD 1. 2. # Medical electrical equipment- general requirements for safety.
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 2 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.
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 pressed as a response to an active alert 2. On/Off 3 3. Suspend alerts for 15 minutes 4 4. Download reports 5. Speaker/ buzzer 5 Figure 5: Bedside Unit Indicators and Keys Bedside Unit Controls and Indicators The Bedside Unit contains the following controls and indicators: 1.
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 3. Sensor Connector 1 4. Network Connector Other connectors (for future use) are 2 clearly labeled as not in use.
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.
The EarlySense System’s User Interface and Screens User Interface Interaction with the user interface is via touch screen. Touching some functions (Such as the Discharge and Trends buttons) will open additional screens, while other buttons will open additional adjustment functions in the Home screen (Such as Patient Turn q and Bed Exit sensitivity level). For any interaction, the screen must be unlocked by touching the lock image in the upper left corner of the Home screen.
System Messages and Alerts There are four types of system messages and alerts: List of messages/alerts in this category Example High/Low HR High/Low RR Patient Signal Lost Bed Exit Patient Out of Bed Extremely High Motion Patient Turn is OFF – Low Patient Movement Patient Turn is OFF – Air Mattress Motion Detected Turn Counter Exceeded Technical Alert – indicates that there is a technical problem with the system: Check Sensor No AC Power Very Low Battery System Malfunction Functional Message - Informativ
1. Lock/Unlock status 2. Nurses details ( Name, Ext. Number and assigned color 3. Patient details (ID, Room and Bed numbers) 4. Date/Time 5. Battery status/AC indicator 6. Pause 7. Admit /Discharge patient 8. Enable/Disable heart rate alerts 9. Settable "High" HR threshold 10. Current heart rate 11. Settable "Low" HR threshold 12. Enable/Disable RR alerts 13. Settable "High" RR threshold 14. Current respiratory rate 15.Settable "Low" RR threshold 16. Enable/Disable movement alerts 17.
23. Clock time of last self movement 24.Operational buttons - to open additional screens Figure 8: Home Screen The following menus are accessed from the bottom of the Home Screen. Menu Use For Adding an event (See Recording and Viewing Events, page 50).
Viewing trends (See Trends, page 51) Setting or deactivating Alerts (See Alerts, page 34).
4 System Operation Overview The EarlySense System is designed to display and log respiration rate, heart rate and movement parameters in an automatic contact-free manner when the patient is lying in bed. The System is indicated for use in indoor environments. Monitoring of the patient begins automatically as soon as the patient gets into bed.
If the system cannot detect (or measure) the momentary heart or respiration rate for more than 1 minute, the last measured result of HR or RR will be displayed on screen in grey and the blinking heart or lung icon will stop blinking. Positioning the Bedside and Sensing Units The Bedside Unit should be mounted to the wall beside the patient’s bed.
Caution ! Handle the Bedside Unit with care. Do not drop, bang or shake the Bedside Unit. Rough handling can break the internal circuit boards. Figure 9: Positioning the Sensor and Bedside Units Turning the System On/Off Turn the EarlySense System "ON" by pressing the On/Off button on the front of the Bedside Unit (See Figure 5). The Admit Window will automatically appear. After admitting the patient, the Home Screen will be displayed.
The battery icon displayed on the main screen indicates the status of the battery and if the battery is being recharged. Figure 10: No AC Power Warning The battery icon displayed on the main screen indicates the status of the battery as follows: Battery is charged and Green with a lightning connected to a power outlet Green Battery is charged but disconnected from a power outlet Orange System is disconnected from power outlet, battery is not charged.
Red Battery is almost empty. System is about to shut down. The lightning symbol on the battery indicates that the battery is charging. After Electrical Power is Restored 1. Make sure that the system is plugged into the Electrical Outlet. 2. Turn the System On by pressing the On/Off switch on the front of the Bedside Unit (See Figure 5). The System automatically starts operating, as detailed above (see Turning the System On/Off – page 24).
Figure 11: Patient Admit Screen 2. Insert the patient's name (Letters only), MRN (ID) (Alphanumeric only), room number (digits only) and bed number (Alphanumeric only). The MRN (medical record number), Room No. and Bed No. must be entered for the patient to be admitted. Choose a color to assign the patient to a nurse, in case you are using the EarlySense Central Display Station (also referred to as “Patient Care Manager”) 3. To advance to the Patient Demographics screen (Figure 12) press Next. 4.
Figure 12: Patient Demographics Screen The following additional fields can also be entered but are not mandatory: Gender: Choose M or F. Date of Birth: Enter the patient’s date of birth (Figure 13).
Choose Done to finish admitting the patient, or Cancel to return to the Home screen without admitting the patient. If after 10 minutes you have not pressed a button the screen will close automatically without admitting the patient. 5. After pressing Done, you will be asked two setting questions. The first is whether you want to set a Bed Exit alert for this patient (Figure 14). If you choose Yes, the Bed Exit alert will be enabled automatically with the default setting of sensitivity level.
Figure 14: Bed Exit Alert Figure 15: Patient Turn Reminder 30
Discharging a Patient / Ending a Patient Monitoring Session ("Discharge") Warning To avoid recording patient data under an erroneous name you must perform the discharge procedure before beginning monitoring of a new patient. When the recording session is completed perform the "Discharge" procedure: 1. In the Home screen choose Discharge. The Confirm Discharge screen will open (Figure 16) 2. Choose Yes. Figure 16: Confirm Discharge Screen 3.
Figure 17: Admit Confirmation Screen 4. Touch Yes to admit a new patient and No to return to the Home screen without any patient being admitted. Pausing a Patient Monitoring Session The Pause button stops the recording session temporarily, while the patient’s identification and trends are saved. At any time the patient’s recording can be resumed, and all the previous trends will be displayed as usual.
Figure 18: Pause Screen 2. To continue the recording session, press Resume at the Pause Screen (Figure 18). Setting the General Volume The General Volume sets the volume of all alert tones. In addition volumes and tones for individual alerts can also be set (See Alerts Setup Setting Individual Alert Volume and Tone, page 42). Note that the alert volumes are determined by which of the two parameters (General or Alert) was set last and that the default setting for the alerts in the bedside unit is mute.
2. Push the Plus button to raise the volume or the Minus button to lower the volume. 3. Click OK to confirm The Volume icon is marked with an X if the volume is set to zero. Figure 20: Alerts Volume Off Status Alerts Alerts are used to notify personnel of situations that may require attention. The EarlySense System enables the user to define upper and lower thresholds for the heart rate, respiration rate, time out of bed and patient turn.
Alerts Table The system uses the following alerts: Message Color Description High/Low Heart Rate:___ Red Heart Rate exceeds thresholds. High/Low Resp. Rate:___ Red Respiration Rate exceeds thresholds. Bed Exit Red Bed Exit Red System detected that patient is out of bed for a time Sensitivity Settings: 1 (Low) – 6 (High) Patient Out of Bed interval exceeding a preset threshold. For ____ Min Patient Signal Lost Red System cannot detect patient’s signal. Check patient and sensor location.
Turn Counter Exceeded Yellow Threshold time interval for turning the patient expired. Blue Technical alert indicating that the sensor connection is ____ Hours Check Sensor malfunctioning. Reconnect/Replace Sensor or Restart Try to reconnect the sensor and if problem persists replace the sensor (See Troubleshooting page 66). No AC Power Blue An alert indicating that the EarlySense Bedside unit is disconnected from the electrical power outlet.
• Yellow A new alert will become active only if the currently active alert has a lower priority.
Time to alert for Low Respiration Rate High Respiration Rate Max. 150 seconds Max. 120 seconds change in RR Modifying Alert Thresholds When beginning to monitor a new patient, it is advisable to set patient specific alert thresholds. If relevant for a specific patient, Bed Exit alert sensitivity or duration and Patient Turn interval should be set from the relevant section in the home screen next to each function setting (see pages. 44 and 45). To change the default HR and RR thresholds: 1.
Thresholds can be set in the following ranges: Lowest settable limit Highest settable limit threshold threshold Heart Rate 35 BPM 150 BPM Respiratory Rate 8 Br/min 44 Br/min Audible and Visual Alert Notification When an alert is triggered an audible alert sounds and the corresponding alert parameter on the monitor main screen will be shown with its background color corresponding to the alert color, either red or yellow (Blue alerts are not connected to a specific monitoring parameter).
with an “OK” button and remain active as long as the alert condition exists. They disappear only after the technical issue is resolved. The rest of the information in this section relates to red and yellow alerts only. Suspending Red and Yellow Alerts Press the “OK” button to close an active alert (Figure 22). Notice that as long as the alert condition exists, the alert will show up again.
Figure 23: Bed Exit Off When the Patient Turn Counter alert is being disabled, the question “Are you sure you want to set patient turn alert off?” (Figure 24) To disable the alert, choose Yes.
To suspend all red and yellow alerts for 15 minutes, press the hardware Suspend alerts for 15 min button (Figure 5). Press again the same button to enable alerts. Alerts Setup Setting Individual Alert Volume and Tone Press the Alerts button on the bottom of the Home screen. The Alerts Setup screen will open (Figure 25).
• After setting up the alerts, touch Submit to activate these settings or Cancel to preserve the existing settings. Note In addition to changing the individual alert volumes as described above, you can also change the general volume (See page 32) or by setting volume and tone of all in the alerts setup screen. The alert volumes are determined by which of the two parameters (General or Alert) was set last. Note When a patient is admitted or discharged all alert settings will return to default.
Note If the patient is allowed to get out of bed without the nurse being notified, you can disable the Bed Exit alert by touching the bell in the In Bed section of the Home Screen. Configuring the Bed Exit Alert Bed Exit alert can be configured in terms of alert volume and tone (See Setting Individual Alert Volume and Tone, page 42) and sensitivity. Setting Bed Exit Sensitivity Press the Bed Exit Settings button on the lower right of the Home screen. The Bed Exit Settings Area will open (Figure 26).
The active mode of the Bed Exit alert is indicated by the bell icon at the Bed Exit section of the Home screen (Figure 27). Figure 27: Bed Exit Box Patient Turn Patient Turn is used to document change of the patient’s positioning in bed and to produce an alert if the interval set for changing the position has been exceeded (timer expired). The Patient Turn alert is also disabled by default. Setting the Patient Turn Interval The turn interval is referred to as "q".
Figure 29: Patient Turn Box – Disabled Counter Figure 30: Patient Turn Box – Enabled Counter Documenting Patient Turn and Resetting Counter After turning the patient, press Patient Turned within 1 minute from the time that the patient turn was performed. The system logs the event (Figure 31). In addition, the system detects the corresponding change in body movement and verifies the event.
Figure 32: Patient Turn Alert Screen Air Mattress If the Patient Turn alert is turned off and the system detects an air mattress in operating condition, the following alert will appear (Figure 33). Figure 33: Air Mattress Alert After you press “OK” you will be asked if you would like a patient turn reminder for the patient (Figure 34Error! Reference source not found.).
Patient Movement Movement rates are determined in terms of percentage of movement time within a defined period of time as described in the following table. The accuracy of the system in displaying different rates is also presented below.
Figure 35: Low Patient Movement Alert Patient Motion Detection In case that the Patient Turn Reminder is being used, and the system detects additional patient movement during the night – following the first Turn Reminder in the morning you will be suggested to consider re-evaluating Braden score (Figure 36).
Figure 36: Excess Patient Movement Detected Recording and Viewing Events Occurring events can be noted by the user and entered into the system for documentation purposes. These events will then appear in the Trends display. Manually Recording an Event 1. To access the Events menu click Events in the Home Screen. The Events menu appears ( 2. Figure 37).
3. Touch one of the four primary events on the left or secondary events on the right. The button changes color showing that it has been successfully chosen. The following message appears: Recording Event: 4. Touch the Home button to confirm your choice and close the screen or Cancel to cancel your choice. The following Events are available: Primary: • Emerg. Med.
Figure 38: Trends Data Screen Number Name Description 1 Current heart rate Current heart rate in beats per minute 2 Events Displays events that users have manually entered (for documented) during the time displayed 3 Respiratory rate Current respiratory rate in breaths per minute 4 Heart rate trends Displays heart rate in beats (graphs) per minute during the time displayed. 5 Respiration rate Displays respiration rate (graphs) in breaths per minute trends during the time displayed.
6 Scroll back Touch here to scroll back. 7 Alerts Displays alerts that occurred during the time displayed (See Alerts, page 34). 8 Time scale Time scale for data presented 9 Scroll forward Touch here to scroll forward. 10 Movement trends Shows patients movement level while in bed during the timescale presented (See Patient Movement, page 48).
Alert Symbols The following symbols are used in the Trends graph: Icon Meaning Blue Alerts —Technical Alerts: System Malfunction, Sensor Malfunction, Low Battery.
Event Symbols When entered by the user, the following Event symbols are used in the Trends Graph: Intubation Patient Fall Emergency Medication Continuous Medication – Routine Medication Pain Relief Medication Patient Agitation Skin Breakdown General Flag 1 - Can be used in order to mark any desired event of type 1 which is not included in the list of events General Flag 2 - Can be used in order to mark any desired event of type 2 which is not included in the list of events Patient Turn – Inserted au
Setting the Time Scale Upon entering the Trends screen, the default time scale displayed is 3 hours. You can return to this time scale at any time by touching the Default button. Use the buttons under the graph to determine the time scale displayed. If you choose a larger time scale the current time that is in the center of the time scale will remain the center. If you choose a shorter time scale you will be prompted to touch the screen to determine where you would like to center the displayed timescale.
Settings To access the settings click Settings in the Home Screen. The Settings screen has three tabs: Brightness, Setup and Maintenance. Brightness In the Brightness tab (Figure 40) Press the “-” to darken the screen, and press the “+” to brighten it. Please note that if the brightness level is set to the lowest level, the screen might be seen as black in daylight.
Figure 41: Setup Tab Maintenance This mode should be used only by a technician authorized by EarlySense Ltd. Entering the technician mode requires a password. To access the Technician mode, press the Maintenance tab (Figure 42).
Reports Generating Reports (Data Retrieval) Data analysis may be performed on-line during the monitoring session based on the bedside unit display or reports. Reports to be printed may be downloaded at the bedside unit or at the Central Display Station (See EarlySense Central Display Station manual). To ensure the privacy of the patient's medical data a PIN must be entered before reports can be downloaded. The data can be downloaded as CSV file and as a complete report in Acrobat PDF format.
Figure 43: PIN Window Figure 44: Downloading Message 4. The system will automatically download the data (CSV file) and the report for (.PDF) file of the last 2 admitted patients. 5. A message is displayed when the download is completed.
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Figure 45: Example of Printed Report (PDF File) 62
5 Specifications, Maintenance and Troubleshooting Specifications Physical Characteristics Sensing Unit Bedside Unit Dimensions 300 x 210 x 2.5 mm 250 x 260 x 110 mm Weight 160 g 3.
Performance Respiration Rate Heart Rate Movement Range 6 – 45 Br./min 30 - 170 BPM* 0, L, M, H, EH Averaging Period 1 Min. 1 Min. 15 seconds Accuracy ±4% or ±1.5 Br/min, whichever is ±4% or ±5 BPM, greater whichever is greater • The System detects heart rate that is > 1.8 times the respiration rate • Total system accuracy including undetected signals 90% for RR and for HR. The total system accuracy was measured as +/- 10% of the predicate device Alert Thresholds Default: Low=8 Br.
Maintenance and Cleaning The EarlySense System is designed to provide a trouble-free and maintenance-free operation. The only maintenance required is to keep the System clean and dry, and to verify that there is no physical damage to the Bedside Unit and to the Sensing Unit. The sensing unit should be replaced on an annual basis to ensure proper functionality of the system.
Troubleshooting Problem Possible Cause Solution The system is functioning but the AC icon is not displayed on the battery icon Screen is dark but LEDs are on System is unplugged from the Electrical Outlet Reconnect the unit to the Electrical Outlet. The screen was set to be darkened Touch the screen once, it will become brighter. To changes the brightness press the button Settings (see page no. 57).
6 European Representative and Contact Information Contact EarlySense at: European Representative MedNet GmbH Borkstrasse 10 48163 Münster, Germany Phone +49 251 322660 Fax +49 251 3226622 Israel Headquarters EarlySense Ltd. 12 Tzvi St., Ramat Gan 52504, Israel Website: www.earlysense.com 67 USA Headquarters EarlySense Inc. 135 Beaver Street, Suite 211, Waltham, MA 02452 Phone: (781) 373 3228 E Mail: support@earlysense.
