Doc. No. MK600 SUBJECT: EarlySense User Guide – USA (FDA
Contents
1. General Safety Guidelines Warning US Federal Law restricts this device to sale by or on the order ofa physician The data acguired 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 Contact your local distributor for unit disposal 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 EarlySense Sensing Unit should be used only with the EarlySense Bedside Unit and the EarlySense Bedside Unit should be connected only to the EarlySense Sensing Unit The EarlySense Bedside Unit is continuously operated equipment with water 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 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 Def2. SW Version 3 0 13 Document Num MK 600 Revision Ver 11 COPYRIGHT 2011 EARLY SENSE 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 EARLY SENSE SYSTEM AND THE PRODUCTS DESCRIBED HEREIN Contact EarlySense at EarlySense Ltd European Representative Israel USA MedNet GmbH EarlySense Inc Borkstrasse 10 ayete Lid 135 Beaver Street 48163 M nster Germany 12 Tzvi St Suite 211 Waltham MA 02452 Phone 49 251 322660 Phone 781 373 3228 Fax 49 251 3226622 ER EMail support gearlysense com Web site www earlysense com Support Telephone East Coast 617 800 6668 West Coast 818 370 7748 Web site www earlysense com Java COMPATIBLE TEPE OMON Table of Contents 1 Introduction DIE 1 The EarlySense System Bedside Monitor nennen 1 About T his Mar al iir ee ee ne 2 Manual Conventions nennen nemen nakuwa nema na irit nensi nitri rint irent eren tenens 2 Menus Screens and dialog boxes AA 2 Warnings Cautions andNotes ia nene nisi sh innen ns nlsi sienne nnne sins sd enn nnns 3 Ite M 3 WI AA Eege ege ee Ee 4 General Safety Guidelines manana enne nnns 4 General Haza
3. 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 1s intended to aid in the evaluation process of a patient s clinical status and should be interpreted by a health care practitioner only Note o The EarlySense System has not been studied on any specific patient group neither has it been studied as a diagn
4. 1s indicated by the bell icon at the Bed Exit section of the Home screen Figure 27 Bed Exit 3 min Settings Delay 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 For instance if you would like the system to generate an alert as a reminder to turn the patient every 2 hours set q to q2 To change the time interval between the turn reminders touch the q button in the Patient Turn box Figure 28 in the Home screen Figure 8 Using the arrows choose the relevant q number number of hours After 3 sec the arrows will disappear and the change will be applied Patient o EE Self Move Figure 28 Setting Patient Turn Interval Starting the Patient Turn Counter To enable and disable Patient Turn counter touch the Bell Icon in the Patient Turn section that is in the Home screen The counter will become enabled Figure 30 To disable the counter press the Bell icon again Figure 29 ae Y Patient 12 00 00 we An cl Turned U Turn Self Move 14 00 45 Figure 29 Patient Turn Box Disabled Counter Ka Patient s 00 01 en Tuned a Turn Self Move _ Figure 30 Patient Turn Box Enabl
5. 40 Disabling and Enabling Alerts nennen tenen etsi snnt ne EnEn wiki 40 Alerts DP tenemento ur UE hie re em discite ie Le m tried 42 Setting Individual Alert Volume and Tone sss 42 Silencing Aletts E 43 Bed 43 Configuring the Bed Exit Alert nennen ene nennen enhn en enne enne en 44 Setting Bed Exit Sensitivity aa 44 Patent M 45 Setting the Patient Turn Intervalle anna 45 Starting the Patient Turn Counter 0 2 cccesceeccessceseseseneessecceetecunsenesaenseedscesensesceseneuedeeseeceeessateeenaneesteses 45 Documenting Patient Turn and Resetting Counter sse enne 46 Ar Mattress IEEE 47 Patent MOVGMeNt Ia 48 HEo azul 48 Patient Motion BI 49 Recording and Viewing Events 50 Manually Recording an Event 50 Trends AA AA MU UII MUI IM 51 Trends Graph m 51 let beleet eegene ee get eegend ee 54 Event ON IA Aa 55 Setting the Ken 56 Kinyina AA EA 56 Iure 57 BriQhtM SS cfTe 57 Choosing a Language irte tre rtc eo eo nee un 57 Mamtenance E 58 BC ct E m 59 Generating Reports Data Retrieval sssessesee eee eme nnne enne nennen 59 Downloading Patient Data
6. I j v Pause Discharge oom 014 Bed 2 E HR RR i Motion 730 32 901 16 0 None 40 S Ste Bed Ext Sensitivity KW Patio cz li we Bed E si pA y 90 00 e ib Settings M23456 ured Turn Self Move 14 00 In Beg Low High Ve en 7 3 Aa p e Dei 4 ken 2 Settings Events Trends ert Volume 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 If any of the parameters as set by the user cross these specified thresholds an audible and visual alert notification is triggered 34 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 Sensitivity Settings 1 Low 6 High Patient Out of Bed Red System detected that patient is out of bed for a time For Min interval exceeding a preset threshold Patient Signal Lost Red System cannot detect patient s signal Check patient and sensor location Extremely High Motion Yellow Patient Movement Level has been extremely high during the last minute Patient Turn is OFF Yellow Patient Movement Level has been very low during Lo
7. Medium High Extremely High 18 Enable Disable out of bed alert 19 Bed Exit Settings 20 Enable Disable Patient Turns Counter 21 Patient Turn Counter Time passed since last turn documented by nurse 22 Patient Turn Protocol Settings q the counter time setting 1 Hour 2 Hours 4 Hours 6 Hours indicating the number of hours between each reminder 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 Recording Event Emerg Med Cancel 20 mn ib 50744 1220 A 110 55 00 20 00 40 01 00 01220 01 40 02 00 al IM i 2 16 Viewing trends See Trends page 51 PU RR LS es Movement p Turn tk Bed Alerts Setup e 5090020 a s mesas qum m i 1 sief e hu E Aprid 2011 242 nm o e ee T 1 ee em e ee mom Setting or deactivating Alerts See Alerts page 34 Setting the volume level of the bedside unit page 32 Access advanced functions 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
8. 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 In case of CSV file the data can be viewed by the physician using standard available software e g Microsoft Excel The data is presented numerically any other desired graph can be generated by the physician based on the data The PDF report includes both numerical and trend vs time graph that can also be printed and includes information about Heart and Respiratory rates as well as patient s movement in out of bed status alerts history and patient turns See Figure 45 for an example Warning aD The data acquired by the EarlySense System should be interpreted by a healthcare practitioner only Downloading Patient Data and Reports 1 Insert a flash drive with at least 0 5 GB of free space into the USB slot If the flash drive is already inserted it must be removed and re inserted before commencing the data download procedure 2 Press the Download Report button See Figure 5 on the front panel 3 You will be prompted to insert a PIN Figure 43 and click Submit A message will appear on the bottom of the screen informing you that downloading has commenced Figure 44 59 Enter PIN Please Enter your PIN Number unii er Figure 43 PIN Window D 32456BG5 Q W E La P
9. and Renorts enne enne nene enne nns 59 Specifications Maintenance and Troubleshooting eseeeeuuuus 63 Specifications m 63 Ce Ee 63 PEN IA IA AAA 64 BEI ii E 64 lee ele 64 Storage and Transportation Conditions eene enne nnne nennen 64 Maintenance and Cleaning nennen eee en eren enter r enter nennen nnne 65 Cleaning and Disinfection of the Bedside Unit emm eene 65 Cleaning and Disinfection of the Sensing Unit 65 Troubleshooting RM 66 European Representative and Contact Information esee esses 67 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
10. hri e 16 The EarlySense System s User Interface and Gcreens nenne 17 ser Interface a rane 17 System Messages and Alert 18 ele IM A ee i ele Lee 18 Setting the volume level of the bedside unit page 32 seen 21 System OberatiQfi EE 22 aT AN 22 Positioning the Bedside and Sensing Units ssssssssee eene nennen 23 Turning the System On Off niwa renee ennemi nennen EAEAN muwazi nennen nnne 24 Electrical F allure iier ine ia ete sete ei Lec baee pa dece ae teet abd esa tae 24 After Electrical Power is Restored 1 iecit ce erg eibi ace KAKA kei nis andes 26 Patient Information Admit Discharge sss nene nenne nennen ener enne 26 Admitting Ed EE 26 Discharging a Patient Ending a Patient Monitoring Session Dischamge nennen 31 Pausing a Patient Monitoring Session eene nennen nennen nennen nnns 32 setting the General VOM G trn ee nee 33 ACS AAA AAA KAA AA WAA AWA KA AAA KA LEES ee E 34 Alerts Table 35 Multiple Alerts cocci ttr rrt nr E EO E ei P kan 36 Alert lie le 37 Alerting Parameters II HA ia 37 Modifying Alert Kl Ce 38 Audible and Visual Alert Notification nani rennen nn 39 BIA ai AE 39 Suspending Red and Yellow Alerte wakuwa nn
11. non adjustable Blue alerts appear only 39 with an OK button and remain active as long as the alert condition ezists 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 ezists the alert will show up again To close an active alert and temporarily disable for 15 minutes all red and yellow alerts press the 15 min Suspend Alert button Figure 22 To cancel the 15 min suspension press twice on the external Suspend alerts for 15 min button See Figure 5 Disabling and Enabling Alerts When beginning to monitor a new patient it is advisable to set the specific alerts that should be enabled for this specific patient By default all alerts apart from the Bed Exit and Patient Turn alerts are enabled Per each patient s condition the user is advised to enable Bed Exit or Patient Turn alert as required To disable alerts for specific parameters touch the bell symbol next to the alert in either the Home screen or the Alerts Setup screen To enable alerts touch the bell symbol again If an alert is disabled while the alert is active the alert will remain active until it is suspended by the user When the Bed Exit alert is being disabled the question Are you sure you want to set bed exit
12. temporarily disconnected from the bedside unit to avoid a blue Check Sensor technical alert from sounding this function should be used for example when the patient needs to be transported with his her bed and the sensor needs to be disconnected from the Bedside unit To pause the recording session 1 Press the Pause button at the Home screen See Figure 8 A Pause screen will be displayed Figure 18 32 D The Session is paused for ID RTY5 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 At startup and when admitting a new patient following discharge the system returns to default alert settings To set the General Volume 1 Choose the Volume button from the Home screen The General Volume box opens Figure 19 Figure 19 General Volume Box 33 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 4563RT R T
13. 5322 1421 93 TRE 08 E a 2011 S424 1521 06 D May 23 2011 4922 1421 06 D Bar O Sedat DD Undedtt Total May 22 2011 12 00 AM May 22 2011 11 589 PM 23 66 M Gell 200 AM i ef P es Prosctres Pattern Care Peoactwe Pariest Cave 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 0 kg Materials ABS Poly carbonate ABS Poly carbonate 63 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 e The System detects heart rate that is gt 1 8 times the respiration rate e 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 min High 32 Default Alert Low 40 Default Low 0 Br min BPM High 130 BPM High Extremely High movement gt minute Min Max settable Alert Thresholds Low 8 Br min Low 35BPM High 44 Br min High 150
14. BPM Electrical Voltage Input Range 100 240 VAC 50 60 Hz 0 9A max Battery Rechargeable battery Fuses 2x 1 Amp Isolation Medical grade isolation between the Bedside Unit and the power supply Operating Conditions Relative Humidity 30 80 non condensing Ambient Operating Bedside Unit 10 35 C 50 95 F Temperature Sensing Unit 5 40 C 41 104 F Storage and Transportation Conditions Temperature Range 0 50 C 32 122 F Relative Humidity 10 90 non condensing 64 Maintenance and Cleaning The EarlySense System is designed to provide a trouble free and maintenance free operation The only maintenance reguired 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 Cleaning and Disinfection of the Bedside Unit Gently wipe the exterior of the Bedside Unit using soft slightly damp cloth wipes containing anti septic substances Wipes containing alcohols Chlorohexidine and bleach material with concentration up to 5 can be used Avoid excessive liquids Caution e Never open the Bedside Unit housing as this may damage the system e Handle the Bedside Unit with care Do not drop knock or shake the Bedside Unit Rough handling can damage internal circuit boards Cleaning and Disi
15. Doc No MK600 SUBJECT EarlySense User Guide USA FDA version REVISION DESCRIPTION DATE NAME NO 7 Added the need that cable of sensor to be Feb 2 2011 Dalia Argaman connected from back of the bed for safety purposes April 2011 ECO 11 12 Dalia Changed pictured and changed labels class A EMC Software ver 3 0 13 ECO 11 21 June 2011 Shiraz Clarifying children definition updated ECO 12 01 Dec 2011 Shiraz Dalia Aya cleaning and disinfection procedure and changing EverOn to EarlySense System Change name of device to EarlySense ECO 12 13 April 2012 Shiraz Labels with the new EarlySense logo NAME DATE SIGNATURE Written by Shiraz Levkovich Appr Marketing Maayan Wenderow We BEE SE E Appr Product Roman Karasik Appr Clinic Regul Dalia Argaman Appr QA Asaf Grosgold AAA EarlySense 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 EarlySense Proactive Patient Care The EarlySense System EarlySense Model 1 0 Equivalent to model EverOn 1 0 User Guide EarlySense Ltd EarlySense 1 0 User Guide Revised April 2012
16. IPX4 CE nada Figure 2 Sensing Unit Label System Packaging Label Earlysense zZaiySene System Contents wl 1 Control Unit EarlySense Ltd 12 Tzvi St 52504 Ramat Gan ISRAEL Tel 202 470 3430 Figure 3 Packaging Label 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 kd Defibrillation proof type BF IPX4 applied part Fragile handle with care nda af D Keep dry Indoor operation only Sorted disposal mt Os Compliance with Standards The EarlySense System was tested and found to be in compliance with the following standards SAD LE k Medical electrical equipment general requirements IEC 60601 8 for safety Part 1 General Requirements for Safety 2006 How the Medical Electrical Equipment Part 1 General EN IEC 60601 1 2 Requirements for Safety Electromagnetic 2005 Compatibility Requirements and Tests Bedside Unit is supplied The EarlySense System is shipped in a protective package containing the following components e 1 Control Unit Bedside unit e 1 Sensor The System should be unpacked and installed only by an authorized EarlySense technician 3 System Description System Components The system consists of a Sensing Unit and a Bedsid
17. alert off Figure 23 To disable the alert choose Yes 40 Bed Exit Off LI apr JE Are you sure you wantto set bed exit alert off Figure 25 bed Ex 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 Patient Turn Off Are you sure you wantto set patient turn alert off In case the alerts are disabled for a specific parameter the bell icon for the corresponding parameter in the main and alerts setup screens will be marked with an X as follows 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 When entering the Alerts Setup screen the current status of all alerts as shown in the following list is displayed eAlert volume eTone eEnabled disabled Alerts Setup Apr 10 E zd amp J HR SEET RR m i Movement Turn Bed Figure 25 Alerts Setup Screen e Click the plus or minus button to raise each alert volume e Press buttons 1 2 or 3 to choose a Tone 42 e After setting up the alerts touch Submit to activate these settings or Cancel to preserve the existing settin
18. ary Emerg Med Emergency medication given when patient is in distress CPAP BPAP Intubation Patient Fall Secondary Trends Continuous Med routine medication Pain Relief Med pain relief medication Patient Agitation Skin Breakdown a situation that may lead to pressure ulcer development General Flag 1 can be used in order to mark any desired event of type 1 which 1s 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 Trends are displayed in a graph format Trends Graph To view the Trends Data click the Trends button in the lower section of the Home Screen To advance or go back in the time frame press the forward or back arrows 51 ALS TERM io 50744 Trends nalysis J u Jun 20 2011 04731 H ce Cy om 55 M 16 Hg a 100 ur NU N LS 90 May 19 t eM 00 20 00 40 01 00 01 20 01 40 02 00 02 20 02 40 03 00 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 di
19. ause Discharge 1 014 8 2 m Figure 44 Downloading Message The system will automatically download the data CSV file and the report for PDF file ofthe last 2 admitted patients A message is displayed when the download is completed 60 Patient Status Aepert aiu 999999 EarlySense EarlySense Paiieni Status Repani wian Cr 9 Firmar Tie United A a It TIS PM Pal IW Med iet Ma 272 0017 114 PF Acres Mag 14211 2 41 EN Worm es KI il Hari Reom hed ihr kawai buitake at Gender Merisia C i Sania 2011 tcc am Mary 24 2011 a i e i E wl n EE en Be S iam E aat Si Bacci Am To Pm pm GE un em mg mm om ppm zm Cohen Lessor Patient Status Report Pate 10 999999 Proxtive Patient Core Patient Status Report Paka 1 999999 Proectwe Patient Care Updated Ay 23 2011 11 49 PM Admitted May 19 2011 241 PM Updated May 23 2011 11 49 PM Admitted May 19 2011 7 41 PM Roem bed 30V Date ot Birth Roon bad205 2 Hite H Gender Initial H Gender Elpatient Turns Qocumemed se the edit 0000000000000 Alerts and Trends Hep Bnitiat Settings as of May 22 2011 at 4 00 am HR alert Amis 40 120 506AM V 0 0047 AA AR alert ims 8 20 20 AI 081 Bed ext alert Sensitivity 2 1 lowest 6 highest 059M V Patient Tum Counter OFF Je ER WK UC Movement Alert ON Rm V pa 44 Fl Cumulative Trond Age mg egen 00 00 04 000M eme 2011
20. bed The System is indicated for use in indoor environments Monitoring of the patient begins automatically as soon as the patient gets into bed The system design allows the user to set high and low threshold parameters that will alert the user if either heart or respiration rate have crossed predefined thresholds The system can alert the user if patient leaves the bed bed exit and allows the healthcare practitioner to document that s he changed patients position in bed The health care practitioner can insert the event of patient s change of position by documenting the event on the EarlySense bedside screen The system then verifies the change in position and logs the information The system also provides an option to notify the user if a certain amount of time as set by the user has passed since last position changing timer expired The users can decide to activate or deactivate these notifications Data 1s continuously presented on the Bedside Unit main screen The data obtained during the monitoring period is recorded by the system in order to enable off line presentation and data printing The Sensing Unit should be placed under the mattress underneath the patient s chest area and the system should be turned on After approximately 60 120 sec of the patient lying in bed in resting position the system will begin displaying the monitored values on the bedside Unit Home screen By entering the patient s basic information MRN I
21. cally the patient will be admitted and the Bed Exit alert and the Patient Turn Reminder will remain disabled 29 Bed Exit Alert ou want Bed Exit Alert for this pati Figure 14 Bed Exit Alert Patient Turn Reminder Do you want a Patient Turn reminder for this patient Figure 15 Patient Turn Reminder 30 Discharging a Patient Ending a Patient Monitoring Session Discharge Warning STOP 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 Discharge Patient Are you sure you want to discharge the patient Figure 16 Confirm Discharge Screen 3 You will be asked if you want to admit a new patient Figure 17 31 Admit New Patient Would you like to admita new patient 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 Pause should be used when the sensor is
22. d on automatically and can also be found by touching the Admit button in the upper right corner of the Home screen Monitoring can take place without entering a patient ID MRN however it is advisable to enter a new patient ID before starting the monitoring otherwise the monitored information will not be saved and the information will not be transferred to the main nurses station 1 Choose Admit in the Home Screen The first Admit Patient screen will open Figure 11 Note Only letters can be entered in the first and last name boxes and only alphanumeric characters can be entered in the ID box 26 Home Admit Patient Ss sed REH Mame Name Name o ANN eane DN bei ENEE Fabregas WI Nasri wwsner tests ja Clichy lt Back 1of2 Ned o 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 Toreturn to the Home screen without admitting the patient press Cancel or Home To admit the patient and return to the Home screen press Done After pressing Done two questio
23. d 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 2 10 Kg and adults weight lt 111 Kg during sleep and resting condition Note e Definition of Age for Children Children aged 2 and above Contraindications for Use The EarlySense System is contraindicated for use in e Patients in whom proper positioning cannot be achieved or maintained e Patients who do not meet the weight limits tested or specified e Situations where a dry environment cannot be ensured e AnMR environment e An explosive atmosphere or in the presence of flammable anesthetics or gases Warnings and Cautions e The EarlySense System should be installed and serviced only by qualified service personnel authorized by EarlySense Ltd e 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 Mounting of bed side unit to the wal
24. e Unit connected by a cable 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 1s three meter long Sensor Extension Cable Only if required an optional two meter extension cable for the sensor is available de Note Use only one extension cable per sensor 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 ID 123123456 gt Dum Ol aal 20 1 Alert indicator key that can be w m Zeg pressed as a response to an active 85 42 EH i i 2 On Off ib 3 Suspend alerts for 15 minutes 4 Download reports 5 Speaker buzzer 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 2 ON OFF button Use the button
25. ed 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 The verification will appear in the printed report of the same day See Reports page 59 Cancel rent Patient Turned Figure 31 Recording Patient Turned Event If the patient turn interval passes without the Patient Turned button being pressed by the user a Patient Turn alert will occur Figure 32 indicating that the counter has exceeded its time threshold The alert message will disappear by pressing Ok or by documenting a patient turn by pressing Patient Turned If Ok was pressed but the Patient Turned button was not pressed within 15 minutes the alert will go off again 4563RT R T LT 014 2 A Pause Discharg a RR Motion 32 16 5 Patient q j e Bed Ex en Turned jm Seege YA 3436 d In Bed Les LI 4 N amp N b 46 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 Pause Discharge 4563RT R T me 014 Bed 2 Apr 10 2 14 06 VIS D e 32 Figure 33 Air Mattress Alert After you press OK you will be ask
26. ed if you would like a patient turn reminder for the patient Figure 34Error Reference source not found Patient Turn Reminder WA H Do you want a Patient Turn reminder for this patient Figure 34 Patient Turn Reminder In addition if an air mattress is not detected and a Turn Counter Exceeded alert is generated you will be suggested to consider using an air mattress 47 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 Rate Percentage of movement Accuracy of rates Accuracy of rates during defined period displayed displayed For children For adults 0 0 100 100 L Up to 40 100 100 M 40 60 81 81 H 60 80 100 86 EH 80 100 96 94 Patient movement over time can be viewed in Trends See Trends page 51 Low Patient Movement Alert Alerts for movement are displayed in cases of low and extremely high movement An alert for Low movement Figure 35 may come up once a day at 6 00 AM if during the night 00 00 6 00 the amount of patient movement or activity level was below a certain threshold which might imply the patient is in risk for developing pressure ulcers Following dismissing the alert of low movement you will be asked if you want a Patient Turn reminder for this
27. edication Patient Agitation oe ee ee Skin Breakdown bod 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 automatically if a staff member pressed the RESET on patient turn counter and the system detected that patient turn occurred 55 Setting the Time Scale Analysis 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 The Analysis function allows you to see the average respiration heart rate and movement time percentage for a specified interval each day Touch the Analysis in the trends screen to open the Analysis screen Figure 39 g W Analysis Start End se time slot M1200 A 1400 A Show Data Date RR Movement 18 02 09 12 25 00 Figure 39 Analysis Screen Use the arrows to set the time slot you want and then click Sho
28. eration 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 o 1 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 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 If the user attempts to press the touch screen while the system is locked the lock in the upper left corner will show a red flash System Messages and Alerts There are four t
29. gs Note o 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 o When a patient is admitted or discharged all alert settings will return to default Warning 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 STOP The Audible alert in the EarlySense System is not intended for equipment Silencing Alerts A green bell icon indicates that the alert is active Silence alerts volume by setting the alerts volume to zero in either the general alerts volume icon in the Home screen or in the Alerts Setup screen In case the alerts are silenced for a specific parameter the bell icon for the corresponding parameter in the main screen will be displayed with a mute sign as follows Bed Exit The EarlySense System tracks if there is a Bed Exit This alert is disabled by default 43 Note i 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 v
30. horized EarlySense representative Warning If you mount the Monitor to the wall ensure that the wall mount is not placed directly above the patient s bed Caution The patient should not be in direct contact with the Sensing Unit A mattress mattress pad or mattress cover should always be placed as a barrier between the Sensing Unit of the EarlySense System and the patient 23 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 To turn the system off press the On Off switch on the front of the Bedside Unit You will be asked if you are sure you want to turn the system off Confirm turning off by hitting Yes on the touch screen Electrical Failure In case of electrical failure the internal system battery allows the system to function for approximately 30 minutes Check that the problem is not with the system itself by verifying that the power cable is not damaged and is connected both to the Electrical Outlet and to the Bedside Unit 24 The battery icon displayed on the main screen indicates the status of the batte
31. ibrillation 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 Mode 2 The unit is internally powered continuously powered ordinary portable equipment with applie
32. ity of 30 8096 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 e 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 e Avoid using heating blankets Use of heating blankets could affect the safety or effectiveness of the EarlySense System and void the System s warranty e 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 e 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 e Careful oversight should be pr
33. l 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 humid
34. malfunction occurs while an elevated HR is in progress this situation is defined as a multiple alert There can only be one active alert at a time If an additional alert occurs while an alert 1s already active the system will then determine which alert will be active according to the following priority e Blue e Red 36 A new alert will become active only if the currently active alert has a lower priority Alert Triggers Default alert status is Yellow Alert Status Heart Rate ON Respiratory Rate ON Movement ON Patient Turn counter OFF Bed Ezit OFF Default alert threshold values are Low limit threshold High limit threshold Heart Rate 40 BPM 130 BPM Respiratory Rate 8 Br min 32 Br min Patient Turn counter 2 hours default Bed Ezit default Immediate sensitivity 3 Alerting Parameters Low Heart Rate High Heart Rate Time to alert for change in HR Maz 60 seconds Maz 60 seconds 37 Low Respiration Rate High Respiration Rate Time to alert for change in RR Maz 150 seconds Maz 120 seconds 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 Ezit alert sensitivity or duration and Patient Turn interval should be set from the relevant section in the ho
35. me screen next to each function setting see pages 44 and 45 To change the default HR and RR thresholds 1 Touch the upper or lower thresholds in the HR or RR boxes in the Home screen 2 Touch the down pointing arrow to lower the threshold or the up pointing arrow to raise the threshold Figure 21 3 When you reach the desired threshold touch the number displayed or wait 38 Figure 21 Adjusting the HR Upper Threshold 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 A message will appear on the bottom of the window detailing the nature of the Alert Figure 22 and the time passed since alert was raised Room 014 Bed 2 l 11 14 0 E V e d Y Tanz Sa RR rre Motion 32 54 16 0 None 40 8 Filet a2 00 03 ra Beie Turned Settings In Bed Figure 22 Alert Screen Blue Alerts Blue alerts are managed differently than yellow or red alerts Blue alerts cannot be suspended their volume is set at maximum and is
36. nfection of the Sensing Unit Gently wipe the Sensing Unit using a soft slightly damp cloth wipes containing anti septic substances Wipes containing alcohols Chlorohexidine and bleach material with concentration up to 596 can be used Please ensure that the sensor is dry before re use Avoid excessive liquids Caution 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 65 Troubleshooting Possible Cause The system is functioning but the AC icon is not displayed on the battery icon Screen is dark but LEDs are on Blue Alert is On System Malfunction Message Blue Alert is On Check Sensor Message Blue Alert is On Low Battery Message Bedside Unit is not responding ON OFF is not possible The Bedside Unit is operating but no HR or RR is displayed System is unplugged from the Electrical Outlet The screen was set to be darkened or Technical problem System Malfunction Bedside Unit has detected that the sensor is not connected System is unplugged and battery is discharging No electrical power as system is unplugged and battery is discharged or System error Difficulty in detecting a signal Reconnec
37. nitials into the system the data will be transferred to the Central Display Station 1f being used Heart and respiration rates and patient movement level will be continuously displayed on screen Heart and lung icons will blink and the values will appear in white on the screen as long as measurements of HR and RR are current 22 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 The power cable should be connected to the power outlet and the short telephone cable should be connected to the monitor from one side and to the sensor cable on the other side Please make sure the cable is not trailing on the floor Place the Sensing Unit under the patient s mattress and locate it underneath the chest area horizontally Position the sensor so the top surface is facing upwards as marked See Figure 9 Position the cord that connects between the Sensor and the Bedside Unit so that it comes out from under the mattress from the head of the bed in order to not interfere with the movement of the patient in and out of bed If the sensor is placed on a metal framework that does not allow solid support for the sensor please consult your aut
38. ns regarding the required settings will show Figure 14 Bed Exit Alert Note The Patient Demographics screen will not open unless a patient ID MRN has been entered 27 Admit Patient ee WO FO omoto EOIS ooo ooon REIT 2 ors Net 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 Select Date of Birth Figure 13 Date of Birth 28 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 After pressing Done you will be asked two setting guestions 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 If you choose No the Bed Exit alert will be disabled After answering the first question you will be asked whether you want a Patient Turn reminder for this patient Figure 15 If you choose Yes the Patient Turn Counter will be enabled automatically with the default setting of a reminder every 2 hours and if you choose No the Patient Turn Counter will be disabled If after 1 minute you have not pressed a button the screen will close automati
39. olume 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 Figure 26 the Bed Exit Settings Area The Bed Exit Alert can be set either to provide an immediate alert when the patient exits the bed varying in 6 levels of bed exit sensitivity levels or to provide an alert when the patient has been out of bed for a period ranging from 3 20 minutes Use the arrows to choose the desired delay or sensitivity setting After 3 sec the arrows will disappear and the change will be applied e If you want an immediate alert when a patient exits the bed click the arrows to choose a sensitivity ranging from 1 6 with 1 being the least sensitive and 6 being the most sensitive Note that sensitivities 5 and 6 are highly sensitive and might be triggered due to excessive movements of a patient while in bed e f you want the system to alert after a period of time that the patient is out of bed choose the time duration you would like between when the patient leaves the bed and when the alert sounds Use the same set of arrows that you use to set the sensitivity to select the number of minutes for the delayed Bed Exit alert The Bed Exit alert is disabled by default Enable the Bed Exit alert by pressing the bell icon 44 The active mode of the Bed Exit alert
40. ostic 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 Warnings Cautions and Notes Warnings Cautions and Notes are used throughout this manual Warning STOP 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 C Notes contain helpful information and tips Terms HR Heart Rate RR Respiratory Rate 2 Safety
41. ovided when the EarlySense System is used with children e As with all medical equipment carefully route cables and connections to reduce the possibility of tripping entanglement or strangulation e 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 A Caution US Federal Law restricts this device to sale by or on the order of a physician System Labels Bedside Unit Label FarlySense ger Control Unit Caution Federal Law Part No AME 00100 restricts this device to sule by or on the oo order of a physician El wawazi eu Fuses DUT LAMY Warning To be used only with ud EarlySense Ltd EarlySense 3 12 Tzvi st Ramat Gan Part Ne AME 00200 israel 52504 VERA Une C MedNet GmbH Muenstor Germany 49 251 322660 0344 Incorporates WiFi module FCC ID PD9WM3B2200BG Figure 1 Bedside Unit Label Sensing Unit Label FarlySense Early Sense Sensing Unil Part No AME 00200 A adi AN EatySenst Us wa 12 dee Vi im uem ay Van coe mh y RR HA 3784 omm Unt Tel 072 5 H trm conn US Ta 7 617 CODE Ji Carseat bt Lg Ai decomaoet Sq Medne GmbH Munster Germany FCRE ap 322660 a A X
42. patient Figure 34 48 j 4563RT R TL LI n 014 Bed 2 Ki TA HR RR Motion 130 32 4 17 0 Pause Discharge 20 8 Bed Exit Sensitivity v Baton 0000 yo Bed Exit n2 Turned DUM Md ee Settings M23456 Turn Seif Move In Bed Low High EAN 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 49 Excess Movement 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 Events Sim Breakdown General Hag 1 Figure 37 Events Menu 50 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 Event Name gt 4 Touch the Home button to confirm your choice and close the screen or Cancel to cancel your choice The following Events are available Prim
43. rds EE 4 Electrical SHOCK sisi hae NENS 5 Defibrillation AU AA 5 Electric Magnetic Interference wa 1 2 2 tnae AEE EEA hl ela ie 5 WiFi COMMUNICA OM inet tesa 5 l l ugealcce 5 Classification pr 5 Intended US i cacti 6 Contraindications for USC c m 6 Warnings and Cauttons nawa wanu wa nanu wu nanu wu nanu muna niwa nu miwani nenne enne nein nenne innen nennen 6 System ai ai aaa 9 Bedside Unit 9 SENSING W T l 10 System Packaging Laos aaa 10 Explanation of System Labels u nn ee erhoehen 11 Compliance with Standards ierit tetto dcc tena haa ENE ANEREN EE 12 How the Bedside Unit is supplied ssssssssssssssssessseseseneeenere tenentes nennen 12 3 System DescrIptiOnN oeil tnra E Ete X3 REX ERA EK ENENE CER CKXE E KI NEXU XS KAY RE VERA YE EAR REO reg agn 13 System Components rri x p edat Pede i ds Pu Ede trud det ee de eue een b b dee tu zee 13 SI IRIep C ee len eee AAA 13 Sensor Extension Cable etre ceret tote e nera ene da e Edge docu ANE nbn ra secede gered ege Ee 13 Bedside Unit Controls and Indicators eee enemies 14
44. ry and if the battery is being recharged ID 1234567 S L wg Pause Admit n 653 Bed 1 12 UN 2 vu A Motion 130 97 3 Dub EM Cod Ere Sensitivity p Settings 02 3456 a Turn In Bed taw High New Im Operating on Battery Backup Timea T Alar E Figure 10 No AC Power Warning The battery icon displayed on the main screen indicates the status of the battery as follows Green with a lightning Battery is charged and connected to a power outlet Te Green em Battery is charged but disconnected from a power outlet Orange System is disconnected from power outlet battery is not charged 25 Red Th Battery is almost empty m 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 The internal battery automatically recharges when the electrical power is restored If System operation is not restored contact EarlySense Ltd customer support Patient Information Admit Discharge Admitting a Patient The Admit Patient screen appears every time the system is switche
45. splayed 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 11 Out of bed Shows the time intervals when patient has been out of bed Bed Ezit page 43 12 In bed Shows the time intervals patient spent in bed 13 Time period buttons Touch one of these buttons to change the time period 10 min 1 hour 3 displayed in the graph hours 8 hours 1 day 14 Analysis screen Open the Analysis screen Figure 39 53 Alert Symbols The following symbols are used in the Trends graph Icon Meaning EN Blue Alerts Technical Alerts System Malfunction Sensor Malfunction Low Battery v High Low Heart Rate Red Alert Y High Low Respiration Rate Red Alert ete Movement Level High Low Yellow Alert PP el Patient Turn Counter Yellow Alert Hi SR Out of Bed Red Alert H x Signal Lost Red Alert 54 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 M
46. st Coast 617 800 6668 West Coast 818 370 7748
47. t the unit to the Electrical Outlet Touch the screen once it will become brighter To changes the brightness press the button Settings see page no 57 Turn off the system by pressing the On Off switch for 10 seconds and then turn the system back ON by briefly pressing the On Off switch If problem is not resolved call your service engineer Contact a service engineer Check if the sensor is connected to bedside Unit Reconnect if necessary If problem persists replace sensor If problem persists restart system If problem persists call your service engineer Reconnect Bedside Unit to the Electrical Outlet Check connection to the electrical Power Reconnect if necessary If problem persists call the service engineer Check sensor location The sensor should be placed under the mattress below the patient s chest area horizontally Reposition the sensor if it moved from the specified location If the problem persists replace the sensor 66 6 European Representative and Contact Information European Representative MedNet GmbH Borkstrasse 10 48163 M nster Germany Phone 449 251 322660 Fax 49 251 3226622 Contact EarlySense at 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 com Support Telephone Ea
48. 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 reguired 1 USB Connector 2 Nurse Call Connector 3 Sensor Connector 4 Network Connector Other connectors for future use are clearly labeled as not in use Figure 7 Bedside Unit Side View Battery o 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 op
49. w Data The data will appear in the table 56 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 Touching the screen while brightness is set to the lowest level will change the brightness to a higher level in order to be able seeing buttons and labels and enabling adjustment of brightness to higher level manually Advanced Brightness Figure 40 Brightness Choosing a Language In the Setup tab Figure 41 choose the desired language to be used in the system interface and click Done 57 Advanced Setup Maintenance 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 Advanced Maintenance Figure 42 Maintenance Tab 58 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
50. w Patient Movement nighttime 00 00 6 00 Consider setting Patient Turn reminder ON Patient Turn is OFF Yellow Air Mattress was detected on the bed Consider setting Air Mattress Motion Patient Turn reminder ON Detected 35 Turn Counter Exceeded Yellow Threshold time interval for turning the patient expired Hours Check Sensor Blue Technical alert indicating that the sensor connection is Reconnect Replace Sensor malfunctioning 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 Operating on Battery Backup Reconnect the EarlySense bedside unit to the electricity Mains otherwise the bed side will shutdown See Troubleshooting page 66 Very Low Battery Blue An alert indicating that the battery is low and system System Shutting Down is about to shut down Reconnect the control unit to the electricity Mains See Troubleshooting page 66 System Malfunction Blue Technical alert indicating that the system is A malfunctioning r shoul ntact a service engineer Please Contact Service unctioning User should co 5 Eneinser See Troubleshooting page 66 Multiple Alerts Multiple alerts occur when more than one alert is triggered at the same time For instance if a blue system
51. ypes 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 1s a VETT technical problem with the system Check Sensor No AC Power Very Low Battery System Malfunction Functional Message Informative Verrtyng Paloni Tum message Screens The Home Screen displays the monitoring data and provides access to additional menus Choices are selected by touching the screen 18 1 Lock Unlock status 2 Nurses details Name Ext Number and assigned color 3 Patient details ID Room and Pause Discharge Ya d Zu 3 ID 1234567 S L ui H Ge Bed numbers HEH BER 113 20 4 Date Time 5 Battery status AC indicator i 5 4 1 6 0 s 7 Admit Discharge patient None 8 Enable Disable heart rate alerts u n ei 9 Settable High HR threshold 2r eva Le mee a ROT 3 Wa NY 11 Settable Low HR threshold Events Trends Pocrts ER Volume 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 Current movement level 0 Low
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