EarlySense InSight AME-01350-US User Manual Download Page 2 | Manualshive

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EarlySense Modular

Bedside Unit

User Guide

A L L - I N - O N E • SA F E T Y • V I TA L S

EarlySense InSight

TM

0344

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Summary of Contents for InSight AME-01350-US

Page 1: ......

Page 2: ...EarlySense Modular Bedside Unit User Guide ALL IN ONE SAFETY VITALS EarlySense InSightTM 0344...

Page 3: ...rlySense Ltd assumes no responsibility for errors that may appear in this user guide EarlySense Ltd reserves the right to make changes without notice to this user guide and the products described here...

Page 4: ...ation of the EarlySense InSight Device that is placed at the patient s bedside in a safe and efficient manner For user interface explanations please refer to the Remote Control and Display RCD Unit ma...

Page 5: ...20 Physical Characteristics 20 1 4 Additional Specifications 21 1 4 1 System Performance Sensing Unit 21 Set UP 24 2 1 Positioning the InSight Device and Bed Sensing Unit 24 2 2 Positioning the Chair...

Page 6: ...ir Sensing Unit a cushion with a sensor incorporated inside 17 Figure 3 InSight Device Indicators and Keys 18 Figure 4 InSight Device Side View 19 Figure 5 Positioning the Sensing Unit and the InSight...

Page 7: ...cations not expressly approved by EarlySense Ltd could affect the safety or effectiveness of the EarlySense InSight System and void the system s warranty The EarlySense Insight Sensing Units the under...

Page 8: ...tion Wireless Communication The system incorporates an off the shelf certified Wi Fi 802 11b g n communication Module complies with FCC part 15 For proper wireless communication maximum operating dist...

Page 9: ...uthorized by EarlySense Ltd in cooperation with the Biomedical IT Engineering Departments of the hospital Configuration of the LAN WLAN for correct communication between the RCD and the InSight Device...

Page 10: ...ate the possibility of repeated false alerts and alert fatigue which might result in a failure to respond to an actual alert situation All wireless systems are prone to intermittent signal dropout Mak...

Page 11: ...itions that can tolerate intermittent monitoring interruptions Do not pause or turn off an alert remotely if patient safety might be compromised WARNINGS Patient harm risk Do not pause or turn off an...

Page 12: ...netic Radiation IP24 Solid object protected and splash proof accessory IP20 Solid object protected Sorted disposal Manufactured by Date of manufacture MR Unsafe Keep away from magnetic resonance imagi...

Page 13: ...1 3 1 05 EN 301 489 17 V2 2 1 12 This equipment complies with IEC 60601 1 2 for electromagnetic compatibility for medical electrical equipment and or systems ESD Air Discharge was tested to 2kV 4kV 8k...

Page 14: ...ssion FDA US Food and Drug Administration HIS Hospital Information System HR Heart Rate ID Identification number IEC International Electrotechnical Commission IFU Instructions For Use IP24 Solid objec...

Page 15: ...14 Blank page for double sided printing...

Page 16: ...CD Unit that complies with the minimum requirement specifications for the central monitoring station See RCD Unit s documents For detailed information of using InSight with EarlySense CDS please see E...

Page 17: ...onents The system consists of a Sensing Unit a Cradle and InSight Device connected by a cable Figure 1 EarlySense InSight Components 1 InSight Device 3 Bed Sensing Unit to be placed under the mattress...

Page 18: ...is able to detect the patient s Heart Rate Respiratory Rate and Motion while seated Only one Sensigs device can be connected to the EarlySense InSight Device either the Bed Sensing Unit or the Chair S...

Page 19: ...ed on any specific patient group nor has it been studied as a diagnostic tool for any specific disease or medical condition It is meant as an adjunctive tool only for measuring Respiratory Rate Heart...

Page 20: ...Clinical Alerts can be found in Clinical Alerts section on page 27 B Communication LED indicates if communication with external control and display device is intact or not Orange when connected and O...

Page 21: ...ication modules The system contains wireless LAN module which enables wireless communication to the network The module can transmit at either 2 4 GHZ or 5 GHz The system also contains a BLE module for...

Page 22: ...nsing Atmospheric Pressure InSight Device 700 1 060 hPa Sensing Device 500 1 060 hPa Cables Used with the Sensing Units and EarlySense InSight Device Table 7 Cables Connector Name Connector Type Type...

Page 23: ...ed 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 Br min Default Alert Low 40 BPM High 130 BPM Default...

Page 24: ...23 Blank page for double sided printing...

Page 25: ...able should be connected to the InSight Device on the bottom Please make sure the Sensing Unit cable is not trailing on the floor Place the Bed Sensing Unit horizontally under the patient s mattress a...

Page 26: ...vice There should be a possibility to easily access the InSight s front panel as well as access to disconnect InSight Device from the Cradle in case of necessity or malfunction CAUTION The patient sho...

Page 27: ...dication when communication with RCD Unit is intact No light The system is disconnected from the RCD Power indication LED Solid Green The system is connected to AC power and working No light The syste...

Page 28: ...listed below Low Heart Rate High Heart Rate Time to alert for change in HR 90 seconds 90 seconds Low Respiratory Rate High Respiratory Rate Time to alert for change in RR 180 seconds 180 seconds The...

Page 29: ...e the InSight Device Rough handling can damage internal circuit boards Do not clean the InSight Device while in use first detach it form the mains supply 2 8 2 Cleaning and disinfecting the Sensing Un...

Page 30: ...gnetic environment specified below The customer or the user of the EarlySense System should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance...

Page 31: ...800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3...

Page 32: ...000 4 5 0 5 kV 1 kV 2 kV 0 5 kV 1 kV 2 kV Mains power quality should be that of a typical commercial or hospital environment Voltage dips IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 3...

Page 33: ...IPMENT or ME SYSTEM is used exceeds the applicable RF compliance level above the ME EQUIPMENT or ME SYSTEM should be observed to verify normal operation If abnormal performance is observed additional...

Page 34: ...um output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE These guid...

Page 35: ...Appendix 34 B Appendix FCC Compliance Standard Statement...

Page 36: ...that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off an...

Page 37: ...MK 3702 IS US Rev_2 EarlySense com 800AWest Cummings Park Suite 6400 Woburn Massachusetts 01801 USA Phone 781 373 3228...

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