LINET SafeSense 3 Instructions For Use And Technical Description Download Page 1

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SafeSense® 3

Monitoring System

D9U001SFS-0101

Version: 03

Publication Date: 2021-09

Instructions for Use

and Technical Description

Stand-alone Version, Version for Image 3 and

Version for Eleganza 2

Summary of Contents for SafeSense 3

Page 1: ...SafeSense 3 Monitoring System D9U001SFS 0101 Version 03 Publication Date 2021 09 Instructions for Use and Technical Description Stand alone Version Version for Image 3 and Version for Eleganza 2...

Page 2: ...021 All rights reserved All trademarks and brands are the property of the appropriate owners The manufacturer reserves the right to changes in the contents of the instructions for use that relate to t...

Page 3: ...tions 23 6 3 1Use Conditions 23 6 3 2Storage and Transport Conditions 23 6 4Electrical Specifications 23 6 5Electromagnetic Compatibility 24 6 5 1Manufacturer instructions electromagnetic emissions 24...

Page 4: ...bout the risk of fatal injury 1 1 2Structure of Warning Notices SIGNAL WORDS Type and source of danger Measures to avoid the danger 1 2Instructions Structure of instructions Perform this step Results...

Page 5: ...D9U001SFS 0101_03 5 1 4Symbols on the Package FRAGILE HANDLE WITH CARE THIS WAY UP DO NOT POLLUTE THE ENVIRONMENT PAPER RECYCLING SYMBOL...

Page 6: ...afeSense 3 PLAY OR STOP BUTTON TO ACTIVATE OR DEACTIVATE SELECTED MONITORING SELECT AND TIME BUTTON SELECT TYPE OF MONITORING OR SET PERIOD OF SELECTED MONITORING WEEE SYMBOL RECYCLE AS ELECTRONIC WAS...

Page 7: ...APPLIED PARTS TYPE B REFERENCE NUMBER PRODUCT TYPE DEPENDING ON CONFIGURATION SERIAL NUMBER BATTERY HUB PLAY ICON ON STOP ICON OFF DECUBITUS MOVEMENT NOTIFICATION MOTION MONITORING BED EXIT MONITORING...

Page 8: ...DEPARTMENT DO NOT WASH AIR PAD DO NOT BLEACH AIR PAD DO NOT TUMBLE DRY AIR PAD DO NOT WRING AIR PAD DO NOT IRON AIR PAD PROFESSIONAL CHEMICAL CLEANING MODERATE PROCEDURE AIR PAD DO NOT USE PHENOL AIR...

Page 9: ...ILE S PASS E REQUIREMENTS B 117 2013 SECTION 1 NORMAL FLAMMABILITY R Part 1632 6 2013 Edition LINET spol s r o elev ice 5 274 01 Slan The Czech Republic COVER TEXTILE S PASS THE REQUIREMENTS OF CTB 11...

Page 10: ...bar code L I N E T spol s r o elev ice 5 274 01 Slan Czech Republic Made in Czech Republic Fig SafeSense 3 Hub Serial Label example Fig SafeSense 3 Air Pad Type Label Fig SafeSense 3 Air Pad Wash Lab...

Page 11: ...ual to or more than 40 kg and a body mass index BMI equal to or more than 17 according to IEC 60601 2 52 Alert Information signal other than alarm signal MQTT Broker MQTT Broker is a software part of...

Page 12: ...equency HW Hardware ICU Intensive Care Unit IP Ingress Protection IV Intravenous LED Light Emitting Diodes ME Medical Electrical Equipment ON Activation OFF Deactivation ppm parts per million milliont...

Page 13: ...RNING When routing cables from SafeSense 3 in a medical bed avoid squeezing those between parts of the medical bed WARNING Incompatible mattresses can put system functions out of order WARNING To avoi...

Page 14: ...by qualified personnel who have been trained by the manufacturer To avoid injury or crushing take extra caution when operating any moving parts of the bed Never use the system in areas where there is...

Page 15: ...l cleaning personnel 3 2Contraindications Patients in whom proper positioning cannot be achieved or maintained Patients who do not meet the weight limits tested or specified An explosive atmosphere or...

Page 16: ...ring System This system consists of an electronic free pad SafeSense 3 Air Pad located under the mattress which is connected to a hardware unit SafeSense 3 Hub through an air hose From there the data...

Page 17: ...onnectivity Box Hub 5 1 2Version for Image 3 Image 3 bed with SafeSense 3 Fig Diagram of the SafeSense 3 system with Image 3 bed WARNING SafeSense 3 Monitoring System in Version for Image 3 is compati...

Page 18: ...ity Box Hub 5 1 3Version for Eleganza 2 Eleganza 2 bed with SafeSense 3 Fig Diagram of the SafeSense 3 system with Eleganza 2 bed WARNING SafeSense 3 Monitoring System in Version for Eleganza 2 is com...

Page 19: ...Hose 3 Attendant Control Panel Connector with plug only for Image 3 and Eleganza 2 medical bed Hub interconnects parts of the SafeSense 3 system and enables communication between the SafeSense 3 syste...

Page 20: ...D9U001SFS 0101_03 20 5 3Air Pad Fig Air Pad with Air Hose Air Pad connected to the Hub via Air Hose enables Bed Exit Monitoring and Motion Monitoring...

Page 21: ...enables Wetness Monitoring CAUTION Risk of incorrect Wetness Monitoring due to incorrect cleaning of the Wetness Pad For maximum sensitivity of Wetness Monitoring wash the used Wetness Pad before use...

Page 22: ...urse Call cable Version for Eleganza 2 0 34 m Length of Wetness Pad cable 0 7 m Minimum Patient Weight 40 kg Maximum Patient Weight 180 kg Weight of Hub Box 0 5 kg Weight of Stand alone Version Set 2...

Page 23: ...ut Hub max 10 W Ingress Protection according to EN 60529 Hub IPX4 Protection Class Hub Class III Batteries Hub CL18650 29E 2S1P 7 3V 2 67 Ah CR1220 3V LFT 1A Battery Operation max 3 h Time to full cha...

Page 24: ...onverters and other cables than specified and provided by manufacturer of this mo nitoring system could lead to increase of electromagnetic emission or lower the electromagnetic immunity of this monit...

Page 25: ...0 0 UT 250 300 cycle Table 1 IMMUNITY to RF wireless communications equipment Test frequency MHz Band MHz Service Modulation Immunity Test Level V m 385 380 390 TETRA 400 Pulse modulation 18 Hz 27 45...

Page 26: ...environmental conditions WARNING Do not manipulate the bed if the SafeSense 3 Monitoring System is activated on it WARNING SafeSense 3 Monitoring System consists of the parts whose simultaneous worki...

Page 27: ...e 3 Hub Comb like part securing connectors connected to the Hub Hub Holder SafeSense 3 Air Pad Air Hose Cables Nurse Call cable LAN cable Holder of the interconnecting elements for Nurse Call cable an...

Page 28: ...and risk of material damage due to incorrect installation of Air Pad and Wetness Pad Use only mattress compatible with SafeSense 3 system Air Pad must be fixed on the backrest of a medical bed Prevent...

Page 29: ...Sense 3 Hub to the mains power using the compatible cable with adaptor Connect SafeSense 3 Hub to the hardware where CareMonitor Application is installed using LAN cable or remo te WiFi connection Pla...

Page 30: ...on the accessory rail 1 2 3 To fix Hub Holder on an accessory rail Mount Hub Holder on an accessory rail 1 Tighten the safety bolt 2 to fix Hub Holder on the accessory rail To fix Hub in the Hub Hold...

Page 31: ...D9U001SFS 0101_03 31 Fig Position of the Air Pad under the mattress with patient SafeSense 3 5 Fig Air Pad fixed on the Backrest of Image 3 medical bed...

Page 32: ...erlapping ends of the Wetness Pad on the sides of the mattress Four connectors on the Wetness Pad are facing a surface of the com patible mattress Connect Wetness Pad Cable to the 4 connectors on the...

Page 33: ...nse 3 system in the Image 3 medical bed avoid squeezing those cables be tween parts of the medical bed Cables of the SafeSense 3 system and Air Hose must not be tensioned Ensure the Air Hose is correc...

Page 34: ...ir Hose from below up through the hole in the hook on the accessory rail The hook selected for this purpose must be put on the accessory rail in the other way around so it is not possible to use this...

Page 35: ...D9U001SFS 0101_03 35 SafeSense 3 system on the right side of the Image 3 bed 1 2 3 4 5 1 Power Supply Data cable 2 Air Hose 3 LAN cable 4 Nurse Call cable 5 Wetness Pad cable...

Page 36: ...on the accessory rail 1 2 3 To fix Hub Holder on the accessory rail Mount Hub Holder on the accessory rail 1 Tighten the safety bolt 2 to fix Hub Holder on the accessory rail To fix Hub in the Hub Hol...

Page 37: ...D9U001SFS 0101_03 37 Fig Interconnecting elements for Nurse Call cable and LAN cable at head end of the Image 3 bed...

Page 38: ...3 38 Fig Hub back side with tightened grommets and inserted comb like part Fig Hub Connectors back side 1 5 2 3 4 1 NOT AVAILABLE CONNECTOR 2 Nurse Call cable 3 Wetness Pad cable 4 LAN cable 5 Power S...

Page 39: ...D9U001SFS 0101_03 39 Fig Power Supply Data cable in the safety position behind the accessory rail Fig Covered connector for Power Supply Data cable...

Page 40: ...D9U001SFS 0101_03 40 Fig Power Supply Data cable connected to the Hub Fig LAN cable and Nurse Call cable connected to the interconnecting elements for Nurse Call cable and LAN cable...

Page 41: ...D9U001SFS 0101_03 41 Fig Air Hose connected to the Hub Fig Wetness Pad cable connected to the Hub...

Page 42: ...D9U001SFS 0101_03 42 Fig Position of the Air Pad under the mattress with patient SafeSense 3 5 Fig Air Pad fixed on the Backrest of Image 3 medical bed...

Page 43: ...erlapping ends of the Wetness Pad on the sides of the mattress Four connectors on the Wetness Pad are facing a surface of the com patible mattress Connect Wetness Pad Cable to the 4 connectors on the...

Page 44: ...outing cables from SafeSense 3 system in the Eleganza 2 medical bed avoid squeezing those cables between parts of the medical bed Cables of the SafeSense 3 system and Air Hose must not be tensioned En...

Page 45: ...l holder next to the holder with interconnecting ele ments for Nurse Call cable and LAN cable Run the Air Hose upwards and then back above the accessory rail in order to run the Air Hose between the B...

Page 46: ...D9U001SFS 0101_03 46 SafeSense 3 system on the right side of the Eleganza 2 bed 1 2 2 2 3 4 5 1 Power Supply Data cable 2 Air Hose 3 LAN cable 4 Nurse Call cable 5 Wetness Pad cable...

Page 47: ...t and latch side view 1 2 3 To fix Hub Holder on the accessory rail Mount Hub Holder on the accessory rail 1 Tighten the safety bolt 2 to fix Hub Holder on the accessory rail To fix Hub in the Hub Hol...

Page 48: ...D9U001SFS 0101_03 48 Fig Interconnecting elements for Nurse Call cable and LAN cable at head end of the Eleganza 2 bed...

Page 49: ...3 49 Fig Hub back side with tightened grommets and inserted comb like part Fig Hub Connectors back side 1 5 2 3 4 1 NOT AVAILABLE CONNECTOR 2 Nurse Call cable 3 Wetness Pad cable 4 LAN cable 5 Power S...

Page 50: ...D9U001SFS 0101_03 50 Fig Power Supply Data cable in the safety position behind the accessory rail Fig Covered connector for Power Supply Data cable...

Page 51: ...D9U001SFS 0101_03 51 Fig Power Supply Data cable connected to the Hub Fig LAN cable and Nurse Call cable connected to the interconnecting elements for Nurse Call cable and LAN cable...

Page 52: ...D9U001SFS 0101_03 52 Fig Air Hose connected to the Hub Fig Wetness Pad cable connected to the Hub...

Page 53: ...D9U001SFS 0101_03 53 Fig Position of the Air Pad under the mattress with patient SafeSense 3 5 Fig Air Pad fixed on the Backrest of Eleganza 2 medical bed...

Page 54: ...erlapping ends of the Wetness Pad on the sides of the mattress Four connectors on the Wetness Pad are facing a surface of the com patible mattress Connect Wetness Pad Cable to the 4 connectors on the...

Page 55: ...marked by this label To connect Wetness Pad to the SafeSense 3 system Connect the RJ connector on the opposite side of the Wetness Pad cable to the Hub connector in the position 3 Connect 4 connector...

Page 56: ...ly for Stand alone Version WARNING Where the integrity of the external protective conductor in the installation or its arrangement is in doubt use the other power source that is not in doubt Attachmen...

Page 57: ...ble sources of air flow e g air conditioner to ensure you will be informed about statuses whose detection can help you in care for a patient and not about environmental conditions WARNING Do not manip...

Page 58: ...selected period starts again from the beginning after patient movement on the mattress CareMonitor shows chart of the patient movements if it is allowed in the Display settings Alert is triggered if n...

Page 59: ...Image 3 and Eleganza 2 To activate SafeSense 3 Press button Activation LED 5 indicates activated SafeSense 3 when it is lit green It is possible to start or stop monitoring selected by CareMonitor Ap...

Page 60: ...o run the SafeSense Application more than once on one device Check if the SafeSense Application is activated only once when it is flashing in the error mode CAUTION If SafeSense Application is used by...

Page 61: ...Icon in the upper right corner of the CareMonitor Screen provides Global warnings settings and Display settings Bottom bar of the CareMonitor Screen provides access to the 4 screens CareMonitor Scree...

Page 62: ...ossible fall so the nurse should visit patient immediatly 1 2 3 4 1 CareMonitor screen with number of monitored patients 2 Warnings screen with number of notifications 3 Management screen 4 System Set...

Page 63: ...D9U001SFS 0101_03 63 ALERTS Tile Meaning ALERT OF BED EXIT MONITORING ALERT OF MOTION MONITORING ALERT OF DECUBITUS MOVEMENT NOTIFICATION ALERT OF WETNESS MONITORING...

Page 64: ...RING Tile Meaning BED EXIT MONITORING ACTIVATED PATIENT ON THE BED BED EXIT MONITORING ACTIVATED PATIENT OUT OF THE BED NO ALERT INDICATED BECAUSE ALERT NOTIFICATIONS ARE DELAYED INTENTIONALLY EARLY W...

Page 65: ...D9U001SFS 0101_03 65 STATUSES OF MOTION MONITORING Tile Meaning MOTION MONITORING NOT ACTIVATED MONITORING ACTIVATED NO WARNING EARLY WARNING ALERT...

Page 66: ...D9U001SFS 0101_03 66 STATUSES OF DECUBITUS MOVEMENT NOTIFICATION Tile Meaning NOT ACTIVATED OR RESET DECUBITUS MOVEMENT NOTIFICATION ACTIVATED ALERT...

Page 67: ...D9U001SFS 0101_03 67 STATUSES OF WETNESS MONITORING Tile Meaning WETNESS PAD DISCONNECTED WETNESS MONITORING NOT ACTIVATED WETNESS MONITORING ACTIVATED EARLY WARNING ALERT...

Page 68: ...bitus Movement Notification If a set period is changed the countdown related to the previous setting is not reset RESET button serves to reset the running countdown Abbreviation Meaning Wetness Wetnes...

Page 69: ...the window To change a setting of selected monitoring Click on a corresponding sliding button keep it and slide to the required position Click on the Save in the upper right corner of the window NOTE...

Page 70: ...Tiles indicating Bed Exit Monitoring statuses are displayed on the CareMonitor screen OFF Tiles indicating Bed Exit Monitoring statuses are hidden on the CareMonitor screen display wetness ON Tiles i...

Page 71: ...the tile with patient name on the CareMonitor screen To enter settings for single patient Click on the GEAR Icon on the Patient screen 3 2 1 7 6 5 4 8 10 9 1 BACK to the CareMonitor screen 2 GEAR Ico...

Page 72: ...Warning will not be triggered on any CareMonitor user interface connected to the SafeSense 3 system when corresponding status occurs during activated monitoring WARNINGS TURNED OFF Warnings visible o...

Page 73: ...viceId Eth0 IP Wlan0 IP Wifi quality System time Som Serial Id Firmware Version Embedded Version License App Version Fig Patient Details Id First name Last name Department Room number BedNr To change...

Page 74: ...rding to type or department none no grouping is selected 5 Filter of the warnings according to warning type motion decubitus bed exit wetness or according to newness latest only 6 Grouping of the warn...

Page 75: ...k on the button to reset patient data to default configuration and to delete current values of the patient in SafeSense 3 Monitoring System 6 Warnings Settings for Single Patient 7 Patient Details Ide...

Page 76: ...tach button click on the button to turn on monitoring of the selected patient Attached patient is active and monito ring can be set in his her case in the SafeSense 3 Monitoring System To attach patie...

Page 77: ...lete current values of the patient in SafeSense 3 Monitoring System 3 Reset confirmation window press Yes to confirm the reset or No to cancel the reset To reset patient s settings and values Select a...

Page 78: ...itoring 4 Tone indicating alerts of Decubitus Movement Notification 5 Tone indicating alerts of Bed Exit Monitoring 6 Tone indicating alerts of Wetness Monitoring Fig Warnings section of System Settin...

Page 79: ...3 Available language English 4 Dark Mode Sliding Button Fig Display section of the System Settings screen To set language of this user interface Click on the name of an available language To set dark...

Page 80: ...per right corner of the System Settings screen Click on OK on the displayed Caution window Set your user name and your password Ensure that nothing else has been unintentionally changed Click on Save...

Page 81: ...D9U001SFS 0101_03 81 Fig License section of the System Settings screen...

Page 82: ...n The Attendant Control Panel with SafeSense 3 Control is a control element for Image 3 medical bed or Eleganza 2 medical bed The Attendant Control Panel with SafeSense 3 Control indicates Bed Exit Mo...

Page 83: ...atient movement on the bed is tolerated Periods for Motion Monitoring are 10 minutes 30 minutes 60 minutes or 90 minutes Countdown to the selected time limit e g 4 hours starts again from the beginnin...

Page 84: ...tor of Wetness Monitoring Wetness Mo nitoring is activated 1 Deactivation Symbol 2 Indicator of communication between Hub and Attendant Control Panel black arrows communication works orange cross over...

Page 85: ...ent is not present on the mattress Fig Motion Monitoring Alert expired period during which the absence of patient movement on the mattress was tolerated Fig Decubitus Movement Notification Alert nursi...

Page 86: ...to Lock LED error first fault flashing 0 1s lit 0 1s not lit service mode not lit disconnected from the mains power transformer switching error ACCUMULATOR INDICATOR MEANING lit accumulator disconnect...

Page 87: ...Risk of material damage due to steam cleaning of the SafeSense 3 Monitoring System Always remove the components of the SafeSense 3 Monitoring System Hub Box Air Pad Wetness Pad and cables from the Ele...

Page 88: ...on the lying surface 1 Switch off the Hub Box once by pressing and holding the power button until the box switches off 2 Wait approx 10 seconds and switch the box on again briefly press the power but...

Page 89: ...or 10 Socket Address Not Available Error 11 Socket Unsupported Socket Operation Error 12 Socket Unfinished Socket Operation Error 13 Socket Proxy Authentication Required Error 14 Socket Ssl Handshake...

Page 90: ...dition of the original spare parts if some product parts are missing Ask service department of the manufacturer for replacement of any damaged product parts by the original spare parts 14 2Spare Parts...

Page 91: ...packaging through an authorized company more details on www linet cz 15 2Disposal The main objective of the obligations arising from the European Directive No 2012 19 EU on Waste Electric and Electro...

Page 92: ...ase The warranty covers all material and manufacturing re lated failures and errors Failures and errors caused by incorrect use and external effects are not covered Justified complaints will be fixed...

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