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D9U001SFS-0101_03

WARNING!

An additional multiple socket-outlet or extension cord shall not be connected to the medical electrical system.

2 Safety Instructions

WARNING!

This medical device is portable medical electrical equipment!

WARNING!

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the

competent authority of the Member State in which the user and/or patient is established!

WARNING!

No modification of this equipment is allowed.

WARNING!

Inappropriate handling of the power supply cord, e. g. by kinking, shearing or other mechanical damages is

hazardous!

WARNING!

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 avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective

earth.

WARNING!

Only authorised and trained person using the tool is allowed to change Hub battery!

WARNING!

This medical device is not intended for oxygen enriched environment!

WARNING!

This medical device is not intended for use with flammable substances!

WARNING!

You cannot rely unconditionally on alert notifications! This medical device is not intended to be used as an

alarm system! SafeSense® 3 was not developed or tested as a diagnostic tool and must not be considered as

such or as another instrument of that type.

Содержание SafeSense 3

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

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

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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