D6.4 User Manual for d-LIVER instrumentation platform
Contents
1. within the instrument as well as the screen will turn off Then the instrument can be manually switched off with the switch on the back panel It is strongly advised to do so as some parts of the instrument will remain powered otherwise 2 4 Quick User Guide p E o uveron com v0 1 09 09 2014 YOLIVER CSeEM_ Blood Biochemistry Instrument 1 Click on Start Measurement COOPERATION Ni IVER d LIVER_D6 4_v1 0 docx Page 8 14 2 Insert Reservoir Cartridge 3 Insert Processing Cartridge 4 Close cover by sliding to the right side until the stop pressing down a bit and sliding a bit further to the right 5 Wait for instrument preheating VEL IVER d LIVER_D6 4_v1 0 docx Page 9 14 6 Prick finger and apply blood on the capillary of the cartridge If necessary complete blood filling with a second finger prick 7 Wait for the measurement completion If measurement has failed remove cartridge as shown in steps 8 amp 9 and proceed to the measurement again starting at step 1 8 Open cover by the reverse operation of step 4 9 Remove cartridge from instrument VEL IVER d LIVER_D6 4_v1 0 docx Page 10 14 2 5 Precautions Hygiene and Maintenance Blood must always be handled with care If blood is spilled it must be immediately cleaned and disinfected Also if a next of kin carer or health professional helps the patient to perform the finger prick and blood measureme2. IVER_D6 4_v1 0 docx Page 2 14 Table of Contents E oduch esns E EEEE EEE EREE EOE 4 1 1 Disclaimers and Warnings eeneessseoeeesssssssseerresssssssseeeressssssscrresssssssscererssssssseeeereo 4 2 Blood Biochemistry Instrument sssecccoccssssssececcocssssccccoccossssseceoccsssssececesosssssseecesosssse 5 DM SOV E a o E E E EE E AA E EE stoi 5 Dd AMVETS Msta laO esee E E EE E 6 Ar Ur TE a S tae aisaebagceieet tose saa ou calcite aeehaceelctiee 7 Dill SO UARE SUD a E beads EE E E E E E AE 7 Za Mea 0 a An ee ee eee E Te mre ee ae 7 Zee ig UCT OU pot sere rhs opt sgea eect asbenceessezetos E E 8 2A Ower User Cde eeraa A ee 8 2 5 Precautions Hygiene and Maintenance cccccsssessseeccccccceeeeeseeeceeceeseaaeeeseeeeeees 11 20s TOUDE DOON ee E E aenuencestapiesateas 11 S Wembe Dir Oien E EEEE EEEE SE EEE E 11 Jl OVNI N e E E E E E E E E E AT S 11 ILL Pioc Tone Compa MONE aoro o e o O E EEEE 11 S A a eee ener ee mee eee ene aoe Tee er ee error eer Teer 12 Ds IVC ASU CIC NS aa ts cteceee teres as E eueceasostendea E A E E 12 Dede LAOH IIS SOOT ee rn E cove astaanaahone A RE E 13 3 3 1 LED and vibration blinking indications cc ceeeeeseccceceeceaeeeseeeceeeeeeaaeeeeees 13 53 32 Electrode CCI A MN ace ctss sane sdepecesssouetenst ede sessaaeasdecassesastunsdscadessusaateesdeaecousies 14 Die ROSE BOC CO UNG oan E A E EA E dates 14 ee OIA steetoe sa cetrcen saeco eaisc otrssa E cco ciaenctieseeabaiareucte
3. LIVER Grant Agreement no 287596 D LIVER ICT enabled cellular artificial liver system incorporating personalized patient management and support SEVENTH FRAMEWORK PROGRAMME INSTRUMENT Collaborative Project Integrating Project OBJECTIVE ICT 2011 5 1 D6 4 User Manual for d LIVER instrumentation platform Due Date of Deliverable 31 January 2015 Completion Date of Deliverable 6 March 2015 Start date of project 1 October 2011 Duration 48 months Lead partner for deliverable CSEM Revision v1 0 Project co funded by the European Commission within the 7 Framework Programme 2007 2013 Restricted to other programme participants including the Commission Services VA VE R d LIVER_D6 4_v1 0 docx Page 1 14 Document History 4 February 2015 22 February 2015 v0 2 Include SINTEF contribution add introduction and conclusion rephrase some paragraphs 27 February 2015 Include final figures minor updates 6 March 2015 Document Main Author s Stephan Dasen CSEM Frode Strisland SINTEF Trine Seeberg SINTEF Document signed off by David Wenn iXscient Copyright Copyright 2015 CSEM amp SINTEF This document has been produced within the scope of the D LIVER Project and is confidential to the Project s participants The utilisation and release of this document is subject to the conditions of the contract within the 7 Framework Programme grant agreement no 287596 VEL IVER d L
4. Page 12 14 3 3 Troubleshooting 3 3 1 LED and vibration blinking indications Table 1 LED and vibration indications Operation LED indication Turning unit on Fast alternating red Two short Opening for loading ON OFF button in and green in 5 vibrations new software into 3 seconds seconds unit Constant green LED Start up procedure Wait Vibration Function Action Wait in 10 seconds not ready to connect to Bluetooth Slow blinking green Normal operation None Errors when turning Fast alternating red Applications can t be Restart by and green continuous run pushing the ON OFF for 15 sec Fast red diode for 1 Battery too low to Charge second start Normal operation Green light is flashing The sensor belt is on regularly once every and 3 seconds measuring Battery is ok Green and red light is The sensor belt is on Plan for flashing regularly and measuring but charging the once every 3 seconds the battery level is unit getting low less than 20 of full capacity Turning unit off Both green and red Two short Shut down None ON OFF button in indicator lights up for vibrations 5 seconds 3 seconds Both green and red The sensor belt has a Keep device indicator lights up for back log of close to 3 seconds The green measured data that it computer indicator keeps is transmitting to the flashing in a 3 second computer When all sequence data is transmitted it wi
5. age 4 14 2 Blood Biochemistry Instrument The Blood Biochemistry Instrument BBI is a desktop instrument to measure the following blood parameters e blood clotting time e bilirubin e albumin e creatinine e sodium e potassium The instrument has been developed to be used by patients with liver disease in the home setting Therefore it has been developed to be as simple as possible to use and safe for the patient However the clinical evaluation of the instrument will be performed in a supervised environment by trained personal only 2 1 Overview The BBI consists of three parts e The power supply cable e The power supply e The instrument a b c Figure 1 The Blood Biochemistry Instrument is constituted by the instrument a the power supply b and the power supply cable c The screen is fixed on hinges It can be opened and closed like a laptop It is a touchscreen and it is the only interface for the user The black module on the instrument is called the Electromechanical Interface EMI It is there that the Blood Biochemistry Cartridge BCC is hosted during the measurement A cover can be slid on its top The EMI is open when the cover is on the left side and closed when the cover is on the right side Ni IVER d LIVER_D6 4_v1 0 docx Page 5 14 LIVER csem Blood Biochemistry Instrument Touchscreen EMI cover Electromechanical Interface EMI Power Ethernet button connector Power pl
6. g defibrillation This equipment contains radio transmitters and must not be used in areas where such equipment is forbidden e g on board aircraft Do not use several devices with radio transmitters on the body for an extensive time Portable and mobile RF equipment may interfere with medical equipment Though no known problems regarding EMC have been discovered during testing the performance of this equipment cannot be guaranteed when operated together with other body worn RF equipment This equipment may not be used in strong electric or magnetic fields such as Magnetic Resonance or X ray machines or similar Do not use the sensor belt of the Wearable Device if the skin has open wounds or rashes in the chest area Always inspect the equipment before use and if dropped or bumped into something that could possibly harm the unit Do not use if the equipment is deformed or has other visible damage Do not insert any other equipment into the sensor belt of the Wearable Device USB contact than the appropriate electrode or charging cable The current adapter should be CE marked Do not charge the Wearable Device while wearing it on body Do not expose the sensor unit of the Wearable Device to water or other fluids Do not direct the green LED of the Wearable Device that is part of the PPG sensor and located on the backside of the device towards the eyes when the LED is lit Do not modify this equipment VE VE R d LIVER_D6 4_v1 0 docx P
7. intef no 4 Conclusions This deliverable provides a user manual for the Blood Biochemistry Instrument as well as for the Wearable Device It has been written so that anybody can handle these platforms However to avoid any confusion and possible accidental mishandling but also as highlighted in the risk analysis matrix only trained personal should use the instruments and this deliverable used as a checklist Therefore no technical details are provided in this report At this stage the Wearable Device is already undergoing clinical evaluation whereas the BBI still needs to be tested and optimized before being evaluated Therefore some minor updates to the user manual might be required VEL IVER d LIVER_D6 4_v1 0 docx Page 14 14
8. ll turn off and the lights will go off Charging Green light is on The unit is charging Continue charging Green light is flashing The unit is fully Disconnect regularly charged and ready charger to be used VA IVER d LIVER_D6 4_v1 0 docx Page 13 14 Operation LED indication Vibration Function Action Disconnecting Green light will flash Normal Waiting then turn None charger and unit not regularly after 5 turn off off immediately minutes normal turn sequence attached to chest or off sequence unit is taken of chest but not turned off Short push on Short green flash Short This indicates that ON OFF vibration the sensor belt is alive and responsive to user interaction 3 3 2 Electrode detaching It s a known problem that the electrodes might come off when the skin gets wet due to sweat It may be necessary to wash the skin with alcohol before re attaching the electrodes and to shave the area if necessary If the electrodes do seem to come off try to pinch push them again to attach Note this in the logbook 3 3 3 Reset procedure Push the ON OFF button for 15 seconds to reset the unit This might be necessary if the unit for some reason freezes due to incorrect Bluetooth connectivity such as closing the PC application window without disconnecting 3 3 4 Contact In case of other troubles with the Wearable Device you can contact the following person Trine Seeberg 47 22 06 78 03 trine seeberg s
9. nt he she must wear some medical gloves and be careful with possible blood dripping As no liquid flows into the instrument no particular cleaning of the instrument is required Moreover the instrument is not directly in contact with the finger opening so no contamination should arise because of the instrument However the instrument should be kept clean for hygienic reasons It can be cleaned with a dry or damp wipe No water or other liquid should enter the instrument During the measurement the cover should not be opened In case the cover is accidentally opened during the measurement the routine is automatically interrupted and the result rejected The measurement then needs to be restarted with a new cartridge After each measurement the instrument should be visually inspected to see if any liquid has leaked out of the cartridge The region where the capillary of the cartridge appears must be disinfected after each measurement If some blood has dropped on the instrument it should also be carefully cleaned and disinfected Any alcoholic based solution can be used for disinfection The plastic part of the instrument may lose its colour but its function will not be altered If liquid has leaked out of the cartridge and into the instrument CSEM should be contacted see chapter 2 6 2 6 Troubleshooting If a measurement fails the measurement protocol is interrupted and the result if any is rejected The cartridge has to be remo
10. oughout the measurement The next steps can be done at any moment after the preheating of the cartridge After the preheating of the instrument the user is asked to prick his her finger and fill the cartridge capillary The instrument automatically detects when the capillary is filled If the instrument does not react once the blood has been applied on the capillary this means that insufficient blood has been inserted A second finger prick might be necessary Once enough blood has been inserted into the capillary the instrument starts the suction of the blood into the cartridge and the measurement of the various blood parameters The measurement will now continue without further interventions of the user Once the measurement is completed the instrument displays a message that the measurement has been successful or has failed If the measurement has failed the cartridge has to be changed and a full measurement has to be started from the beginning If the measurement has succeeded the data will be sent to the personal Health Manager PHM and a result file is stored on the instrument The cartridge then has to be removed from the instrument Note the cartridge must not be reused 2 3 3 Switch off After a measurement is completed and the cartridge removed from the instrument the instrument can be switched off To do so the user has to click on File gt Exit The application will close MS Windows will shut down and the embedded computer
11. ter or disinfection agent Figure 4 d LIVER Wearable Device 3 1 2 Charging Make sure the device is fully charged before using the device Charging takes approximately 2 hours for a full charge 3 2 Measurements a Prepare device Attach the electrode wires to the connector slot and connect one of the push button on the compartment with one on the belt b Prepare for measurements The device shall only be worn if the skin is intact and without severe rashes Consider shaving the area where the disposable electrodes have to be placed and clean with an alcoholic agent This is to ensure good and stable contact c Placing of the device on the body Fasten the belt around the chest by attaching the second push button on the electronic compartment with the other end of the belt There should be no clothing between the skin and the belt The sensor belt is made of elastic material and can be elongated 4 6 inches The belt should be attached so that is does not change position when you are moving around however do not tighten it so much that it feels uncomfortable d Fasten disposable electrodes Attach the three disposable electrodes to the electrode wires Place electrodes so that the driver current goes through the main chest area e Start measurement Start the measurements by pushing the on off button Connect the device to a computer through Bluetooth HDP or SPP protocol or store data on unit VEL IVER d LIVER_D6 4_v1 0 docx
12. tesddass 14 Mc CONCIISIONS aseo EEEE E 14 Ni IVER d LIVER_D6 4_v1 0 docx Page 3 14 1 Introduction The present document compiles the user manuals of the d LIVER instrumentation platform This consists into two devices the Blood Biochemistry Instrument and the Wearable Device The document is intended to be a support for the end user However training is necessary to handle those devices safely and this will be carried out prior to the clinical evaluation studies 1 1 Disclaimers and Warnings The d LIVER instrumentation platforms are prototype systems developed within the EU project d LIVER The instruments are in the development and testing stage and do not have any medical device approval required to market them in the EU Contract partners cannot be held responsible for incorrect use of this equipment Usage of the equipment that is not described in this documentation is considered incorrect use v v v The system is not intended for life preserving treatment The system is not verified as a diagnostic tool The system has been developed according to industry standards but the system is not CE approved Errors may occur This system must only be configured by trained medical personnel The equipment must be used under supervision by a responsible person who has been trained how to use the system The Wearable Device shall not be used on patients with a pacemaker device The Wearable Device may not be used durin
13. to the application can be found on the Desktop if necessary 2 0 2 Measurement To start the measurement the user has just to click on the Start Measurement button The instructions to follow will be shown on the screen JA d LIVER BBI Setup v0 1 09 09 2014 FOLIVER csemM Blood Biochemistry Instrument dummy Status Instrument ready Idle Error COOPERATION Figure 3 Main user interface The user will first be asked to insert the cartridge into the instrument and close the cover The cartridge is formed by two separate pieces a measurement cartridge and a reservoir cartridge The reservoir cartridge has to be inserted first followed by the measurement cartridge After that the cover should be closed Once the cover is slid to the end it needs to be pressed down and moved a bit further to the right to engage the locking mechanism This process connects the two cartridges together while avoiding leakage between the two parts The instrument detects automatically when the cover is closed and if the cartridges have been inserted Once this is done the instrument automatically preheats the cartridge This operation may take some time and the user is asked to wait It is not necessary for the user to wait for the instrument VEL IVER d LIVER_D6 4_v1 0 docx Page 7 14 to be ready Once the cartridge is preheated the instrument keeps its temperature until the process is started and thr
14. ug Figure 2 BBI and its parts connectors and button On the back panel of the BBI one can find two connectors and one button One connector is the power plug and the button is the power button to switch the instrument on and off The second connector is an Ethernet connector which is not used in normal operation It is only used for distant debugging in case of troubleshooting see chapter 2 6 2 2 Instrument Installation The instrument is intended to be powered by a 230V 50Hz network This means that it works with all European networks It should also work with American 110V 60Hz network but this does not enter into the current field of use of the instrument The power supply cable has to be connected between the power supply and a 230V 50Hz power source The output of the power supply is connected to the power plug of the BBI No other power supply shall be used than the one furnished with the instrument FEL VE R d LIVER_D6 4_v1 0 docx Page 6 14 The touchscreen of the instrument can be opened To switch it on the power button need to be pressed To switch the instrument off the software must first be properly shut down and then the power button can be switched off see chapter 2 3 3 2 3 User Guide 2 3 1 Start up The instrument has to be connected to the power supply It then needs to be switched on The user has to wait a few minutes for MS Windows to start up The application starts automatically However a link
15. ved and the measurement restarted from the beginning with a new cartridge Several malfunctions could lead to an error Whatever the reason the measurement is interrupted One single failure does not need to be reported However if the instrument persistently fails CSEM should be contacted You can contact one of the persons below Stephan Dasen Lingchuan Zhou 41 32 720 50 73 41 32 720 52 40 stephan dasen csem ch lingchuan zhou csem ch For remote debugging the instrument needs to be connected to a wired internet access by connecting an Ethernet cable to the socket on the back panel A remote control software Teamviewer is installed on the computer and the CSEM team may take control of the instrument Before calling be sure that you have wired internet access available for the instrument 3 Wearable Device 3 1 Overview 3 1 1 Electronic compartment The d LIVER wearable device consists of an electronic compartment as shown in Figure 4 On the front side of the compartment there is an on off button and on upper edge are two LEDs to indicate the status of the device and a connector slot for electrodes On the back side are two Vey IVER d LIVER_D6 4_v1 0 docx Page 11 14 push buttons to attach the belt which also have two electrodes the PPG sensor used in the pulse transit time PTT measurements and an IR temperature sensor The compartment 1s designed to be splash protective and can be gently swiped with a soft cloth with wa
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