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C-FLOW™ Monitor User Manual - USM1000A -Dec 29, 2014

1. an marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency interval is applied Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the c FLOW Monitor is used exceeds the applicable RF compliance level above the cFLOW Monitor should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the c FLOW Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Technical Information Recommended Separation Distances Table B 10 outlines the recommended separation distances between portable and mobile RF communications equipment and the c FLOW Monitor for the c FLOW Monitor that is not life Supporting 2014 Ornim Medical Ltd B 9 Table B 10 Recommended Separation Distances Recommended Separation Distances between portable and
2. Power to the Monitor is ON Monitor is connected to mains power or is operating on battery power Note Power LED illumination is also steady green during system start up Battery Status Indicator On the c FLOW Monitor front panel a Battery LED indicator illuminates to indicate the current battery status as explained in Table 2 2 below BAT LED Table 2 2 Battery Status LED Illumination LED State Battery Status Power to the Monitor is OFF Monitor is not connected to mains power 2014 Ornim Medical Ltd Power to the Monitor is ON Orange steady t Battery is semi charged charging in progress Power to the Monitor is ON Battery is fully charged Green steady Monitor is not connected to mains power or mains power is OFF Green blinking s Monitor is operating on battery power Battery is fully charged Monitor is not connected to mains power or mains power is OFF Monitor is operating on battery power Battery is semi charged Note Connect the Monitor to a mains power source to recharge Orange blinking the battery Routine use of the Monitor connected to mains Battery LED on Monitor power is recommended Front Panel Monitor is not connected to mains power or mains power is OFF Monitor is operating on battery power oO Battery capacity is low or battery is depleted Warning message Red blinking is displayed see Battery Capacity Low on page 1 2
3. 0 0 ccc ccc cc cece ccc eee tect eee ee eeenees 1 6 Centers es 54 oe ee hae ene 25 AEE so TT TETTE a ese 1 6 System Safety Labels issicrrresrisisstrudd rrian est turra nra N ENARE Se ee ee a ee 1 7 c FLOW System Name Plate Lapel lt d vind 4a ue de 6404445 14545 HERE Ed HEN EO HEE OLEH ES OR ERD OE RDO 1 7 eT ee has caer ae Ree GEESEECO GEES LEEOCAECOGEEOGECOGEREOAEE EE S18 03620515 8428408 1 9 Location of Safety Labels on System ComponentsS 0 0 cece eee ee ee eee ee ee eee eee nee 1 10 Safety Labels on Accessories and Disposables 0 ccc cc eee eee e eee e eee enes 1 11 ee a oe ek ee hs ee eee ees 1 14 Guidelines for Safe Handling of the c FLOW Monitor ccc eee c cence teen eenes 1 15 Environmental Requirements 0 cc ee ee eee eee eee eee eee eee eee e eee e ene 1 16 2014 Ornim Medical Ltd Ix Sa PO no ae ee oh eh oo ee eh oe ee eee ees 1 16 Patient Safety and Handling Guidelines ccc ccc ee cee cee cere eee eee eee cens 1 17 Og oc os eo kk a i Se E 1 17 OCU re FON Er ee ha oe oh a or ee ee 1 17 Use of Accessories and Disposables ccc cece eet cet eee cence eee e eee eecenes 1 18 CE ee ETET ee ee ee eee eres eee ee ee ere ee ee es ere eee eee ee ee 1 18 Bea er Fo 0h 46h dk a ee ee E A E E a 8 Be hed E ds 1 19 Seige te ag Eo EAT ee ee a a ee ee ee ee ee ee ee ee 1 20 Patient Monitoring Data Archive Procedure ccc ccc ccc c eee c ence eee eeeeeees 1
4. Figure 3 12 Resolution Options Menu Note Changing the resolution option will affect the amount of data visible in the Monitoring area The default is 15 Minutes highest resolution The Zoom tool may be used at any stage irrespective of the current Monitoring state Menu Menu Tapping the Menu icon opens a list of options described below Display Settings gt Archive Maintenance Set Gain Control About Close Menu Figure 3 13 Menu Options 2014 Ornim Medical Ltd 3 21 a Display Settings provides access to Set Y Scale and Thresholds dialog box and controls for hiding showing grid with or without Threshold line See Setting Thresholds Sety Scale Grid Close Menu m Archive used to archive patient data for the current patient Refer to the procedure described in Archiving Patient Monitoring Data on page 5 16 Maintenance used for the Activating the Screen Lock Feature An additional option System Setup is for use by Ornim Medical personnel only Lock Screen System Setup Close Menu Set Gain Control enables the user to control the c FLOW Monitor Gain setting by adjusting the Gain value in order to achieve optimal signal strength Set Gain Control Note Gain Values selection options are in increments of 01 through 10 the default value is 10 Adjustments to the Gain Value affect both Sensor 1 and Sensor 2 simultaneously a About provides details of system
5. xides hypochlorite lacquer thinners ammonia or acetone based cleaning solutions Use of these materials may cause irreparable damage to the Monitor Before cleaning the Monitor make sure the Screen Lock utility is activated Important This is accessed from the Menu gt Maintenance option For details see Activating the Screen Lock Feature on page 3 21 e To Clean the c FLOW Monitor 1 Make sure the system shutdown procedure has been completed and that the Monitor is disconnected from electrical power Refer to the System Shutdown Procedure on page 4 11 2 Clean the Monitor surfaces with a soft cloth damped in a mild detergent solution Do not soak the cloth in the cleaning solution or spray the solution directly onto the Monitor 3 Wipe the surfaces with a soft clean dry cloth 4 Wait until the c FLOW Monitor surfaces are thoroughly dry before turning ON power to 2014 Ornim Medical Ltd the system 6 2 Cleaning Procedures Cleaning the LCD Display It is recommended to clean the c FLOW Monitor LCD Display regularly as described in the following procedure This will help to maintain the LCD Display in good condition and ensure optimal visual clarity during system use When cleaning the LCD Display do not use abrasive scouring powders or pads caustic ae oxides hypochlorite lacquer thinners ammonia or acetone based cleaning solutions materials may cause irreparable damage to the
6. 21 Chapter 2 Introduction to the c FLOW System I kk oa 8 6 4 hE 8 E E E E eee 2 1 Saem Ns 00 45s ooo oo ohh oe ew Rh EREN ee 8 oes 2 2 er 2 ood ee eee ou bos Fas OSS PES OR eee OH E O64 se 245s Shares eee eee eee ees 2 2 ee Se 3 oe bee se eee 8k wk HO a Oe 5 ee ewok es 2 13 Plea a e S a 6 a ee ee eee 2 15 Boo eac 65 4 3 3 5889 E TE E E oe OS 9 84 4k E E EE E E E 6945 44445054405469 409845 2 16 Operating ts oo ee hee e084 8 hh ek ees 2 18 Sea TR e e a ee ee ce ee ee E EE eee eer E are a ener eee T er rere E E 2 ee Fe ETEEN AE TAS Ee TTET E E EEEE A I he ee 28 EET T s eue ea a r E EE E EE EO hohe E E E E A E E T TT 2 19 x c FLOW User Manual Pie Pe 5 oe coc ode cas E ee hee ee a ee ee eens TE 2 19 Threshold CCAR ONS oo yn a ee 6 ok Oe ERR E ESAS HR EEPE ERRARTE ERASER Oe Eee 2 19 Baseline SENINI oe ku be bo ee a ee a eee ees 2 20 PE Ore FUNCIONS ak shoes 2 565609594050 45 kOe es 05 EFRA ee oe RREN 2 20 ACA OT EE eds T 6 4 E E 8 ee beet beeeess 2 21 Chapter 3 Using the c FLOW Touch Screen Introduction to the TOUCH Screen 1cc iio ceaue ein euewd 60444064 44s DO e eRe ECE w eee 3 1 Petty EAEN EEEE TTE ESANETAN ek ee 3 1 a Aa e CTs cca ek oo EE E E ES ETT 3 2 Sensor Location COMTO 6 5 5 455 45 55 4545555 455 564 3450 REEE RRRS 3 7 Er Ns on ee oe ak hae OS SR a EEEIEE hee eee 3 9 Sensor Signal WIIG UO so ur bn bei eke be hbe hho dR ESS ees FS ode 55d 4 Sek b4 eee ee 3 10 Br Cualty TG Ooo ee 5a 4 ee eee eyo oene bas e
7. 466004008 440644048 848 Oo Ke 9 eee ees 5 7 elated ba gh a ee ee E E ee ee ee ae ee ae ee EE T ee E 5 7 Setting Scale and Threshold Levels 0 00 e eee eee eee 5 7 Bree er ee a aes ee T EE oe nearer eee ae eer ede hee ow E ne eee ekeesee ses 5 7 Monitoring a Patient er ee ne ee eee ee ee ee 5 9 Starting a Monitoring 56550 ks ova ww headend ieee 44 e055 b4 00 600550 6944005 444545 58S oR 5 9 Viewing and Browsing Monitored Data ccc ee ee eee e tenet eee e eens 5 11 Adjusting the Gain Value 5 11 Setting a Baseline 2014 Ornim Medical Ltd xiii 5 12 Pause Monitoring 5 14 Miarkine am bo ee ee a a ee a eee ee ee re er ee ee ee ee eer ee ne ee ere eer 5 14 Responding to a Threshold Indicator lt 2 icc eek do dee eewedeeu decks skew eebaes C0404 KRA ORES 5 14 Completing the Monitoring Procedure ccc ccc cc cee ce eect eee eee e eee eeeeeees 5 15 eid e aa 6 ee dh oe wk be berks bebe ke 6S E E EEE ORES SS 5 15 Disconnecting the SANGO Ss ca dee dae cd debs 585 55544 r ei broek bod 4599505655 1954505555 5 15 Removing ti ck ee hho en hehe bee wee eee ted ob5oee eee ee eek ewes 5 16 Archiving Patient Monnorine UGS scsckucesSeckaeees ve daed cxbein hore h eect wes ewndes send eceui 5 16 Chapter 6 System Care and Maintenance Care and Maintenance Overview ccc cece cence eee teen e eee e sere eee eee eneees 6 1 General Care and Maintenance Guidelines 0 0 cece ee eee eee eee eee e e
8. Indicators 7 Real time Numerical Measurements CFI 8 Horizontal Scroll Bar used for Data browsing 9 Menu and Zoom Tool 10 Marker Tools see Event Markers Patient Information Tapping the Patient button opens the Patient Information window providing access to the following read only information a Patient Number automatically generated by the c FLOW system numbers are incremental m Patient Creation Time Date and Time Patient File created in the system database Patient Information Figure 3 2 Patient Information Window 2014 Ornim Medical Ltd New Patient Important When adding a New Patient to the system c FLOW monitoring data acquired from a previous patient as well as any Event messages will be erased from the display and will no longer be accessible to the user Tapping the New button opens the New Patient dialog box enabling the user to add a new Patient file to the c FLOW system database New Patient Figure 3 3 New Patient Dialog Box New Patient Number number automatically generated by the c FLOW system numbers are incremental and cannot be edited the first four digits relate to the system and thereafter to the patient ID It is recommended to make a note of this computer generated Patient Number and keep a record of it together with the actual Patient ID for future reference Cancel returns to the Main Screen with no change OK create
9. LCD Display To Clean the LCD Display 1 Verify that power to the Monitor is OFF 2 Carefully clean the LCD Display using any commercially available screen cleaner AN caution Never spray any cleaning solutions directly onto the screen When done use a clean dry lint free cloth to remove all excess moisture from the screen 4 Wait until the LCD Display surface is thoroughly dry before turning ON power to the c c FLOW User Manual FLOW Monitor 6 3 Cleaning the Reusable Accessories It is recommended to clean the Sensors after use and always between patients To Clean the Sensors 1 Clean each Sensor surface carefully using a soft clean cloth and isopropyl alcohol 70 in accordance with standard hospital protocol Z CAUTION Do not immerse a Sensor in liquid 2 Dry each Sensor surface thoroughly before docking the Sensor in the Sensor Docking 2014 Ornim Medical Ltd 6 4 Station c FLOW User Manual Appendix A Troubleshooting Guide General Missile Sammie Cause Solution connection between Sensor and _ and reattach the Sensor to the single use Single Use Smart Pad Smart Pad Use the Set Gain Control menu to adjust the Gain Insufficient reflection from patient s skin until signal indicator shows full green See Step 2 on page 5 9 Improper connection between the Sensor and the c FLOW Monitor Call Ornim Medical Technical Support Disconnect the Senso
10. VAC SIECMICA ASI lines amp 120 VAC mains Mains power quality should be that of a typical commercial or transient burst 4 4 kV for input output 1 kVTr Th 5 50 ns hospital environment IEC 61000 4 4 lines 5 kHz on External Monitor 2 0 CM 1 kV DM Tr Th Surge 1 kV differential mode 1 2 50 8 20 us on Mains power quality should be that of a typical commercial or IEC 61000 4 5 2 kV common mode 230 VAC amp 120 VA hospital environment mains 2014 Ornim Medical Ltd B 7 Voltage dips lt 5 Ur gt 95 10 ms Mains power quality should be that of a typical commercial or short interruptions gt 95 dip in Ur for 60 100 ms 3 hospital environment If the user of the c FLOW Monitor and voltage 0 500 ms requires continued operation during power mains interruptions it variations on 0 5 cycles gt 95 5 s on 230 VAC is recommended that the c FLOW Monitor be powered from an power supply 40 Ur amp 120 VAC mains interruptible power supply or a battery input lines 60 dip in Ur for 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Power frequency 3 A m 50 Hz at 230 VAC 50 60 Hz and battery Power frequency magnetic fields should be at levels magnetic field 3 Alm 60 Hz at 120 VAC Characteristic of a typical location in a typical commercial or IEC 61000 4 8 and battery hospital environment NOTE Uy is the AC mains voltage prior to appli
11. icons on a vertical cursor see Figure 3 23 When selecting one of these Markers by tapping the appropriate rectangle the corresponding details are displayed in a tooltip date and time of the Event the displayed value on the event time for each parameter as well as the marker legend Patient New Admin wT er 2014 09 11 09 07 58 Laser On 4 A A MA MAI pam pe A a mr x J Ma 1 Laser On Figure 3 23 Markers and Selected Marker showing Tooltip By tapping the X button on the detailed marker tooltip the tooltip is closed 3 34 c FLOW User Manual Event Markers Show Hide Markers Tap the Show Hide button to hide or display all Markers Jumping to Next Marker Use the right left arrows as required to navigate to the next Marker Adding a Marker A Marker may be added to indicate a specific point of interest at any time as required irrespective of the current Monitoring status When adding a Marker one of the following two scenarios is applicable a Mark Now In this scenario no tapping on the Monitoring area is required therefore no cursor is set on the display Irrespective of the currently displayed data the Marker time is set at the actual current time at which the user tapped the Mark Now button A typical example would be an Event Marker to indicate drug administration Mark Used to add a Marker for a selected time point of interest in the past In this case the user sets a curs
12. it will not be required in future 2014 Ornim Medical Ltd 3 37 Chapter 4 System Preparation Startup and Shutdown System Preparation Overview The following information describes preparation of the c FLOW system for a Monitoring procedure This includes positioning the Monitor on a table top surface or mounting on the Roll Stand connecting cables turning ON power etc The system preparation procedures may be performed by personnel who have received system training from Ornim Medical and should be carried out in the order in which they are described First time Use Unpacking and installation of the c FLOW system as well as all calibration and initial setup procedures are performed by Ornim Medical personnel Note No installation or additional procedures are required by the user Positioning the c FLOW Monitor Z WarNinc To prevent possible damage to the c FLOW Monitor always secure it to the Roll Stand or 2014 Ornim Medical Ltd 4 1 place securely on a flat stable surface that is free of dirt and debris Do not place the c FLOW Monitor near a radiator or heating unit AN caution Donot use the Monitor adjacent to or stack it with other equipment Do not cover the Monitor while in use When considering a suitable position for the c FLOW Monitor in the clinical environment it is recommended to observe the following precautions When lifting or carrying the Monitor use
13. part complying with IEC 60601 1 E gt Dx O Manufacturer name and address 2014 Ornim Medical Ltd Authorized representative in the European Union name and address Laser Safety Labels In compliance with IEC 60825 1 2 Edition safety standards the c FLOW Sensors are labeled with a laser radiation exposure warning illustrated below Figure 1 2 Laser Warning Label The above laser safety warning label is located on each Sensor cable see Figure 1 4 on page 1 11 1 10 c FLOW User Manual System Safety Labels Location of Safety Labels on System Components Label on Monitor Rear Panel lt E f A System Label ee f y Figure 1 3 c FLOW Monitor System Name Plate Label on Rear Panel J a gt 2014 Ornim Medical Ltd 1 11 Safety Labels on Accessories and Disposables Safety Label on Sensors Each of the two Sensors has a safety label attached to the cable For an explanation of the symbols used see Table 1 2 Safety Label Figure 1 4 Sensor and Cable showing Safety Label Location Table 1 2 Sensor Safety Label Symbol Descriptions Icon Symbol Description Laser radiation exposure warning Caution Consult the instructions for use for important cautionary information such as warnings and precautions Serial number 1 12 c FLOW User Manual System Safety Labels Label on Smart Pad Pa
14. procedure or step needing particular care or consideration as shown in the example below N caution Do not use a Smart Pad if it was dropped prior to or during positioning Notes Notes are used to provide additional information for the purpose of clarification or to stress details of particular importance The backup battery is charged automatically whenever mains power to the c FLOW Monitor is ON No battery charging procedures are required by the user Important Make sure both Sensors are securely docked in the Sensor Docking Station before proceeding to the 2014 Ornim Medical Ltd System Startup Procedure Procedure Instructions Procedure instructions are clearly identified with a symbol followed by numbered procedure steps To Turn OFF Power to the Monitor 1 Verify that active monitoring has been stopped and the system is in Pause Mode Check that Sensor 1 and Sensor 2 are both docked in their Sensor Docking Station 2 On the Operator Panel press and release the On Off button 3 Next step Terms and Abbreviations The following terms and abbreviations are used throughout the manual Term Abbreviation Meaning CFI Blood Flow Index CT Computerized Tomography ICU Intensive Care Unit LED Light emitting diode MRI Magnetic Resonance Imaging NICU Neuro Intensive Care Unit yi c FLOW User Manual OR Operating Room Session Monitorin
15. see Disconnecting the AC Power Cable 4 12 c FLOW User Manual Disconnecting the AC Power Cable To Disconnect the AC Power Cable 1 Turn OFF the On Off power switch on the rear panel refer to Figure 4 4 2 Turn OFF the mains power wall outlet switch 3 Disconnect the AC power cable from the wall outlet 4 Disconnect the AC power cable from the power input socket at the rear of the Monitor refer to Figure 4 4 2014 Ornim Medical Ltd System Shutdown Procedure Cleaning the Monitor and Accessories The c FLOW Monitor and Accessories should be cleaned after use and always between patients For cleaning procedures and recommendations refer to the following important m Cleaning the c FLOW Monitor on page 6 2 Cleaning the LCD Display on page 6 3 Cleaning the Reusable Accessories on page 6 4 Storage When Not in Use In the event that the c FLOW Monitor will not be used for a prolonged period more than two weeks it should be stored in a clean dry environment For the manufacturer s recommended environmental conditions during storage of the Monitor and Accessories refer to Table B 6 on page B 5 Sensors are sensitive medical instruments that can easily be damaged by improper handling or storage 4 14 c FLOW User Manual Chapter 5 Patient Monitoring c FLOW Monitoring Overview This chapter details the procedures typically required for Patient Monitoring sessions u
16. the Sensor Docking Station 2 Carefully push the Sensor down into the Cradle B until it is properly seated C 3 Repeat Step 1 and Step 2 to place the other Sensor in the opposite Sensor Docking Station 2014 Ornim Medical Ltd 4 7 System Startup Procedure Turning ON Power to the Monitor To Turn ON Power to the Monitor Important Make sure both Sensors are securely docked in the Sensor Docking Station shown in Figure 4 5 before proceeding 1 Turn the mains power wall outlet switch to ON 2 Turn the On Off power switch Figure 4 4 on the Monitor rear panel to the ON position The LED above the On Off button on the operator panel illuminates orange 3 Press the On Off button on the Operator Panel The LED above the On Off button illuminates green and the system boot up process commences a PW A a A Figure 4 6 On Off Button on Operator Panel During system start up a series of screens are displayed while the system performs automatic self testing 4 8 c FLOW User Manual Positioning the c FLOW Monitor On completion of the Start up process approximately 2 minutes the Main screen is displayed as shown in Figure 4 7 2014 Ornim Medical Ltd 4 9 system Startup Procedure 11 10 2012 11 58 08 Figure 4 7 c FLOW Main Screen after System Startup Note On the right of the Main Screen E Power status indicator shows AC power connected see sta
17. use with the c FLOW system Do not connect the Sensors to any other medical device Before activation of a Sensor make sure no active implants for example a pacemaker are located within the acoustic beam The recommended precautions below help to ensure safe handling and reliable operation of the 2014 Ornim Medical Ltd 1 19 Sensors Take care not to drop or knock the Sensors Before using a Sensor always examine it for visible cracks or signs of damage Never use a cracked or damaged Sensor Donotimmerse a Sensor in liquid Before disconnecting a Sensor always make sure the system is in Pause Mode Use of Accessories and Disposables Disposable Smart Pads Smart Pads for use with the c FLOW system are intended for single use only Z caution Reuse of a disposable Smart Pad may cause a risk of cross contamination or affect measurement accuracy and or c FLOW system performance A Smart Pad can be used while the patient is undergoing a CT Scan However it is NOT suitable for use during MRI Scanning In the event that the patient is transferred to an MRI environment the Smart Pad must be removed The recommended precautions below help to ensure safe handling and reliable operation of the Smart Pads 1 20 c FLOW User Manual Prior to use and attachment of a Smart Pad check the package carefully for signs of damage Check the expiry date is valid Do not use a Smart Pa
18. used m It is not recommended to use an extension cord to connect the c FLOW Monitor to a mains power outlet Electrical Shock Hazard 1 4 c FLOW User Manual AAWARNING To eliminate the risk of electrical shock operators should always adhere to the following precautions m Do not remove system covers m Do not attempt to replace fuses Contact Ornim Medical Technical Support Turn OFF power to the system before performing cleaning procedures Dry surfaces thoroughly before reconnecting power to the system Note Should technical assistance be required contact Ornim Medical Technical Support For contact details see inside front cover of this manual Laser Hazards Laser Hazards The c FLOW system is a Class 1 laser product The c FLOW system is equipped with an embedded Class 3B laser Avoid looking into the beam sources located on the Sensors Use of controls or adjustments or performance of procedures other than those specified in this manual may result in hazardous radiation exposure Z caution Laser equipment not in use should be protected against unqualified use 2014 Ornim Medical Ltd 1 5 Protection Against Ingress of Liquids The c FLOW system is protected against the ingress of liquids in accordance with the IEC 60601 1 3 Edition safety standard Electromagnetic Compatibility EMC The c FLOW system complies with the EMC standard IEC 60601 1 2 3 Editio
19. 0 Important Reconnect the Monitor to a mains power source immediately to recharge the battery Laser Status Indicator On the c FLOW Monitor front panel a Laser LED indicator illuminates to indicate the current laser status as explained in Table 2 3 below Table 2 3 Laser Status LED Illumination LASER LED LED State Laser Status 2 8 c FLOW User Manual system Configuration Power to the Monitor is OFF off Monitor is not connected to mains power Power to the Monitor is ON 2 During system start up LED blinks green at several stages i e when a series of system self tests are in progress before the c FLOW screen is displayed Green blinking Power to the Monitor is ON off System is in dle mode Monitoring has not yet commenced After tapping the Start button active Monitoring is about to PASER Ea cy commence r Green blinking LED blinks for a few times then illumination becomes steady a t4 Monitoring is in progress Laser Status LED on ff System is in Pause mode the current Monitoring Session has Monitor Front Panel j been paused by tapping the Pause button While active Monitoring is progress no illumination of Laser LED indicates the Laser is not operating correctly In Important Saag no graph or values for the relevant Sensor will be displayed on the Main Screen The user should check the following possible causes of malfun
20. LOW System Cables c FLOW User Manual AC Power Cable Length 1 5 m 4 9 ft Sensor 3 m 9 8 ft System Specifications Laser Specifications Class 1 laser product Environmental Specifications The manufacturer s environmental recommendations for operation storage and transport of the c FLOW Monitor and accessories are shown in Table B 6 Table B 6 Recommended Environmental Conditions Condition Ambient Temperature eee alee Lel Altitude condensing 15 C 32 C Om 3000m Operation 20 90 59 F 90 F Oft 9843ft 20 C 60 C Om 15000m Storage Transport 10 90 4 F 140 F Oft 49213ft 2014 Ornim Medical Ltd Technical Information Electro Magnetic Compatibility EMC Electro Magnetic Emissions Manufacturer s Declaration and Guidance Z WARNING The use of accessories transducers and cables other than those specified may result in increased EMISSIONS or decreased IMMUNITY of the c FLOW Monitor The c FLOW Monitor should not be used adjacent to or stacked with other equipment and that if ZAwarNing_ adjacent or stacked use is necessary the c FLOW Monitor should be observed to verify normal operation in the configuration in which it will be used Table B 7 Guidance and Manufacturer s Declaration Electro magnetic Emissions The c FLOW Monitor is designed to be used in the electro magnetic environment spe
21. LOW User Manual personnel or by anyone authorized by Ornim Medical Note It is recommended that this manual be kept in close proximity to the system at all times and that the procedures for operation and safety precautions be reviewed periodically by system users Responsibility of the Manufacturer Clinical Decisions The practitioner is solely responsible for all clinical use of the c FLOW system and for any results obtained by use of the system All clinical decisions prior to and throughout the monitoring procedure shall be made by the practitioner based upon his her professional opinion Responsibility of the Manufacturer The manufacturer considers itself responsible for the effects on safety reliability and performance of the equipment only if a Service maintenance procedures and repairs of the c FLOW system are carried out by Ornim Medical personnel or anyone authorized by Ornim Medical Ltd T The equipment is used in accordance with instructions for use important Owners and operators should always adhere to the following precautions 2014 Ornim Medical Ltd lil a Refrain from modifying the c FLOW system hardware or software in any way Never allow untrained personnel to operate the c FLOW system a In the event of system malfunction always report to Ornim Medical Ltd authorized representatives only Conventions Used in this Manual Safety instructions are provided for the protection
22. Mrnim medical Non Invasive Real Time Continuous amp Bedside Monitor User Manual Manufacturer Authorized Representative in the European Community iat ais Obelis s a Ornim Medical Ltd 15 Atir Yeda St Bd G n ral Wahis 53 Kfar Saba 4464312 Israel 1030 Brussels Belgium Tel 972 0 8 9282801 Tel 33 2 732 59 54 Fax 972 0 8 9282805 e Fax 33 2 732 60 03 e mail info ornim com mail mail obelis net For technical assistance or customer support contact Ornim Medical Technical Support USA Tel 1 866 811 6384 Canada Tel 1 866 316 2209 Ornim Medical Customer Services support ornim com 2014 Ornim Medical Ltd All rights reserved Document Number USM1000A December 2014 Preface Copyright Notice This document is delivered subject to the following conditions and restrictions The c FLOW User Manual contains proprietary information of Ornim Medical Ltd This information is supplied solely for the purpose of assisting authorized users of Ornim Medical products The instructions presented in this manual should in no way supersede established medical protocol concerning patient care and diagnosis This manual is designed to serve as an accompanying document to the c FLOW system It is not intended to take the place of c FLOW System Training which must be completed by the operator before using the system No part of the contents of this manual may be used for any other purposes discl
23. Sensor 2 screen when knob turned clockwise To scroll in reverse direction turn counter clockwise 3 Monitoring area Sensor 1 Figure 3 16 Display Control Knob Scrolling Order and Logic 2014 Ornim Medical Ltd 3 25 Messages and Pop ups Messages and Pop ups In the upper area of the Main Screen the c FLOW system displays balloon style messages as and when applicable Patient New Mira 2013 06 09 12 22 12 Laser Un i C7 Figure 3 17 Informative Message These messages which provide the user with additional information are categorized into three types in accordance with severity as follows E Informative Warning a Error Note A displayed message automatically disappears after a specified time out period approximately 10 seconds 3 26 c FLOW User Manual Whenever a message is displayed the Event Message Indicator icon refer to Table 3 1 on the right of the screen changes to show an exclamation remark informing the user of an unread message Moreover if the message indicates an Error a red exclamation remark is displayed in a flashing icon to indicate an unread critical Event This forces the user to open a pop up message and confirm reading of the message in order to continue operation of the system as shown in Figure 3 18 Invalid Operation A Marker can t be setat the specified time Figure 3 18 Message Pop up When a message pop up contains additional informati
24. all peak on the left rapidly descending to a tail of short wavy lines illustrated on the eft in Figure 3 8 In the event that signal noise is detected it is reflected in the graph display and the normal smooth graph shape changes accordingly An example of signal quality deterioration is shown below right c FLOW User Manual Main Screen Figure 3 8 Signal Quality Graphs Note Generally impaired Sensor signal quality may be improved with a few simple steps For instructions on corrective action refer to Appendix A Troubleshooting Guide Monitoring Area An example of the c FLOW Main Screen Monitoring area is shown below 2014 Ornim Medical Ltd 3 13 Sensor 1 data Sensor 2 data Figure3 9 Monitoring Area Monitoring in Progress The c FLOW system provides the option to use one Sensor only or both Sensor 1 and Sensor 2 For each Sensor CFI Trendlines displayed horizontally across the screen provide a graphic representation of measured values Real time measured parameters are shown as numeric values on the right of the screen Note To the right of each numeric value an area labeled BL provides access to a feature that enables the 3 14 user to set a Baseline value as a reference level for that parameter For details see Setting a Baseline on page 5 12 c FLOW User Manual Main Screen For easy identification Trendlines are color coded to indicate measured parameter values in
25. ally for all monitored parameters as required To Set a Baseline 1 a Tap the area labeled BL to the right of the displayed numeric value corresponding to the monitored parameter for which the baseline setting is required The Set Baseline dialog box opens Figure 5 11 OR b Tap anywhere on the relevant trendline Providing the cursor display is set to ON this automatically takes the value from the cursor position at the time when the user tapped the relevant trendline as the reference for the baseline 2014 Ornim Medical Ltd 5 13 Set Baseline i P1 CFI Manual P2 CFI Manual Figure 5 11 Set Baseline Dialog Box Note The Set Baseline dialog box provides the option of two methods for setting the baseline Manual values can be changed manually Cursor Value providing the cursor display is set to ON automatically takes the value from the cursor position at the time when the user tapped the relevant trendline see illustration below In addition the user has the option to show or hide the baseline in the chart display of the selected parameter 2 Make the appropriate selection for each required baseline If preferred change the method from Manual to Cursor Value Set Baseline Parameter Method Cursor Value P1 CFI Manual 3 When done tap OK The Set Baseline dialog box closes The newly set Baseline values are now displayed in the Monitoring area In addition if
26. alog box opens Archive Figure 5 13 Archive Dialog Box 3 Tap the OK button to continue c FLOW User Manual The data archiving procedure commences 4 When archiving is complete remove the memory from the USB port Chapter 6 System Care and Maintenance Care and Maintenance Overview General Care and Maintenance Guidelines Cleaning of the c FLOW Monitor and accessories is recommended after use and always between patients Refer to the following procedure instructions as applicable m Cleaning the c FLOW Monitor m Cleaning the LCD Display m Cleaning the Reusable Accessories ZAWARNING Do not perform cleaning procedures when power to the c FLOW Monitor is ON This may be hazardous to the user and or may cause damage to the system When performing cleaning procedures always inspect the Monitor surfaces and external cables AC power cable and Sensor cables for signs of wear or visible physical damage Z cauTion Do not use any system component or accessory if damage or impaired functionality is suspected 2014 Ornim Medical Ltd Contact Ornim Medical Technical Support for assistance It is recommended that users routinely observe the on screen Battery status indicator for operation of the recharging process 5 20 c FLOW User Manual Cleaning Procedures Cleaning the c FLOW Monitor When cleaning the Monitor do not use abrasive scouring powders or pads caustic detergents
27. by tapping the Start button Laser Status Indicators In the Sensor Location Control areas for each Sensor labeled P1 and P2 an on screen Laser Status Indicator is displayed above each graphic image The information displayed is dynamically updated in accordance with the current system status as explained in Figure 3 7 below 2014 Ornim Medical Ltd 3 9 Figure3 7 Laser Status Indicators Legend Figure 3 7 1 Laser Off ready for New Patient Both Sensors connected to patient on screen Sensor locations marked Start button tapped Monitoring about to 2 commence Laser Warmup flashes for a few seconds see 2A then shows Laser On no graphs see 2B until Monitoring starts 3 Laser On Monitoring in progress both Sensors acquiring data 4 Laser Off Monitoring paused 3 10 c FLOW User Manual Sensor Signal Indicators For each Sensor the panel on the left side of the Main Screen displays Sensor Signal indicators Shown as a segmented triangle each indicator provides a graphical representation of signal light intensity for that specific Sensor When an indicator displays between two and six green colored bars signal light intensity is acceptable for Monitoring see the examples below Main Screen mm P P Se ee The display of a Poor Light or Excessive Light indicator is explained in Table 3 4 below Table 3 4 Sensor Signal Indicators Poor or Excessiv
28. cation of the test level Table B 9 Guidance and Manufacturer s Declaration Electromagnetic Immunity for the c FLOW Monitor that is Not Life Supporting The c FLOW Monitor is designed to be used in the electromagnetic environment specified below The equipment s user must ensure that it is used in such an environment IEC 60601 Compliance Immunity Test Test Level Level Recommended Electro magnetic Environment Portable and mobile RF communications equipment should be used no closer to any part of c FLOW Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 V rms 3 VRMS 0 15 80 MHz IEC 61000 4 6 150 kHz to 80 MHz 80 AM 2 Hz on 230 VA mains Sensors 1 amp 2 External monitor B 8 c FLOW User Manual Recommended separation distance d 1 2 vPd 1 2vP from 80 MHz to 800 MHz d 2 3 vP from 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Radiated RF 3 V m 3 V m 80 MHz 2 5 GHz Field strengths from fixed RF transmitters as determined by an IEC 61000 4 3 80 MHz to 2 5 GHz 80 AM 1 kHz electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment
29. cified below The equipment s user must ensure that it is used in such an environment Emission Test Compliance Recommended Electro magnetic Environment The c FLOW Monitor uses RF energy only for its internal function RF emissions CISPR 11 Group 1 Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Harmonic emissions IEC 61000 3 2 Class A The c FLOW Monitor is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes B 6 c FLOW User Manual Voltage fluctuations flicker emissions Complies IEC 61000 3 3 Technical Information Table B 8 Guidance and Manufacturer s Declaration Electro magnetic Immunity The c FLOW Monitor is designed to be used in the electromagnetic environment specified below The equipment s user must ensure that it is used in such an environment IEC 60601 Compliance Immunity Test Test Level Level Recommended Electro magnetic Environment Electrostatic Floors should be wood concrete or ceramic tile If floors are discharge ESD 6 kV contact 6 kV contact covered with synthetic material the relative humidity should be at IEC 61000 4 2 8 kV air 8 kV air discharge least 30 2 kV Tr Th 5 50 ns 2 kV for power supply 5 kHz on 230
30. ckaging Each single use Smart Pad is packaged in a single pack labeled as shown in Figure 1 5 below rn c FLOW nim Smart Pad I n 1 XXXX XXXX REF XXX0000X Obelis s a Orim Medical Ltd Te re Bd G n ral Wahis 53 vide ats Yeda 1030 Brussels Belgium Tel 32 2 732 59 54 arak 4404312 Fax 32 2 732 60 03 Tel 972 8 9282801 E Mail mail obelis net PKG1006A REV AO Figure 1 5 Smart Pad Single Pack Label Note For an explanation of the symbols used see Table 1 3 Table 1 3 Smart Pad Packaging Symbol Descriptions Icon Symbol Description wt Batch code 2014 Ornim Medical Ltd 1 13 IN Use by date m Catalog number J ww CE mark of certification Caution Refer to operating instruction manual and any accompanying documents Do not reuse Do not use if package is damaged Indicates contents have not been sterilized Manufacturer name and address 1 ED eLE Authorized representative in the European Union name and address c FLOW User Manual system Safety Labels System Software The c FLOW system operates with dedicated c FLOW software designed and developed by Ornim Medical AN cauTION Do not attempt to install additional software programs on the c FLOW Monitor hard disk Important In the event that additional software is installed prop
31. clinical measured values are monitored and assigned with the relevant level high normal or low according to current threshold levels it will stay permanent regardless any future threshold lines settings changes In the Set Y Scale and Threshold dialog box use the tools provided as required Tap the parameter tab the relevant parameter bars are exposed and enabled for setting By pressing and dragging the numerical scroll buttons handles on the bars set new threshold y scale values for the specified parameter on the desired channel Sensor 2014 Ornim Medical Ltd 3 31 Tap the As in P1 checkbox the values set by the user for Sensor 1 will be emulated on Sensor 2 Tap the Set to Default button default configured values will be set to all parameters only after OK button pressed Tap the Cancel button returns to Main Screen no changes saved Tap the OK button the changes are saved causing the following O Scale range if changed will be modified on the Monitoring Area charts o Threshold lines if set to be displayed will be located on the new relative positions Oo New measured clinical values will be assigned with the related level in accordance with newly set Threshold levels and color coded accordingly Oo Any existing notification will be updated to correspond to the newly set Thresholds For easy identification the display of real time CFI values and Trendlines are color coded t
32. cordingly the system requires a line supply of 100 to 240 VAC 3A 50 60 Hz single phase The c FLOW system is equipped with an internal backup battery rechargeable Smart Lithium lon Battery Pack 14 4V In the event of loss of mains power to the system this provides backup for at least 30 minutes 2014 Ornim Medical Ltd 1 3 The backup battery is charged automatically whenever mains power to the c FLOW Monitor is ON No battery charging procedures are required by the user The c FLOW Monitor is fitted with two fuses 2A located in a fuse housing on the rear panel AAWARNING Fuses should only be replaced by qualified personnel or under the direction of qualified personnel For assistance contact Ornim Medical Customer Services Grounding Grounding is mandatory for proper and safe operation of the system Grounding for the c FLOW Monitor is provided through the grounding conductor in the AC power cable ZAWARNING Always observe the following safety precautions Do not connect the c FLOW Monitor to a power supply that does not meet the local electrical standards or that is not properly grounded Use the AC power cable supplied with the system or an equivalent Medical Grade AC power cable and to ensure proper grounding connect to a receptacle marked HOSPITAL ONLY or HOSPITAL GRADE When connecting the c FLOW Monitor to an uninterruptible power supply UPS a Medical Grade UPS must be
33. ction see Appendix A Troubleshooting Guide Thresholds Status Indicator and Silence Button On the c FLOW Monitor front panel a Thresholds LED indicator illuminates to indicate the current Thresholds status as explained in Table 2 4 below Table 2 4 Thresholds Status LED Illumination Thresholds LED LED State Threshold Status 2014 Ornim Medical Ltd 2 9 ef Power to the Monitor is OFF 2 Monitor is not connected to mains power Sa Power to the Monitor is ON THRESHOLDS ae ere ri Off Monitoring is in progress acquired data is within user defined Threshold parameters O Monitoring is in progress acquired data is currently above or a E ie below user defined Threshold parameters Red blinking An audible alert sounds continuously Silence threshold button has been pressed Monitoring is in progress acquired data is still above or below user defined Threshold parameters To adjust parameters refer to Setting Thresholds on page 3 27 t3 After 5 mins if acquired data is still above or below user Red steady defined Thresholds Status LED Threshold parameters an audible alert sounds continuously on Monitor Front Panel again Threshold parameters have been adjusted satisfactorily Off Monitoring is in progress acquired data is within user defined Threshold parameters During Patient Monitoring the Silence button located beneath the LED is used to silence an audible T
34. d if the package integrity appears jeopardized For example the package is not completely sealed is open or damaged a After opening the package examine the Smart Pad and do not use if it appears cracked or damaged in any visible way Do not use a Smart Pad if it was dropped prior to or during positioning Dispose of used Smart Pads in accordance with hospital protocol and local safety regulations Important For patients requiring long term monitoring it is recommended to change the Smart Pads every 2 3 days Remove old adhesive residue then clean and dry the area well before applying a new Pad Battery Capacity Low On the c FLOW Monitor front panel a Battery LED indicator illuminates to indicate the current battery status Note For an explanation of Battery Status LED indicator illumination see Table 2 2 on page 2 8 When using the c FLOW Monitor is recommended to routinely observe the on screen power status indicator shown in Figure 3 4 on page 3 5 If the system is not currently connected to the mains power and the internal backup Battery capacity is approaching low refer to Table 3 2 on page 3 6 it is necessary to reconnect the system to a mains power source in order to recharge the Battery 2014 Ornim Medical Ltd 1 21 When the battery capacity is low the Battery status LED indicator on the front panel blinks red In addition a pop up error message is displayed Figure 1 6 left Tappin
35. e To Attach a Smart Pad to the Patient 1 Make sure the skin area has been properly prepared as previously described 2 Peel off the protective film covering the silicon cushion on the Smart Pad Figure 5 1 c FLOW User Manual Figure 5 1 Removing the Protective Film from the Silicone Cushion 3 Peel off the protective film on the underside of the Smart Pad to expose the adhesive surface Figure 5 2 Figure 5 2 Removing the Protective Film from the Smart Pad 4 With the adhesive side facing downwards carefully place the Smart Pad over the required area silicone pad in the correct position and press it down on all sides to secure it firmly on the patient s skin Figure 5 3 2014 Ornim Medical Ltd 5 3 Figure 5 3 Attaching a Smart Pad to the Skin 5 Apply a small amount of ultrasound gel to the silicone cushion in the center of the Pad then spread it evenly Figure 5 4 Figure 5 4 Spreading Ultrasound Gel onto the Silicone Cushion The Pad is now ready for attachment of a Sensor proceed to the instructions Connecting a Sensor to a Smart Pad 6 Repeat Step 1 through Step 5 attaching a Smart Pad to additional skin areas as required 5 4 c FLOW User Manual Patient Preparation Connecting a Sensor to a Smart Pad To Connect a Sensor to a Smart Pad 1 Remove the required Sensor from the Sensor Docking Station then holding the Sensor in one hand apply a quantity of ultrasound gel to the S
36. e Light Condition Display Graph Area Recommended Corrective Action Poor Light x Sensor signal indicator shows one bar colored green No graph is displayed No values presented in the Numerical Measurements area Adjust the Gain Value for instructions see Adjusting the Gain Value on page 5 11 Note Gain adjustments may be made either in Monitoring or Pause mode For additional assistance refer to the Troubleshooting Guide 2014 Ornim Medical Ltd Excessive Light Sensor signal X indicator shows all bars colored red No graph is displayed Adjust the Gain Value for instructions see Adjusting the Gain Value on page 5 11 Note Gain adjustments may be made either in No values presented aan Monitoring or Pause mode in the Numerical Measurements area For additional assistance refer to Troubleshooting Guide Signal Quality Indicators When the system is in Monitoring Mode the left side of the Main Screen displays a signal quality graphs for each Sensor as follows m Upper area Sensor 1 m Lower area Sensor 2 Each graph provides an easily recognizable visual display to indicate to the user at a glance the present signal quality for the relevant Sensor as detected by the c FLOW Monitor Each graph comprises a blue colored line representing the laser signal When the Sensor signal quality is good the graph shape is typically a t
37. ea 6 6 45444 655848 a ore ee be ieoeeeess 3 11 ek EEEE E AENT E N EE eo T E ee ee 3 12 Navigation and Display Options sssssessssseseesessecoeseecesoesecececcecceceeo 3 15 Hor oma 0 lE goo eeeoc ded eae bono ooo ee ENRETA TEER ENEE REAR 3 15 Serolling the Patient History Cie oa oho ee keene bird ised ed 9G 8 ee oe dees 3 16 Sade M eee a a ee ee ree ee er re ee ee ee 3 17 Fane Bs oss oo oe 4 ESEE E E E E E EE E E EEE E ee ees 3 18 PG oo E E E ee a a a eh ee 3 19 2014 Ornim Medical Ltd Xi Using the Display Control KNOD s 4 0 44 654 cued Bees kee ee WR OR ERO LEE OR ee kde SDR AE SAE 3 22 Messages and POD NS 66 0k 65 66654540445 0 EH OF ASHES EKG 9S 156 0054 456664554 RE HSS 3 23 Pe Be og ei oh EEO SONS eo he a ee se EE ek 3 25 fie cu eM seo ee ee ee ee ee ee Pe eee ae rer ee 3 26 Threshold Indicator oss 5 oh 6 0 ooh oe he RSE Eh 06S ean eens 3 26 AE TT in hy ek ee gk Re oe ho eee ocean ee 3 27 ers i S rirerire FrEE oe eo ek 2 3 29 Selecting a Marker and Viewing DeIAIS 4 640k esos bi eh es be hi eh ee ee eh eee ek ob eee ehh eee dees 3 30 Show Hide Mork ono ae ob eb a eee ees ab odo bb 555855555000 954555050554535450046858 3 31 Jumping to Next Marker acct dscdtecddscdtecddecdeeen pid eo een Shi eo ee Oedd SRS SRE TSE eee es 3 31 aame a NO oe 8 ee ok a a ee a a 3 31 ceea NMR ok 8 ocd oe A OA SS ee aAa 3 33 Chapter 4 System Preparation Startup and Shutdown System Preparation OVErvieW 1 cc cc cc ccc cece eee eee ee eet
38. each side of the Monitor front panel provide a docking point for each of the two Sensors Note Each docking point is fitted with an interlock shown in Figure 2 2 to prevent system self testing whenever the Sensors are not docked Figure 2 2 Sensor Docking Station Empty and with Sensor Docked Legend Figure 2 2 gt Sensor Docking Station 2 Sensor Docking point amp Interlock 4 i Sensor Docked in Docking Station c FLOW User Manual system Configuration Qi Sensor cable hook When not in use and also during system start up each Sensor must be placed in its respective Sensor Docking Station see above N caution The c FLOW Monitor can operate with either one or two Sensors connected to the patient However if only one Sensor is in use the second Sensor must be docked in the Sensor Docking Station Display Control Knob The LCD Display Control Knob is located in the lower right corner of the Operator Panel at the front of the c FLOW Monitor Figure 2 3 Display Control Knob The Knob has a ridged outer ring for easy turning when scrolling through the display screens the center button can be pressed to make a selection from a drop down menu or confirm a command operating like the lt Enter gt key on a keyboard When using the Display Control Knob movement through the screen areas and controls will always follow the path logic illu
39. ead Cerebral locations labeled C5 through C8 on eft side of the head Limbs Image Muscular locations labeled M1 through M4 on right side of the body Muscular locations labeled M5 through M8 on left side of the body 2 Tap ona different Sensor location as required 3 Tap OK to accept the new location The dialog box closes the newly selected Sensor location is now updated on the display During Monitoring this will be shown in the current session Monitoring area 2014 Ornim Medical Ltd 5 9 Monitoring a Patient Starting a Monitoring Session To Start a Monitoring Session 1 Check that all required display settings have been selected as previously described Make sure the appropriate on screen Sensor locations have been marked correctly 2 Check the on screen Sensor Signal indicators and make sure that each indicator displays between two and six green colored bars signal light intensity is optimal for Monitoring If necessary adjust the Gain Control see Adjusting the Gain Value on page 5 11 3 Tap the Start button above the Monitoring area Monitoring commences The following changes occur in the display a The Start button color changes to green a Clinical numeric values will start being displayed a Real Time Indication small ball on charts right edges appears ao Trendlines progression commences a A Sensor Location label for example C7 M3 etc is displayed in the Monitoring area correspond
40. ecurely fastened in position on the Roll Stand 7 Release the locking brakes and move the Roll Stand into the required position Make sure it is standing on a level surface then lock the brakes again to prevent movement Note Later whenever it is necessary to remove the Monitor from the Roll Stand pull the locking pin down to release it before sliding the Monitor off the Roll Stand 2014 Ornim Medical Ltd 4 5 Connecting the AC Power Cable To Connect the AC Power Cable 1 Plug the AC power cable into the power input socket at the rear of the Monitor Figure 4 4 Connecting the AC Power Cable to the c FLOW Monitor 2 Plug the other end of the AC power cable into the mains power wall outlet Awarnnse Do not turn ON the On Off power switch yet see important note below Make sure both Sensors are securely docked in the Sensor Docking Station before proceeding to the i system Startup Procedure Follow the instructions for Placing the Sensors in the Sensor Docking Station 4 6 c FLOW User Manual Positioning the c FLOW Monitor Placing the Sensors in the Sensor Docking Station To Place the Sensors in the Sensor Docking Station 1 Holding one of the Sensors in one hand position it in the correct orientation with the face of the Sensor appropriately aligned with the corresponding Sensor Docking Station as shown A in Figure 4 5 A B C Figure 4 5 Placing a Sensor in
41. ee eeees 6 1 Cleaning cies a ee 6 2 Cleaning the c FLOW Monitor a4 cic ice each ee 8665 65554 154455454 046 054545464556 1044545 be EEE 6 2 O ta gig OS BYRDS o ee ee eee 6 3 Cleaning the Reusable Accessories 1 uenee 6 4 Appendix A Troubleshooting Guide General Troubleshooting Guidelines 0 ccc ccc ccc etc teec eee eee e ee een eens A 1 xiv c FLOW User Manual Appendix B System Specifications and Technical Information System Performance Specifications and Accuracy ccc cece cc ence eee eee e ee eneceens B 1 Operating Modes and Monitored Parameters 0 0 cc ccc ee eee ee eee tent eee eens B 1 Acousti CUNT Wikasireie Gs cx ox 06 6465 9954 OG EEE Ee re ee ee bo OO 8 4 ee B 2 System Spet CaS ek ee oe ee ee AE ee ee ee B 4 i I a eek 0 5 EE ee a 4 ee B 4 Sae Elo ahi se a Cee ee ee eae ee ee ee ee ee ee re ee eee eee ee eee ee B Bice ecm tC sc hey oe ee ee ee B 5 Environmental Specifications 0 ee ee eee eee eee e eee eee e teen eee e eens B 5 aa Sale ok oe E eee eee B 6 Electro Magnetic Compatibility Oct eae oh 5400 oe oe bed ada e841 oe ees ees ed 99 44594540 00 B 6 2014 Ornim Medical Ltd XV Chapter 1 Safety Information General Safety Considerations The c FLOW Monitor is designed and manufactured to ensure maximum safety of operation The system should be used and maintained in accordance with Ornim Medical recommended guidelines and in strict compliance with the saf
42. eee e eee tees neees 4 1 Bt Wn be eos he ee a we r r A AAR 4 1 Positioning the c FLOW Monitor cc ccc cee cen cee cette cee eee e eee eeneeenes 4 2 Tae tO MOUM amp xo oh he ae 05 GSE hk A r ee es 4 3 Mounting the Monitor on the Roll Stand ose 6 6194446464640444654 0004006555 56584458 06484008000 805 4 4 System Startup Procedure back cok b4 he 60S SRG 4 KEEN eee eed 4 8 Turning ON Fow r to he MOTO oc ova es ene e ca ee eeee gece Seen eee 66e 60000059 588 PENERE ERER 4 8 System Shutdown Procedure 614624545 6594460 005 6064006000400 409440 edd HEE EOE 4 11 xii c FLOW User Manual Turning OFF Power to the Monitor 0 0 ccc ee eee tee e ee eee eee bette een n ene 4 11 Disconnecting the AC ge ge oe ee er eae ae ae aera eee eee eee ee eres wer 4 12 Cleaning the Monitor and Accessories 16 ce cece eee e ene e eee nee eens 4 13 ide ecm cig eg ee ee ee ee ee er ee ee 4 13 Chapter 5 Patient Monitoring c FLOW Monitoring Overview ccc ccc cece eet eee nett e eee e eee eee eee ences 5 1 Patient Plat 6 e oa 09668 oh 4 RO Ee os bes 68 he ee 5 2 Patient Positioning ss ssessssserssririrrerri tarta 6 eed 2 os FO Oba dae 684 548 4 EES eS 5 2 ee ogee ce oe eo ee eo E E ee ab ee eee eee 5 2 Pr Se ee P ee ee ee ee ee ee ee ee eee ee ee ee eee eee eee 5 3 Connecting a Sensor to a Smart Pad lt 6 oso 0 ear ka 04 00 erranen b6 dO HES ADELE RET Aw EERE HERE EO RE SS 5 5 Creating a New Patient Fie co dees a cek ee
43. ensor surface as shown in Figure 5 5 Figure 5 5 Applying Ultrasound Gel to the Sensor 2 Spread the ultrasound gel well over the sensor to remove any air bubbles as shown in Figure 5 6 2014 Ornim Medical Ltd 5 5 Figure 5 6 Spreading Ultrasound Gel to Remove Air Bubbles 3 With the Sensor facing downwards carefully position the Sensor into the plastic framework on the Smart Pad 4 Make sure the silicone cushion and Sensor are in correct alignment with each other Then using two fingers gently press the Sensor downwards to cradle it securely between the two plastic snaps Note The unique design of the Sensor and the Smart Pad enable users to perform this step easily using one hand only The Sensor is now connected to the Smart Pad with the ultrasound gel forming an intact seal between the Sensor and the patient s skin 5 6 c FLOW User Manual Figure 5 7 Sensor Connected to the Smart Pad For long term monitoring of patients it is recommended to change the Smart Pads every Important 2 3 days When attaching a replacement Pad clean and dry the area thoroughly before reapplying fresh ultrasound gel to the center of the Pad and to the Sensor Creating a New Patient File Creating a New Patient File Adding a New Patient Refer to the information and explanations provided for New Patient on page 3 4 Note It is recommended to make a note of the c FLOW system computer generated Pati
44. ent Number and keep a record of it together with the actual Patient ID for future reference 2014 Ornim Medical Ltd 5 7 Before creating a New Patient remember to Save the data information currently displayed for an Pred existing patient if required before proceeding to Add a New Patient refer to Archiving Patient Monitoring Data on page 5 16 Setting Scale and Threshold Levels When setting the required Trendline Threshold upper and lower levels refer to the information in Setting Thresholds on page 3 27 Marking Sensor Locations Note The on screen display of Sensor locations is described in Sensor Location Controls on page 3 7 See also Sensor Anatomical Location Indicators on page 3 8 If necessary the user may select a new location for the P1 Sensor or P2 Sensor connected to the head or limbs as described in the following procedure Note On screen Sensor Locations cannot be marked when the c FLOW system is in Monitoring Mode Later if necessary to change the position of a Sensor then remark its location Pause Mode must first be activated To Mark Sensor Locations 1 Tap the current Sensor location The Set Sensor Location dialog box opens c FLOW User Manual Channel1 Set Probe Location Figure 5 8 Set Sensor Location Dialog Box Note The on screen Sensor Locations provide the following options Head Image Cerebral locations labeled C1 through C4 on right side of the h
45. er operation of the c FLOW system cannot be guaranteed by the manufacturer In addition the warranty may be voided 2014 Ornim Medical Ltd 1 15 Guidelines for Safe Handling of the c FLOW Monitor Guidelines for Safe Handling of the c FLOW Monitor The c FLOW Monitor is a sturdy portable unit designed to be moved easily Whenever handling the system operators should observe the following safety precautions A When connecting the Monitor to AC power make sure the provided voltage is in the allowed range Use the AC power cable supplied with the system or an equivalent Medical Grade AC power cable and to ensure proper grounding connect to a receptacle marked HOSPITAL ONLY or HOSPITAL GRADE Do not attempt to operate the system if any cables are missing or broken or cannot be connected properly The precautions recommended below help to ensure safe and reliable operation of the system Do not knock the Monitor or damage system covers Do not pull stretch or kink system cables Do not cover or drape anything over the Monitor during system operation Observe the manufacturer s recommended environmental conditions outlined in Environmental Requirements Make sure the Monitor is correctly positioned as described in Space and Positioning c FLOW User Manual Do not disconnect any cables from the c FLOW Monitor during active Patient Monitoring When disconnecting the AC power cable do not pull
46. es Patient Safety and Handling Guidelines The guidelines below are recommended for patient safety and comfort a Select an area for Sensor attachment that is as flat as possible Do not apply a Smart Pad to skin that is not intact or that shows signs of infection allergic conditions burns etc Always make sure the skin area is properly shaved to ensure good adhesion of the Smart Pad and to minimize patient discomfort during removal Infection Control AN cauTION Smart Pads for use with the c FLOW system are intended for single use only 1 18 c FLOW User Manual Adequate cleaning of the c FLOW Monitor and Sensors is necessary to prevent patient to patient disease transmission It is the responsibility of the equipment user to verify and maintain the effectiveness of the infection control procedures in use Note For cleaning instructions refer to Cleaning Procedures on page 6 2 Electricity Power Failure In the event of power down or interruption in the mains power supply during Patient Monitoring the c FLOW Monitor internal backup battery will sustain power to the system for at least 30 minutes Use of Accessories and Disposables Sensors Use ONLY Sensors supplied by Ornim Medical Use of Sensors supplied by other manufacturers could result in c FLOW system malfunction and may cause serious injury to the patient and or medical personnel The Sensors supplied by Ornim Medical are for dedicated
47. ety precautions warnings and operating instructions contained in this User Manual AN caution Only users who have been trained in its use may operate the c FLOW system Safety Checks Before Using the System Before using the c FLOW system operators should always perform the following routine checks Inspect the external cables AC power cable and Sensor cables for signs of wear or visible physical damage Inspect the Sensors for signs of wear or visible physical damage Make sure the c FLOW Monitor is suitably positioned with adequate clearance around it to provide easy access see Positioning the c FLOW Monitor on page 4 2 2014 Ornim Medical Ltd 1 1 a f using the Roll Stand check that it is on a level surface and that the two locking castor wheels are locked to prevent movement of the c FLOW Monitor during the monitoring procedure Do not use any system component or accessory if impaired functionality is suspected Do not replace change modify alter any part of the c FLOW system components Prescription Notice Federal USA law restricts this device to sale by or on the order of a physician In addition the user uld be properly trained in use of the system Equipment Classification The c FLOW system is classified as follows Medical Device Directive MDD Class IIb m Electric shock protection Type BF Mode of operation Continuous Laser output Class 1 Compliance
48. for attachment to the patient 2 Sensor Cables 2014 Ornim Medical Ltd 2 13 Sensor Cables permanently connected to c FLOW Monitor front 3 panel Each Sensor has two sensor cables that are an integral part of the Sensor and the c FLOW Monitor The two Sensors remain permanently connected to the front of the c FLOW Monitor Figure 2 1 When not in use Sensors must be placed in their Sensor Docking Station see Figure 2 2 on page 2 4 caution The c FLOW Monitor can operate with either one or two Sensors connected to the patient However if only one Sensor is in use the second Sensor must be placed in the Sensor Docking Station When not in use it is mandatory to leave the Sensors docked in their Sensor Docking Station gt m m While the system is in Monitoring mode one LED on the relevant Sensor is Q illuminated green steady illumination In Pause mode or whenever docked the Sensor LED blinks green 2 14 c FLOW User Manual System Configuration Accessories Optional Roll Stand Providing a convenient mounting option for the c FLOW Monitor the Roll Stand enhances maneuverability of system within the clinical environment Figure 2 8 Roll Stand The Roll Stand is easily movable and has five caster wheels all of which are lockable to prevent movement of the system during monitoring procedures For convenience the Roll Stand acce
49. g Show Details displays a reminder for the user to connect the c FLOW Monitor to the mains power in order to charge the battery Figure 1 6 right Error Message A Battery Low Error Message Please make sure the monitor is connected to mains power to enable battery charging 19 1 Battery Low Figure 1 6 Battery Low Error Message and Show Details When the battery capacity is low in the event that the message is ignored the system will automatically shut down safely Patient Monitoring Data Archive Procedure Patient Monitoring Data Archive Procedure The c FLOW system Archive utility provides the option to download a patient s measurement data acquired during Patient Monitoring sessions to external media memory stick flash drive if required Later this may be accessed on any external PC and reviewed for further diagnostic analysis 1 22 c FLOW User Manual Note Refer to the instructions for Archiving Patient Monitoring Data on page 5 16 2014 Ornim Medical Ltd 1 23 Chapter 2 Introduction to the c FLOW System System Overview The c FLOW system is designed for use in any Neuro Intensive Care Unit NICU Intensive Care Unit ICU or Operating Room OR by specialist clinicians Intensivists Anesthesiologists and or other medical professionals for the non invasive monitoring of microcirculation blood flow in adult tissue Note For specific indications refer to
50. g period time during which patient is actively monitored 2014 Ornim Medical Ltd Vii Contents Bea A ea rd ceca eine ee rie es i Teao ES in E ii SP L eA A AAEN NEA AT AA ii perational Use of the FLOW oO S1 8 ieiistieciireininriirieninerinrrrnianinemaniamaes ii Responsibility of the Manufacturer s ssesessesesessecessesessesessecesosoesseoesosoesesoecesoecsesseoesoeoessscesesoecseoeoe iii Conventions Used in this Manual seissrssessrsroksissuiscrnarninsainna annan EE Aaaa iv Tamme and FONG cerra erie vi 2014 Ornim Medical Ltd viii Chapter 1 Safety Information General Safety Considerations ccc ccc cee cece cet cette eee ee eee eee ee eeeees 1 1 Safety Checks Before Using the System cc eee eect eee e eee e eee enee 1 1 PCN Po oe ee 608 eee 0 4 ee ee ew heer eine cees 1 2 Equipment Classification 4 v54 05 0 96d0 000d 8 eee ee Se bee Oe ee OE 1 2 Compliance with International Standards ccc cece cee eee e eect tent eee eeees 1 2 Be tre T eae ee ee 9 TE A A EEE oe oe eae 445s ee eee 1 3 aeua Bicol gaa 11k ae ee ee ESENE EENE ee rer er eee eee ree ee re ee re ee 1 3 Re oo Ge ob ae ead ea ee ee oe eee EERE EE oo a ee eee 6 er ee eee nese 1 4 erste Beli se ag 62 gs ee er ee en ee a er ee ee a ae ee ee eee ee ree 1 4 ee li IETT EESTE eek a eH Oo ek ee 1 5 Protection Against Ingress of Liquids 1 0 cc ccc cee cee cet cee cece ee eee e ee eeeees 1 5 Electromagnetic Compatibility EMC
51. hreshold Indicator signal if required For more details see Responding to a Threshold Indicator on page 5 14 2 10 c FLOW User Manual System Configuration Rear Panel Figure 2 5 c FLOW Monitor Rear Panel 1 AC power input refer to Figure 2 6 2 Air vents 2014 Ornim Medical Ltd 2 11 AC Power Input ym LOW3310 l ET i 3310 A SS 2 D 3 ome Figure2 6 AC Power Input Legend Figure 2 6 1 ON OFF power switch 2 Fuse housing see warning below 3 AC power input socket Refer to the procedure for Connecting the AC Power Cable on page 4 6 AAWARNING Fuses should only be replaced by qualified personnel or under the direction of qualified For assistance contact Ornim Medical Customer Services 2 12 c FLOW User Manual System Configuration Accessories Standard Sensors The c FLOW system is equipped with two Ultrasound UTLight Sensors When attached to the required location these are used to acquire real time measurement of blood flow throughout the monitoring process Each Sensor which is clearly labeled Sensor 1 or Sensor 2 is coupled to the patient s skin by way of a single use Smart Pad For details see Smart Pads Note Users have the option of using only one Sensor Sensor 1 or Sensor 2 or both as required Figure2 7 Sensor with Sensor Cable Legend Figure 2 7 1 Sensor
52. ialog box opens Figure 5 10 Set Gain Control e Cancel Set to Default N Figure 5 10 Set Gain Control Dialog Box Note Gain Values selection options are in increments of 01 through 10 the default value is 10 Adjustments to the Gain Value affect both Sensor 1 and Sensor 2 simultaneously 2 Type the required value in the Gain Value input field or tap Set to Default then tap OK 3 Check the displayed Sensor Signal indicators and make sure that each indicator displays between two and six green colored bars i e signal light intensity is optimal for Monitoring For details see Sensor Signal Indicators on page 3 10 4 If necessary make further Gain Value adjustments until the setting is appropriate 5 12 c FLOW User Manual Monitoring a Patient For an explanation of Poor Light and or Excessive Light see Table 3 4 on page 3 10 Setting a Baseline The option to set a baseline for any monitored parameter is a useful feature that provides a reference level as defined by the user from which a change is noticeable Typically a baseline may be set after a period of approximately 5 minutes of active monitoring by which time sufficient data has been acquired to enable use of this feature Note The procedure for setting or adjusting a baseline may be performed either during active monitoring or when the c FLOW Monitor is in Pause mode This can be done individually for single monitored parameters or glob
53. ing the relevant Sensor P1 or P2 a Figure 5 9 illustrates the Monitoring in Progress screen 5 10 c FLOW User Manual Monitoring a Patient 2014 09 02 14 28 38 Laser On 1004 D4 ail Laser On Figure 5 9 Monitoring in Progress When the system is in active Monitoring mode one LED on each Sensor is illuminated green steady illumination While the system is in Monitoring mode if necessary it is possible to detach a Sensor from the patient without the need to Stop the Monitoring process Data will not be acquired during the time in which the Sensor is not attached to the patient When the Sensor is reattached Monitoring will resume automatically On screen Sensor Locations cannot be marked when the c FLOW system is in Monitoring Mode In important Q event that it is necessary to change the position of a Sensor then remark its location Pause Mode must first be activated After marking the location Monitoring is resumed by tapping the Start button 2014 Ornim Medical Ltd 5 11 Viewing and Browsing Monitored Data While Monitoring is in progress view and browse the displayed data as required For easy navigation refer to the information previously described a Scrolling the Patient History Data on page 3 16 Scrolling to Real Time on page 3 17 Adjusting the Gain Value To Adjust the Gain Value 1 Tap the Menu icon then select the Set Gain Control option The Set Gain Control d
54. mobile RF communications equipment and the c FLOW Monitor The c FLOW Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the c FLOW Monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and c FLOW Monitor as recommended below according to the maximum output power of the communications equipment Distance apart in terms of the emitter s frequency m 150 kHz to 80 MHz 80 MHz to 800 MHz d 800 MHz to 2 5 GHz Rated maximum output power d 1 2vP 1 2vP d 2 3vP of the transmitter W 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 B 10 c FLOW User Manual
55. n for medical electrical equipment To ensure the c FLOW system is protected from EMC interference users should always observe caution tn following precautions Electrical medical equipment needs special precautions regarding EMC and must be used according to the EMC information provided in the accompanying documents supplied with the c FLOW system Do not operate the c FLOW Monitor in the presence of electromagnetic interference Interference may be caused by electrosurgery diathermy magnetic resonance imaging or other equipment m Portable and mobile RF communications equipment may affect operation of this device For guidance and recommendations refer to Electro Magnetic Compatibility EMC on page B 6 1 6 c FLOW User Manual Biocompatibility The disposable Smart Pads supplied for use with the c FLOW system comply with the ISO 10993 1 standard as follows m Biological evaluation of medical devices Part 1 Evaluation and Testing 2014 Ornim Medical Ltd 1 7 System Safety Labels The c FLOW Monitor and accessories are equipped with product compliance and safety labels These are strategically positioned to provide important information regarding safe operation of the system The following provides explanations for the symbols and icons used as well as details of the label locations c FLOW System Name Plate Label The c FLOW system name plate label located on the Monitor rear
56. nces a new session In the Monitoring area sessions are clearly 2014 Ornim Medical Ltd 3 15 identifiable by a vertical black area on the display background between each session as shown in Figure 3 10 The gap between Monitoring sessions is synchronized to the time line c FLOW User Manual Main Screen Session 2 Session 3 Session 1 Mika 2013 06 11 17 51 20 10 C7 Laser On P 1 Laser On Figure 3 10 c FLOW Main Screen showing Monitoring Sessions 2014 Ornim Medical Ltd 3 17 Navigation and Display Options Horizontal Scroll Bar Located beneath the Monitoring area the horizontal scroll bar is used for scrolling seamlessly through the displayed data and browsing the patient data history 1 1 3 5 Figure3 11 Horizontal Scroll Bar Legend Figure 3 11 Description 1 Real Time Indicators Actual current time 2 Horizontal Scroll bar 3 Scroll bar thumb Tap then hold and drag through the Monitoring sessions 4 Left arrow Jumps one page backwards in time 5 Right arrow Jumps one page forwards in time 3 18 c FLOW User Manual Navigation and Display Options The horizontal scroll bar is active irrespective of the current Monitoring mode The size of the scroll bar thumb is relative to the amount of data in the current patient s data history buffer maximum 10 days The displayed width of the scroll bar thumb is determined by the current zoom resol
57. o indicate measured parameter values in relation to the Threshold values that are currently set as defined by the user a Grey within upper and lower Threshold values Yellow above upper Threshold value Red below lower Threshold value 3 32 c FLOW User Manual Event Markers Event Markers The c FLOW system Markers feature enables the user to mark Events points of interest in time as part of the monitoring measurement values history storing and archiving For example an Event may be drug delivery changing position of the patient etc Event Markers which are displayed in the Monitoring area are created using the Marker tools located in the lower right corner of the Main Screen as shown in Figure 3 22 2 3 4 Figure 3 22 Marker Tools Legend Figure 3 22 Description 1 Mark now Used to add a Marker to indicate a specific point of interest Note Using this tool no tapping of the LCD display is required the Marker is synchronized with the actual current time at which the tool is used Refer to the scenarios described in Adding a Marker 2 Left arrow Jumps backwards in time to previous Marker 3 Show Hide Markers Toggles between markers displayed or hidden from view 4 Right arrow Jumps forwards in time to next Marker 2014 Ornim Medical Ltd 3 33 The available Event Markers are displayed in the Monitoring area as small gray rectangular
58. of system operators The conventions described below are used to classify and identify hazards that will or may occur if instructions are ignored Warnings Two types of Warning are used these identify a known risk or specific type of hazard as shown below Do not proceed beyond a Warning message until the conditions are fully understood and the appropriate preventive action has been taken Electrical Hazard Warning used to identify conditions or actions for which there is a known risk of Electrical Shock which may cause serious or even fatal injury if the instructions are ignored An example is shown below ZAWARNING Do not open system covers The c FLOW Monitor has no user serviceable parts iV c FLOW User Manual Non Electrical Hazard Warning used to identify conditions or actions for which a specific hazard of a non electrical nature is known to exist which may cause personal injury or equipment damage if the instructions are ignored An example is shown below ZAWARNING To prevent possible damage to the c FLOW Monitor always secure it to the Roll Stand or place securely on a flat stable surface that is free of dirt and debris Conventions Used in this Manual Cautions Cautions are used to identify conditions or actions for which a potential hazard may exist which will or can cause minor personal injury or equipment damage if the instructions are ignored Cautions may also be used to highlight a
59. on it may be viewed by tapping the Show Details button as seen in the example below 2014 Ornim Medical Ltd 3 27 Event error Log Details Test Message Random 93 Event Error Log Details r 1 Test Messuue Pandan Figure 3 19 Example of Message Pop up and Additional Details All messages irrespective of type are saved in a dedicated Message Event Log and can be accessed later if required For details see Message Event Log Messages and Pop ups Message Event Log By tapping the Event Message Indicator icon see Figure 3 4 the Events and Errors Log dialog box opens listing all Event and Error messages that have been displayed for the current patient 3 28 c FLOW User Manual Events and Errors Log 9 9 2014 7 20 17 AM Archiving Error 9 9 2014 7 20 17 AM Archiving Error a 9 9 2014 9 14 21 AM Battery Low 9 9 2014 9 15 49 AM Archiving Error Figure 3 20 Events and Errors Log When a listed Event is currently selected tapping View Log opens a dialog box enabling the user to view additional information pertaining to that Event similar to the example in Figure 3 19 Threshold Indicators As previously described the measured parameter values and Trendlines displayed in the Monitoring Area are color coded in accordance with the threshold level as currently set by the user As soon as any measured value Flow approaches the High or Low level an audible indication sounds The sound stops onl
60. or on Monitoring area taps at the required point in time and adds a corresponding Marker To Add a Marker 1 Tap the Mark or Mark Now button as applicable A predefined Marker Legend List is displayed 2014 Ornim Medical Ltd 3 35 ntubsnon Sardiat arrest Arrhythmia Hyper hypotenson Respiratory arest Hyperven lation Administration of blood unit starv enc Artifacts Figure 3 24 Marker Legend List If required the Marker Legend List may be customized in accordance with user preferences Contact Ornim Medical Technical Support for assistance in this regard 2 Select the required Legend option A Marker is now added to the Monitoring area in accordance with the relevant time and with the selected legend The Marker will be synchronized in all existing views By selecting Close Menu in Step 2 no Marker is added and the Menu is closed Any Marker or group of Markers is accompanied by an additional notation on the horizontal scroll bar A small triangle is displayed located in the relative position on the loaded buffer Figure 3 25 Figure 3 25 Markers on Horizontal Scroll Bar 3 36 c FLOW User Manual Event Markers Clearing a Marker Tapping the Delete button on the detailed marker tooltip deletes the Marker and removes any related indications from the screen The action of clearing a Marker is irreversible Before doing so always make sure the correct Marker is currently selected and that
61. osed to any person or firm or reproduced by any means without the express prior written permission of Ornim Medical Ltd The text and drawings in this manual are for the purposes of illustration and reference only The specifications on which they are based are subject to change without notice 2014 Ornim Medical Ltd i Trademarks c FLOW and UTLight are trademarks of Ornim Medical Ltd Other company and brand product and service names are for identification purposes only and may be trademarks or registered trademarks of their respective holders This product is covered by Ornim Medical Ltd patents pending Intended Use The non invasive c FLOW Monitor is intended for use as an adjunct monitor of microcirculation blood flow in tissue The c FLOW Monitor is intended for monitoring of adults The prospective clinical value of data from the c FLOW Monitor has not been demonstrated in disease states The c FLOW Monitor should not be used as the sole basis for diagnosis or therapy Operational Use of the c FLOW System This manual describes the operation and use of the c FLOW Monitor and should be read before using the system Any monitoring procedures performed using the c FLOW system must be carried out by validly licensed clinicians who have undergone training in the use of the system important Do not use this system if you have not been adequately trained in its use by Ornim Medical ii c F
62. panel see Figure 1 3 shows details of all applicable input and output specifications certifications manufacturer etc Refer to Table 1 1 for a description of the symbols used Wrnim c FLow medical Model No c FLOW3310 100 240 V 0 7 A max 50 60 Hz 80VA E 2xT2A 250 V CLASS 1 LASER PRODUCT 0473 a Ornim Medical Ltd EC Obelis s a aid 15 Atir Yeda Ec REP Bd G n ral Wahis 53 Kfar Saba 1030 Brussels Belgium Israel 4464312 Tel 32 2 732 59 54 Tel 972 8 9282801 Fax 32 2 732 60 03 E Mail mail obelis net LBP1005A REV AO Figure1 1 c FLOW System Name Plate Label Table 1 1 c FLOW System Name Plate Label 1 8 c FLOW User Manual system Safety Labels Iicon Symbol Description Serial number Manufacturing date Catalog number I HG B Fuse quantity type and rating CE 0473 CE mark of certification Caution Refer to operating instruction manual and any accompanying documents Waste Electrical and Electronic Equipment WEEE Disposal Indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment Identifies degree of protections against electric shock Indicates Equipment Type BF applied part for medical equipment Identifies a BF type applied
63. put Measurements TIS non scan AAPRT gt 1cm2 Index label MI 2014 Ornim Medical Ltd B 1 0 29 max 0 22 max 0 74 max Associated acoustic pr 3 MPa 0 29 max alain P mW o osma y oO zem dae S min of P3 zs ITA 3 33 4 max zs Ec zamma 208 SSS owen PRR Hz 7 a wamama om SY IsPTA 3 at max MII 103 max mW cmz2 Operating control Duty cycle conditions Performance and Accuracy The global maximum values for Cerebral and Muscle modes for c FLOW Monitor Transducer Model ISPTA 3 IPA TIC TIS Mi P B 2 c FLOW User Manual vaio 03 mien 36 When Uncertainties U 975 CI 95 THERMAL INDICES and the MECHANICAL INDEX are below 1 0 for all device settings 2014 Ornim Medical Ltd B 3 System Specifications c FLOWw Monitor Table B 2 c FLOW Monitor Dimensions and Weight 28 cm 11 ins 28 cm 11 ins Nett Weight 34 cm 9 kg 13 4 ins 19 8 Ibs Table B 3 c FLOW Monitor LCD Display Parameter Details Size of Screen Resolution 10 4 800 x 600 pixels Electrical Specifications Table B 4 c FLOW System Electrical Specifications Power Source AC Input Internal Backup Battery Fuse x 2 provides power to the c FLOW Monitor for at least 30 minutes Specifications 100 240 VAC 50 60 Hz 0 7A max Nominal operating voltage 14 4V 2A Table B 5 c F
64. r by pulling them forwards 3 On each leg slide the locking clip colored red fully upwards as shown in Figure 4 1 to lock each leg in position A click will be heard when the leg lock engages Front Leg Unlocked Front Leg Locked Figure 4 1 Locking the Support Legs 2014 Ornim Medical Ltd 4 3 Mounting the Monitor on the Roll Stand Note The c FLOW Monitor and the Roll Stand are both supplied with a ready fitted mounting bracket as shown in Figure 4 2 Guide Rails Locking Pin Mounting Bracket Mounting Bracket Fitted to Monitor Base Roll Stand Mounting Bracket Figure 4 2 Mounting Brackets To Mount the Monitor onto the Roll Stand 1 Make sure the Monitor is in shut down mode and that Sensor cables and AC Power cable have been disconnected from the system 2 Make sure the Roll Stand is standing on a level surface Lock the brakes on the two locking caster wheels to prevent movement 3 Pull down the locking pin see Figure 4 2 from beneath the Roll Stand mounting bracket 4 4 c FLOW User Manual Positioning the c FLOW Monitor 4 Lift the Monitor and hold it carefully aligning the edges of the base mounting bracket with the rails on the sides of the Roll Stand mounting bracket refer to Figure 4 2 5 Carefully slide the Monitor onto the mounting bracket rails until it clicks into position Figure 4 3 Mounting the Monitor on the Roll Stand Check that the Monitor is now s
65. r from the Smart Pad Clean Unclean Sensor surface the surface of the Sensor with a soft lens cleaning tissue or equivalent then reconnect the Sensor Coupling medium is not intact Replace single use Smart Pad Defective Sensor Call Ornim Medical Technical Support None of the above solutions resolved the issue Call Ornim Medical Technical Support Excessive light Detach and reattach the Sensor to the single use P1 Smart Pad If issue persists use the Set Gain Control menu to adjust the Gain until signal indicator shows full green Refer to Step 2 on page 5 9 None of the above solutions resolved the issue Call Ornim Medical Technical Support Poor light H Excessive reflection from patient s skin 2014 Ornim Medical Ltd Poor signal Wait 5 minutes Sensor not attached properly If issue persists reattach the Sensor Sensor malfunction Call Ornim Medical Technical Support Hardware failure Restart the system If issue persists call Ornim Medical Technical Support A 1 2014 Ornim Medical Ltd Appendix B System Specifications and Technical Information System Performance Specifications and Accuracy Operating Modes and Monitored Parameters Table B 1 c FLOW System Vital Signs Monitoring Parameter Specifications Range Flow O 100 arbitrary units Screen Refresh Rate Every 3 5 seconds History Data Up to only the last 10 days per patient Acoustic Out
66. rameter CFI for each data acquisition channel as required During an active Monitoring session should any of the high or low thresholds be reached the user receives warning by way of a visual display an audible sound and illumination of the Threshold Indicator LED on the front panel Note For a detailed explanation and instructions refer to the following Threshold Indicator States on page 3 26 Setting Thresholds on page 3 27 m Setting Scale and Threshold Levels on page 5 7 m Responding to a Threshold Indicator on page 5 14 Baseline Settings The option to set a baseline for any monitored parameter is a useful feature that provides the user with a reference level for that parameter For details see Setting a Baseline on page 5 12 Advanced Functions Currently not operative applicable for future system version 2 20 c FLOW User Manual Clinical Workflow 2014 Ornim Medical Ltd 2 21 Clinical Workflow 2014 Ornim Medical Ltd 2 23 Figure 2 11 c FLOW System Typical Workflow Chapter 3 Using the c FLOW Touch Screen Introduction to the Touch Screen The c FLOW Monitor Touch Screen provides the user with full control of operation of the Sensors and a continuous real time display of acquired measurements both graphically and numerically Interaction with the Touch Screen is by way of touching tapping the screen with one finger or by using the display control knob to scroll th
67. relation to the Threshold values that are currently set as defined by the user Grey within upper and lower Threshold values m Yellow above upper Threshold value m Red below lower Threshold value The same color coding is used for the numeric display of CFI values When Monitoring is actively in progress progression of the Trendlines is visible reflecting new measured values In addition a dedicated real time indication appears on the right of the screen in the form of a ball shaped icon During Monitoring in the event of any occurrence of poor Sensor signal strength this will be shown in the display for that corresponding parameter and Sensor by the measured value indicator changing from a numeric value to PS indicating poor signal For suggested corrective action refer to Appendix A Troubleshooting Guide When the user scrolls backwards the display real time state is turned off in this case the indication disappears and the Monitoring area appears frozen no progression during monitoring To return the display to real time the user is able to evoke the jump back to real time by tapping one of the displayed numeric values on the right of the screen For more details refer to Scrolling to Real Time The system will remain in Monitoring Mode until such time as the user taps the Pause button thereby ending the current Monitoring session The system instantly switches to Pause Mode Tapping the Start button comme
68. rough the menus and activate the appropriate on screen tools In addition to facilitating quick selection of the applicable controls these actions enable smooth scrolling browsing and scaling of the display as required Navigation between the operator controls and the monitoring and browsing areas is enhanced by the logical grouping of displayed data and drop down menus These features are described and illustrated in Navigation and Display Options Main Screen The c FLOW Monitor Main Screen has been specially designed to give a clear uncluttered view of measured data and to provide quick and easy access to the on screen tools used for controlling the monitoring processes and reviewing data in current and previous monitoring sessions Figure 3 1 explains the screen layout and controls 2014 Ornim Medical Ltd 3 1 Note When initially turning ON power to the c FLOW Monitor after completion of the system startup process the c FLOW Main Screen is displayed as shown in Figure 4 7 on page 4 9 2 4 1 Tia 2014 09 02 14 28 38 Laser On k M5 R 5 6 Laser On 7 10 8 9 Figure3 1 c FLOW Main Screen Monitoring Mode Legend Figure 3 1 1 Patient Information and Create New Patient buttons 2 Monitoring Area 3 Start Pause Buttons 4 Current Date and Time 3 2 c FLOW User Manual Main Screen 5 Sensor Location Controls and Sensor Signal Indicators 6 Message and Status
69. s Rear Panel AC Power Input a Internal backup battery 14 4V rechargeable a Carry handle Note The c FLOW Monitor is fitted with two lockable supporting legs at the front These provide stability and ensure correct angle positioning when standing the unit on a table top surface In addition the Monitor is supplied with a mounting bracket ready fitted to the base providing a convenient option for users to mount the Monitor onto the Roll Stand optional accessory see Figure 2 8 as preferred Operator Panel Touch Screen LCD Display The c FLOW Monitor has a 10 4 LCD Display on the front panel that enables full control and continuous real time monitoring of the acquired patient data This may be used as a Touch Screen whereby the operator interacts with the system by simply touching or tapping the screen with one finger Alternatively all commands may be initiated using the Display Control Knob located beneath the LCD Display to scroll through the menus and activate the appropriate on screen tools The operator has the option of using the Touch Screen only the Display Control Knob only or a combination of both as preferred 2014 Ornim Medical Ltd 2 3 The LCD Display contrast and brightness settings may not be adjusted by the operator For a more detailed explanation of the Touch Screen refer to Introduction to the Touch Screen on page 3 1 Sensor Docking Stations The Sensor Docking Stations located one
70. s a New Patient in the system ieee une Tapping OK clears the Main Screen of any monitoring data currently displayed in Main Screen A warning message prompts for confirmation of the command Tap Yes to confirm 3 4 c FLOW User Manual Main Screen Patient Data Loss Warning A New patient operation clears current patient dala Please press No and archive the data if requiered otherwise press Yes a cm Message and Status Indicators Message and Status indicators are shown in the upper right area of the Main Screen Icons provide a visual indication of the status of four categories of information explained below 1 Figure 3 4 Message and Status Indicators Legend Figure 3 4 Description 1 Event Message Indicators Provides a visual indication of Event Message status for the current patient only See Table 3 1 for details Tap icon to access Message Event Log for current Patient 2 Power Status Indicators Provides a visual indication of Power Status mains power either connected or disconnected as well as charged status of the backup Battery See Table 3 2 for details 3 Threshold Indicators Provides a visual indication of Threshold status See Table 3 3 for details 4 Help Currently disabled applicable to future system version 2014 Ornim Medical Ltd Table 3 1 Event Message Indicators State Indicated icon A No new Event Unread E
71. sing the c FLOW system The information and guidelines provided include the following Patient Preparation a Creating a New Patient File Monitoring a Patient a Completing the Monitoring Procedure Important When Monitoring a patient always observe the guidelines and recommendations for the use of Sensors and Smart Pads outlined in the following m Sensors On page 1 18 Disposable Smart Pads on page 1 19 Patient Preparation Patient Positioning When using the c FLOW system it is recommended that the patient be placed in the supine position 2014 Ornim Medical Ltd 5 1 Skin Preparation Preparation of the patient s skin should be accordance with standard hospital protocol In addition the following guidelines are recommended a Select an area for Sensor attachment that is as flat as possible a Skin should be intact clean dry and the area should be hairless Skin should be shaved as necessary to remove excessive hair arms legs etc For attachment of Sensors to the patient s head If possible select a hairless area Otherwise a suitably sized area should be shaved to ensure secure adhesion of the Smart Pad to the skin Important Clean the skin areas well using the sterile alcohol wipes supplied with the Smart Pad Z caution not apply a Smart Pad to skin that is not intact or that shows signs of infection allergic conditions burns etc Patient Preparation Attaching Smart Pads o
72. sor Anatomical Location Indicators Channel P1 signal indicator see Sensor Signal Indicators Sensor 2 Laser Status indicator see Laser Status Indicators Anatomical orientation label Left Anatomical orientation label Right Sensor 2 location marker see Sensor Anatomical Location Indicators OI N O oO BI O Channel P2 signal indicator see Sensor Signal Indicators Figure 3 5 Sensor Location Controls Sensor 1 and Sensor 2 Sensor Anatomical Location Indicators When attaching a Sensor to the patient the user is required to mark the appropriate anatomical location for the relevant Sensor connected to the head or limbs using the on screen indicators illustrated in Figure 3 6 This procedure is described in Marking Sensor Locations on page 5 7 c FLOW User Manual Main Screen Channel1 Set Probe Location Figure 3 6 Sensor Anatomical Location Indicators Sensor 1 and Sensor 2 The on screen Sensor location selection options are labeled as follows Head Cerebral locations C1 through C4 right C5 through C8 left a Limbs Muscular locations M1 through M4 right M5 through M8 left On screen Sensor Locations cannot be marked when the c FLOW system is in Monitoring Mode In Important fag event that it is necessary to change the position of a Sensor then remark its location Pause Mode must first be activated After marking the location Monitoring is resumed
73. ssory is fully assembled during installation by Ornim Medical personnel complete with a ready fitted mounting bracket This enables users to slide the Monitor 2014 Ornim Medical Ltd 2 15 onto the Roll Stand and secure into position quickly and safely For instructions see Mounting the Monitor on the Roll Stand on page 4 4 Disposables Smart Pads The disposable Smart Pads supplied for use with the c FLOW system are used to attach the Sensors to the required location on the patient Each pad is packaged in a non sterile single pack ready for use on one patient only Smart Pads are intended for single use only caution Reuse of a disposable Smart Pad may cause a risk of cross contamination or affect measurement accuracy and or system performance As shown in Figure 2 9 each Smart Pad pack contains one Smart Pad one sterile alcohol wipe for patient skin preparation and one adhesive remover wipe c FLOW i REF ASY1003A Figure 2 9 Smart Pad in Single Pack 2 16 c FLOW User Manual System Configuration Note For details of the Smart Pad safety label refer to Figure 1 5 Each Smart Pad is specially designed with an adhesive surface on the underside for attachment to the patient s skin and a plastic framework on top shaped to hold the Sensor As shown in Figure 2 10 the framework incorporates two snap lock clips to secure the Sensor firmly in position on the pad Note An intact seal be
74. strated in Figure 3 16 For detailed instructions refer to Using the Display Control Knob on page 3 22 2014 Ornim Medical Ltd USB Port lf required Patient Monitoring Data may be archived to external media for example memory stick flash drive via the USB port located on the c FLOW Monitor front panel above the On Off button Such information can be used externally for further diagnostic analysis a Figure 2 4 USB Port Note The USB port supports USB 2 0 or higher Refer to the instructions for Archiving Patient Monitoring Data on page 5 16 Donot use the USB Port during active Monitoring When connecting to the USB Port use ONLY an isolated device i e any removable media with no external power supply such as a memory stick flash drive etc On Off Button and Power Status Indicator The On Off Button located on the front of the Operator Panel lower left corner is used to commence the system start up procedure c FLOW User Manual Table 2 1 PWR LED Power LED on Monitor Front Panel System Configuration An LED above the On Off button provides an indication of system power status as outlined in Table 2 1 System Power Status LED Indicator LED State Off System Power Status Monitor is not connected to mains power Power to the Monitor is OFF Orange steady S Monitor is connected to mains power Power to the Monitor is OFF Green steady
75. t be displayed on the left above the horizontal scroll bar See example below 2014 Ornim Medical Ltd 3 19 Scrolling to Real Time When the c FLOW Monitor is in real time display mode i e the trendline is progressing reflecting new measured values on charts during monitoring a dedicated real time indication ball on chart right side appears By scrolling backward by user the display real time state turned off in this case the indication disappears and the charts are frozen no progression during monitoring The following actions return the c FLOW Monitor to real time mode all when monitoring state is ON 1 Scrolling to current time by dragging the thumb into the right edge of the scroll bar 2 Tapping one of the numeric values displayed on screen 3 Relevant timeout has expired no user activity applied By tapping in the Monitoring area i e activating the cursor or by using the Display Control knob the user can browse through the currently displayed clinical data The cursor moves according to the clicked screen location or knob rotation displaying the relevant values of each parameter corresponding to the cursor location Zoom Tool Ll tapping the Zoom Tool icon opens a menu of available Resolution Options enabling the user to select the preferred option 3 20 c FLOW User Manual Navigation and Display Options 15 Minutes 30 Minutes 1 Hour 6 Hours 24 Hours 72 Hours Close Menu
76. the user the c FLOW system loads the most recent patient history i e the monitoring data acquired from the last patient to be actively monitored before system shutdown The last patient data loading process continues in the background until complete During this time the message Loading History Data is displayed on the right of the Main Screen as shown in Figure 4 7 on page 4 9 The system will remain in dle Mode until such time as Patient Monitoring is commenced by the user Threshold Indicators Monitoring Mode Monitoring Mode is actively initiated by the user Whenever the Start button is tapped the system automatically enters this mode in which measurement data is actively acquired in real time The on screen display of this data is in accordance with the display parameters currently selected by the user The system will remain in Monitoring Mode until such time as the user taps the Pause button thereby ending the current Monitoring session The system instantly switches to Pause Mode Pause Mode During a current Monitoring session Pause Mode is activated by the user when tapping the Pause button to stop active Monitoring The system will remain in Pause Mode until the user taps the Start button whereby the system switches to Monitoring Mode A new Monitoring session has now commenced Threshold Indicators The c FLOW system provides the user with the ability to define high and low thresholds for the monitored pa
77. the Show option was selected the baseline is displayed as a horizontal gray line on the relevant chart and is also shown as a numerical value above the BL label see the examples in Figure 5 12 5 14 c FLOW User Manual Monitoring a Patient Figure 5 12 Baseline Values Displayed Pause Monitoring To Pause a Monitoring Session 1 Tap the Pause button Active Monitoring stops the system is now in Idle mode The Pause button blinks orange for a few seconds thereafter the Start button is enabled ready for use 2 When ready tap the Start button to commence a new Monitoring session Note While the system is in Pause mode the LED on the relevant Sensor blinks green When active Monitoring is resumed the LED is illuminated steady green Marking an Event A point of interest may be marked at any time Refer to the following step by step instructions as applicable Adding a Marker on page 3 31 a Jumping to Next Marker on page 3 31 2014 Ornim Medical Ltd 5 15 a Clearing a Marker on page 3 33 Responding to a Threshold Indicator For details refer to Threshold Indicators on page 3 26 5 16 c FLOW User Manual Completing the Monitoring Procedure Completing the Monitoring Procedure Stop Monitoring To Stop a Monitoring Session 1 Verify that active Monitoring is now no longer required then tap the Pause button Active Monitoring stops the system is now in Pause Mode 2 Proceed to the ins
78. the cable itself always hold the plug Note For cleaning instructions refer to the manufacturer s recommended guidelines as outlined in Cleaning Procedures on page 6 2 For safe handling of Sensors and Smart Pads refer to Use of Accessories and Disposables Environmental Requirements The manufacturer s environmental recommendations for operation and storage of the c FLOW Monitor and accessories are shown in Table 1 4 Table 1 4 Recommended Environmental Conditions Condition Ambient Temperature SENG oe Gsi Altitude condensing 15 C 32 C Om 3000m Operation 20 90 59F 90 F Oft 9843ft 20 C 60 C Om 15000m Storage Transport 10 90 4 F 140 F Oft 49213ft Space and Positioning It is recommended that the c FLOW Monitor be placed on a solid surface and that the inlet ports are open to freely circulating air Verify that the air inlets are not obstructed 2014 Ornim Medical Ltd To prevent possible damage to the c FLOW Monitor always secure it to the Roll Stand or place securely on a flat stable surface that is free of dirt and debris Do not place the c FLOW Monitor near a radiator or heating unit AN caution Donot use the Monitor adjacent to or stack it with other equipment Do not cover the Monitor while in use For more details see Positioning the c FLOW Monitor on page 4 2 Patient Safety and Handling Guidelin
79. the carry handle provided for this purpose The handle is located on the top of the Monitor refer to Figure 2 1 on page 2 2 Position the Monitor at an adequate distance from walls etc to allow for cooling air to flow through the vents in the rear panel without obstruction Verify that these air inlets are not obstructed Use a mains power outlet located sufficiently close to the Monitor to prevent pulling or stretching of the AC power cable The cable length is 1 5m 4 9 ft Position the Monitor at a distance of no more than 2m 6 5 ft from the patient to prevent pulling stretching or entanglement of the Sensor cables This will also allow sufficient freedom of movement for attaching the Sensors to the patient without placing strain on the Smart Pads The Sensor cable length is 3m 9 8 ft Make sure the Monitor is suitably positioned with adequate clearance around it to provide easy access during use In addition refer to the following instructions as applicable Table top Mounting Mounting the Monitor on the Roll Stand c FLOW User Manual Positioning the c FLOW Monitor Table top Mounting The c FLOW Monitor may be positioned on any table top or flat stable surface Perform the steps below for optimal secure table top positioning To Position the Monitor on a Table Top 1 Carefully place the Monitor in the required position on the stable surface 2 Unfold the two supporting legs at the front of the Monito
80. the details provided in Intended Use on page ii The system comprises the c FLOW Monitor and two uniquely designed ultrasound UTLight Sensors used with disposable Smart Pads For a detailed explanation of these components refer to the following m c FLOW Monitor on page 2 2 m Sensors On page 2 13 Smart Pads on page 2 16 2014 Ornim Medical Ltd 2 1 Connection of the Sensors to the patient is a quick and simple procedure Thereafter user interaction with the system is via an easy to read Touch Screen and or display control knob providing intuitive control of all data monitoring and reviewing processes System Configuration c FLOW Monitor Carry Handle Sensor Docking Station Sensor Docking Station Sensor Cable Hook Sensor Cable Hook LCD Display Battery Status Indicator Laser Status Indicator Power Status Indicator USB Port O a wh Display Control Knob Silence Threshold Indicator Button Threshold Indicator On Off Button Figure2 1 c FLOW Monitor The c FLOW Monitor comprises the following main components Computerized Control and Display Unit 22 c FLOW User Manual system Configuration Operator Panel includes Touch Screen LCD Display Display Control Knob USB Port On Off Button and Power Status Indicator Battery Status Indicator Laser Status Indicator and Thresholds Status Indicator and Silence Button a Sensor Docking Stations and Sensor cable hook
81. tructions for Disconnecting the Sensors below Disconnecting the Sensors To Disconnect a Sensor from an Smart Pad 1 Carefully disconnect the Sensor from the Smart Pad 2 Using isopropyl alcohol 70 carefully clean the Sensor surface to remove all traces of ultrasound gel Replace the Sensor in the Sensor Docking Station 4 Remove the Smart Pad as described in the procedure below Repeat Step 1 to Step 4 to remove any remaining Sensors connected to the Patient Typically it is recommended that Sensors are returned to the Sensor Docking Station and remain docked until further use of the c FLOW Monitor is required For more details refer to Storage When Not in Use on page 4 13 Removing the Smart Pads 2014 Ornim Medical Ltd 5 17 To Remove the Smart Pads 1 Carefully peel the Smart Pad away from the patient s skin 2 Dispose of the Smart Pad A CAUTION Dispose of used Smart Pads in accordance with hospital protocol and local safety regulations Archiving Patient Monitoring Data The following procedure can only be performed when the c FLOW system is in Pause Mode and only for the Current Patient To Download Patient Monitoring Data 1 Insert a memory stick into the USB port on the Operator Panel Use ONLY an isolated device i e any removable media with no external power supply such as a memory stick flash drive etc 2 Tap the Menu button then select Archive The Archive di
82. tus indicators in Figure 3 4 on page 3 5 m The message Loading History Data is displayed This remains until the last most recent patient data loading process is complete 4 10 c FLOW User Manual Note Figure 4 7 shows the Main Screen after System Startup as normally seen However on initial use of a c FLOW Monitor since no history data is available for loading the Monitoring area is blank see Figure 4 8 4 Continue with the Patient Preparation procedures Cum 2013 06 11 17 53 43 Laser Off P atil 0 Laser Off P2 e o Menu e 4 2014 Ornim Medical Ltd 4 11 Figure 4 8 c FLOW Main Screen after System Startup First time Use System Shutdown Procedure System Shutdown Procedure Turning OFF Power to the Monitor e To Turn OFF Power to the Monitor 1 Verify that active monitoring has been stopped and the system is in Pause Mode Check that Sensor 1 and Sensor 2 are both docked in the Sensor Docking Station 2 Onthe Operator Panel press the On Off button do not hold the button down for more than 2 seconds A pop up message is displayed prompting the user to confirm the shut down command Notice gt Are You sure you want to close c FLOW Application Figure 4 9 System Shut down Confirmation Message 3 Press Yes to continue The system shutdown process commences On completion the LCD screen is blank 4 Proceed to disconnect the c FLOW Monitor from the mains power
83. tween the Sensor surface and the patient s skin is further ensured by the Smart Pad s centrallylocated silicone cushion and the use of ultrasound gel s 2 A 3 2 1 4 Figure2 10 Smart Pad Components Legend Figure 2 10 1 Sensor holder 2 Snap lock clip Silicone cushion Underside of Smart Pad 3 upper side covered with peel back 4 covered with peel back film film Important For patients requiring long term monitoring it is recommended to change the Smart Pads every 2 3 days Remove old adhesive residue then clean and dry the area well before applying a new Pad 2014 Ornim Medical Ltd For instructions on using Smart Pads refer to the following Skin Preparation on page 5 2 a Attaching Smart Pads on page 5 3 c FLOW User Manual Operating Modes The c FLOW system has four operating modes Startup Idle Monitoring and Pause each described below Startup Mode After turning ON power to the c FLOW Monitor the system boot up process commences followed by software initialization and a series of automatic self testing processes Sensors must be docked during this mode On completion the Main Screen is displayed and the system automatically enters dle Mode During the automatic self testing processes the Laser LED on the front panel will blink several times Idle Mode In the initial stage of Idle Mode which is similar to Pause Mode however not initiated by
84. ution When jumping page by page through the display the size of the jump is relative to the currently selected resolution option Scrolling the Patient History Data Regardless of the c FLOW Monitoring state the user can browse the current patient history data using the scroll bar control located on the bottom of the Main Screen Figure 3 11 The scroll bar thumb width represents the ratio of the displayed data time range on charts to that of the total loaded history time range see Note above By dragging the thumb or by using the Display Control knob the user can scroll backwards or forwards in time the charts follow the scrolling accordingly and display the relevant data By pressing the arrows on the right and left edges of the scroll bar the display jumps into the next page in accordance with the current time slice The oldest time that can be viewed scrolled to is the latest of the following 10 days prior to current time m Patient creation time a Last loaded patient history data chunk during load history state on startup History scrolled data is relative to the following a Clinical measurements trendline Sessions graphical background emphasizing monitoring time a Markers Note Depending on the currently selected resolution option refer to Figure 3 12 when browsing the patient history data if the displayed time is earlier than this patient s New Patient creation time the date and time will no
85. vent Table 3 2 Power Status Indicators AC Power Backup Battery Connected Fully charged Connected Semi charged Charging in progress Connected Capacity Low Charging in progress Disconnected Fully charged Disconnected Semi charged Disconnected Capacity Low Charging required Table 3 3 Threshold Status Indicators icon State Indicated c FLOW User Manual Main Screen a No Threshold Indicator Q Threshold Indicator On Threshold Indicator silenced Sensor Location Controls On the left side of the Main Screen there are two Sensor Location Control areas each containing a representational graphic image By default these show a head selection of a limbs image is optional Labeled to show right and left orientations these are used for on screen marking of the physical position of Sensors attached to the patient as follows Upper area Sensor 1 labeled P1 Lower area Sensor 2 labeled P2 At the top of each area there is an indication of the current status of the relevant Laser Off Warmup or On examples of which are illustrated in Table 3 7 Below each graphic is a Sensor Signal Indicator labeled P1 and P2 respectively for details see Sensor Signal Indicators 2014 Ornim Medical Ltd 3 7 Legend Figure 3 5 1 Sensor 1 Laser Status indicator see Laser Status Indicators Sensor 1 location marker see Sen
86. version etc 3 22 c FLOW User Manual Navigation and Display Options About c FLOW Activating the Screen Lock Feature The Screen Lock feature is typically used when moving the patient from one room to another while connected to the c FLOW Monitor To Activate Screen Lock 1 Tap the Menu icon 2 Select Lock Screen from the available options Figure3 14 Activating Lock Screen The Screen Lock feature is activated 2014 Ornim Medical Ltd 3 23 Hereafter any tapping of the LCD display will evoke display of the Screen is Locked message shown below until such time as the Display Control Knob is pressed thus releasing the Screen Lock CHD a2 1 A Figure 3 15 Screen Locked Message Before cleaning the Monitor make sure the Screen Lock utility is activated Using the Display Control Knob In addition to using the LCD Display as a Touch Screen navigation of the screens and selection of required options may also be achieved using the Display Control Knob Figure 2 3 on page 2 5 as follows To move through the screen areas Rotate the knob clockwise or counter clockwise To select an appropriate option Press the center of the knob Movement through the screen areas and controls will always follow the order and path shown below 3 24 c FLOW User Manual Navigation and Display Options 1 Outer Track Note Illustration shows movement through Monitoring area
87. with International Standards The c FLOW system is designed to comply with international safety standards for medical electrical equipment that include the following Standard Description MDD 93 42 EEC EU Medical Device Directive 1 2 c FLOW User Manual dec Medical electrical equipment Part 1 General requirements for safety and essential IEC 60601 1 3 Edition performance Pe Medical electrical equipment Part 1 2 General requirements for basic safety and essential IEC 60601 1 2 3 Edition performance Collateral standard Electromagnetic compatibility Requirements and tests a cect Medical electrical equipment Part 2 37 Particular requirements for the basic safety and IEC 60601 2 37 3 Edition essential performance of ultrasonic medical diagnostic and monitoring equipment IEC 60825 1 2 Edition Safety of laser products Part 1 Equipment classification and requirement Electrical Safety Electrical Safety For details of the electrical safety standards to which the c FLOW system complies refer to the information provided in Compliance with International Standards AAWARNING Do not open system covers The c FLOW Monitor has no user serviceable parts Electrical Requirements Electrical installation of the c FLOW system must meet all current local state and national electrical codes and be in accordance with the requirements specified in this manual see below Ac
88. y whenever either of the following conditions are met 2014 Ornim Medical Ltd 3 29 Measured value is no longer approaching the High or Low region Threshold Indicator is silenced by the user by tapping the Silence icon Threshold Indicator States The Threshold indicators show one of three states Off On or Silenced Table 3 5 Threshold Indicator States icon State Indicated No Threshold Indicator Threshold Indicator On Threshold Indicator silenced Threshold Indicators Setting Thresholds Regardless of the c FLOW system monitoring state the user may set the required Threshold levels thereby defining high normal and low levels per channel for the monitored CFI clinical values In addition the maximal and minimal boundaries can be defined on the Y scale focusing display only on a narrower wider range of values To Set Y Scale and Threshold Levels 1 Use the Display Control Knob or tap the Menu icon 2 Select Set Y Scale from the available options The Set Y Scale and Threshold dialog box opens see Figure 3 21 3 30 c FLOW User Manual Note When setting Threshold parameters it is recommended to use the Display Control Knob Alternatively The Set Y Scale and Thresholds dialog box can be also be opened by tapping the Threshold indicator icon on the upper right side of the Main screen Set Y Scale and Thresholds Figure 3 21 Set Y Scale and Thresholds As soon as

C-FLOW™ Monitor User Manual - USM1000A -Dec 29, 2014

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C-FLOW&trade; Monitor User Manual - USM1000A -Dec 29, 2014

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C-FLOW™ Monitor User Manual - USM1000A -Dec 29, 2014