CRIT-LINE
®
III
User Manual
4040 Nelson Avenue, Concord, CA 94520 USA
Toll Free 1-800-546-5463 · 801-451-9000
Fax 801-549-9250
http://fmcna-crit-line.com/
Страница 1: ...CRIT LINE III User Manual 4040 Nelson Avenue Concord CA 94520 USA Toll Free 1 800 546 5463 801 451 9000 Fax 801 549 9250 http fmcna crit line com ...
Страница 2: ...40 Nelson Avenue Concord CA 94520 USA Fresenius Medical Care and triangle logo are trademarks of Fresenius Medical Care Holdings Inc or its affiliated companies All other marks are the property of their respective owners CRIT LINE III is a trademark of Fresenius Medical Care North America This document is compatible with the CRIT LINE III monitor Document No CL80020031 Rev H Printed in the United ...
Страница 3: ...1 Internal Memory 1 12 Optional Accessories 1 13 Symbols 1 14 Section 2 Set Up Procedures Pre priming Attachment of the Blood Chamber 2 1 Post priming Attachment of the Blood Chamber 2 2 Sensor Clip Attachment 2 3 Section 3 Using the CRIT LINE III Clearing the Memory 3 1 Running a Patient 3 3 Setting the Date and Time 3 6 Setting the Date 3 6 Setting the Time 3 7 Entering the Patient ID Station ID...
Страница 4: ...nsor Obstruction 6 2 No Blood Detected 6 2 Low Voltage 6 2 Section 7 Performance Characteristics Operational Considerations 7 1 Percent Blood Volume Change 7 1 Corrections for Mean Cell Volume in Hct Sampling 7 1 Reference Standard for Hematocrit 7 2 Reference Standard for Oxygen Saturation 7 2 Hemoglobin Estimation 7 2 General Precautions 7 2 Standard Specifications 7 4 Section 8 Instrument Maint...
Страница 5: ...ons and a collection of Tech Notes to answer questions and assist you in the clinical use of the CRIT LINE Each section covers a specific range of topics Some topics may be addressed in greater detail in other sections and are clearly referenced throughout the manual Individual sections instruct you on how to set up the monitor use it during a dialysis session and instrument maintenance The advanc...
Страница 6: ...in real time the following blood parameters hematocrit percent change in intravascular blood volume and oxygen saturation Proper use of the CLM III can result in optimized fluid removal while preventing morbid events that result from blood volume depletion This is accomplished via staff adjustment of ultrafiltration while monitoring graphically displayed changes in the patient s circulating blood ...
Страница 7: ...t a language press the and keys at the same time When the language screen appears scroll to the desired language and press Once the SELECT key has been pressed the CLM III automatically returns to the MAIN MENU All subsequent menus from this point forward will be in the selected language The language can be changed at any time by following the process described above MENU SELECT ...
Страница 8: ...ystem 1 3 ______________________________________ 1 3 The CLM III at a Glance Fig 1 The CLM III Monitor Serial Data Port Power Switch DC Input Port Parallel Data Port Carrying Handle Sensor Clip Cable Fig 2 The Back Panel ...
Страница 9: ...rate the CLM III To enter main and optional menu screens press the MENU key To move the cursor use the UP ARROW or DOWN ARROW keys To enter your selection press the SELECT key The individual keys may have specific functions when working in a particular mode These functions are clearly displayed on the display screen The warning light flashes red when a warning message appears or when the Hct Limit...
Страница 10: ...he icons of the screens that you will see on the way to your final display choice Using the appropriate keypad choices you can navigate through the screens in the mapped order Primary Display Screens The MAIN MENU screen allows you to choose the operating mode of the CLM III NOTE New Monitors sold after January 2006 may not display the H ABF option on the Main Menu NOTE New Monitors sold after Aug...
Страница 11: ...fter selection of PATIENT RUN SPOT CHECK and RECIRCULATION on the MAIN MENU The MEMORY FULL screen appears whenever the monitor is turned on and there is data in the memory or if there is not enough space to save another patient run The STARTUP SPLIT screen menu appears after pressing the MENU key while viewing the STARTUP screen Its icon is the same as the STARTUP screen without the menu displaye...
Страница 12: ...modes SPOT CHECK RECIRCULATION CALIBRATION OUTPUT OPTIONS and CONTRAST has a specific menu screen associated with its functions You can locate most of this information in Section 5 Advanced Features Output Options is located in Section 4 Ending a Session and Contrast in Section 3 Using the CRIT LINE III Shown below are the specific icons associated with the individual menus When there is more than...
Страница 13: ...resenius suggest that the brick portion of the power supply be mounted to the top of the Crit Line Monitor or to the dialysis machine using Velcro plastic ties or other means in order to prevent the brick from hanging down from the power jack which can result in the power jack coming loose or even breaking Mounting the brick portion of the power supply will also keep it off the floor and less like...
Страница 14: ...Remote spot checking data transfer or a power failure may require battery use The LOW VOLTAGE warning message See Section 6 indicates a low battery state This state may be corrected by connecting the CLM III to a power supply otherwise the CLM III will turn off after a two minute countdown A discharged battery will fully charge in 36 hours when properly connected to its power supply adapter regard...
Страница 15: ...USE THE PACKAGE HAS THE LOT NUMBER MONTH AND YEAR IT WAS MADE AND EXPIRATION DATE The CLM III is highly sensitive to the optical properties of the CRIT LINE Blood Chamber Reprocessing of blood chambers may sterilize the blood chamber but does not restore the optical properties of an unused sterile blood chamber Therefore it is important that a new sterile blood chamber be used during each monitori...
Страница 16: ...CRIT LINE Blood Chamber The sensor clip locks into place around the blood chamber Incorrect placement will most likely result in incorrect measurements See Section 2 for more information Whenever the CLM III is not being used the sensor clip should be placed on the verification filter on the side of the monitor This provides protection from damage and keeps the sensor elements clean See section 8 ...
Страница 17: ...ion 3 Clearing the Memory When the data is printed or downloaded the entire contents of the memory are printed or downloaded Data cannot be selectively erased All files are deleted when clearing the memory WARNING ONCE ERASED DATA CANNOT BE RECOVERED BE SURE THAT PRINTING DOWNLOADING ACTIVITIES ARE SUCCESSFUL PRIOR TO CLEARING THE MEMORY Example memory configuration The internal memory configures ...
Страница 18: ... allows the treatment profile to be sent wirelessly to the server radio to have the treatment profile printed Wireless Printer Radio Server Part CL10023030 Print wirelessly from the Crit Line Monitor to any printer in your facility The server radio which is connected to a computer receives information from the client radio and sends this data to the printer software which then sends it to a printe...
Страница 19: ...s which are used to identify the CLM III s critical characteristics The following is an explanation for each of these internationally accepted symbols Class II Equipment Type BF Equipment For use within temperature limits Read Instructions Before Use Certification European Manufacture Identification CRIT LINE III Monitor Label ...
Страница 20: ...onnector is secure in the dialyzer 3 Remove the white cap from the blood chamber and attach it into the twist lock fitting of the arterial blood tubing set 4 Ensure that all connections are tight and that there is no kinking at the arterial tubing set connection 5 Prime the entire circuit with saline and remove air bubbles in the dialyzer using normal priming procedures making sure that no air bub...
Страница 21: ... air into the dialyzer and blood chamber It is therefore important to remove the air in the blood chamber by inverting the dialyzer and tapping it until all air bubbles have migrated past the blood chamber to the air trap 5 Remove the hemostat clamps and restart the blood pump 6 Ensure the outside of the blood chamber is dry before attaching the sensor clip NOTE Improper attachment of the arterial...
Страница 22: ...zer circuit and the blood pump must be running These conditions must be met prior to selecting START RUN If START RUN is selected prior to placing the sensor clip on the blood chamber or if the blood circulating within the dialyzer is still mixing with saline the initial hematocrit will be diluted and the hematocrit value will be lower than the true circulating hematocrit Starting while the sensor...
Страница 23: ... to record up to 26 hours of continuous data Internal memory is non volatile Therefore in the event that the monitor is turned OFF the memory will be maintained until it is erased Anytime patient monitoring has taken place and the power is cycled from OFF to ON MEMORY FULL will be displayed Once this message is displayed memory must be cleared before the CLM III will allow any monitoring activity ...
Страница 24: ...y Position the cursor next to MEMORY CLEAR with the arrow key press SELECT Y denotes Yes N denotes No Press MENU to clear the memory Press SELECT to save the memory for future printing downloading NOTE Once the memory has been cleared data cannot be retrieved If you do not want to clear the data i e you want to print or download data prior to erasing the output options feature must be selected see...
Страница 25: ... screen the INITIAL DATA screen has a prompt for data inputs in the reverse video in the lower left of the screen providing the options shown below You may ignore the PATIENT ID prompt and proceed by simply pressing the SELECT key These fields can also be entered during the run if desired Select START RUN to ignore input fields and begin patient monitoring NOTE Entering the patient and station ID ...
Страница 26: ...hlighted window will instruct you to either set a Hct Limit or to wait ten seconds for the PROFILE screen to appear You can choose to set a Hct Limit at this time or access this screen later to set a limit The Hct Limit is adjusted or set by pressing or see Section 5 Hematocrit Limit If there is no keypad input the screen will proceed to the default profile screen after 10 seconds see example abov...
Страница 27: ...ue is calculated from the measured Hct The oxygen saturation SAT is reflective of an arterial saturation if the blood monitored is from a fistula or graft or a venous saturation if blood is coming from a central venous line See Section 7 for further information NOTE If any of the four information windows appear in reverse video this means that the CLM III is momentarily revalidating data Previousl...
Страница 28: ...tings are maintained The clock and calendar have been installed so that data whether printed or downloaded will be time and date coded The INITIAL DATA screen is the only screen where the date and time may be set Date and time can only be adjusted in between patient runs NOTE The internal clock runs on a 24 hour clock standard Setting the Date To set the date Scroll the cursor next to DATE ADJUST ...
Страница 29: ...d setting the date scroll to RETURN on the DATA MENU and press SELECT This will return you to the INITIAL DATA screen If you make a mistake simply repeat the above process Setting the Time Choose TIME ADJUST from the INITIAL DATA screen Using the same procedure used to set the date set the hours 24 hour clock and minutes of the internal clock Once the time has been set scroll to RETURN and press S...
Страница 30: ...initial setup the patient and station ID can be entered at any time during the dialysis session or at the end of the treatment session Entering the Patient ID You can enter the PATIENT ID from either the INITIAL DATA screen prior to starting a run or the SETUP screen during a run To enter the PATIENT ID from the INITIAL DATA screen Scroll to PATIENT ID and press SELECT The alpha numeric data entry...
Страница 31: ...n gathered Patient data is erased from the monitor when the current dialysis session is stopped Entering the Station ID Once you are back into the INITIAL DATA screen scroll to STATION ID and press SELECT This will open and activate the numeric data entry window Scroll to the first digit of the Station ID and press SELECT Next scroll to the second digit of the STATION ID and press SELECT This will...
Страница 32: ... during the run Save the data and continue on to patient monitoring Entering the Patient ID and Station ID from the Profile screen You can enter the PATIENT and STATION ID and NAME after you have started blood volume monitoring and a PROFILE screen has been activated To exit the PROFILE screen and enter the START UP screen press SELECT or MENU Once in the START UP screen press MENU The START UP me...
Страница 33: ...tering the PATIENT and STATION ID and NAME To get back to the PROFILE screen scroll to CONTINUE in the SETUP MENU and press SELECT This will return you to the START UP screen which will then automatically revert to the PROFILE screen after 10 seconds _______________________________________ 3 5 Default Screen Selection The preset default display screen is the BV blood volume screen PROFILE START UP...
Страница 34: ... SELECT and then pressing MENU Once in the START UP MENU window scroll down to the choices under DEFAULT SCREEN Choose the parameter you wish to monitor and press SELECT Changing the default screen from BV to either of the other two options will only change the default for that specific dialysis session Cycling the power or starting a new patient run will always reset the default screen to the blo...
Страница 35: ...will lighten the screen and each press of will darken the screen Once the contrast has been adjusted press the MENU button to save the adjustment setting To return to the MAIN MENU without saving contrast adjustments made press the SELECT button Contrast can only be changed in between patient runs Older model CLM III s may not have the option to adjust the screen contrast in the Main Menu If you h...
Страница 36: ...he Dialysis Session Monitoring with the CLM III should be concluded prior to the rinse back procedure stopping the blood pump or moving the sensor clip back to the verification filter Otherwise the CLM III may indicate a false Hct reading If the CLM III does read a false Hct it will cause the blood volume and Hct graphs to rescale Rescaling makes the information on the graph difficult to interpret...
Страница 37: ... screen Press MENU to access the START UP menu The START UP Menu will be displayed Position the cursor next to SETUP STOP Press SELECT If you desire you may input Patient ID Station ID or Name at this time To stop position the cursor next to STOP and press SELECT ...
Страница 38: ...layed Select Patient Run to begin another monitoring session See Section 4 Output Options NOTE If the CLM III calculates that there is not enough memory to record five additional hours of dialysis data the MEMORY FULL screen will appear prompting you to download and or clear the memory before attempting to initialize another patient run Reference the appropriate heading in Spot Check Recirculation...
Страница 39: ... Section on Printing Graphs and Data Retrieval for additional information on this subject The OUTPUT OPTIONS menu can be reached from either the MAIN MENU screen or the MEMORY FULL screen Printing Choose the printing method desired to print all Patient Runs in memory OUTPUT MAIN OUTPUT MEMORY ...
Страница 40: ... more information refer to the Tech Notes Section on Printing Graphs and Data Retrieval Printed data for each PATIENT RUN consists of three graphs on a single page of 8 5 by 11 5 inch paper These graphs include a profile of the hematocrit percent blood volume change and oxygen saturation Also included is the information as shown on the following sample printout If RECIRCULATION or SPOT CHECK tests...
Страница 41: ...NOTE Downloading data does not erase the files from the memory Data files are only erased when the memory has been manually cleared see Section 3 Clearing the Memory Selecting a Printer The Crit Line has several print drivers from which to choose If using a Hewlett Packard HP or HP compatible printer the HP LaserJet driver should be selected The Printy A and B drivers are to be used when printing ...
Страница 42: ...sual alarm when the patient s hematocrit has reached a pre selected hematocrit limit level Prior to setting a hematocrit limit the user should fully understand this subject see the Tech Notes Section on Hypovolemia A hematocrit limit can be set and or changed at any time during the monitoring process When viewing the START UP screen prior to the automatic change to the PROFILE screen the HCT LIMIT...
Страница 43: ...ashed horizontal line on the graph In the BV profile mode the Hct Limit is converted into BV units and appears as the CRIT LINE shown above This line will appear in both the BV and the Hct profile screens No Hct Limit information is displayed when viewing an oxygen saturation profile screen When the patient s hematocrit rises to the level of the hematocrit limit an audible warning will sound and t...
Страница 44: ...the default value of 0 25 to another value press the MENU and DOWN ARROW keys at the same time Scroll to the desired value and press the select button To save this value scroll to SAVE and press Select Otherwise the previously selected default value the value which appears next to the word SAVE will be the default value once the CLM III power has been recycled __________________ 5 3 Recirculation ...
Страница 45: ...move to the START UP screen Then press MENU to bring up the START UP menu Scroll the cursor next to RECIRCULATION and press Select NOTE When performing a recirculation test during patient monitoring the CLM III will continue to monitor blood parameters No data will be lost or significantly altered while performing recirculation tests If you began the path to RECIRCULATION directly from the MAIN ME...
Страница 46: ...selecting CANCEL This calculated value is also present on printed charts and downloaded data see Section 4 Output Options If more than one recirculation test is performed during a PATIENT RUN only the most recent value will be displayed and printed If RECIRCULATION is accessed from the MAIN MENU the SAVE option will appear at the end of the RECIRCULATION measurement SAVE allows the user to record ...
Страница 47: ...lowing steps From the MAIN MENU scroll to SPOT CHECK Press Select The INITIAL DATA screen will appear so you can input the PATIENT and STATION ID Scroll the cursor next to START RUN and press Select The START UP screen will appear and denote SPOT CHECK in the warning or message block The notation SC will appear in the upper right corner of the display screen to indicate that you are in the Spot Ch...
Страница 48: ...rns you to the MAIN MENU Whenever SAVE is selected the current PATIENT ID and STATION ID are recorded into memory along with their corresponding Hct and O2 Sat readings If you do not plan to print or download the spot check data it is not necessary to save the files in order to monitor another patient NOTE If you choose SAVE be sure to change the PATIENT ID and STATION ID numbers as you move from ...
Страница 49: ...ally result in the display of erroneous information If an error or component failure is detected the system will display an error message and stop recording parameter values see Section 6 Warning Messages Verification Filter The verification filter is a specially modified blood chamber attached to the side of the monitor It is included with each instrument and can be used to verify that the instru...
Страница 50: ...ON MENU Scroll the cursor next To VERIFY ACCURACY and press Select The message block on the display screen will read VERIFYING ACCURACY In sixty seconds one of two possible messages will be displayed Verification Passed or Verification Failed ...
Страница 51: ... is unable to verify accuracy it will prompt you to retry the VERIFY ACCURACY routine again after ensuring that the sensor clip is properly attached to the verification filter and the verification filter is clean If the VERIFY ACCURACY routine fails the second time the monitor will return to the original CALIBRATION MENU Check to make sure that the sensor clip is properly attached to the verificat...
Страница 52: ... CALIBRATION MENU and will only allow you to select RE CALIBRATE This safety feature prevents patient monitoring if the monitor is not providing data representative of actual values If the CLM III should fail both the VERIFY ACCURACY and RE CALIBRATE routines either the Sensor clip is improperly attached to the verification filter or the CLM III s self diagnostic capabilities have determined that ...
Страница 53: ...he dialysis session when the key was pressed These markers appear on each profile screen and the printed graphs This feature is useful for marking the time of various clinical interventions and events saline bolus administration Trendelenburg etc and or physiological changes food intake etc that occur during the treatment Event markers can be inserted after five minutes or monitoring and as freque...
Страница 54: ...e of the message The WARNING or MESSAGE BLOCK is found in the lower right corner of the display in reverse video If you are currently viewing a profile screen the display of a warning or message will automatically changes the display to the START UP screen as illustrated below WARNING or MESSAGE BLOCK Warning messages that can be displayed in the Warning or Message Block include Sensor Obstruction...
Страница 55: ... etc or that the sensor is detached from the CRIT LINE Blood Chamber To correct this condition make sure that the sensor is firmly locked onto the blood chamber and that blood not saline is flowing through the blood chamber _______________________ 6 3 Low Voltage When the Low Voltage message appears you have two minutes before the CLM III will automatically shut itself OFF To prevent this from hap...
Страница 56: ... concentration of the blood being monitored see Tech Note Oxygen Saturation Accuracy NOTE It is recommended that the CLM III be periodically compared to other acceptable techniques for determining hematocrit and oxygen saturation values The CLM III should be discontinued from use and returned for servicing if a significant deviation from referenced standards is detected Percent Blood Volume Change...
Страница 57: ...luence comparison results Abnormal patient states can also affect data For more information on Oxygen Saturation accuracy see the Application Guide Section on Oxygen Saturation Accuracy Hemoglobin Estimation The CLM III monitor displays a hematocrit based hemoglobin value The monitor does NOT actually measure hemoglobin rather it calculates hemoglobin from the measured hematocrit value The followi...
Страница 58: ...erations Factors such as food and water intake and postural changes e g recumbent versus sitting may significantly affect the circulating blood volume during dialysis and can be observed by the instrument Nonetheless the CLM III only measures the changes occurring in the circulating blood volume and should not be confused with volumetric control devices which measure only the amount of fluid remov...
Страница 59: ...RICAL SHOCK PROTECTION OXYGEN SATURATION ACCURACY Class II 55 100 2 Sat Hct 18 Internally powered Type BF ACCESS BLOOD FLOW Estimates flow rates WATER PROTECTION 50ml min 2500ml min 15 Splash proof RECIRCULATION CAPABILITY ANESTHETIC SUITABILITY Estimates recirculation values 4 Not suitable BATTERY CAPACITY MODE OF OPERATION 2 hours continuous on full charge Continuous FULL CHARGE TIME BATTERY 36 ...
Страница 60: ... of any commercial window cleaner or vinegar and water can be used to clean the inside surfaces of the Sensor Clip If disinfection is necessary the several varieties of surface disinfectants i e Cavicide Envirocide etc can be used These cleaning agents should be wiped NOT SPRAYED onto the Crit Line Do not immerse the Sensor Clip WARNING Do not use abrasive materials alcohol or solvents to clean th...
Страница 61: ...play screen unless it becomes necessary to disinfect the screen Apply the cleaner directly to the soft cloth followed with a soft cloth dampened with water 8 4 Service All repairs must be directed to an authorized service center Contact the Technical Service Department at 800 546 5463 or 801 451 9000 or your local distributor for the location of the nearest service center __________________ 8 5 Wa...
Страница 62: ... electrical safety testing If the location where it will be used wants to perform this test they may do so at their discretion See below for an explanation on why the electrical safety testing is not required The UL STD 60601 1 is the governing standard for electrical medical products Testing to this standard protects you from items such as electrical shock excessive energy output fire or other ha...
