Home

CRIT-LINE® III User Manual

1. 8 3 Electrical Safety Testing uio aa 8 3 Contents Your Guide to the User Manual This user manual has been designed to assist you in operating the CRIT LINE III Monitor It provides an overview and guide to the monitor s use during hemodialysis This manual includes a comprehensive table of contents eight unique sections 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 advanced features topics enhance the CRIT LINE s usefulness and clinical effectiveness iii The CRIT LINE System Section 1 The CRIT LINE System The CRIT LINE System includes the CRIT LINE III Monitor CLM with its sensor clip the power supply adapter and the disposable CRIT LINE Blood Chamber sold separately The headings in this section are as follows Introduction mane eoi E RHODE Eee 1 1 e Language ee e ene eene 1 2 e CUM UM ata Glance ie iu etre terere ER 1 3 The Keypads ode S 1 4 e Display e Advanced Feature
2. eene 1 6 Power Supply eem eene 1 7 e Disposable Blood 1 8 er pte upto niet apa l9 e Internal Memory uoo etes ome Pre POP ete tede 1 10 e Optional Accessories esses esses mene ehem hse eene 1 11 Symbols edea 1 1 Introduction Welcome to CLM III a non invasive optical technology that helps ensure better clinical outcomes patient safety and staff confidence The CLM III continuously monitors 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 volume in real time during the treatment session By continuously monitoring hematocrit and oxygen saturation the CLM III provides diagnostic information concerning the vascular compartment during hemodialysis therapy The CLM III is used in conjunction with the CRIT LINE blood chamber a sterile disposable viewing window that is inserted into the patient s extra corporeal blood tubing Blood parameters are displayed approximately one minu
3. You can enter the PATIENT and STATION ID and NAME after you have started blood volume monitoring and a PROFILE screen has been activated 38 1 BVa 5 7 HGB 12 8 TIME 1 a 94 Select Hct Limit wait 19 for Pro 3 10 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 menu will then appear The cursor will be next to SETUP STOP Press SELECT Using the CRIT LINE The SETUP MENU will be accessed and provide the option to enter the PATIENT and STATION ID and NAME SETUP MENU PRTIENT STATION ID 99 Het start 15 5 Het max 15 5 Sat min 73 Recire x TOA Het Limit DATE 03701701 TIME 19 08 38 ID STATION ID 99 CONTINUE STOP From this point follow the instructions in the previous section for entering 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 PROFILE 08080 START UP 00090 The preset default display screen is the BVA blood volume screen DEMO HCT 37 4 HOB O TIME 01 32 33 DEMO 5
4. 1 5 Secondary Display 5 1 6 Advanced Feature 1 7 Power Supply pene Reo eerie unie 1 8 Disposable Blood Chamber ses 1 10 Sensor CU TETTE 1 11 internal 1 12 Optional 0 1 13 1 14 Section 2 Set Up Procedures Pre priming Attachment of the Blood 2 1 Post priming Attachment of the Blood Chamber 2 2 Sensor Clip ATac DIO DE s endo unt eee mtra 2 3 Section 3 Using the CRIT LINE III Clearing the Memory sc ette a er et as e tre eror tet 3 1 R nno a Patent sex sente ettet 3 3 Setting the Date and 3 6 Setting the da decd tea Gl 3 6 Seling the 3 7 Entering the Patient ID Station ID and 3 8 Entering the Patient ID sess 3 8 Entering Ihe Station IB eite 3 9 Entering the Name iia rd bees 3 9 Entering the Patient Station ID from Profile Screen 3 10 Default Screen 3 11 Screen Contrast Adjustment 3 13 Contents Section 4 Ending a Session Ending the Dialysis Session sss 4 1 O but ODIOTDS uh e RM 4 4 PANUNG PERCENT 4
5. 2 1 Pre priming Attachment of the Blood Chamber Follow these basic steps to attach the disposable CRIT LINE Blood Chamber to the dialyzer during the pre dialysis setup 1 Inspect the blood chamber and its sterile package prior to use Do not use any blood chamber where the package has expired been opened or otherwise compromised Refer to the blood chamber package label to ensure that the blood chamber expiration date has not expired 2 Remove the blood chamber from its sterile package and remove the red cap Attach it by inserting it perpendicular into the arterial fitting of the dialyzer Twist the wings of the blood chamber until the lure lock connector 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 bubbles are trapped inside the blood chamber NOTE Any air bubbles present in the blood chamber will cause the hematocrit reading to be inaccurate and the instrument may display the message NO BLOOD DETECTED NOTE Improper attachment of the arterial line to the Disposable Blood Chamber can cause blood saline to leak onto and into the Sensor Clip The connection of the Disposable B
6. HCT 37 8 12 8 S TIME 01 30 38 6 HGB 12 7 SAT 94 UT TIME 02 08 SAT 84 Using the CRIT LINE If you wish to see the profile for hematocrit or oxygen saturation as shown above you can change the default screen selection To change the profile display access the START UP MENU window If you are in the PROFILE screen this is done by first accessing the START UP screen by pressing either MENU or SELECT and then pressing MENU Once in the START UP MENU window scroll down to the choices under DEFAULT SCREEN kSETUP STOP RECIRCULRTION DEFAULT SCREEN Lua Choose the parameter you wish to monitor and press SELECT HCT SRT CONTINUE Changing the default screen from BVA 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 blood volume profile NOTE In the upper right hand corner of the START UP screen a BVA SAT or indicates the current default screen 3 12 Using the CRIT LINE 3 6 Screen Contrast Adjustment MAIN 09080 08080 CONTRAST To adjust the screen contrast select the CONTRAST option from the MAIN MENU MAIN ME NU PATIENT RUN SPOT CHECK RECIRCULATION CALIBRATION SELECT OPTION by moving cursor OUTPUT OPT
7. CRIT LINE User Manual WI FRESENIUS v MEDICAL CARE as North 900 West Kaysville UT 84037 USA Toll Free 1 pus 546 5463 801 451 9000 x 801 54 9 9250 ww c m CRIT LINE 0086 U S Federal law restricts this device to sale by or on the order of a physician Frequency duration and parameters of treatment are to be determined by the prescribing physician Fresenius Medical Care 695 North 900 West Kaysville UT 84037 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 LINEe III is a trademark of Fresenius Medical Care North America This document is compatible with the CRIT LINEelll monitor Document No 43 0002 Rev F Last Update January 2013 Printed in the United States of America WE FRESENIUS v MEDICAL CARE Contents Contents Table of Contents amp ii Your Guide to the User Manual Section 1 The CRIT LINE System ho ce ten n dta 1 1 Language 5 1 1 2 The CLM III At A 1 3 Fig 1 The CLM III Fig 2 Back Panel The OV DAO ttu nM 1 4 Display SS 1 5 Primary Display Screens
8. CRITLINE CRITLINE CAUTIONS Power Supply Power perse em ONLY AVERTISSEMENT Voltage 120 V AC 230 V AC VAC V DC RECHARGEABLE POWER SOURCE POSSIBLE EXPLOSION HAZARD IF USED IN THE PRESENCE Frequency sonz sonz di ae Power 20 VA 20 VA Use only the supplied power supply with this monitor ly uni i Power Supply Output 12 V DC 15W Sep deus a y unit to monitor vester A This instrument is not intended for home 30175 Hannover 129 is use and is restricted to use or purchase Comey by or on the order of a physician Eu stanco ocio tue Ue 10c Do not use the CRIT LINE Blood Chamber your local distributor 50F 5 A For U S assistance call 801 451 9000 if the package has been compromised a HemaMetrics 7 Properly dispose of each Blood Chamber 695 North 900 West e qu 24 after use Blood Chambers should not be Kaysville Utah 84037 S000783 CERTIFIED TO reused for any reason USA CAN CSA STD 22 2 NO 601 1 LABEL 80020047 REV F SN U S amp INTERNATIONAL PATENTS APPLY 1 14 Set Up Procedures Section 2 Set Up Procedures This section details how to setup the CLM III for patient monitoring during dialysis Section headings include e Pre priming attachment of the blood 2 1 e Post priming attachment of the blood chamber 2 2 e Sensorclip attachment
9. Where HyH 1 X100 Ho Het start Current Hct 3 5 Using the CRIT LINE 3 3 Setting the Date and Time MAIN INITIAL 08080 08080 The CLM III is equipped with an internal clock and calendar that are powered by a real time clock battery This battery is different than the battery that powers the CLM III when it is not powered by a power supply When the power is off the settings 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 INITIAL DATA PATIENT ID STATION ID 81 SELECT OPTION ADJUST by moving cursor Scroll the cursor next to DATE ADJUST and press Select TIME ADJUST PATIENT ID STRTION ID i DATE TIME DATE MENU S croll the cursor next INITIAL DATA pos to MONTH and press EE Select SELECT OPTION RETURN bu moving cursor PATIENT ID seek STRTION ID 91 DATE 61 64 61 TIME 18 64 29 3 6 Using the CRIT LINE The month data entry window will appear To set the month Scroll the cursor next to the current PMONTH 01 month Press D
10. the monitor will indicate that it is ready for clinical use It is not necessary to VERIFY ACCURACY if RE CALIBRATE is successful If RE CALIBRATE fails the instrument is unable to re calibrate itself to the necessary parameters If this should occur make sure the verification filter is clean and that the sensor clip has been properly attached Refer to Section 2 RE CALIBRATE may be retried until successful If VERIFY ACCURACY and RE CALIBRATE should both fail the CRIT LINE will prevent you from exiting the 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 VERIFICATION FAILED SELECT RE CALIBRATE SENSOR MALFUNCTION RETRY OR REFER TO THE USER MANUAL CALIBRATION DONE READY FOR CLINICAL USE SELECT RETURN RE CALIBRATION HAS FAILED RETRY OR REFER TO THE USER MANUEL INVALID SELECTION SYSTEM IS NOT READY FOR CLINICAL USE 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 a problem exists If you are certain the sensor clip is properly attached to the verification filter and RE CALIBRATE continues to fail contact your service representative NOTE If you wish to verify accuracy after data has been collected i e
11. BVA units and appears as the CRIT LINE shown above This line will appear in both the BVA 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 the red light located between the arrow keys will flash To silence the alarm press any key Press the Up Arrow key or Down Arrow key to raise or lower the value of the hematocrit limit as indicated after patient assessment 5 2 0806010689096 Advanced Features 5 2 Hysteresis The CLM III has a hysteresis alarm delay feature This feature prevents the alarm from turning off until the patient s Hct is 0 25 Hct units lower than the established Hct Limit This feature has been added to prevent the alarm from sounding ON and OFF as the patient s Hct toggles at the Hct Limit To change 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 CRASH CRIT RLRRM SHUTOFF HCT Limit n MAIN MENU 10 25 8 5 1 8 SELECT OPTION SRUE by moving cursor RETURN IDC C3 44 9989 x12 4U Unofficial Rele
12. section details the warning messages that may appear in the WARNING or MESSAGE BLOCK on the screen of the CLM III It also describes the appropriate action necessary for correcting the cause 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 MESSAGE BLOCK Warning messages that can be displayed in the Warning or Message Block include e Sensor senes 6 1 e No Blood 6 2 s LOW Voltages i no e tp ie i PORC aa 6 6 1 Warning Messages 6 1 Sensor Obstruction ERROR This message appears when the sensor is obstructed or the SENSOR blood becomes so dense e g a blood clot that it absorbs too OBSTRUCTION much light for a hematocrit measurement in the normal blood parameter range If the patient s hematocrit is below 60 and this warning message appears the sensor is probably obstructed with a foreign material that has come between the sensor clip and the blood chamber To correct this problem remove any foreign materials that could be causing an obstruction see Section 8 Cleaning the Sensor Clip 6 2 No Blood Detected ERROR This message indicates that an ins
13. 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 instrument is operating within normal parameters see Section 1 The CRIT LINE III At A Glance For verification attach the CLM III sensor clip to its verification filter so that it locks firmly into place MAIN MENU PRTIENT RUH SPOT CHECK RECIRCULRT ION gt CALIBRATION SELECT OPTION From the MAIN MENU scroll by moving cursor OUTPUT OPTIONS the cursor next to CONTRAST CALIBRATION and FMC U8 19 2 SN 1922411817 412 00 5 8 Advanced Features From the CALIBRATION MENU PUERIFY ACCURACY Scroll the cursor next CALIBRATION RETURN To VERIFY ACCURACY MENU SELECT OPTION by moving cursor and press Select FMC C3 08 19 2 SN 1947 112915 The message block on the display screen will read VERIFYING ACCURACY PUERIFY ACCURACY CALIBRATION RETURN MENU SELECT OPTION by moving cursor UERIF VI PLEASE WAIT 00 5 NG ACCURACY FMC C3 08 19 2 SN 1947M112915 In sixty seconds one of two possible messages will be displayed Verification Passed or Verification Failed 5 9 Advanced Features The screen will read VERIFICATION PASSED READY FOR CLINICAL USE SELECT RETURN indicating
14. 4 Data Downloading 4 6 Selecting 1 etes 4 6 Section 5 Advanced Features Hematocrit Limit Holt Limit 5 1 FAY SICTOGNG 5 3 Recirculation Dies arae tdi cx 5 3 ODOLCHeCRIBO ripis 5 6 Calibration Procedures 5 8 5 8 Marking Clinical 1 5 12 Section 6 Warning Messages Sensor 6 2 No Blood Detected 6 2 Low Voltage i detiene toe 6 2 Section 7 Performance Characteristics Operational 5 7 1 Percent Blood Volume 7 1 Corrections for Mean Cell Volume Hct Sampling 7 1 Reference Standard for Hematocrit 7 2 Reference Standard for Oxygen Saturation 7 2 Hemoglobin Estimation sess 7 2 General Precautions ae it eren 7 2 Standard 7 4 Section 8 Instrument Maintenance Cleaning the Sensor Clip esses nennen 8 1 Cleaning the CLM II 8 2 Cleaning the Display 8 2 org 8 2 Warranty TET PEE CERE 8 2 Preventative
15. ABILITY Not suitable MODE OF OPERATION Continuous BATTERY Type Rechargeable sealed lead battery 12V 2A h Battery is replaceable Polarity labeled on battery Mode of insertion Via 2 pin Molex connector replaceable Instrument Maintenance Section 8 Instrument Maintenance This section explains how to care for the CLM III The headings in this section include the following e Cleaning the Sensor 8 1 Cleaning the CLM 8 2 e Cleaning the Display 8 3 DETVICE EE 8 4 e Warranty sit Maines dos haat dente Dottor odes 8 5 e Preventative Maintenance sess 8 6 e Electrical Safety Testing sese 8 7 8 1 Cleaning the Sensor Clip The CRIT LINE Sensor Clip is a sensitive electro optical assembly critical to the successful operation of the CLM III monitor The outside surfaces of the sensor clip can be cleaned with the same cleaning agents used to clean the dialysis machine It is recommended that a standard dilute bleach solution or any of the several varieties of surface disinfectants be used The use 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
16. AY 04 Select YEAR DATE MENU Yv Yoo ODN Koo eNi Koo Nop RETURN To set the day scroll the cursor next to DAY in the DATE MENU and press SELECT The numeric data entry window will then appear Scroll the cursor next to the number of the first digit in the current day Press Select Do the same for the second digit in the day and press SELECT The DATE MENU window will then become active again allowing you to set the YEAR using the same procedure NOTE If you inadvertently choose a wrong digit when correcting the day and year scroll to DEL delete and push SELECT to erase the entry If the day or year is a single digit number you must select zero as the first digit and then select the digit that signifies the day or year Once you have finished 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 Select This will return you to the INITIAL DATA screen NOTE If you inadvertently choose the wrong first digit scroll to DEL delete and press SELECT to erase the entry If the hour or minute is a single digit number you can enter the single digi
17. ELECT DUTPUT OPTIONS MEMORY CLEAR MEMOR Y FULL Clear Memory Y denotes Yes SELECT of N denotes No by moving q Y MENU N SELECT Press MENU to clear the Clearing Memory will memory result in data loss 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 Section 4 Output Options 3 2 Using the CRIT LINE 3 2 Running a Patient MEMORY MAIN INITIAL SETUP PROFILE 08080 08080 08080 08080 08080 Once the memory has been cleared the MAIN MENU screen will appear By default the cursor will be PATIENT RUN next to PATIENT RUN SPOT CHECK RECIRCULRTION CRLIBRRTION OUTPUT OPTIONS MAIN MENU Pressing Select will activate the Initial Data screen SELECT OPTION bu moving cursor CONTRRST FMC C3 U8 19 2 Software Version SN 1922 118177 x12 0U Monitor Serial Number Battery Voltage The next 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
18. IONS gt CONTRAST Scroll the cursor next to CONTRAST and press Select FMC C3 08 19 2 SN 19224118177 x12 0U From the buttons to lighten or SPOT CHECK darken th screen contrast RECIRCULATION aH ABE CALIBRATION Each press of CA OUTPUT OPTIONS will lighten the screen and_each press of CW will darken the screen 10 C3 RETURN 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 may not have the option to adjust the screen contrast in the Main Menu If you have an older CLM III that requires the screen contrast to be adjusted contact the spare parts department to order a screen adjustment kit 3 13 Ending a Session Section 4 Ending A Session This section explains how to end a monitoring session Also included in this section are instructions on how to use the output options on the CLM III The headings in this section are as follows e Ending the Dialysis Session eese 4 1 e Output 5 emen 4 2 4 1 Ending the Dialysis Session PROFILE STARTUP SETUP OUTPUT 08080 08080 08080 08060 Monitoring with th
19. M12 0U Printing Choose the printing method desired PRINT SERIAL to print all Patient Runs in memory OUTPUT PRINT PARALLEL MENU DATA DOWNLOAD MEMORY CLEAR SELECT OPTION SELECT PRINTER by moving cursor RETURN Ending a Session Information can be transferred by using either the parallel or serial port located on the back panel See Section 1 The CRIT LINE At A Glance Fig 2 The port you select will depend on whether or not the printer you are using has a parallel or serial data port most new printers have both For 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 EMA METRICS CRIT LINE Instrument S N 174 300001 Patient ID Name Station ID Het start 30 2 Date 05 04 1998 Het max 36 5 Start Time 09 00 04 Limit 38 Stop Time 12 15 32 Sat min 88 2 Calibration Date 03 03 1998 Recirculation 13 Last Verification Date 05 03 1998 If RECIRCULATION or SPOT CHECK tests have been conducted from the MAIN MENU the results will be printed on one separate page for each patient tested NOTE Printing data does not clear the memory Once printing has taken place the data can
20. R ITS STERILITY HAS OTHERWISE BEEN COMPROMISED PRIOR TO 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 monitoring session The viewing area of the disposable blood chamber should be kept clean and free of obstruction Air bubbles trapped in the CRIT LINE Blood Chamber may cause the instrument to underestimate the hematocrit measurement A blood clot may also alter the hematocrit measurement WARNING PROPERLY DISPOSE OF THE BLOOD CHAMBER AFTER USE Disposable Blood Chamber The CRIT LINE System 1 9 Sensor Clip The CLM III s sensor clip is comprised of an electronic light emitter detector unit housed in precision molded clip The sensor detects the absorption and scattering properties of light transmitted through the whole blood as it flows through the 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 Sensor Clip Whenever the CLM III is not being used the sensor clip should be placed on the verification filter on the side
21. RCULRTION DEFRULT SCREEN ETE HCT SAT CONTINUE RUN start Het Cmax Sat Recire x TOR 1 6 The INITIAL DATA screen allows the input of various parameters It appears after selection of PATIENT RUN SPOT CHECK and RECIRCULATION on the MAIN MENU INITIAL C 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 MEMORY 09080 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 displayed STARTUP 08080 The CRIT LINE System 1 6 Advanced Feature Pathways From the MAIN MENU various operational modes can be accessed Selecting patient run directs you to the PROFILE screen after passing the INITIAL DATA screen and the STARTUP screen Each of the other 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 one way to reach a specific mode more than one icon y p gt pa
22. RY 1 Do not place the power supply in or near an area that is or has the potential to become wet 2 Do not use the power supply that shows signs of corrosive build up 3 Do not use a power supply that shows signs of damage such as frayed cords 4 Protect the power supply from dropping KEEP DRY 1 8 The CRIT LINE System The CLM III utilizes a green charging indicator light on the bottom of the keypad to indicate that the monitor is plugged into an AC wall outlet and that the battery is charging If the green charging indicator light is not illuminated and a known good working power supply is plugged into the CLM III the keypad will need to be replaced Contact the spare parts department to order a replacement font panel bezel assembly amp kit The voltage indicator located next to the lightning symbol at the bottom left corner of the MAIN MENU screen indicates the voltage of the power source i e AC wall outlet or battery This voltage must be above 10 3V for the monitor to operate If the battery is fully charged the CLM III will function for approximately 2 hours on battery power During continuous clinical use the CLM III should be attached at all times to a plugged in power supply adapter Doing so will ensure that the battery is always fully charged 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 st
23. after a patient run instead of prior to a patient run the MEMORY FULL screen will appear You must erase all data prior to performing a verify accuracy test Any data you want to retain must be printed or downloaded prior to performing the verify accuracy test Advanced Features 5 6 Marking Clinical Interventions and Events PROFILE 08090 The CLM III provides the capability of inserting clinical intervention event markers into the profile screens Pressing either the UP or DOWN ARROW keys activates event markers This encodes a marker in the data file and positions a visible arrow on the display screen at the point during the dialysis session when the key was pressed These markers appear on each profile screen and the printed graphs Press o CO 5 to insert an Event Marker 8 18 This feature 1s useful for marking the time of various clinical interventions and events saline bolus 20 administration HCT 43 5 BVa 17 4 Trendelenburg etc and or HGB 14 3 SAT 95 physiological changes food PET Rasen TIME 02 52 intake etc that occur during the treatment Event markers can be inserted after five minutes or monitoring and as frequently as every five minutes for the duration of the session For retrieving data after a monitoring session see the Tech Notes Section on Printing Graphs and Data Retrieval 5 12 Warning Messages Section 6 Warning Messages This
24. ase 5 3 Recirculation C a INITIAL z STARTUP z RECIRC Ej z E E PROFILE START UP 2 RECIRC 5 3 Advanced Features The CLM III has an access recirculation feature that estimates the amount of blood that is being recirculated back into the dialysis circuit instead of the patients circulating volume This feature provides good indication of the effectiveness of the patient s access 1 fistula graft or catheter To utilize this feature proceed to the MAIN MENU MAIN MENU PRTIENT RUN SPOT CHECK PREC ERTULATION Scroll the cursor next to SELECT OPTION POEIPRHTION RECIRCULATION and by moving cursor OUTPUT OPTIONS press Select CONTRAST FMC U8 19 2 SN 1922M116177 x12 0U This feature is also available during a patient run To momentarily leave profile monitoring and conduct a recirculation test press MENU or SELECT to move to the START UP screen Then press MENU to bring up the START UP menu 7 Scroll the cursor next to RECIRCULATION and press Select RECIRCULATION DEFAULT SCREEN HCT SAT CONTINUE RUN NOTE When performing a recirculation test during patient monitoring the CLM will continue to monitor blood parameters No data will be lost or significantly altered while performing recirculation tests If you began the pa
25. ate 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 regardless of whether or not the CLM III is in the ON or OFF position If the CLM III Monitor has run to battery extinction you must first turn the power switch OFF and then reestablish power Be sure the green indicator light is on and wait 20 seconds before turning the monitor ON Once the CLM III is connected to its power supply adapter full monitoring functions return regardless of battery status Refer to the graph below for approximate operating time of the CLM III when operating on battery power Charging time refers to the length of time the CLM III has been connected to its power supply adapter after it has automatically shut OFF CRIT LINE III BATTERY CHARGING E 2 Ll lt a CHARGING TIME 1 9 The CRIT LINE System 1 8 Disposable Blood Chamber The CRIT LINE Blood Chamber is a sterile disposable cuvette designed to insure a consistent viewing area for the CLM sensor in order to provide accurate repeatable measurements The blood chamber is attached to the arterial side of the dialyzer during the pre dialysis set up procedure See Section 2 for more information WARNING DO NOT USE THE BLOOD CHAMBER IF ITS PACKAGE HAS BEEN OPENED EXPIRED O
26. be entered during the run if desired RUN PATIENT ID STRTION ID 11 DRTE RDJUST TIME RDJUST NAME INITIAL DATA SELECT OPTION bu moving cursor PATIENT ID STATION ID 11 DATE TIME 11 11 11 19 00 55 3 3 Select START RUN to ignore input fields and begin patient monitoring Using the CRIT LINE The START UP screen will appear as shown below until a valid starting hematocrit value has been determined The initialization process takes approximately one minute START UP Screen Blood parameter monitoring begins as soon as numeric data appears on the screen The highlighted 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 CA or Cw 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 above NOTE You can never set a hematocrit limit that is lower than the starting or current hematocrit Using the CRIT LINE Once a PROFILE SCREEN appears it can be exited at any time by press either Suec Pressing either of these keys will cause the START UP screen to appear 5 Anytime the START UP screen 15 accessed the moni
27. be erased by selecting MEMORY CLEAR then MENU to Clear Memory After printing successfully select MEMORY CLEAR then Menu to Clear Memory to move back to the MAIN MENU Once you have printed you cannot return to the MAIN MENU until you have cleared the memory 4 5 Ending a Session Data Downloading This option allows data to be downloaded from the CRIT LINE III as text files at the conclusion of a monitoring session Data can also be retrieved continuously during the monitoring session by proper connection of the serial port to a computer Information is transferred from the serial data port located on the back I O panel see Section 1 The CRIT LINE III at A Glance for specific location After downloading data you have the options of clearing the memory or selecting RETURN to enter the MAIN MENU Unlike printing you do not have to clear the memory to return to the MAIN MENU after downloading 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 to the Printy family of printers The default print driver is the HP LaserJet Also available is the pc printer option whi
28. ch is used with the printer software to generate a printout from a computer This option is the preferred option when a compatible printer is not available To select a driver scroll the cursor to SELECT PRINTER found in the OUTPUT MENU and press SELECT To select a print driver SELECT PRINTER PHP LASERJET HN OUTPUT PRINTY A PRINTY B SELECT SEIKO 3445 SELECT OPTION SEIKO 414 The diver selected P PORE PC PRINTER will then have the RETURN double asterisks to its left To return to the MAIN MENU select RETURN 4 6 Advanced Features Section 5 Advanced Features The CLM III provides several advanced features Although these advanced features are not necessary for day to day operation of the CLM III using them will allow you to maximize the effectiveness of the monitoring process These advanced features include e Hematocrit m 9 JAYSICTESIS Lise SERRE UD e Recirculation s es e emen Marking Clinical Interventions and Events 5 1 Hematocrit Limit Hct Limit START UP e PROFILE 2 C 00090 The Hct Limit feature provides way for the clinician to be alerted via an audible and visual alarm when the patient s hematocrit has reached a pre selected hematocrit limit level Prior to
29. e 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 Warranty Fresenius Medical Care will repair or replace at its sole option any product that it feels was defective at the time of shipment to the original purchaser if it is returned prepaid within one year of date of shipment Repair or replacement shall be the exclusive remedy Any repair or attempt to repair other than by the factory automatically voids this warranty unless authorized by Fresenius Medical Care Under no circumstances will Fresenius Medical Care be liable for any direct or indirect incidental or consequential loss damage or expense of any kind including without limitation loss of profits economic loss medical expenses or personal injury claims whether such claim is 8 2 Instrument Maintenance based on warranty contract tort and negligence or otherwise Its liability being hereby limited solely to repair or replacement This warranty is expressly in lieu of any other express or implied warranties including any implied warranty or merchantability or fitness for any particular purpose and of any other obligation on the part of Fresenius Medical Care No person has the authority to bind Fresenius Medical Care to any other representation or warranty with respect to these products and the pu
30. e 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 Properly ending a monitoring session will prevent unnecessary rescaling To end a monitoring session z Press MENU or SELECT a Bua 18 20 HCT 38 1 BVa 5 7 HGB 12 6 SAT 94 ased TIME 01 54 4 1 Ending a Session This switches the display to the START UP screen Press MENU to access the START UP menu Hab start The START UP Menu will be displayed kSETUP STOP Position the cursor next to RECIRCULRTION SETUP STOP DEFAULT SCREEN HCT SAT Press SELECT CONTINUE RUN Hab starto Het amp max Sat mind Recire TOA PATIENT ID SETUP MENU STRTION ID 17 NAME CONTINUE PATIENT ID STATION ID Het start Hab Het Cmax Sat min Recirc X TOA ABF Het Limit To stop position the cursor next to STOP and press SELECT m m m m m W DRTE 91 27 85 13 14 4 2 Ending a Session This ends monitoring of the current run and stops the collection of data The Patient ID and Name will be erased but the Station ID Ti
31. eck 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 patient to patient so that the processed data is saved under the correct identification Selecting SAVE erases the current PATIENT ID The STATION ID is saved for subsequent runs The information contained in the saved data files can be printed or downloaded if desired see Section 4 Output Options for more information Selecting STOP completes the spot checking session Data can be downloaded if desired at this time but must be cleared from memory to proceed with any additional patient monitoring 5 7 Advanced Features 5 5 Calibration Procedures 080 MAIN CAL 08080 The CLM is calibrated by the manufacturer and should require no further calibration However the instrument is equipped with a verification filter to access and insure accuracy Also a self calibration routine can be performed if indicated by the verification routine The monitor is required to be verified for accuracy at least once per month The last date when the verify accuracy test was performed will appear on every treatment printout The CLM III monitor is designed to detect component and memory failures that could potentially result in the display of erroneous information If an error or component failure is detected the system
32. eens MAIN MENU SELECT OPTION by moving cursor FMC C3 U8 19 2 SN 1922M110177 X12 0V The MAIN MENU screen allows you to choose the operating mode of the CLM III RUN SPOT CHECK RECIRCULATION NOTE New Monitors sold after January CRLIBRRTION 2006 may not display the AH ABF option QUTPUT OPTIONS on the Main Menu CONTRAST NOTE New Monitors sold after August 2011 may not display the TQA option on the Main Menu The STARTUP screen is the central Hct 35 9 display for most CLM III functions All Hct Limit measurements warnings or messages can be viewed from this screen STARTUP 09080 The PROFILE screen displays a plotted graph of the change in the measured parameters versus time to allow you to see the trend in those measurements HCT 38 6 19 1 S TIME 02 10 PROFILE 08080 BVa 6 9 SAT 95 1 5 The CRIT LINE System The secondary display screens provide you with specific function menus and data entry points Secondary Display Screens PSTART RUN PATIENT ID STRTION ID 11 DRTE RDJUST TIME RDJUST NAME INITIAL DATA SELECT OPTION by moving cursor PATIENT ID STATION ID OUTPUT OPTIONS MEMORY CLEAR MEMORY FULL SELECT OPTION by moving cursor Clearing Memory will result in data loss kSETUP STOP RECI
33. er contains the date and time while the footer contains the patient and station ID information 3 HR PATIENT RUN FOOTER 1 HEADER 2 1 HR PATIENT RUN FOOTER 2 HEADER 3 Each patient run begins with a header and ends with a footer The entire data file including all headers footers and data is downloaded or printed at the same time Each file is printed on a separate output page SPOT CHECK FOOTER 3 LAST HEADER LAST DATA LAST FOOTER ETC The CRIT LINE System 1 11 Optional Accessories Optional accessories are available to maximize the CLM convenience and performance capability These accessories include I V Pole Mount Part 4 CL90000023 The pole mount securely positions CLM to the I V pole of the dialysis machine Using the pole mount frees the space on the top of the dialysis machine and providing an excellent viewing angle of the CLM III s screen Wireless Printer Radio Client Part CL10023029 Print wirelessly from the Crit Line Monitor to any printer in your facility The client radio attaches to the Crit Line Monitor This 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
34. g blood samples from patients with serum sodium levels of 137 mEq L Changes in affect the micro centrifuge derived hematocrit values as follows 1 unit decrease in spun hematocrit per 12 mEq L increase in Na Abnormal sodium concentration may occur due to e Useof blood bank blood with sodium citrate 2165 mEq L e Use of normal saline 0 9 NaCl as diluent 2154 mEq L e Over hydration 137 mEq L Hemolysis Hemolysis may affect hematocrit determination although no changes in CLM III measurements have been noted for plasma hemoglobin levels below 551 7 2 Performance Characteristics Abnormal Patient Conditions The CLM III has not been tested for all possible blood conditions Some of these conditions include sickle cell anemia macrocytic anemia and hyperlipidemia Certain drugs and or medications may cause idiopathic hyperlipidemias such as the prostaglandins e g Alprostadil and the intralipids given intravenously These conditions may cause the hematocrit measurement to be inaccurate Other Considerations 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 removed Furthermore w
35. he anti coagulant solution The effect of either on the in vitro erythrocyte can be significant Reference Standard for Hematocrit When comparing CLM III data with other hematocrit determination techniques there are several considerations separate from MCV which are necessary to ensure that data is comparable and consistent For more information on Hematocrit accuracy see the Tech Notes Section on CRIT LINE Hematocrit Accuracy Reference Standard for Oxygen Saturation The CLM is calibrated for oxygen saturation measurement using the IL 482 682 CO Oximeter Instrumentation Laboratory Inc Lexington MA as the reference standard Using a standard other than the IL 482 682 CO Oximeter may influence 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 following equation is used to calculate Hgb from the measured Hct value Hgb HCT 2 94 General Precautions Bubbles in a Sample Air bubbles trapped in the CRIT LINE Blood Chamber or in the blood sample drawn for comparison will cause poor correlation between the CLM III and the reference standard Abnormal Na Levels The CLM III was calibrated usin
36. hile a patient s plasma refilling rate may vary depending on diet state of health medications temperature and posture the CLM III does not measure the rate of refilling The CLM III measures the change in total intravascular blood volume 7 3 Performance Characteristics 7 2 Standard Specifications INSTRUMENT RANGE Hematocrit Hct 10 Hct 60 Hct Oxygen Saturation 5596 100 Hct 2 18 OPERATING AND STORAGE TEMPERATURE 50 F to 104 F 10 C to 40 C Avoid extreme temperatures during transportation lt 32 2110 F HEMATOCRIT ACCURACY 10 Hct 60 Hct 1 Hct SD OXYGEN SATURATION ACCURACY 55 100 2 Sat Hct gt 18 ACCESS BLOOD FLOW Estimates flow rates 50ml min 2500ml min 15 RECIRCULATION CAPABILITY Estimates recirculation values gt 4 BATTERY CAPACITY 2 hours continuous on full charge FULL CHARGE TIME 36 hours PHYSICAL DIMENSIONS 5 25 H 8 25 W 11 63 L 5 Ibs HD BLOOD FLOW RATE CAPABILITY 50 ml min 1300 ml min INTERNAL DATA STORAGE Sufficient to store up to 26 hours of data indefinitely 7 4 INPUT 12 VDC 1 Ampere 12 watts 1 2A max POWER SUPPLY UNIT Universal regulated supply 100VAC 240VAC 12 VDC 1 25 Ampere Output COMMUNICATIONS PORTS 8 position keyed modular jack Keyed RJ 45 serial port DB female parallel port ELECTRICAL SHOCK PROTECTION Class Internally powered Type BF WATER PROTECTION Splash proof ANESTHETIC SUIT
37. ion ID and press SELECT Next scroll to the second digit of the STATION ID and press SELECT This will save your entry and return you to the INITIAL DATA screen NOTE If the station ID is only one digit select zero as the first digit DEL delete will also allow you to erase a previous entry Entering the Name The CLM III also provides the option to enter up to 12 digits for name or ID number The ability to enter this data has been included so that printed and downloaded data can be easily identified and it will only appear on the printed data sheet and the downloaded data The option is only available in the English software To enter a name or ID number scroll to NAME and press SELECT INITIAL DATA RA PRTIENT ID STRTION ID 99 SELECT DRTE RDJUST bu moving cursor TIME ADJUST Scroll to NAME and press SELECT PRTIENT ID STRTION ID 3 9 Using the CRIT LINE This will activate the alpha numeric data entry window Scroll to each letter or number you wish to enter and press SELECT Once the entry is complete scroll to SAVE and press SELECT to return to the INITIAL DATA screen prior to starting the run or the Setup Screen during the run Save the data and continue on to patient monitoring Entering the Patient ID and Station ID from the Profile screen PROFILE START UP SETUP 08080 08080 08080
38. lect INITIAL DATA PATIENT ID STRTION ID 11 SELECT OPTION DRTE RDJUST bu moving cursor TIME ADJUST PRTIENT ID STRTION ID DRTE 11 TIME 13 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 Check mode 5 6 Advanced Features Once a Hct and Sat value has been determined another Hct and Sat sample may be taken by attaching the CLM III sensor clip onto the next patient s CRIT LINE Blood Chamber Once attached the SPOT CHECK message on the screen will flash indicating that data is being processed When complete the asterisks in the Hct and Sat boxes will be replaced with number values Pressing the MENU key will switch the screen to the SETUP MENU SAVE completes the data file SETUP MENU PATIENT ID xxx PATIENT and STATION ID and STATION 11 NAME can be changed as needed EM DN T n CONTINUE to Spot Check the next Hct patient Sat mim 75 STOP STOP returns you to the MAIN MENU DATE 11 11 11 TIME 13 26 13 Whenever SAVE is selected the current PATIENT ID and STATION ID are recorded into memory along with their corresponding Hct and Sat readings If you do not plan to print or download the spot ch
39. lood Chamber to the arterial line must be leak proof This can only be done by holding the Disposable Blood Chamber not the dialyzer securely in one hand and attaching the arterial line with the other hand twisting at the wings Be careful that you do not cross thread the connection and then thoroughly check for leakage at both connection points before attaching the Sensor Clip Ensure there is no kinking in the bloodlines 2 1 Set Up Procedures 2 2 Post priming Attachment of the Blood Chamber If the tubing set is already primed a disposable CRIT LINE Blood Chamber can be installed by following the same basic instruction found in Section 2 1 with the following changes 1 Pre prime the blood chamber using a 3ml syringe of sterile saline to remove air 2 Stop the blood pump and the dialysate lines 3 Apply hemostat clamps to both the arterial and venous tubing lines 4 Disconnect the arterial tubing set from the dialyzer and attach the CRIT LINE Blood Chamber to the arterial side of the dialyzer and bloodline in the manner described in Section 2 1 NOTE Post prime attachment of the blood chamber may introduce 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 b
40. lood chamber is dry before attaching the sensor clip NOTE Improper attachment of the arterial line to the Disposable Blood Chamber can cause blood saline to leak onto and into the Sensor Clip The connection of the Disposable Blood Chamber to the arterial line must be leak proof This can only be done by holding the Disposable Blood Chamber not the dialyzer securely in one hand and attaching the arterial line with the other hand twisting at the wings Be careful that you do not cross thread the connection and then thoroughly check for leakage at both connection points before attaching the Sensor Clip Ensure there is no kinking in the bloodlines 2 2 Set Up Procedures 2 3 Sensor Clip Attachment When properly attached the sensor clip will lock into place on the blood chamber It can be attached in either direction on the blood chamber Ensure that it is secure prior to proceeding NOTE The sensor clip must be attached before monitoring takes place i e before pressing START RUN Care must be taken to ensure that the sensor clip is properly in place before attempting monitoring in order to ensure accuracy of the initial hematocrit reading The CLM III s sensor clip is continuously scanning for blood In order for the sensor to determine a true starting hematocrit value which initiates the processing of data blood must be flowing throughout the dialyzer circuit and the blood pump must be running These conditions mus
41. mance Characteristics Section 7 Performance Characteristics The headings in this section are as follows Operational Considerations cesses eene 7 1 e Standard Specifications sess ene ene 7 2 7 1 Operational Considerations Each component of whole blood erythrocytes plasma etc absorbs light differently The CLM III trans illuminates the blood with multiple wavelengths of light allowing the various components to be identified and measured optically The level of oxygen saturation can also be measured by detecting the different absorption characteristics of hemoglobin in its oxygenated and deoxygenated forms However to determine the hematocrit value the absorption and scattering characteristics of the entire red blood cell must be considered as well as the absorption qualities of hemoglobin see Tech Note CRIT LINE Hematocrit Accuracy The CLM III s measurement of oxygen saturation compensates for different hematocrit levels and is thus a hematocrit independent oximeter Likewise the hematocrit determination feature is insensitive to both changes in oxygen saturation and changes in the serum protein 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 should be discontinued from use and returned for
42. me and Date remain in the memory NOTE The sensor clip should be removed from the blood chamber and secured on the verification filter at this time The MAIN MENU will now be displayed MAIN MENU edades Select Patient Run to begin SPOT CHECK F RECIRCULATION another monitoring session SELECT OPTION Sore i i ipe a sors OUTPUT OPTIONS See Section 4 Output Options CONTRRST FMC U8 19 2 SN 1922M116177 x12 0U NOTE If the CLM 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 and Calibration for specific information on the other menu choices provided on the MAIN MENU screen see Section 5 Advanced Features 4 3 Ending a Session 4 2 Output Options MAIN OUTPUT MEMORY E gt OUTPUT 2 The OUTPUT OPTIONS menu can be reached from either the MAIN MENU screen or the MEMORY FULL screen MAI N ME N U RUN ME MORY bOUTPUT OPTIONS SPOT CHECK MEMORY CLEAR RECIRCULATION F U L CALIBRATION SELECT OPTION SELECT OPTION by moving cursor OUTPUT OPTIONS by moving cursor CONTRAST Clearing Memory will FMC C3 U8 19 2 result in data 1055 5 1922 110177
43. ntering the Patient and Station 1 34 e Default Screen 3 5 e Screen Contrast 3 6 3 1 Clearing the Memory MEMORY 08080 The CLM III s memory is designed 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 NOTE Printing or downloading data will not clear the memory Once one or both of these options have been completed the data must be cleared by selecting MEMORY CLEAR on the MEMORY FULL screen MEMORY FULL will appear whenever e The CLM is turned on and there is data in memory e There is not enough memory to monitor a new five hour treatment e There is data in the memory prior to performing an accuracy verification test 3 1 Using the CRIT LINE The MEMORY FULL screen provides two options e output via printing or downloading data see Section 4 Output Options e Clearing the Memory To proceed beyond this screen the memory must be cleared by Position the cursor next to MEMORY CLEAR with the arrow key press S
44. of the CRIT LINE You will see the mark which is a circle with the letters ETL inside of it Next to this mark is the phrase ETL Listed Conforms to UL STD 60601 1 This means that the device was tested to the 60601 1 safety standard as established by UL Underwriters Laboratory and that is equivalent to other safety testing for Europe and Canada Also on the label are two boxes one inside the other This symbol demonstrates that the device is a Class II electrical equipment device The UL 60601 1 standard which we are compliant to defines Class II as equipment in which protection against electric shock does not rely on basic insulation only but in which additional safety precautions such as double insulation or reinforced insulation are provided there being no provision for protective earthing or reliance upon installation conditions This means that the device does not use the ground third prong of the AC cord to rely on grounding Some buildings do not have good ground systems in their building wiring and so it is hit or miss as to the quality of the ground connection of the device Again the CRIT LINE monitor will always read passing values because it is Class II device 8 3
45. of the monitor This provides protection from damage and keeps the sensor elements clean See section 8 for cleaning instructions Never remove the clip from the verification filter by pulling on the sensor cable The CRIT LINE System 1 10 Internal Memory MAX 26 HR EQUIVALENT The CLM III records data via an internal non volatile memory There is enough memory to store a total of 26 hours of dialysis sessions or data from 170 spot checking and or recirculation tests If there is data in the memory when the CLM III is first turned on this data must be erased before proceeding The option to print or download data prior to clearing memory is always available See Section 3 Clearing the Memory Prior to returning to the MAIN MENU screen from any monitoring activity the CLM III determines if there is enough room in the memory to store at least five additional hours of data If not it will prompt you to clear the memory See Section 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 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 HEADER 1 Example memory configuration The internal memory configures the data into a file as illustrated in the example on the left The head
46. pled with the on screen directions comprise all that is needed to operate the CLM III To enter main and optional menu screens press the MENU key To move the cursor use the UP ARROW or Warning Light DOWN ARROW keys To enter your selection press the SELECT key Battery Charging Indicator 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 has been exceeded The small green light at the bottom of the keypad indicates the CLM III is connected to its power supply adapter and that the battery is charging 1 4 1 5 Display Screens The CRIT LINE System The CLM III utilizes three primary display screens and several secondary screens that contain specific feature menus To use the CLM III simply follow the correct path to the function you desire To assist you each screen has a corresponding icon seen to the right of the actual screen in this section The path that you need to take to get to a specific function will be mapped at the beginning of each section detailing that function in this manual Below each sections title are the 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 Scr
47. ppear Enter up to four characters any combination of letters numbers and spaces to identify the current patient To enter the PATIENT ID Scroll to the PATIENT ID first STATION ID character DRTE RDJUST and press TIME RDJUST SELECT 3 8 Using the CRIT LINE Do the same for each character If you wish to enter a space scroll to that option instead of a letter Once you have entered the third letter or space pressing SELECT will take you back to the INITIAL DATA screen If you choose less than four characters pressing SAVE will take you back to the INITIAL DATA screen NOTE If the patient s ID is only one letter select the letter and then select SPACE twice If you inadvertently select the wrong first initial select DEL delete to erase the entry You can change the Patient ID Station ID or NAME any time during the dialysis session If you plan on storing more than one dialysis session recirculation test or spot check be sure to always enter the patient ID so the printout can be referenced back to the individual patient for which data has been 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 Stat
48. radio and sends this data to the printer software which then sends it to a printer Crit Line Printer Software Part CL10029504 This allows for the printout of treatment profiles at the end of each treatment No patient data is stored when using this software Crit Line Reporter Software Part CL10029500 This software is used to record individual blood volume profiles It is also capable of recording recirculation data electronic storage of treatment date as well as treatment profile printouts Data Download Serial Cable Part CL90000012 This custom made DB9 RJ 45 cable is used for serial data downloading and serial printing This cable is specially modified and cannot be store bought Blood Chamber Tubing Adapter Set Part CL10021039 Individually packaged and pre sterilized disposable blood chamber tubing adapter set for use with CRRT Single use only disposable packaged 36 per box For a complete listing of all products visit our website at www crit line com The CRIT LINE System 1 12 Symbols The CLM III label located on the base of each CLM III has several descriptive symbols which are used to identify the CLM 5 critical characteristics The following is an explanation for each of these internationally accepted symbols Class II Equipment Type BF Equipment Read Instructions For use within Before Use temperature limits Manufacture Identification Certification European CRIT LINE Monitor Label
49. rchaser accepts the products subject to all terms hereof Any product returned to Fresenius Medical Care for replacement becomes the property of Fresenius Medical Care 8 6 Preventative Maintenance The CRIT LINE Monitor does not require any preventative maintenance It is calibrated by the manufacturer and should require no further calibration However the instrument is equipped with a verification filter to access and insure accuracy The monitor will force you to perform the verify accuracy test every 30 days if the internal clock battery is active If the verify accuracy test has not been performed for 30 days the Calibration Menu will appear when the CRIT LINE is turned ON and a verify accuracy test must be performed see section 5 Calibration Procedures The last date when the verify accuracy test was performed will appear on every treatment printout 8 7 Electrical Safety Testing The CRIT LINE monitor does not require 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 hazards and mechanical hazards such as pinching moving parts and crushing Locate the grey label on the bottom
50. ring Press CRNCEL CANCEL REDO VENOUS gt 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 selected recirculation test results in memory and also to add the patient ID if not already done Tests that are saved will appear on a separate page when the printed Hitting save goes back to recirculation but that test is saved Hitting return goes to recirculation for the next test 5 5 Advanced Features 5 4 Spot checking MAIN INITIAL STARTUP SPOT 08080 08080 100090 100090 The CLM can also be utilized to quickly measure hematocrit and oxygen saturation values of multiple patients To perform spot check measurements perform the following steps PRTIENT MAIN MENU SPOT CHECK From the MAIN MENU RECIRCULRTION scroll to SPOT CHECK CRLIBRRTION Press Select SELECT OPTION bu moving cursor OUTPUT OPTIONS CONTRAST FMC 08 19 2 5 1922 110177 X12 0V The INITIAL DATA screen will appear so you can input the PATIENT and STATION ID ISTART RUN Scroll the cursor next to START RUN and press Se
51. servicing if a significant deviation from referenced standards is detected Percent Blood Volume Change The percent change in blood volume is strictly an inverse function of the recorded change in the measured hematocrit value This formula holds true if the number of red blood cells in whole blood is not significantly affected by dialysis and if the change in mean cell volume MCV is small Percent Blood Volume Change BVA Hettary Hetcurrent 11100 Percent change in blood volume is a calculation based on the hematocrit value recorded at the beginning of the session See Tech Note CRIT LINE Hematocrit Accuracy Corrections for Mean Cell Volume in Hematocrit Sampling The CLM III measures blood parameters in vivo As a result there is no need to remove a sample of blood from its natural environment i e the dialysis tubing circuit when measuring blood parameters Once blood is removed from the body changes in the hematocrit value are due mainly to the interaction of the erythrocyte and anti coagulants such as EDTA and sodium citrate 7 1 Performance Characteristics The handling of the blood outside the body provides many opportunities for error in measurement technique The effect of the anti coagulants is measured as a change in mean cell volume MCV Using MCV as a correction standard eliminates the need to estimate and individually correct for the effect of the concentration of EDTA or the sodium concentration of t
52. 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 block will blink and display asterisks instead of numbers The Hct Limit that is typically set for any given patient is one or two Hct units below the hematocrit at which that patient experiences morbidity i e nausea vomiting lightheadedness etc thereby providing a comfortable margin of safety for the patient run The Hct Limit can be set by pressing the up or down arrow keys The Hct Limit can never be set below the starting Hct or the current Hct level whichever is higher 5 1 ct Limit or or Profile Advanced Features Each press of C will raise the Hct limit one unit and im 41 T Sat 9 1 isa Hct limit ct Limit or for Profile To set the Hct Limit during a monitoring session press the MENU key to return back to the START UP screen The value can be entered as explained above using the arrow key s Upon returning to the BVA profile monitoring screen the Hct limit will be converted to appropriate units and displayed as a dashed horizontal line on the graph HCT 38 6 HGB 13 1 SAT 95 a TIME 02 10 In the BV profile mode the Hct Limit is converted into
53. t and then select SAVE to enter that digit Or you can select zero as the first digit and then select the digit that signifies the hour or minute NOTE Once you have initiated blood volume monitoring you cannot reset the date and time without cycling the power clearing the memory and accessing the INITIAL DATA screen But you can also change the date and time between patient runs 3 7 Using the CRIT LINE Ill 3 4 Entering the Patient ID Station ID and Name MAIN INITIAL 08080 09080 The CLM provides the additional option of entering a patient and station ID This information will appear at the top of printed graphs as well as any downloaded data This option will enable you to keep better track of patient records If this information is not entered during the 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 INITIAL DATA idc diia Scroll to PATIENT ID dd and press SELECT STATION ID i SELECT OPTION DRTE RDJUST by moving cursor TIME ADJUST PATIENT ID NAME STRTION ID 91 DRTE 1 0 TIME 18 40 15 The alpha numeric data entry window will a
54. t 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 clip is still on the verification filter will reflect the hematocrit and oxygen control values as the starting values The initial hematocrit value is the starting point from which all blood volume calculations are made Therefore it is essential that the first hematocrit value measured by the CLM III be indicative of the circulating blood To ensure an accurate initial Hct reading visually verify proper blood flow in the dialyzer circuit prior to pressing START RUN See Section 4 Ending the Run for information on when to remove the Sensor Clip 2 3 Using the CRIT LINE Section 3 Using the CRIT LINE Blood volume monitoring is the primary function of the CLM III This section explains how to get from the initial screen i e the screen that appears when the CLM III is turned to the blood volume profile oxygen saturation and hematocrit screens The headings in this section include the following Clearing the 3 1 Running a Patient oec ccrte e Setting the Date and 888 33 e E
55. te after measurement has begun and are displayed continuously thereafter throughout the dialysis treatment 1 1 The CRIT LINE System 1 2 Language Selection The CLM III offers menu screens in several languages English is the default language To select a language press the 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 LRNGURGE SELECTION MAIN MENU ESPANOL SPANISH DEUTSCH GERMAN FRANCAIS FRENCH SELECT OPTION by moving cursor ITALIANO ITALIAN JAPANESE RETURN IDC C3 8 88 12 10 1 2 The CRIT LINE System 1 3 The CLM at a Glance Verification Filter Display screen Fig 1 The CLM III Monitor Carrying Handle Power Switch DC Input Port Serial Data Port Parallel Data Port Sensor Clip Cable Fig 2 The Back Panel 1 3 The CRIT LINE System 1 4 The Keypad Operating the CLM III is done entirely through the keypad menu driven system The keypad is used to choose the CLM III s modes of operation These modes are listed on display screens which show other modes of operation and their associated menu choices The following instructions cou
56. th will be shown MAIN MENU SELECT OPTION by moving cursor FMC C3 U8 19 2 5 1922 110177 x12 0V RUN SPOT CHECK RECIRCULRTION CRLIBRRTION OUTPUT OPTIONS CONTRAST 1 7 SPOT RECIRC CAL OUTPUT 00090 08080 09080 CONTR 08000 08000 The CRIT LINE System 1 7 Power Supply Adapter The power supply adapter supplied with the CLM III must be used as the connector to the AC power source During normal monitoring the power supply adapter should be plugged into a grounded AC wall outlet and connected to the CLM III via the power supply socket on the back panel see Figure 2 European and Japanese Power Supplies are not earth grounded The CLM III has dual classification It is a class I device when operated on internal batteries and a class II device when connected to an AC outlet WARNING Fresenius 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 likely to get wet See warning message below WARNING TO PREVENT POWER SUPPLY FROM OVERHEATING OR FAILURE KEEP POWER SUPPLY D
57. th to RECIRCULATION directly from the MAIN MENU an INITIAL DATA screen will appear allowing you to enter necessary patient and station data You will then proceed through the STARTUP screen to RECIRCULATION The CLM displays a list of instructions on how to perform a recirculation test This list is abbreviated from the comprehensive instructions available in the Tech Notes Section on Crit Line Access Recirculation 5 4 Advanced Features The CLM III estimates recirculation by measuring the effect on hematocrit that a bolus of saline has when injected into the venous and arterial lines NOTE See the Tech Notes Section on Access Recirculation for additional information on this subject Follow the on screen directions and press the MENU key RECIRCULRTION PROCEDURE To Setup the Recirculation Mode Set UFR to minimum Prepare the Uenous Line Readu Bolus of Hormal Saline Press the Uenous keu Push the Bolus of Saline VENOUS gt To resume monitoring Press CANCEL CANCEL P At the conclusion of the test the recirculation percentage will be displayed on the screen CONF IGURE RECIRCULATION PROCEDURE To Continue with Recirculation ARTERIAL 1 Prepare the Arterial Line 2 Ready Bolus of Normal Saline 3 Press the Arterial key It is now possible to REPEAT the 4 Push the Bolus of Saline HM test or continue monitoring by selecting CANCEL To resume monito
58. that the instrument 1s ready for clinical use Select RETURN to go to the MAIN MENU PUERIFY ACCURACY CALIBRATION RETURN MENU SELECT OPTION by moving cursor VERIFICATION PASSED READY FOR CLINICAL USE SELECT RETURN FMC C3 U8 19 2 SN 1947H112915 If the CLM III 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 1 Verify that the sensor clip is properly attached to the VERIFICATION FILTER 2 Make sure that the filter is clean If testing continues to fail RETURN for SERVICE ATTACH NSOR TO VERIFICATION FILTER 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 verification filter ATTACH SENSOR TO VERIFYING ACCURACY VERIFICATION FILTER PLEASE WAIT 02 00 5 10 Advanced Features Select RE CALIBRATE During this 4 minute routine the monitor internally corrects deviations from calibration coefficients set at the factory The monitor may determine that the sensor is the cause of the malfunction Retry VERIFY ACCURACY after properly attaching the sensor clip to the verification filter If this message continues it is necessary to contact your service representative Upon successful completion of RE CALIBRATE
59. the Crit Line Do not immerse the Sensor Clip The Sensor Clip assembly is potted with silicon in an effort to seal the clip electronics from liquids If liquids infiltrate the Sensor Clip electronics they will corrode This corrosion will cause malfunction of the CLM III monitor and the unit will require factory repair If a failed clip has been sprayed and dried as outlined above for normal cleaning warranty repair of the unit will remain in force Monitors for repair with evidence of immersion of the sensor in solvents or liquid will not be covered under warranty 8 1 Instrument Maintenance 8 2 Cleaning the CLM III The CLM III outer casing should only be cleaned with a standard dilute bleach solution or with any of the several varieties of surface disinfectants i e Cavicide Envirocide etc These products should be sprayed onto a soft cloth and then the cloth should be used to clean the monitor Solutions such as Envirocide when mixed in proper ratios may also be used to clean the CLM III 8 3 Cleaning the Display Screen The display screen may be cleaned with a soft damp cloth The use of paper towels or abrasive materials during cleaning may scratch the display screen When possible avoid cleaners or any other liquids on the display 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 Servic
60. tor will again automatically 18 revert to the PROFILE screen in 10 seconds if no 2 other keypad input takes place HCT 38 1 BVa 5 7 HGB 12 6 SAT 94 UU TIME 01 54 Blood parameters are monitored continuously throughout the entire dialysis session In the lower portion of the PROFILE screen there are five information windows that indicate length of time the patient has been monitored TIME the current instantaneous Hct HCT instantaneous estimated HgB Hemoglobin percent change in blood volume BVA and the oxygen saturation SAT The displayed HgB value 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 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 Previously recorded values will continue to display until new stable values are measured and the reverse video clears The BV PROFILE screen is the default profile screen of CLM III The main function of the BV PROFILE screen is to show the continuous percentage change in a patient s circulating intravascular blood volume over the course of a dialysis session Using the hematocrit data the CLM III calculates and graphically displays the percent change in blood volume
61. ufficient number of red blood cells are present in the medium being viewed by the sensor e g monitoring the saline prime monitoring when air DETECTED bubbles are present in the blood chamber during a saline flush 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 WARNING When the Low Voltage message appears you have two minutes LOW VOLTAGE before the CLM will automatically shut itself OFF SHUTDOWN IN prevent this from happening immediately attach the CLM III to 02 00 power supply adapter that is plugged into a power outlet If the CLM III is running without its power supply adapter the internal battery powers the unit A fully charged battery will operate the CLM III for approximately two hours before it needs to be recharged see Section 1 Power Supply If the CLM III automatically shuts off after the two minute countdown it will not restart with the simple connection of the external power The power switch must be turned off for approximately 20 seconds before attempting to turn the unit on again This resets the internal electronic battery protection circuitry If the unit is turned on with insufficient power at this point the unit will auto shutdown in two seconds to protect the battery 6 2 Perfor

CRIT-LINE® III User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

CRIT-LINE&reg; III User Manual

Contents

Download Pdf Manuals

Related Search

Related Contents

CRIT-LINE® III User Manual