Related Manuals for Fresenius Medical Care CRIT-LINE III
Summary of Contents for Fresenius Medical Care CRIT-LINE III
- Page 1 CRIT-LINE ® 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/...
- Page 2 Fresenius Medical Care 4040 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.
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Page 3: Table Of Contents
Contents Contents Table of Contents ...............i & ii Your Guide to the User Manual .........iii Section 1 The CRIT-LINE III System Introduction ................1-1 Language Selection ..............1-2 The CLM III At A Glance ............1-3 Fig.1 The CLM III Fig.2 Back Panel... - Page 4 Contents Section 4 Ending a Session Ending the Dialysis Session ............4-1 Output Options ................4-4 Printing ................4-4 Data Downloading ............4-6 Selecting a Printer ............4-6 Section 5 Advanced Features Hematocrit Limit – (Hct Limit) ............ 5-1 Hysteresis .................. 5-3 Recirculation ................
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Page 5: Your Guide To The User Manual
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”... -
Page 6: Section 1 The Crit-Line Iii System
The CRIT-LINE III System Section 1 The CRIT-LINE III System The CRIT-LINE System includes the CRIT-LINE III Monitor (CLM III) 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: ... -
Page 7: Language Selection
The CRIT-LINE III 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 MENU 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. -
Page 8: The Clm Iii At A Glance
The CRIT-LINE III System ______________________________________ 1.3 The CLM III at a Glance 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... -
Page 9: The Keypad
The CRIT-LINE III 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. -
Page 10: Display Screens
The CRIT-LINE III System ____________________________ 1.5 Display Screens 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. -
Page 11: Secondary Display Screens
The CRIT-LINE III System The secondary display screens provide you with specific function menus and data entry points. Secondary Display Screens 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. -
Page 12: Advanced Feature Pathways
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. -
Page 13: Power Supply Adapter
The CRIT-LINE III 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). - Page 14 The CRIT-LINE III 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.
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Page 15: Disposable Blood Chamber
The CRIT-LINE III 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 III’s 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. -
Page 16: Sensor Clip
The CRIT-LINE III System _______________________ 1.9 Sensor Clip The CLM III’s sensor clip is comprised of an electronic light emitter/detector unit housed in a 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. -
Page 17: Internal Memory
The CRIT-LINE III System _______________________________ 1.10 Internal Memory 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. -
Page 18: Optional Accessories
The CRIT-LINE III System _________________________________ 1.11 Optional Accessories Optional accessories are available to maximize the CLM III’s convenience and performance capability. These accessories include: I.V. Pole Mount– Part # CL90000023 The I.V. pole mount securely positions the CLM III to the I.V. pole of the dialysis machine. -
Page 19: Symbols
The CRIT-LINE III 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 III’s critical characteristics. The following is an explanation for each of these internationally accepted symbols:... -
Page 20: Section 2 Set-Up Procedures
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: Pre-priming attachment of the blood chamber………………....2.1 Post-priming attachment of the blood chamber ………………………….2.2 ... -
Page 21: Post-Priming Attachment Of The Blood Chamber
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 Pre-prime the blood chamber using a 3ml syringe of sterile saline to remove air. -
Page 22: Sensor Clip Attachment
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. -
Page 23: Section 3 Using The Crit-Line Iii
Using the CRIT-LINE III Section 3 Using the CRIT-LINE III 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 on), to the blood volume profile, oxygen saturation and hematocrit screens. -
Page 24: Clearing The Memory
Using the CRIT-LINE III The MEMORY FULL screen provides two options: Data output via printing or downloading data (see Section 4–Output Options) 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 SELECT. -
Page 25: Running A Patient
Using the CRIT-LINE III ________________________________ Running a Patient INITIAL MEMORY MAIN SETUP PROFILE Once the memory has been cleared, the MAIN MENU screen will appear. By default, the cursor will be next to PATIENT RUN. Pressing Select will activate the Initial Data screen. - Page 26 Using the CRIT-LINE III 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.
- Page 27 Using the CRIT-LINE III Once a PROFILE SCREEN appears, it can be exited at any time by press either . Pressing either of these keys will cause the START UP screen to MENU SELECT appear. Anytime the START UP screen...
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Page 28: Setting The Date And Time
Using the CRIT-LINE III ___________________________________________ Setting the Date and Time MAIN INITIAL 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. -
Page 29: Setting The Time
Using the CRIT-LINE III The month data entry window will appear. To set the month: Scroll the cursor next to the current month. Press Select. To set the day, scroll the cursor next to DAY in the DATE MENU and press SELECT. -
Page 30: Entering The Patient Id, Station Id And Name
Using the CRIT-LINE III ________________________________________________ Entering the Patient ID, Station ID and Name MAIN INITIAL The CLM III 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. -
Page 31: Entering The Station Id
Using the CRIT-LINE III 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. - Page 32 Using the CRIT-LINE III 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.
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Page 33: Default Screen Selection
Using the CRIT-LINE III The SETUP MENU will be accessed and provide the option to enter the PATIENT and STATION ID and NAME. 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. - Page 34 Using the CRIT-LINE III 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.
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Page 35: Screen Contrast Adjustment
Using the CRIT-LINE III _______________________________________ Screen Contrast Adjustment MAIN CONTRAST To adjust the screen contrast, select the CONTRAST option from the MAIN MENU. Scroll the cursor next to CONTRAST, and press Select From the Contrast Adjust Screen use the UP and DOWN arrow buttons to lighten or darken the screen contrast. -
Page 36: Section 4 Ending A Session
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: ... - Page 37 Ending a Session This switches the display to the START-UP 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...
- Page 38 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, Time, 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.
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Page 39: Output Options
Ending a Session ___________________________ 4.2 Output Options OUTPUT MAIN MEMORY OUTPUT NOTE: See the Tech Notes 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... - Page 40 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).
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Page 41: Data Downloading
NOTE: See the Tech Notes Section on Printing Graphs and Data Retrieval for additional information on this subject 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. -
Page 42: Section 5 Advanced Features
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: ... - Page 43 Advanced Features Each press of will raise the Hct limit one unit, and each press will lower the Hct limit one unit. 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).
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Page 44: Hysteresis
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. - Page 45 You will then proceed through the STARTUP screen to RECIRCULATION. The CLM III 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 III Access Recirculation.
- Page 46 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.
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Page 47: Spot-Checking
Advanced Features _________________________ 5.4 Spot-checking STARTUP SPOT MAIN INITIAL The CLM III can also be utilized to quickly measure the hematocrit and oxygen saturation values of multiple patients. To perform spot check measurements, perform the following steps From the MAIN MENU scroll to SPOT CHECK. - Page 48 Advanced Features NOTE: A Hct Limit cannot be set during spot checking, nor will the monitor revert to a profile monitoring screen. Once a Hct and Sat value has been determined, another Hct and O Sat sample may be taken by attaching the CLM III sensor clip onto the next patient’s CRIT-LINE Blood Chamber.
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Page 49: Calibration Procedures
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). - Page 50 Advanced Features From the CALIBRATION 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.
- Page 51 Advanced Features The screen will read “VERIFICATION PASSED READY FOR CLINICAL USE SELECT RETURN” indicating that the instrument is ready for clinical use. Select RETURN to go to the MAIN MENU. 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.
- Page 52 Advanced Features Select RE-CALIBRATE. During this 4-minute routine, the monitor internally corrects deviations from calibration VERIFICATION FAILED coefficients set at the factory. SELECT RE-CALIBRATE The monitor may determine that the sensor is the cause of the malfunction. Retry VERIFY ACCURACY after properly SENSOR MALFUNCTION attaching the sensor clip to the verification filter.
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Page 53: Marking Clinical Interventions
Advanced Features _____________________________________________________________ 5.6 Marking Clinical Interventions and Events PROFILE 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. -
Page 54: Section 6 Warning Messages
Warning Messages Section 6 Warning Messages This 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. -
Page 55: Sensor Obstruction
Warning Messages _________________________________ 6.1 Sensor Obstruction ERROR SENSOR This message appears when the sensor is obstructed or the 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. -
Page 56: Section 7 Performance Characteristics
Performance Characteristics Section 7 Performance Characteristics The headings in this section are as follows: Operational Considerations……………………………………………….. 7.1 Standard Specifications…………………………………………………… 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. -
Page 57: Reference Standard For Hematocrit
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 the anti-coagulant solution. -
Page 58: Performance Characteristics
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. -
Page 59: Standard Specifications
Performance Characteristics 7.2 Standard Specifications INSTRUMENT RANGE INPUT Hematocrit (Hct): 10 Hct – 60 Hct 12 VDC/1 Ampere/12 watts Oxygen Saturation: 55% – 100% 1.2A max (Hct 18) POWER SUPPLY UNIT OPERATING AND STORAGE Universal regulated supply 100VAC – 240VAC TEMPERATURE 50º... -
Page 60: Section 8 Instrument Maintenance
Instrument Maintenance Section 8 Instrument Maintenance This section explains how to care for the CLM III. The headings in this section include the following: Cleaning the Sensor Clip……………………………………... 8.1 Cleaning the CLM III………………………………….... 8.2 Cleaning the Display Screen…………………………………. 8.3 ... -
Page 61: Cleaning The Clm Iii
__________________ 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. -
Page 62: Preventative Maintenance
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 purchaser accepts the products subject to all terms hereof.
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