CRIT-LINE III User Manual Rev F Jan 2013

CRIT-LINE III ®

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-LINE® III is a trademark of Fresenius Medical Care North America. This document is compatible with the CRIT-LINE® III monitor. Document No. 43-0002 Rev F (Last Update January 2013) Printed in the United States of America.

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 The Keypad ... 1-4 Display Screens ... 1-5 Primary Display Screens ... 1-5 Secondary Display Screens ... 1-6 Advanced Feature Pathways ... 1-7 Power Supply Adapter ... 1-8 Disposable Blood Chamber ... 1-10 Sensor Clip ... 1-11 Internal Memory ... 1-12 Optional Accessories ... 1-13 Symbols ... 1-14

Section 2 Set-Up Procedures Pre-priming Attachment of the Blood Chamber ... 2-1 Post-priming Attachment of the Blood Chamber ... 2-2 Sensor Clip Attachment ... 2-3

Section 3 Using the CRIT-LINE III Clearing the Memory ... 3-1 Running a Patient. ... 3-3 Setting the Date and Time ... 3-6 Setting the Date. ... 3-6 Setting the Time ... 3-7 Entering the Patient ID, Station ID and Name ... 3-8 Entering the Patient ID ... 3-8 Entering the Station ID ... 3-9 Entering the Name ... 3-9 Entering the Patient/Station ID from Profile Screen ... 3-10 Default Screen Selection ... 3-11 Screen Contrast Adjustment ... 3-13

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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 ... 5-3 Spot-checking ... 5-6 Calibration Procedures ... 5-8 Verification Filter ... 5-8 Marking Clinical Interventions ... 5-12

Section 6 Warning Messages Sensor Obstruction ... 6-2 No Blood Detected ... 6-2 Low Voltage ... 6-2

Section 7 Performance Characteristics Operational Considerations ... 7-1 Percent Blood Volume Change... 7-1 Corrections for Mean Cell Volume in Hct Sampling ... 7-1 Reference Standard for Hematocrit ... 7-2 Reference Standard for Oxygen Saturation ... 7-2 Hemoglobin Estimation ... 7-2 General Precautions ... 7-2 Standard Specifications ... 7-4

Section 8 Instrument Maintenance Cleaning the Sensor Clip ... 8-1 Cleaning the CLM III ... 8-2 Cleaning the Display Screen ... 8-2 Service ... 8-2 Warranty ... 8-2 Preventative Maintenance ... 8-3 Electrical Safety Testing ... 8-3

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Contents

Your Guide to the User Manual This user manual has been designed to assist you in operating the CRITLINE 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.

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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:            

Introduction……………………………………………………………... 1.1 Language Selection……………………………………………………... 1.2 CLM III at a Glance…………... 1.3 The Keypad……………………….…………………………………….. 1.4 Display Screens…………………... 1.5 Advanced Feature Pathways……………………………………………. 1.6 Power Supply Adapter………………………………………………….. 1.7 Disposable Blood Chamber…………………………………………….. 1.8 Sensor Clip…………………... 1.9 Internal Memory……………... 1.10 Optional Accessories……………... ……………………………………. 1.11 Symbols…………………………... 1.12

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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 minute after measurement has begun and are displayed continuously thereafter throughout the dialysis treatment.

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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

MENU

and

keys at the same

time. When the language screen appears, scroll to the desired language and press

SELECT

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.

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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

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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. The following instructions, coupled 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.

MENU

To move the cursor, use the UP ARROW or DOWN ARROW keys.

To enter your selection, press the SELECT key.

Warning Light

SELECT

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.

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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. 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 Screens The MAIN MENU screen allows you to choose the operating mode of the CLM III. NOTE: New Monitors sold after January 2006 may not display the H ABF option on the Main Menu NOTE: New Monitors sold after August 2011 may not display the TQA option on the Main Menu

The STARTUP screen is the central display for most CLM III functions. All measurements, warnings, or messages can be viewed from this screen.

STARTUP

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.

PROFILE

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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.

INITIAL

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

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

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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 path” will be shown. SPOT

RECIRC.

CAL

OUTPUT

CONTR.

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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). (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 DRY 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.

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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. Contact the spare parts department to order a replacement font panel (bezel assembly & 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 state may be corrected by connecting the CLM III to a power supply; otherwise, the CLM III will turn off after a twominute 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.

CRIT-LINE III BATTERY CHARGING CHARACTERISTICS

2.5 2.0 1.5 (HRS)

OPERATING TIME

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.

1.0 0.5 0

0 35

5 10 15 CHARGING TIME REQUIRED (HRS)

20

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25

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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. (See Section 2 for more information). WARNING: DO NOT USE THE BLOOD CHAMBER IF ITS PACKAGE HAS BEEN OPENED, EXPIRED, OR 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

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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 CRITLINE 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 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.

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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 spotchecking 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. All files are deleted when clearing the memory. WARNING: ONCE ERASED, DATA CANNOT BE RECOVERED. BE SURE THAT PRINTING/DOWNLOADING ACTIVITIES ARE SUCCESSFUL PRIOR TO CLEARING THE MEMORY.

HEADER 1 3 HR. PATIENT RUN FOOTER 1

Example memory configuration: The internal memory configures the data into a file as illustrated in the example on the left. The header contains the date and time, while the footer contains the patient and station ID information.

HEADER 2

MAX. 26 HR. EQUIVALENT

1 HR. PATIENT RUN FOOTER 2 HEADER 3 SPOT CHECK DATA

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.

FOOTER 3 LAST HEADER LAST DATA LAST FOOTER ETC.

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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. 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 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

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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:

Class II Equipment

Type BF Equipment

!

For use within temperature limits

Read Instructions Before Use

Manufacture Identification Certification European

CRIT-LINE III Monitor Label

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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 Sensor clip attachment ………………………………………...2.3

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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 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.

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