Fresenius Medical Care CRIT-LINE III User manual

CRIT-LINE®III
User Manual
4040 Nelson Avenue, Concord, CA 94520 USA
Toll Free 1-800-546-5463 · 801-451-9000
Fax [phone]
http://fmcna-crit-line.com/

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
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.
This document is compatible with the CRIT-LINE®III monitor.
Document No. CL80020031 Rev H
Printed in the United States of America.

Contents
i
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

Contents
ii
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

Contents
iii
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.

The CRIT-LINE III System
1-1
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
_______________________
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.

The CRIT-LINE III System
1-2
_________________________________
1.2 Language Selection
The CLM III offers menu screens in several languages. English is the default
language. To select a language, press the and keys at the same
time. When the language screen appears, scroll to the desired language and press
Once the SELECT key has been pressed, the CLM III automatically returns to the
MAIN MENU. All subsequent menus from this point forward will be in the selected
language. The language can be changed at any time by following the process
described above.
MENU
SELECT

The CRIT-LINE III System
1-3
______________________________________
1.3 The CLM III at a Glance
Fig. 1 The CLM III Monitor
Serial Data Port
Power Switch
DC Input Port
Parallel Data Port
Carrying Handle
Sensor Clip Cable
Fig. 2 The Back Panel

The CRIT-LINE III System
1-4
_____________________
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.
To move the cursor, use the UP ARROW or
DOWN ARROW keys.
To enter your selection, press the SELECT key.
The individual keys may have specific functions when working in a particular mode.
These functions are clearly displayed on the display screen.
The warning light flashes red when a warning message appears or when the Hct
Limit 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.
MENU
SELECT
Battery Charging
Indicator
Warning Light

The CRIT-LINE III System
1-5
____________________________
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.
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.
STARTUP
PROFILE

The CRIT-LINE III System
1-6
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.
The MEMORY FULL screen appears
whenever the monitor is turned on and
there is data in the memory, or if there
is not enough space to save another
patient run.
The STARTUP/SPLIT screen menu
appears after pressing the MENU key
while viewing the STARTUP screen.
Its icon is the same as the STARTUP
screen without the menu displayed.
INITIAL
MEMORY
STARTUP

The CRIT-LINE III System
1-7
___________________________________________
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.

The CRIT-LINE III System
1-8
____________________________________
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.

The CRIT-LINE III System
1-9
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 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.
0 5 10 15 20 25 30
35
CHARGING TIME
REQUIRED (HRS)
OPERATING TIME (HRS)
CRIT-LINE III BATTERY CHARGING
CHARACTERISTICS
2.5
2.0
1.5
1.0
0.5
0

The CRIT-LINE III System
1-10
_______________________________________
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

The CRIT-LINE III System
1-11
_______________________
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. The sensor clip locks into place around the blood chamber.
Incorrect placement will most likely result in incorrect measurements. (See Section
2 for more information).
Whenever the CLM III is not being used, the sensor clip should be placed on the
verification filter on the side of the monitor. This provides protection from damage
and keeps the sensor elements clean. (See section 8 for cleaning instructions). Never
remove the clip from the verification filter by pulling on the sensor cable.
Sensor Clip

The CRIT-LINE III System
1-12
_______________________________
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.
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.
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.
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.
MAX.
26 HR.
EQUIVALENT
HEADER 1
HEADER 3
FOOTER 1
SPOT CHECK
DATA
FOOTER 2
HEADER 2
3 HR. PATIENT
RUN
1 HR. PATIENT
RUN
LAST DATA
LAST HEADER
FOOTER 3
LAST FOOTER
ETC.

The CRIT-LINE III System
1-13
_________________________________
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.
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.
For a complete listing of all products, visit our website at http://fmcna-crit-line.com/

The CRIT-LINE III System
1-14
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
Certification European Manufacture Identification
CRIT-LINE III Monitor Label

Set Up Procedures
2-1
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
_______________________________________________________________
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.