Fresenius Crit-Line IV Sistema di terapia a calore --REF TP472 Manual del operador

Crit-Line IV User’s Guide

P/N CL80050002 Rev D Crit Line IV User’s Guide

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Crit Line IV User’s Guide P/N CL80050002 Rev D ii

Crit Line IV User’s Guide

© Copyright 2016, 2017, Fresenius USA, Inc.—All Rights Reserved

This document contains proprietary information of Fresenius Medical Care Renal
Therapies Group, LLC and its affiliates (“Fresenius Medical Care”). The contents of this
document may not be disclosed to third parties, copied, or duplicated in any form, in
whole or in part, without the prior written permission of Fresenius Medical Care.

Fresenius Medical Care, the triangle logo, Crit-Line IV and CLiC are trademarks of
Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. All other
trademarks are the property of their respective owners.

Caution: US Federal law restricts this device to sale only by or on the order of a
physician.

Indications for Use: The Crit- Line IV System is used to non-invasively measure
hematocrit, oxygen saturation and percent change in blood volume. The Crit-Line Clip
(CLiC) measures hematocrit, percent change in blood volume and oxygen saturation in
real time for application in the treatment of dialysis patients with the intended purpose of
providing a more effective treatment for both the dialysis patient and the dialysis
technician. Based on the data that the monitor provides, the clinician/nurse, under
physician direction, intervenes (i.e. increases or decreases the rate at which fluid is
removed from the blood) in order to remove the maximum amount of fluid from the
dialysis patient without the patient experiencing the common symptoms of dialysis which
include nausea, cramping and vomiting.

The Crit-Line IV is a Clinical Laboratory Improvement Amendment (CLIA) exempt
instrumentation device.

US Patent Nos. 8,287,739, 8,130,369 and pending, comparable and/or related patents.

iii P/N CL80050002 Rev D Crit Line IV User’s Guide

Table of Contents

Operating Instructions ..................................................................................1

Conventions .................................................................................................1

Compliance ..................................................................................................2

General Warnings ........................................................................................3

Crit-Line IV System Overview ......................................................................5

Crit-Line IV System .................................................................................7

CLiC Verification Filter .............................................................................8

Power Supply Adapter .............................................................................9

Initial setup of the Crit-Line IV monitor ...................................................... 10

Setup Menu Screen ................................................................................... 14

Selecting the Printer Port ..................................................................... 16

Setting the date .................................................................................... 17

Setting the Station ID ........................................................................... 18

Selecting the Output Port ..................................................................... 19

Setting the time .................................................................................... 20

Selecting the displayed language ........................................................ 21

Changing the volume level ................................................................... 22

Auto vs Standard Run Mode ................................................................ 22

System Information Screen ....................................................................... 24

CLiC Device Verification ............................................................................ 26

Verifying accuracy on the CLiC ............................................................ 26

Field calibration on the CLiC ................................................................ 29

Connecting the Crit-Line Blood Chamber ................................................. 32

Connecting the CLiC Device to the Crit-Line Blood Chamber .................. 36

Using the Crit-Line IV monitor ................................................................... 38

Main Menu screen ................................................................................ 39

Patient Run Menu Screen ......................................................................... 40

Manually entering a Patient ID ............................................................. 42

Selecting Patient ID from a list ............................................................. 43

Patient Treatment Monitoring Screen ....................................................... 44

Reading Graphs on the Patient Treatment Monitoring Screen ................. 45

The BV (Blood Volume) graph ............................................................. 48

The Sat (Oxygen Saturation) graph ..................................................... 48

The Hct (Hematocrit) graph .................................................................. 48

Menu Buttons ....................................................................................... 49

Crit Line IV User’s Guide P/N CL80050002 Rev D iv

Setting an Event Marker ....................................................................... 50

Setting the Blood Level (BV) Alert Level .............................................. 51

Setting the O2 Alert Level ..................................................................... 52

Ending a Patient Treatment Monitoring Session .................................. 53

Patient Run Option Menu Screen .............................................................. 54

History Menu Screen ................................................................................. 56

Selecting a treatment from the list ........................................................ 58

DEMO Mode .............................................................................................. 59

Built-in session selection ...................................................................... 59

Built-in session profiles ......................................................................... 60

Replacing the CLiC device ........................................................................ 64

Crit-Line IV Monitor Care ........................................................................... 68

Cleaning and Disinfecting the Crit-Line IV monitor .............................. 68

CLiC Device Disposal ........................................................................... 68

Troubleshooting, Alerts & Messages ......................................................... 69

Appendix ................................................................................................... 74

Product Improvement Policy ................................................................ 74

Warranty ............................................................................................... 74

Crit-Line IV Monitor Spare Parts .......................................................... 75

Additional Information ........................................................................... 75

Crit-Line IV Monitor Specifications ....................................................... 76

EMC Compliance ................................................................................. 77

ZigBee Radio ........................................................................................ 77

Glossary .................................................................................................... 78

Index .......................................................................................................... 79

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Crit Line IV User’s Guide P/N CL80050002 Rev D vi

Operating Instructions

These instructions are for the operation of the Crit-Line IV monitor. The
Crit-Line IV must only be operated by a trained operator according to these
instructions.

Conventions

Symbol Description

Warning! A warning is a statement that identifies conditions or

actions that could result in harm to the patient or operator. Warnings
found in this manual outside of this section are designated with the
warning symbol.

Caution: A caution is a statement that identifies conditions or
actions that could result in damage to the machine or injury to the
operator.

Note: Notes are advisory comments or recommendations regarding
practices or procedures associated with the use of the Crit-Line IV
device.

Follow Instructions for Use.

Button

Manufacturer.

Operating temperature (example).

Radio Transmitter.

A button refers to specific locations on the display screen that may
be selected by the user to make changes to these display settings or
parameters.

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Compliance

Symbol Description

CLIA

EXEMPT

MR

258841

E362958

Clinical Laboratory Improvement Amendments Exempt. The use of
the verification filter exempts the device from requiring periodic
factory calibration.

Type BF equipment for protection against electric shock.

Magnetic Resonance unsafe.

CLiC Device:
[CAN/CSA-C22.2 No. 60601-1:08]
[ANSI/AAMI ES60601-1:2005]
Certified By CSA for use in Canada and the U.S.

Crit-Line IV Monitor is UL listed:

MEDICAL-GENERAL MEDICAL EQUIPMENT
AS TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH
CAN/CSA-22/2 No. 60601-1 (2008)
ANSI/AAMI ES60601-1 (2005)

Crit Line IV User’s Guide P/N CL80050002 Rev D 2

General Warnings

Warning: Read manual before use.

Warning: The Crit-Line IV monitor and Crit-Line in a Clip

(CLiC) device described herein do not contain parts which can

be serviced. No modification of this equipment is allowed.
Caution: The Crit-Line in a Clip (CLiC) device used by the Crit

Line IV is a sensitive electro-optical device. Use special care

when handling, storing, or cleaning the device. See the Crit-

Line IV Monitor Care section (page 68)
Caution: Use only a stylus or fingertip to operate the touch

screen of the Crit-Line IV monitor.
Caution: The Crit-Line IV Monitor is not intended to be

connected to a public or hospital network.
Caution: Air bubbles trapped in the Crit-Line Blood Chamber or

in the blood sample drawn for comparison of Hct and O

2

Saturation will cause poor correlation between the Crit-Line IV

measurement and the reference standard.
Caution: The CLiC device calibration was verified using blood

samples with serum sodium levels of 137 mEq/L. Changes in
[Na+] affect the micro centrifuge-derived hematocrit values as
follows: 1 unit decrease in “spun” hematocrit per 12 mEq/L
increases in [Na+].

Abnormal sodium concentration may occur due to:

 Use of blood bank blood with sodium citrate (165

mEq/L)

 Use of normal saline (0.9% NaCl) as diluent (154

mEq/L)

Over hydration (<137 mEq/L)

 Caution: Hemolysis may affect hematocrit determination

by reporting higher Hct values, although no changes in
Crit-Line IV monitor measurements have been noted for

plasma hemoglobin levels below 5gm%.

Caution: The Crit-Line IV monitor 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.
Caution: 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

3 P/N CL80050002 Rev D Crit Line IV User’s Guide

by the instrument. Nonetheless, the Crit-Line IV monitor 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,
while a patient’s plasma refilling rate may vary depending on
diet, state of health, medications, temperature, and posture, the
Crit-Line IV monitor does not measure the rate of refilling. The
Crit-Line IV monitor measures the change in total intravascular

blood volume.
Note: The Crit-Line IV monitor is only a tool used to

compliment a hemodialysis treatment. Operators must rely on
their own clinical assessment of the patient to administer the

treatment, as per the standard of care.

Note: If the Crit-Line IV monitor displays the message “Verify

Accuracy” the CLiC device must be verified for accuracy before

using it to monitor the treatment. To verify the CLiC device
automatically, clip the device on its verification filter, which is
attached to its cable.

Note: Hemoglobin oxygen saturation (O2 Sat) values have a

wide range depending on the type of vascular access and other
factors. An O2 Sat value from a Central Venous Catheter will
typically be lower than a value from an arteriovenous fistula or
graft.

Crit Line IV User’s Guide P/N CL80050002 Rev D 4

Crit-Line IV System Overview

CLiC
Verification
Filter

ZigBee
Radio
(Optional)

Crit-Line IV monitor — System View

Crit-Line IV
Monitor

Crit-Line
Blood
Chamber

CLiC
Device

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CLiC USB
Connector

Power Switch

ZigBee Radio
USB Connector

Crit-Line IV monitor — Bottom View

Serial COM1

Power Supply
Adapter power
connection

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Crit-Line IV System

The Crit-Line IV monitor is used to non-invasively measure a
hemodialysis patient’s hematocrit, oxygen saturation and calculate percent
change in blood volume. These measurements occur in real time in order to
provide a more effective treatment. Under the direction of a physician, the
clinician/nurse can increase or decrease the ultrafiltration (UF) rate in order
to remove the maximum amount of fluid without the patient experiencing
the common dialysis related complications which include hypotension,
nausea, cramping and vomiting.

Essential Performance

The essential performance for the Crit-Line IV system is to measure within
the specified accuracy, Hematocrit (Hct) and Oxygen Saturation (02 Sat).

Crit-Line IV Monitor

The Crit-Line IV monitor is a touch screen display device. The monitor
mounts to the IV pole of the hemodialysis machine by means of the pole
mount. The monitor is operated by touching buttons on the display.
Menus are navigated by pressing buttons which allows the operator to do
the following:

 Display the hematocrit, oxygen saturation and percent change in

blood volume measurements in real time during a dialysis
treatment.

 Review and print previous treatment data.
 Perform setup activities to control basic features of the Crit-Line IV

monitor.

CLiC Device

The CLiC device connects via a cable with a USB connector to the port on
the bottom left of the Crit-Line IV monitor.

The CLiC device is a sensor that when placed on the Crit-Line Blood
Chamber, located between the arterial bloodline and the blood inlet port of
the hemodialyzer, monitors the patient’s hematocrit, oxygen saturation and
percent change in blood volume. The CLiC device clips onto the Crit-Line
Blood Chamber and shines light through the lens of the Crit-Line Blood
Chamber onto a sensor on the opposite side of the blood chamber. This
sensor detects the level of absorption and scattering of the light as it is
transmitted through the patient’s blood as it flows through the blood
chamber.

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CLiC Verification Filter

Each CLiC device is paired with a verification filter that is unique to that
device. The CLiC Verification Filter is attached to the CLiC device’s USB
cable. The verification filter is used to periodically verify the accuracy of
the CLiC device. The CLiC device should be securely clipped to the
verification filter when it is not in use.

Note: When the CLiC device is stored on its verification filter,

the Crit-Line IV monitor will automatically verify the accuracy
of the CLiC device on a daily basis.

Note: If the CLiC device is not stored on the CLiC Verification

Filter, the device must be verified at least once per month. If it
has been more than 30 calendar days since the CLiC was last
verified, the Crit-Line IV monitor will display an alert message

informing the user that the CLiC needs to be verified.

Disposable Crit-Line Blood Chamber

The Crit-Line Blood Chamber is a sterile, disposable piece designed to
ensure a consistent viewing area for the CLiC device sensor. This provides
accurate, repeatable Hematocrit and oxygen saturation measurements.

ZigBee Radio (Optional)

The ZigBee Radio is used for printing data at the end of a patient
treatment. The ZigBee Radio connects via a USB port on the bottom of
the Crit-Line IV monitor and wirelessly sends data to another ZigBee
Radio which is connected to a computer in the treatment area. This
computer must have a copy of the Crit-Line Printer Software (Version 1.5
or later) loaded and running. The Crit-Line Printer Software receives the
data and generates a report that is automatically sent to the default printer
listed on the computer.

Note: Multiple Crit-Line IV monitors with ZigBee Radios can be

used in one facility at the same time to print data wirelessly to a
single computer in the treatment area.

Note: The Crit-Line IV monitor does not require the ZigBee
Radio to be installed for monitoring a patient treatment.

Note: ZigBee is a specification for a suite of high-level

communication protocols used to create personal area networks
built from small, low-power digital radios. ZigBee is based on an

IEEE 802.15 standard.

Crit Line IV User’s Guide P/N CL80050002 Rev D 8

Power Supply Adapter

The Power Supply Adapter [P/N CL44300012] provides power to the Crit­Line IV monitor. It is plugged into the power supply connection on the
bottom right side of the Crit-Line IV monitor and connects to a hospital
grade power cord [P/N CL90000035] which is plugged into a grounded
alternating current (AC) wall outlet.

Warning: Use only approved Power Supply Adapter provided

by Fresenius Medical Care.

Warning: Keep the power supply adapter dry to prevent

overheating or failure. Additionally, observe the following:

 Do not place the Power Supply Adapter in or near an area

that is or has the potential to become wet.

 Do not use the Power Supply Adapter if it shows signs of

corrosive buildup on any of the electrical connections.

 Do not use the Power Supply Adapter if it shows signs of

damage such as frayed cords.

 Protect the Power Supply Adapter from being dropped.

Note: The Crit-Line IV monitor does not have any backup power

capabilities.

Note: If the Power Supply Adapter becomes disconnected from

the Crit-Line IV monitor during a patient treatment, immediately
reconnect the Power Supply Adapter. The Crit-Line IV monitor
will give the option to continue monitoring the existing
treatment.

Note: In the event of a power loss no data from an active patient

treatment monitoring session is lost. If the power is restored
within 15 minutes the Crit-Line IV monitor will give the option
to continue monitoring the existing treatment.

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Initial setup of the Crit-Line IV
monitor

Follow these basic steps to install the Crit-Line IV monitor in a clinical

1 Attach Crit-Line IV monitor to IV pole

setting.

Note: Ensure that the following items are included in the

package. If all items are not present, contact Customer Service
[phone].

 Crit-Line IV monitor with attached pole mount
 CLiC device with verification filter attached to USB

cable

 ZigBee radio (Optional)
 Power Supply Adapter
 Power Cord

1. Remove the Crit-Line IV monitor from packaging.

2. Open the pole mount clamp by turning the knob counterclockwise

(CCW) as shown.

3. Position the pole mount clamp around the IV pole and turn the knob

clockwise (CW) to tighten as shown.

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2 Connect CLiC device to Crit-Line IV monitor

1. Remove the CLiC device from packaging.

2. Gently push the USB connector on the CLiC cable into one of the USB

sockets on the bottom of the monitor as shown below.

3. Attach the verification filter to the IV pole by grasping the verification

filter near the base of the verification filter clip, and gently pushing it
onto the IV pole. The verification filter clip will snap into place around
the IV pole as shown.

USB
Socket

CLiC USB
Connector

3 Connect ZigBee radio to Crit-Line IV monitor (Optional)

1. Remove ZigBee radio from packaging.

2. Insert the ZigBee radio into the Crit-Line IV monitor by gently pushing

the USB connector on the ZigBee radio into one of the USB sockets on
the bottom of the monitor as shown.

USB
Socket

ZigBee
Radio

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4 Connect Power Supply Adapter to Crit-Line IV monitor

1. Remove Power Supply Adapter and Power Cable from packaging.

2. Insert the Power Supply Adapter into the pole mount clamp with the

attached cable facing upward as shown.

Attached
Cable

Power Supply
Adapter

3. Insert the Power Cord into the Power Supply Adapter.

4. Insert the power supply plug into the Power Supply Adapter power

connector on the bottom of the Crit-Line IV monitor as shown.

Power
Connector

Power Supply
plug

5. Plug the Power Cord into a grounded alternating current (AC) wall

outlet.

Crit Line IV User’s Guide P/N CL80050002 Rev D 12

6. Flip the power switch to the ON position.

Power
Switch

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Setup Menu Screen

The Setup Menu screen of the Crit-Line IV monitor

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Setup Menu screen

The Setup menu is used to modify the system configuration of the Crit­Line IV monitor. This menu is shown on the facing page.

Listed below are the features available on this menu.

Feature Description

Printer Port button – Selects the output port for printing patient

treatment data.

Date button – Allows for changing the Crit-Line IV monitor date.

Station ID button – Allows for the assignment of a Station ID to

the Crit-Line IV monitor.

Output Port button – Selects the output port for downloading
patient treatment data.

Time button – Allows for changing the Crit-Line IV monitor time.

Language button – Allows for the selection of the display

language for the Crit-Line IV monitor.

Volume button – Allows for changing the volume level of the
audio alerts.

Auto Run button – Enables or disables the ability for the Crit­Line IV to automatically start/end a patient treatment monitoring
session.

When enabled, the Crit-Line IV monitor will initiate a patient
treatment when a transition from the verification filter to blood is
detected by the CLiC. The patient treatment monitoring is
automatically terminated when a transition from blood to the
verification filter is detected.

Return button – Returns to the Main Menu.

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Selecting the Printer Port

Selecting the Printer Port button allows the user to select what output port

to use for printing the patient treatment data. Follow these basic steps to
select the printer port.

1 Press the Printer Port button

Once the Printer Port button is pressed, the printer port selection menu

will appear.

2 Make selection

Press one of the three buttons to select the printer port:

 DB9 button – Selects com port 1 (COM1) as the printer port.
 ZigBee button – Selects the ZigBee radio as the printer port.
 Cancel button – Returns to the Setup Menu screen without

changing the printer port.

DB9
Button

ZigBee
Button

Note: The current selection is shown with orange asterisks

the button.

Note: The ZigBee radio will be selected as the printer port in

*

on

most cases.

Crit Line IV User’s Guide P/N CL80050002 Rev D 16

Setting the date

Selecting the Date button allows the date to be changed. Follow these

basic steps to set the date.

1 Press the Date button

Once the Date button is pressed, the date selection menu will appear.

2 Make selection

Follow these basic steps to select a new date for the Crit-Line IV monitor.

1. Press the Month, Day or Year display field to select the item to

change.

2. Press the yellow up

or down button until the desired value is

displayed.

3 Return

Press the Ok button to save the new date selected. Press the Cancel button

to return to the Setup Menu without changing the date.

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Setting the Station ID

Selecting the Station ID button allows the user to enter an identification

number for the Crit-Line IV monitor. A two (2) character alpha-numeric
ID can be entered. Follow these basic steps to enter a Station ID.

1 Press the Station ID button

Once the Station ID button is pressed, the Enter Station ID screen will

appear.

2 Enter the Station ID

Enter the Station ID using the onscreen keypad. As characters are entered
they will display in the top window.

3 Return

Once the Station ID has been entered, press the Save button to keep the
Station ID or the Cancel button to discard the Station ID.

Crit Line IV User’s Guide P/N CL80050002 Rev D 18

Selecting the Output Port

Selecting the Output Port button allows the user to select what output port

to use for downloading patient treatment data. Follow these basic steps to
select the output port.

1 Press the Output Port button

Once the Output Port button is pressed, the output port selection menu

will appear.

2 Make selection

Press one of the three buttons to select the output port:

 DB9 button – Selects com port 1 (COM1) as the output port.
 ZigBee button – Selects the ZigBee radio as the output port.
 Cancel button – Returns to the Setup Menu screen without

changing the output port.

DB9
Button

ZigBee
Button

Note: The current selection is shown with orange asterisks

the button.

Note: COM1 will be selected as the output port in most cases.

on

*

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Setting the time

Selecting the Time button allows the time to be changed. Follow these

basic steps to change the time.

1 Press the Time button

Once the Time button is pressed, the time selection menu will appear.

2 Make selection

Follow these basic steps to select a new time for the Crit-Line IV monitor.

1. Press the Hour, Minute or Second display field to select the item

to change.

2. Press the yellow up

or down button until the desired value is

displayed.

3 Return

Press the Ok button to save the new time selected. Press the Cancel

button to return to the Setup Menu without changing the time.

Crit Line IV User’s Guide P/N CL80050002 Rev D 20

Selecting the displayed language

Selecting the Language button allows the user to select what language the

Crit-Line IV monitor will display. Follow these basic steps to select the
displayed language.

1 Press the Language button

Once the Language button is pressed, the language selection menu will

appear.

2 Make selection

Press the button of the desired language. The current selection is displayed
at the top of the language selection menu.

3 Return

Press the Ok button to save the new language selection. Press the Cancel

button to return to the Setup Menu without changing the language.

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Changing the volume level

Selecting the Volume button allows the user to change the volume level of

the audible alerts. Follow these basic steps to change the volume.

1 Press the Volume button

Once the Volume button is pressed, the volume selector will appear.

2 Change volume

Press the yellow up or down button to increase or decrease the volume
and play an audio tone at the current volume. The current volume level is
also displayed as a blue bar graph to the left of the yellow buttons.

3 Return

Press the Ok button to save the new volume selection. Press the Cancel

button to return to the Setup Menu without changing the volume.

Auto vs Standard Run Mode

For the Crit-Line IV to indicate an accurate change in blood volume during
a Patient Run, it is necessary for the patient’s first measured Hematocrit to
be accurate and stable. Residual saline from pretreatment priming of the
bloodline will cause the initial Hematocrit reading to be low or unstable as
it mixes with the patient’s blood at start of treatment.

Note: In Standard Run Mode (Auto Run disabled) the clinician is

required to wait at least five (5) minutes after patient blood is
introduced into the dialysis circuit before beginning a Crit-Line
Patient Run. This wait ensures any saline residuals are fully mixed
into the blood and the measured Hematocrit is accurate and stable.

In Standard Mode (Auto Run disabled) actions associated with starting

and terminating a patient treatment monitoring session requires user input

through touch screen selections of [Start Run] or [End Run].

Crit Line IV User’s Guide P/N CL80050002 Rev D 22

To automate the process of starting and ending a treatment session the Crit­Line IV features an Auto Run Mode. When Auto Run is enabled, a Patient
Run will start automatically after the following sequence of events occurs:

1. The CLiC is first connected to the Verification Filter

2. The CLiC is next connected to a blood bearing CLiC blood

chamber

3. The Crit-Line IV senses that a stable Hematocrit level has been

achieved i.e. saline prime is fully mixed into the patient’s blood
as indicated by a sufficient period of either flat or slightly
negative slope to the monitored Hematocrit

When Auto Run is enabled, an active Patient Run treatment monitoring

session will automatically end - without having to select the [End Run]

button - when the CLiC is removed from the CLiC blood chamber and
placed on the verification filter.

Note: Neither Standard Mode nor Auto Run Mode will

automatically generate a Patient ID. Patient IDs must be entered
by the user.

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System Information Screen

The System Information screen of the Crit-Line IV monitor

Crit Line IV User’s Guide P/N CL80050002 Rev D 24

Crit-Line IV monitor system information screen.

Pressing the About button from the Main Menu screen displays the system

information screen. This screen shows basic monitor settings as well as
the status of the attached CLiC device. This screen is shown on the facing
page.

Listed below are the features available on this screen.

Feature Description

Time

Unit ID Displays the Crit-Line IV monitor serial number and software

Station ID Displays the Crit-Line IV monitor station identification number.

CLiC ID Displays the serial number, software version and software

Displays the current date and time. The date is in
MM/DD/YYYY format. The time is in HH:MM:SS format.

version.

date of the attached CLiC device.

Filter ID

CLiC Status

Last Verified

Printer Port

Data Port

Technical
Service #

Customer
Service #

Displays the verification filter identification value. This value
must match the value located on the verification filter.

Displays the operational status of the attached CLiC device.
There are three (3) possible messages:

 OK – The CLiC device is operating normally.

 Fail – The CLiC device has either failed a verification

of accuracy or is nonfunctional and cannot be used for
patient treatment monitoring.

 Not Responding – The CLiC device is not

communicating with the Crit-Line IV monitor. Check
the USB connection of the CLiC to the Crit-Line IV
monitor.

Displays the date of the last successful CLiC verify accuracy.
This is also displayed on the Main Menu screen under the
Verify Accuracy button.

Displays the printer port selection.

Displays the download data port selection

Displays the technical service telephone number.

Displays the customer service telephone number

Return button – Returns to the Main Menu.

25 P/N CL80050002 Rev D Crit Line IV User’s Guide

CLiC Device Verification

Verifying accuracy on the CLiC

Selecting the Verify Accuracy button from the Main Menu screen allows

the user to perform a manual verification of accuracy on the CLiC.

Note: In most cases, it is not necessary to perform a manual

verification. If the sensor clip is placed onto the verification
filter, the Crit-Line IV monitor will automatically perform a
verification test once per day and the date of the most recent

successful verification will be displayed below the Verify
Accuracy button.

Follow these basic steps to manually verify accuracy.

1 Place CLiC on Verification Filter

2 Press the Verify Accuracy button

Once the Verify Accuracy button is pressed, the following screen will

appear. This screen will remain for approximately ten (10) seconds.

Note: The user cannot access the Patient Run Menu screen until
a successful verification has taken place.

Note:

given to perform a field calibration.

1. Hold the CLiC device such that one side is held by the index finger

and other side held by the thumb. Squeeze the clip to spread the
sensor elements apart.

2. Place the CLiC device over the verification filter such that the

sensor elements cover the middle portion of the verification filter.

3. Release the clip to allow the sensor elements to seat on the

verification filter.

4. Make certain that the CLiC device has locked securely into place on

the verification filter by noting the audible and tactile click.

If the verification fails two or more times, the option is

Crit Line IV User’s Guide P/N CL80050002 Rev D 26

3 Verify passed

If successful, the following screen will appear. Press the Ok button to

return to the Main Menu screen. At this point the verification is complete
and no further action is required.

4 Verify failed

If the verification failed, the following screen will appear.

Follow these basic steps to address a failed verification of accuracy.

1. Ensure that the CLiC is properly seated on the verification filter.

Refer to step

1 Place CLiC on Verification Filter on the

previous page for detailed instructions on proper placement of
CLiC on the verification filter.

2. Ensure that the verification filter is clean of any foreign material

and that the surface is not scratched or damaged.

27 P/N CL80050002 Rev D Crit Line IV User’s Guide

3. Press the Verify button to repeat the verification of accuracy. If
successful, the following screen will appear. Press the Ok button to

return to the Main Menu screen. At this point the verification is
complete and no further action is required.

4. If the verification fails again, the following screen will appear.

At this point the user may do one of the following:

 Repeat the verification. Refer to step

steps 1 through 3 on the previous page.

 Perform a field calibration. Refer to the

on the CLiC

section below.

 Change the CLiC device. Refer to the

CLiC device

section (page 64).

 Cancel the verification process by pressing the Cancel

button.

Note: If the operator chooses to cancel a failed verification

process the device will not be available for patient treatment
monitoring.

4 Verify failed sub

Field calibration

Replacing the

Crit Line IV User’s Guide P/N CL80050002 Rev D 28

Field calibration on the CLiC

Selecting the Field Calibration button from the Verify failed menu screen

allows the user to perform a field calibration on the CLiC.

Note: This option will only be made available if the verification

of accuracy fails multiple times.

Follow these basic steps to perform a field calibration.

1 Press the Field Calibration button

Once the Field Calibration button is pressed, the following screen will

appear.

29 P/N CL80050002 Rev D Crit Line IV User’s Guide

2 Press the Filter ID button

Once the Filter ID button is pressed, the Enter Filter ID screen will appear.

1. Enter the verification filter ID using the onscreen keypad. As
characters are entered they will display in the top window. The
filter ID is located in the middle of the verification filter, as shown.

2. Once the verification filter ID has been entered, press the Save

button.

3 Press the Ok button

Once the Ok button is pressed, a verification of accuracy will be performed

as described in the

Note: If the verification of accuracy continues to fail, the CLiC is

no longer suitable for clinical use and should be replaced.

Verifying accuracy on the CLiC section.

Crit Line IV User’s Guide P/N CL80050002 Rev D 30

This Page Intentionally Blank

31 P/N CL80050002 Rev D Crit Line IV User’s Guide

Connecting the Crit-Line
Blood Chamber

1 2 3

Crit Line IV User’s Guide P/N CL80050002 Rev D 32

Connecting the Crit-Line Blood Chamber

Follow these basic steps to attach the disposable Crit-Line Blood Chamber
(P/N CL10041021) to the dialyzer during the extracorporeal bloodline
setup before priming the bloodlines.

Note: The Crit-Line Blood Chamber is intended for single use

only. A new unopened sterile blood chamber must be used for
each monitoring session.

1 Inspect Crit-Line Blood Chamber and packaging

Inspect the Crit-Line Blood Chamber and its sterile package prior to use.
Refer to the blood chamber package label to ensure that the blood chamber
sterilization has not expired.

Warning: Do not use the Crit-Line Blood Chamber if its

package has been opened or its sterility has otherwise been
compromised prior to use. The viewing area of the disposable
blood chamber should be kept clean and free of obstruction.

2 Connect Crit-Line Blood Chamber to dialyzer

Remove the blood chamber from its sterile package and aseptically attach
it to the arterial port of the dialyzer (as shown on the facing page). Make
sure the connection is tight. PUSH and TWIST. Use the wings and not the
lens to tighten.

33 P/N CL80050002 Rev D Crit Line IV User’s Guide

3 Continue setting up the bloodlines

b

Continue to set up the bloodlines per instructions provided by the
hemodialysis machine’s operators manual.

When connecting the arterial bloodline to the Crit-Line Blood Chamber
(not the dialyzer), hold the Crit-Line Blood Chamber securely in one hand
and aseptically attach the dialyzer end of the arterial bloodline with the
other hand. Be careful that you do not cross-thread the connection. The
connection of the Crit-Line Blood Chamber to the arterial bloodline must
not leak.

Make sure that no air is in the Crit-Line Blood Chamber after priming.
Any air present in the Crit-Line Blood Chamber may cause the hematocrit
and oxygen saturation readings to be inaccurate.

Note: To prevent air bubbles from entering the blood chamber,

ensure that all connections to the CLiC Blood Chamber are tight.

Note: To detect air bubbles, look at the viewing area of the CLiC

Blood Chamber. If air bubbles are present once blood has
entered the extracorporeal circuit, they will be clearly visible. If
no air bubbles are present, the entire viewing area of the CLiC
Blood Chamber will be filled with fluid.

Note: To remove air bubbles, gently tap the chamber until all air

bubbles exit the viewing area of the chamber. Vertical
orientation of the CLiC

lood chamber will expedite this process.

Crit Line IV User’s Guide P/N CL80050002 Rev D 34

This Page Intentionally Blank

35 P/N CL80050002 Rev D Crit Line IV User’s Guide

Connecting the CLiC Device
to the Crit-Line Blood
Chamber

1 2 3

Crit Line IV User’s Guide P/N CL80050002 Rev D 36

Connecting the CLiC Device to the Blood Chamber

Follow the steps below to clip the CLiC device to the Crit-Line Blood
Chamber (P/N CL10041021) before connecting to the patient’s vascular
access:

1 Pinch open the CLiC device

Hold the CLiC device such that one side is held by the index finger and
other side held by the thumb. Squeeze the clip to spread the sensor
elements apart.

2 Clip CLiC device on Blood Chamber

Caution: Before attaching the CLiC device, check carefully for

leaks at the connections between the blood chamber and the
dialyzer and the blood chamber and the arterial blood line.
Improper attachment of the arterial bloodline to the Crit-Line
Blood Chamber can cause blood or saline to leak onto and into
the CLiC device. This can damage the CLiC device.

Note: Make sure that the CLiC device is plugged into a USB port
located on the bottom of the Crit-Line IV monitor.

1. Place the CLiC device over the Crit-Line Blood Chamber so that the
optical sensor covers the lens of the Crit-Line Blood Chamber.

2. Release the clip to allow the optical sensor to seat on the viewing area
of the Crit-Line Blood Chamber.

3. Make certain that the CLiC device has locked securely into place on the
Crit-Line Blood Chamber by noting the audible and tactile click.

4. Ensure that the CLiC device is perpendicular to the top of the dialyzer
and cannot be easily rotated up or down while attached to the blood
chamber to ensure its proper placement.

Note: Make sure that the CLiC device is properly in place before

starting the treatment. If the CLiC device is not properly seated
on the Crit-Line Blood Chamber, the accuracy of the hematocrit
and oxygen saturation readings may be adversely affected.

37 P/N CL80050002 Rev D Crit Line IV User’s Guide

Using the Crit-Line IV monitor

Verify Accuracy

The Main Menu screen of the Crit-Line IV monitor

CLiC Status

Crit Line IV User’s Guide P/N CL80050002 Rev D 38

Main Menu screen

When the Crit-Line IV monitor is first turned on, the Main Menu screen
will appear. This screen is shown on the facing page.

Listed below are the features available on this menu.

Feature Description

Patient Run button – Activates the Patient Run menu.

History button – Activates the Patient History menu.

Verify Accuracy button – Initiates a manual verification of

accuracy.

The last successful verification date is shown below the button
in bold black print.

Setup button – Activates the Setup menu.

About button – Activates a display showing system

information.

CLiC Status indicator – Displays the operational status of the
attached CLiC device. There are five (5) possible states:

 Passed Verification with Verification Filter – The

green background indicates that the CLiC device has
passed a verification of accuracy and is operating
normally. The CLiC is shown attached to the
Verification Filter to indicate that the CLiC device
detects the Verification Filter.

 Passed Verification without Verification Filter – The

green background indicates that the CLiC device has
passed a verification of accuracy and is operating
normally. The CLiC is shown without the Verification
Filter to indicate that the CLiC device does not detect
the Verification Filter.

 Failed Verification with Verification Filter – The

orange background indicates that the CLiC device has
not passed a verification of accuracy and is not ready
for use. The CLiC is shown attached to the Verification
Filter to indicate that the CLiC device detects the
Verification Filter.

 Failed Verification without Verification Filter – The

orange background indicates that the CLiC device has
not passed a verification of accuracy and is not ready
for use. The CLiC is shown without the Verification
Filter to indicate that the CLiC device does not detect
the Verification Filter.

 Not Responding – The blue background and red “No”

symbol indicates that the CLiC is not plugged into the
USB port on the bottom of the Crit-Line IV monitor.

39 P/N CL80050002 Rev D Crit Line IV User’s Guide

Patient Run Menu Screen

The Patient Run Menu screen of the Crit-Line IV monitor

CLiC Status

Crit Line IV User’s Guide P/N CL80050002 Rev D 40

Patient Run Menu screen

The Patient Run menu is used for entering patient ID information and
initiating patient treatment monitoring. This menu is shown on the facing
page.

Listed below are the features available on this menu.

Feature Description

Start Run button – Initiates patient treatment monitoring.

Patient ID button – Allows for manually entering a Patient ID.

Patient List button – Allows for the selection of a Patient ID

from a list.

Demo Run button – Initiates demonstration patient treatment
monitoring. The demonstration treatment is a built-in four hour
treatment generated at the rate of one minute per second.

Return button – Returns to the Main Menu.

CLiC Status indicator – Displays the operational status of the
attached CLiC device. There are five (5) possible states:

 Passed Verification with Verification Filter – The

green background indicates that the CLiC device has
passed a verification of accuracy and is operating
normally. The CLiC is shown attached to the
Verification Filter to indicate that the CLiC device
detects the Verification Filter.

 Passed Verification without Verification Filter – The

green background indicates that the CLiC device has
passed a verification of accuracy and is operating
normally. The CLiC is shown without the Verification
Filter to indicate that the CLiC device does not detect
the Verification Filter.

 Failed Verification with Verification Filter – The

orange background indicates that the CLiC device has
not passed a verification of accuracy and is not ready
for use. The CLiC is shown attached to the Verification
Filter to indicate that the CLiC device detects the
Verification Filter.

 Failed Verification without Verification Filter – The

orange background indicates that the CLiC device has
not passed a verification of accuracy and is not ready
for use. The CLiC is shown without the Verification
Filter to indicate that the CLiC device does not detect
the Verification Filter.

 Not Responding – The blue background and red “No”

symbol indicates that the CLiC is not plugged into the
USB port on the bottom of the Crit-Line IV monitor.

41 P/N CL80050002 Rev D Crit Line IV User’s Guide

Manually entering a Patient ID

Selecting the Patient ID button allows the user to enter a patient specific

identification. Up to a nineteen (19) character alpha-numeric ID can be
entered. Follow these basic steps to manually enter a patient ID.

1 Press the Patient ID button

Once the Patient ID button is pressed, the Patient ID entry screen will

appear.

2 Enter the Patient ID

Enter the Patient ID using the onscreen keypad. As characters are entered
they will display in the top window.

3 Return

Once the Patient ID has been entered, press the Save button to keep the
Patient ID or the Cancel button to discard the Patient ID.

Crit Line IV User’s Guide P/N CL80050002 Rev D 42

Selecting Patient ID from a list

Selecting the Patient List allows the user to view the patient ID list for all

patients ID’s that have been entered into the Crit-Line IV monitor within
the previous thirty (30) calendar days. Follow these basic steps to select a
patient ID from the list.

Note: Patient treatment monitoring sessions are stored in the Crit

Line IV monitor for thirty (30) calendar days.

Note: Session data will be deleted automatically 30 calendar
days after the date it was stored.

1 Press the Patient List button

Once the Patient List button is pressed, the patient ID selection screen will

appear.

2 Select Patient ID from list

Use the up and down arrows to navigate the list of patient IDs. Then select
the patient ID for the upcoming treatment by pressing the patient ID. The
selected patient ID will be displayed in the top window.

3 Return

Once the patient ID has been chosen, press the Select button to confirm the
entry. Press the Cancel button to return to the Patient Run menu without

selecting a patient ID.

43 P/N CL80050002 Rev D Crit Line IV User’s Guide

Patient Treatment Monitoring
Screen

Elapsed Time

Real Time Data Graphical Data Dialogue / Status Box

Menu
Buttons

The Patient Treatment Monitoring screen showing BV and O

Patient Treatment Monitoring screen

The Patient Treatment Monitoring screen is used for monitoring the
patient’s hematocrit, oxygen saturation and percent change in blood
volume in real time during a dialysis treatment.

Crit Line IV User’s Guide P/N CL80050002 Rev D 44

Sat graphs

2

Reading Graphs on the

∆

Patient Treatment Monitoring
Screen

Elapsed Time

The Patient Treatment Monitoring screen showing BV and O2 Sat graphs with markers

Dialogue / Status Box

BV Graph

∆BV Alert
Level

O2Sat Graph

O2 Alert
Level

Hct Graph

Hct Alert
Level

O2 Alert
Level

The Patient Treatment Monitoring screen showing Hct and O2 Sat graphs with markers

45 P/N CL80050002 Rev D Crit Line IV User’s Guide

Flat

∆BV Graph

∆BV% = 0.0

Flat
O2Sat Graph

The Patient Treatment Monitoring screen with the CLiC device attached to the Verification
Filter showing flat BV and O

Sat graphs.

2

Note: If the Patient Treatment Monitoring session is conducted

with the CLiC device attached to the Verification Filter, there
will be no variation in the displayed values at any time during the
course of the monitoring session. This will produce flat ΔBV,
Hct and O
providing constant values.

Sat graphs as a result of the Verification Filter

2

Note: If this condition is observed, and patient treatment

monitoring on blood was intended, do the following:

 Properly place the CLiC device onto the patient’s blood

chamber.

 Press the button to activate the Patient Run

Option Menu screen.

 Press the button to restart the Patient

Treatment Monitoring session.

Crit Line IV User’s Guide P/N CL80050002 Rev D 46

Reading Graphs on the Patient Treatment Monitoring screen

The Patient Treatment Monitoring screen can display either Blood Volume
(ΔBV%) or Hematocrit (Hct) on the upper graph depending on display

selection. The display selection is made from the Patient Run Option

menu. On the lower graph, the Oxygen Saturation (O
always display. The BV and O

Sat graphs are displayed by default.

2

Sat) graph will

2

These screens are shown on the previous pages.

Graphing of the data begins after the Crit-Line IV monitor senses blood
and the hematocrit has been stable for sixty seconds. The graphs may be
resized to display a larger range during the treatment depending on the
min/max values.

Listed below are features common to all graph displays:

Feature Function

Elapsed Time – The elapsed time from the beginning of the
treatment. The elapsed time does not include any time
during which the treatment is paused.

Initial Hct– The initial (starting) hematocrit (Hct) value is
recorded along with the first data point when graphing
begins.

Initial est. Hb – The initial (starting) estimated hemoglobin
(Hb) value is recorded along with the first data point when
graphing begins. It is calculated based on the hematocrit
reading.

Patient ID – Refers to the Patient ID assigned to the patient
treatment monitoring session. The PID will only display if it
was entered.

Blood volume (BV) change profile – Displays one of the
following:

 Establishing Profile – The profile is established

over the first 15 minutes of data when the treatment
is initially started or if the treatment resumes. No
profile is shown during this time.

 Previous 15 Minute Profile – The current profile as

computed over the previous 15 minutes of data. The
profile may be:

A BV change is less than or equal to -3% per hour

(default)

B BV change is more than -3% and less than or

equal to -6.5% per hour

C BV change exceeds -6.5% per hour

 No Profile – No profile is shown while a treatment is

paused. Once resumed, a new profile will be
established.

Current Hematocrit (Hct) value.

47 P/N CL80050002 Rev D Crit Line IV User’s Guide

Current estimated Hemoglobin (Hb) value calculated from
the current Hematocrit using the following equation:

Hb = Hct/2.94

Blood Volume Change – The percent change in blood
volume since the start of the treatment. The BV change
value is calculated from the following equation:

∆BV% = [(Hct initial/Hct current) – 1]* 100.

Current Oxygen Saturation value.

Minimum Oxygen Saturation – The minimum oxygen
saturation value over all data points.

The BV (Blood Volume) graph

Note: The BV graph is the default upper graph displayed on the

Patient Treatment Monitoring screen.

The BV (Blood Volume) change graph is displayed as a fill graph. A line
is filled from 0 to the BV value. As the dialysis treatment progresses, fluid
is taken out of the blood by the hemodialysis machine’s ultrafiltration
pump. This will result in a greater percentage of the blood being red blood
cells and the blood volume fill graph will trend downwards and approach
the BV alert level if set. When set; the BV alert level is drawn as a dotted
line across the BV graph.

To set the BV Alert Level, refer to the section

Setting the BV Alert Level (Page 51)

The Sat (Oxygen Saturation) graph

The O

Sat (Oxygen Saturation) graph is a line graph drawn from the

2

previous oxygen saturation value. When set; the O
a dotted line across the Oxygen Saturation graph. To set the O

Level, refer to the section Setting the O

Note: Hemoglobin oxygen saturation (O2 Sat) values have a

wide range depending on the type of vascular access and other
factors. An O2 Sat value from a Central Venous Catheter will
typically be lower than a value from an arteriovenous fistula or
graft.

The Hct (Hematocrit) graph

The Hct (Hematocrit) graph is a line graph drawn from the previous
hematocrit value. As the dialysis treatment progresses, fluid is taken out of
the blood by the hemodialysis machine’s ultrafiltration pump. This will
result in a greater percentage of the blood being red blood cells and the
hematocrit line graph will trend upwards and approach the alert level if set.

When set the Hematocrit Alert Level is drawn as a dotted line across the
Hct graph. The Hematocrit Alert Level cannot be set directly, but is
calculated from the BV Alert Level (see the BV Alert Level button in the

Alert Level is drawn as

2

Alert Level (Page 52)

2

Alert

2

Crit Line IV User’s Guide P/N CL80050002 Rev D 48

Patient Treatment Monitoring screen section for more information).

When the alert is triggered, the message “BV Alert Level” is displayed. To

set the BV Alert Level, refer to the section Setting the BV Alert Level

(Page 51).

Menu Buttons

Listed below are the features available from the menu buttons.

Feature Description

Menu button – Activates the Patient Run Option menu.

Running / Paused button – Pauses or resumes the patient

treatment monitoring.

When monitoring is paused the button background color
flashes from red to blue.

Markers button – Allows the user to enter intervention or
symptom event markers on the BV, Hct and O

BV Alert Level button – Sets the BV (Blood Volume) Alert
Level.

When the cumulative ∆BV% change drops below the
set BV alert level, the Crit-Line IV monitor displays the alert
message “BV Alert Level”. This message will occur until the
∆BV% cumulative change increases above the set BV alert
level, the user changes the level, or sets the BV Alert Level to
OFF.

graphs.

2

O

Alert Level button – Sets the oxygen saturation alert level.

2

When the current O
the alert message “O2 Alert Level” is displayed in the Status
Box. The message will occur until the O

Alert Level, the user changes the level, or sets the O2 Alert

O

2

Level to OFF.

Sat value drops below the O2 Alert Level,

2

level rises above the

2

End Run button – Terminates patient treatment monitoring and
returns to the Patient Run menu.

49 P/N CL80050002 Rev D Crit Line IV User’s Guide

Setting an Event Marker

Selecting the Markers button displays a menu to insert an event marker on

the ΔBV%, Hct and O

Sat graphs.

2

1 Press the Markers button

Once the Markers button is pressed, the event marker selection screen will

appear.

2 Select event marker type

Press the Symptom button to display a yellow diamond on the graphs.
Press the Intervention button to display a black triangle on the graphs.

Press the Cancel button to return without selecting an event marker.

Note: To prevent clutter on the graphs, the time between entering

markers must be at least ten (10) minutes apart. If events occur
more frequently than 10 minutes, the operator must document
them manually in the patient treatment record

Note: Adding event markers encodes the markers in the patient

treatment history file. These markers appear on each profile
screen in the printed graphs.

Note: If the clinical event being marked is a patient symptom,

the operator selects the Symptom button. A yellow diamond

on the graphic display indicates an event related to a symptom.
Note: If the clinical event being marked is an intervention to

prevent a potential symptomatic response from the patient, the
operator selects the Intervention button. A black triangle on

the graphic display indicates an event related to an intervention.

Crit Line IV User’s Guide P/N CL80050002 Rev D 50

3 Confirm selection

Once the Marker has been selected, the event marker confirmation screen

will appear.

Press the Confirm button to display the selected marker on the graphs.
Press the Cancel button to return without selecting an event marker.

Setting the Blood Level (BV) Alert Level

Selecting the BV Alert Level button displays a menu to set the BV Alert

Level.

1 Press the BV Alert Level button

Once the BV Alert Level button is pressed, the BV alert level selection

screen will appear to the left of the BV Alert Level button.

2 Select BV Alert Level

Set the BV Alert Level by pressing the yellow up or down

button
until the desired level is displayed in the BV Alert Level box to the right of
the select screen. The dotted line on the ΔBV% graph moves to the set BV
Alert Level. The default value is -15%.

Note: As fluids are removed from the patient, the patients’ blood

volume decreases resulting in a negative (-) ΔBV%.

Note: Pressing the button reduces the absolute ΔBV% Alert

Level. For example pressing the button will change the
ΔBV% from (-14%) to (-13%). While this may appear counter­intuitive, the change is positive.

Note Pressing the button increases the absolute ΔBV% Alert

Level. For example pressing the button will change the

51 P/N CL80050002 Rev D Crit Line IV User’s Guide

ΔBV% from (-13%) to (-14%). While this may appear counter-

intuitive, the change is negative.

3 Return

Press the Confirm button to confirm the entry. Press the Cancel button to
return to the original setting. Press the Disable button to set the BV alert

level to OFF.

Setting the O

Alert Level

2

Selecting the

O2 Alert Level

Saturation) alert level.

1 Press the O2 Level button

Once the O2 Alert Level button is pressed, the 0

screen will appear to the left of the O

button displays a menu to set the

Alert Level selection

2

Alert Level button.

2

O

(Oxygen

2

2 Select O2 Alert Level

Set the O2 Alert Level by pressing the yellow up or down
the desired level is displayed in the O
selection screen. The dotted line on the O
Level. The default value is 89%.

Note: Pressing the button increases the O

Pressing the button decreases the O

3 Return

Press the Confirm button to confirm the entry. Press the Cancel button to
return to the original setting. Press the Disable button to set the O

level to OFF.

button until

Alert Level box to the right of the

2

graph moves to the set O2 Alert

2

Alert Level.

2

Alert Level.

2

alert

2

Crit Line IV User’s Guide P/N CL80050002 Rev D 52

Ending a Patient Treatment Monitoring Session

1 Press the End Run button

Once the End Run button is pressed, the End Patient Run option menu

will appear.

2 Make selection

Press the Print report button to terminate and print the Crit-Line IV

patient treatment monitoring session.

Press the Do not print report button to terminate the Crit-Line IV patient

treatment monitoring session without printing.

Press the Cancel button to return to the Crit-Line IV patient treatment

monitoring session.

Note: When a Crit-Line IV patient treatment monitoring session

is ended, either by printing or not printing, the system returns to

the Patient Run menu.
Note: If electing not to print, patient treatment monitoring

sessions are only stored for thirty (30) calendar days after which

the data is automatically deleted.

3 Remove the CLiC device from the Crit-Line Blood Chamber

When the treatment is complete, pinch the CLiC device to spread the
sensor elements apart and gently remove the device from the Crit-Line
Blood Chamber. Store the CLiC device by clipping it to its verification
filter, which is attached to its USB cable. Discard the disposable Crit-Line
Blood Chamber with the rest of the bloodlines following appropriate
hazardous waste handling requirements.

53 P/N CL80050002 Rev D Crit Line IV User’s Guide

Patient Run Option Menu
Screen

The Patient Run Option Menu screen of the Crit-Line IV monitor

Crit Line IV User’s Guide P/N CL80050002 Rev D 54

Patient Run Option Menu screen

The Patient Run Option menu is used for modifying or entering patient ID
information during a treatment as well as restarting a patient treatment
monitoring session and selecting displayed graphs. This menu is shown on
the facing page.

Listed below are the features available on this menu.

Feature Description

Patient ID button – Allows for manually entering a Patient ID.

See the Manually entering a Patient ID section for
instructions.

BV / Hct Graph button – Alternates between the BV and Hct
graphs being displayed on the upper graph of the Patient
Treatment Monitoring Screen.

Restart Run button – Restart the Patient Treatment Monitoring
session. This will establish new starting Hct, O
∆BV% values. The elapsed time will reset to zero and all
graphs will be cleared.

Sat, Hb and

2

Volume button – Allows for changing the volume level of the
audio alerts. See the Changing the volume level section for
instructions.

Continue Run button – Returns to the Patient Treatment
Monitoring Screen.

55 P/N CL80050002 Rev D Crit Line IV User’s Guide

History Menu Screen

Current Selection
of Patient
Treatment Data

Menu
Buttons

The History Menu screen of the Crit-Line IV monitor

Crit Line IV User’s Guide P/N CL80050002 Rev D 56

History Menu screen

The History menu is used for reviewing, printing and downloading patient
treatment monitoring data from previous treatment sessions. This menu is

shown on the facing page. The History menu is accessed by selecting the

History button on the Main menu

Note: Patient treatment monitoring sessions are stored in the Crit

Line IV monitor for thirty (30) calendar days.

Note: Session data will be deleted automatically 30 calendar

days after the date it was stored.

Note: The last patient treatment monitoring session is the default
selection.

Listed below are the features available on this menu.

Feature Description

Run List button – Allows for the selection of a previous

patient treatment monitoring session from a list.

The list of treatments includes a patient ID number along with
the date of its corresponding treatment. The order of the
treatments in the list is based on the date of the treatment
with the most recent treatment at the top of the list.

Print button – Prints the selected patient treatment data.

Download button – Downloads the selected patient

treatment data. This option is typically used for research
purposes and not in typical clinical environments.

Return button – Returns to the Main Menu.

57 P/N CL80050002 Rev D Crit Line IV User’s Guide

Selecting a treatment from the list

Selecting the Run List button allows the user to view previous patient

treatment monitoring sessions from the past thirty (30) calendar days.
Follow these basic steps to select a previous patient treatment monitoring
session from the list.

1 Press the Run List button

Once the Run List button is pressed, the Select Patient Run screen will

appear.

2 Select a treatment session from list

Use the up and down arrows to navigate the list of previous patient
treatment monitoring sessions. Press the treatment session on the
displayed list to select it. The current selection will be displayed in the
upper window.

3 Return

Once the treatment has been chosen, press the Select button to confirm the
entry. Press the Cancel button to return to the History menu without

selecting a previous treatment.

Crit Line IV User’s Guide P/N CL80050002 Rev D 58

DEMO Mode

The Crit-Line IV has a group of built-in patient treatment monitoring
sessions. These sessions are provided to demonstrate some of the
capabilities of the device as well as to provide training data. The built-in

patient treatment monitoring sessions are accessible by selecting the Demo
button on the Patient Run Menu screen.

Note: When in DEMO mode, the image on the display is updated

at a rate of one minute per second. It takes approximately four
minutes to complete the session.

Built-in session selection

The Crit-Line IV currently has seven built-in patient treatment monitoring
sessions. The default session will be selected unless one of the other
sessions is selected. A built-in treatment session can be selected by:

Note: When in DEMO mode, the menu buttons remain active.

1. Entering a patient id of 1 thru 6

2. Selecting the Demo button from the Patient Run menu.

Note: The Patient ID for a built-in session is “DEMO RUN”

followed by the session index. For example if session 4 is
selected then the Patient ID will be “DEMO RUN 4”. If the
default session is selected the Patient ID will be “DEMO RUN”.

59 P/N CL80050002 Rev D Crit Line IV User’s Guide

Built-in session profiles

The following graphs show the built-in session data:

Default Session

Session #1

Crit Line IV User’s Guide P/N CL80050002 Rev D 60

Session #2

Session #3

61 P/N CL80050002 Rev D Crit Line IV User’s Guide

Session #4

Session #5

Crit Line IV User’s Guide P/N CL80050002 Rev D 62

Session #6

63 P/N CL80050002 Rev D Crit Line IV User’s Guide

Replacing the CLiC device

How to replace the CLiC

The CLiC device may be changed on the Crit-Line IV monitor. This will
be required if the CLiC continues to fail a verification of accuracy.

Note: The CLiC may be replaced with the Crit-Line IV monitor

turned on. However, it is recommended that the CLiC be
replaced with the Crit-Line IV monitor turned off.

Follow these basic steps to replace the CLiC device.

1 Remove old CLiC from Crit-Line IV monitor

Follow these basic steps to remove the old CLiC from the Crit-Line IV
monitor.

1. Remove the CLiC from the Crit-Line IV monitor by gently pulling

the USB connector on the CLiC out of the USB socket on the
bottom of the monitor as shown.

USB

2. Remove the verification filter from the IV pole by grasping the

verification filter and gently pulling it away from the IV pole as
shown.

3. If the CLiC is being replaced due to repeated verification of

accuracy failures; disinfect the CLiC device and dispose of it
according to U.S. federal regulations 29CFR1910.145, 1910.1030
and appropriate state or local laws.

Socket

CLiC USB
Connector

Crit Line IV User’s Guide P/N CL80050002 Rev D 64

2 Insert new CLiC into Crit-Line IV monitor

Follow these basic steps to insert the new CLiC into the Crit-Line IV
monitor.

1. Insert the CLiC into the Crit-Line IV monitor by gently pushing the

USB connector on the CLiC into one of the USB sockets on the
bottom of the monitor as shown.

USB
Socket

CLiC USB
Connector

2. Attach the verification filter to the IV pole by grasping the

verification filter near the base of the verification filter clip, and
gently pushing it onto the IV pole. The filter will snap into place
around the IV pole as shown.

3 Place CLiC on Verification Filter

1. Hold the CLiC device such that one side is held by the index finger

and other side held by the thumb. Squeeze the clip to spread the
sensor elements apart.

2. Place the CLiC device over the verification filter such that the

sensor elements cover the middle portion of the verification filter.

3. Release the clip to allow the sensor elements to seat on the

verification filter.

4. Make certain that the CLiC device has locked securely into place on

the verification filter by noting the audible and tactile click.

65 P/N CL80050002 Rev D Crit Line IV User’s Guide

4 Enter verification filter ID

1. If the Crit-Line IV monitor is off, turn it on.

2. One of the following two screens will appear. The Crit-Line Clip

change detected screen shown on the left will appear if the Crit­Line IV monitor detects a new CLiC. The Change Clip screen
shown on the right will appear as part of the verification of
accuracy failure process.

Note: The Crit-Line Clip change detected screen will appear

when the CLiC is changed outside of the verification of accuracy
failure process.

Crit Line IV User’s Guide P/N CL80050002 Rev D 66

5 Press the Filter ID button

Once the Filter ID button is pressed, the Enter Filter ID screen will appear.

1. Enter the verification filter ID using the onscreen keypad. As

characters are entered they will display in the top window. The
filter ID is located in the middle of the verification filter, as shown.

2. Once the verification filter ID has been entered, press the Save

button.

6 Press the Ok button

Once the Ok button is pressed, a verification of accuracy will be performed

as described in the

Note: Ensure that the CLiC is properly seated on the verification
filter before pressing the Ok button.

Verifying accuracy on the CLiC section.

67 P/N CL80050002 Rev D Crit Line IV User’s Guide

Crit-Line IV Monitor Care

Cleaning and Disinfecting the Crit-Line IV monitor

The Crit-Line IV monitor is a sensitive electro-optical device. Use care
when cleaning the exterior of the Crit-Line IV monitor, the CLiC device
and verification filter so as not to damage them. The exterior of the CLiC
device, verification filter, and the Crit-Line IV monitor should be cleaned
after every treatment. These can all be cleaned with very dilute bleach or

CLiC Device Disposal

other suitable hospital disinfectant.

Freshly prepared dilute bleach solution (1:100) is currently recommended
by the Center for Disease Control as a suitable disinfectant for the
Hepatitis virus. Because surface contamination is the general mode of
transmission for this type of virus, thorough cleaning of the exterior is
essential.

Caution: Wipe the Crit-Line IV monitor or CLiC device with a

cloth dampened with the cleaning solution; do not spray the
solution on the

Crit-Line IV monitor or CLiC device. Do not

immerse the CLiC device in any type of liquid. If liquids infiltrate
the device, they will damage it.

Caution: Do not use abrasive materials or solvents to clean the

Crit-Line IV monitor or CLiC device. Doing so may cause

damage.

Caution: Be careful not to scratch or damage the verification

filter. If the verification filter is scratched or damaged, it may
cause the CLiC device to fail verification of accuracy.

If the Crit-Line IV monitor or CLiC device becomes contaminated with
blood, they must be thoroughly disinfected before the next treatment.
Freshly prepared dilute bleach solution (1:100) or surface disinfectants
such as Cavicide or Envirocide can be used to disinfect the CLiC device.

If the CLiC device continues to fail verification of accuracy, even after
recalibration, the device is no longer suitable for clinical use. Disinfect the
CLiC device before disposing of it according to U.S. federal regulations
29CFR1910.145, 1910.1030 and appropriate state or local laws.

Crit Line IV User’s Guide P/N CL80050002 Rev D 68

Troubleshooting, Alerts &
Messages

The following troubleshooting section is a guide to help you troubleshoot
Crit-Line IV monitor messages and alerts.

Messages shown on the Crit-Line IV monitor are listed alphabetically.
These messages are triggered by conditions and events related to the use of
the Crit-Line IV monitor that occur during operation. The messages will
reset when the condition causing them is corrected. In some cases, you
must reset them yourself.

Warning: Performing the recommended action may or may not

clear the message or alert.

Note: Audio alerts may be muted by pressing any location on the

screen.

Note: If you have any questions, please call Crit-Line Technical
Service at [phone].

69 P/N CL80050002 Rev D Crit Line IV User’s Guide

Message Purpose of Message Type Action Required

-∆BV% greater than
8%/hr

BV Alert Level The current blood volume

Change Clip The screen will appear as part

Check sensor clip
(CLiC) placement. To
monitor blood, ensure
sensor clip is on the
patient’s blood
chamber and press
‘Start Run’.

CLiC malfunction
detected

Replace CLiC

CLiC not
communicating.
Check the CLiC USB
connection

Crit-Line Clip change
detected

The current blood volume
percentage rate of change is
greater than -8% per hour.
This is activated independent
of the BV Alert setting.

percentage or hematocrit has
dropped below the BV Alert
Level set.

of the verification of accuracy
failure process.

To inform the operator that a
patient treatment monitoring
session is about to start with
the CLiC device attached to
the verification filter instead of
the blood chamber.

The CLiC device has reported
an internal failure to the Crit­Line IV and is not operational.

The Crit-Line IV monitor has
not received data from the
CLiC device.

The screen will appear when
the Crit-Line IV detects a
different CLiC device.

Alert

Alert

Message

Message

Alert

Alert

Alert

This message will occur until the ∆BV% change decreases below -8% per
hour.

Assess the patient for any changes in physiologic state.

This message will occur until the ∆BV% change increases above the set BV
alert level, the user changes the level or sets the BV Alert Level to OFF.

Refer to the Replacing the CLiC Device (Page 64) section for detailed
instructions.

Place the sensor clip (CLiC) device on the Blood Chamber and press the
Start Run button.

Replace the CLiC device. Refer to the Replacing the CLiC Device (Page

64) section for detailed instructions

Check the CLiC device’s USB cable:

 Make sure the cable is securely connected to one of the Crit-Line IV

monitor’s USB ports.

 Wait up to one minute for the message to clear.

If the message is not cleared:

 Turn the Crit-Line IV monitor OFF and back ON.

 When prompted, resume patient monitoring.

Replace the CLiC device if the system is unable to resume communications
with the CLiC. Refer to the Replacing the CLiC Device (Page 64) section
for detailed instructions.

Refer to the Replacing the CLiC Device (Page 64) section for detailed
instructions.

Crit Line IV User’s Guide P/N CL80050002 Rev D 70

Message Purpose of Message Type Action Required

Downloading print
data

Fatal Application
Error

Hct Change

Detected abnormal
change in Hct. Press
‘Restart’ to start over
or press ‘Continue’ to
continue.

No Blood The CLiC device no longer

No wireless USB
device. Ensure
wireless USB device
is connected then
turn monitor OFF and
back ON.

O2 Alert Level The current Oxygen

Informs the operator that data
is being transmitted to the
Crit-Line Printer Software

This screen will appear if an
operating system level error
occurs within the Crit-Line IV.

The Hct changed by more
than 5 in the first 10 minutes.

This is an indication that there
has been a transition from
saline to blood.

senses blood in the Blood
Chamber.

To inform the operator that the
ZigBee radio is not connected
to a USB port on the bottom of
the Crit-Line IV or is not
communicating with the
ZigBee radio when an attempt
was made to print using the
ZigBee radio.

Saturation has dropped below

Alert Level set on the

the O

2

Patient Treatment Monitoring
screen.

Message

Message

Alert

Alert

Message

Alert

No action required. The message will be cleared once the data transfer has
been completed.

Turn the Crit-Line IV monitor OFF and ON. If the message is not cleared
when the Crit-Line IV monitor is powered back on, call Crit-Line
Service at [phone].

Evaluate the starting Hct value for the patient. If the patient treatment
monitoring session was started with the saline prime still in the line, It may
be necessary to restart the patient treatment monitoring session.

Check the Crit-Line Blood Chamber:

 Make sure there is proper blood flow: There should be no air or

bubbles in the chamber.

 Make sure the CLiC device is properly seated on the Crit-Line Blood

Chamber: The device should be placed perpendicularly over the
chamber and cannot be rotated up or down.

Verify that the ZigBee radio is securely connected to one of the Crit-Line IV
monitor’s USB ports. Turn the Crit-Line IV monitor OFF and back ON.

Note: If this screen was encountered after ending a patient
treatment, the patient treatment may be printed when the Crit-Line
IV monitor is powered back on by printing from the History Menu.
Refer to the History Menu Screen (Page 56) section for detailed
instructions.

Assess the patient for any changes in physiologic state.

The message will occur until the O2 level rises above the O2 Alert Level;
the user changes the level, or sets the O2 Alert Level to OFF.

Technical

71 P/N CL80050002 Rev D Crit Line IV User’s Guide

Message Purpose of Message Type Action Required

Patient monitoring
was interrupted
unexpectedly.

Continue patient
monitoring?

To inform the operator that an
active patient treatment
monitoring session was
unexpectedly terminated.
This is typically due to a
power cycle during a
treatment monitoring session.

Message

Press the Yes button to continue monitoring the patient treatment session.
Press the No button to close the monitoring session.

Note: The option to resume monitoring a patient treatment
session will only be given if power is restored with the CLiC device
attached to the disposable blood chamber and the CLiC device
detects blood in the system.

Print error The patient treatment data

was not printed.

This message is displayed if
the printer countdown timer
(see “Waiting to Print” below)
reaches zero, indicating that
permission to print from the
Crit-Line Printer Software was
not received by the Crit-Line
IV in the allowable time.

Sensor Obstruction Something is blocking the

CLiC device’s optical sensor.

Message

Alert

Press the Ok button to clear the warning.

Note: Check the printer connections and try printing the patient
treatment data again from the History Menu screen. For detailed
instruction on printing, see the History Menu screen (Page 56)
section.

Note: Check the printer port settings and verify that the correct
port is selected. For detailed instruction on printer port selection,
see Selecting the Printer Port (Page 16)

Note: Check the host computer and verify that the host printer
software application is running.

Check the Crit-Line Blood Chamber:

 Remove the CLiC device from the blood chamber and check for

obstructions.

 Reattach the CLiC device to the blood chamber.

 Wait up to one minute for the message to clear.

If the message is not cleared:

 Cancel the patient treatment monitoring session.

 From the Main Menu screen, perform a manual verification of

accuracy by pressing the Verify button.

Note: For detailed instruction on manually performing a

verification of accuracy, see the CLiC Device Verification (Page

26) section.

Crit Line IV User’s Guide P/N CL80050002 Rev D 72

Message Purpose of Message Type Action Required

Verification Filter
Detected

Select “End Run” to
end session

Verify – Attach sensor
clip (CLiC) to
verification filter

Verify Failed The verification of accuracy

The Crit-Line IV detected a
transition from blood to the
verification filter during a
patient treatment monitoring
session.

The CLiC device has not been
verified within the past 30
calendar days or has failed
verification.

test shows that the CLiC
device is not ready for use
during treatment.

Message

Message

Message

If the change was intentional because the treatment monitoring session has
ended, end the monitoring session. Otherwise, place the CLiC device back
on the blood chamber

Note: This message will only occur in Standard Run Mode. For
more details regarding Auto vs Standard Run Mode, see the
vs Standard Run Mode (Page 22) section.

Verify the CLiC device:

 Place the CLiC device on the CLiC Verification Filter, which is

attached to its USB cable.

 Press the Ok button to clear the message.

Perform a manual verification of accuracy by pressing the Verify button

Note: For detailed instruction on manually performing a verification
of accuracy, see the CLiC Device Verification (Page 26) section.

Re-Verify the CLiC device:

 Ensure the CLiC device is on the CLiC Verification Filter, which is

attached to its USB cable.

 Press the Verify button to perform another verification of accuracy.

 Press the Cancel button to clear the message.

Auto

Note: For detailed instruction on manually performing a

verification of accuracy, see the CLiC Device Verification (Page

26) section.

Waiting to print To inform the operator that the

Crit-Line IV is waiting for
permission to print from the
Crit-Line Printer Software on
the computer used for printing.

Message

No action required. The printer countdown timer displayed next to the
message informs the operator that printing is pending.

Printing may be canceled at any time by pressing the Cancel button

Note: If the printing is canceled the treatment session may be
printed at a later time by printing the treatment from the History
Menu. For detailed instruction on printing, see the History Menu
screen (Page 56) section

73 P/N CL80050002 Rev D Crit Line IV User’s Guide

Appendix

Product Improvement Policy

The CLiC device was designed and built to comply with the product
specifications noted below. It is the intention of Fresenius Medical Care
to improve products continuously, a process which may result in
modifications to specifications or equipment produced in the future.
Such product improvements shall not incur any obligation to make
similar changes or improvements to equipment previously produced.
These changes or improvements may or may not be applicable or
usable with previously produced equipment. Where possible,
improvements will be made available at reasonable prices. Any such
improvement shall not be construed as corrections of any perceived
deficiency.

Warranty

Sale of the parts described or referenced herein is expressly conditioned
upon the terms and conditions set forth below. Any additional or
different terms or conditions set forth by the Purchaser to Fresenius
Medical Care, (herein called "the Company") shall not be effective or
binding, and the terms set forth herein shall not be modified or
amended, unless assented to in writing by an authorized official of the
Company located in Waltham, Massachusetts.

LIMITED WARRANTY: The Company warrants to the Purchaser

that the equipment delivered is free from defects in material or
workmanship for the periods specified below, provided the equipment
is used and maintained in accordance with the original manufacturer's
operating instructions:

The Crit-Line IV monitor and Crit-Line in a Clip (CLiC) device shall
be warranted for three hundred and sixty-five (365) days from the date
of purchase.

The Company will repair or replace, at its option, using new or
reconditioned parts and/or assemblies, any parts subject to this
warranty, which are proven defective in materials or workmanship.
Such repair and replacement will be made without cost to the
Purchaser, and the Company reserves the right to determine the
location at which the repair or replacement will be accomplished. The
Warranty does not apply to any equipment which is misused, abused,
neglected, tampered with, damaged by accident, flood, fire, or other
hazard, subjected to abnormal or unusual electrical or fluid stress,
improperly installed or operated, or not maintained in accordance with
the care instructions set forth in the operating manual for the
equipment.

Crit Line IV User’s Guide P/N CL80050002 Rev D 74

Routine maintenance is not covered under warranty. Modifications,
alterations, installation and service by any other than a Fresenius
Medical Care authorized representative may void the warranty.

WARRANTIES APPLICABLE TO EQUIPMENT EXTEND ONLY
TO THE PURCHASER, AND ARE NOT ASSIGNABLE OR
TRANSFERABLE, AND SHALL NOT APPLY TO AUXILIARY
EQUIPMENT, OR DISPOSABLE ACCESSORIES. THE
FOREGOING WARRANTY SHALL BE IN LIEU OF ANY OTHER
WARRANTIES, EXPRESSED IMPLIED OR STATUTORY,
RESPECTING THE EQUIPMENT OR ANY PARTS OR
COMPONENTS THEREOF, AND THE COMPANY MAKES NO
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE. THE PURCHASER'S SOLE AND
EXCLUSIVE REMEDY IN CONTRACT, TORT, OR UNDER ANY
OTHER THEORY AGAINST THE COMPANY RESPECTING THE
EQUIPMENT AND ITS USE SHALL BE THE REPLACEMENT OR
REPAIR OF THE EQUIPMENT AND ITS PARTS AS DESCRIBED
ABOVE, AND NO OTHER REMEDY (INCLUDING, WITHOUT
LIMITATION, CONSEQUENTIAL DAMAGES) SHALL BE
AVAILABLE TO THE PURCHASER. The Company shall have no
further obligation or liability with respect to the equipment or its sale,
operation and use, and the Company neither assumes, nor authorizes
the assumption of, any obligation or liability in connection with such
equipment.

Crit-Line IV Monitor Spare Parts

Crit Line IV Monitor P/N CL65000012

CLiC Device P/N CL10041001
Pole Mount P/N CL10054004
Crit Line IV User’s Guide P/N CL80050002

ZigBee Radio P/N CL90000076

Crit Line Printer Software P/N CL10029504

Power Supply Adapter P/N CL44300012

Power Cord P/N CL90000035

Note: Call Fresenius Medical Care Customer Service Spare

Parts at [phone].

Additional Information

For more information, please contact:

Fresenius USA Manufacturing

4040 Nelson Avenue
Concord, CA 94520

75 P/N CL80050002 Rev D Crit Line IV User’s Guide

Crit-Line IV Monitor Specifications

Dimensions Crit-Line IV Monitor: 5.50”H, 9.00”W,

1.60”L (14.0cm H, 22.9cm W, 4.1cm L)

Pole Mount:: 3.5”H, 5.75”W, 4.00”L

(8.9cm H, 14.6cm W, 10.2cm L)

Weight Crit-Line IV Monitor: 0.80 lbs. (363 gm)

Pole Mount: 1.25 lbs. (567 gm)

Operating Conditions 50 °F to 104 °F (10 °C to 40 °C)

Storage & Transportation Conditions -4 °F to 125 °F (-20 °C to 51 °C)

Altitude 0 – 9843’ (0 – 3000 m)

Internal Data Storage Stores previous 30 calendar days of

patient treatment data.

Power to Monitor 12 VDC / 1A / 12W

Power Supply 100 – 240V / 50 – 60 Hz / 0.3A Min.

Communication Ports (used) DB9 Serial (COM1) / 9600 Baud 8N1

USB ZigBee Radio

Water Ingress Protection IP-64 front panel. Do not immerse in

liquid.

Anesthetic Suitability Not suitable

Modes of Operation Continuous

CLiC Sensor See CLiC IFU,

Document # CL80040002

Crit Line IV User’s Guide P/N CL80050002 Rev D 76

EMC Compliance

Medical electrical equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided herein.

The Crit-Line IV monitor is intended for use in the electromagnetic environment specified below. The user
of the Crit-Line IV monitor should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment –guidance

EN 55011:2007
per EN 60601-1­2:2007
EN 55011:2007
per EN 60601-1­2:2007
Harmonic
Emissions
IEC 60601-1­2:2007,
EN 61000-3-2
Voltage
Fluctuations /
Flicker Emissions
IEC 60601-1­2:2007,
EN 61000-3-3

Group 1 The Crit-Line IV monitor uses radio frequency (RF) energy only for its

internal function. Therefore, its RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.

Class A The Crit-Line IV monitor is suitable for commercial, industrial, or

business use. This classification covers devices for usage in all
establishments other than domestic and that are not directly connected

Class A

Complies

to a low voltage power supply network, which supplies domestic
environment.

Warning: This Class A equipment is intended for use in industrial areas
and hospitals. There may be potential difficulties in ensuring
electromagnetic compatibility in other environments, such as the
domestic environment, due to conducted as well as radiated
disturbances."

ZigBee Radio

When installed, the following table provides details regarding the ZigBee Radio.

Manufacturer
Model
FCC ID
FCC Compliance
Frequency Band
Type of Modulation
Effective Radiated Power
Transmission Standard
Radio

Telegesis (www.telegesis.com)
ETRX3USB-LRS
S4GEM35X2
Class B Digital Device

2.4GHz ISM Band
Digital direct sequence spread spectrum stranceiver
+20dBm typical output power
IEEE802.15.4

This product contains a radio transmitter. If any
interference is suspected, move the product farther
away from the equipment being interfered with.
Interference with other equipment is unlikely as the
ZigBee Radio is very low power.

77 P/N CL80050002 Rev D Crit Line IV User’s Guide

Glossary

Blood Volume – The amount of blood circulating in a cardiovascular system.
CLiC – The Crit-Line Clip (CLiC) is a device used to non-invasively measure

hematocrit, oxygen saturation and percent change in blood volume.

CLiC Status – The operational status of the CLiC device.
Crit-Line Blood Chamber – A single use, sterile chamber that attaches to a blood

line. The Crit-Line blood chamber provides a docking point for a CLiC device.

Event – A symptom or intervention that takes place during a patient treatment

monitoring session. Events can be marked using event markers.

Hb – Abbreviation for hemoglobin. The hemoglobin value displayed by the Crit-

Line IV monitor is an estimate based on hematocrit.

Hct – Abbreviation for hematocrit. This is the percent of red blood cells in blood.
Initial Hb – This is the Hb value recorded at the beginning of a patient treatment

monitoring session.

Initial Hct – This is the Hct value recorded at the beginning of a patient treatment

monitoring session.

O

Sat – Abbreviation for oxygen (O2) saturation. The value is a percentage of the

2

maximum oxygen (O

Output Port – This identifies a data port used to transmit serial data to a host device.

The options on the Crit-Line IV monitor are Serial COM 1 (DB9) and ZigBee

radio.

Patient ID – This is an alpha-numeric string used to link a patient to a patient

treatment monitoring session.

Patient Run – See Patient Treatment Monitoring Session.
Patient Treatment Monitoring Session – This term is used to identify the block of

time that the Crit-Line IV monitor is monitoring the patient treatment. During

a treatment monitoring session the Crit-Line IV collects and displays Hct,

ΔBV%, and O

Printer Port – This identifies a data port used to communicate with the host printer

software. The options on the Crit-Line IV monitor are Serial (COM 1 (DB9))

and ZigBee radio.

Profile – This term is used to identify the rate of change for the

Line IV monitor identifies three profile types: A = Rate of change of < 3% per

hour, B = Rate of change between 3% and 6.5% per hour and, C = Rate of change

greater than 6.5% per hour.

Station ID – This is a 2-digit value used to link a Crit-Line IV monitor to a specific

dialysis station.

Touch Screen – An electronic visual display that the user can control through simple

gestures by touching the screen with a finger or stylus.

Verification Filter – A filter unique to each CLiC device used to periodically verify

the accuracy of the CLiC device.

ZigBee Radio – A radio based on the ZigBee wireless communication technology.

ΔBV% - A percent change in the blood volume. This formula is ΔBV% = [(Initial

Hct/Current Hct)-1]*100

Sat data.

2

) carrying capability of blood.

2

ΔBV%. The Crit-

Crit Line IV User’s Guide P/N CL80050002 Rev D 78

Index

Attach sensor clip (CLiC) to verification

filter, 73
Auto Run, 15, 22
Blood Line, 37
Blood Volume, 3, 51, 70
BV Alert Level, 70
Change Clip, 70
Check sensor clip (CLiC) placement, 70
CLiC, 2, 3, 7, 8, 10, 11, 15, 25, 26, 27,

37, 39, 41, 53, 64, 65, 66, 67, 68, 70,

72, 74, 75, 76
CLiC malfunction detected, 70
CLiC not communicating., 70
CLiC Status, 25, 39, 41
Crit-Line Blood Chamber, 3, 7, 8, 32,

33, 36, 37, 53, 71, 72
Crit-Line Clip change detected, 70
DB9, 16, 19, 76
Event Markers, 49, 50
Fatal Application Error, 71
Verification Filter Detected, 73
Hb, 48
Hct, 3, 47, 48, 49, 50, 55, 71, 76
Hct Change, 71
Initial Hb, 47
Initial Hct, 47
IV pole, 7, 10, 11, 64, 65
No Blood, 71
No wireless USB device, 71
O2 Alert Level, 71

O2 Sat, 3, 44, 45, 46, 47, 48, 49, 50, 52,

71, 76
Output Port, 15, 16, 19
Patient ID, 41, 42, 43, 47, 55, 59
Patient monitoring was interrupted

unexpectedly, 72
Patient Treatment Monitoring Session, 9,

15, 43, 47, 55, 57, 58, 59, 70, 72, 73
Pole Mount, 7, 10
Power Cord, 9, 10, 12, 75
Power Supply Adapter, 9, 10, 12, 75
Print error, 72
Printer Port, 15, 16, 25
Profile, 47, 60
Sensor Obstruction, 72
Station ID, 15, 18, 25
Technical Services, 69, 71
Touch Screen, 7
USB, 11, 25, 37, 39, 41, 53, 64, 65, 70,

71, 73, 76
Verification Filter, 2, 4, 8, 10, 11, 15, 25,

26, 27, 30, 39, 41, 53, 64, 65, 67, 68,

73
Verify Accuracy, 4, 25, 26, 39
Verify Failed, 73
Waiting to print, 73
ZigBee, 16, 19, 71, 75, 76, 77

ΔBV%, 47, 48, 49, 50, 51, 70
ΔBV% greater than 8%, 70

79 P/N CL80050002 Rev D Crit Line IV User’s Guide

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Crit Line IV User’s Guide P/N CL80050002 Rev D