2008T Hemodialysis
Machine with CLiC
User’s GUide
™
Device
2008T Hemodialysis Machine With CLiC Device User’s Guide
© Copyright 2014 - 2016, 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, 2008, DIASAFE, Crit-Line 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.
The 2008T hemodialysis machine is manufactured by:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
(800) 227-2572
The CLiC device is manufactured by:
Fresenius USA, Inc. - Kaysville
695 North 900 West
Kaysville, Utah 84037
(800) 546-5463
Contact Fresenius Medical Care Technical Support for applicable Field Service Bulletins. The spare
parts manual for the model 2008T and other information may be found on our website at
www.fmcna.com
Caution: Federal (US) law restricts this device to sale only by or on the order of a physician.
Caution: Frequency, duration, and parameters of treatment are to be determined by the prescribing
physician.
Note: Not all features are available in all regions.
Indications for Use:
2008T Hemodialysis Machine:
The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy.
Crit-Line Clip Monitor (CLiC) (Optional):
The Crit-Line Clip Monitor is used with the 2008T Hemodialysis Machine to non-invasively measure
hematocrit, oxygen saturation and percent change in blood volume. The CLiC device 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 clinician. 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 complications of dialysis which include nausea,
cramping and vomiting.
The CLiC blood chamber is a sterile, single use, disposable, optical cuvette designed for use with the
CLiC monitor’s sensor clip during acute and chronic hemodialysis therapy to non-invasively measure
hematocrit, percent change in blood volume and oxygen saturation. The blood chamber is connected
between the arterial bloodline and the dialyzer within the extracorporeal circuit during the
hemodialysis treatment.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 1
Table of Contents
Operating Instructions ............................................................................ 3
General Warnings .................................................................................. 3
2008T Hemodialysis Machine with CLiC Device Overview ..........................4
Connecting the Crit-Line Blood Chamber ....................................................6
Connecting the CLiC Device to the Blood Chamber ....................................8
Monitoring the Treatment from the “Crit-Line” Screen .............................. 10
Reading Graphs on the “Crit-Line” Screen ................................................ 12
The Blood Volume (BV) Graph ............................................................. 14
The Oxygen (O2) Saturation Graph ...................................................... 16
The Hematocrit Graph .......................................................................... 18
The Blood Pressure Graph ................................................................... 20
Ending a CLiC Device Monitored Treatment ............................................. 22
CLiC Device Care ...................................................................................... 24
Cleaning and Disinfecting the CLiC Device ......................................... 24
CLiC Device Disposal ........................................................................... 24
Troubleshooting ......................................................................................... 25
Service Mode ............................................................................................ 30
Enabling the CLiC device in Service Mode .......................................... 30
Selecting the Crit-Line Graph Type ...................................................... 30
Calibrating the CLiC device .................................................................. 30
Appendix ................................................................................................... 31
Product Improvement Policy ................................................................ 31
Warranty ............................................................................................... 31
CLiC Spare Parts ................................................................................. 32
Additional Information ........................................................................... 32
Crit-Line in a Clip Specifications ........................................................... 33
Manufacturer’s Electromagnetic Compatibility (EMC) Declaration ...... 34
2 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Operating Instructions
These instructions are for the optional CLiC device. The 2008T
hemodialysis machine hardware must contain Functional Board software
version 2.61 or greater. The CLiC device for the 2008T hemodialysis
machine must only be operated according to these instructions.
For complete instructions on operating the 2008T hemodialysis machine,
refer to the 2008T Hemodialysis Machine Operator’s Manual (P/N
490122).
General Warnings
Warning: The values shown in pictures in this User’s Guide are
for example only. Parameters must be entered as prescribed by
the patient’s physician. Failure to enter correct parameters could
result in serious injury or death.
Caution: The Crit-Line in a Clip (CLiC) device is a sensitive
electro-optical device. Use special care when handling, storing,
or cleaning the device.
Note: The CLiC device is only a tool used to complement a
treatment on the 2008T hemodialysis machine. Operators must
rely on their own clinical assessment of the patient to administer
the treatment, as per the standard of care.
Note: If the 2008T hemodialysis machine displays the message
“Crit-Line needs verification,” 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. After one
minute, the CLiC should be verified.
To verify the CLiC device manually, go to the Dialysis Mode
“Test & Options” screen, select the Verify Crit-Line button, and
press the CONFIRM key. When an ‘X’ appears in the ‘OK’
field, the CLiC device has been successfully verified.
Note: The Crit-Line option must be set to “ON” in Service Mode
in order to use the CLiC device during a hemodialysis treatment.
The Blood Volume or Hematocrit graph option is also set in
Service Mode. The Blood Volume graph is displayed by default.
Note: If the Crit-Line option is selected, the BTM and BVM
module options are not available.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 3
2008T Hemodialysis Machine
with CLiC Device Overview
CLiC
Verification
Filter
Crit-Line in a Clip
USB
Connector
2008T Hemodialysis Machine
“Crit-Line” screen
(CLiC)
Red
Light
Optical
Sensor
Disposable
Crit-Line
Blood
Chamber
4 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
2008T Hemodialysis Machine with CLiC Overview
The CLiC device is used to non-invasively measure a hemodialysis
patient’s hematocrit, oxygen saturation and percent change in blood
volume. These measurements occur in real time in order to provide a more
effective treatment. The measurements are displayed on the 2008T
hemodialysis machine’s “Crit-Line” screen. 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.
The system consists of software for the 2008T hemodialysis machine, a
Crit-Line in a Clip (CLiC) device, a CLiC device-specific verification filter
which is used to calibrate and verify the CLiC device, and a disposable
Crit-Line Blood Chamber.
CLiC Device
The CLiC device connects via a cable with a USB connector to the port on
the right side of the 2008T hemodialysis machine display screen.
The CLiC device contains a sensor that monitors the patient’s hematocrit,
oxygen saturation and percent change in blood volume during dialysis. The
CLiC device clips onto the Crit-Line Blood Chamber which is positioned
between the arterial bloodline and the inlet port of the dialyzer. The CLiC
device shines a red light through the lens of the Crit-Line Blood Chamber
and onto a sensor on the opposite side of the blood chamber. This sensor
detects the level of absorption and scattering of the red light as it is
transmitted through the patient’s blood, which flows through the blood
chamber.
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.
CLiC Verification Filter
The CLiC device features a verification filter unique to each CLiC device.
The verification filter is used to periodically verify the accuracy of the
CLiC device. The CLiC Verification Filter is attached to the CLiC device’s
USB cable. The CLiC device should be securely clipped to the verification
filter when it is not in use.
When the CLiC device is stored on its verification filter, the 2008T
hemodialysis machine automatically verifies the accuracy of the CLiC
device when entering Dialysis Mode.
If the CLiC device is not stored on the CLiC Verification Filter, the device
must be verified at least once per month.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 5
Connecting the Crit-Line
Blood Chamber
1 2 3
6 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
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 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.
3 Continue setting up the bloodlines
Continue to set up the bloodlines as described in Chapter 2, “Connecting
the Extracorporeal Blood Circuit,” in the 2008T Hemodialysis Machine
Operator’s Manual (P/N 490122).
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.
Note: Make sure that no air is in the Crit-Line Blood Chamber
after priming. Any air present in the Crit-Line Blood Chamber
will cause the hematocrit reading to be inaccurate.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 7
Connecting the CLiC Device
to the Blood Chamber
1 2 3
8 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
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 the USB
port located on the right side of the 2008T hemodialysis machine
display screen.
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.
3 Check for proper blood flow before starting the Tx Clock
When starting the blood pump at the beginning of treatment, visually
verify proper blood flow in the extracorporeal circuit, including the CritLine Blood Chamber, before starting the Tx Clock.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 9
Monitoring the Treatment
from the “Crit-Line” Screen
The “Crit-Line” screen showing BV and O
10 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Sat graphs
2
Monitoring the hemodialysis treatment from the “Crit-Line” screen
When the CLiC device is used for treatment with the 2008T hemodialysis
machine, the “Crit-Line” screen replaces the “BTM BVM” screen. Most of
the commonly viewed data from other screens are grouped on the “CritLine” screen for convenient monitoring.
Listed below are the features of the “Crit-Line” screen that can also be
found on other screens.
Feature Description
Art Press Arterial Pressure – The value displayed on the “Home” screen
(mmHg)
Ven Press Venous Pressure – The value displayed on the “Home” screen
(mmHg)
TMP TMP (Transmembrane Pressure) – The value displayed on the
“Home” screen (mmHg)
UF Goal UF Goal – The UF goal selected for the treatment and set on the
“Home” screen (ml)
UF Rate UF Rate – The UF rate selected for the treatment and set on the
“Home” screen (ml/h)
UF Rmvd UF Removed – The UF removed at a given point in the treatment
and displayed on the “Home” screen (ml)
Dial Flow Dialysate Flow – The dialysate flow rate selected for the treatment
and set on the “Home” screen (ml/min). The dialysate flow rate can
also be turned on or off from the “Dialysate” screen.
Temp Temperature – The temperature of the dialysate as displayed on
the “Home” screen (°C)
Cond Conductivity – The conductivity of the dialysate as displayed on the
“Home” screen (mS/cm)
Blood Flow Blood Flow Rate – The current blood pump rate (ml/min)
Hep Rate Heparin Rate – The heparin pump rate set on the “Heparin” screen
(ml/h)
Note: As on the “Heparin” screen, this value will flash when the
heparin pump is off unless both the “Heparin” screen Rate and
Infusion Time buttons are set to 0 (zero).
Kecn Kecn – The current Kecn (amount of sodium clearance)
measurement. The Kecn is also displayed on the “Kt/V AF”
screen’s “OLC Data” subscreen.
Treatment (Tx) Clock – This button runs or pauses the treatment
and displays the Remaining Time of Dialysis (RTD). The green
segment of the pie chart represents the amount of treatment
completed and grows as the treatment progresses. A Tx Clock
button and an RTD button to set the RTD are also located on the
“Home” screen.
For a full description of these buttons, see the 2008T Hemodialysis
Machine Operator’s Manual (P/N 490122).
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 11
Reading Graphs on the “CritLine” Screen
The “Crit-Line” screen showing BV and O
Sat graphs with markers
2
The “Crit-Line” screen showing Hct and BP graphs with markers
12 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Reading Graphs on the “Crit-Line” Screen
The “Crit-Line” screen can display either Blood Volume (BV) or
Hematocrit (Hct) on the upper graph depending on the Service Mode
setting.
On the lower graph, the Oxygen Saturation (O2 Sat) graph can be changed
to display blood pressures by selecting the graph and pressing the
CONFIRM key.
The BV and O2 Sat graphs are displayed by default.
Graphing of the data begins after the CLiC device reads blood sensed and
the hematocrit has been stable for sixty seconds with the Tx Clock and
blood pump running. Graphs are displayed for a minimum of four (default)
and a maximum of ten hours. The Hct and O
vertically during the treatment depending on the min/max values and alert
levels.
Listed below are features common to all graph displays:
Feature Function
Elapsed Time – The time the Tx Clock and CLiC device are
running. If the Tx Clock is paused or an event pauses the
treatment (such as blood alarms), then the Elapsed Time is
paused along with CLiC device data collection.
Sat graphs are resized
2
Initial Hct – The initial hematocrit (Hct) value is recorded
along with the first data point when graphing begins.
Initial est. Hb – The estimated initial hemoglobin (Hb) value
is recorded along with the first data point when graphing
begins. It is calculated based on the hematocrit reading.
Markers button – Selecting this button displays a menu to
insert an event marker on the BV (or Hct) and O
Use the or (up or down) keys on the keyboard to select
either ‘Symptom’ or ‘Intervention’. Pressing the CONFIRM
key places the marker and the current ∆BV%, Hct, and
oxygen saturation values on the latest point on the graph;
pressing the Escape key exits the menu without placing a
marker.
The Symptom marker is displayed as a yellow diamond
The Intervention marker is displayed as a black
triangle
Note: Markers can only be set at a minimum of ten minute
intervals (depending on graph size) and when the Tx Clock
is running and the CLiC device is not disabled. Resizing the
graph may cause markers to rotate in order to better fit the
space depending on the limits. If there is not enough space
between markers, the machine will not place a marker in
order to prevent overlap.
Sat graphs.
2
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 13
The Blood Volume (BV)
Graph
The “Crit-Line” screen showing BV and O
14 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Sat graphs
2
The BV (Blood Volume) graph
Note: The BV graph is the default upper graph displayed on the
“Crit-Line” screen. To display the Hct graph instead of the BV
graph, call a qualified service technician.
The BV (Blood Volume) graph is displayed as a fill graph. A line is filled
from 0 to the ΔBV% value. As the dialysis treatment progresses, fluid is
taken out of the blood by the 2008T 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 alert level. The BV alert level is drawn as a blue dotted line across the
BV graph.
The following is displayed to the right of the BV graph:
Feature Function
Current blood volume change profile – The profile starts
calculating after the first two blood volume measurements and
is computed over the previous 15 minutes of data. The profile
can be:
A BV change is less than or equal to -3% per hour
B BV change is more than -3% and less than or equal to
C BV change exceeds -6.5% per hour
(default)
-6.5% per hour
Current Hematocrit value.
Current estimated Hemoglobin value calculated from the
current Hematocrit:
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% =
BV Alert Level button – Sets the BV (Blood Volume) Alert
Level (under physician direction). When the current ∆BV%
drops below the set BV alert level, the 2008T hemodialysis
machine stops the UF pump and displays the alert message
“Rel. Blood Volume Low”. The alert can be cleared by lowering
the alert level or by setting the BV Alert Level to OFF. After
clearing the alert, the UF pump will automatically turn back on
to the UF Rate set on the “Home” screen.
To set the BV Alert Level, select the BV Alert Level button
and enter the desired value using the or (up or down)
keys or the numbers on the keyboard and press the CONFIRM
key. To turn the BV Alert level OFF, enter “0” (zero) on the
keyboard and press the CONFIRM key.
The BV Alert Level can be set from -1 to -20 or 0 for OFF. The
default setting is -15. The BV alert level is drawn as a blue
dotted line across the BV graph.
[(Hct initial/Hct current) – 1] x 100
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 15
The Oxygen (O2) Saturation
Graph
The “Crit-Line” screen showing BV and O2 Sat graphs
16 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
The O2 Sat (Oxygen Saturation) graph
Oxygen saturation is the default display on the “Crit-Line” screen’s bottom
graph.
Note: If blood pressure readings are displayed instead of the
measured oxygen saturation, touch or select the Blood Pressure
graph on the screen. The message “Press Confirm to switch to
O2 graph. Press Escape to return to BP graph.” is
displayed. Press the CONFIRM key to confirm the selection.
To switch back to the Blood Pressure graph, select the graph
again and press the CONFIRM key to confirm the selection.
The O2 Sat (Oxygen Saturation) graph is a line graph drawn from the
previous oxygen saturation value. The O
dotted line across the Oxygen Saturation graph.
The following is displayed to the right of the Oxygen Saturation graph:
Feature Function
Current Oxygen Saturation value.
Alert Level is drawn as a green
2
Minimum Oxygen Saturation – The minimum oxygen
saturation value over all data points.
O2 Alert Level button – This button sets the oxygen saturation
alert level. When the current O
Alert Level, the alert message “Oxygen Saturation Low” is
displayed in the Status Box. The alert can be cleared by
lowering the alert level or by setting the O
To set the O2 Alert Level, select the O2 Alert Level button and
enter the desired value using the or (up or down) keys or
the numbers on the keyboard and press the CONFIRM key.
To turn the O
keyboard and press the CONFIRM key.
The O2 Alert Level defaults to 89 and can be set from 45 to 95.
Setting the O
Alert Level OFF.
Alert level OFF, enter “0” (zero) on the
2
Alert Level to any value 44 or lower turns the O2
2
Sat value drops below the O2
2
Alert Level to OFF.
2
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 17
The Hematocrit Graph
The “Crit-Line” screen showing Hct and O
18 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Sat graphs
2
The Hct (Hematocrit) graph
Note: To display the Hematocrit graph on the “Crit-Line” screen
instead of the default BV graph, call a qualified service
technician.
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 2008T 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.
The Hematocrit Alert Level is drawn as a black 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, on page 15 for
more information). The line will appear on the graph after the initial Hct is
determined. When the alert is triggered, 2008T hemodialysis machine
stops the UF pump and displays the alert message “Rel. Blood Volume
Low”. The alert can be cleared by lowering the alert level or by setting the
BV Alert Level to OFF. After clearing the alert, the UF pump will
automatically turn back on to the UF Rate set on the “Home” screen.
To set the BV Alert Level, select the BV Alert Level button and enter the
desired value using the or (up or down) keys or the numbers on the
keyboard and press the CONFIRM key. To turn the BV Alert level OFF,
enter “0” (zero) on the keyboard and press the CONFIRM key.
The following features pertain to the Hematocrit graph:
Feature Function
Initial Hct – The initial hematocrit (Hct) value is recorded
along with the first data point when graphing begins.
Initial est. Hb – The estimated initial hemoglobin (Hb) value
is recorded along with the first data point when graphing
begins. It is calculated based on the hematocrit reading.
Current blood volume change profile – See page 15 for
more information.
Current Hematocrit value.
Current estimated Hemoglobin value calculated from the
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 19
current Hematocrit:
Hb = Hct/2.94
Blood Volume Change – See page 15 for more information.
The Blood Pressure Graph
The “Crit-Line” screen showing BV and Blood Pressure graphs
20 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Displaying blood pressure on the “Crit-Line” screen
Blood Pressure readings can be displayed instead of the measured Oxygen
Saturation. To change the O
(Blood Pressure) graph, touch or select the O
Sat (Oxygen Saturation) graph to the BP
2
Sat graph on the screen. The
2
message “Press Confirm to switch to Blood Pressure graph. Press
Escape to return to O2 graph.” is displayed. Press the CONFIRM key
to confirm the selection.
To switch back to the O2 Sat graph, select the graph again and press the
CONFIRM key to confirm the selection.
Reading the blood pressure graph on the “Crit-Line” screen
Similar to the Blood Pressure graph on the “Trends” and “Blood Pressure”
screens, the BP (Blood Pressure) graph is drawn as a series of black
dumbbells between the systolic and diastolic blood pressures. On the “CritLine” screen, the systolic (upper) and diastolic (lower) numbers are also
displayed. If the value is out of range (as specified by the parameters on the
“Blood Pressure” screen), the dumbbell will be drawn in red. Blood
pressure readings are recorded only when the treatment clock is running.
Note: If there is not enough space between blood pressure
measurements, the graph will not display a measurement in order
to prevent overlap.
Note: Markers do not appear on the Blood Pressure graph.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 21
Ending a CLiC Device
Monitored Treatment
22 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Ending a CLiC device monitored treatment
When the treatment is complete and the Tx Clock is paused, 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.
Printing a treatment report
When RTD is zero and the Tx Clock is paused, a Print button will appear
on the “Crit-Line” screen in place of the Markers button.
To clear the data on the “Crit-Line” screen without printing, press the New
Tx key and then press the CONFIRM key.
See the “CLiC Spare Parts” section on page 32 for information on kits
necessary to connect and use a printer.
The image on the facing page is an example of a CLiC device monitored
treatment printout; below is an explanation:
Item Description
S/N The CLiC device’s four digit serial number (printed on the
device’s verification filter).
Patient ID The first 6 digits of the “Test & Options” screen Patient ID
number. This is the unique identifier for this report.
Note: If the Patient ID is fewer than 6 digits long, or if there is
no Patient ID, this field will display six ones (“111111”).
Hct (start) The initial hematocrit (Hct) value is recorded along with the
first data point when graphing begins.
Hct (max) The highest level of hematocrit during treatment.
Hct Limit The hematocrit limit (indirectly set based on the BV Alert
Level on the “Crit-Line” screen).
~Hgb (start) The estimated initial hemoglobin (Hb) value recorded along
with the first data point when graphing began.
Sat (min) The minimum oxygen saturation value over all data points.
Station ID Not applicable.
Date The date of the treatment.
Start Time The time the dialysis treatment began.
Stop Time The time the dialysis treatment ended.
Calibration Date The date the CLiC device was factory calibrated.
Last Verification
Date
The last date the CLiC device was verified for accuracy in
Dialysis Mode.
HCT Graph Hematocrit graph
%BV Graph Blood Volume graph
SAT% Graph Oxygen Saturation graph
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 23
CLiC Device Care
Cleaning and Disinfecting the CLiC Device
The CLiC device is a sensitive electro-optical device. Use care when
cleaning the device and the verification filter so as not to damage them.
The exterior of the CLiC device, verification filter, and the 2008T
hemodialysis machine should be cleaned after every treatment. These can
all be cleaned with very dilute bleach or 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 CLiC device with a cloth dampened with the
cleaning solution; do not spray the solution on the 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
CLiC device. Doing so may damage the sensor.
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 the verification test.
If the CLiC device becomes contaminated with blood, it 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.
CLiC Device Disposal
If the CLiC device continues to fail the verification test 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.
24 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Troubleshooting
The following troubleshooting section is a guide to help you troubleshoot
CLiC device alerts, warnings, or advisory messages. For a complete list of
2008T hemodialysis machine messages, please see the Troubleshooting
section of the 2008T Hemodialysis Machine Operator’s Manual, P/N
490122.
Messages shown in the 2008T hemodialysis machine software are listed
alphabetically. These messages are triggered by conditions and events
related to the use of the CLiC device that occur in the machine 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 alert, warning or advisory messages displayed. An alert,
warning or advisory message may stop the UF Pump until the
conditions causing these messages are corrected and cleared. The
dialysis treatment will continue during these messages.
Note: CLiC devices taken out of service should be tested and
repaired by a qualified service technician.
Note: If you have any questions, please call Fresenius Medical
Care Technical Support anytime at (800) 227-2572.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 25
hemodialysis machine’s USB port.
cannot be used until the next treatment.
its USB cable.
clears, the CLiC device is verified.
select the Verify Crit-Line button to initiate the verification process
manually.
for the dialysis treatment. Disconnect the CLiC device cable from
the USB port and contact a qualified service technician.
attached to its USB cable.
clears, the CLiC device is verified.
Crit-Line button to start the verification process manually.
Make sure the cable is securely connected to the 2008T
Wait up to one minute for the message to clear.
Check the CLiC device’s USB cable:
Advisory
message
The 2008T hemodialysis
machine has not received
data from the CLiC device.
The Status Box displays the
warning message “Crit-Line:
Disconnect the CLiC device cable from the USB port.
Press the ‘Y’ key on the Keyboard to disable the CLiC device.
If the Status Box warning message “Crit-Line: No Comm” is not cleared, the
CLiC device cannot be used for the dialysis treatment.
No Comm”
Contact a qualified service technician.
The CLiC device is not monitoring the patient. The CLiC device
If this message is displayed during the treatment:
Advisory
message
The CLiC device must be
verified before it is available
for use during treatment.
Place the CLiC device on the verification filter, which is attached to
Wait up to one minute for the message to clear. If the message
If verification fails, select the “Test & Options” screen-button and
If the message is displayed before the treatment starts:
If the message is still not cleared, the CLiC device cannot be used
Place the CLiC device on the CLiC Verification Filter, which is
Wait up to one minute for the message to clear. If the message
Verify the CLiC device:
Advisory
message
The CLiC device has not been
verified within the past 30
days. The Hct/BV graph on
the “Crit-Line” screen will be
disabled.
Select the “Test & Options” screen-button then select the Verify
If the message is not cleared:
Wait up to one minute for the message to clear.
Disconnect the CLiC device cable from the USB port.
Contact a qualified service technician.
If the message is still not cleared, the CLiC device cannot be used for the
dialysis treatment.
26 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Message Purpose of Message Type Action Required
Check cable or press
‘Y’ to disable Crit-Line
Crit-Line disabled.
Must verify Crit-Line.
Crit-Line needs
verification
bubbles in the chamber.
Chamber: The device should be placed perpendicularly over the
chamber and cannot be rotated up or down.
RESET key to disable the CLiC device.
hemodialysis machine’s USB port.
obstructions.
Make sure there is proper blood flow: There should be no air or
Make sure the CLiC device is properly seated on the Crit-Line Blood
If the message is not cleared, the CLiC device cannot be used for the
dialysis treatment.
Warning Check the Crit-Line Blood Chamber:
the CLiC device no longer
senses blood in the Crit-Line
Blood Chamber.
Remove the device from the Crit-Line Blood Chamber.
Disconnect the CLiC device cable from the USB port and press the
Contact a qualified service technician.
Make sure the cable is securely connected to the 2008T
Wait up to one minute for the message to clear.
Warning Check the CLiC device’s USB cable:
machine has not received
data from the CLiC device.
Disconnect the CLiC device cable from the USB port.
Press the ‘Y’ key on the Keyboard to disable the CLiC device.
Contact a qualified service technician.
If the message is not cleared, the CLiC device cannot be used for the
dialysis treatment.
Remove the CLiC device from the blood chamber and check for
Warning Check the Crit-Line Blood Chamber:
CLiC device’s optical sensor.
Reattach the CLiC device to the blood chamber.
Wait up to one minute for the message to clear.
Remove the CLiC device from the Crit-Line Blood Chamber.
Disconnect the CLiC device cable from the USB port.
Press the RESET key to disable the CLiC device.
If the message is not cleared, the CLiC device cannot be used for the
dialysis treatment.
Contact a qualified service technician.
Place the CLiC device on the CLiC Verification Filter, which is attached to
its USB cable.
Advisory
message
device must be clipped to its
verification filter.
Message Purpose of Message Type Action Required
Crit-Line: No Blood The Tx Clock is running and
Crit-Line: No Comm The 2008T hemodialysis
Crit-Line: Obstruction Something is blocking the
Crit-Line on Filter? To verify the CLiC device, the
27 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Disconnect the CLiC device cable from the USB port.
Press the RESET key to disable the CLiC device.
Contact a qualified service technician.
No action required. The CLiC device is ready for use during treatment.
Alert Level can be
2
Alert Level button,
2
Alert Level button on the “Crit-
2
Alert level OFF, select the O
2
Note: If you press the New TX key and then press the CONFIRM
key, the Crit-Line data for the completed treatment will be lost.
Note: At the direction of a physician, a new O
enter “0” (zero) on the keyboard, and press the CONFIRM key.
To turn the O
The alert can be cleared by setting the O
printer and try to print again. If unable to print, contact a qualified service
technician.
Line” screen to OFF.
Alert Level button,
2
Alert Level, select the O
2
enter the desired value using the keyboard and press the
selected.
To change the O
CONFIRM key.
Press the CONFIRM key to switch to the Blood Pressure graph.
Or
Press the CONFIRM key to switch to the Oxygen Saturation graph.
Or
Press the Escape key to return to the Oxygen Saturation graph.
Press the Escape key to return to the Blood Pressure graph.
Advisory
Warning Press the RESET key to clear the warning. Check the connections to the
message
Advisory
message
Sat
Alert Level set on the
2
Sat graph field on the “Crit-
System error. Warning The CLiC device cannot be used for the dialysis treatment.
28 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Message Purpose of Message Type Action Required
Crit-Line: System
Error
successful.
Crit-Line Verified The verification test was
report was not printed.
Failed To Print The CLiC device treatment
The current Oxygen
Oxygen Saturation
Saturation has dropped below
Low
“Crit-Line” screen.
the O
2
The operator has selected the
O
Line” screen; the machine is
prompting the operator to
choose between displaying
the BP graph or the O
graph
Press Confirm to
switch to Blood
Pressure graph.
Press Escape to
return to O2
Advisory
message
2
The operator has selected the
graph.
BP graph field on the “Crit-
Press Confirm to
switch to O2 graph.
Sat graph or the BP
2
choose between displaying
graph.
the O
Line” screen; the machine is
prompting the operator to
Press Escape to
return to BP graph.
Alert Assess the patient for any changes in physiologic state.
Note: At the direction of a physician, a new BV Alert Level can be
selected.
To change the BV Alert Level, select the BV Alert Level button,
enter the desired value using the keyboard and press the
enter “0” (zero) on the keyboard, and press the CONFIRM key.
to the UF Rate set on the “Home” screen.
To turn the BV Alert level OFF, select the BV Alert Level button,
After clearing the alert, the UF pump will automatically turn back on
CONFIRM key.
Place the CLiC device on the CLiC Verification Filter, which is
attached to its USB cable.
clears, the CLiC device is verified.
Wait up to one minute for the message to clear. If the message
Crit-Line button. This will start the verification process manually.
Wait up to one minute for the message to clear.
Select the “Test & Options” screen-button then select the Verify
Disconnect the CLiC device cable from the USB port.
Press the RESET key to disable the CLiC device.
Contact a qualified service technician.
The alert can be cleared by setting the BV Alert Level button on the “Crit-
Line” screen to OFF.
Alert Assess the patient for any changes in physiologic state.
The current blood volume
percentage or hematocrit has
dropped below the BV Alert
Level set on the “Crit-Line”
screen. The UF pump has
been turned off.
Verify the CLiC device:
Advisory
message
that the CLiC device is not
ready for use during
treatment.
If the message is not cleared:
If the message is still not cleared, the CLiC device cannot be used for the
dialysis treatment.
Message Purpose of Message Type Action Required
Rel. Blood Volume
Low
Verify Failed The verification test shows
29 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Service Mode
Note: This section describes setting Crit-Line screens and
calibrating the CLiC device in Service Mode. It is strongly
recommended that you contact a qualified service technician if
any Service Mode changes must be made.
Enabling the CLiC device in Service Mode
The Crit-Line option must be set to ‘Yes’ in Service Mode in order to use
the CLiC device during a hemodialysis treatment. The Crit-Line option is
located on the Service Mode “Options: Module Options” screen. Note that
the BTM and BVM module options are unavailable if Crit-Line is selected.
Selecting the Crit-Line Graph Type
The default “Crit-Line” screen graph is the BV (Blood Volume) Graph. To
change the graph, enter the “Options: Module Options” screen in Service
Mode and use the Crit-Line Graph button to choose between Hct
(Hematocrit) and BV (Blood Volume) graphs. Press the CONFIRM key
to confirm the selection.
Calibrating the CLiC device
The CLiC device only needs calibration if verification fails in Dialysis
Mode. Calibration may extend the usable life of the CLiC device. To
calibrate the CLiC device, plug the CLiC device USB cable into the USB
port on the right side of the 2008T hemodialysis machine display screen
(located under the flap). Power on the 2008T hemodialysis machine into
Service Mode and go to the “Options: Calibrate Monitor” screen. Select
the Crit-Line Calibration screen-button to enter the “Crit-Line
Calibration” screen. Follow the instructions on the screen:
1. After the initial message “Initializing CLiC…” clears, attach the CLiC
device to the verification filter on its USB cable.
2. Enter the serial number printed on the verification filter by selecting the
Crit-Line S/N button and using the keyboard. Note that the serial
number is case-sensitive. Press Enter on the keyboard to continue.
3. Press the CONFIRM key to calibrate the CLiC device. After the
message “Calibrating…” clears, the message “Calibration
30 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
successful” should appear.
Do not disconnect the CLiC device at any time during the calibration
process. If the message “Calibration failed” appears, disconnect the
device and do not use it for treatment.
Appendix
Product Improvement Policy
The CLiC device was designed and built to comply with these product
specifications. It is the intention of Fresenius USA Marketing, Inc. 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 USA Marketing,
Inc., (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 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.
Routine maintenance is not covered under warranty. Modifications,
alterations, installation and service by any other than a Fresenius USA
Marketing, Inc. authorized representative may void the warranty.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 31
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.
CLiC Spare Parts
CLiC device P/N CL10041001
Crit-Line Blood Chamber P/N CL10041021
CLiC Holder P/N 290760
Crit-Line Printer Client Kit P/N 190929
Crit-Line Printer Server Kit P/N 190930
Note: Call Fresenius Medical Care Customer Service Spare Parts
at (800) 227-2572.
Additional Information
For more information, please contact:
Fresenius USA, Inc.
4040 Nelson Avenue
Concord, CA 94520
Manufactured by Fresenius USA, Inc. - Kaysville
695 North 900 West
Kaysville, Utah 84037
(800) 227-2572 (800) 546-5463
32 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Crit-Line in a Clip Specifications
Dimensions 1.75”H, 1.00”W, 3.00”L
Weight 0.25 lbs.
Cable length 42”
Operating Temperature 50 °F to 104 °F (10 °C to 40 °C)
Unit will be warm to the touch during use
(max. 55.3 °C @ 40 °C ambient)
Storage and Transportation Temperature -40 °F to 257 °F (-40 °C to 125 °C)
Oxygen Saturation Instrument Range &
Accuracy
@ Hct Accurate
within ± 3%
Accurate
within ± 5%
45 – 60 60 – 100 50 – 100
20 – 45 50 – 100 30 – 100
10 – 20 Not Specified 40 – 100
Hematocrit Instrument Range & Accuracy 10 Hct – 60 Hct: ± 1 Hct SD
Power 5 VDC / MAX 0.36A, USB bus powered
Water Ingress Protection IPX0 (CLiC device)
IPX1 (2008T hemodialysis machine)
Anesthetic Suitability Not suitable
Modes of Operation Continuous or Standby
Note: The CLiC device is a Clinical Laboratory Improvement Amendment (CLIA) exempt
instrumentation device
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 33
–
Manufacturer’s Electromagnetic Compatibility (EMC) Declaration
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 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or user of the 2008T hemodialysis machine should ensure it is used in such an environment.
Emissions test Compliance Electromagnetic environment –guidance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Guidance and manufacturer’s declaration –electromagnetic emissions
Group 1 The 2008T hemodialysis machine uses RF energy only for its internal
functions. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Class A The 2008T hemodialysis machine is suitable for use in all establishments
other than domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic purposes.
Harmonic
emissions
Not
applicable
IEC 61000-3-2
Voltage
fluctuations/
Not
applicable
flicker emissions
IEC 61000-3-3
Guidance and manufacturer’s declaration –electromagnetic immunity
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T hemodialysis machine should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment
guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC 61000-4-5
Voltage Dips, short
interruptions, and
voltage variation on
power supply input
lines
IEC 61000-4-11
Power-Frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTEUT is the a.c. mains voltage prior to application of the test level.
±6 kV contact
±8 kV air
(Level 3)
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % UT
(>95 % dip in U
)
T
for 0.5 cycles
40 % U
(60 % dip in U
T
)
T
for 5 cycles
70 % U
(30 % dip in U
T
)
T
for 25 cycles
<5 % U
(>95 % dip in U
T
)
T
for 5 seconds
±6 kV contact
±8 kV air
(Level 3)
±2 kV for power
supply lines
±1 kV for input/output
lines
±1 kV line(s) to line(s)
±2 kV line(s) to earth
<5 % U
(>95 % dip in U
for 0.5 cycles
40 % U
(60 % dip in U
for 5 cycles
70 % U
(30 % dip in U
for 25 cycles
<5 % U
(>95 % dip in U
for 5 seconds
3 A/m 3 A/m
Floors should be wood, concrete, or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Mains power quality should be that of
a typical commercial and/or hospital
environment.
Mains power quality should be that of
a typical commercial or hospital
environment.
T
)
T
Mains power quality should be that of
a typical commercial or hospital
environment. If the user of the 2008T
T
)
T
hemodialysis machine requires
continued operation during power
mains interruptions, it is recommended
that the 2008T hemodialysis machine
T
T
)
T
)
T
be powered from an uninterruptible
power supply or a battery.
Power frequency magnetic fields
should be at levels characteristic of a
typical location in a typical commercial
or hospital environment.
34 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Guidance and manufacturer’s declaration –electromagnetic immunity
The 2008T hemodialysis machine is intended for use in the electromagnetic environment specified below. The
customer or the user of the 2008T hemodialysis machine should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any part
of the 2008T hemodialysis machine, including
cables, than the recommended separation
distance calculated from the equation
applicable to the frequency of the transmitter.
If abnormal performance is observed such as
TMP alarms or blood leak alarms, additional
measures may be necessary, such as reorienting or relocating the equipment.
Recommended separation distance
Conducted RF
IEC61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
1.2
P
1.2
P80 MHz to 800 MHz
2.3 P 800 MHz to 2.5 GHz
where P is the maximum output power rating of
the transmitter in watts (W) according to the
transmitter manufacturer and d is the
recommended separation distance in meters
(m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey,a
should be less than the compliance level in
each frequency range. b
Interference may occur in the
vicinity of High Frequency Surgical
Equipment (such as electrocautery
devices) or other intentional radio
frequency emitting equipment
typically marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which the
2008T hemodialysis machine is used exceeds the applicable RF compliance level above, the2008T
hemodialysis machine should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as re-orienting or relocating the 2008T hemodialysis machine.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
2008T Hemodialysis Machine with CLiC Device User’s Guide P/N 490206 Rev E 35
r
portable and mobile RF communications equipment and the 2008T hemodialysis machine
The 2008T hemodialysis machine is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the 2008T hemodialysis machine can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 2008T hemodialysis machine as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output power of
transmitter
W
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects, and people.
Recommended separation distances between
Separation distance according to frequency of transmitte
m
150 kHz to 80 MHz
d = 1.2 P
80 MHz to 800 MHz
d = 1.2 P
800 MHz to 2.5 GHz
d = 2.3 P
CDX System Wifi Adapter
IEEE802.11b/g Adapter
Radio Frequency (RF): 2.412 Ghz to 2.462 Ghz
Power: 61mW
Modulation: Direct Sequence Spread Spectrum, Orthogonal Frequency Division
Multiplexing
IEEE802.11b/g/n dual band Adapter
Radio Frequency (RF): 2.412 Ghz to 2.462 Ghz, 5.18 Ghz to 5.825 Ghz
Power: 110mW
Modulation: Direct Sequence Spread Spectrum, Orthogonal Frequency Division
Multiplexing
CLiC Wireless Printer
Radio Frequency (RF): 902.217 Mhz to 927.492 Mhz
Power: 52mW
Modulation: Frequency Hopping Spread Spectrum Frequency Shift Keying
36 P/N 490206 Rev E 2008T Hemodialysis Machine with CLiC Device User’s Guide
Indications for Use: The 2008T machine is indicated for acute and chronic dialysis therapy. The CLiC device is used with the 2008T
hemodialysis machine to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume. The CLiC device
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 clinician. 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 complications of dialysis which include nausea, cramping and vomiting. The CLiC blood chamber is a sterile, single use, disposable,
optical cuvette designed for use with the CLiC monitor’s sensor clip during acute and chronic hemodialysis therapy to non-invasively
measure hematocrit, percent change in blood volume and oxygen saturation. The blood chamber is connected between the arterial
bloodline and the dialyzer within the extracorporeal circuit during the hemodialysis treatment.
Caution: Federal (US) law restricts these devices to sale by or on the order of a physician.
Note: Read the Instructions for Use for safe and proper use of these devices. For a complete description of hazards, contraindications,
side effects and precautions, see full package labeling at www.fmcna.com.
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