Diapact® CRRT 16 Appendix

Table of contents

16 Appendix.................................................................................................................................................16-3
16.1 Haemoperfusion - Introduction .......................................................................................................16-3
16.2 Switching on and Initial Tests ..........................................................................................................16-4
16.3 Therapy Selection.................................................................................................................................16-5
16.4 Preparation ............................................................................................................................................16-6
16.4.1 Installation of Consumable Material..............................................................................................16-6
16.5 Priming..................................................................................................................................................16-12
16.5.1 Connection of Adsorber to Blood Lines .......................................................................................16-13
16.5.2 Disconnection of Ultrafiltration Line............................................................................................16-14
16.5.3 Rinsing of Adsorber ...........................................................................................................................16-15
16.5.4 Alarms ...................................................................................................................................................16-17
16.5.5 Setting UF Rate to Zero....................................................................................................................16-18
16.5.6 Setting Treatment Parameters .......................................................................................................16-19
16.5.7 Menu Selection in Preparation.......................................................................................................16-20
16.6 Therapy..................................................................................................................................................16-20
16.6.1 Connecting the Patient ....................................................................................................................16-21
16.6.2 Start of Therapy..................................................................................................................................16-22
16.6.3 Menu Selection in Therapy..............................................................................................................16-22
16.7 End of Therapy ....................................................................................................................................16-24
16.7.1 Disconnecting the Patient ...............................................................................................................16-24
16.7.2 Menu Selection at End of Therapy ................................................................................................16-25
16.8 Special Functions ...............................................................................................................................16-26

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16 Appendix

16.1 Haemoperfusion - Introduction

When using the Diapact® CRRT to perform Haemoperfusion the SCUF mode – to be selected under dialysis
therapies, continuous (see page 16-5) – is used with a different set-up. During all the steps SCUF will be
displayed on the screen as therapy mode selected.

The instructions on the screen will describe SCUF. Please follow this Instructions for Use carefully
for Haemoperfusion as there are some changes in the order of steps to be carried out that differ
from the SCUF screens displayed.

Please note it is of absolute importance that you follow manufacturer’s instructions for use for all the products.

Description
In Haemoperfusion therapy the Diapact® CRRT machine pumps blood from the vascular access of the patient via
an extracorporeal circuit through the Adsorber. Life threatening toxins are removed as the blood passes over the
adsorbent surface and the treated blood is returned to the patient.

Blood side
Blood pump

Adsorber

Venous
chamber

Indication

The Haemoperfusion is indicated for the removal of life threatening toxic substances from the patient’s blood.
The attending physician is responsible for choosing the suitable therapy, based on medical and analytical findings
and the general health and condition of the patient.

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16.2 Switching on and Initial Tests

¾ Switch on the Diapact® CRRT with the power switch
ON/OFF (I/O) on the back of the machine.
The device starts with the ROM test.

¾ Check whether the and keys

are lit during the ROM test.

The ROM test is followed by the display test.

¾ Compare the character lines in the supervisor field
and confirm by pressing the

key if both series are identical.

¾ While the key is being pressed, the buzzer of

the safety system is activated for 2 seconds.
¾ Check that the buzzer can be heard.

If the display test is passed successfully, the empty

loadcell test follows.
¾ Check whether the bag holder is empty.
¾ Confirm the weight values with the

key if they are within the allowed range. The

maximum deviation between both displayed values
is allowed to be ±60 g and the values must not
exceed -60 and +60 g.

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16.3 Therapy Selection

Having successfully passed the initial selftests, the
machine switches to the <THERAPY SELECTION>
screen to select the therapy mode.
<CONTINUOUS> dialysis therapies is selected by
default.
¾ Confirm <CONTINUOUS> with the

key.

The following screen displays the possible therapy

options.

<CVVH> is selected by default.

¾ Select <SCUF> using the

or the key.
¾ Confirm the selection with the

key.

The key lights up and SCUF is displayed in

the supervisor field.

¾ Press the key for final confirmation of the

selected therapy modality.

If the selection after the confirmation with the

key is not finally confirmed with the

key, the device returns automatically to the

<THERAPY SELECTION> screen where the therapy
mode can be selected.

Back selection

Moving with the or keys to

<BACK SELECTION> and confirmation with

allows to return to the screen where the

therapy mode can be selected.

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16.4 Preparation
After modality selection and confirmation, the display
shows the following <PREPARATION> screen.
Several tests are performed. The respective test is
displayed in the therapy status field:

• Power relay test

• SAD reference test
• SAD counter test
• Red detector test
• Blood leak detector test
• Zero pressure test

16.4.1 Installation of Consumable Material

When the tests have been performed successfully, the
<PREPARATION> screen displays <Device test
finished> and the steps to set-up the machine are
displayed.
The consumable material for the therapy comprises of:
• SCUF kit
• Haemoperfusion by-pass/cap, art. no. 7210956
• 2L isotonic sodium chloride solution
• Adsorber (Charcoal Cartridge) + consumable
materials specified by Adsorber manufacturer
e.g. I.V 5 % glucose and heparinised isotonic
sodium chloride solution
• 500 ml sodium chloride solution for re-infusion
at end of therapy.
• 2 Scissor clamps
¾ Follow the instruction steps 1, 3, 4, 5, 6, 7 on the
screen. Do not place adsorber in filter holder. Set-up
the device as described in the following:

The lines of the SCUF kit are colour-coded to facilitate the set-up.
• Arterial line (red)
• Venous line (blue)
• Ultrafiltration line (yellow)

Pumps used:
• Blood pump (MP1)
• Ultrafiltration pump (MP2) (during priming and rinsing only)

Risk of infection and blood loss for the patient by damaged packaging or components
or incorrect handling of disposables
¾ Only open the packaging of the disposables just before its use.
WARNING ¾ Use aseptic technique when handling disposables.
¾ Ensure during set-up that the packaging of the material used (line system,
adsorber, solution bags) is undamaged.
¾ During set-up check the material for integrity.
¾ Observe the respective instructions for use.

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Installation of bags
¾ Attach the 2L bag with isotonic sodium chloride
solution and the collecting bag to the bag holder of the
load cell.
¾ Close the clamp of the outlet on collecting bag (the
tube equipped with the plug at the lower position)

If the weight on the load cell is unevenly distributed, there is a risk that the device
may topple.
¾ Distribute weight on the bag holder evenly.
CAUTION The maximal load of the load cell is 27 kg.

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Insertion of the arterial line (red)

¾ Connect the end of the line with the spike/Luer Lock
connector to the bag of isotonic sodium chloride Solution
on the bag holder of the load cell.
¾ Insert the pump segment into the blood pump (MP1).
¾ Connect the transducer protector before the blood pump
to the pressure sensor PA (red).
¾ Insert the arterial air trap into the intended holder.
¾ Connect the transducer protector to the pressure sensor
PBE (red).
¾ Connect the red Luer Lock connector of the arterial line to
the adsorber by-pass adapter and hang it over the filter
holder.
¾ If continuous heparinisation is required, connect the
heparin line to the external heparin pump previously filled
with heparin. For further information regarding
anticoagulation setting please refer to chapter 11,
Perfusor Interface.
¾ Close the clamp of the heparin line if it is not used.
¾ Close the clamps at the sampling ports before the blood
pump (MP1).

Do not connect the arterial line to the adsorber before priming.

Removal of air is important to prevent loss of surface area.

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Insertion of the ultrafiltration line (yellow)

¾ Remove the Hansen connector and connect the line to
the arterial line (red) behind the blood pump (Post-
Blood pump port).
¾ Ensure that the clamp on the post-blood pump port of
arterial line (red) is unclamped.
¾ Insert the line into the blood leak detector (BLD).
¾ Insert the pump segment into the ultrafiltration pump
(MP2).
¾ Connect the transducer protector to the pressure
sensor PSC/PD2 (white).
¾ Connect the Luer Lock connector to the collecting bag
attached to the load cell.

Ensure closure of the clamp of the collecting bag outlet (the tube equipped with the plug at the
lower position).

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Insertion of the venous line (blue)

¾ Attach the rinsing bag to the infusion pole.
¾ Insert the venous air trap into the intended holder and fix
the venous line in the line fixing above the pumps.
¾ Insert the venous line beneath the drip chamber into the
safety air detector (SAD) and the safety air clamp (SAK)
under the detector.
¾ Connect the transducer protector to the pressure sensor
PV (blue).
¾ Connect the blue Luer Lock connector to the other end of
the adsorber by-pass adapter.
¾ Close the clamp at the unused connection of the venous
air trap and tighten cap.

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Set-up overview
¾ Check the set-up before starting the priming procedure.
¾ Take care that all connections are firmly screwed together.
¾ Check that all pump segments are inserted clockwise.
¾ Check that the arterial line and venous line are connected
to the adsorber by-pass adapter.
¾ Check that the following clamps are closed:
• Sampling port before the blood pump.
• Heparin line if it is not used
• Unused line at the venous chamber
• Line with the plug at the collecting bag(s)
¾ Check that Ultrafiltration line is connected to the arterial
post-blood pump port.
¾ Ensure arterial post-blood pump port is unclamped.

Ensure that all relevant clamps are opened and that all connections are firmly screwed together
before starting the priming procedure.

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16.5 Priming
¾ After set-up of the consumables and checking the
connections, select <PRIMING> and confirm by
pressing the

key.
The automatic priming program starts.

During priming and rinsing the following tests are

performed: load cell test, ultrafiltration pump test
(MP2), disposable leakage test and level regulation
test. The respective step of the procedures and the test
is displayed in the therapy status field.

After the preparation phase has been finished, the

system gives an acoustic signal and shows the
<PREPARATION> screen with message <Ready for
therapy> in the therapy status field and the pump will
stop.

Instead of the instructions on the screen follow the

set-up as described in the next section:

Ensure connection is tight and correct.

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16.5.1 Connection of Adsorber to Blood Lines

¾ Fix adsorber to the filter holder following directional
instructions on the adsorber.
¾ Clamp the arterial line just before the adsorber by-pass
adapter with a scissor clamp as shown in Fig. 1.
¾ Use another scissor clamp to clamp the venous line just
after the adsorber by-pass adapter as shown in Fig. 1.
¾ Aseptically disconnect the venous line from the adsorber
by-pass adapter and connect to top of the adsorber
unless otherwise stated by adsorber manufacturer’s
instructions for use as shown in Fig. 2.
¾ Aseptically disconnect the arterial end from the adsorber
by-pass adapter and connect to the bottom of the
adsorber unless otherwise stated by adsorber
manufacturer’s instructions for use as shown in Fig. 2.
¾ Remove both scissor clamps from venous and arterial
line.
Fig. 1 Fig. 2

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16.5.2 Disconnection of Ultrafiltration Line

¾ Clamp arterial post blood pump port.
¾ Disconnect the UF-line from the Luer Lock of the arterial
post blood pump port and cap arterial post blood pump
port with a sterile cap as shown in Fig. 1.
¾ Open the cover of the ultrafiltration pump (MP2), remove
UF-line and discard.
¾ Leave the collecting bag on the scale, clamped.
¾ Close the cover of the ultrafiltration pump (MP2).
¾ Make sure that all relevant clamps are open.

Fig. 1 Fig. 2

Carefully follow Adsorber Manufacturer’s instructions for use.

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16.5.3 Rinsing of Adsorber

For further rinsing specified for the adsorber by the
manufacturer’s instructions for use:
¾ Hang the necessary rinsing solutions
recommended by the adsorber manufacturer onto
the bag holder of the load cell.
¾ Clamp arterial line.
¾ Connect the end of the line with the spike/Luer
Lock connector to the solutions recommended by
the adsorber manufacturer.
¾ Unclamp arterial line.

¾ Select <RINSING> and confirm with the

key.

Manual Adsorber Leakage Test

During the Rinsing, perform a manual leakage test
to check the proper connection of the adsorber, as
follows:

¾ After 30 seconds press to stop blood pump.

¾ Select the level regulation by pressing the

key, the key lights up.

¾ Keep the key pressed until the PV reaches

250 mmHg (Note: PV high alarm limit is sounded
+300 mmHg).
¾ Note PV when stable. Wait 15 seconds and
observe for a decrease in pressure.

¾ To silence the PV high alarm tone press .

¾ If the PV does not increase using the or

the PV decreases more than or equal to 20
mmHg, consider the test failed.
(Example: PV observed when stable = 250 mmHg.
After 15 seconds, PV = 230 mmHg (or less) – test
failed.)
• Check and tighten the adsorber connections
and the closure of the clamp of arterial post
blood pump port.
• Repeat the test.
¾ If the Pressure is stable, consider the test
successful.
• Select the level regulation by pressing the

key, the key lights up.

• Keep the key pressed till all the air is

removed from the venous line.

¾ Press to start the blood pump.

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¾ Rinse the adsorber with as much of the

recommended solutions as specified in the
manufacturer’s instructions for use.
¾ When the necessary rinsing volume is reached
with the solutions recommended by the adsorber
manufacturer, to finish the rinsing select

<RINSING> again and confirm with the

key.
¾ Select <ENTER THERAPY> and confirm
by pressing the

key.
The device switches automatically to
<PARAMETERS SETTING>.

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16.5.4 Alarms
Cause(s)
PA lower than PA min 812 • Blood pump velocity too high
• Thresholds set inadequately
• Catheter or fistula needle not ¾ Correct position of catheter or
optimally positioned or lumen
displaced
• Arterial line clamped
• Device failure
Saline bag empty 1025 • Arterial line clamped
• Air in the line, bag empty
UF pump test, self test failed 902 • UF-line not connected
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16 Appendix
Remedial action
¾ Adapt the blood flow to the
patient situation
¾ Adjust thresholds
fistula needle
¾ Check clamp on arterial line
¾ Contact technical service
¾ Check clamp on arterial line
¾ Change the bag(s)
¾ Clamp line before adsorber
¾ Use PE level regulation to
remove the air and correct the
level in the chamber. Check
venous chamber and correct
level if necessary
¾ Check connection of UF-line to
post blood pump port
16-17
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16.5.5 Setting UF Rate to Zero

The ultrafiltration rate in SCUF as safety-relevant
parameter is displayed on a black background. For
Haemoperfusion please set the ultrafiltration rate to
zero.
¾ Activate <UF rate> by pressing the

key.

The value is inversely displayed on a black

background

¾ Set the UF Rate to ZERO by pressing the

key to decrease to ZERO

¾ Confirm with the key.

The actual value is displayed in the supervisor field,
flashing on a black background.
¾ Compare the value displayed in the supervisor field
with that shown in the fluid-side parameters field
and confirm with the

key if they are identical.

Any changes to the safety-relevant parameters

must always be confirmed with the

key.

Risk of Blood loss

¾ Post-Blood pump port is clamped and capped.
¾ Ensure Ultrafiltration line is DISCONNECTED.
WARNING

If the safety-relevant data are not confirmed, whether they are changed or not, the
system will not start the therapy.

Set UF-Rate to ZERO to prevent unecessary alarms.

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16.5.6 Setting Treatment Parameters

¾ Select the parameter to be set with the

or key.
¾ Activate the parameter by pressing the

key.
¾ Change the value with the

or key
and confirm the change with the

key.
¾ To exit <PARAMETERS SETTING>, press the

key.

¾ To confirm parameters press key.

Note: The therapy time should be set according to the

physician’s prescription!

These treatment data can be set at any time during

the preparation phase or the therapy if the
<PARAMETERS SETTING> option is displayed.

The following data can be set in the indicated ranges:

Parameter Unit Default Min Max Increments

Blood-side parameters
Blood flow ml/min 50 10/5 500 5/10
PA min. mmHg -150 -400 PA max. 10
PA max. mmHg 100 PA min. 200 10
PBE max. mmHg 400 0 500 10
PV window mmHg 100 80 160 10
PFD mmHg 200 100 450 10
max. pressure drop
TMP max. mmHg 450 100 600 10
Fluid-side parameters
PD2 min. mmHg -50 -250 250 10
UF rate ml/h 100 0/80 2000 10/100
UF bag volume l 0.00 -25.00 00.00 0.10/1.00
Therapy time h:min 00:00 00:00 72:00 0:05/0:30

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16.5.7 Menu Selection in Preparation

Back selection
Choosing back selection allows to return to the
<THERAPY SELECTION> screen (Section 4.2).

¾ Select <BACK SELECTION> and press the key.

¾ Confirm by pressing key.

16.6 Therapy
¾ To switch from <PREPARATION> to <THERAPY>,
select <ENTER THERAPY> and press the

key.
¾ Confirm the start of the therapy by pressing the
flashing

key while <THERAPY> is flashing in the

supervisor field.

The Diapact® CRRT is now in the therapy status as

indicated in the therapy status field.
¾ Confirm the blood leak recalibration
by pressing the

key.
¾ Start the blood pump for circulation
by pressing the

key.

Bag change volume

¾ Not required for Haemoperfusion.

Risk of Blood loss

¾ Post-Blood pump port is clamped and capped.
¾ Ensure Ultrafiltration line is DISCONNECTED.
WARNING

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16.6.1 Connecting the Patient

¾ Stop the blood pump by pressing the

key.
¾ Connect the arterial line to the arterial access of
the patient.
¾ Start the blood pump by pressing the

key and adjust the

flow rate using the

or keys.
¾ Check that the withdrawal pressure (arterial
pressure – PA) is within the prescribed range.
¾ When the blood starts to fill the venous line, stop
the blood pump and connect the venous line to
the venous access of the patient.
¾ Start the blood pump again by pressing the

key and adjust the blood flow slowly

dependent on the patient’s condition by using the

or keys.
¾ Check that the arterial and venous pressure values
displayed on the screen are within the normal
range.

During therapy, the arterial chamber should be about 50 % filled, the venous chamber
about 80 %.

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16.6.2 Start of Therapy

After the blood has been circulating for 2-3 minutes
without alarms, the therapy can be started.
¾ Select <THERAPY> and activate by pressing the

key.

<THERAPY> in the menu selection field is blackened

and in the therapy status field <Running> is indicated.
The treatment is now in progress and the parameter
overview is displayed.
The current pressure and flow data of the blood side
and the fluid side are displayed on the screen.

Risk of blood loss and contamination for the patient

¾ In continuous therapies, the pump segment can become damaged in the course of
time. In order to avoid the risk of pump segment damage, it is recommended to
WARNING change the line at the latest every 72 hours.

16.6.3 Menu Selection in Therapy

Parameter setting
See Section 4.3.3

Totals overview
¾ Select <TOTALS OVERVIEW> and confirm
by pressing the

key.
¾ To return to the <PARAMETERS OVERVIEW> screen
select <TOTALS OVERVIEW> and then press the

key.

The <TOTAL OVERVIEWS> screen displays:

On the left (blood-side) part of the screen
• Current blood flow
• Treated blood volume of the current time
segment
• Treated blood volume of the whole treatment
(sum of all time segments)
• Therapy time of the current time segment
• Therapy time of the whole treatment (sum of
all time segments)

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On the right (fluid-side) part of the screen

• Current ultrafiltration rate
• Ultrafiltration volume of the current time
segment
• Ultrafiltration volume of the whole treatment
(sum of all time segments)
Therapy reset
<THERAPY RESET> allows to adjust the current values
for treated blood volume, therapy time and
ultrafiltration volume to zero. The following volumes
and the time are added up from the values marked
with Σ.
This allows to follow the data during a certain time
segment of the treatment. The system can warn the
user to execute a therapy reset by setting the therapy
time parameter for the required time.
¾ Select <THERAPY RESET> and confirm by pressing

the key followed by the key.

Pressure overview
<PRESSURE OVERVIEW> allows an overview of all
pressures recorded in the system.
¾ Select <PRESSURE OVERVIEW> and
confirm by pressing the

key.
¾ Select <PARAMETERS OVERVIEW> to return to the
<PARAMETERS OVERVIEW> screen and
confirm by pressing the

key.

Bag change
¾ Not required for Haemoperfusion.

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16.7 End of Therapy

¾ Select <END OF THERAPY> and confirm
by pressing the

key.
¾ Confirm by pressing the

key.

The blood pump (MP1) continues to run at reduced

speed (50 ml/min).

16.7.1 Disconnecting the Patient

¾ Stop the blood pump by pressing the

key.
¾ Turn the adsorber by 180° unless otherwise stated
by adsorber manufacturer’s instructions for use.
¾ Clamp arterial line close to patient’s arterial
access.
¾ Disconnect the arterial line from the patient’s
arterial access and connect it to the 500mls of
isotonic saline solution.
¾ Start the blood pump by pressing the

key and return the blood in the

extracorporeal circuit to the patient.
¾ Stop the blood pump just before the isotonic
saline solution enters the patient by pressing the

key.
¾ Clamp venous line close to patient’s venous
access.
¾ Disconnect the venous line from the patient’s
venous access.
¾ Remove disposable materials and solutions from
the device.

Dispose of disposable materials and fluids which have been removed from the device in
accordance with local regulations.
Therapy data are stored in the machine for 30 minutes. They can be recalled by switching
on the Diapact® CRRT within this time frame.

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16.7.2 Menu Selection at End of Therapy

Totals overview
The option <TOTALS OVERVIEW> shows the summary
of the pivotal treatment data as described (Section
8.4.3)
¾ Select <TOTALS OVERVIEW> and confirm
by pressing the

key.
¾ To return to the <END OF THERAPY> screen, select
<TOTALS OVERVIEW> and confirm with the

key.

Blood leak recalibration

¾ Not required for Haemoperfusion.

Back to therapy
The option <BACK TO THERAPY> returns to the just
finished therapy.
¾ Select <BACK TO THERAPY> and confirm by
pressing the

key. The key lights up.

¾ Confirm by pressing the

key.
¾ Start the therapy again by pressing the

key.

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New therapy
The option <NEW THERAPY> allows to start a new
therapy immediately after the one just finished. The
device switches directly to therapy selection.
¾ Select <NEW THERAPY> and
confirm by pressing the

key. The key lights up.

¾ Confirm by pressing the

key.

16.8 Special Functions

Automatic temporary reduction of the blood flow

If PA min is reached, blood flow automatically drops to 25 % (but not higher than 60 ml/min) to prevent
standstill of the blood pump caused by movement of the patient.

Risk of blood loss and infection for the patient

¾ To guarantee the safe therapy for the patient, the consumables (line system,
adsorber, solutions) used in the just finished therapy must be completely replaced.
DANGER

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