GETINGE GROUP Maquet CARDIOSAVE IABP User manual

IAB Insertion / CARDIOSAVE® IABP Operation
Quick Reference Guide
Note: This is an abbreviated guide.
For complete instructions, refer to IAB
Instructions for Use and CARDIOSAVE
Operating Instructions.

| 2 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist | IAB SIZING
Intra-aortic Balloon
Reference Sizing Guide
34cc 40cc 25cc
30cc
Note: This information is to be used as a guidance only. Clinical information and patient factors such as torso length should be considered when selecting the appropriate balloon size. SENSATION and SENSATION PLUS
6'
5'
5'4" to 6'0"
(162cm - 183cm)
5'0" to 5'4"
(152cm - 162cm)
< 5'0"
(< 152cm)
5'4" & taller
(≥ 162cm)
INTRA-AORTIC BALLOON
NEW SIZING GUIDE
SENSATION PLUS®8Fr.
MEGA®8Fr.
7.5Fr.SENSATION PLUS®
MEGA®7.5Fr.MEGA®7.5Fr.
SENSATION®7Fr.SENSATION®7Fr.
7.5Fr.
LINEAR®7.5Fr.
LINEAR®
7.5Fr.
LINEAR®
are ber-optic IAB catheters.
40cc 50cc

| 3 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist | MEGA & LINEAR
INSERTION
Preparing the IAB Catheter
MEGA
® and LINEAR® IAB Catheter
Firmly attach one-way
valve to male luer fitting
of IAB catheter.
Apply a 30cc vacuum. Remove syringe while
keeping one-way valve
in place.
Remove stylet, then manually
flush inner lumen with 3-5cc
of flush solution.
3
21 4
IAB SIZING

| 4 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist | MEGA & LINEAR
INSERTION
MEGA and LINEAR IAB Catheter
Sheathless Insertion
Spread tissue at incision
to facilitate sheathless
insertion.
Insert needle at 45˚ angle
or less, then insert 0.025"
(0.06cm) guidewire.
Make small incision at
exit of guidewire.
Insert vessel dilator over
guidewire, tapered end first,
then remove.
Remove IAB catheter from
T-handle by pulling STRAIGHT
out to avoid damaging it.
Do not dip, wipe, or handle
membrane prior to insertion.
Advance IAB catheter into
artery using short strokes
until correct placement is
achieved, then advance
sheath seal as close to
insertion site as possible.
Secure IAB catheter to
patient’s leg using STATLOCK
®
IAB Stabilization Device or
sutures.
9
11
10
786
5

| 5 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
MEGA and LINEAR IAB Catheter
Sheathed Insertion
1 Advance sheath over
guidewire into artery
using a rotary motion.
2 Withdraw introducer dilator
leaving sheath in place.
Insert needle at 45˚ angle
or less, then insert 0.025"
(0.06cm) guidewire.
Make small incision at
exit of guidewire.
Insert introducer dilator
into sheath hub and twist
lock in place to secure.
Advance IAB catheter through
sheath using short strokes until
correct placement is achieved,
then advance sheath seal into
hub of sheath.
Remove IAB catheter from
T-handle by pulling STRAIGHT
out to avoid damaging it.
Do not dip, wipe, or handle
membrane prior to insertion.
1
2
8
7
6
5
Secure IAB catheter to
patient’s leg using STATLOCK
®
IAB Stabilization Device or
sutures.
9
10 11
MEGA & LINEAR
INSERTION

| 6 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
MEGA and LINEAR IAB Catheter
Pressure Monitoring Set-Up
Remove guidewire and
aspirate 3cc of blood
from inner lumen.
Attach a standard arterial
pressure monitoring
apparatus.
Remove one-way valve
from IAB catheter.
Connect IAB catheter’s
male luer fitting to female
luer fitting of catheter
extender.
Connect male luer fitting
to Pneumatic Module of IABP.
Manually flush inner
lumen with 3-5cc of flush
solution.
12 13 14
15
Connection to IABP
16 17
MEGA & LINEAR
INSERTION

| 7 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Preparing the IAB Catheter
SENSATION PLUS® and SENSATION® IAB Catheter
Firmly attach one-way
valve to male luer fitting
of IAB catheter.
Apply a 30cc vacuum.
Remove syringe while
keeping one-way valve
in place.
Remove stylet, then manually
flush inner lumen with 3-5cc
of flush solution.
3
2
14
SENSATION PLUS &
SENSATION INSERTION

| 8 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
SENSATION PLUS and SENSATION IAB Catheter
Sheathless Insertion
Spread tissue at incision
to facilitate sheathless
insertion.
Insert needle at 45˚ angle
or less, then insert guide-
wire (7.5Fr./8Fr. IAB: 0.025"
(0.06cm) / 7Fr. IAB: 0.018"
(0.05cm).
Make small incision at
exit of guidewire.
Insert vessel dilator over
guidewire, tapered end first,
then remove.
Remove IAB catheter from
T-handle by pulling STRAIGHT
out to avoid damaging it.
Do not dip, wipe, or handle
membrane prior to insertion.
Advance IAB catheter into
artery using short strokes
until correct placement is
achieved, then advance
sheath seal as close to
insertion site as possible.
Secure IAB catheter to
patient’s leg using STATLOCK
®
IAB Stabilization Device or
sutures (SENSATION PLUS
includes STATLOCK
®
in
IAB box).
9
11
10
78
6
5
Note: Continue on page 10,
step #13.
SENSATION PLUS &
SENSATION INSERTION

| 9 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
SENSATION PLUS and SENSATION IAB Catheter
Sheathed Insertion
1 Advance sheath over
guidewire into artery
using a rotary motion.
2 Withdraw introducer dilator
leaving sheath in place.
Insert needle at 45˚ angle
or less, then insert guide-
wire (7.5Fr./8Fr. IAB: 0.025"
(0.06cm) / 7Fr. IAB: 0.035"
(0.09cm).
Make small incision at
exit of guidewire.
Insert introducer dilator
into sheath hub and twist
lock in place to secure.
Remove IAB catheter from
T-handle by pulling STRAIGHT
out to avoid damaging it.
Do not dip, wipe, or handle
membrane prior to insertion.
1
2
8
765
7Fr. IAB only:
9a Remove 0.035" (0.09cm)
guidewire and
9b Replace with 0.018"
(0.05cm) guidewire.
Advance IAB catheter through
sheath using short strokes until
correct placement is achieved,
then advance sheath seal into
hub of sheath.
Secure IAB catheter to patient’s
leg using STATLOCK
®
IAB
Stabilization Device or sutures
(SENSATION PLUS includes
STATLOCK
®
in IAB box).
10 11
9a
9b 12
SENSATION PLUS &
SENSATION INSERTION

| 10 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
SENSATION PLUS and SENSATION IAB Catheter
Pressure Monitoring Set-Up
Remove one-way valve
from IAB catheter.
Connect IAB catheter’s
male luer fitting to female
luer fitting of catheter
extender.
Connect male luer fitting of
catheter extender to Pneumatic
Module of IABP. Insert fiber-optic
sensor connector into IABP’s
sensor input receptacle until
it clicks.
Connection to IABP
Remove guidewire and
aspirate 3cc of blood
from inner lumen.
Manually flush inner
lumen with 3-5cc of flush
solution.
Attach a standard arterial
pressure monitoring
apparatus.
13 14 15
18
16 17
Note: With SENSATION PLUS,
a reliable pressure signal may be
obtained via the inner lumen,
if needed.
SENSATION PLUS &
SENSATION INSERTION

| 11 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
CARDIOSAVE Initial Set-up
Open helium
tank (if not already
opened).
Press POWER
button to turn
IABP ON.
1
2
Connect fiber-optic sensor
connector for Maquet/
Datascope fiber-optic IAB.
Connect pressure cable
for conventional IAB.
Connect ECG cable.
Connect IAB.
3
4
5
4
OR
CARDIOSAVE SET-UP

| 12 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Initial Set-up using a Maquet/Datascope Fiber-optic IAB (continued)
Note: With a Maquet/Datascope fiber-optic IAB,
there is no need to zero. Calibration occurs
automatically after pressing START. Operator
may invoke a calibration anytime by pressing
and holding CALIBRATE PRESSURE key for
2 seconds, while assisting.
Pressing the START key
• Automatically purges and lls IAB
• Automatically performs an in vivo calibration
• Automatically selects most appropriate
lead and trigger
• Automatically sets ination and deation timing
Verify Aug. Alarm is set 10mmHg below
patient’s augmented diastolic pressure
(approx. 3 minutes after initiation of assist).
12
2
12
1
12
12
He
Inflated
Deflated
Balloon Pressure
116
Aug Alarm
Augmentation
IAB Frequency 1:1
106
mmHg
mmHg
Pressure
130
80
30
Arterial Source: Fiber-Optic
102
52
(84)
MEAN
Inflation Deflation
Auto 0.0
Trigger: ECG
bpm
Rate
80
Lead: Auto - II
ECG
0.5
mV
Verify
AUTO
Press
START
6
CARDIOSAVE SET-UP

| 13 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Initial Set-up using a Conventional IAB (continued)
Pressing the START key
• Automatically purges and lls IAB
• Automatically selects most appropriate
lead and trigger
• Automatically sets ination and deation timing
Verify Aug. Alarm is set 10mmHg below
patient’s augmented diastolic pressure
(approx. 3 minutes after initiation of assist).
12
2
12
1
12
12
He
Inflated
Deflated
Balloon Pressure
116
Aug Alarm
Augmentation
IAB Frequency 1:1
106
mmHg
mmHg
Pressure
130
80
30
Arterial Source: Fiber-Optic
102
52
(84)
MEAN
Inflation Deflation
Auto 0.0
Trigger: ECG
bpm
Rate
80
Lead: Auto - II
ECG
0.5
mV
12
2
12
1
12
12
He
Ina ted
De ated
Balloon Pressure
116
Aug Alarm
Augmentation
IAB Frequency 1:1
106
mmHg
mmHg
Pressure
130
80
30
Arterial Source: Fiber-Optic
102
52
(84)
MEAN
Ination Deation
Auto 0.0
Trigger: ECG
bpm
Rate
80
Lead: Auto - II
ECG
0.5
mV
6
Verify
AUTO
Press
START
7
CARDIOSAVE SET-UP

| 14 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
CARDIOSAVE Operation Modes
Auto Operation Mode
Semi-Auto Operation Mode
• Automatic lead and trigger selection
• Automatic and continuous ination and
deation timing management
- User has ability to ne-tune deation timing
• Automatic management of irregular rhythms
• Automatic in vivo calibration (when using a
Maquet/Datascope ber-optic IAB)
• Operator selects most appropriate lead and trigger
source
• Operator establishes timing, then CARDIOSAVE
automatically adjusts timing with heart rate and
rhythm changes
• Automatic management of irregular rhythms
• Automatic in vivo calibration (when using a
Maquet/Datascope ber-optic IAB)
CARDIOSAVE
OPERATION

| 15 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist | CARDIOSAVE
OPERATION
CARDIOSAVE Monitor Display and Touchscreen
Monitor Display Touchscreen
Hold For Continuous
Ref
Line
Hold 2 Sec.Hold 2 Sec.
Lock
Screen
Open
Menus Preferences Print
Strip
Freeze
Display
Aug
Alarm
IAB
Fill
Trigger Sources Augmentation
IAB Frequency Timing IAB Frequency
Close
Menus
Ination
Deation
Timing
O
Max
Augmentation
IAB
Frequency
1:2
1:3
1:1
Sources
Auto
Default
20
II
Direct
ECG
Pressure
Pacer Detection
Pressure Threshold
Thresholds
Default
Internal
Pacer A
Pacer V/AV
Pressure
ECG
Trigger
Auto Semi
Auto
OPERATION MODE
Hold 2 Sec.
Semi
Auto
Calibrate
Pressure
Auto Standby
Standby Start
Start
Start
Auto
106
Aug
Alarm
12
2
12
1
12
12
He
Inflated
Deflated
Balloon Pressure
116
Aug Alarm
Augmentation
IAB Frequency 1:1
106
mmHg
mmHg
Pressure
130
80
30
Arterial Source: Fiber-Optic
102
52
(84)
MEAN
Inflation Deflation
Auto 0.0
Trigger: ECG
bpm
Rate
80
Lead: Auto - II
ECG
0.5
mV

| 16 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist | CARDIOSAVE
OPERATION
CARDIOSAVE Lock Screen Feature
Touchscreen will Lock:
• Automatically after 2 minutes of inactivity
• When operator presses LOCK SCREEN key
for 2 seconds
Touchscreen Unlocked
Touchscreen will Unlock:
• Automatically with any Technical, High, Medium,
or Low Priority Alarm
• When operator presses UNLOCK SCREEN key
Touchscreen Locked
Hold For Continuous
Ref
Line
Hold 2 Sec.Hold 2 Sec.
Lock
Screen
Open
Menus Preferences Print
Strip
Freeze
Display
Aug
Alarm
IAB
Fill
Trigger Sources Augmentation
IAB Frequency Timing IAB Frequency
Close
Menus
Inflation
Deflation
Timing
O
Max
Augmentation
IAB
Frequency
1:2
1:3
1:1
Sources
Auto
Default
20
II
Direct
ECG
Pressure
Pacer Detection
Pressure Threshold
Thresholds
Default
Internal
Pacer A
Pacer V/AV
Pressure
ECG
Trigger
Auto Semi
Au to
OPERATION MODE
Hold 2 Sec.
Semi
Auto
Calibrate
Pressure
Auto Standby
Standby Start
Start
Start
Auto
106
Aug
Alarm
Unlock
Screen
Screen is locked
to unlock press
Unlock Screen button
Hold For Continuous
Ref
Line
Hold 2 Sec.Hold 2 Sec.
Lock
Screen
Open
Menus Preferences Print
Strip
Freeze
Display
Aug
Alarm
IAB
Fill
Trigger Sources Augmentation
IAB Frequency Timing IAB Frequency
Close
Menus
Ination
Deation
Timing
O
Max
Augmentation
IAB
Frequency
1:2
1:3
1:1
Sources
Auto
Default
20
II
Direct
ECG
Pressure
Pacer Detection
Pressure Threshold
Thresholds
Default
Interna l
Pacer A
Pacer V/AV
Pressure
ECG
Trigger
Auto Semi
Auto
OPERATION MODE
Hold 2 Sec.
Semi
Auto
Calibrate
Pressure
Auto Standby
Standby Start
Start
Start
Auto
106
Aug
Alarm

| 17 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
CARDIOSAVE Triggers
Triggering
• A Trigger is the signal that CARDIOSAVE uses to
identify the beginning of the next cardiac cycle
• When CARDIOSAVE recognizes the trigger event,
it will deate the balloon if not already deated
• Trigger Source keys are only active while in
Semi-Auto operation mode
CARDIOSAVE Triggers
ECG
Trigger event is the R-Wave
• Trigger of choice when an adequate R-Wave is present
• Pacer spikes are automatically rejected
Pressure
Trigger event is the systolic upstroke
• Trigger of choice (with a regular rhythm) when an
adequate R-Wave is not present
• A xed pressure threshold can be manually set while
in Semi-Auto operation mode
Pacer V/AV
Trigger event is the Ventricular pacer spike
• Typically used when ECG triggering is unsuccessful
and a V or AV pacer is being used
• Must be 100% paced
• Only available in Semi-Auto operation mode
Pacer A
Trigger event is the R-Wave
• Recommended only if atrial pacer tails are interfering
with R-Wave detection while in ECG trigger
• Only available in Semi-Auto operation mode
Internal
Trigger event is asynchronous at a fixed rate of 80 BPM
• Only used when there is no mechanical cardiac cycle
(i.e.: cardiopulmonary bypass or asystole)
• Rate can be adjusted from 40 to 120 BPM
• Only available in Semi-Auto operation mode
CARDIOSAVE
OPERATION

| 18 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Theory of Counterpulsation Therapy
Inflation: increases supply of oxygen
to the myocardium.
Deflation: decreases demand for oxygen
by the left ventricle.
How it works
• Balloon inates at onset of diastole
(when aortic valve closes)
• Displaces blood, causing an increase
in aortic pressure
Benefits
• Increases coronary artery perfusion
• Increases mean arterial pressure
How it works
• Balloon deates just prior to systolic
ejection (before aortic valve opens)
• Results in a rapid decrease in aortic
pressure
Benefits
• Decreases afterload
• Decreases cardiac workload
• Increases cardiac output
CARDIOSAVE
OPERATION

| 19 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Timing
Proper IABP Timing
Timing refers to the positioning
of inflate and deflate points on
the arterial pressure waveform.
Inflation
• Occurs at the dicrotic notch
• Appears as a sharp “V”
• Ideally diastolic augmentation rises
above systole
Deflation
• Occurs just prior to systolic ejection
• Results in a reduction in assisted
end diastolic pressure
• Results in a reduction in assisted
systolic pressure
Diastolic
Augmentation
Assisted Systole
Unassisted
Systole
Assisted End
Diastolic Pressure
Unassisted End
Diastolic Pressure
One Cardiac Cycle
CARDIOSAVE
OPERATION

| 20 | IAB Insertion / CARDIOSAVE Operation | Cardiac Assist |
Timing Errors
Early Inflation
Inflation of IAB prior to aortic valve
closure.
Waveform characteristics
• Ination of IAB prior to dicrotic notch
• Diastolic augmentation encroaches onto
systole (may be unable to
distinguish)
Physiologic Effects
• Potential premature closure
of aortic valve
• Potential increase in
LVEDV/LVEDP/PCWP
• Increased left ventricular wall
stress or afterload
• Aortic regurgitation
• Increased MVO2 demand
Late Inflation
Inflation of IAB markedly after closure
of aortic valve.
Waveform characteristics
• Ination of IAB after dicrotic notch
• Absence of sharp “V”
• Sub-optimal diastolic augmentation
Physiologic Effects
• Sub-optimal coronary artery
perfusion
Unassisted
Systole Assisted
Systole
Diastolic
Augmentation
Dicrotic
Notch
Unassisted
Systole Assisted
Systole
Diastolic Augmentation
Dicrotic
Notch
Aortic
Valve
Closure
CARDIOSAVE
OPERATION