IAB INSERTION CS300 OPERATION Quick Reference Guide PN 0002-08-1043 R2

| 2 | IAB Insertion / CS300 Operation | Cardiac Assist |

IAB SIZING

INTRA-AORTIC BALLOON REFERENCE SIZING GUIDE

25cc

34cc

40cc

50cc

Approx. ht: < 5'0" (< 152cm)

Approx. ht: 5'0" to 5'4" (152cm - 162cm)

Approx. ht: 5'4" to 6'0" (162cm - 183cm)

Approx. ht: ≥ 5'4" (≥ 162cm) 6' 5' 4'

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.

MEGA AND LINEAR IAB CATHETER ®

®

Preparing the IAB Catheter

1

2

3

4

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 | IAB Insertion / CS300 Operation | Cardiac Assist |

MEGA & LINEAR INSERTION

MEGA & LINEAR INSERTION

| 4 | IAB Insertion / CS300 Operation | Cardiac Assist |

MEGA AND LINEAR IAB CATHETER Sheathless Insertion

4 5

5 6

7

8

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.

Spread tissue at incision to facilitate sheathless insertion.

9

10

11

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® Stabilization Device or sutures.

MEGA AND LINEAR IAB CATHETER Sheathed Insertion

2

1

5

6

7

8

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.

1 Advance sheath over guidewire into artery using a rotary motion. 2 Withdraw introducer dilator leaving sheath in place.

9

10

11

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 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® Stabilization Device or sutures.

| 5 | IAB Insertion / CS300 Operation | Cardiac Assist |

MEGA & LINEAR INSERTION

MEGA & LINEAR INSERTION

| 6 | IAB Insertion / CS300 Operation | Cardiac Assist |

MEGA AND LINEAR IAB CATHETER Pressure Monitoring Set-Up

12

13

14

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.

15

16

17

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 Safety Disk of IABP.

Connection to IABP

SENSATION PLUS AND SENSATION IAB CATHETER ®

™

Preparing the IAB Catheter

1

2

3

4

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.

| 7 | IAB Insertion / CS300 Operation | Cardiac Assist |

SENSATION PLUS & SENSATION INSERTION

SENSATION PLUS & SENSATION INSERTION

| 8 | IAB Insertion / CS300 Operation | Cardiac Assist |

SENSATION PLUS AND SENSATION IAB CATHETER Sheathless Insertion

4 5

6

7

8

Insert needle at 45˚ angle or less, then insert guidewire (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.

Spread tissue at incision to facilitate sheathless insertion.

9

10

11

Note: Continue on page 10, step #13.

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® Stabilization Device or sutures (SENSATION PLUS includes STATLOCK® in IAB box).

SENSATION PLUS AND SENSATION IAB CATHETER Sheathed Insertion

2

1

5

6

7

8

Insert needle at 45˚ angle or less, then insert guidewire (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.

1 Advance sheath over guidewire into artery using a rotary motion. 2 Withdraw introducer dilator leaving sheath in place.

9b

10

11

12

7Fr. IAB only: 9a Remove 0.035" (0.09cm) guidewire and 9b Replace with 0.018" (0.05cm) guidewire.

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 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® Stabilization Device or sutures (SENSATION PLUS includes STATLOCK® in IAB box).

9a

| 9 | IAB Insertion / CS300 Operation | Cardiac Assist |

SENSATION PLUS & SENSATION INSERTION

SENSATION PLUS & SENSATION INSERTION

| 10 | IAB Insertion / CS300 Operation | Cardiac Assist |

SENSATION PLUS AND SENSATION IAB CATHETER Pressure Monitoring Set-Up

13

14

15

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.

16

17 15

18

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 Safety Disk of IABP. Insert fiber-optic sensor connector into IABP’s sensor input receptacle until it clicks.

Connection to IABP

Note: With SENSATION PLUS, a reliable pressure signal may be obtained via the inner lumen, if needed.

CS300 INITIAL SET-UP

IAB SENSOR INPUT

!

4

Connect fiber-optic IAB: for MAQUET/Datascope fiber-optic IAB.

OR

2 IABP

OFF

ON

Open helium tank (if not already opened).

1 Turn IABP on.

4

Connect pressure cable: for conventional IAB.

3

Connect ECG cable.

5

Connect IAB.

| 11 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 SET-UP

| 12 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 SET-UP

INITIAL SET-UP USING A MAQUET/DATASCOPE FIBER-OPTIC IAB (CONTINUED) Intelligent Counterpulsation ALARM MESSAGES

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(&* T R I G G E R PP$XWR 7KUHVKROG

P9 ADV ISORIES

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U LEAD U GAIN

PRESSURE SOURCE

IAB FILL MODE

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SLOW GAS ALARM

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OPERATION MODE

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6





ECG

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SYSTOLIC



DIASTOLIC



MEAN

mmHg

mmHg



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Press START

bpm

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IAB STATUS

Verify AUTO

HEART RATE

+(/3 $YDLODEOHIRU$ODUP$GYLVRU

Pressing the START key Q Automatically purges and fills IAB Q Automatically performs an in vivo calibration Q Automatically selects most appropriate lead and trigger Q Automatically sets inflation and deflation timing

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 ZERO PRESSURE key for 2 seconds, while assisting.

+HOLXP %DWWHU

mmHg

AUG. mmHg

AUG. ALARM mmHg

Verify Aug Alarm is set 10mmHg below patient’s augmented diastolic pressure.

Intelligent Counterpulsation

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INITIAL SET-UP USING A CONVENTIONAL IAB (CONTINUED) A L A RM ME SSA GE S

(&* T R I G G E R PP$XWR 7KUHVKROG

P9

ECG

20 mm Auto Threshold

TRIGGER

A DV ISORIE S

O P E R AT I O N M O D E HEART RATE bpm

AUTO

126

No Zero

Semi Auto

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79

U LEAD U GAIN

,, 1RUPDO

Zero Pressure PRE SSURE ([WHUQDO

Manual

SOURCE

SYSTOLIC

Pediatric Only

mmHg





E CG







START

STANDBY



Hold 2 Sec. IA B FIL L MODE $XWR

'HIO

6

85

DIASTOLIC mmHg

TRIGGER SOURCE

.2

Defl.

ECG

96

140 Pacer V/AV

Pressure

120

Pacer A

Internal

m/Advisory

MEAN mmHg

&KHFN,$%&DWKHWHU IAB FREQUENCY

ALARM MESSAG ES

P9

ADV ISORIES

ECG

AUG. mmHg

U LEAD U GAIN

PRESSURE

AUG. ALARM SOURCE mmHg

IAB FILL MODE

Helium

Alarm Mute

Battery

7

IAB Fill

A U G M E N TAT I O N

7ULJJHU6HOHFWQRWDYDLODEOHLQ$XWR0RGH MAX %DWWHU,Q8VH

1:1

,, 1RUPDO

1:2

HEA RT RATE PLQLQ Earlierbpm

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$XWR

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$872

OFF

No Zer o

SYSTOLIC



DIASTOLIC

'HIO



MEAN

AUG.



OPERATION MODE

$XWR



Help

SYSTOLIC



DIASTOLIC



MEAN



AUG.

IAB DEFLATION



Later

mmHg

mmHg

Earlier

mmHg

mmHg

AUG. ALARM mmHg

Later

Ref. Line

Press START Aug.

Alarm Pressing the START key Q Automatically purges and fills IAB Hold 2 Sec.Q Automatically selects most appropriate lead and trigger Q Automatically sets inflation and deflation timing

| 13 | IAB Insertion / CS300 Operation | Cardiac Assist |

+(/3 $YDLODEOHIRU$ODUP$GYLVRU

+HOLXP %DWWHU

mmHg

mmHg



$FWLYH

PLQLQ 6WDQGE

No Z ero

IA B STA TUS 

([WHUQDO

1:3

$FWLYH

TRIGGER (&* IAB INFLATION $XWR MODE

PP$XWR OPE RATION 7KUHVKROG

SLOW G AS ALARM

IAB STATUS

Verify AUTO

SL OW GA S A L A RM

Intelligent Counterpulsation

bpm



$872 

,QIO

HEART RATE

+(/3 $YDLODEOHIRU$ODUP$GYLVRU

Open Menu

mmHg

mmHg

ECG/AP Sources

Verify Aug Alarm is set 10mmHg below patient’s augmented diastolic Inflation pressure. Inter val

Pump Options

Freeze Display

User Preferences

Print Strip

AUG. ALARM mmHg

+HOLXP %DWWHU

Hold For Continuous

Back

CS300 SET-UP

| 14 | IAB Insertion / CS300 Operation | Cardiac Assist |

VAULT COPY

CS300 OPERATION MODES Auto Operation Mode Automatic lead and trigger selection Q Automatic and continuous inflation and deflation timing management - User has ability to fine-tune deflation timing Q Automatic management of irregular rhythms Q Automatic in vivo calibration (when using a MAQUET/Datascope fiber-optic IAB) Q

Semi-Auto Operation Mode Operator selects most appropriate lead and trigger source Q Operator establishes timing, then CS300 automatically adjusts timing with heart rate and rhythm changes Q Automatic management of irregular rhythms Q Automatic in vivo calibration (when using a MAQUET/Datascope fiber-optic IAB)

AUTO

Semi Auto

Q

Manual Operation Mode Q

For pediatric use only

Manual

CS300 SET-UP

VAULT COPY CS300 MONITOR AND KEYPAD

TRIGGER SOURCE ECG Pressure Pacer V/AV Pacer A Internal

| 15 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 OPERATION

| 16 | IAB Insertion / CS300 Operation | Cardiac Assist |

VAULT COPY

CS300 TRIGGERS Triggering

CS300 Triggers

A Trigger is the signal the CS300 uses to identify the beginning of the next cardiac cycle Q When the CS300 recognizes the trigger event, it will deflate the balloon if not already deflated Q Trigger Source keys are only active while in Semi-Auto operation mode

ECG Trigger event is the R-Wave Q Trigger of choice when an adequate R-Wave is present Q Pacer spikes are automatically rejected Q Gain can be adjusted while in Semi-Auto or Manual operation mode

Q

TRIGGER SOURCE ECG Pressure Pacer V/AV Pacer A Internal

Pressure Trigger event is the systolic upstroke Q Trigger of choice (with a regular rhythm) when an adequate R-Wave is not present Q A fixed pressure threshold can be manually set while in Semi-Auto or Manual operation mode Pacer V/AV Trigger event is the Ventricular pacer spike Q Typically used when ECG triggering is unsuccessful and a V or AV pacer is being used Q Must be 100% paced Q Only available in Semi-Auto or Manual operation mode Pacer A Trigger event is the R-Wave Q Recommended only if atrial pacer tails are interfering with R-Wave detection while in ECG trigger Q Only available in Semi-Auto or Manual operation mode Internal Trigger event is asynchronous at a fixed rate of 80 BPM Q Only used when there is no mechanical cardiac cycle (i.e.: cardiopulmonary bypass or asystole) Q Rate can be adjusted from 40 to 120 BPM Q Only available in Semi-Auto or Manual operation mode

CS300 OPERATION

THEORY OF COUNTERPULSATION THERAPY

Inflation: increases supply of oxygen to the myocardium.

Deflation: decreases demand for oxygen by the left ventricle.

How it works

How it works

Q

Q

Balloon inflates at onset of diastole (when aortic valve closes) Displaces blood, causing an increase in aortic pressure

Benefits Q Q

Q

Q

Balloon deflates just prior to systolic ejection (before aortic valve opens) Results in a rapid decrease in aortic pressure

Benefits

Increases coronary artery perfusion

Q

Decreases afterload

Increases mean arterial pressure

Q

Decreases cardiac workload

Q

Increases cardiac output

| 17 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 OPERATION

| 18 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 OPERATION

TIMING Timing refers to the positioning of inflate and deflate points on the arterial pressure waveform.

Diastolic Augmentation Unassisted Systole

Proper IABP Timing

Assisted Systole

INFLATION Q Occurs at the dicrotic notch Q Appears as a sharp “V” Q Ideally diastolic augmentation rises above systole Unassisted End Diastolic Pressure

DEFLATION Occurs just prior to the next systolic event Q Results in a reduction in assisted end diastolic pressure Q Results in a reduction in assisted systolic pressure Q

One Cardiac Cycle

Assisted End Diastolic Pressure

TIMING ERRORS Early Inflation

Diastolic Augmentation Unassisted Systole

Assisted Systole

Physiologic Effects Potential premature closure of aortic valve

Inflation of IAB prior to aortic valve closure.

Q

Waveform characteristics

Q

Q Q

Inflation of IAB prior to dicrotic notch Diastolic augmentation encroaches onto systole (may be unable to distinguish)

Q

Potential increase in LVEDV/LVEDP/PCWP Increased left ventricular wall stress or afterload

Q

Aortic regurgitation

Q

Increased MVO2 demand

Dicrotic Notch

Late Inflation Diastolic Augmentation Unassisted Systole

Assisted Systole

Inflation of IAB markedly after closure of the aortic valve. Waveform characteristics Q

Aortic Valve Closure

Physiologic Effects Sub-optimal coronary artery perfusion

Q

Inflation of IAB after dicrotic notch

Q

Absence of sharp “V”

Q

Sub-optimal diastolic augmentation

Dicrotic Notch

| 19 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 OPERATION

| 20 | IAB Insertion / CS300 Operation | Cardiac Assist |

CS300 OPERATION

TIMING ERRORS Diastolic Augmentation Assisted Systole

Early Deflation Premature deflation of IAB during diastolic phase.

Q Q

Assisted End Diastolic Pressure Q

Diastolic Augmentation

Sub-optimal diastolic augmentation

Q

Sub-optimal afterload reduction

Assisted end diastolic pressure may be equal to or less than unassisted end diastolic pressure

Q

Increased MVO2 demand

Assisted systolic pressure may rise

Deflation of IAB after aortic valve has opened.

Q

Unassisted End Diastolic Pressure

Q

Angina may occur as a result of retrograde coronary blood flow

Q

Late Deflation

Q

Potential for retrograde coronary and carotid blood flow

Deflation of IAB is seen as a sharp drop following diastolic augmentation

Waveform characteristics

Assisted End Diastolic Pressure

Q

Waveform characteristics Q

Unassisted End Diastolic Pressure

Physiologic Effects Q Sub-optimal coronary perfusion

Assisted end diastolic pressure may be equal to or higher than unassisted end diastolic pressure Rate of rise of assisted systole is prolonged Diastolic augmentation may appear widened

Physiologic Effects Afterload reduction is essentially absent Increased MVO2 consumption due to left ventricle ejecting against a greater resistance and a prolonged isovolumetric contraction phase IAB may impede left ventricular ejection and increase afterload