Procedures

Step-by-step reference pages in the order an emergent insertion unfolds: prepare the console, connect the balloon and start, verify the support is real, respond to alarms, keep the pump running. Each step carries its reason and its source.

Insertion technique itself (access, guidewire, sheath, advancing to position) is governed by the IAB catheter Instructions for Use and is not reproduced here.

1 · Prepare the console

1. Start-up and Getting Started checklist · 16 steps AC3
   Every initiation of therapy, from a cold console to the first assisted beat.
2. Zero the FiberOptix™ sensor before insertion · 10 steps AC3O
   Every time a FiberOptix™ IAB is prepared for insertion on an AC3 Optimus™, before the balloon leaves the tray.

2 · Connect the balloon and start

1. Connect the IAB and start counterpulsation · 8 steps AC3
   Immediately after IAB insertion, with ECG and arterial pressure (AP) already connected and (if FiberOptix™) the sensor zeroed before insertion.
2. Confirm balloon position and function from the console · 6 steps AC3
   In the first minutes after starting counterpulsation, and again after any patient repositioning or transfer.

3 · Verify support

1. Assess timing on the arterial waveform · 12 steps AC3
   After triggering has been verified and the pump has started; after any change of trigger mode, timing method or settings; and whenever hemodynamics change.
2. Protective Pumping™ balloon sizing check · 8 steps AC3
   After triggering, timing and BPW shape have been assessed at start-up; after any balloon volume change; and whenever HIGH PRESSURE alarms or a squared BPW raise the question of an occlusive balloon.
3. FOS MAP calibration against a reference line · 10 steps AC3O
   The FOS was not zeroed (or was zeroed improperly) before IAB insertion and its numeric values do not match a known accurate AP from another source.

4 · Respond to alarms and problems

1. Suspend and restore alarms · 9 steps AC3
   Briefly, while correcting an alarm condition that would otherwise keep stopping the pump: the helium leak test and an in-use helium tank exchange are the two manual-specified uses.
2. Helium leak test · 16 steps AC3
   Possible HE Loss 2, Possible HE Loss 3 or LARGE HE LEAK alarm with no blood in the driveline tubing; the helium tank losing pressure faster than expected; any other suspected helium leak.
3. Pump stopped: protecting the balloon · 6 steps AC3
   Any time pumping stops after therapy has begun: a pump shutdown by a high-priority alarm, a system failure, or a deliberate PUMP OFF.

5 · Keep the pump running

1. Change the helium tank · 21 steps AC3
   HELIUM TANK LOW OR EMPTY alarm (tank pressure below 100 psi); helium icon RED (below 125 psi) or BLACK (empty or tank off); before any transport with a low tank; weekly checkout reading of 100 psi or less.
2. Annual battery load test · 10 steps AC3
   Annually (begin after the unit's first year), and more often if battery run time is shorter than expected.