Sterilization Workflow & Sterile Field
Mixed reprocessing strategy: autoclave for mechanical hardware, STERRAD VHP for sensor head, gamma for single-use cartridges. Validated SAL 10⁻⁶.
Reprocessing partitions the system into three sterility classes. Mechanical hardware (halo, frame, distal shroud, needle holder) is steam-autoclaved at 134 °C for 18 min per ISO 17665. The sensor head and electronics shroud are VHP-compatible (STERRAD 100NX standard cycle) since steam is incompatible with the lens cement and CMOS package.
Single-use cartridges are gamma-irradiated at 25–40 kGy per ISO 11137 with verified SAL of 10⁻⁶. Each lot is dosimetry-mapped and the dose-mapping report is linked to the cartridge RFID payload so the robot rejects out-of-spec lots.
The sterile field is established with a draped, sealed end-effector shroud that mates to the kinematic coupling through a sterile silicone bellows; bellows leakage is monitored by a 0.5 kPa differential-pressure sensor.
| Parameter | Value | Unit | Tolerance / Note |
|---|---|---|---|
| Autoclave cycle | 134 °C / 18 min | ISO 17665, halo + frame + shroud | |
| VHP cycle | STERRAD 100NX std | Sensor head + electronics shroud | |
| Gamma dose | 25–40 | kGy | Cartridges only |
| Validated SAL | 10⁻⁶ | Per ISO 11137 / 17665 | |
| Bellows leak threshold | 0.5 | kPa | |
| Reprocessing cycles | ≥ 200 | Mechanical hardware lifecycle |