First Time Use - Devicor mammotome elite Anleitung

Instructions For Use
IMPORTANT:
Inspect all packaging before use. If product packaging is compromised or product is dropped when
removing packaging, use the following protocol:
• Holster: Follow Cleaning the Holster and Disinfecting the Holster procedures.
• Probe: Dispose as it is no longer a sterile instrument.
Verify compatibility of all minimally invasive instruments and accessories prior to using the instrument (Refer to Warnings
and Precautions).

First Time Use

Holster ships without a full battery charge. The Holster must be completely charged prior to first time use. Clean and
disinfect the Holster, according to Cleaning the Holster and Disinfecting the Holster. To charge the battery, place the
Holster in the Charging Base. The Holster will indicate proper placement by an audio indicator. Once the Holster has
been fully charged, as indicated by a solid green light on the Battery Indicator, it may be removed from the Charging
Base for use. An audio indicator will sound when the Holster is removed from the Charging Base. The battery will require
approximately 200 minutes to fully charge.
IMPORTANT:
The Holster MUST BE FULLY CHARGED before the initial use.
Loading the Probe
1. Using sterile technique, remove the Probe from the package. To avoid damage, do not drop the device into the
sterile field. If the Probe comes in contact with a non-sterile surface, it must be disposed of in the appropriate
container.
• The Probe is packaged with a protective sleeve over the trocar shaft. It is recommended that the protective
sleeve remain on the trocar shaft until the Probe is ready to be introduced into the percutaneous site. Take
care to avoid injury when removing the sleeve.
2. Grasp the Probe body and align the Alignment Tab with the Holster notch. Begin pushing the Probe base into the
Holster cavity while lining up the Holster's Alignment Tab with the Holster notch in the Probe body (See Illustration
3, Step 1).
3. Push the Probe body firmly into the Holster until a click is heard indicating the Locking Tabs have engaged the
Holster (See Illustration 3, Step 2).
Illustration 3
CAUTION:
To avoid pinching fingers while loading the Probe into the Holster, grasp the Holster on the sides above the
logo and near the Probe Locking Tabs.
4. If the Probe has been properly inserted, the Holster will automatically turn on and begin an initialization sequence.
During initialization, the motor is audible and the active Biopsy Indicator Light is illuminated solid orange. At the
end of a successful initialization, the Holster beeps 2 times and the active Biopsy Indicator Light illuminates green
indicating the system is ready for sampling.
• If the Probe is inserted into the Holster incorrectly, the initialization sequence WILL NOT begin.
• If the system is not ready for sampling, the Holster will beep 3 times and the Fault Indicator Light will
illuminate amber. See Troubleshooting for the corrective action.
CAUTION:
Moving parts. Ensure nothing is blocking the needle aperture at this time.
• If the Holster is left undisturbed for 30 seconds after loading a Probe, the Holster will enter a sleep mode to conserve
battery charge. During sleep mode, the Biopsy and Battery Indicator Lights will turn off and the buttons will be
5