6 Stratos LV/LV-T Technical Manual

For transurethral resection of the prostate, it is recommended that the cautery ground plate be placed under the buttocks or around the thigh, but not in the thoracic area where the current pathway could pass through or near the CRT-P system.

1.5.2 Storage and Sterilization

Storage (temperature) – Recommended storage temperature range is 5° to 55°C (41°-131°F). Exposure to temperatures outside this range may result in CRT-P malfunction (see Section 7.1).

Low Temperatures – Exposure to low temperatures (below 0°C) may cause a false elective replacement indication to be present. If this occurs, warm the device to room temperature and reset the ERI with magnet application (see Section 7.1).

Handling – Do not drop. If an unpackaged CRT-P is dropped onto a hard surface, return it to BIOTRONIK (see Section 7.1).

FOR SINGLE USE ONLY - Do not re-sterilize the CRT-P or accessories packaged with the CRT-P, they are intended for one-time use.

Device Packaging – Do not use the device if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised. Return the device to

BIOTRONIK.

Storage (magnets) – Store the device in a clean area, away from magnets, kits containing magnets, and sources of electromagnetic interference (EMI) to avoid damage to the device.

Temperature Stabilization – Allow the device to reach room temperature before programming or implanting the device. Temperature extremes may affect the initial device function.

Use Before Date – Do not implant the device after the USE BEFORE DATE because the device may have reduced longevity.