Mintek Pacemaker LV-T ユーザーズマニュアル
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.
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).
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).
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).
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.
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.
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.
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.
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.
BEFORE DATE because the device may have reduced
longevity.