Medtronic PROTECTA XT DR D314DRG, Руководство для клиницистов

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Medtronic implantable devices are intended for single use only. Do not resterilize and
reimplant explanted devices.
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Please use the Tachyarrhythmia Product Information Report to return explanted
devices to Medtronic for analysis and disposal.
2.3 Handling and storage instructions
Carefully observe these guidelines when handling or storing the device.
2.3.1 Device handling
Checking and opening the package – Before opening the sterile package tray, visually
check for any signs of damage that might invalidate the sterility of the package contents.
If the package is damaged – The device packaging consists of an outer tray and inner
tray. Do not use the device or accessories if the outer packaging tray is wet, punctured,
opened, or damaged. Return the device to Medtronic because the integrity of the sterile
packaging or the device functionality may be compromised. This device is not intended to
be resterilized.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before
shipment. This device is for single use only and is not intended to be resterilized.
Device temperature – Allow the device to reach room temperature before it is programmed
or implanted. Device temperature above or below room temperature may affect initial device
function.
Dropped device – Do not implant the device if it has been dropped on a hard surface from
a height of 30 cm (12 in) or more after it is removed from its packaging.
“Use by” date – Do not implant the device after the “Use by” date because the battery
longevity could be reduced.
For single use only – Do not resterilize and reimplant an explanted device.
2.3.2 Device storage
Avoid magnets – To avoid damaging the device, store the device in a clean area away
from magnets, kits containing magnets, and any sources of electromagnetic interference.
Temperature limits – Store and transport the package between –18 °C and +55 °C (0 °F
and 131 °F). Electrical reset may occur at temperatures below –18 °C (0 °F). Device
longevity may decrease and performance may be affected at temperatures above +55 °C
(131 °F).
Medtronic PROTECTA™ XT DR D314DRG
24 Clinician Manual