User's Manual

normal use. However, electronic devices are susceptible to many environmental
stresses including, but not limited to, the following examples.
• The unit is designed to be used indoors in a clinic or hospital.
• The unit should not be dropped or mishandled in such a manner as to cause
physical damage to the unit. This may impair device function. Even if the unit
works immediately after being dropped, operational damage may have
occurred that may not be observed until some future time.
• Fluid should not be spilled on the unit. Even though care is exercised in design
and manufacture of the unit to minimize leakage, fluid incursion may occur,
which could impair functioning of the unit.
• The patient connector may be affected by electrostatic discharge (ESD). In an
environment likely to cause ESD, such as a carpeted floor, discharge any
charge collected on your body before touching the device.
• Do not open the device. The patient connector is constructed to minimize risk
from environmental factors. Opening the unit may make the unit susceptible to
environmental factors and may expose the patient or user to hazardous voltage
or current.
• Rapid temperature changes may affect proper operation. Always allow the
temperature to stabilize in the environment in which the device is used before
using the device.
• Prolonged storage or operation of the device in high humidity may affect proper
operation.
If there is any concern that damage has occurred, the unit should be returned to
Medtronic for inspection and any needed repair.
Besides these listed examples, various other environmental factors may impair
proper performance of the unit in the hospital setting. Always use good health
management practices to prevent environmental damage to the unit.
1.7 Regulatory compliance
1.7.1 US Federal Communications Commission (FCC)
FCC ID: LF524965 (for patient connector). Contains FCC ID: T7V1316.
This device complies with part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that
may cause undesired operation.
1.8 Patient Connector functions
The patient connector communicates with an implanted device. The patient
connector also communicates with the Medtronic app running on a mobile device.
1.9 Security
1.9.1 What hospitals and clinics can do to promote the security of patient
connectors
Maintain good physical controls over the patient connector. Having a secure
physical environment prevents access to the internals of the patient connector.
Only connect the patient connector to managed, secure networks.
Update the software on the patient connector when Medtronic updates are
available.
To increase security, store the patient connector and paired mobile device together
in a secure location when not in use.
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M999999A Medtronic Confidential DRAFT Composed: 2014-11-20 11:53:03
XSL-Stylesheet J - Size-selectable package
manual 24-JAN-2014