User's Manual

Use of unapproved power supply – Use only the Medtronic-supplied power
supply with the patient connector. Use of an unapproved power supply may damage
equipment or impact user or patient safety.
1.6 Precautions
Attaching the tether kit – Do not overtighten the screw when attaching the tether
kit.
Autoclaving – Do not autoclave the patient connector.
Damaged equipment – If the case of the patient connector is cracked or if any of
the connectors are damaged, contact your Medtronic representative. If there is
damage to the power supply cord, replace the part and dispose of it according to
local regulations or return the part to Medtronic.
Do not immerse – Take care to prevent liquid from entering the patient connector.
Do not immerse the patient connector or any accessories in any liquid or clean them
with aromatic or chlorinated hydrocarbons.
Electrocautery/external defibrillation – Do not position the patient connector
over an implanted device during electrocautery or external defibrillation
procedures.
Maintenance and service – Do not modify or do any maintenance or service on
the patient connector while you are using it. Doing any of these tasks on the patient
connector while it is in use can lower its effectiveness. Contact Medtronic at the
number on the back cover of this manual if your patient connector is not working
properly.
Product and packaging labels and information – If labels or information appear
to be missing from the product or packaging, contact your local Medtronic
representative at the address and telephone number located on the back cover of
this document.
Radio-frequency (RF) interference – Portable and mobile RF communications
equipment can interfere with the operation of the patient connector. Although this
system has been approved, there is no guarantee that it will not receive interference
or that any particular transmission from this system will be free from interference. To
avoid interference, do not use the patient connector and mobile device within 2 m (6
feet) of a television, computer monitor or screen, or other wireless communications
equipment such as wireless home network devices, mobile phones, cordless
telephones and their base stations, or “walkie-talkies”. Using your patient connector
near these devices could interfere with communication between your implanted
heart device and the patient connector.
Security – Maintain adequate physical security of the patient connector to prevent
unauthorized use that could lead to harm to patients. Bluetooth communication in
the patient connector is encrypted for security. Inductive telemetry (A/B) uses
short-range communication to protect patient information. If the patient connector
should fail, there is no risk of patient harm.
Use of wireless devices – The patient connector incorporates radio-frequency
(RF) communications components which may affect other devices and equipment
in the medical environment. The use of wireless devices in the medical environment
must be evaluated and authorized by the responsible organization. RF interference
may affect device performance.
1.6.1 Environmental precautions
To ensure safe and effective operation, use the device with care to avoid damage to
the patient connector from environmental factors that may impair its function. Care
is exercised in design and manufacturing to minimize damage to devices under
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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