Adverse Events; Product Description; Control Unit - Codman MedStream 91-4205 Manual Del Usuario

Leave a 50 cm space between pumps if implanting more than one
MedStream pump in a patient. Implanting MedStream pumps nearer than
50 cm can cause occasional interruption of communications between the
pump and the control unit.
Be aware that medical electrical equipment needs special precautions
regarding electromagnetic compatibility. This equipment must be installed
and put into service according to the electromagnetic compatibility
information provided in this manual. (See Appendix A for more information.)
Be aware that communications between the pump and the control unit might
be interrupted if the patient has another implant that communicates via radio
frequency, such as a pacemaker.
Be aware that electromagnetic interferences can affect communications
between the control unit and the pump. If the "Transmission Error" message
appears despite all attempts to correctly position the control unit, consider
moving the patient to an area with fewer electronic devices and high-energy
radio frequency equipment.
Be aware that communication between the control unit and the pump might
be affected by usage of another control unit in close vicinity. This issue only
arises when both of the following conditions are met:
1) Communication between one control unit and pump is in progress
AND
2) A second control unit in close vicinity initiates a communication
with a pump.
Note: Communication is not affected by the presence of another control unit
when it is not actively communicating with a pump.
Be aware that the control unit is a portable RF communications device that
can affect medical electrical equipment.
Be aware that the use of cables other than those included with the
control unit can result in increased emissions or decreased immunity of
the equipment.
Avoid using the control unit adjacent to or stacked with other electronic
equipment. If adjacent or stacked use is necessary, observe the system to
verify normal operation in the configuration in which it will be used.
Allow the control unit to come to operating temperature range of 10ºC to
40ºC (50ºF to 105ºF) before turning the power on. This is a concern if the
control unit is stored in an environment outside of the operating temperature
range. Operating the control unit while it is outside the operating temperature
range might cause it to shut down.
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Use only the battery charger provided with the control unit to recharge the
control unit battery.
Avoid exposing the control unit to ultraviolet light.
Do not remove the hardware key from its slot in the control unit. The control
unit software will lock if the hardware key is missing or damaged.
Do not remove or replace the control unit battery.
Use only with computer equipment that complies with IEC 60950-1.

Adverse Events

There are no known adverse events associated with use of the MedStream

Control Unit.

PRODUCT DESCRIPTION

Control Unit
The MedStream Control Unit is a hand-held, battery-powered, electronic
module that houses power and control logic circuits. The control unit uses
radiofrequency to communicate with a MedStream pump. Use the control
unit to:
• prepare the pump preoperatively
• initialize the pump and start infusion postoperatively
• refill the pump
• noninvasively check the status of an implanted pump and change the
dosage parameters
• deliver a bolus dose of medication directly from the pump's drug reservoir
• view a log of transactions performed with the control unit
• transmit a record of a past transaction or of a pump's current settings to
a compatible computer printer
The control unit (see Figure 1) includes the following features:
• Liquid crystal display (LCD) screen
• Power/Escape button
• Roller key and Back button for navigating screens
• Antenna
• Hardware key
• USB port for printer
• USB port for PC
• Strap
• Battery charger connection
• Transmit button
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