Important; Brief Product Description; Indications; Contraindications - Codman MedStream 91-4205 Manual Del Usuario

ENGLISH
IMPORTANT INFORMATION
Please Read Before Use
MedStream™ Control Unit
(Catalog No. 91-4205)
FCC ID: T9I-914205
IC: 6518A-914205
IMPORTANT: This equipment has been tested and found to comply
with the limits for a Class B digital device, pursuant to part 15 of the
FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in
a commercial environment. This equipment generates, uses, and
can radiate radio frequency energy and, if not installed and used in
accordance with the instruction manual, may cause harmful interference
to radio communications. Operation of this equipment in a residential
area is likely to cause harmful interference in which case the user will be
required to correct the interference at his own expense.
IMPORTANT: This device complies with the Class B limits for radio noise
emissions as set out in the interference-causing equipment standard
entitled "Digital Apparatus" ICES-003 of Industry Canada. Operation is
subject to the following two conditions: (1) this device may not cause
interference, and (2) this device must accept any interference, including
interference that may cause undesired operation of the device.

Brief Product Description

The MedStream Control Unit is part of a system for the intrathecal delivery
of selected drugs for pain management or relief of spasticity. It is designed
for communicating with and programming the MedStream™ Programmable
Infusion Pump.
CAUTION: Do not use the MedStream Control Unit without ensuring
a thorough familiarity with the information contained in this manual, the
pump instructions and the MedStream Infusion System Programming
Guide (#914282). Failure to adhere to these instructions can result in patient
complications ranging from failure of the intended therapy to drug underdose
or overdose.
206102-001-D.indb 3 206102-001-D.indb 3

Indications

The MedStream Control Unit is used to program the MedStream
Programmable Infusion Pump for the medication therapy indicated in the
pump Instructions for Use.

Contraindications

There are no known contraindications for the use of the control unit.
Observe all contraindications relating to the use of the prescribed drug.

WARNINGS

Do not modify or change the control unit. Unauthorized changes or
modifications to the control unit might cause a malfunction that could result
in serious patient injury or death and could void the user's authority to
operate the equipment.
Immediately investigate with the control unit if the pump alarm sounds.
Immediately empty the pump reservoir if the error message is "Pump
Hardware Failure." These conditions can cause a drug overdose. See the
MedStream Infusion System Programming Guide for further information.
Do not open the control unit case. There are no user serviceable parts.
See Service and Repair.
Do not immerse the control unit in liquid. Damage to the unit may result.
Do not use the control unit in the presence of flammable gases or near
flammable materials.

PRECAUTIONS

Do not use the MedStream Control Unit with any other programmable
infusion pump.
Do not place the pump on a metal surface when using the control unit for
preoperative preparation.
Do not expose the control unit or the hardware key to electromagnetic fields
or ionizing radiation, such as MRI or X-rays.
Be aware that the MedStream pump might be unable to communicate with
the control unit if the pump is in the vicinity of another metallic implant.
3
9/15/2014 6:26:37 PM 9/15/2014 6:26:37 PM