CVRx BAROSTIMIPG1 Manual De Usuario
BAROSTIM NEO LEGACY REFERENCE GUIDE
4-2
Implantable Pulse Generator
Warnings
• The IPG is a single-use-only device. Do not re-sterilize or reuse. Reuse of this product may result in
malfunction or adverse events such as infection or death.
• Do not implant product if
the expiration “Use Before” date has been reached.
• Do not implant the IPG if the storage package has been damaged, compromising the product sterility.
• Persons allergic to silicone, titanium, or polyurethane may have an allergic reaction to the IPG.
• Patients who manipulate the IPG through the skin may damage or disconnect the lead from the pulse
• Persons allergic to silicone, titanium, or polyurethane may have an allergic reaction to the IPG.
• Patients who manipulate the IPG through the skin may damage or disconnect the lead from the pulse
generator.
Precautions
• Neo Legacy is compatible with lead models 101x only. Do not use Neo Legacy with lead models 103x.
• Do not store the IPG outside the temperature range of -4° F (-20° C) to 122° F (50° C).
• Electrocautery may damage the IPG. Position electrocautery as far as possible from the IPG and items
• Electrocautery may damage the IPG. Position electrocautery as far as possible from the IPG and items
connected to it.
• Do not implant an IPG if the device has been dropped.
• The battery life of the IPG is limited. Patients should be counseled that replacements will be needed.
• IPG operation may cause artifacts in electrocardiogram (ECG) tracings.
• Do not insert a Carotid Sinus Lead in the IPG connector without verifying that setscrews are sufficiently
• The battery life of the IPG is limited. Patients should be counseled that replacements will be needed.
• IPG operation may cause artifacts in electrocardiogram (ECG) tracings.
• Do not insert a Carotid Sinus Lead in the IPG connector without verifying that setscrews are sufficiently
retracted.
• Prior to tightening the setscrews, make sure that lead is fully inserted into the IPG connector module.
• Do not ultrasonically clean the IPG.
• Do not incinerate the IPG. Extreme heat could cause the internal battery to explode.
• Therapeutic radiation may damage the IPG. Damage to the IPG due to therapeutic radiation may not be
• Do not ultrasonically clean the IPG.
• Do not incinerate the IPG. Extreme heat could cause the internal battery to explode.
• Therapeutic radiation may damage the IPG. Damage to the IPG due to therapeutic radiation may not be
immediately detectable.
• Lithotripsy procedures can damage the IPG. Position the IPG outside the ultrasound water bath.
• External defibrillation may cause damage to the IPG. During a defibrillation procedure, space electrodes
• External defibrillation may cause damage to the IPG. During a defibrillation procedure, space electrodes
as far as practical from the IPG. Verify proper IPG function after defibrillation procedures. In addition, if
it is practical, it is suggested that the IPG be turned off during defibrillation.
it is practical, it is suggested that the IPG be turned off during defibrillation.
• Sterile package seal integrity can be damaged by moisture. Do not expose to liquids.
• If any of these 3 situations is observed, a CVRx representative should be contacted immediately.
• If any of these 3 situations is observed, a CVRx representative should be contacted immediately.
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Low lead impedance, less than 300 Ohms, may indicate a short in the lead.
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High lead impedance, greater than 3000 Ohms, may indicate poor lead connection to IPG or
a lead fracture.
a lead fracture.
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Drastic changes in lead impedance may indicate a problem with a lead.
• Do not place the IPG on a magnetic instrument drape. Doing so may place the IPG in an inhibit or
“Magnet Mode” which will halt pulse outputs.
• An additional IPG should be available in the event of compromised sterility or if damage is induced
during surgery.