User Manual Part 1

INFORMATION FOR USE

PRECAUTIONS

1-9

•STATPACEsettings.When a pulse generator is programmed to STAT

PACE settings, it will continue to pace a t the high-energy STAT PACE

values if it is not reprogrammed. The use of STAT PA CE parameters will

decrease dev ice longevity.

• Biventricular pacing therapy. This device is intended to provide

biventricular pacing therapy. Programming the device to provide RV-only

pacing, or programming the RV pace amplitude below the pacing threshold

(resulting in LV-only pacing), is not intended for the treatment of heart

failure. The clinical effects of LV-only or RV-only pacing for the treatment of

heart failure have not been established.

• Pacing and sensing margins. Consider lead maturation in your choice of

pacing amplitude, pacing pulse width, and sensitivity settings.

• An acute pacing threshold greater than 1.5 V or a chronic pacing

threshold greater than 3 V can result in loss of capture because

thresholds may increase over time.

• An R-wave amplitude less than 5 mV or a P-wave amplitude less than

2 mV can result in undersensing because the sensed amplitude may

decrease after implan ta tio n.

• Pacing lead impedance should be within the range of 200  and

2000 .

• Line-powered equipment. Exercise extreme caution if testing leads u sing

line-powered equipment because leakage current exceeding 10 µA can

induce ventricular ﬁbrillation. Ensure that any line -p owered equipment is

within speciﬁcations.

• Proper programming of the lead conﬁguration. If the Lead Conﬁgu rat ion

is programmed to Bipolar when a unipolar lead is implanted, pacing will

not occ ur.

• Proper programming of the shock vector. If the shoc k vector is

programmed to RVcoil>>RAcoil and the lead does not have an RA coil,

shocking will not occur.

• Replacement device. Implanting a replacement device in a subcutaneous

pocket that previously housed a larger device may result in pocket air

entrapment , migration, erosion, or insu fﬁcient grounding between the

device and tissue. Irrigating the pocket with sterile saline solution decreases

the pos sibility of pocket air entrapmen t and in su fﬁcient grounding. Suturing

the de vice in place reduces the possibility of migration and erosion.

- DRAFT -