Leads – ICF 09B, ICQ 09B

Model
ICF 09B
 ICQ 09B
Polarity
 Bipolar Bipolar
Chamber
 Atrium/Ventricle Atrium/Ventricle
Fixation
 Helical screw
Extendable/retractable		 Helical screw
Extendable/retractable

Material
Inner insulation
 Silicone MED 4719 Silicone MED 4719
Outer insulation
 Silicone MED 4719 Polyurethane (55D)
Conductor MP 35 N nickel alloy MP 35 N nickel alloy
Helix electrode
 Platinized platinum alloy Titanium nitride coated
platinum alloy
Ring electrode
 Platinized platinum alloy Titanium nitride coated
platinum alloy

Diameter
Body
 2.03 mm (6F) 1.93 mm (5.7F)
Ring 1.98 mm 1.98 mm
Helix
 1.17 mm 1.17 mm

Introducer size
One lead
7F 7F
With guide wire 9F 9F
   
Tip/Ring distance
 10 mm 10 mm

Electrode surface area
Helix 4.2 mm² 4.2 mm²
Helix length 1.8 mm 1.8 mm
Ring 22 mm² 22 mm²


     
Coil resistance
Unipolar
30Ω(52 cm)
 30Ω(52 cm)
  33Ω(58 cm) 33Ω(58 cm)
Bipolar 55Ω(52 cm) 55Ω(52 cm)
  61Ω(58 cm) 61Ω(58 cm)
Steroid < 1.0 mg
dexamethasone acetate		 < 1.0 mg
dexamethasone acetate
Standard lengths 45, 52, 58, 65, 85 cm 25, 35, 45, 52, 58, 65, 85, 110 cm
Connector IS-1 BI IS-1 BI
Serial number VMR LFM

Crystalline

Indications, Contraindications, Warnings

Intended Use

Vitatron implantable transvenous leads are designed to be used with pulse generators as part of a cardiac pacing system. See product labeling for specific directions regarding application.

Contraindications

When tricuspid valvular disease is present, use of a transvenous ventricular lead is contraindicated. In patients with mechanical tricuspid heart valves, use of endocardial ventricular leads is contraindicated. Use of a passive fixation atrial lead may be contraindicated in the absence of a right atrial appendage. Do not use steroid eluting leads in patients for whom a single dose of 1.0 mg dexamethasone sodium phosphate may be contraindicated.

Warnings

An implanted lead forms a direct, low-resistance current path to the myocardium. Therefore, use only battery-powered equipment during lead implantation and testing to protect against fibrillation caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.

Precautions

Use an anchoring sleeve with all leads. Leads should be handled with great care at all times. Any severe bending, kinking, stretching, handling with surgical instruments or excessive force when inserting a stylet may cause permanent damage to the lead. Chronic repositioning may adversely affect a steroid lead's low-threshold performance.

Potential Complications

The potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions that can occur when the lead is being inserted and/or repositioned: valve damage (particularly in fragile hearts, e.g., infants), fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis, and pneumothorax.