Medtronic 2ACH20 Technical Manual
ACHIEVE ADVANCE™
2ACH15, 2ACH20, 2ACH25
Mapping Catheter
Technical Manual
Caution: Federal law (USA) restricts
this device to sale by or on the order
of a physician.
The following list includes trademarks or registered
trademarks of Medtronic in the United States and possibly in
other countries. All other trademarks are the property of their
respective owners.
Achieve Advance, Arctic Front, Medtronic
Explanation of symbols
Refer to the package labels to see which of the following symbols apply to this product.
Lot number
Reorder number
Use by
Sterilized using ethylene oxide
Do not reuse
Do not resterilize
t
Do not use if package is damaged
Do
Package contents
Consult instructions for use
Product documentation
Keep dry
Keep away from heat and sunlight
Storage temperature
Transit temperature
Humidity limitation
Manufacturer
Authorized representative in the European Community
1 Description
1.1 mm (3.3 Fr)
165 cm
146 cm
15 mm 20 mm
6mm
4mm
2ACH15
2ACH20
25 mm
6mm
2ACH25
8 electrodes 8 electrodes
10 electrodes
This document is intended to be used with the Achieve Advance mapping catheter.
The mapping catheter is an intra-cardiac electrophysiology (EP) recording catheter and can
be used for cardiac stimulation during electrophysiology studies.
The mapping catheter is compatible for use with, and may be used to support and position,
all catheters in the Medtronic Arctic Front CryoAblation Catheter family. Refer to the
applicable Arctic Front Technical Manual for additional instructions for use.
Figure 1. Achieve Advance mapping catheter dimensions
The distal mapping section of the mapping catheter is a circular loop with eight or ten evenly
spaced electrodes to map electrical conduction between the left atrium and the pulmonary
veins. See Catheter specifications, section 7, for detail.
Figure 2. Achieve Advance mapping catheter loop
The mapping catheter should only be used with the Medtronic catheter connecting cable
(Model 2ACHC), which interfaces with standard EP recording equipment. For cable
instructions, see the 2ACHC catheter connecting cable instructions for use.
1.1 Contents of package
The mapping catheter is supplied sterile. The package contains the following items:
■
1 Achieve Advance mapping catheter
■
Product documentation
2 Indications for use
The Achieve Advance mapping catheter is indicated for multiple electrode
electrophysiological mapping of the cardiac structures of the heart, i.e. recording or
stimulation only. The Achieve Advance mapping catheter is designed to obtain electrograms
in the atrial regions of the heart.
3 Contraindications
The Achieve Advance mapping catheter is contraindicated as follows:
■
For use as an ablation device
■
For use with transseptal sheaths featuring side holes larger than 1.00 mm (0.04 in) in
diameter
■
Retrograde approach
Electrophysiology studies are contraindicated when the patient’s underlying cardiac disease
makes it likely that induced arrhythmias will be extremely difficult to terminate and carry a
high risk of death, as in the following conditions:
■
An active systemic infection
■
Left atrial thrombus
■
Pulmonary vein stents
■
Prosthetic heart valve (tissue or mechanical)
■
Myxoma
■
Interatrial baffle or patch
■
Conditions where the manipulation of the catheter within the heart would be unsafe
■
Acute myocardial infarction
4 Warnings and precautions
For single use only – This catheter is intended only to be used once for a single patient. Do
not reuse, reprocess, or resterilize these devices for purpose of reuse. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device or create a risk of
contamination of the device that could result in patient injury, illness, or death.
Do not resterilize – Do not resterilize the catheter for purpose of reuse. Resterilization may
compromise the structural integrity of the device or create a risk of contamination from the
device that could result in patient injury, illness, or death.
Qualified users – This equipment should be used only by or under the supervision of
physicians trained in cardiac catheterization procedures.
Device disposal – Dispose of catheter according to hospital biohazard requirements.
Expiration date – Check to verify the catheter is within the expiration date. Do not use if the
product date has expired.
Sterile package inspection – Inspect the sterile packaging prior to use. If the sterile
packaging of the device is damaged, do not use. Contact your local Medtronic
representative.
Improper connection – Do not connect the mapping catheter to a radiofrequency (RF)
generator or use it to deliver RF energy. Doing this may cause catheter malfunction or patient
harm.
Induced arrhythmias – Catheter procedures may mechanically induce arrhythmias.
Fluoroscopy required for catheter placement – Use of fluoroscopy during catheter
manipulation and placement is strongly advised. Manipulating the catheter without
fluoroscopy may result in damage to cardiac and vascular structures.
X-ray and fluoroscopic exposure – Minimize x-ray and fluoroscopic exposure. Due to the
intensity of the x-ray beam and the duration of the fluoroscopic imaging during catheter
procedures, patients and laboratory staff may be subjected to acute radiation injury and
increased risk for somatic and genetic effects. Take all appropriate measures to minimize
x-ray exposure to both patients and clinical staff. The long-term effects of protracted
fluoroscopy have not been established.
Catheter positioning around the chordae tendineae – Avoid positioning the catheter
around the chordae tendineae as this increases the likelihood of catheter entrapment within
the heart, which may necessitate surgical intervention or repair of injured tissues.
Other catheters, devices, or wires – Avoid catheter entanglement with other catheters,
devices, or wires. Such entanglement may necessitate surgical intervention.
Prosthetic heart valves – Do not pass the catheter through a prosthetic heart valve
(mechanical or tissue). The catheter may become trapped in the valve, damaging the valve
and causing valvular insufficiency or premature failure of the prosthetic valve.
Achieve Advance Technical Manual 3
Loading...