Frequently Asked Questions (BDS)
How does the technology of the NOGA® XP System compare to conventional approaches to mapping?
How does the navigation system work?
What are the indications for using the NOGA® XP System?
When is use of the NOGA® XP System contraindicated?
Are the magnetic fields used in the NOGA® XP System dangerous to the patient or to the staff?
How many times may I use a mapping catheter or reference patch?
Why is the position of the reference patch (on the patient's back) important?
What is the accuracy of the measured position of the catheter tip?
How many points do I need to acquire to make a map?
How long does it take to acquire a map?
How many patient files can be stored on the system hard disk before I must erase data?
How can I become a qualified NOGA® XP System User?
What international standards does the NOGA® XP System comply with?
How does the technology of the NOGA® XP System compare to conventional approaches to mapping?
The NOGA® XP System utilizes a location detection technology via a location detection device (location pad) and sensors in the mapping catheter and an external location reference patch. Physicians are familiar with obtaining information via "mapping" catheters. The NOGA® XP System differs from some others in the way data is presented, on-screen, in real-time, to the physician. Data is presented in 3D color-coded shape reconstructions of the heart. This color-coding enables quick visualization of the activation of the mapped tissue, in correlation with its anatomical location.
How does the navigation system work?
The NOGA® XP Mapping and Navigation System is comprised of a miniature passive magnetic field sensor embedded in the mapping catheter and reference patch, an external ultra-low magnetic field emitter (the location pad), and a processing unit (the COM unit). The location pad, placed under the patient table, generates an ultra-low magnetic field (0.05-0.5 gauss) with known temporal and spatial distinguishing characteristics that "code" the mapping space around the patient's chest. The location sensors determine the location and orientation of the mapping catheter in 6 degrees of freedom (X, Y, Z and roll, pitch and yaw) by sensing changes in the magnetic field.
What are the indications for using the NOGA® XP System?
The intended use of the NOGA® XP System is catheter-based cardiac electromechanical mapping. The NOGA® XP System provides important information on the electrical and mechanical activities of the heart, in a procedure that uses the same techniques and tools as other cardiac catheter mapping systems. You can use the NOGA® XP System on patients who are eligible for a conventional cardiac catheterization study
When is use of the NOGA® XP System contraindicated?
Use of the NOGA® XP System is contraindicated in the same cases where cardiac catheterization is contraindicated. The NOGA® XP System has no specific contraindications per se.
Are the magnetic fields used in the NOGA® XP System dangerous to the patient or to the staff?
No. The fields emitted are not dangerous to the patient or to the staff and no protective measures need be taken. The fields are very small - approximately the same strength as the earth's magnetic field. According to international standards on exposure to magnetic fields, the fields used in the NOGA® XP System are not dangerous even for full time occupational exposure.
Will the magnetic fields used in the NOGA® XP System affect any of the other equipment in the operating room?
The NOGA® XP System interferes with newer fluoroscopy systems that use magnetic field based proximity sensors. In such cases, contact the system supplier to arrange for desensitization of the detection system.
WARNING: The functioning of the NOGA® XP System could possibly interfere with the programming or interrogating of implantable cardiac pacemakers or defibrillators. Do not use the system while programming or interrogating any cardiac pacemakers or defibrillators.
How many times may I use a mapping catheter or reference patch?
The mapping catheters and reference patch are designed for single use only. They are not designed for reuse, and cannot be resterilized.
Why is the position of the reference patch (on the patient's back) important?
Accurate map reconstructions are dependent on distance calculations between a stable source (the Location Reference patch) and the Mapping catheter. The location reference patch/catheter should be centered at least 9 cm over the location pad. Once a point has been acquired, it should not move.
What is the accuracy of the measured position of the catheter tip?
Animal and clinical studies have shown the measured position of the catheter tip to be accurate to ± 1 mm.
How many points do I need to acquire to make a map?
The number of points needed depends on the type of map you wish to make and the size of the chamber being mapped. When creating a detailed map of the entire heart chamber you will probably need to acquire between 50-60 points. If you wish to map only a selected area of the chamber, sufficient detail may be acquired by as few as 10-30 points.
How long does it take to acquire a map?
The time required to acquire a map will depend on the type of map being acquired, patient anatomy, the ease of maneuverability of the catheter in the individual case, and your experience with the system. A fully detailed 60-point map created with manually accepted points could take approximately 30-40 minutes to create, while a small regional map may take only a few minutes.
How many patient files can be stored on the system hard disk before I must erase data?
This depends on how many maps are made for each patient and how many points are in each map. Remembering that a patient file can consist of several maps, on an average, you should be able to save approximately 500 maps on the hard disk. Thus, the number of patient files will vary depending on the number of maps acquired for each patient. We strongly recommend that you routinely backup your data to CDs at the end of each procedure, or at least once a week (using the Backup function), and regularly remove older patient data from the system at least once a month.
CAUTION: Never delete a procedure from the hard disk unless you have backed up the data. Once data is deleted from the hard disk, it cannot be recovered unless it was backed up to a CD.
How can I become a qualified NOGA® XP System User?
You need to be a medical practitioner and to have participated in a NOGA® XP System training course.
What international standards does the NOGA® XP System comply with?
The NOGA® XP System complies with the Medical Device Directive 93/42/EEC and with the EMC directive 89/336/EEC as amended by 92/31/EEC and 93/68/EEC and the CE mark has been affixed to the product.
The NOGA® XP System is certified to the following standards:
- .IEC 60601-1 1988 + A1/1991 + A2/1995
- .EN60601-1/1999+A1/1993 + A2/1995 + A13/1996
- .UL 60601-1/2003 Second Edition
- .CAN/CSA 22.2 No. 601.1 - M90
- .IEC 60601-1-1/2000
- .EN 60601-1-1 /2001
- .EN/IEC 60601-1-2/2001
- .EN 55011/1998 + A1/1999 + A2/2001 Class A Group I
- .IEC 60601-2-25/1993 +A1/1999
- .EN 60601-2-25/1995 +A1/1999
- .EN/IEC 60601-2-27/1994
