The ScopeGuide operating instructions explicitly advise against using ScopeGuide on patients with a critical active implantable device, such as a pacemaker and an implantable cardioverter defibrillator.
The use of magnetic field-generating devices adjacent to, or in the vicinity of, a pacemaker or ICD should be avoided due to their construction. Please note that the response of the device to any magnetic field will be dependent on how it has been programmed for that specific patient.
For some pacemakers, subjecting the device to a magnetic field may result in asynchronous pacing, whilst in others, a period of device diagnostics is initiated, after which pacing is resumed. Devices with depleted batteries may experience pacing instability and, in severe cases, cease to provide paced output. Exposing a pacemaker or ICD to a magnetic field will not necessarily modify or suspend pacing, but it may.
On this basis, it is strongly advised to contact the Cardiac Department responsible for implanting the device or the manufacturer for further advice and guidance.
To assist the Cardiac Department or the manufacturer, Olympus has conducted separate testing with the endoscope, the position-detecting probe (MAJ-1878), the reference plate (MAJ-1860), or the hand coil (MAJ-1859) when connected to ScopeGuide (UPD-3). The magnetic flux density is close to 0 nT when the above equipment is 60 cm away from the measurement instrument and approximately 250 nT when the distance is 0 cm. Please note that due to the characteristic of the magnetic flux density, Olympus is unable to determine the exact distance at which the magnetic flux density becomes zero.
Please note, no testing has been carried out by Olympus, and therefore neither Olympus Medical, Olympus Corporation Ltd, nor KeyMed (Medical & Industrial Equipment) Ltd, nor any person or persons authorised to represent Olympus can accept any liability or responsibility in the event of an adverse incident occurring as a result of use of the ScopeGuide on any patient fitted with a pacemaker or ICD.