Bard Sherlock 3CG TCS, Инструкция по эксплуатации, Страница: 7 / 28

5
Sherlock 3CG™ Tip Confirmation System
Warnings
Warning: This product should only be operated by qualified medical personnel.
Warning: Do not power the Sherlock 3CG™ TCS in the presence of noncontained flammable anesthetic gases. Explosion may result.
Warning: Do not attempt to sterilize the sensor. Damage to the equipment may occur.
Warning: The following actions void the warranty of the Sherlock 3CG™ TCS and may result in injury or equipment damage.
- Opening or servicing the Site~Rite™ 6 Ultrasound System with Sherlock 3CG™ TCS by anyone other than Bard Access Systems’
authorized service personnel.
- Removing system labels by anyone other than Bard Access Systems’ authorized service personnel.
- Connecting the sensor or applied patient components to any unauthorized system or accessory. Refer to Section 1.4 for complete components.
- Installation of unauthorized software.
- Modification of system software settings without authorization by Bard Access Systems.
Warning: If the
Site~Rite™ 6 Ultrasound System with
Sherlock 3CG™ TCS is visibly damaged, discontinue use immediately. Use of the damaged system
may result in injury or equipment damage.
Warning: Do not submerge the sensor in liquid or allow fluid to enter the connectors. Damage to the equipment may occur.
Warning:
Sherlock 3CG™ TCS is not intended to diagnose or treat disease.
Warning: Only Bard Access Systems’ authorized service personnel should attempt to service this equipment. Site~Rite™ 6 Ultrasound System contains static
sensitive components and circuits. Failure to observe proper static control procedures may result in damage to the system.
Warning:
Do not rely on ECG signal detection for catheter tip positioning when interpretation of the external or intravascular ECG P-wave is difficult.
For example, when:
- P-wave is not present
- P-wave is not identifiable
- P-wave is intermittent
These conditions may be a result of heart rhythm abnormalities, atrial fibrillation, atrial flutter, severe tachycardia or presence of cardiac rhythm
devices. In these cases, rely on magnetic navigation and external measurement for tip positioning and use chest x-ray or fluoroscopy to confirm
catheter tip location, as indicated by institutional guidelines and clinical judgment.
Warning: Do not rely on ECG signal detection for catheter tip positioning when there are no observable changes in the intravascular P-wave. In this case,
rely on magnetic navigation and external measurement for tip positioning and use chest X-ray or fluoroscopy to confirm catheter tip location, as
indicated by institutional guidelines and clinical judgment.
Warning: Do not place and/or use the Sherlock 3CG™ TCS in the presence of strong magnetic fields such as Magnetic Resonance Imaging (MRI) devices.
The high magnetic fields created by an MRI device will attract the equipment with a force sufficient to cause death or serious injury to persons
between the equipment and the MRI device. This magnetic attraction may also damage the equipment. The magnetic and the RF fields associated
with the MRI environment may interfere with the display of ECG waveforms. Consult the MRI manufacturer for more information.
Warning: Do not remove Sherlock 3CG™ TCS enclosures. To avoid electrical shock, use only the power cord supplied with the system and connect only to
properly grounded wall outlets. Only Bard Access Systems qualified personnel should service the system
Warning: Ensure all connecting cables and connections are electrically insulated and do not come into contact with other electrical cables or metal surfaces.
Warning:
Ensure that the patient does not directly or indirectly contact non-insulated metal surfaces.
Warning: Place skin electrodes carefully at locations indicated in these Instructions for Use and ensure good skin-electrode contact. Failure to do so may cause
unstable ECG waveforms and/or ECG waveforms that are not described in these Instructions for Use. In such a case, rely on magnetic navigation
and external measurement for tip positioning and use chest X-ray or fluoroscopy to confirm catheter tip location, as indicated by the institutional
guidelines and clinical judgment.
Precautions
Caution:
Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Caution:
Do not pull the cables to disconnect from the system. Pulling the cable may damage the cable or cable connection.
Caution:
Excessive twisting or bending of the sensor cable may cause system failure.
Caution:
Use only Bard Access Systems’ cleaning and disinfection procedures. Failure to do so may damage the device.
Caution:
Do not use excessive force when connecting or disconnecting the Fin Assembly to or from the sensor or equipment damage may occur.
Caution:
When the sensor is not in use, store in the holster, roll stand basket or other secure location to avoid damage.
Caution:
Do not allow any ferromagnetic objects, e.g., wired undergarments, metal instruments, watches, jewelry, electronics, metal bedrails, etc. to be
within 12 in (30 cm) of the sensor once the calibration process is complete. These items may interfere with the sensor's ability to accurately locate
the Sherlock
™
Stylet tip.
Caution:
Equipment operating in close proximity may emit strong electromagnetic or radio frequency interference which could affect the performance
of this device. Avoid operating the device near pumps, cauterizers, diathermy equipment, cellular phones, or other portable and mobile radio
frequency communications equipment. Maintain equipment separation of at least 5 ft (1.5 m).
Caution:
Electrodes should be applied only to intact, clean skin (e.g., not over open wounds, lesions, infected or inflamed areas).