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Indications For Use

The Sherlock 3cg^™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3cg^™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG).When relying on the patient’s ECG signal, the Sherlock 3cg^™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICCtip placement confirmation in adult patients.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P wave asin atrial fibrillation, atrial flutter, severe tachycardia, and pacemaker driven rhythm. In such patients, who are easily identifiable prior to catheter insertion,the use of an additional method is required to confirm PICC tip location.

Please consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and directions for use.

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This section specifies warnings and precautions specific to the functionality of the Sherlock 3cg^™ TCS.

See the Bard Access Systems' catheter Instructions for Use (IFU) for possible complications associated with peripherally inserted central catheter (PICC) placements and ECG positioning.

Warnings, Precautions and Safety Information

Warnings

Warning: This product should only be operated by qualified medical personnel.

Warning: Do not power the Sherlock 3cg^™ TCS in the presence of 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 Sherlock 3cg^™ TCS Standalone or Sherlock 3cg TCS-enabled Ultrasound System 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.
• Installation of unauthorized software.
• Modification of system settings without authorization by Bard Access Systems.

Warning: If the Sherlock 3cg^™ TCS Standalone or Sherlock 3cg^™ TCS-enabled Ultrasound System 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. The Sherlock 3cg^™ TCS 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.

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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: The Sherlock 3cg^™ TCS must only be charged with the Medical Grade Power Supply.

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).

Caution: Placement of red electrode outside of the correct region may result in reduced ECG performance.

Caution: Discontinue electrode use immediately if skin irritation occurs.

Caution: To avoid damage to the device operating system, shutdown the device through the Power Control button.

Bard, Sherlock, Sherlock 3CG, Site~Rite and Site~Rite Vision are trademarks and or registered trademarks of C. R. Bard Inc. © 2021 C. R. Bard Inc. All rights reserved.

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