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Bard Sherlock 3CG Tip Confirmation System User Manual

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For use with Site~Rite Vision II Ultrasound System
INSTRUCTIONS FOR USE (IFU)

Questions and Answers:

Bard Sherlock 3CG Tip Confirmation System Specifications

General IconGeneral
BrandBard
ModelSherlock 3CG Tip Confirmation System
CategoryMedical Equipment
LanguageEnglish

Summary

Sherlock 3CG Instructions for Use

System Symbols and Indicators

Overview and System Description

Indications for Use

Guidance and positioning of Peripherally Inserted Central Catheters (PICCs).

Post Market Clinical Trial

Assessment of ECG method for correct PICC tip positioning in adult patients.

Sherlock 3CG TCS Description

Aid in PICC tip positioning via magnet tracking and ECG technology.

ECG Positioning

Utilizes ECG signal for catheter tip positioning based on P-wave amplitude changes.

Magnetic Navigation Technology

System Components

General Warnings

Usage and Environmental Warnings

ECG Signal Variability and Limitations

Rely on magnetic navigation/X-ray for intermittent P-waves or no observable changes.

MRI and Electrical Safety

Avoid MRI; use correct power cord and grounded outlets; ensure cable insulation.

Electrode Placement and Patient Contact

Place electrodes on intact skin; ensure patient does not contact metal surfaces.

General Precautions

Regulatory and Handling Precautions

Physician order required; do not pull cables, twist, bend, or use excessive force.

Storage and Interference Precautions

Store sensor properly; keep ferromagnetic objects and RF sources at least 5 ft away.

Skin and System Care Precautions

Apply electrodes to clean skin; discontinue if irritation occurs; shutdown via power button.

System Assembly

Connecting the Sherlock TCS Sensor

Connect the Sherlock 3CG™ TCS Sensor to the Site~Rite Vision™ II Ultrasound System via USB.

System Information and Layout

Enabling Ultrasound and TCS Layout

Procedure to enable ultrasound and Sherlock 3CG™ TCS waveform display on the screen.

Graphical Interface Overview

Site-Rite Vision II Ultrasound Mode

Display of Ultrasound Imaging and Sherlock 3CG™ TCS External ECG.

TCS Mode Screen Layout

Magnet Tracking Display and Controls

Sherlock 3CG TCS Controls and Indicators

Description of main controls and indicators for the Sherlock 3CG™ TCS system.

PICC Compatibility and Print Settings

Audio Information and Parallax

Parallax Effect Explained

Explanation of parallax as a difference in object location from two viewpoints.

Catheter Care and Device Preparation

Device Preparation Steps

Steps for preparing the device, positioning patient, and measuring catheter length.

Sensor Preparation and Placement

Procedure for preparing the sensor with the Fin Assembly and placing it in the holder.

ECG Electrode Placement

Calibration and Catheter Insertion

Final Magnet-Tracking Calibration

Procedure for final calibration before catheter insertion in TCS Mode.

Catheter Insertion and Tip Positioning

Guidance on inserting the catheter and using magnetic navigation for tip positioning.

Magnetic Navigation and ECG Tip Navigation

ECG Positioning Guidance

Guidance on using ECG waveforms for catheter tip positioning in the cavo-atrial junction.

Procedural Record and Printout

Magnetic Navigation Only Mode

Troubleshooting and Error Messages

Error Screens and Solutions

Identifies common error screens and provides solutions for sensor and magnet errors.

ECG Troubleshooting

Solutions for flat-line, poor, wandering, absent ECG signals, and abnormal waveforms.

Magnetic Navigation Troubleshooting

Solutions for magnetic navigation failures, erratic behavior, and disappearing icons.

Cleaning and Disinfection Procedures

Product Warranty Information

Service and Repair Information

Technical Specifications and Disposal

Operational and Storage Conditions

Specifies operating and storage temperature and humidity ranges for the system.

Disposal Information

Information on returning the product for end-of-life recycling.

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