- Helps to position PICC tip in proximity to the cavoatrial junction in adult patients
- Allows for prompt infusion therapy and immediate release of the PICC line as compared to chest X-ray and other post-procedural confirmation methods
- Eliminates costs associated with confirmatory chest X-ray
- Provides immediate feedback to the
clinician on PICC tip position - Eliminates time previously spent waiting
for X-ray confirmation readings - Eliminates X-ray exposure to the
patient and clinician
Any alterations of cardiac rhythms that change the normal presentation of the P-wave limit the use of this technology. In these instances, confirm PICC tip location using an alternative method. Please consult Instructions for Use for additional safety information.
Features
The Sapiens* Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). Sapiens* TCS provides real-time catheter tip location information by using the patient's cardiac electrical activity.
Sapiens* TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.
Two clinical studies involving 362 patients have shown that catheter tip placement using the Sapiens* technology was confirmed with chest X-ray or fluoroscopy to be at the desired location in 97% of the cases.†
- 97% at the cavoatrial junction or within +/- 1 cm
- 3% in middle or lower SVC greater than 1 cm and up to 3 cm away from the cavoatrial junction
- No adverse events or complications were reported
†Data on File (Bard Access Systems, Inc.,
Salt Lake City, Utah)
Features
- Dynamic ECG waveform
Changes in P-wave morphology allow clinician to position catheter tip at a specific/desired location relative to the
cavoatrial junction - Static ECG baseline
Provides comparative ECG waveform for interpretation of P-wave changes and to assist in maximum P-wave identification - Ability to maintain sterile field
Through-drape connection allows clinician to maintain maximal barrier sterile field during placement
Probe and wireless remote allow the clinician to maintain sterility while interfacing with Sapiens* TCS - Tip location documentation
Allows for PICC tip location to be easily documented in patient's chart or stored in a computer database - Meet guidelines
By helping to position the PICC tip in proximity to the cavoatrial junction, the Sapiens* TCS technology helps clinicians comply with AVA and INS guidelines for proper PICC tip placement
Benefits
- Indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in
adult patients. - Allows for immediate confirmation of proper PICC tip position at the bedside and immediate release of the PICC line
which helps to reduce time to infusion therapy‡ - Helps reduce nurse time spent on PICC tip repositioning and improves efficiency associated with PICC
tip positioning‡ - Eliminates costs associated with chest X-ray and time previously spent waiting for X-ray confirmation readings
- Eliminates X-ray exposure to the patient and clinician when PICC placement is confirmed with Sapiens* TCS
Limitations
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 the institutional guidelines and clinical judgment.
Do not rely on ECG signal detection for catheter tip positioning when there are no observable changes in the P-wave. 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 the institutional guidelines and clinical judgment.
Comprehensive and Integrated Solution
With the addition of Sapiens* TCS, Bard Access Systems now
offers a comprehensive solution combining:
- Site-Rite* Ultrasound:
Vessel assessment and access - Sherlock* II Tip Location System (TLS):
Magnetic tip tracking - Sapiens* Tip Confirmation System (TCS):
ECG positioning and confirmation
Seeing is Believing…
See The Vein
Site-Rite* 6 and Site-Rite* VISION
Site-Rite* Ultrasound Systems provide ULTRASOUND GUIDANCE for placement of catheters in vascular structures.
Helps to Meet Industry Guidelines
The Site-Rite* Ultrasound Systems meet AHRQ (Agency for Healthcare Research and Quality) recommendations for use of real-time ultrasound guidance for central line placement.
Decreased Complications1
Clear vessel visualization helps reduce risk of inadvertent arterial puncture, hematoma or pneumothorax.
Reduced Venipunctures1
Reduction in the number of venipuncture kits used to achieve success.
1J. Santolucito. "A retrospective evaluation of the timeliness of physician initiated PICC referrals." Journal of Vascular Access Devices. Fall 2001 pp. 20-26
See The Tip
The Sherlock* II TLS technology provides real-time directional PICC TIP LOCATION and orientation identification via magnetic tip tracking.
Helps reduce risks associated with "blind"
catheter placement
Audible and visual signals indicate location of
tip position with an accuracy of 1 cm
Designed to cover more anatomical landmarks
See The Wave
Sapiens* TCS
The Sapiens* Tip Confirmation System (TCS) is indicated for use as an alternative method to chest X-ray and fluoroscopy
for PICC tip placement confirmation in adult patients.
Sapiens* TCS helps to position the PICC tip in proximity
to
the cavoatrial junction when the patient's P-wave is
present, identifiable, and consistent and allows for
IMMEDIATE CONFIRMATION of PICC tip position
at the
patient's bedside.
Allows for immediate release of the
PICC
line which helps to reduce time to
infusion therapy‡
Helps reduce nurse time spent
on PICC
tip repositioning and
improves
efficiency associated
with PICC tip positioning‡
Eliminates costs
associated with
chest
X-ray and time
previously spent waiting
for X-ray confirmation readings
Eliminates X-ray exposure to the patient and
clinician when PICC placement is confirmed with Sapiens* TCS
Please consult product labels and inserts for any indications, contraindications, hazards, warnings, cautions and instructions for use.
Specifications
PowerPICC SOLO*2 Catheters with Sherlock 3CG* TPS Stylet for use with Sapiens* TCS
| Product Code | Type of Catheter | Tray |
|---|---|---|
| 1194108D | 4 Fr. SL PowerPICC SOLO*2 Catheter | Max Barrier Tray |
| 1194108 | 4 Fr. SL PowerPICC SOLO*2 Catheter | Full Tray |
| 1295108D | 5 Fr. DL PowerPICC SOLO*2 Catheter | Max Barrier Tray |
| 1295108 | 5 Fr. DL PowerPICC SOLO*2 Catheter | Full Tray |
| 1396108D | 6 Fr. TL PowerPICC SOLO*2 Catheter | Max Barrier Tray |
| 1396108 | 6 Fr. TL PowerPICC SOLO*2 Catheter | Full Tray |
PowerPICC* Catheters with Sherlock 3CG* TPS Stylet for use with Sapiens* TCS
| Product Code | Type of Catheter | Tray |
|---|---|---|
| 1174108D | 4 Fr. SL PowerPICC* Catheter | Max Barrier Tray |
| 1174108 | 4 Fr. SL PowerPICC* Catheter | Full Tray |
| 1175108D | 5 Fr. SL PowerPICC* Catheter | Max Barrier Tray |
| 1175108 | 5 Fr. SL PowerPICC* Catheter | Full Tray |
| 1275108D | 5 Fr. DL PowerPICC* Catheter | Max Barrier Tray |
| 1275108 | 5 Fr. DL PowerPICC* Catheter | Full Tray |
| 1385108D | 5 Fr. TL PowerPICC* Catheter | Max Barrier Tray |
| 1385108 | 5 Fr. TL PowerPICC* Catheter | Full Tray |
| 1386108D | 6 Fr. TL PowerPICC* Catheter | Max Barrier Tray |
| 1386108 | 6 Fr. TL PowerPICC* Catheter | Full Tray |
Sapiens* TCS Hardware
| Product Code | Description |
|---|---|
| 9770101 | Sapiens* TCS for Site~Rite Vision* System (Includes Sherlock* II TLS Sensor and mounting hardware) |
| 9770102 | Sapiens* TCS for Site~Rite* 5 or Site-Rite* 6 System (Includes Sherlock* II TLS Sensor and mounting hardware) |
| 9770103 | Standalone Sapiens* TCS (Includes Sherlock* II TLS Sensor, ECG Module, Remote Control, Display and Display Power Supply) |
| 9770104 | Sapiens* TCS Display and Display Power Supply |
| 9770068 | Sapiens* TCS Remote Control |
Product codes 9770101 & 9770102 include the following to upgrade Site~Rite* 5, Site~Rite* 6 and Site~Rite Vision* Systems to Sapiens* TCS: Mounting Arm & Counterbalance, Display, Display Power Supply, ECG Module, Remote Control, and Sherlock* II TLS Sensor.
Kit Components
| Description | Maximal Barrier Standard Tray | Full Tray |
|---|---|---|
| PICC | • | • |
| Microintroducer (length and size PICC dependent) | • | • |
| Guidewire, 0.018 in. | • | • |
| Scalpel, safety | • | • |
| IV catheter, 20 Ga. | • | • |
| Introducer needle, 21 Ga. | • | • |
| Needle hypodermic, safety, 25 Ga. | • | • |
| Filter straw | • | • |
| Wound closures (pkg of three) | • | • |
| Transparent dressing | • | • |
| Drape, fenestrated | • | |
| Drape, full body, fenestrated | • | |
| Bouffant cap | • | |
| Surgical gown | • | |
| Towel, absorbent | • | |
| Poly underdrape | • | • |
| Tourniquet, latex-free | • | • |
| Face mask | • | • |
| Surgical tape | • | • |
| Scissors | • | • |
| Measuring tape | • | • |
| End cap (one per PICC lumen) | • | • |
| Syringes | • | • |
| Surgical gloves, sterile, latex-free | • | • |
| 2 ChloraPrep* solution one-step applicator (1 tinted, 1 clear) | • | |
| Lidocaine | • | • |
| Saline | • | • |
| Alcohol wipe | • | • |
| Gauze pad, 4 in. x 4 in. | • | • |
| Gauze pad, 2 in. x 2 in. | • | • |
| StatLock* catheter stabilization device | • | • |
| ECG Electrodes (3) and Leads Assembly | • | • |
| Remote Control Holder and Elastic Bands | • | • |
| Patient Checklist | • | |
| Room Stop Sign | • | |
| Patient Safety Guide | • |
Resources
Please refer to the below-listed Instructions for Use (IFUs) for any indications, contraindications, hazards, warnings and cautions.