Bard SHERLOCK User manual
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- SHERLOCK* TIP LOCATION SYSTEM mc-oo56-oo o713426 o6o6r -
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- INSTRUCTIONS FOR USE -
[ IFU ]
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TIP LOCATION SYSTEM
- TABLE OF CONTENTS -
[1] Introduction_______________________________
[2] Product Description_________________________
Components______________________________
[3] Indications for use___________________________
[4] Warnings / Precautions______________________
[5] Service Information__________________________
[6] Instructions for use_________________________
Step 1: Patient Preparation_________________
Step 2: Sherlock* Detector Preparation__________
Step 3: Catheter Placement and
Determination of Tip Position_____________
[7] Troubleshooting guide___________________________
[8] Maintenance_________________________________
[9] Speci cations_________________________________
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1] INTRODUCTION
e Sherlock catheter tip location detector is designed to aid in the placement of central venous catheters by
providing real-time catheter tip location information relative to external physical landmarks. It is designed
to operate with Bard Access Systems kits labeled, “with Sherlock” Tip Location Stylet.
2] Description
e Sherlock detector consists of the following components:
- Sherlock Sensor Module
- Sherlock Screen Module
- AC adaptor and power cord
- Carrying Case
- Sherlock Stylet [included with specially marked central venous catheter kits]
- Sensor Holder Pouch [included with specially marked central venous catheter kits]
e Sherlock detector is packaged in its own carrying case with the sensor module, screen module and
AC adaptor and power cord. e sensor module is a small, remotely powered detector that is permanently
attached to an extension cable. It is designed to track catheter tip movement, detect catheter tip orientation,
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and sense the catheter tip end point. e Sherlock detector may be placed over the right third intercostal
space as recommended by the 1998 AVA Position Statement, although external measurements can never
exactly represent the internal venous anatomy. e extension cable connects the sensor module to the
screen module. e screen module is a hand-held, battery-operated instrument that illustrates the
location and direction of the specialized magnetic stylet tip as it passes under the sensor. is special stylet
is only located in Bard Access Systems central venous catheter kits "with Sherlock" Tip Location Stylet.
Both audio and visual cues are presented to the clinician.
e AC adaptor charges the internal system battery located in the screen module. e detector can be
powered by the internal battery or the external power supply. e Sherlock stylet and sensor holder pouch
are single-use items and are packaged with Bard Access Systems central venous catheters intended to be
used only with the Sherlock catheter tip location detector.
No magnetic energy is generated by the screen or sensor module. Permanent magnets are encapsulated
within the tip of the Sherlock stylet. As the stylet is advanced under the sensor module, the module detects
the magnetic eld that is generated by the stylet. e position and direction of the stylet tip is calculated
and then displayed on the screen module.
Note: e Sherlock detector can be used on patients who have implanted cardiac rhythm devices such
as pacemakers and de brillators. When a cardiac rhythm device is present, it is recommended that the
Sherlock tip location system stylet be placed on the contralateral side.
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is booklet describes the controls, information displays, and proper use of the Sherlock catheter tip
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location detector. Insertion instructions for catheters incorporating Sherlock stylets are packaged with the
Bard Access Systems catheter kits and should be consulted on an individual basis.
Components
Sherlock Detector Sensor Module Screen Module
AC Adaptor and Power Cord
Sherlock Carrying Case. e carrying case can be attached to the Site~Rite* roll stand basket using the
straps provided on the rear of the carrying case.
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Detector with AC
adapter inserted
Display Screen Information
Start-up Screen Start/Calibration Sensor Module Unplugged Calibrating
Ready for Use Stylet Tip Position Mute/No Mute Battery Charge
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Low Battery Magnetic Error Repair Needed
3] Indications For Use
e Sherlock Tip Location System (TLS) detector quickly locates and con rms the position of specially
designed, magnet-tipped Peripherally Inserted Central Catheters [PICCs] and Central Venous Catheters
[CVCs] during initial placement. is device may be used by appropriate caregivers in hospitals, long-term
care facilities or home-care settings.
e Sherlock Tip Location System (TLS) detector provides rapid feedback to the caregiver, but was not
designed to replace conventional methods of placement veri cation. Users are urged to con rm correct
placement according to their established institutional protocol and clinical judgment.
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Note: Use of the Sherlock detector is not recommended with catheters that are not speci cally marked
with the Sherlock catheter tip location system trademark and logo, and manufactured by Bard
Access Systems.
4] Warnings / Precautions
Warnings
DANGER: Do not operate the Sherlock detector in the presence of ammable anesthetic
gases – potential explosion hazard.
Precautions
1 - Federal [U.S.A.] law restricts this detector to sale by or on the order of a physician.
2 - Do not submerge the Sherlock sensor or screen in water or other uids.
3 - Do not attempt to sterilize.
4 - e Sherlock sensor and screen must only be used with Bard Access Systems central venous
catheters that contain the Sherlock stylet.
5 - Wired undergarments may a ect the performance of the Sherlock detector.
6 - Avoid contact between the Sherlock sensor module and strong magnetic elds such as MRIs.
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7 - Do not allow any ferromagnetic objects, e.g. metal instruments, watches, jewelry, electronic
detectors, metal bedrails, etc. to be within 30 cm [12 in] of the Sherlock sensor module once the
calibration process is complete. e sensor module may detect the item’s magnetic eld, which
will interfere with the sensor module’s ability to accurately locate the Sherlock stylet tip.
8 - Active electric motor driven equipment, such as pumps should not be used within
ve feet of the Sherlock sensor module during the catheter insertion procedure as they may
interfere with Sherlock's detection of the stylet.
9 - Temporary disruption of the cardiac rhythm device may occur if the Sherlock tip location stylet
passes within 1 cm of the cardiac rhythm device. Use care if placing the Sherlock tip location stylet
on the same side as the cardiac rhythm device.
Note: A nal con rmation of the catheter tip location must still be determined based on the
protocol of the facility.
Possible Complications
- Ferromagnetic interference
- Temporary disruption of cardiac rhythm devices
- Sensor or screen malfunction
Complications associated with central venous catheter placements. For possible complications
consult Bard Access Systems catheter “Instructions for Use”.
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5] Service and Information
For questions regarding service please call Bard Access Systems at 1-800-545-0890.
e Sherlock detector contains no user serviceable parts. Only Bard Access Systems authorized service
personnel should attempt to service this equipment.
Note: Servicing of the battery pack or the combination AC adaptor must be performed only by Bard
Access Systems authorized service personnel.
e following actions void the warranty of the Sherlock detector:
- Opening or attempting to open the Sherlock sensor or screen modules.
- Removal of system labels by anyone other than by Bard Access Systems authorized service personnel.
- Opening or attempting to open the Sherlock battery pack or the combination AC adaptor.
- Connecting the Sherlock screen module to any power source other than the Sherlock combination
AC adaptor and battery pack.
- Connecting the Sherlock screen module to any AC adaptor other than the one provided with
the detector.
- Connecting the Sherlock detector to any unauthorized accessory.
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