Baylis Medical DEX-14 Instructions For Use

Instructions for Use
Electrophysiology Cable (DEX-14)
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801 Fax: (514) 488-7209
www.baylismedical.com
© Copyright Baylis Medical Company Inc., 2022
The Baylis Medical logo is a trademark and/or a registered trademark of Baylis
Medical Company Inc. in the United States of America and/or other countries.
All other trademarks or registered trademarks are property of their respective
English
Carefully read all instructions prior to use. Observe all contraindications, warnings
and precautions noted in these instructions. Failure to do so may result in patient
Complications.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a
physician.
I. DEVICE DESCRIPTION
The Electrophysiology Cable (DEX-14) connects the Baylis Medical Company Inc.
EPstarFixed Electrophysiology Catheter with Lumen (DLF) to diagnostic
electrophysiology equipment (diagnostic
electrocardiography system and/or cardiac stimulator. This cable conducts
intracardiac potentials between the DLF and a catheter input module of the
diagnostic EP equipment.
Detailed information concerning the DLF is contained in a separate manual that
accompanies the DLF Instructions for Use.
The dimensions for the Electrophysiology Cable (DEX-14) can be found on the
device label and in section VII "PRODUCT SPECIFICATIONS". The
Electrophysiology Cable (DEX-14) has a single 14-pin connector on one end that
mates with the DLF, and fourteen single-pin connectors on the other end that mate
with the catheter input module of diagnostic EP equipment.
II. INDICATIONS FOR USE
The Electrophysiology Cable (DEX-14)
Electrophysiology Catheter with Lumen can be used in the evaluation of a variety
of cardiac arrhythmias from endocardial and intravascular sites.
III. CONTRAINDICATIONS
The Electrophysiology Cable (DEX-14) is not recommended for use with any other
electrophysiology catheter.
IV. WARNINGS
The Electrophysiology Cable (DEX-14) is a single-use device. Do not attempt
•
to re-use or re-sterilize the device. Re-sterilization of the cable may
compromise the device performance.
The Electrophysiology Cable (DEX-14) must only be used with a BMC
•
EPstar Fixed Electrophysiology Catheter with Lumen (DLF). Attempts to use
it with other diagnostic catheters and devices can result in complications.
• Laboratory staff and patients can undergo significant X-ray exposure during
diagnostic catheterization procedures due to the continuous usage of
fluoroscopic imaging. This exposure can result in acute radiation injury as
well as increased risk for somatic and genetic effects. Therefore, adequate
measures must be taken to minimize this exposure.
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owners.
EP equipment), such
used with the EPstar
• Avoid exposing the connectors of the Electrophysiology Cable (DEX-14) to
any fluids during a procedure. Exposure to fluids may result in shorting of
electrical signals.
Diagnostic electrophysiology equipment is susceptible to electromagnetic
•
interference. Do not operate near equipment that generate strong
electromagnetic fields.
Do not alter this device in any way.
•
V. PRECAUTIONS
• Do not attempt to use the Electrophysiology Cable (DEX-14) or ancillary
equipment before thoroughly reading the accompanying Instructions for Use.
Use only for cardiac electrophysiological examinations.
•
Catheterization procedures should be performed only by trained physicians
•
in a fully equipped catheterization laboratory.
The sterile packaging should be visually inspected prior to use to detect any
•
compromise. Ensure that the packaging has not been damaged. Do not use
the equipment if the packaging has been compromised.
• Visually inspect the cable to ensure there is no damage to the insulating
material. Do not use the cable if there is any damage.
• Never disconnect the Electrophysiology Cable (DEX-14) from the catheter
by pulling on the cable. Failure to disconnect the cable properly may result
in damage to the cable.
• Do not twist the Electrophysiology Cable (DEX-14) while inserting it to or
disconnecting it from the catheter connector. Twisting the cable may result
in damage to the pin connectors.
Do not bend the cable excessively. Excessive bending or kinking of the
•
cable may damage the integrity of the cable and may lead to patient injury.
Care must be taken when handling the cable.
• Adequate filtering must be used to allow continuous monitoring of the
electrocardiogram (ECG) signals during the procedure.
• Store under stable conditions, avoiding vibration and shock (including during
transportation).
• Avoid exposure to direct sunlight.
• Use only with legally marketed diagnostic EP equipment.
Baylis Medical Company Inc. relies on the physician to determine, assess and
communicate to
electrophysiology procedure.
VI. ADVERSE EVENTS
There are no adverse events associated with the use of this device. Adverse
events associated with the use of this device as part of a larger system are
indicated for the EPstar Fixed Electrophysiology Catheter with Lumen (DLF).
VII. PRODUCT SPECIFICATIONS
Model Number
Overall Useable Length
Catheter Connector
Diagnostic Equipment Connectors
Compatible Catheter Models
VIII. INSPECTION PRIOR TO USE
Perform the following checks before the patient is presented for the procedure.
These tests will allow you to verify that the equipment you will use is in proper
working order. Do these tests in a sterile environment. Do not use defective
equipment.
as an
KEY ITEMS
Sterility
Visual Check
IX. EQUIPMENT REQUIRED
Diagnostic electrophysiology procedures should be performed in a specialized
clinical setting equipped with a fluoroscopy unit, radiographic table, physiologic
Fixed
recorder, emergency equipment and instrumentation for gaining vascular access.
X. DIRECTIONS FOR USE
All instructions for equipment required should be carefully read, understood, and
followed. Failure to do so may result in complications.
Ensure that the EPstar catheter is properly positioned in the patient and the
diagnostic EP equipment is set up before connecting the Electrophysiology Cable
(DEX-14).
1. Connect the 14-pin catheter connector of the cable to the connector of the
EPstar catheter. The catheter connector is circular and keyed for proper
alignment. Line up the arrow markings on the connector with the catheter
receptacle and gently push in until the connector are mated. Any attempt to
connect the cable otherwise will damage the pins on the connector. Use of
excessive force may result in damage to the connector pins.
2. Connect the single-pin connectors at the diagnostic EP equipment end of the
cable to the catheter input module of the diagnostic EP equipment. Observe
the marking on each single-pin connector as they correspond to the
electrode position of the catheter ("D" is associated with the most Distal
electrode, where the remaining numbers indicate the relative position of the
electrode from the tip of the catheter).
each individual patient all foreseeable
DEX-14
7.5 feet (2.3m)
14-pin (Plug)
Single-pin (Plug, DIN 42802-2) × 14
DLF-6-10-55-95R
QUESTION? WARNINGS AND EXPLANATIONS
The Electrophysiology
supplied sterile for its initial use.
Is the
connector packaging to ensure the package has not been
cable sterile? damaged and sterility has not been compromised.
Do not use if cable is not sterile.
Have you done Ensure connectors and the cable have no visible
damage, such as discoloration, cracks, label
a visual check
on the entire fading, cable splice, or kinks. Do not use
system? damaged equipment.
DMR DEX 3.3 V-5 25-May-2022 (DEX-14)
risks of an
Cable (DEX-14) is
Inspect the