Right Atrial Electrocardiography (RAECG) Adapter
Safety and Efficacy Considerations:
Do not use if package has been previously opened or
damaged.
Warning: Prior to use read all package
insert warnings, precautions, and instructions.
Failure to do so may result in severe patient injury
or death.
Do not alter the adapter during use.
Procedure must be performed by trained personnel
well versed in anatomical landmarks, safe technique
and potential complications.
Indications for Use:
The RAECG Adapter permits verification of catheter
tip position using electrocardiography.
Contraindications:
None known.
Warnings and Precautions:*
1. Warning: Sterile, Single use: Do not reuse,
reprocess or resterilize. Reuse of device creates
a potential risk of serious injury and/or infection
which may lead to death.
2. Warning: Due to the risk of exposure to HIV
(Human Immunodeficiency Virus) or other
blood borne pathogens, health care workers
should routinely use universal blood and body-
fluid precautions in the care of all patients.
Carefully read all warnings and precautions
throughout procedure instructions.
RAECG Adapter
Electro-Shock Warnings:
1. Warning:
Strict
monitoring equipment and good grounding
techniques are mandatory when using a saline-
filled catheter as a transvenous ECG electrode.
All equipment should comply with American
Heart Association recommendation of being
incapable of delivering more than 10 microamp
leakage
current
electrocautery protection filter should be
inserted between ECG cable and ECG machine.
Rubber cap must be over stainless steel male
electrical
isolation
to
the
patient.
RAECG button when adapter is in-line but not
in use.
2. Warning:
complications associated with right atrial and
inadvertent right ventricular catheterization
whenever
introduced is intentionally passed beyond
junction of superior vena cava and right atrium.
3. Warning: Any premature heart beat might
indicate catheter touching heart; withdraw
catheter and check position.
A Suggested Procedure:
Use sterile technique.
1. Aseptically place catheter intravenously.
2. Sterile Operator – Pass distal or female end of a
sterile length of IV tubing to non-sterile assistant.
3. Non-sterile Assistant – Luer-Lock adapter to IV
tubing and flush system with an ionic salt solution,
e.g. 0.9% saline solution, 4% sodium chloride or
8.4% sodium bicarbonate solution. Meticulously
remove all air bubbles and blood clots.
4. Sterile Operator – Luer-Lock male or proximal end
of sterile IV tubing to catheter.
5. Non-sterile Assistant – Flush entire assembly.
6. Sterile Operator – Remove rubber protective cap
from stainless steel male button on adapter.
7. Non-sterile Assistant – For ECG machines without
lead selectors, connect negative terminal lead of
ECG to adapter, the positive terminal to left leg,
and the ground terminal lead to left arm. For ECG
machines with lead selectors, choose lead II on
of
ECG machine and place right arm lead to adapter.
8. Sterile Operator – Advance or withdraw saline
filled catheter until size of the P wave of ECG trace
just begins to progressively get larger. At this point,
catheter tip should be at cavoatrial junction. If tip is
advanced further into right atrium, P wave will
either be as large as R wave or become biphasic. If
An
catheter enters right ventricle, P wave will
disappear and a wider QRS will appear.
9. Continue with procedure.
1
Arrow-Johans™
Physician
must
be
central
venous
catheter
®
aware
of
being