Arrow MAC Manual

Inspected Dimensions:
Folded Length: 7-1/2" (19 cm)
Folded Width: 5-1/2" (14 cm)
MAC Multi-Lumen Central Venous Access Product
™
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 catheter or any other kit/set component
during insertion, use, or removal.
Procedure must be performed by trained personnel well
versed in anatomical landmarks, safe technique, and
potential complications.
Precaution: When
Catheterization Product with Contamination Guard for
use only with MAC™ Multi-Lumen Central Venous
Access Device (MAC™ companion product), clinicians
must be aware of the potential complication of Cardiac
Tamponade (see complications warning included in all
Arrow Central Venous Catheter Products) (refer to
Fig. 1).
Indications for Use:
The Arrow Central Venous Access Product permits venous
access and catheter introduction to the central circulation.
Contraindications:
None known.
using Central Venous
Fig. 1
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: Practitioners
complications associated
catheter introduction
17
perforation, pleural and mediastinal injuries,
6,9,12,14
air embolism,
duct laceration,
4
thrombosis, inadvertent arterial puncture,
damage, hematoma, hemorrhage,
and occlusion.
3. Warning: Do not apply excessive force in removing
guide wire, dilator or catheter. If withdrawal
cannot be easily accomplished, a chest x-ray should
be obtained and further consultation requested.
4. Warning: The practitioner must be aware of
potential air embolism associated with leaving open
needles, sheaths, or catheters in venous puncture
sites or as a
disconnects. To lessen the risk of disconnects, only
securely tightened Luer-Lock connections should
be used with this device. Follow hospital protocol
for all sheath and side port maintenance.
5. Warning: Hemostasis valve must be occluded at all
times to minimize the risk of air embolism or
hemorrhage. If catheter introduction is delayed, or
catheter is removed, temporarily cover valve
opening with sterile-gloved finger until catheter or
obturator is inserted. Use Arrow obturator, either
included with this product or sold separately, as
dummy catheter with hemostasis valve assembly.
This will ensure that leakage does not occur and
inner seal is protected from contamination.
6. Warning: Passage of the guide wire into the right
heart can cause dysrhythmias, right bundle branch
7
block, and a perforation of the vessel wall, atrial or
ventricular.
7. Warning: Practitioners must be aware of the
potential for entrapment of guide wire by any
implanted device in the circulatory system (ie. vena
cava filters, stents). Review patient's history before
catheterization procedure to assess for possible
implants. Care should be taken regarding the
length of spring-wire guide inserted.
recommended that if patient has a circulatory
system implant, catheter procedure be done under
direct visualization to minimize the risk of
guidewire entrapment.
8. Warning: Products containing sharps safety feature
components are designed to reduce the risk of
accidental needle and sharps related sticks. Care
must still be taken to minimize the risk of sharps
injury. Clinicians must adhere to state/federal
OSHA standards for blood borne pathogens when
starting, discontinuing, or maintaining a central
venous catheter to minimize the risk of exposure.
1
must be aware
with percutaneous
including vessel
sheath embolism, thoracic
3
bacteremia, septicemia,
7
5
dysrhythmias
consequence of inadvertent
14
2
of
wall
1,13
nerve
It is