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Arrow MAC - User Manual

Arrow MAC
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1
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 using Central Venous
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).
Fig. 1
Indications for Use:
The Arrow Central Venous Access Product permits venous
access and catheter introduction to the central circulation.
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: Practitioners must be aware of
complications associated with percutaneous
catheter introduction including vessel wall
perforation,
17
pleural and mediastinal injuries,
1,13
air embolism,
6,9,12,14
sheath embolism, thoracic
duct laceration,
3
bacteremia, septicemia,
thrombosis,
4
inadvertent arterial puncture,
7
nerve
damage, hematoma, hemorrhage,
5
dysrhythmias
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 consequence of inadvertent
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.
14
6. Warning: Passage of the guide wire into the right
heart can cause dysrhythmias, right bundle branch
block,
7
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.
2
It is
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.
MAC
Multi-Lumen Central Venous Access Product
Inspected Dimensions:
Folded Length: 7-1/2" (19 cm)
Folded Width: 5-1/2" (14 cm)
Warning & Heart:
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Summary

Safety and Efficacy Considerations

General Safety and Efficacy

Guidelines for safe use, including package integrity and trained personnel.

Critical Cardiac Placement Warning

Instruction to avoid placing catheter in right atrium or ventricle to prevent severe injury or death.

Indications for Use

Venous Access and Introduction

Permits venous access and catheter introduction into the central circulation.

Contraindications

No Known Contraindications

Currently, no specific contraindications are known for this product.

Warnings and Precautions

Single Use and Sterility

Device is sterile and single-use; reuse poses serious injury/infection risk.

Catheter Introduction Complications

Awareness of complications like vessel perforation, air embolism, and infection is crucial.

Withdrawal Force Warning

Avoid excessive force during removal; consult for difficult withdrawals.

Air Embolism Risk from Disconnects

Luer-Lock connections minimize air embolism risk from inadvertent disconnects.

Hemostasis Valve Occlusion

Keep hemostasis valve occluded to prevent air embolism or hemorrhage.

Right Heart Passage Complications

Guide wire passage into right heart can cause dysrhythmias or perforation.

Guide Wire Entrapment Risk

Be aware of guide wire entrapment with implanted devices; use visualization.

Sharps Injury Prevention

Adhere to OSHA standards for sharps injury and bloodborne pathogen exposure.

Bloodborne Pathogen Precautions

Use universal precautions due to risk of HIV and other bloodborne pathogens.

Blood Sampling Port

Temporarily shut off ports during blood sampling to minimize contamination.

Catheter Suture Warning

Avoid suturing directly to catheter OD to prevent damage or flow impedance.

Indwelling Catheter Inspection

Routinely inspect indwelling catheters for flow, security, and correct connection.

Insertion Site Redressing

Maintain insertion site with regular, meticulous redressing using aseptic technique.

Material Weakening by Solvents

Alcohol and acetone can weaken polyurethane; avoid direct contact.

Disinfectant Solvent Precautions

Some disinfectants contain solvents; ensure insertion site is dry before dressing.

Sharps Disposal Compliance

Dispose of sharps in designated containers per OSHA standards.

Venous Access Verification

Techniques to verify venous access, including waveform analysis.

Spring-Wire Guide Aspiration Warning

Aspiration with spring-wire guide in place risks air introduction.

Hemostasis Valve Occlusion Reminder

Keep hemostasis valve occluded to prevent air embolism or hemorrhage.

Catheter Shield Positioning

Proper positioning of the catheter contamination shield during insertion.

Catheter Contamination Shield Locking

Securely lock the catheter contamination shield's distal hub to the assembly cap.

Catheter Securement

Methods for securing the access device, including staple anchoring.

Access Device Removal Precautions

Precautions for removing the access device, avoiding scissors and monitoring for air.

Suggested Procedure

Sterile Technique and Preparation

Emphasizes sterile technique, patient positioning, and site preparation.

Needle Disposal and Safety

Use of SharpsAwayII cup for safe, locked disposal of needles to prevent reuse.

Catheter and Shield Advancement

Advancing the catheter through the contamination shield and dilator.

Flow Directed Catheter Balloon Integrity

Check balloon integrity if flow-directed; do not exceed recommended volume.

Dilator and Hemostasis Valve Assembly

Insert dilator into hemostasis valve assembly for placement.

Introducer Needle and Aspiration

Insert introducer needle, aspirate venous blood for confirmation.

Arrow Advancer Instructions

Straightening the Spring-Wire Guide

Straighten the 'J' tip of the spring-wire guide by retracting it into the Advancer.

Spring-Wire Guide Insertion into Syringe

Insert the spring-wire guide tip into the syringe plunger and advance 10 cm.

Advancing the Spring-Wire Guide

Advance the spring-wire guide to the desired depth using the Advancer mechanism.

Alternate Spring-Wire Guide Technique

Option to use a straightening tube separately for advancing the spring-wire guide.

Arrow Raulerson Syringe Instructions

Guidewire Advancement and Verification

Techniques to verify venous access, including waveform analysis.

Spring-Wire Guide Aspiration Warning

Aspiration with spring-wire guide in place risks air introduction.

Hemostasis Valve Occlusion Reminder

Keep hemostasis valve occluded to prevent air embolism or hemorrhage.

Catheter Shield Positioning

Proper positioning of the catheter contamination shield during insertion.

Catheter Contamination Shield Locking

Securely lock the catheter contamination shield's distal hub to the assembly cap.

Catheter Securement

Methods for securing the access device, including staple anchoring.

Access Device Removal Precautions

Precautions for removing the access device, avoiding scissors and monitoring for air.

References

Cited Literature

List of cited medical literature and sources used in the document.

Arrow MAC Specifications

General IconGeneral
BrandArrow
ModelMAC
CategoryMedical Equipment
LanguageEnglish

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