TZ Medical ARC User manual

ARC
Adjustable Radial Cuff
Instructions for Use
1. Peel package from upper edge and open onto sterile
field.
2. After the procedure, ensure access site is clean and dry,
and clear sheath with flush solution, withdrawing the
sheath approximately 1 inch (2-3 cm). (See fig. 1)
3. With patient’s palm facing up, orient device with
compression balloon on top and balloon port pointed
towards thumb. Gently slide “C” portion of the device over
the wrist from the thumb side. Ensure the target area of
the compression balloon is placed directly over sheath
access site. (See fig. 2)
4. Holding ARC in-place, clasp the buckle into place around
the patient’s wrist. (See fig. 3). Move balloon slide laterally
or medially from top of device as needed to ensure
optimal placement over radial artery. (See fig. 4)
Warning: The device must be placed differently when used
on the left or right wrist. For right wrist ensure the balloon
port of the device is facing the patient palm.
16607 R1.3
Buckle
Balloon
Slide
Velcro Strap
Luer
Lock
“C” Cuff
Syringe
fig. 4
fig. 1
fig. 2
fig. 3

5. Holding compression balloon pressure in place with one
hand connect the Velcro™ strap into top of “C” portion of
device. Pull Velcro™ strap perpendicular to wrist until device
is taut around the wrist. (See fig. 5) Secure end of Velcro™
strap to the bottom of the device.
6. Attach the syringe to the inflation port of the compression
balloon and inflate (18 ml). (See fig. 6)
Caution: Over injection may be painful to the patient and
cause damage to compression balloon.
Warning: Check to make sure you are injecting into
compression balloon and not sheath side port or through any
other device.
Note: ARC device utilizes a standard luer lock syringe to
inflate and deflate compression balloon.
7. Remove sheath, confirm there is no bleeding from the
access site by viewing site through compression balloon
window. If bleeding is observed, inject more air into balloon
until bleeding stops. (See fig. 7)
8. Adjust compression balloon pressure to provide
appropriate hemostasis, and pulse distal to access site.
(See Fig.8)
Notes: The minimum pressure necessary should be used.
Ideally a residual pulse should be palpable while occluding
the ulnar artery (Allen’s Test) and a minimally affected pulse
waveform should be visible on a plethysmograph with O2
saturation remain normal if monitoring with an oximeter.
(See fig. 8)
Warning: If it is necessary to totally occlude the radial artery
to achieve hemostasis, the artery should not be occluded for
more than 10-15 minutes before flow is restored.
9. Once total hemostasis has been established, removal of
the ARC device should be performed in accordance with your
facilitiespostcareprocedures.
Device Removal Recommendation:
Remove air from compression balloon slowly and observe
hemostasis at access site until device is loosened. If bleeding
isobserved, retighten device to theoriginal pressure until
bleeding stops. If there is no bleeding noted, dry the access
area and apply sterile dressing in accordance with facility
policy.
Note: If oozing occurs, a standard pressure dressing should
be applied to assist in achieving hemostasis. Assure patency
fig. 5
fig. 6
fig. 8
fig. 7

ARC™ (Adjustable Radial Cuff) Device
Manufacturers information
LIMITED WARRANTY
TZ Medical warrants the ARC™ device free from material and workmanship defects until the expiration date is
reached. TZ Medical shall not assume liability for consequential, incidental, or special expense directly relating
from the product usage. Warranty liability and the buyer’s exclusive remedy is expressly limited to
replacement of the ARC™ device, used under normal use and service, by the Company as having been
defective in materials or workmanship. The buyer is directly obligated to return the device to the Company
Forexaminationandreplacement.
No employee, representative or agent of TZ Medical has the authority to bind, amend or alter the warranty.
Any purported alteration amendments, or implied representation shall not enforceable by the buyer against TZ
Medical.
THIS WARRANTY IS IN LIEU OR ANY IMPLIED OR EXPRESSED WARRANTIES, INCLUDING THOSE OF
MERCHANTABILITY OR FITTNESS FOR ANY OTHER OBLIGATION ON THE PART OF TZ MEDICAL.
TZ Medical
17750 SW Upper Bones Ferry Road, Ste. #150
Portland, OR 97224
Office 800.944.0187
Fax [phone]
PATENT AND TRADEMARKS
This device may be covered by one or more U.S. or international patents.
ARC™ is a registered trademark of TZ Medical
CONTENTS

SYMBOLS & GLOSSARY
REF
Caution: Federal Law (US) restricts device sale by or
on the order of a physician
CONTENT
Contents of this package
Compression Assist Device
COMPRESSION ASSIST DEVICE
STERILE EO
Ethylene Oxide Sterilization
Do not Reuse Single Use only
LOT
Lot number
Use By date
Manufacturer
Keep Dry- Protect from moisture
Do not use if package is damaged
Keep out of direct sunlight
Consult Instructions For Use
35°C
0°C
Maximum Temperature. 35ºC; Minimum
Temperature, 0ºC for at least an hour before use
0413
Complies with Medical Device Directive 93/42/EEC
Does Not Contain Natural Rubber Latex
Device Description
TZ Medical ARC™ device is a sterile, single use disposable device.
The TZ Medial ARC™ radial artery hemostasis device is a radial compression device consisting of a rigid
polycarbonate “C” shaped brace, a flexible strap containing a PVC backing, hook and loop fasteners, and
two buckles which attach to the ends of the brace, a collapsible bubble fixed to an adjustable slider with a
tube and universal luer lock, as well as a low durometer TPE pad opposite of the bubble for patient
comfort. Each device also includes a standard male luer locking syringe.
The device comes in three
sizes: Small (Size) (#RCB-0047)
Medium (Size) (#RCB-0048)
Large (Size) (#RCB-0049)
Indications for Use
When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in
controlled compression hemostasis of the radial artery after a transradial procedure; the device is designed
to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of
the radial artery (patent hemostasis).
Contraindications
Radial Access is contraindicated in patients with an impaired or abnormal Allen’s or Modified Allen’s test
(1&2) or patients that do not have two functional arteries (radial and ulnar).
Adverse Events
Warning
Catalog Number

•Confirm that you are injecting air into the ARC™ device and NOT into the side port of the radial sheath or
any other device.
•Over inflation of the balloon (above 20 ml of air) may cause numbness, patient discomfort or RAO
(radial artery occlusion).
•Under inflation of the balloon (under 12 ml or air) may affect the devices ability to assist or maintain
hemostasis.
•Do not soak or wipe with agents containing organic solvents.
•The patient should not be left unattended while the ARC™is in use.
Precautions
•USA Caution Federal Law (US) restricts device sale by or on the order of a physician.
•The safety and effectiveness of the ARC™ device has not been fully established for use with children and
pregnant women.
•Inspect sealed packaging prior to use. Do not use if original packaging is damaged or opened.
•The ARC™ device is a “SINGLE USE DEVICE”, reuse, resterilization or repackaging after cleaning attempts
may result in patient infections.
•The device should be used only by clinicians or those properly trained in the used of the device.
•Only use air for inflation. Do not use other media for inflation.
•Depending on patient’s condition and the degree of balloon pressure, an adverse event including artery
occlusion, hypodermia hematoma, hemorrhage, pain, or numbness may occur. Check the progress of
hemostasis and adjust the air pressure according.
•Do not use the air syringe for other purposes than to inflate the ARC device. It is not designed for other
purposes.
•The ARC device can be inflated only by using the air syringe. If other devices are used, adequate air
compression cannot be achieved.
•Do not put excessive pressure on the tip of the air syringe; this may result in damage of the tip. If the
syringe tip is broken while connected to the ARC device, it could cause air leakage and bleeding.
•When connecting the air syringe to the ARC™device, keep the plunger in place. Releasing the plunger
will cause the air to expel from the device. Loss of air compression may cause bleeding.
•While using, be careful not to put excessive load on the balloon that could break it. Be careful that no
foreign particles get into the air injection port as this may cause air leakage.
•If there is itching or redness of the skin while compressing, stop using and treat appropriately.
•At extremely low temperature, there is a possibility of damage due to decrease in resistance to shock.
•Take care not to damage the ARC ™device with needle, scissors, and other sharp instruments. This may
result in air leakage and bleeding.
•The device should be used immediately after opening the package and disposed of safely and properly
after use.
•Care should be taken to prevent infection during manipulation.
•Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.
•Hemostasistimes mayvarypatienttopatientdependentonthefollowing:
Systolic blood pressure exceeding 160 mmHg.
Platelet level less than 250,000 units.
Patients currently receiving GPIIb/IIIa or Coumadin.

Adverse Events
Radial access can be associated with problems deriving from puncture, hemostasis or guide management,
including, but not limited to hematoma, paresthesia, pseudoaneurysm, arteriovenous fistula, perforation of
the artery or radial artery occlusion.
Recommendations
A thumb or index finger oximeter or plethysmograph should be attached and monitored during hemostasis
process (2).
Patient Care Recommendations
•Monitor site and patient for 1 hour post device removal.
•Instruct patient not to bend or remove wrist for 24 hours post hemostasis.
•Patient should not lift any excessive weight or immerse wrist in water for the first 24 hours post
hemostasis.
•Providepatientwithfacility instructionssheetandreviewitwithpatient.
References
1. Barbeau GR, Arsenault F, Dugas L, et al. Evaluation of the ulnopalmar arterial arches with pulse
oximetry and plethysmography. Am Heart J.2OO4 Mar; 147 (3):489-93.
2. Patel T, Garzona C, Patel's Atlas of Transradial Intervention: The Basics 1st Edition. 2007