This device is not protected against water. Equipment is not suitable for use in the
presence of flammable anesthetic mixture with air, oxygen, or nitrous oxide. The
rechargeable batteries supplied in this unit are not field replaceable. If you have
any issues please contact (800) 604-2487 for a replacement unit.
1.
Labropoulos N, OH D.S, Golts, E, et al.: Improved Venous Return By Elliptical, Sequential and Seamless
Air-cell Compression. Loyola University Medical Center, January 2003.
2.
Kamm R: Unsteady Venous Blood Flow Resulting From Different Modes of External Compression
Cambridge, MIT, 1996
DESIGN PHILOSOPHY
Pneumatic compression is a clinically proven modality for reducing the risks
associated with deep vein thrombosis
1
. The Circul8 Max Vascular Therapy System
is a self-contained, compact DVT therapy device that is tubeless, portable,
lightweight, and battery-operated. Due to Circul8 Max’s portability, with no
separate pumps and hoses, patients can use it at all times, ensuring maximum
mobility during any phase of care. Additionally, Circul8 Max incorporates
asymmetric compression for the superior emptying of veins
2
that consists of an
intermittent pneumatic compression device with sequential, asymmetrical,
gradient, graduated, compression distal to proximal, duplicating the blood flow
of an ambulating patient. Circul8 Max provides potentially life-saving mechanical
DVT prophylaxis to patients with a continuum of DVT preventative care in the
pre-, intra-, and post-surgery phases, expertly designed to provide
increased compliance with breathable cuffs that enhance patient experiences
.
PURPOSE OF THIS DEVICE
The purpose of the Circul8 Max is to aid in the prevention of DVT by helping to
stimulate blood flow in the legs. This is accomplished by an electronically controlled
pump delivering a set amount of air to the leg cuffs that, in turn, compress the
calf or calves to aid blood flow out of the lower extremities. The pump will inflate
each leg cuff to a preset pressure of 55 mmHg and deflate once the pressure is
reached. The cycles are repeated on each device until the power is turned off.
Internal rechargeable batteries allow the Circul8 Max to be completely portable,
thus preventing interruptions in treatment.
Indications for Use
The Circul8 Max Vascular Therapy System, model 08-0036, is intended to be an easy
to use portable system prescribed by a physician for use in the home or clinical
setting to help prevent the onset of DVT in patients by stimulating blood flow in
the extremities (simulating muscle contractions).
This device can be used to
:
•
Aid in the prevention of DVT
•
Enhance blood circulation
•
Diminish post-operative pain and swelling
•
Reduce wound healing time
•
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and
diabetic leg ulcers, chronic venous insufficiency, and reduction of edema in
the lower limbs
•
As prophylaxis for Deep Vein Thrombosis (DVT) by persons expecting to be
stationary for long periods of time
CONTRAINDICATIONS
The Circul8 Max Vascular Therapy System MUST NOT be used to treat the following
conditions:
•
Persons with suspected, active, or untreated: deep vein thrombosis,
ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe
congestive heart failure, thrombphlebitis, or an active infection.
•
On the legs where cuffs would interfere with the following conditions: vein
ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive
edema, or extreme deformity of the leg.
•
On any neuropathy.
•
On extremities that are insensitive to pain.
•
Where increased venous or lymphatic return is undesirable.
TECHNICAL DATA
Specifications:
Main Unit:
Dimensions: 5.17” X 2.6” X 1.48” (125 X 62.5 X 33.3mm)
Weight: Approx. 0.74 lb (335g)
Mode of Operation: Cyclic
Source of Power: 3.7 volt Li-ion battery
CAUTION:
Charge batteries using only the power supply provided
by Ortho8 Inc.
POWER SUPPLY:
Class II, input: 100 - 240 Vac, 50 - 60 Hz, output: 5 Vdc @ 2.0 Amp
Use only UL/60601-1 approved power supplies from Ortho8 Inc. for use in
hospital settings.
Output:
Mode of Operation: Continuous
SYSTEM OPERATING ENVIRONMENT:
Temperature: +5 Degrees C (41 Degrees F) to +40 degrees C (104 degrees F)
Humidity: 30%-75%
DEFAULT SETTINGS:
Leg Pressure (not adjustable) 55mmHg
Cycle time: 60 Seconds
TOLERANCES:
Pressure 10%
BATTERY CHARGE:
Takes approximately 4 hours (from
depleted state).
USER MAINTENANCE
Contains no serviceable parts. Contact Ortho8 Inc.Customer
Service at (800) 604-2487
Inspect the unit and all components for any damage that may have occurred
during shipping or general handling prior to each use (for example, frayed or cut
charging cord, cracked plastic housings, torn cuffs, etc). Refer to image of Circul8
Max for description of all components.
Do not attempt to connect the wall supply if any damage is noticed.
Avoid subjecting the units to shocks, such as dropping the pumps.
Do not handle the leg cuffs with any sharp objects. If a bladder is punctured or
you notice a leak, do not attempt to repair the unit or cuffs. Replacement units
are available through customer service.
Avoid folding or creasing the bladder during use and transportation of the units.
Battery is not replaceable, replacement units are available through customer
service.
Contact Ortho8 Inc. to receive replacements instructions for any damaged items.
STORAGE
Store in a dry location between -25⁰C (-13⁰F) and +70⁰C (158⁰F).
Do not expose to heat exc70⁰C (158⁰F).
Do not store items in direct sunlight
.
Federal Law restricts this device to sale by or on the order of a licensed practitioner
Ortho8 Inc. • Model No. 08-0036 • ©2021 Ortho8 Inc.
Document #IFU -
04-0020
Rev
A.
Customer Support: (800) 604-2487
•
• www.Ortho8.com •
2217 Plaza Drive, Rocklin, CA 95765
CALF CUFF APPLICATION
Wrap the cuff(s) around the calf and secure the Velcro to hold it in place.
Make sure the wrap is snug but not too tight. When one or both wrap(s)
are secured on the leg(s), the device(s) are ready for operation.
1
V A S C U L A R T H E R A P Y S Y S T E M
(Compressible Limb Sleeve Device)
TURNING THE DEVICE ON
When the wraps are secured on your legs, PRESS and HOLD the
WHITE power button for about a second until two BEEP
tones are heard, and the
p
ower light is illuminated on each
device. To turn the device OFF, PRESS and HOLD the WHITE
power button for about a second. You will hear two BEEP
tones, and all lights on the device will no longer be
illuminated.
3
When both wraps are secured on your legs, they should
look like the picture above.
Left Leg Pictured.
2
USING THE DEVICE
The device will make a quiet “humming” sound when inflating
and squeezing your leg. THIS IS NORMAL. The wraps will inflate
once a minute. IF you FEEL air releasing around the legs, this is
normal. This is a function of the device to keep your legs cool.
4
QUICK START GUIDE
Prescription
only
The use of accessories, power supplies and cables other than
those specified, with the exception of components sold by the
manufacturer of the Circul8 Max as replacement parts, may result in
increased emissions or decreased immunity of the Circul8 Max
Class II medical electrical equipment
This unit is a electromechanical device that includes printed
circuit boards and rechargeable batteries. Do not discard in landfill.
Consult local county requirements for proper disposal instructions
This symbol designates the degree of protection against electrical shock
from the wrap as being a type BF applied part
Follow the instructions for use
MR Unsafe
Single Patient - Multiple Use
Non sterile
Latex Free
Temperature Limit
-25º C
70º C