Ortho8 Circul8 max User manual

This device is not protected against water. Equipment is not suitable for use in the

presence of ammable anesthetic mixture with air, oxygen, or nitrous oxide. The

rechargeable batteries supplied in this unit are not eld 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 Dierent Modes of External Compression

Cambridge, MIT, 1996

DESIGN PHILOSOPHY

Pneumatic compression is a clinically proven modality for reducing the risks

associated with deep vein thrombosis1. 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 veins2that consists of an

intermittent pneumatic compression device with sequential, asymmetrical,

gradient, graduated, compression distal to proximal, duplicating the blood ow

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

stimulatebloodow in the legs. This is accomplished by an electronically controlled

pump delivering a set amount of air to the leg cus that, in turn, compress the

calf or calves to aid blood ow out of the lower extremities.The pump will inate

each leg cu to a preset pressure of 55 mmHg and deate once the pressure is

reached. The cycles are repeated on each device until the power is turned o.

Internal rechargeable batteries allow the Circul8 Max to be completely portable,

thus preventing interruptions in treatment.

Indications for Use

The Circul8 MaxVascularTherapy 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 ow 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 insuciency, 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

Specications:

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 cus, 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 cus with any sharp objects. If a bladder is punctured or

you notice a leak, do not attempt to repair the unit or cus. 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 exceeding +70⁰C (158⁰F).

Do not store items in direct sunlight

Federal Law restricts this device to sale by or on the order of a licensed practitioner

Document #IFU -

04-0020

Rev A.

Customer Support: (800) 604-2487

•

[email protected]

• www.Ortho8.com •

2217 Plaza Drive, Rocklin, CA 95765

CALF CUFF APPLICATION

Wrap the cu(s) around the calf and secure theVelcro 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.

VASCULAR THERAPY SYSTEM

(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 power 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.

When both wraps are secured on your legs, they should

look like the picture above.

Left Leg Pictured.

USING THE DEVICE

The device will make a quiet “humming” sound when inating

and squeezing your leg. THIS IS NORMAL. The wraps will inate

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.

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 aelectromechanical 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

BATTERY INDICATOR

To correctly indicate the state of the battery and charger,

there are SIX stages of the BATTERY INDICATOR as follows:

Battery icon: Remains illuminated at all times during operation.

Solid Green All Three Bars: 100% battery life remaining.

Solid Green Two Bars: 67% to 100% battery life remaining, when

charging in use or sleep mode, third bar pulses until fully charged.

Solid Green One Bar: 33% battery life remaining, second and third

bar pulses alternately until 100% charged when charging in use or

sleep mode.

Flashing Yellow Bar: Power Button will ash Yellow, and“BL”quickly

ashes on the LED display. The battery will last 30- 60 minutes or less.

Flashing RED Bar: Battery will last ve minutes or less.“BC”quickly

ashes on the LED display until auto shut down or the device(s) are

connected to the power supply. Audible alarm will continuously sound

until the device powers down, or the power supply adapter is plugged

into a wall socket.

INSTRUCTIONS

POWER ON

Press and hold the power button for One Second, and the device will turn on.

When the device is powered on, C8 is displayed followed by a double digit

number, audible alarm beeps twice. Refer to the battery indicator section on

below for battery life expectancy.

After a four-second delay, the device is on, and the LED display will always remain

on (unless in night mode). The device applies compression to the leg(s) in cycles.

During each cycle, the device inates the cu to 55mmHg pressure, holds the

pressure for four seconds, and then releases the pressure.

Cu ination oc curs in 6 to 12 se conds. During cu  in ation, the devi ce will

display dynamic pressure in ve-degree i ncrements 0 0-05-10-15-20-25-30-

35-40-45-50-55. During hold, the device will display “55” and applies pressure

for four seconds. Afterward, the pressure is released. The cycle repeats after 50

seconds of idle time. During the 50 seconds of idle time between compression

cycles, the display pulses a lower right dash for 48 seconds and will Fast Flash

“00”for the remaining two seconds before the next ination of pump activation.

POWER OFF

When the Device is operating, Press and Hold the power button on top of the

device for One Second

The device is in“sleep”mode—no visible illumination.

SYSTEM

COMPONENTS

USING THE ACADAPTER /

BATTERY CHARGER

CHARGING THE BATTERY: USE ONLY THE CHARGER PROVIDED BY

ORTHO 8 INC.

Use of the wrong charger can cause excessive heat, damage to the charging

cir cuit, and shorten the life of the battery.

THE DEVICE POWERED OFF

Insert the supplied power supply plug into the two ports at the bottom end of

the device and connect the power supply adapter to the wall socket. The

battery indicator icon on the LED Display will illuminate three flashing green

bars and provide the current charge status. Once the device is fully charged, all

three bars will be solid green. A full charge of a depleted battery should take

approximately four hours. Refer to the battery indicator on the this page

for battery life expectancy.

THE D EVICE POWERED ON

Insert the supplied power supply plug into the two ports at the bottom end of

each device and connect the power supply adapter to the wall socket. For

extended operation periods or to charge the battery during treatment

sessions, the AC adapter CAN be connected while the device is in use.

The Power Button will be illuminated, and the battery indicator icon on the LED

Display will illuminate three ashing g reen bars p roviding the c urrent charge

status. Once the device is fully charged, all three bars will be solid green. Refer to

the battery indicator on this page for battery life expectancy.

NOTE Inspect the Circul8 Max unit and follow the cleaning and disinfecting procedures prior to each use.

WARNINGDevice must be turned o and disconnected from the wall outlet prior to and during cleaning

or disinfecting.

DO NOT IMMERSE UNIT IN ANY LIQUID FOR ANY REASON

•

Clean the outer surface of the pump unit using a soft cloth, moistened with soapy water or 70%

isopropyl alcohol.

•The Circul8 Max cus are designed for single

patient use only.

•Medical Electrical Equipment needs special

precautions regarding EMC. Portable and

mobile RF Communications Equipment can be

aected by other Medical Electrical Devices.

•Cus used in combination with warming

devices may cause skin irritation. Regularly

check for patent discomfort, compliance, and

skin irritation.

•To prevent extremity compartment syndrome,

special attention should be given to patients

who are positioned in the supine lithotomy

position for extended lengths of time. This

includes patients with or without cus.

WARNINGS AND PRECAUTIONS

CLEANING AND DISINFECTING

•

Do not use abrasive or volatile cleaners.

•

Do not place cuffs in dryer.

•

NEVER remove the unit from the cuff.

•

Hand wash the exterior of the cuffs using a soft cloth, moistened with soapy

water or 70% isopropyl alcohol and let air dry.

•

To ensure the unit is completely dry prior to use, leave unit in the OFF

condition and disconnected from the wall outlet for 30 minutes after cleaning or

disinfecting.

•D o not open or remove covers. No user serviceable

parts inside. Direct all unit issues to Ortho8 Inc.

•If pulsations or throbbing occur, the cuff may be

wrapped too tightly. Loosen immediately.

•Stop using device if swelling occurs; consult a

Physician.

•Device is to be used only by the patient prescribed,

and only for its intended use.

•Ensure the pump control unit is turned off and

unplugged from the wall outlet prior to and while

cleaning or disinfecting.

•Equipment should not be used in the presence

of any flammable anesthetic mixture with air,

oxygen, or nitrous oxide.

•Do not immerse in any liquid for any reason.

•Do not operate device in a wet environment.

•Allow cus to warm to room temperature if exposed

to temperatures below 5⁰C or (41⁰F).

•Do not subject the unit to extreme shocks, such as

dropping the pump.

•Contains no user serviceable parts. Contact Ortho8

Inc. Customer Service.

•Do not place any items in an autoclave.

•Operation of this device can be done by the patient.

•No Service is to be attempted while the device is in

use.

•This device is NOT to be altered or modied.

Display

Power Button

Battery Indicator

Charging Port

ALARMS

Low Pressure or Leak “LP”

Power button ashes red and display will ash LP simultaneously following a Low-Pressure event. Audible alarm will sound, and the

Power Button will ash RED. The alarm will continue for 30 seconds (unless the device is powered OFF) and automatically turn the device OFF.

Make sure the wrap is attached snuggly to the leg.Turn the device OFF, and then turn the device back ON. If the device continues to alarm after this step, DO NOT try to x

the device. Call customer service for a replacement device at (800) 604-2487.

High Pressure or Leak “HP”

Power button ashes red and display will ash HP simultaneously following a High-Pressure event. Alarm will continue for 30

seconds (unless the device is powered OFF) and automatically turn the device OFF. The pump will turn o, and the solenoid will open, releasing the air in the bladder

compressing the leg(s).

Turn the device OFF, and then turn the device back ON. If the device continues to alarm after this step, DO NOT try to x the device. Call customer service for a replacement

device at (800) 604-2487.

Battery Low “BL” –

Power button ashes red and display will ash BL simultaneously when the battery is low. Plug-in power supply immediately.

Battery Critical “BC” –

If the battery voltage drops below a critical level, cycling stops, an audible alarm will sound, display will flash BC and POWER

BUTTON WILL FLASH RED. Plug-in power supply immediately.

ALARM RESET:

To reset an alarm, the device must be turned OFF then turned back ON. If not manually turned OFF within 30 seconds of such an alarm condition occurring, the device

automatically turns itself OFF. Once the device is turned back on, the alarm is RESET.

OPTIONS

By Prescribing Physician Only

Device use time (amount of time the device is powered ON) is monitored and stored by the MPU (Microprocessor Device) and can be requested by prescribing Physician only.

NIGHT MODE