Bio Compression Systems SC-2004-OC Bedienungsanleitung

SEQUENTIAL CIRCULATOR

Operating Instructions

Quality Medical Products Since 1983

Table of Contents

Introduction ...................................................................................................................3

Intended Use..................................................................................................................3

Device Description and Operating Principle...............................................................3

Warnings and Precautions...........................................................................................6

Operating Instructions..................................................................................................7

Accessories.................................................................................................................10

Product Specifications ............................................................................................... 12

Environmental Specifications.................................................................................... 13

Symbol Glossary......................................................................................................... 15

Contact Information.................................................................................................... 16

Introduction

Congratulations on your purchase of your sequential circulator and garments.

Package Contents

• Sequential Circulator pump

• Power cord

• Instructions for use

• Blocker bar(s)

• Garment(s) possibly - packed separately

Intended Use

Sequential Circulators are pneumatic compression devices intended for either primary

or adjunctive treatment of primary or secondary lymphedema. The devices are also

intended for additional or alternate treatment of venous insufficiency and chronic venous

stasis ulcers associated with venous insufficiency as well as general treatment for

swelling of the extremities. The devices are intended for both home and hospital use.

Contraindications

Compression IS NOT recommended in the following conditions:

• Infections in the limb, including cellulitis, without appropriate antibiotic coverage

• The presence of lymphangiosarcoma

• Suspicion or confirmation of the presence of Deep Vein Thrombosis (DVT)

• Inflammatory phlebitis or episodes of pulmonary embolism

• Congestive Heart Failure (CHF)

• Active cancer except for palliative care

• Other indications as identified by the treating physician

Device Description and Operating Principle

Sequential Circulators provide gradient pneumatic compression for the treatment of

lymphedema and associated venous disorders. Sequential gradient compression helps

to increase blood flow and move excess lymph away from the affected area for

clearance from the body. This device can provide sequential (distal to proximal)

inflation/deflation cycles of compressed air at prescribed pressures.

Pneumatic compression devices are proven to reduce limb swelling associated with

lymphedema, help close up chronic ulcers, and act as a prophylaxis for Deep Vein

Thrombosis (DVT).

Guidelines for Treatment

A physician is required to prescribe these settings, but general guidelines are listed

below:

• It is ultimately the physician’s responsibility to prescribe the setting and it should be

written on the prescription upon referral. Every patient is unique and communication

with the physician is important when setting the pressure.

• 50 mmHg works well for most patients. However, a different pressure might be

prescribed for your personal need and tolerance.

• Presence of fibrotic tissue may require as much as 80 mmHg in order to soften the

fibrotic tissue and achieve reduction. Once the tissue is soft, the compression can be

readjusted to 50 mmHg.

• Patients with a history of Congestive Heart Failure (CHF), which is controlled with

medication, should never be in a flat position while pumping. They should be in a

reclined position with elevated legs during treatment. Their treatment regimen duration

may be divided into twice a day 30 minutes per treatment.

• Patients with a history of Deep Vein Thrombosis with or without a filter may require

less compression. These patients will generally tolerate 40 mmHg. Patients with a filter

may need to divide their treatment into twice a day, 30 minutes per treatment. It is

suggested that the provider obtain a negative Doppler study from the physician for their

records.

Front Panel and Key Features

Key Functions

1. Power On/Off Button

2. Pressure Knob

3. Garment Connector Bar Ports

4. Auxiliary Air Supply Ports (shown with Blocker Bars)

5. Blocker Bars (uninstalled)

6. Garment Connector Bar

Warnings and Precautions

US federal law restricts this device to sale by or on the order of a

physician.

Electrical Medical Equipment

• To avoid the risk of electric shock, burns, fire, injury, or improper treatment, read the

entire instruction manual before operating this device

• Use of accessories or a power cord not specified or provided by Bio Compression

Systems could result in increased electromagnetic emissions or decreased

electromagnetic immunity of this equipment and result in improper operation

• Portable RF communications equipment (including cell phones and peripherals such

as antenna cables and external antennas) should be used no closer than 12" (30 cm) to

any part of the device including the power cord - otherwise, degradation of the

performance of this equipment could result

• Use of this equipment adjacent to or stacked with other equipment should be avoided

because it could result in improper operation

Do Not Use

• For any contraindicated condition

• If the pump, accessories, or power cord are damaged or have been immersed in water

• With any accessories or power cord not specified or provided by Bio Compression

Systems

• In the presence of flammable anesthetics or in an oxygen rich environment

• In an MRI environment

• Near water, in a wet environment, or where aerosols are being sprayed

• While sleeping

• For any use not described in this manual

Ask A Doctor Before Use If You Have

• Insensitive, irritated, injured skin, or skin conditions in/around treatment sites

When Using This Product

• Examine the device, accessories, and power cord for damage before using or cleaning

• Handle garments with care - do not fold or crease, use near a heat source, handle with

sharp objects, clean with abrasive materials, or place in a washing machine or dryer

• Do not stand or walk while wearing garments as this can cause a fall

• Always wear clothing, bandages, or stockings underneath garments for hygienic

reasons and to avoid irritation

• Never share garments or use someone else’s garments - single-patient use only

• Avoid folding, pinching, or kinking tubing as this can obstruct air flow

• Do not wrap tubing around limb as this can restrict blood flow

• Do not operate pump on a soft surface, under a blanket or covering, or near a heat

source

• Never adjust pump settings unless directed by a physician

• Do not carry or suspend the device using tubing, valves, or the power cord as handles

• Do not submerge the device or allow liquids to enter the device

• Never attempt to open, repair, or modify the device - no modification of this equipment

is allowed

Stop Use And Ask A Doctor If

• Changes in skin appearance occur such as color changes, blisters, welts, or increased

swelling

• You feel burning, itching, increased pain, numbness, or tingling

In the event the pump stops working (e.g., power failure), release pressure by

disconnecting the garment.

Any serious incident that has occurred in relation to the device must be reported

to Bio Compression Systems. In the European Union (EU), incidents should also be

reported to the competent authority of the Member State in which the user and / or

patient is established.

Keep out of reach of children and pets.

Operating Instructions

The patient is the intended user and can safely use all functions.

Preparing the Device for Use

• Remove garment(s) and cardboard underneath from box

• Lift pump out of box and remove protective end caps – save packaging for transport

and storage

• Place pump on a flat sturdy surface –pump must be close enough for the controls to

be reached during use

• Attach power cord and plug into outlet

• Remove garment(s) from plastic bag, unroll, and spread flat

Connecting the Garment(s)

• Locate the connector bar at the end of garment tubing

• Line up numbers on connector bar with numbers on pump

• Squeeze the sides and insert into pump – you will hear a “click” when connected

• When using the SC-2008-OC Sequential Circulator, locate the second connecter bar

and repeat previous steps

• When using two garments, remove blocker bar(s) and repeat previous steps

Putting the Garment(s) On

• Leg sleeve: unzip, place foot in and use straps to guide garment on, pull up zipper to

secure

• Arm sleeve: slide arm through larger opening

Operating the Device

• Sit in a comfortable reclined position with legs elevated within reach of controls

• Set pressure by turning knob

• Press “Power On/Off” button to turn on

• Run for treatment time determined by physician

• Upon the completion of treatment or to stop treatment, press “Power On/Off” button to

turn off

• Wait until light goes out

• Squeeze sides of connector bar and pull to disconnect garment from pump

• Press garment to remove remaining air until loose enough to remove

• Unzip (if applicable) and remove garment

Cleaning

The pump, garment, and tubing can be wiped down using a damp (not wet) soft cloth

while unplugged –if more thorough pump cleaning or garment disinfection is desired,

use the following directions.

Pump and tubing cleaning

• Unplug and wipe down using a damp (not wet) soft cloth with mild antibacterial soap

as needed

• Do not use bleach

Garment Disinfection

• Disconnect from pump and open to expose all sides

• Prepare a solution of 1/3 cup of laundry detergent per 1 gallon of warm water (20 mL

laundry detergent per 1 L water) in a sink or container large enough to hold the garment

• Place garment in solution but do not submerge or place connectors in water as this will

damage the device

• Soak for 30 minutes with mild agitation every 5-10 minutes - hard to remove soil may

require hand washing using a soft clean cloth while garment is in solution

• Rinse with warm water and allow to air dry

• Repeat previous steps using a solution of 1 cup of bleach per 1 gallon of warm water

(60 mL bleach per 1 L warm water)

Storing and Transporting

• Keep and reuse packaging for transporting the device

• Store in a dry location away from a source of heat and free of pests

Servicing and Repairs

• Contact Bio Compression Systems for servicing –there are no user serviceable parts

• Tampering, modifying, or dismantling this device in any way voids the warranty

• When contacting Bio Compression Systems, please have your model number and

serial number ready

Troubleshooting

Pump does not turn on:

1. Check to see if the pump is plugged in

2. Unplug and examine power cord for damaged - if damaged, contact Bio Compression

Systems

3. Check circuit breaker to make sure outlet has power

4. Contact Bio Compression Systems

Garment does not deflate:

1. Check garment connection to pump

2. Check garment hose for damage, kinks, or twists

3. Check garment for damage

4. Contact Bio Compression Systems

Pressure seems low:

1. Check garment connection to pump

2. Check garment hose for damage, kinks, or twists

3. Check garment for damage

4. Contact Bio Compression Systems

Device is loud or making strange noises:

1. Make sure pump is on a stable surface

2. Assure stable surface is free and clear of any loose object

3. Contact Bio Compression Systems

Accessories (SC-2004-OC, SC-2004FC-OC)

REF

Description

GA-3045-H

4-Chamber Adjustable Leg Sleeve - Half

GA-3045-L

4-Chamber Adjustable Leg Sleeve - Large

GA-3045-M

4-Chamber Adjustable Leg Sleeve - Medium

GA-3045-S

4-Chamber Adjustable Leg Sleeve - Small

GN-3045-L

4-Chamber Narrow Leg Sleeve - Large

GN-3045-M

4-Chamber Narrow Leg Sleeve - Medium

GN-3045-S

4-Chamber Narrow Leg Sleeve - Small

GS-3035-L

4-Chamber Arm Sleeve - Large

GS-3035-M

4-Chamber Arm Sleeve - Medium

GS-3035-S

4-Chamber Arm Sleeve - Small

GS-3035-SH-L-L

4-Chamber Arm & Shoulder Sleeve - Large, Left

GS-3035-SH-L-R

4-Chamber Arm & Shoulder Sleeve - Large, Right

GS-3035-SH-M-L

4-Chamber Arm & Shoulder Sleeve - Medium, Left

GS-3035-SH-M-R

4-Chamber Arm & Shoulder Sleeve - Medium, Right

GS-3035-SH-S-L

4-Chamber Arm & Shoulder Sleeve - Small, Left

GS-3035-SH-S-R

4-Chamber Arm & Shoulder Sleeve - Small, Right

GS-3045-H

4-Chamber Leg Sleeve - Half

GS-3045-L

4-Chamber Leg Sleeve - Large

GS-3045-M

4-Chamber Leg Sleeve - Medium

GS-3045-S

4-Chamber Leg Sleeve - Small

GV-3000

4-Chamber Vest

GW-3045-H

4-Chamber Wide Leg Sleeve - Half

GW-3045-L

4-Chamber Wide Leg Sleeve - Large

GW-3045-M

4-Chamber Wide Leg Sleeve - Medium

GW-3045-S

4-Chamber Wide Leg Sleeve - Small

GWA-3045-H

4-Chamber Wide Adjustable Leg Sleeve - Half

GWA-3045-L

4-Chamber Wide Adjustable Leg Sleeve - Large

GWA-3045-M

4-Chamber Wide Adjustable Leg Sleeve - Medium

GWA-3045-S

4-Chamber Wide Adjustable Leg Sleeve - Small

GXWA-3045

4-Chamber Extra Wide Adjustable Leg Sleeve

GXW-3045

4-Chamber Extra Wide Leg Sleeve

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