SUN SCIENTIFIC Aero-Wrap User manual

Aero-Wrap™ Compression Systems IFU | USER GUIDE
User Guide and
Instructions for Use
Aero-Wrap™ Compression Systems
Aero-Wrap™
Aero-Wrap™ Flex

Table of Contents
Chapter 1 Before You Get Started ......................1
1.1 Aero-Wrap™ Product Introduction & Components...........1
1.2 How to Contact Sun Scientific ..............................2
1.3 Safety Precautions ........................................3
1.4 Explanation of Symbols ....................................3
1.5 Indications for Use .........................................3
1.6 Contraindications ..........................................4
1.7 Precautions and Warnings .................................4
Chapter 2 Operating Instructions ......................6
2.1 Applying Aero-Wrap™......................................6
2.2 Applying Aero-Wrap™ Flex .................................9
2.3 Inflating Aero-Wrap™ and Aero-Wrap™ Flex...............12
2.4 Deflating Aero-Wrap™ and Aero-Wrap™ Flex .............14
2.5 Removing Aero-Wrap™ and Aero-Wrap™ Flex ............ 14
2.6 Optional: Using the Extension Panel...................... 15
2.7 Optional: Attaching the Under-Sock.......................15
Chapter 3 System Cleaning and Care ..................16
Chapter 4 Warranty and Service Information . ..........17

1Customer Service Toll-Free: 855.656.5656 (US Only)
CHAPTER 1
Before You Get Started
Know your device. Read the manual carefully and learn the
device’s operation and limitations before use.
1.1 Aero-Wrap™ Systems Product Introduction and
Components.
• Aero-Wrap™ and Aero-Wrap™ Flex are single-patient, reusable
compression systems designed to provide static pneumatic
compression to the lower-leg to treat a number of different conditions
as identified in section 1.5.
• Aero-Wrap™ and Aero-Wrap™ Flex come in unilateral (single leg) and
bilateral (two leg) configurations.
• Each Aero-Wrap™ system contains:
• Inflatable Wrap(s): Lower-leg compression sleeve with attached foot portion.
• Under-Sock(s): Comfort liner to be worn under the sleeve.
• AeroGauge™: Hand pump that provides adjustable static pneumatic compression.
• Each Aero-Wrap™ Flex system contains:
• Inflatable Flex Wrap(s): Lower-leg compression sleeve without attached foot portion.
• Under-Sock(s): Comfort liner to be worn under the sleeve.
• AeroGauge™: Hand pump that provides adjustable static pneumatic compression.
• Foot Compression Strap(s): Separate elastic foot strap, allowing for maximum ankle mobility.

2
1. 2 How to Contact Sun Scientic.
If you have questions about your Aero-Wrap™ please contact Sun
Scientific:
Customer Service: Toll-free (U.S. only) at 855.656.5656
Monday–Friday, 9:00 a.m. – 5:00 p.m. EST.
You may also email us at [email protected].
Or contact your local distributor.
Aero-Wrap™ Aero-Wrap™ Flex
Valve and Valve Cap
Under-Sock
AeroGauge™
Foot Compression
Strap

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1. 3 Safety Precautions.
• Should the upper or lower leg develop pain or the foot become pale,
cool or numb, remove Aero-Wrap™.
• Take caution while using in a pressurized environment, such as an
airplane, as compression within the sleeve is likely to change. If you feel
a noticeable change in compression, deflate and re-inflate to proper
levels.
• Care should be taken to use proper footwear when using Aero-Wrap™
while walking/doing activities. Failure to do so can cause damage to the
bottom of Aero-Wrap™ and could be a potential slipping hazard to the
user.
1. 4 Explanation of Symbols.
1. 5 Indications for Use.
Aero-Wrap™ Compression systems are designed to provide static
compression therapy, in the inpatient and outpatient setting to provide
treatment for:
1. Venous stasis ulcers
2. Leg ulcers
3. Chronic venous insufficiency
4. Lymphedema
Customer Service Toll-Free: 855.656.5656 (US Only)
To indicate the maximum
and minimum temperature
limits at which the item
shall be stored, transported
or used.
Refer to instruction manual Warning Caution: see
instructions for use
Store in a clean
dry area
between 0 - 49 C
°°
0
°
°
49 C

4
1. 6 Contraindications.
Aero-Wrap™ should not be used if you have one or more of the following
conditions:
• Decompensated acute heart failure
• Severe peripheral arterial disease (critical limb ischemia including
ischemic rest pain, arterial wounds, or gangrene)
• Acute thrombophlebitis, acute deep venous thrombosis
• Existing pulmonary edema
• Existing pulmonary embolisms
• Infection in the lower leg
• Where increased venous or lymphatic return is undesirable
• Allergy to materials
**Attention people with diabetes: We recommend you speak with your
physician before use of this product. An ABI ankle pressure of at least 0.5 is
necessary for safe use of compression therapy.**
1. 7 Precautions and Warnings.
• No side effects are currently known. However, if a negative result
should occur (i.e. skin irritations) from the use of Aero-Wrap™ or Aero-
Wrap™ Flex, please discontinue use of the product and consult with a
medical professional.
• Use of Aero-Wrap™ directly against the skin without use of the Under-
Sock or liner of your choice may cause irritation.
• Compression to a leg which already has a partially blocked blood supply

5
could lead to potentially serious complications. Do not use Aero-Wrap™
if you have compromised blood flow. If you have a question, please
consult a physician before using this product.
• The compression applied by Aero-Wrap™ should never be painful or be
uncomfortable. If you experience discomfort, reduce the compression
level or remove Aero-Wrap™ systems.
• Caution should be used on patients with neuropathy or limbs
insensitive to pain.
• Ensure no abrasive material is in contact with the skin.
• Follow all wound care instructions provided by your clinician.
• Not made or processed with natural rubber latex.
• Do not use in an MRI environment or hyperbaric chamber.
• Do not use any other inflation source other than those provided in
Aero-Wrap™ .
• Disconnect prior to defibrillation.
• To prevent strangulation or choke hazards keep Aero-Wrap™ products
away from babies and children.
• Sun Scientific is not liable for damage or injuries which have been
caused by improper handling or misuse.
Customer Service Toll-Free: 855.656.5656 (US Only)

6
CHAPTER 2
Operating Instructions
Follow the steps outlined below for Applying, Inating,
Deating, and Removing Aero-Wrap™.
2.1 Applying Aero-Wrap™.
Aero-Wrap™ sleeves can be worn with the detachable Under-Sock
provided or with a liner of your choice.
1. From a comfortable seated position hold Aero-Wrap™ so that the hook
and loop straps are open.
Aero-Wrap™ inside view
Heel
opening
Slots to snap in
Under-Socks
Foot portion
Attached Under-Sock Detached Under-Sock

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With the attached Under-Sock - Pull the Under-Sock up so that it
reaches to the junction below your knee, positioning Aero-Wrap™ as
shown below.
Without the attached Under-Sock - Step your heel into the triangular
opening as shown below.
(Aero-Wrap™ should not be worn directly on your skin. If your physician
has provided any wound care instructions, they should be followed first).
2. Secure the straps from bottom to top. This will align the elastic portion
with the back of your calf. Continue up the leg securing the remaining
straps. The straps may require readjustment later in the fitting process.
When securing the straps, you should feel as though the sleeve is snug
but not tight. Adjust the straps if necessary so they do not bunch.
Customer Service Toll-Free: 855.656.5656 (US Only)
Attached Under-Sock Detached Under-Sock
Liner of
your choice
Provided
Under-Sock
Aero-Wrap™ proper orientation
Elastic
portion