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

3
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

7
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

8
3. Optional: Trim the foot strap. Aero-Wrap™ has a long foot strap to
accommodate different foot sizes. If the foot strap is too long it can be
trimmed to reduce excess material by following the instructions below:
1. Apply Aero-Wrap™ per instructions.
2. With the foot straps secured, check to see if there is extra material
that extends beyond the hook and loop pad.
3. Use scissors to carefully trim the extra material that extends beyond
the hook and loop pad on the top of your foot.
(see diagram on next page)
Ankle straps
Foot straps
Attached Under-Sock Detached Under-Sock
Aero-Wrap™ being secured Fully Applied Sleeve

9
2.2 Applying Aero-Wrap™ Flex.
Aero-Wrap™ Flex sleeves can be worn with or without the detachable
Under-Sock and Foot Compression Strap.
1. From a comfortable seated position hold Aero-Wrap™ Flex so that the
hook and loop straps are open.
Customer Service Toll-Free: 855.656.5656 (US Only)
Extra
material
Slots to snap in
Under-Socks
Foot
Compression
Strap(s)
Attached Under-Sock Detached Under-Sock
Aero-Wrap™ Flex inside view

With the attached Under-Sock - Pull the Under-Sock up so that it
reaches to the junction below your knee, positioning Aero-Wrap™ Flex
as shown below.
Without the attached Under-Sock - Start by wrapping the lower portion
around your leg and securing the bottom strap. Work your way up by
securing each strap with the elastic portion hugging the back of your
calf. (Aero-Wrap™ Flex 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
10
Liner of
your choice
Provided
Under-Sock
Elastic portion
Attached Under-Sock Detached Under-Sock
Aero-Wrap™ Flex proper orientation

11
sleeve is snug but not tight. Adjust the straps if necessary so they do not
bunch.
3. Optional: Foot Compression Strap(s). Aero-Wrap™ Flex includes an
optional elastic Foot Compression Strap(s). To apply: Over the included
Under-Sock or your chosen liner, open the strap with the writing face up
and position it under the arch of your foot. Pull and secure the hook and
loop tabs to apply compression.
Customer Service Toll-Free: 855.656.5656 (US Only)
Open the strap(s)
with the writing
face up.
Attached Under-Sock Detached Under-Sock
Aero-Wrap™ Flex proper orientation
Fully Applied Sleeve with
Foot Compression Strap

2.3 Inating Aero-Wrap™ and Aero-Wrap™ Flex.
IMPORTANT INSTRUCTION: Prior to inflating the sleeve, you should
be able to easily slide one finger between the liner-layer and the
sleeve. Having this space allows the chambers to appropriately
inflate to provide air compression. If you intend to wear a shoe while
wearing Aero-Wrap™, put the shoe on prior to inflating the sleeve.
Aero-Wrap™ and Aero-Wrap™ Flex are inflated with the AeroGauge™
Hand Pump for static compression.
1. Turn the dial on the AeroGauge™ so the desired compression
level is selected. You should feel a soft click when the dial is
appropriately set at the compression level.
12
Selection indicator

13
IMPORTANT INSTRUCTION: It’s recommended to start gradually
with the compression level. Begin at the 20–30 mmHg option and
check your leg(s) for any reaction after two hours of use. Gradually
increase the duration and compression level, if desired. Consider if
your physician or health care professional may have advised you on
the desired compression level for you and your condition. You should
follow your health care professionals recommendations.
Walking, exercising or other vigorous activities engage the calf
muscles, creating a natural pumping action; this may help reduce
swelling and you may be required to adjust the hook and loop straps
or add air to the sleeve.
2. Remove the valve cap located on the sleeve and insert the tip of
the AeroGauge™ pump into the valve. Slowly squeeze the bulb
approximately 15 times to inflate the chambers. When squeezing
the pump, make sure your fingers do not cover the dial area where
the compression levels are displayed.
Customer Service Toll-Free: 855.656.5656 (US Only)
NOTE: You may hear a “hiss” until
the selected compression is attained.
The pump is designed to release
excess air to prevent filling the wrap
above the selected level.
Pump inserted
into valve

2.4 Deating Aero-Wrap™ and Aero-Wrap™ Flex .
There are two ways to deflate:
1. The first way is to locate the valve cap on the side of the sleeve on both
Aero-Wrap™ and Aero-Wrap™ Flex (the same place you inserted the pump
to inflate the chambers). Flip the cap upside down and press the tip of the
cap into the valve until the compression has been released.
2. The second way is to insert the AeroGauge™ into the valve. Position the
dial so that the arrow is in between two of the inflation values.
2.5 Removing Aero-Wrap™ and Aero-Wrap™ Flex .
1. Once deflated, carefully peel each hook tab from its loop pad. Take
care to not pull any tab too far as this can cause a rip.
14
Valve
Cap flipped
upside down
to release air
Deflate Options

2.6 Optional: Using the Extension Panel
Aero-Wrap™ and Aero-Wrap™ Flex can be adjusted with an Extension
Panel (purchased separately) which can adjust the shape or width of
the sleeve for patients who do not fit within the traditional product
measurements. The Extension Panel is attached with hook to the sleeve
and can be angled to provide extra width where required.
2.7 Optional: Attaching/Detaching the Under-Sock
Aero-Wrap™ and Aero-Wrap™ Flex have detachable Under-Sock(s) that
can be snapped into and out of the slots on the sleeve.
15Customer Service Toll-Free: 855.656.5656 (US Only)
Extension
Panel
Under-Sock
Stud
Button Slot on Sleeve
Stud Button: To
attach the Under-
Sock snap the
studs into the slots
on the sleeve

.
1616
CHAPTER 3
System Cleaning Instructions
CAREFULLY REMOVE THE UNDER-SOCK, AEROGAUGE, EXTENSION
PANEL etc. BEFORE CLEANING AND INSPECTION.
CAUTION: Avoid the following for the Aero-Wrap™
• Do not submerge.
• Do not disassemble.
• Do not machine dry.
• Do not iron.
• Do not machine
wash
• Do not dry clean.
• Do not autoclave.
• Do not swim or
bathe with wrap.
Aero-Wrap ™ and Aero-Wrap™ Flex can be cleaned, as needed, using a
damp cloth and mild household soap or laundry detergent, and hung to
dry.
Under-Sock(s) can be cleaned in the washing machine with laundry
detergent. Remove the Under-Sock from the Aero-Wrap before washing
the Under-Sock. Air dry.
AeroGauge™ can be cleaned, as needed, using a damp cloth and mild
household dish washing soap . Don’t submerge in water or fluid as this
will damage the pump.
Foot Compression Strap can be cleaned in the washing machine with
laundry detergent. Air dry.

17Customer Service Toll-Free: 855.656.5656 (US Only)
CHAPTER 4
Warranty and Service
Information
Our warranty service to the system offers the following coverage
• Aero-Wrap™ and Aero-Wrap™ Flex: 90 Days
Sun Scientific Inc. warrants its Aero-Wrap™ systems to be free from
defects in workmanship and materials for the periods listed above from
the date Device is delivered to the original purchaser (“Warranty Period”).
This Limited Warranty is extended only to the original purchaser and
is non-transferable. Sun Scientific’s sole obligation under this Limited
Warranty shall be, at its sole discretion, to repair or replace a Device
which is defective in either workmanship or material. This is the sole
remedy of the Purchaser. In addition, this Limited Warranty does not
cover any Device which may have been damaged in transit or has been
subject to misuse, neglect, or accident; or has been used in violation of
Sun Scientific instructions including, without limitation, the instructions
contained in this document.
• THERE ARE NO WARRANTIES OTHER THAN THOSE EXPRESSLY
STATED HEREIN.
17Customer Service Toll-Free: 855.656.5656 (US Only)