Breg VPULSE User manual

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User’s Manual
Breg, Inc.
2885 Loker Ave. East
Carlsbad, CA, USA
[phone] [phone]
www.breg.com
2797
Scan QR Code
For Instructional
Video
www.breg.com/vp

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Introduction
The Breg VPULSE®provides a unique combination of preventative and rehabilitative therapies:
• Intermittent sequential compression therapy to help prevent hospital-acquired venous
thromboembolism.
• Intermittent dynamic compression therapy to help reduce swelling.
• Controlled cold therapy to reduce discomfort and swelling.
Designed to provide a continuity of care from the hospital, surgery center, and clinic to self-treatment at
home, the VPULSE helps patients comply with post-operative instructions.
Contents of Package
Lid
Ice Bottles
2 VPULSE Sequential Compression Therapy pads
(Available with the C00002 assembly only)
Tubing Set
Container
User’s Manual
Transformer/
Power Cord
Data Card Port
2 Ice Bottles
(stored/shipped
inside container)
Symbols 4
Indications, Contraindications and Warnings 5
Medical Professional Patient Discharge Protocol 7
System Operation 8
Operating Instructions
• Using the System with Ice and Water 9
• Using the System with Ice Bottles 10
• Applying Therapy Wraps and Pads 11
• Using the Start/Stop Buttons 12
• Alarms 13
• Alerts 14
Troubleshooting 15
Cleaning, Care and Maintenance 16
Warranty 17
General Safety 17
Electrical Safety 18
Specifications 19
Catalog Items 22
CAUTION: Federal Law restricts this device to sale by, or on the order of, a
licensed healthcare practitioner.
Table of Contents

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Symbols
The Caution or Warning symbol precedes an
operational step that could cause damage to
the user or instrument if the patient does not
take certain precautions. Cautions or Warnings
are located in the main text, are preceded
by a Caution or Warning statement and are
accompanied by this symbol in the left margin.
Symbol ISO 7010-M002: refer to the Users
Manual for instructions for product usage.
This device is offered for sale by or on the order
of a licenced healthcare practitioner. Use only
as prescribed.
Medical Device Safety Symbol IEC 60417-5333:
Type BF Applied part complying with IEC 60601-
1 to provide protection against electric shock.
The part of the device in contact with the patient
is floating from earth ground.
Protected against spraying water.
Medical Device Symbol IEC 60417-5031: The
product operates from direct current.
Medical Device Symbol IEC 60417-5172: Class II
Equipment.
Medical Device Symbol IEC 60417-5570:
Unlocking, Handle.
Medical Device Symbol IEC 60417-5569:
Locking, Handle.
Minimum water reservoir fill line. Step 1 of filling
the water reservoir.
Maximum ice reservoir fill line. Step 2 of filling
the water reservoir. Note that either ice or the
VPULSE Ice Bottles can be used for cold therapy.
Follow local governing ordinances and recycling
plans regarding disposal or recycling of device
components. If unclear, please refer to Breg for
proper disposition of this product.
Manufactured by Breg, Inc.
2797 This product conforms to the directive 93/42
EEC for medical devices. The identification
number of the Notified Body is 2797.
Date of manufacture, year XXXX, week YY.
Single patient multiple use.
Cold therapy enable function.
Start /Stop the therapy session.
Dynamic compression therapy enable function.
Sequential compression therapy enable
function.
Indications
The VPULSE is intended to function as an
intermittent, external compression device for
extremities to prevent and reduce complications
of poor circulation. This includes:
• Deep vein thrombosis
• Chronic venous insufficiency
• Venous stasis ulcers
• Post-mastectomy edema and chronic
lymphedema
• Reduction of edema associated with soft tissue
injuries such as burns, postoperative edema,
and ligament sprains
• Localized cold therapy for post-traumatic and
post-surgical medical and/or surgical conditions
• Aid in blood flow back to the heart
• Treatment and assistance in healing of
cutaneous ulceration (wounds), reduction
of wound healing time, enhancement of
arterial circulation (blood flow), reduction
of compartmental pressures, reduction of
edema (swelling), reduction of the need for
anticoagulant (blood thinning) medications
Contraindications: Cold Therapy
Medical professionals and patients should be
aware of situations where cold therapy may
not be appropriate, detrimental to a specific
condition or otherwise contraindicated for use,
including patients with:
• Diabetes
• Cold uticaria
• Cryoglobulinemia
• Raynaud’s syndrome
• Proximal cold hemoglobinuria
• Vasospastic disease
• Cold hypersensitivity
• Compromised local circulation
• History of cold injury, frostbite, or adverse
reactions to local cold application
• Patients who are incoherent due to general
anesthesia, sedation, or coma
• Local tissue infection
• Hand/wrist or feet/ankle surgery with
polyneuropathy
Warnings: Cold Therapy
If the patient has any of the following clinical
risk factors, use of cold therapy may result
in serious cold-induced injury, including full
thickness skin necrosis:
• Pathologic sensitivity to cold
• Behaviors that negatively affect circulation,
including poor nutritional status, smoking
and tobacco use, excessive caffeine use, and
excessive alcohol use
• Cold application area desensitization due to
local anesthesia or regional nerve block
• Taking medications that have a negative effect
on peripheral vascular circulation, including
beta adrenergic blockers and local epinephrine
use (such as in local anesthetics)
If the risk of cold-induced injury outweighs
the benefits of cold therapy, do not prescribe
the VPULSE cold therapy. If you prescribe this
product to patients with risk factors, consider
taking special measures to control the risk, such
as:
• Recommend more frequent skin checks.
• Require more frequent follow-up examinations.
• Use an insulation barrier between the pad and
skin.
• Prescribe shorter durations of application, less
frequent application, or eliminate nighttime
application.
The VPULSE can be cold enough to cause
serious injury including full skin necrosis.
Excessive moisture at the application site due
to excessive bleeding, sweating, or condensation
may increase the risk of serious cold-induced
injury, including full thickness necrosis.
Inspect the skin under the cold therapy pad
(by lifting the edge) as prescribed, typically every
1 to 2 hours. Do not use VPULSE cold therapy
if dressing, wrapping, bracing or casting over
the cold therapy pad prevents skin checks. Stop
using and contact your practitioner immediately
if you experience any adverse reactions, such
as: increased pain, burning, increased swelling,
itching, blisters, increased redness, discoloration,
welts, other changes in skin appearance, or any
other reaction identified by your practitioner

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Contraindications: Compression
Therapy
Patients with the following conditions should
NOT USE Intermittent Pneumatic Compression
Therapy:
• Presumptive evidence of congestive heart
failure
• Suspected/observed pre-existing deep vein
thrombosis or pulmonary embolism
• Suspected/observed deep acute venal
thrombosis (phlebothrombosis)
• Suspected/observed inflammatory phlebitis
process
• Suspected/observed pulmonary edema
• Suspected /observed pulmonary embolism
• Suspected/observed acute inflammations of
the veins (thrombophlebitis)
• Suspected/observed decompensated cardiac
insufficiency
• Suspected/observed arterial dysregulation
• Suspected/observed erysipelas
• Suspected/observed carcinoma and carcinoma
metastasis in the affected extremity
• Suspected/observed decompensated
hypertonia
• Suspected/observed acute inflammatory skin
diseases or infection
• Suspected/observed venous or arterial
occlusive disease
• Determined venous and lymphatic return is
undesirable
• Suspected/observed Raynaud’s Disease
• Suspected/observed poor peripheral circulation
• Suspected/observed hypersensitivity to cold
• Medical situations where increased venous and
lymphatic return is undesirable
• Leg gangrene
• Recent skin graft
• Extremity containing a fracture
• Extremities that are not sensitive to pain
If pulsations or throbbing occur, the
cuff may be wrapped too tightly. Loosen
Immediately.
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 cuffs.
Patients should not walk with tubing
connected to cuffs.
Cuffs used in combination with warming
devices may cause skin irritation. Regularly
check for patent discomfort, compliance, and
skin irritation.
Close supervision is necessary when
this appliance is used by unconscious or
incapacitated patients and those with poor
circulation.
When using this system, regularly check the
skin where the pads are applied as prescribed.
Warnings: Cold and
Compression Therapies
Patients with any of the following cogni-
tive risk factors should only use VPULSE under
direct supervision of a medical professional
or the direct supervision of a caretaker, if pre-
scribed by a medical professional:
• Young children and elderly
• Cognitive disabilities
• Communication barriers
• Use of medications that have a negative
effect upon mental capacity
If patient has any of the cognitive risk factors,
above, medical professional or caretaker should
provide skin checks.
Patients should take caution in applying
therapy pads over open sores and abrasions. At
a minimum, these areas should be cleaned and
bandaged.
As with all prescription medical devices,
failure to follow product instructions or adjusting
setting and performing therapy applications
without the express direction and/or supervision
of your trained health care provider may lead to
improper product performance and the potential
for serious injury. For medical questions, please
consult your health care provider.
Use only according to your practitioner’s
instructions regarding the frequency and duration
of application and length of breaks between
uses, how and when to inspect the skin, and
total length of treatment. Do not use this device
if you did not receive or do not understand the
instructions.
DO NOT wrap the therapy pads as to restrict
blood or fluid flow. Regularly check the therapy
area.
DO NOT place a cast over a pad. Casting
over the pad and tubing set may restrict
necessary air circulation and proper operation.
Medical Professional Patient
Discharge Protocol
Follow this protocol prior to discharging the
patient from facility care to home use
1. Patient Screen. Screen the patient for any
contraindications and/or applicable warnings.
If the patient has anycontraindications, do not
dispense the Breg VPULSE to the patient.
If any of the warnings apply to the patient,
determine the appropriateness of application
of the VPULSE to that patient.
2. Instructions for Use. Instruct the patient on
how to properly use the Breg VPULSE. Review
the Operating Instructions in this document
and affixed to the unit with each patient.
Be aware of any nerve irritation and/or
muscular reaction that are associated with skin
sensitivity and irritation. If observed, discontinue
therapy until the cause is determined.
DO NOT operate without water in the system.
Doing so may damage your system and void the
product warranty.
Warnings: Compression
Therapy
If patient experiences pain, swelling,
sensation changes or any unusual reactions
while using the compression therapy, they are to
stop using the therapy and consult their medical
professional immediately.
Special attention should be given to those
patients with neuropathies or tissue viability
problems (i.e. diabetes, arterial or venous
insufficiencies).
3. Prescription. Instruct the patient regarding the
licensed healthcare practitioner’s prescribed
protocol: frequency and duration of use and
length of breaks between uses, how and
when to inspect the skin, and total length of
treatment. The duration of acyclic application
may vary depending upon the patient. If
the patient does not experience pain relief,
the physician may increase the duration of
cold therapy application. As the application
duration is increased, the frequency of the skin
inspections should increase.
4. Potential for Injury. Inform the patient
that improper use can result in serious skin
injury, including full thickness skin necrosis.
Emphasize the importance of following the
prescribed protocol, proper pad application,
and skin inspection.
5. Proper Pad Application. Instruct the patient
to use only the Breg VPULSE Cold Therapy
Pads designed for the body part being
treated; other pads may be colder, increasing
the risk of serious cold-induced injury,
including full thickness skin necrosis. Do not
cover the VPULSE Cold Therapy Pad with
dressing, wrapping, bracing or casting that
prevents the patient from checking the skin
under the pad.
6. Skin Inspection. Instruct the patient to inspect
the skin receiving cold treatment per the
practitioner’s instructions, typically every 1
to 2 hours. If dressing, wrapping, bracing, or
casting over the VPULSE Cold Therapy Pad
prevents the ability of the patient to perform
skin checks under the pad regularly, do not
dispense Breg VPULSE Cold Therapy to the
patient.
7. Discontinue. Instruct the patient to stop
using Breg VPULSE and contact his/her
licensed health care practitioner immediately
if they experience any adverse reactions,
such as: increased pain, burning, increased
swelling, itching, blisters, increased redness,
discoloration, welts, or other changes in skin
appearance.
8. Documentation. Provide the patient a
prescription for the duration of the total
treatment period, the frequency and duration
of individual treatment sessions, and the
frequency of skin inspections

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System Operation
The VPULSE consists of a container, tubing set
and a family of single-patient application pads.
The pads are applied to the body to deliver three
different and important therapeutic treatments.
There are two types of pads to deliver three
different therapies:
• The patient can apply (1) or (2) sequential
compression therapy pad(s) to the calves for
preventative treatment of venous thrombo-
embolism.
And/Or
• The patient can apply (1) thermal-compression
pad to a specific body part such as the knee
or shoulder for cold therapy and/or dynamic
compression therapy to manage pain and
swelling for post-operative recovery
The container contains:
• An air pump and reservoir for inflating portions
of each pad;
• A water pump and patient-filled ice water
container for circulating water into the thermal-
compression pad; and supporting controls to
deliver and monitor the treatment therapies.
Once power is connected to the VPULSE, it is
powered ON. The patient can then select which
therapies to use and start the treatment session.
Pressurized air and/or cooled water is circulated
through the tubing set from the container to
the pads. The air pressure is cycled until the
therapy session is stopped by the patient.
The temperature of the therapy is not adjustable
and designed not to drop below 42oF (5.5oC). The
compression of the therapy is not adjustable.
NOTICE TO USERS
If any serious incident has occurred in relation
to the device, report to Breg and the competent
authority of the Member State in which the user
and/or patient is established.
Operating Instructions
Using the System with Ice and Water
Pour cold
water into the
container to
the “WATER”
level indication
on the inside of
the container.
Remove the two
Ice Bottles from
the container.
Pour ice water into
the container until
even with the “ICE”
level indication on
the inside of the
container.
Place the lid onto the
container and turn
clockwise until the
handle clicks into
position.
1 2
3 4
Every VPULSE is quality tested before being sold. When un-packing your new system, it is
normal to find moisture in the VPULSE water reservoir due to the testing.
DO NOT overfill.
DO NOT operate without water.
DO NOT operate with hot water.

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Operating Instructions
Using the System with Ice Bottles
Place the two Ice Bottles
into the container.
Place the lid onto the
container and turn
clockwise until the
handle clicks into
position.
Fill Ice Bottles
with water.
Freeze Ice
Bottles.
1. Fill the Ice Bottle with tap water. Freeze the
filled Ice Bottle for a minimum of 6 hours in any
household freezer to ensure maximum cold
therapy.
The time the Ice Bottle will stay frozen is
approximately 2 to 6 hours. Use additional Ice
Bottles for longer treatment.
To avoid skin irritation or cold burn, DO NOT hold frozen Ice Bottles for an extended period. DO
NOT use the Ice Bottles directly on skin for therapeutic purposes.
2. Place the frozen Ice Bottle into the container.
Make sure water is already in the VPULSE unit
up to the water line. For longer duration of
sustained cold water temperature, add ice in
addition to the Ice Bottle to the water reservoir
(as desired). Only fill the Ice Bottles with water.
To order additional Ice Bottles please call
1.800.321.0607 or 1.760.795.5440.
If your VPULSE includes the Ice Bottle pair or you purchased them as an accessory, please follow the
instructions below to prepare the Ice Bottles for use.
Pour cold water
into the container
to the “WATER”
level indication
on the inside of
the container.
Remove the two Ice
Bottles from the
container.
1 2
3 4
5 6
Fill Ice Bottles with water only
Apply the Sequential Compression Therapy pads to the patient’s calves.
Apply 1 Cold-Dynamic Compression pad to the appropriate body part (Example: knee)
(Refer to the other available pads for the application instructions for each pad.)
Center the pad behind the
patient’s calf.
Wrap one side of the pad, as
shown, around the front of the
patient’s leg.
Secure by wrapping the 3 “fingers” in the
order shown around to the front. Apply pads
to both calves. Adjust so snug. Do not over
tighten.
Center the pad over the patient’s knee with the
connector pointing down.
Wrap straps around the knee to secure the pad.
Attach the container to the pads using the
corresponding colored connectors as shown. The
connectors make a “click” sound when fastened
properly.
Plug the container into a grounded AC outlet.
Apply therapy pads only to body part indicated for the associated pad. failure to follow the
product instructions may lead to improper product performance and the potential for serious
injury.
1 2 3
4 5
6 7
Attach the Container to the pads via the tubing set.
Operating Instructions
Applying Therapy Wraps and Pads

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Start/Stop
Cold Only Sequential Compression (Calf)
Pad Only
Dynamic Compression Only
To Pause or Discontinue Use.
Press the Start/Stop
button to stop.
Disconnect by
depressing the
side buttons of the
connectors.
Remove the Sequential Compression
Therapy pads and Thermal-
Compression pad.
Press the button of the desired therapy or combination of therapies. The buttons selected will be
illuminated.
Operating Instructions
Using the Start/Stop button to start, change, pause or stop therapies.
To add therapy, first press Start/Stop button, select the therapy button and press the Start/Stop button
again to continue.
Push the Start/Stop button to begin.
Sequential Compression may
alarm if:
• The time to inflate the pad is
too short or too long.
To resolve:
• Make sure the sequential compression
therapy pads are properly applied to the
calf and connected properly.
• Press sequential compression and then
press the Start/Stop button. If the issue
is not resolved, contact Customer Care for
further instructions.
Alarms
When an alarm occurs, the system will stop the therapy session, sound an audible alert and illuminate
in RED the function key of the alarm area.
To stop an alarm, press the function key that is flashing.
Cold Therapy may alarm if:
• Too low or too high a therapy
temperature may be detected
by the system.
To resolve:
• Check the tube connection at the
container and at the cold-compression pad.
• Ensure appropriate ice or water level.
• Activate the cold therapy and press start. If
the issue is not resolved, press the cold
therapy button to deactivate.
• If prescribed, ensure the sequential therapy is
activated and press Start/Stop button to
resume sequential therapy. Contact Customer
Care for further instructions.
Dynamic Compression may
alarm if:
• The time to inflate the pad is
too short or too long.
To resolve:
• Check the tube connection at the container
and at the cold-compression pad.
• Make sure the cold-compression therapy
pads are properly applied to the body and
connected properly.
• Press dynamic compression and then
press the Start/Stop button. If the issue
is not resolved, contact Customer Care for
further instructions.
Should the system fail to restart after an alarm has sounded and the stated resolutions have not reset
the System, contact Customer Care at Breg, 1.800.321.0607 or 1.760.795.5440 for further assistance.

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Troubleshooting
Frequently asked questions in
troubleshooting the VPULSE:
1. What should I do if the VPULSE does not
seem to get cold?
• Check the inside and outside of the water
reservoir for cracks, punctures or other signs
of damage. If damage is noted, please contact
Customer Care at Breg, 1.800.321.0607 or
1.760.795.5440.
• Make sure that the water container is properly
filled with water.
DO NOT operate the system with a water
container not filled with water or
not filled to the MINIMUM fill line, before
ice or Ice Bottles are added.
DO NOT operate the system with a water
container filled with water above the
MAXIMUM fill line, or with a tubing set
not properly connected.
• Check that enough ice is added to the water
container and that the tubing is not kinked.
• Check the power connection.
2. What should I do if the tubing set does not
connect to the VPULSE or pad?
• Check the tubing set and connectors for cracks,
punctures or other signs of damage. If damage
is noted, contact Customer Care at Breg,
1.800.321.0607 or 1.760.795.5440.
• Make sure the correct connectors are mating.
Check the color and number of connections.
• Make sure no foreign objects are blocking the
fluid connectors.
3. What should I do if the system does not turn
on?
• Check wall adapter power connection at the
wall.
• Check the outlet to ensure it is properly
powered.
• Check wall adapter is connected at back of the
Control Unit.
• Make sure no foreign objects are blocking the
fluid connectors.
• Check that the front panel keys illuminate
when pressed.
• Check that the Start/Stop key ( ) illuminates
GREEN when pressed.
4. What should I do if the system is not pumping
water through the pad?
• Check power connection.
• Check that the tubing set is properly connected.
• Check that the pads are properly connected.
• Check that the water reservoir is properly filled
with cold water.
• Check that the Cold Therapy button has been
selected and the function illuminates WHITE.
• Check that the Start/Stop key ( ) illuminates
GREEN when pressed.
• Check that the tubing is not kinked.
• Start the system to ensure that the water is
flowing into the water reservoir. A return
stream is visible inside water reservoir.
5. What should I do if the system is not pumping
any air through the pad?
• Check power connection.
• Check that the tubing set is properly connected.
• Check that the pads are properly connected.
• Check that the front panel keys illuminate
when pressed and that a compression therapy
is selected. If the compression keys are both
continuously illuminated RED and VIOLET
the air pump might not be providing sufficient
pressure.
• If compression keys are both continuously
illuminated RED, the DATA card may not be
installed, the card may be full, or experiencing
a problem. Open the DATA door and reinstall
the DATA card.
• Check that the Start/Stop key ( ) illuminates
GREEN when pressed.
• Check that pad is inflating.
• Check the dynamic or sequential therapy mode
is enabled.
Refer to Breg Customer Care, 1.800.321.0607 or 1.760.795.5440 if
these actions are ineffective.
Alerts
Flashing GREEN
• The Stop/Start button will flash
when the system is initializing.
To resolve:
• This may occur after power disruption or
after the system was improperly shut down.
Dynamic Compression VIOLET
and Sequential Compression RED
To resolve:
• The air pump is not achieving pressure,
contact Customer Care
Dynamic Compression and
Sequential Compression keys
Solid RED
To resolve:
• The SD card is not properly installed, the
card is full or faulty. Remove or reinstall
the card. If this condition persists contact
Customer Care.
• Cold Therapy is still active during this
condition.

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Warranty
Breg, Inc. warrants that this product is free from defects in workmanship, materials,
and fitness for use for 90 days from initial purchase under normal use for which it was
intended and under direct supervision of a licensed health care practitioner.
Breg, Inc.’s obligation under this warranty is limited to the replacement or repair of any
defective part or parts of this product. All expressed or implied warranties, including
the warranty of merchantability and fitness for a particular purpose, are limited to the
actual warranty period set forth above. No other warranty, express or implied, is given
and no affirmation of or by seller, by words or action, will constitute a warranty.
General Safety
This section is used to highlight certain operating
procedures and recommendations. Important
Safety Instructions / Read all instructions before
using.
The device should never be left unattended
when plugged in. Unplug from outlet when not in
use and before putting on or taking off parts.
No modification of this equipment is allowed.
DO NOT use around flammable materials.
Close supervision is necessary when this appliance
is used near pets
The VPULSE pads are supplied non-sterile.
DO NOT sterilize these pads. Doing so may
compromise the functionality of the pad(s) and
may result in possible patient injury.
All VPULSE pads are intended for single
patient use and NOT intended for reuse or to be
washed or cleaned. Doing so may compromise
the functionality of the pad(s) and may result in
possible patient injury.
DO NOT lay on top of the pad connectors.
Doing so may result in patient injury.
DO NOT use pins or sharp objects to secure
the therapy pads or hoses. Doing so may damage
the system and compromise function.
The device is intended for single patient multiple
use.
DO NOT kink or sharply bend the tubing
set. Doing so may damage the system and
compromise the function.
Use this appliance only for its intended
use as described in this manual. DO NOT
use attachments not recommended by the
manufacturer. DO NOT use attachments from
other manufacturers. Connecting parts not
supplied by Breg will void the warranty and may
cause damage to the system and potential injury
to the patient.
Ensure the handle of the device is properly
installed and fully engaged prior to carrying the
system. For proper use, please reference the
handle locking and unlocking icons.
Use proper precautions in carrying the device
to avoid injury.
DO NOT carry this appliance by the supply
cord or use the supply cord as a handle.
When setting up the system, route the supply
cord and tubing set to avoid tripping and to
encourage ease of walking around the device.
DO NOT carry this appliance by the tubing
set or use the tubing set as a handle.
Keep the tubing set, the device and pads
away from heated surfaces.
Never operate the appliance without the
handle, the tubing set, and the pad(s) completely
connected.
Never operate the appliance with any foreign
objects (other than ice or Ice Bottles provided) in
the water reservoir.
.
Cleaning your VPULSE
To clean your VPULSE, please follow these simple
steps:
1. Remove electrical cord.
2. Fill the empty water container to the MAX fill
line with fresh, room temperature water. DO
NOT USE ANY CLEANING SOLUTIONS IN THE
WATER RESERVOIR AS THESE SOLUTIONS
COULD DAMAGE THE WATER PUMP AND
THERAPY PADS.
3. Replace the handle and connect power.
Connect all pads and enable all functions.
4. Operate the system for 10 minutes.
5. Empty the water reservoir.
6. Repeat these actions periodically.
Please use only the following cleaning agents
when cleaning the outside of yourVPULSE system:
warm water with mild detergent, Lysol©, 70%
isopropyl alcohol, Cidex©, or 10% bleach solution.
Patients should not use cleaning or
decontamination methods different from those
recommended by the manufacturer without first
checking with the manufacturer that the proposed
methods will not damage the equipment.
Care and Maintenance
• DO NOT store the pad in its shipping bag. The
shipping bag may trap the moisture remaining
in the pad.
• Store the VPULSE unit in a safe, cool and dry
place when not in use.
• Ensure the water container is empty of water
and dry to avoid bacterial growth and
contamination.
• Wipe down the device with a soft, damp cloth.
DO NOT use abrasive cleaner. NEVER immerse
the unit into any liquid.
• Keep away from all solvents and harsh deter-
gents. Please refer to cleaning instructions
prior to cleaning your VPULSE.
• DO NOT attempt to repair the VPULSE. There
are no patient-serviceable parts. Repair of the
system by an unauthorizedpersonmay void the
product warranty.
• To store, disconnect the electrical cord, the
tubing set and the pad.
Storage
Remove water from the Thermal-Compression pad by
rolling the pad up while still connected and squeezing
the water back into the Container.
Remove the Ice Bottles from the unit. Separate the
bottles and pour the water out, air dry.
Dump the water out of the side Control Unit so that the
control buttons and other electrical components
stay dry. When empty, let the unit “air dry” completely.
For long term storage, please use the shipping materials
and container supplied with the VPULSE.
1
2
3
Lysol®is a registered trademark of Reckitt Benckiser Inc.
Cidex®is a registered trademark of Johnson & Johnson Corp.

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Never drop or insert any object into any
opening
Excessive lint or dust may impede the flow
of water through the system. To minimize this
occurrence, keep the handle properly installed
and fully engaged when not filling or emptying
the device.
DO NOT stand on or in the appliance.
DO NOT place the appliance or operate the
appliance while it is on a surface more than 1 foot
above the floor.
Unplug this product before filling or cleaning.
Fill with water and ice or water and Ice Bottles
provided by Breg only. DO NOT use any Ice
Bottles other than those provided by Breg.
`DO NOT place the tubing set, power cord
or use any pad around the neck to avoid the
possibility of strangulation.
Electrical Safety
When using an electrical appliance, especially
when children are present, basic safety
precautions should always be followed.
Electromagnetic Interference
This device has been tested and found to
comply with the limits for Medical Devices
according to IEC 60601-1-2:2014+AMD1:2020.
These limits are designed to provide
reasonable protection against harmful
interference in typical medical installations.
This equipment generates and radiates radio
frequency energy and, if not installed and used
in accordance with the instructions, may cause
harmful interference to other devices in the
vicinity. There is no guarantee that interference
does cause harmful occurrence in a particular
installation.
If this equipment does cause harmful
interference to other devices, which can be
determined by turning the equipment off and
on, the user can try to correct the interference
by one or more of the following measures:
• Reorient or relocate this device.
• Increase the physical separation between this
device and the other devices(s).
• Connect the equipment into an outlet or
circuit different from the one where the other
device(s) are connected.
Essential Performance
This device contains Essential Performance
per IEC 60601-1, Edition 3.2 and IEC 60601-1-2,
Edition 4.1
The VPULSE system notifies the user through
audible/visual alarms when the sequential
therapy mode ceases to function or delivers a
pressure out of the specified range.
Environmental Conditions
This device has been tested and found to
comply with the environmental conditions for
Medical Devices according to IEC 60601-1-
2:2014+AMD1:2020 and IEC 60601-1-6:2010+AM
D1:2013+AMD2:2020. These conditions are
designed to provide reasonable environmental
operating ranges for the equipment. Extreme
changes in the environmental conditions or
operating outside the specific operating ranges,
such as temperatures, pressure and humidity, may
impact the performance of this device. The user
can try to correct these conditions by relocating
this device to a more moderate environment.
Interference From Other Products
If this equipment is interfered with by other
devices, which can be determined by turning that
equipment off and on, the user can try to correct
the interference by one or more of the following
measures:
• Reorient or relocate this device.
• Increase the physical separation between this
device and the other devices(s).
Electromagnetic Interference and Emissions
Use of this equipment adjacent to or stacked
with other equipment should be avoided
because it could result in improper operation.
Use of accessories, transducers and cables
other than those specified or provided by the
manufacturer of this equipment could result
in increased electromagnetic emissions or
decreased electromagnetic immunity of this
equipment and result in improper operation.
Portable RF communications equipment
(including peripherals such as antenna cables
and external antennas) should be used no closer
that 30 cm (12 inches) to any part of the VPULSE
including cables specified by the manufacturer.
Otherwise, degradation of the performance of
this equipment could result.
DANGER – TO REDUCE THE RISK OF
ELECTRICAL SHOCK, DO NOT DISASSEMBLE
THE UNIT. REFER SERVICING TO THE
MANUFACTURER:
1. Always unplug this appliance from the
electrical outlet immediately after using and
before cleaning.
2. DO NOT use while bathing or in a shower.
3. DO NOT place or store appliance where it can
fall or be pulled into a tub or sink. DO NOT
place in or drop into water or other liquid.
4. DO NOT reach for a product that has fallen into
water. Unplug immediately.
Only use the power supply provided with the
unit. Failure to do this could damage the unit,
power supply, and/or create a potential injury to
the patient. Please contact Breg Customer Care if
a replacement wall adapter is required.
Never operate this appliance if it has a
damaged cord, plug or wall adapter, if it is not
working properly, if it has been dropped or
damaged, or dropped into water.
Keep the power cord away from heated
surfaces.

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MODEL
PHYSICAL
Size (approximately)
Weight (dry)
Dual Tubing Set
CONTROLS
THERMAL SYSTEM
Operating limit
Operating period
Circulating System
Reservoir Capacity
Reservoir Fluid
Water Flow Rate
PNEUMATIC SYSTEM
Dynamic Compression
peak pressure
Sequential Compression
peak pressure
ELECTRICAL SYSTEM
System
Voltage
Frequency
Power
Leakage Current
Specifications
VPULSE, C00001
9.8” x 14.3” x 11.25”
(249mm x 364mm x 286mm)
5 lbs. (2.27 kg)
10 ft. (2.4m)
Keypad interface
42°F minimum (5.5°C )
Ice or frozen Ice Bottles
will last for 2-6 hours
Submersible pump
1.2 gallons (4.4 liters)
water
3.2 gph (12 lph) typical
50mmHg (6.6kPa) ± 10%
60mmHg (8.0kPa) ± 10%
TPU Polyether bladder, Pol-
yurethane foam with 100%
Polyester fabric lamination
PVC plastic bladder, Polyu-
rethane foam with 100%
Polyester fabric lamination
12VDC, 100-240Vac
50/60Hz
15W max
300μA max
Wall Adapter
Input
Frequency
Output
OPERATING
ENVIRONMENT
Atmospheric Pressure
Humidity
Temperature
TRANSPORT & STORAGE
ENVIRONMENT
Atmospheric Pressure
Humidity
Temperature
REGULATORY
Classification
Type of Equipment
REGULATORY
APPROVALS
UE24WCP1-120200SPA
100-240Vac, 800μA max
50/60Hz
12VDC, 2.08A
525 to 795 mmHg
(700hPa – 1060hPa)
15% to 93% relative non-
condensing
41°F – 104°F (5°C – 40°C)
179 to 795 mmHg
(240hPa – 1060hPa)
up to 93%
-13°F – 158°F (-25°C –
70°C)
Expected Service Life: 300
hours from date of first use.
Class II Equipment
Type BF
IEC 60601-1, Edition
3.2 Medical electrical
equipment - Part 1:
General requirements for
basic safety and essential
performance.
CAN/CSA-C22,2 no 60601-
1-08 (R2008): Medical
Electrical Equipment Part1:
General Requirements
for Medical Electrical
Equipment.
IEC 60601-1-
2:2014+AMD1:2020 edition
4.1 Medical electrical
equipment - Part 1-2:
General requirements for
basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests.
VPULSE is a trademark of
Breg, Inc.
A brief summary of the tests carried out in accordance with IEC 60601-1-2:2014+AMD1:2020 is shown
below.
The VPULSE is suitable for use in the specified electromagnetic environment. The consumer and/or user of the VPULSE
should ensure that it is used in an electromagnetic environment as described below:
The VPULSE uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause interference
in nearby electronic equipment.
The VPULSE is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Emissions Test Compliance Electromagnetic Environment Guidance
Group 1
Class B
Class B
Complies
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonic Emissions
IEC 61000-3-2
Voltage fluctuations / flicker emissions
IEC 61000-3-3
Portable and mobile RF communications equipment should be
used no closer to any part of the VPULSE, including cables, than the
recommended separation distance calculated from the equation
appropriate for the frequency of the transmitter.
Recommended Separation Distance
d=1,2√P
d=1,2√P 80 MHz to 800 MHz
d=2,3√P 800MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an elec-
tromagnetic site survey (a), should be less than the compliance
level in each frequency range (b).
Interference may occur in the vicinity of equipment marked with the
following symbol:
Immunity Test Electromagnetic Environment Guidance
Conducted Disturbances
induced by RF Fields
IEC 61000-4-6
Radiated RF EM fields
IEC 61000-4-3
IEC 60601-1-2
Test Level
3V
0.15MHz – 80MHz
6V in ISM & amateur radio
bands between 0.15Mz –
80MHz
80% AM at 1kHz
10 V/m
80 MHz – 2.7 GHz
80% AM at 1 kHz
Floors should be wood, concrete, or ceramic tile. If floors are covered
with synthetic material, the relative humidity should be at least 30%.
Main power quality should be that of a typical commercial and/or
hospital environment.
Main power quality should be that of a typical commercial and/or
hospital environment.
Immunity Test Electromagnetic Environment Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surges (line to line)
IEC 61000-4-5
Proximity Fields from RF
Wireless Communica-
tions Equipment
IEC 61000-4-3
IEC 60601-1-2
Test Level
± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15
kV air
± 2 kV
100 kHz repetition frequency
± 0,5 kV, ± 1 kV
Reference IEC 60601-1-
2:2014+AMD1:2020 table 9
The VPULSE is suitable for use in the specified electromagnetic environment. The user of the VPULSE should ensure that it
is used in an electromagnetic environment as described below:

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Main power quality should be that of a typical commercial and/or
hospital environment. If the user of the VPULSE requires continued
operation during power main interruptions, it is recommended that the
VPULSE be powered from an uninterruptible power supply or a battery.
If improper operation occurs, it may be necessary to position the
VPULSE further from sources of power frequency magnetic fields or to
install magnetic shielding. The power frequency magnetic field should
be measured in the intended installation location to ensure that it is
sufficiently low.
Voltage Dips and Fluctua-
tions
IEC 61000-4-11
Voltage Interruptions
IEC 61000-4-11
Rated Power Frequency
Magnetic Fields
IEC 61000-4-8
0% for ½-cycle at 0°, 45°,
90°, 135°, 180°, 225°, 270°,
and 315°
0% for 1-cycle and 70% for
25 cycles at 0°
0% for 250 cycles
30 A/m
50Hz
Proximity Magnetic Fields
IEC 61000-4-39
IMMUNITY TEST LEVELS TO DISTURBANCES FROM PROXIMITY MAGNETIC FIELDS
Test Frequency Modulation Immunity Test Level (A/m)
30 kHz
134.2 kHz
13.56 MHz
CW
Pulse modulation1
2.1 kHz
Pulse modulation1
50kHz
8
65
7.5
Catalog Items
To order additional items from Breg, please refer to the following items:
Catalog Item
C00001
C00002
C00003
C00004
C00005
C00013
C00016
C00017
C00020
C00006
C00007
C00008
C00009
C00010
C00018
C00024
Description
Breg VPULSE w/o Pads
Breg VPULSE with Sequential Compression Pad (2)
Breg Cold/Compression Pad, Knee, L
Breg Cold/Compression Pad, Shoulder
Breg Cold/Compression Pad, Foot/Ankle
Breg Cold/Compression Pad, Hip
Breg Cold/Compression Pad, Universal
Breg Cold/Compression Pad, Knee
Breg Cold/Compression Pad, Back
Accessories
Breg VPULSE Sequential Compression Pad set (2x)
Breg VPULSE Spare Ice Bottle Set
Breg VPULSE12VDC-24W Wall Adapter
Breg VPULSE Thermal/Compression Tubing Set
Breg VPULSE Sequential Compression Tubing Set
Breg VPULSE Complete Tubing set
Breg VPULSE Power Extension Cable
¹Modulate carrier using 50% duty cycle square wave. Immunity test levels specified as RMS before modulation is applied.

E/U AUTHORIZED REPRESENTATIVE
MDSS GmbH
Schiffgraben 41
D-30175 Hannover
Germany
EC REP
Breg, Inc.
2885 Loker Ave. East
Carlsbad CA 92010, USA
Phone: [phone]
Fax: [phone]
www.breg.com
© 2022 Breg, Inc.
All rights reserved.
VPULSE is a registered
trademark of Breg, Inc.
AW-100149 Rev L 05/22