User's Manual - Breg, Inc.
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User’s Manual
Breg, Inc. Scan QR Code
2885 Loker Ave. East For Instructional
Carlsbad, CA, USA Video
(800) 321-0607 (760) 795-5440
www.breg.com www.breg.com/vp
2797
1 of 23Introduction Table of Contents
The Breg VPULSE® provides a unique combination of preventative and rehabilitative therapies: Symbols 4
• Intermittent sequential compression therapy to help prevent hospital-acquired venous Indications, Contraindications and Warnings 5
thromboembolism.
Medical Professional Patient Discharge Protocol 7
• Intermittent dynamic compression therapy to help reduce swelling. System Operation 8
• Controlled cold therapy to reduce discomfort and swelling. Operating Instructions
Designed to provide a continuity of care from the hospital, surgery center, and clinic to self-treatment at • Using the System with Ice and Water 9
home, the VPULSE helps patients comply with post-operative instructions.
• Using the System with Ice Bottles 10
• Applying Therapy Wraps and Pads 11
• Using the Start/Stop Buttons 12
Contents of Package • Alarms 13
• Alerts 14
Lid
Troubleshooting 15
Cleaning, Care and Maintenance 16
Warranty 17
General Safety 17
Tubing Set
Container Data Card Port Electrical Safety 18
Specifications 19
Catalog Items 22
Transformer/
Power Cord
User’s Manual
2 Ice Bottles
(stored/shipped
inside container)
2 VPULSE Sequential Compression Therapy pads CAUTION: Federal Law restricts this device to sale by, or on the order of, a
(Available with the C00002 assembly only)
Ice Bottles
licensed healthcare practitioner.
2 of 23 3 of 23Symbols Indications Warnings: Cold Therapy
The Caution or Warning symbol precedes an
operational step that could cause damage to Cold therapy enable function. The VPULSE is intended to function as an If the patient has any of the following clinical
the user or instrument if the patient does not intermittent, external compression device for risk factors, use of cold therapy may result
take certain precautions. Cautions or Warnings extremities to prevent and reduce complications in serious cold-induced injury, including full
are located in the main text, are preceded Start /Stop the therapy session. of poor circulation. This includes: thickness skin necrosis:
by a Caution or Warning statement and are • Deep vein thrombosis
accompanied by this symbol in the left margin. • Pathologic sensitivity to cold
• Chronic venous insufficiency
Dynamic compression therapy enable function. • Behaviors that negatively affect circulation,
• Venous stasis ulcers
including poor nutritional status, smoking
• Post-mastectomy edema and chronic
Symbol ISO 7010-M002: refer to the Users and tobacco use, excessive caffeine use, and
Manual for instructions for product usage. Sequential compression therapy enable lymphedema
excessive alcohol use
function. • Reduction of edema associated with soft tissue
• Cold application area desensitization due to
injuries such as burns, postoperative edema,
Follow local governing ordinances and recy- local anesthesia or regional nerve block
This device is offered for sale by or on the and ligament sprains
order of a licenced healthcare practitioner. Use cling plans regarding disposal or recycling of • Taking medications that have a negative effect
• Localized cold therapy for post-traumatic
only as prescribed. device components. If unclear, please refer to on peripheral vascular circulation, including
and post-surgical medical and/or surgical
Breg for proper disposition of this product. beta adrenergic blockers and local epinephrine
conditions
use (such as in local anesthetics)
Medical Device Safety Symbol IEC 60417-5333: • Aid in blood flow back to the heart
Type BF Applied part complying with IEC Manufactured by Breg, Inc. • Treatment and assistance in healing of
If the risk of cold-induced injury outweighs
60601-1 to provide protection against electric cutaneous ulceration (wounds), reduction the benefits of cold therapy, do not prescribe
shock. The part of the device in contact with of wound healing time, enhancement of
the patient is floating from earth ground.
the VPULSE cold therapy. If you prescribe this
This product conforms to the directive 93/42 arterial circulation (blood flow), reduction
2797
EEC for medical devices. The identification
product to patients with risk factors, consider
of compartmental pressures, reduction of taking special measures to control the risk, such
number of the Notified Body is 2797.
Protected against spraying water. edema (swelling), reduction of the need for as:
anticoagulant (blood thinning) medications • Recommend more frequent skin checks.
Date of manufacture, year XXXX, week YY. • Require more frequent follow-up examinations.
Medical Device Symbol IEC 60417-5031: The
product operates from direct current.
Contraindications: Cold Therapy • Use an insulation barrier between the pad and
skin.
Single patient multiple use. • Prescribe shorter durations of application, less
Medical professionals and patients should be
Medical Device Symbol IEC 60417-5172: Class aware of situations where cold therapy may frequent application, or eliminate nighttime
II Equipment. not be appropriate, detrimental to a specific application.
condition or otherwise contraindicated for use, The VPULSE can be cold enough to cause
including patients with: serious injury including full skin necrosis.
Medical Device Symbol IEC 60417-5570: • Diabetes
Unlocking, Handle.
• Cold uticaria Excessive moisture at the application site due
• Cryoglobulinemia to excessive bleeding, sweating, or condensation
Medical Device Symbol IEC 60417-5569: • Raynaud’s syndrome may increase the risk of serious cold-induced
Locking, Handle. • Proximal cold hemoglobinuria injury, including full thickness necrosis.
• Vasospastic disease
• Cold hypersensitivity Inspect the skin under the cold therapy pad
Minimum water reservoir fill line. Step 1 of • Compromised local circulation (by lifting the edge) as prescribed, typically
filling the water reservoir. • History of cold injury, frostbite, or adverse every 1 to 2 hours. Do not use VPULSE cold
reactions to local cold application therapy if dressing, wrapping, bracing or
Maximum ice reservoir fill line. Step 2 of filling • Patients who are incoherent due to general casting over the cold therapy pad prevents skin
the water reservoir. Note that either ice or anesthesia, sedation, or coma checks. Stop using and contact your practitioner
the VPULSE Ice Bottles can be used for cold • Local tissue infection immediately if you experience any adverse
therapy. • Hand/wrist or feet/ankle surgery with reactions, such as: increased pain, burning,
polyneuropathy increased swelling, itching, blisters, increased
redness, discoloration, welts, other changes in
skin appearance, or any other reaction identified
by your practitioner
4 of 23 5 of 23Be aware of any nerve irritation and/or Warnings: Compression Patients should take caution in applying 3. Prescription. Instruct the patient regarding
muscular reaction that are associated with skin Therapy therapy pads over open sores and abrasions. At the licensed healthcare practitioner’s
sensitivity and irritation. If observed, discontinue a minimum, these areas should be cleaned and prescribed protocol: frequency and duration
therapy until the cause is determined. If patient experiences pain, swelling, of use and length of breaks between uses,
sensation changes or any unusual reactions bandaged.
how and when to inspect the skin, and total
DO NOT operate without water in the while using the compression therapy, they are length of treatment. The duration of acyclic
to stop using the therapy and consult their As with all prescription medical devices,
system. Doing so may damage your system and failure to follow product instructions or adjusting application may vary depending upon the
void the product warranty. medical professional immediately. patient. If the patient does not experience
setting and performing therapy applications
Special attention should be given to those without the express direction and/or supervision pain relief, the physician may increase the
Contraindications: Compression patients with neuropathies or tissue viability of your trained health care provider may lead to duration of cold therapy application. As
problems (i.e. diabetes, arterial or venous improper product performance and the potential the application duration is increased, the
Therapy insufficiencies). for serious injury. For medical questions, please frequency of the skin inspections should
Patients with the following conditions should consult your health care provider. increase.
If pulsations or throbbing occur, the
NOT USE Intermittent Pneumatic Compression cuff may be wrapped too tightly. Loosen 4. P
otential for Injury. Inform the patient
Therapy: Immediately. Use only according to your practitioner’s that improper use can result in serious skin
• Presumptive evidence of congestive heart instructions regarding the frequency and injury, including full thickness skin necrosis.
To prevent extremity compartment duration of application and length of breaks
failure Emphasize the importance of following the
syndrome, special attention should be given between uses, how and when to inspect the
• Suspected/observed pre-existing deep vein prescribed protocol, proper pad application,
to patients who are positioned in the supine skin, and total length of treatment. Do not
thrombosis or pulmonary embolism and skin inspection.
lithotomy position for extended lengths of use this device if you did not receive or do not
• Suspected/observed deep acute venal time. This includes patients with or without 5. P
roper Pad Application. Instruct the patient
thrombosis (phlebothrombosis) understand the instructions.
cuffs. to use only the Breg VPULSE Cold Therapy
• Suspected/observed inflammatory phlebitis Pads designed for the body part being
process Patients should not walk with tubing DO NOT wrap the therapy pads as to
treated; other pads may be colder, increasing
• Suspected/observed pulmonary edema connected to cuffs. restrict blood or fluid flow. Regularly check the
the risk of serious cold-induced injury,
• Suspected /observed pulmonary embolism therapy area.
Cuffs used in combination with warming including full thickness skin necrosis. Do not
• Suspected/observed acute inflammations of devices may cause skin irritation. Regularly cover the VPULSE Cold Therapy Pad with
the veins (thrombophlebitis) DO NOT place a cast over a pad. Casting
check for patent discomfort, compliance, and dressing, wrapping, bracing or casting that
• Suspected/observed decompensated cardiac over the pad and tubing set may restrict
skin irritation. prevents the patient from checking the skin
insufficiency necessary air circulation and proper operation.
under the pad.
• Suspected/observed arterial dysregulation Close supervision is necessary when
this appliance is used by unconscious or 6. S
kin Inspection. Instruct the patient to
• Suspected/observed erysipelas
incapacitated patients and those with poor
Medical Professional Patient inspect the skin receiving cold treatment per
• Suspected/observed carcinoma and carcinoma
metastasis in the affected extremity circulation. Discharge Protocol the practitioner’s instructions, typically every
• Suspected/observed decompensated 1 to 2 hours. If dressing, wrapping, bracing,
When using this system, regularly check Follow this protocol prior to discharging the or casting over the VPULSE Cold Therapy Pad
hypertonia patient from facility care to home use
the skin where the pads are applied as prevents the ability of the patient to perform
• Suspected/observed acute inflammatory skin
prescribed. 1. Patient Screen. Screen the patient for any skin checks under the pad regularly, do not
diseases or infection
contraindications and/or applicable warnings. dispense Breg VPULSE Cold Therapy to the
• Suspected/observed venous or arterial Warnings: Cold and If the patient has anycontraindications, do not patient.
occlusive disease
• Determined venous and lymphatic return is Compression Therapies dispense the Breg VPULSE to the patient. 7. D
iscontinue. Instruct the patient to stop
undesirable Patients with any of the following cogni- If any of the warnings apply to the patient, using Breg VPULSE and contact his/her
• Suspected/observed Raynaud’s Disease tive risk factors should only use VPULSE under determine the appropriateness of application licensed health care practitioner immediately
• Suspected/observed poor peripheral direct supervision of a medical professional of the VPULSE to that patient. if they experience any adverse reactions,
circulation or the direct supervision of a caretaker, if pre- 2. Instructions for Use. Instruct the patient on such as: increased pain, burning, increased
• Suspected/observed hypersensitivity to cold scribed by a medical professional: how to properly use the Breg VPULSE. Review swelling, itching, blisters, increased redness,
• Medical situations where increased venous and the Operating Instructions in this document discoloration, welts, or other changes in skin
• Young children and elderly
lymphatic return is undesirable and affixed to the unit with each patient. appearance.
• Cognitive disabilities
• Leg gangrene
• Communication barriers 8. D
ocumentation. Provide the patient a
• Recent skin graft
• Use of medications that have a negative prescription for the duration of the total
• Extremity containing a fracture
effect upon mental capacity treatment period, the frequency and duration
• Extremities that are not sensitive to pain
of individual treatment sessions, and the
If patient has any of the cognitive risk factors,
frequency of skin inspections
above, medical professional or caretaker
should provide skin checks.
6 of 23 7 of 23System Operation Operating Instructions
The VPULSE consists of a container, tubing set Using the System with Ice and Water
and a family of single-patient application pads.
The pads are applied to the body to deliver three Every VPULSE is quality tested before being sold. When un-packing your new system, it is
different and important therapeutic treatments. normal to find moisture in the VPULSE water reservoir due to the testing.
There are two types of pads to deliver three
different therapies: DO NOT overfill.
• The patient can apply (1) or (2) sequential DO NOT operate without water.
compression therapy pad(s) to the calves for
preventative treatment of venous thrombo- DO NOT operate with hot water.
embolism.
And/Or
• The patient can apply (1) thermal-compression 1 2
pad to a specific body part such as the knee
or shoulder for cold therapy and/or dynamic Remove the two Pour cold
compression therapy to manage pain and Ice Bottles from water into the
swelling for post-operative recovery the container. container to
the “WATER”
The container contains: level indication
• An air pump and reservoir for inflating portions on the inside of
of each pad; the container.
• 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 3 4
therapies to use and start the treatment session.
Pour ice water into Place the lid onto
Pressurized air and/or cooled water is circulated the container until the container and
through the tubing set from the container to even with the “ICE” turn clockwise until
the pads. The air pressure is cycled until the level indication on the handle clicks into
therapy session is stopped by the patient. the inside of the position.
container.
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.
8 of 23 9 of 23Operating Instructions Operating Instructions
Using the System with Ice Bottles Applying Therapy Wraps and Pads
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. 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
1. Fill the Ice Bottle with tap water. Freeze the 2. P
lace the frozen Ice Bottle into the container.
injury.
filled Ice Bottle for a minimum of 6 hours in any Make sure water is already in the VPULSE unit
household freezer to ensure maximum cold up to the water line. For longer duration of Apply the Sequential Compression Therapy pads to the patient’s calves.
therapy. sustained cold water temperature, add ice in
addition to the Ice Bottle to the water reservoir
The time the Ice Bottle will stay frozen is (as desired). Only fill the Ice Bottles with water.
approximately 2 to 6 hours. Use additional Ice
Bottles for longer treatment. To order additional Ice Bottles please call
1.800.321.0607 or 1.760.795.5440.
Fill Ice Bottles with water only
1 2 1 2 3
Remove the two Ice Fill Ice Bottles Center the pad behind the Wrap one side of the pad, as Secure by wrapping the 3 “fingers” in the
Bottles from the with water. patient’s calf. shown, around the front of the order shown around to the front. Apply
container. patient’s leg. pads to both calves. Adjust so snug. Do not
over tighten.
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.)
3 4
Freeze Ice Pour cold
Bottles. water into the
container to the
“WATER” level
indication on
the inside of the
container.
4 5
Center the pad over the patient’s knee with the Wrap straps around the knee to secure the pad.
connector pointing down.
Attach the Container to the pads via the tubing set.
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.
5 6
Place the two Ice Bot- Place the lid onto
tles into the container. the container and
turn clockwise until
the handle clicks into
position.
6 7
Attach the container to the pads using the Plug the container into a grounded AC outlet.
corresponding colored connectors as shown. The
connectors make a “click” sound when fastened
properly.
10 of 23 11 of 23Operating Instructions Alarms
Using the Start/Stop button to start, change, pause or stop therapies. 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.
Press the button of the desired therapy or combination of therapies. The buttons selected will be To stop an alarm, press the function key that is flashing.
illuminated.
Cold Therapy may alarm if: To resolve:
• Too low or too high a • Check the tube connection at the
therapy temperature may be container and at the cold-compression pad.
detected by the system.
• Ensure appropriate ice or water level.
• Activate the cold therapy and press start. If
the issue is not resolved, press the cold
Cold Only Dynamic Compression Only Sequential Compression (Calf) therapy button to deactivate.
Pad Only
Push the Start/Stop button to begin. • 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 To resolve:
alarm if:
• Check the tube connection at the container
• The time to inflate the pad is and at the cold-compression pad.
too short or too long.
Start/Stop • Make sure the cold-compression therapy
pads are properly applied to the body and
connected properly.
To add therapy, first press Start/Stop button, select the therapy button and press the Start/Stop
button again to continue. • Press dynamic compression and then
press the Start/Stop button. If the issue
To Pause or Discontinue Use. is not resolved, contact Customer Care for
further instructions.
Sequential Compression may To resolve:
alarm if:
• Make sure the sequential compression
• The time to inflate the pad is therapy pads are properly applied to the
too short or too long. 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.
Press the Start/Stop Disconnect by Remove the Sequential
button to stop. depressing the Compression Therapy pads and
side buttons of the Thermal-Compression pad. Should the system fail to restart after an alarm has sounded and the stated resolutions have not reset
connectors. the System, contact Customer Care at Breg, 1.800.321.0607 or 1.760.795.5440 for further assistance.
12 of 23 13 of 23Alerts Troubleshooting
Frequently asked questions in • Make sure no foreign objects are blocking the
troubleshooting the VPULSE: fluid connectors.
• Check that the front panel keys illuminate
1. What should I do if the VPULSE does not when pressed.
seem to get cold? • Check that the Start/Stop key ( )
Flashing GREEN To resolve:
illuminates GREEN when pressed.
• Check the inside and outside of the water
• The Stop/Start button will flash • This may occur after power disruption or reservoir for cracks, punctures or other signs 4. What should I do if the system is not pumping
when the system is initializing. after the system was improperly shut of damage. If damage is noted, please contact water through the pad?
down. Customer Care at Breg, 1.800.321.0607 or • Check power connection.
1.760.795.5440. • Check that the tubing set is properly
• Make sure that the water container is properly connected.
filled with water. • Check that the pads are properly connected.
DO NOT operate the system with a water • Check that the water reservoir is properly
container not filled with water or not filled with cold water.
filled to the MINIMUM fill line, before • Check that the Cold Therapy button has been
ice or Ice Bottles are added. selected and the function illuminates WHITE.
• Check that the Start/Stop key ( )
DO NOT operate the system with a illuminates GREEN when pressed.
water container filled with water above • Check that the tubing is not kinked.
the MAXIMUM fill line, or with a tubing • Start the system to ensure that the water
Dynamic Compression and To resolve: set not properly connected. is flowing into the water reservoir. A return
Sequential Compression keys stream is visible inside water reservoir.
• Check that enough ice is added to the water
Solid RED • The SD card is not properly installed, the
container and that the tubing is not kinked. 5. What should I do if the system is not pumping
card is full or faulty. Remove or reinstall
• Check the power connection. any air through the pad?
the card. If this condition persists contact
Customer Care. • Check power connection.
2. What should I do if the tubing set does not • Check that the tubing set is properly
connect to the VPULSE or pad? connected.
• Cold Therapy is still active during this • Check the tubing set and connectors for
condition. • Check that the pads are properly connected.
cracks, punctures or other signs of damage. If • Check that the front panel keys illuminate
damage is noted, contact Customer Care at when pressed and that a compression therapy
Breg, 1.800.321.0607 or 1.760.795.5440. is selected. If the compression keys are both
• Make sure the correct connectors are mating. continuously illuminated RED and VIOLET the
Check the color and number of connections. air pump might not be providing sufficient
• Make sure no foreign objects are blocking the pressure.
fluid connectors. • If compression keys are both continuously
Dynamic Compression VIOLET To resolve: illuminated RED, the DATA card may not be
and Sequential Compression 3. What should I do if the system does not turn installed, the card may be full, or experiencing
RED • The air pump is not achieving pressure, on? a problem. Open the DATA door and reinstall
contact Customer Care • Check wall adapter power connection at the the DATA card.
wall. • Check that the Start/Stop key ( )
• Check the outlet to ensure it is properly illuminates GREEN when pressed.
powered. • Check that pad is inflating.
• Check wall adapter is connected at back of the • Check the dynamic or sequential therapy mode
Control Unit. is enabled.
Refer to Breg Customer Care, 1.800.321.0607 or 1.760.795.5440 if
these actions are ineffective.
14 of 23 15 of 23Cleaning your VPULSE Storage Warranty
To clean your VPULSE, please follow these simple Breg, Inc. warrants that this product is free from defects in workmanship, materials,
steps: 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.
1. Remove electrical cord. Breg, Inc.’s obligation under this warranty is limited to the replacement or repair of any
2. Fill the empty water container to the MAX fill defective part or parts of this product. All expressed or implied warranties, including
line with fresh, room temperature water. DO the warranty of merchantability and fitness for a particular purpose, are limited to the
NOT USE ANY CLEANING SOLUTIONS IN THE actual warranty period set forth above. No other warranty, express or implied, is given
WATER RESERVOIR AS THESE SOLUTIONS
and no affirmation of or by seller, by words or action, will constitute a warranty.
COULD DAMAGE THE WATER PUMP AND 1
THERAPY PADS.
Remove water from the Thermal-Compression pad by
3. Replace the handle and connect power.
Connect all pads and enable all functions.
rolling the pad up while still connected and squeezing General Safety DO NOT kink or sharply bend the tubing
the water back into the Container. set. Doing so may damage the system and
4. Operate the system for 10 minutes. This section is used to highlight certain operating compromise the function.
5. Empty the water reservoir. procedures and recommendations. Important
6. Repeat these actions periodically. Safety Instructions / Read all instructions before Use this appliance only for its intended
using. use as described in this manual. DO NOT
Please use only the following cleaning agents use attachments not recommended by the
when cleaning the outside of your VPULSE The device should never be left unattended manufacturer. DO NOT use attachments from
system: warm water with mild detergent, Lysol©, when plugged in. Unplug from outlet when not other manufacturers. Connecting parts not
70% isopropyl alcohol, Cidex©, or 10% bleach in use and before putting on or taking off parts. supplied by Breg will void the warranty and may
solution. No modification of this equipment is cause damage to the system and potential injury
allowed. to the patient.
Patients should not use cleaning or
decontamination methods different from those Ensure the handle of the device is properly
DO NOT use around flammable materials.
recommended by the manufacturer without installed and fully engaged prior to carrying the
first checking with the manufacturer that 2
Close supervision is necessary when this system. For proper use, please reference the
the proposed methods will not damage the Remove the Ice Bottles from the unit. Separate the handle locking and unlocking icons.
appliance is used near pets
equipment. bottles and pour the water out, air dry.
The VPULSE pads are supplied non-sterile. Use proper precautions in carrying the
Care and Maintenance DO NOT sterilize these pads. Doing so may device to avoid injury.
• DO NOT store the pad in its shipping bag. The compromise the functionality of the pad(s) and
may result in possible patient injury. DO NOT carry this appliance by the supply
shipping bag may trap the moisture remaining
cord or use the supply cord as a handle.
in the pad.
• Store the VPULSE unit in a safe, cool and dry All VPULSE pads are intended for single
patient use and NOT intended for reuse or to be When setting up the system, route the
place when not in use.
washed or cleaned. Doing so may compromise supply cord and tubing set to avoid tripping and
• Ensure the water container is empty of water
the functionality of the pad(s) and may result in to encourage ease of walking around the device.
and dry to avoid bacterial growth and
contamination. possible patient injury.
DO NOT carry this appliance by the tubing
• Wipe down the device with a soft, damp cloth.
DO NOT lay on top of the pad connectors. set or use the tubing set as a handle.
DO NOT use abrasive cleaner. NEVER immerse 3 Doing so may result in patient injury.
the unit into any liquid.
Dump the water out of the side Control Unit so that the Keep the tubing set, the device and pads
• Keep away from all solvents and harsh deter- control buttons and other electrical components DO NOT use pins or sharp objects to away from heated surfaces.
gents. Please refer to cleaning instructions stay dry. When empty, let the unit “air dry” completely.
prior to cleaning your VPULSE. secure the therapy pads or hoses. Doing so may
damage the system and compromise function. Never operate the appliance without the
• DO NOT attempt to repair the VPULSE. There For long term storage, please use the shipping
handle, the tubing set, and the pad(s) completely
are no patient-serviceable parts. Repair of the materials and container supplied with the VPULSE.
The device is intended for single patient connected.
system by an unauthorized person may void
the product warranty. multiple use.
Never operate the appliance with any foreign
• To store, disconnect the electrical cord, the Lysol® is a registered trademark of Reckitt Benckiser Inc. objects (other than ice or Ice Bottles provided) in
tubing set and the pad. Cidex® is a registered trademark of Johnson & Johnson Corp.
the water reservoir.
16 of 23 . 17 of 23Never drop or insert any object into any Essential Performance and external antennas) should be used no closer
opening that 30 cm (12 inches) to any part of the VPULSE
This device contains Essential Performance per including cables specified by the manufacturer.
Excessive lint or dust may impede the flow IEC 60601-1, Edition 3.2 and IEC 60601-1-2, Otherwise, degradation of the performance of
of water through the system. To minimize this Edition 4.1 this equipment could result.
occurrence, keep the handle properly installed
and fully engaged when not filling or emptying The VPULSE system notifies the user through DANGER – TO REDUCE THE RISK OF
the device. audible/visual alarms when the sequential ELECTRICAL SHOCK, DO NOT DISASSEMBLE
therapy mode ceases to function or delivers a THE UNIT. REFER SERVICING TO THE
DO NOT stand on or in the appliance. pressure out of the specified range. MANUFACTURER:
1. Always unplug this appliance from the
DO NOT place the appliance or operate the Environmental Conditions
electrical outlet immediately after using and
appliance while it is on a surface more than 1 foot before cleaning.
above the floor. This device has been tested and found to
comply with the environmental conditions 2. DO NOT use while bathing or in a shower.
Unplug this product before filling or for Medical Devices according to IEC 3. DO NOT place or store appliance where it can
cleaning. Fill with water and ice or water and Ice 60601-1-2:2014+AMD1:2020 and IEC fall or be pulled into a tub or sink. DO NOT
Bottles provided by Breg only. DO NOT use any 60601-1-6:2010+AMD1:2013+AMD2:2020. place in or drop into water or other liquid.
Ice Bottles other than those provided by Breg. These conditions are designed to provide
reasonable environmental operating ranges 4. DO NOT reach for a product that has fallen
for the equipment. Extreme changes in into water. Unplug immediately.
`DO NOT place the tubing set, power cord
or use any pad around the neck to avoid the the environmental conditions or operating
outside the specific operating ranges, such as Only use the power supply provided with the
possibility of strangulation. unit. Failure to do this could damage the unit,
temperatures, pressure and humidity, may impact
Electrical Safety the performance of this device. The user can try power supply, and/or create a potential injury to
to correct these conditions by relocating this the patient. Please contact Breg Customer Care if
When using an electrical appliance, especially a replacement wall adapter is required.
when children are present, basic safety device to a more moderate environment.
precautions should always be followed. Interference From Other Products Never operate this appliance if it has a
Electromagnetic Interference If this equipment is interfered with by other damaged cord, plug or wall adapter, if it is not
This device has been tested and found to devices, which can be determined by turning that working properly, if it has been dropped or
comply with the limits for Medical Devices equipment off and on, the user can try to correct damaged, or dropped into water.
according to IEC 60601-1-2:2014+AMD1:2020. the interference by one or more of the following
These limits are designed to provide measures: Keep the power cord away from heated
reasonable protection against harmful • Reorient or relocate this device. surfaces.
interference in typical medical installations. • Increase the physical separation between this
This equipment generates and radiates radio device and the other devices(s).
frequency energy and, if not installed and used
Electromagnetic Interference and Emissions
in accordance with the instructions, may cause
harmful interference to other devices in the Use of this equipment adjacent to or
vicinity. There is no guarantee that interference stacked with other equipment should be
does cause harmful occurrence in a particular avoided because it could result in improper
installation. operation.
If this equipment does cause harmful
Use of accessories, transducers and cables
interference to other devices, which can be
other than those specified or provided by the
determined by turning the equipment off and
manufacturer of this equipment could result
on, the user can try to correct the interference
in increased electromagnetic emissions or
by one or more of the following measures:
decreased electromagnetic immunity of this
• Reorient or relocate this device.
equipment and result in improper operation.
• Increase the physical separation between this
device and the other devices(s). Portable RF communications equipment
• Connect the equipment into an outlet or (including peripherals such as antenna cables
circuit different from the one where the other
device(s) are connected.
18 of 23 19 of 23A brief summary of the tests carried out in accordance with IEC 60601-1-2:2014+AMD1:2020 is
Specifications shown below.
MODEL VPULSE, C00001 Wall Adapter UE24WCP1-120200SPA The VPULSE is suitable for use in the specified electromagnetic environment. The consumer and/or user of the VPULSE
Input 100-240Vac, 800μA max should ensure that it is used in an electromagnetic environment as described below:
PHYSICAL 9.8” x 14.3” x 11.25” Frequency 50/60Hz Emissions Test Compliance Electromagnetic Environment Guidance
Size (approximately) (249mm x 364mm x 286mm) Output 12VDC, 2.08A
RF Emissions Group 1 The VPULSE uses RF energy only for its internal function. Therefore,
Weight (dry) 5 lbs. (2.27 kg) CISPR 11 its RF emissions are very low and are not likely to cause interference
Dual Tubing Set 10 ft. (2.4m) in nearby electronic equipment.
OPERATING 525 to 795 mmHg RF Emissions Class B
CONTROLS Keypad interface ENVIRONMENT (700hPa – 1060hPa) CISPR 11 The VPULSE is suitable for use in all establishments, including
Atmospheric Pressure 15% to 93% relative non- Harmonic Emissions Class B domestic establishments and those directly connected to the public
THERMAL SYSTEM 42°F minimum (5.5°C ) condensing IEC 61000-3-2 low-voltage power supply network that supplies buildings used for
Operating limit Ice or frozen Ice Bottles Humidity 41°F – 104°F (5°C – 40°C) Voltage fluctuations / flicker emissions Complies domestic purposes.
Operating period will last for 2-6 hours IEC 61000-3-3
Temperature
Circulating System Submersible pump Immunity Test IEC 60601-1-2 Electromagnetic Environment Guidance
Reservoir Capacity 1.2 gallons (4.4 liters) TRANSPORT & STORAGE Test Level
Reservoir Fluid water ENVIRONMENT Portable and mobile RF communications equipment should be
Water Flow Rate 3.2 gph (12 lph) typical Atmospheric Pressure 179 to 795 mmHg Conducted Disturbances 3V
used no closer to any part of the VPULSE, including cables, than the
(240hPa – 1060hPa) induced by RF Fields 0.15MHz – 80MHz
recommended separation distance calculated from the equation
PNEUMATIC SYSTEM Humidity up to 93% IEC 61000-4-6 6V in ISM & amateur radio
appropriate for the frequency of the transmitter.
50mmHg (6.6kPa) ± 10% Temperature -13°F – 158°F (-25°C – bands between 0.15Mz –
Dynamic Compression
80MHz
peak pressure 70°C) Recommended Separation Distance
80% AM at 1kHz
Sequential Compression 60mmHg (8.0kPa) ± 10% d=1,2√P
peak pressure d=1,2√P 80 MHz to 800 MHz
Expected Service Life: d=2,3√P 800MHz to 2,5 GHz
ELECTRICAL SYSTEM 300 hours from date of
where P is the maximum output power rating of the transmitter in
first use.
watts (W) according to the transmitter manufacturer and is the
System recommended separation distance in metres (m).
Voltage TPU Polyether bladder, REGULATORY
Frequency Polyurethane foam with Classification Class II Equipment Radiated RF EM fields 10 V/m
Field strengths from fixed RF transmitters, as determined by an
Power 100% Polyester fabric Type of Equipment Type BF IEC 61000-4-3 80 MHz – 2.7 GHz
electromagnetic site survey (a), should be less than the compliance
Leakage Current lamination 80% AM at 1 kHz
level in each frequency range (b).
REGULATORY IEC 60601-1, Edition
APPROVALS 3.2 Medical electrical Interference may occur in the vicinity of equipment marked with the
equipment - Part 1: following symbol:
PVC plastic bladder, Polyu- General requirements for
rethane foam with 100% basic safety and essential
Polyester fabric lamination performance.
The VPULSE is suitable for use in the specified electromagnetic environment. The user of the VPULSE should ensure that
CAN/CSA-C22,2 no it is used in an electromagnetic environment as described below:
60601-
1-08 (R2008): Medical
12VDC, 100-240Vac Electrical Equipment Part1: Immunity Test IEC 60601-1-2 Electromagnetic Environment Guidance
50/60Hz General Requirements Test Level
15W max for Medical Electrical Electrostatic ± 8 kV contact Floors should be wood, concrete, or ceramic tile. If floors are
300μA max Equipment. discharge (ESD) ± 2 kV, ± 4 kV, ± 8 kV, ± 15 covered with synthetic material, the relative humidity should be at
kV air least 30%.
IEC 61000-4-2
IEC 60601-1-
2:2014+AMD1:2020 Electrical fast
edition 4.1 Medical ± 2 kV
transient/burst Main power quality should be that of a typical commercial and/or
electrical equipment 100 kHz repetition frequency
hospital environment.
- Part 1-2: General IEC 61000-4-4
requirements for basic
safety and essential ± 0,5 kV, ± 1 kV
Surges (line to line)
performance - Collateral IEC 61000-4-5 Main power quality should be that of a typical commercial and/or
Standard: Electromagnetic hospital environment.
disturbances -
Requirements and tests.
Proximity Fields from RF Reference IEC 60601-1-
VPULSE is a trademark of Wireless Communica- 2:2014+AMD1:2020 table 9
Breg, Inc. tions Equipment
IEC 61000-4-3
20 of 23 21 of 23Voltage Dips and Fluctua-
tions
0% for ½-cycle at 0°, 45°,
90°, 135°, 180°, 225°, 270°,
Main power quality should be that of a typical commercial and/or
hospital environment. If the user of the VPULSE requires continued
Catalog Items
and 315° operation during power main interruptions, it is recommended that
IEC 61000-4-11
0% for 1-cycle and 70% for the VPULSE be powered from an uninterruptible power supply or a To order additional items from Breg, please refer to the following items:
25 cycles at 0° battery.
If improper operation occurs, it may be necessary to position the
VPULSE further from sources of power frequency magnetic fields or to Catalog Item Description
install magnetic shielding. The power frequency magnetic field should
be measured in the intended installation location to ensure that it is
C00001 Breg VPULSE w/o Pads
sufficiently low.
C00002 Breg VPULSE with Sequential Compression Pad (2)
C00003 Breg Cold/Compression Pad, Knee, L
Voltage Interruptions 0% for 250 cycles C00004 Breg Cold/Compression Pad, Shoulder
IEC 61000-4-11
C00005 Breg Cold/Compression Pad, Foot/Ankle
C00013 Breg Cold/Compression Pad, Hip
C00016 Breg Cold/Compression Pad, Universal
C00017 Breg Cold/Compression Pad, Knee
Rated Power Frequency
C00020 Breg Cold/Compression Pad, Back
30 A/m
Magnetic Fields 50Hz
IEC 61000-4-8
Accessories
C00006 Breg VPULSE Sequential Compression Pad set (2x)
IMMUNITY TEST LEVELS TO DISTURBANCES FROM PROXIMITY MAGNETIC FIELDS
Proximity Magnetic Fields C00007 Breg VPULSE Spare Ice Bottle Set
IEC 61000-4-39 C00008
Test Frequency Modulation Immunity Test Level (A/m) Breg VPULSE 12VDC-24W Wall Adapter
C00009 Breg VPULSE Thermal/Compression Tubing Set
C00010 Breg VPULSE Sequential Compression Tubing Set
30 kHz CW 8
C00018 Breg VPULSE Complete Tubing set
Pulse modulation1 C00024 Breg VPULSE Power Extension Cable
134.2 kHz 2.1 kHz 65
Pulse modulation1
13.56 MHz 50kHz 7.5
¹Modulate carrier using 50% duty cycle square wave. Immunity test levels specified as RMS before modulation is ap-
plied.
22 of 23 23 of 23Manuel d’utilisation
Breg, Inc. Scannez le QR-code
2885 Loker Ave. East pour accéder à la vidéo
Carlsbad, CA, États-Unis de démonstration
(800) 321-0607 (760) 795-5440
www.breg.com www.breg.com/vp
2797
1 sur 23Présentation Table des matières
Le VPULSE® de Breg offre une combinaison unique de traitements de prévention et de rééducation : Symboles 4
• Thérapie par compression séquentielle intermittente pour aider à prévenir la thrombose veineuse acquise Indications, contre-indications et avertissements 5
en milieu hospitalier.
Protocole de sortie du patient pour le personnel médical 7
• Thérapie par compression dynamique intermittente pour aider à réduire les enflures.
Fonctionnement du système 8
• Traitement par le froid contrôlé pour réduire l’inconfort et les enflures.
Instructions d’utilisation
Conçu pour assurer la continuité des soins de l’hôpital, du centre de chirurgie et de la clinique à l’auto- • Utilisation du système avec des glaçons et de l’eau 9
traitement à domicile, le VPULSE aide les patients à suivre les consignes post-opératoires.
• Utilisation du système avec les bouteilles 10
• Application des compresses et coussinets de thérapie 11
• Utilisation des boutons Marche/Arrêt 12
Contenu de l’emballage • Alarmes 13
• Alertes 14
Couvercle
Guide de dépannage 15
Nettoyage, entretien et maintenance 16
Garantie 17
Sécurité générale 17
Jeu de tubes
Réservoir Orifice pour la carte Sécurité électrique 18
de données
Spécifications 19
Articles du catalogue 22
Transformateur/Cordon
d’alimentation
Mode d’emploi
2 bouteilles
(rangées/expédiées
à l’intérieur du
réservoir)
2 coussinets de thérapie par compression séquentielle VPULSE MISE EN GARDE : La loi fédérale américaine n’autorise la vente de ce dispositif
(Disponible avec l’ensemble C00002 uniquement)
Bouteilles
que par un professionnel de santé agréé ou sur ordonnance de ce dernier.
2 sur 23 3 sur 23Symboles Indications Avertissements : Traitement par
Le symbole Mise en garde ou Avertissement Traitement par le froid activé. Le VPULSE est conçu pour fonctionner comme
le froid
précède une étape opérationnelle qui pourrait
un dispositif de compression externe intermittent Si le patient présente l’un des facteurs de
nuire à l’utilisateur ou endommager l’appareil
pour les membres afin de prévenir et de réduire les risque cliniques suivants, l’utilisation du traitement
si le patient ne prend pas certaines précautions. Démarrer/Arrêter la séance de thérapie.
complications d’une mauvaise circulation sanguine. par le froid peut entraîner des blessures graves
Les mises en garde ou les avertissements sont
indiqués dans le texte principal, sont précédés
Par exemple : causées par le froid, notamment une nécrose
d’un énoncé et sont accompagnés de ce Thérapie par compression dynamique activée. • Thrombose veineuse profonde cutanée sur toute l’épaisseur de la peau :
symbole dans la marge de gauche. • Insuffisance veineuse chronique
• Ulcères veineux • Sensibilité pathologique au froid
• Œdème post-mastectomie et lymphœdème • Comportements qui affectent négativement la
Thérapie par compression séquentielle activée.
chronique circulation sanguine, y compris un mauvais état
Symbole ISO 7010-M002 : reportez-vous au
• Réduction des œdèmes associés à des lésions nutritionnel, le tabagisme, une consommation
Mode d’emploi pour obtenir des instructions
des tissus mous comme les brûlures, les œdèmes excessive de caféine et d’alcool
sur l’utilisation du produit. Suivez les décrets gouvernementaux et les
postopératoires et les entorses ligamentaires • Désensibilisation de la zone d’application de
programmes de recyclage de votre localité
• Traitement par le froid localisé pour les affections froid due à une anesthésie locale ou à un blocage
concernant la mise au rebut ou le recyclage
nerveux localisé
Ce dispositif est proposé à la vente par ou sur des composants du dispositif. En cas de médicales et/ou chirurgicales post-traumatiques
• Prise de médicaments qui ont un effet négatif
ordonnance d’un professionnel de santé agréé. doute, veuillez consulter Breg pour connaître et post-chirurgicales
Ne l’utilisez que selon la prescription.
sur la circulation vasculaire périphérique, y
la mise au rebut appropriée de ce produit. • Aide au retour du flux de sang vers le cœur
compris les bêtabloquants et l’utilisation locale
• Traitement et assistance à la guérison des
d’épinéphrine (comme les anesthésiques locaux)
ulcérations cutanées (plaies), réduction du
Symbole de sécurité pour dispositifs médicaux Fabriqué par Breg, Inc. temps de cicatrisation des plaies, amélioration Si le risque de blessures causées par le froid
CEI 60417-5333 : Partie appliquée de type BF de la circulation artérielle (circulation sanguine), dépasse les bienfaits de la thérapie par le froid, ne
conforme à la norme CEI 60601-1 pour fournir réduction des pressions compartimentales, prescrivez pas le traitement par le froid VPULSE. Si
une protection contre les électrocutions. La 2797
Ce produit est conforme à la directive 93/42 réduction des œdèmes (enflures), réduction du vous prescrivez ce produit à des patients présentant
partie du dispositif en contact avec le patient CEE relative aux dispositifs médicaux. besoin en médicaments anticoagulants des facteurs de risque, envisagez de prendre des
est isolée de la terre. Le numéro d’identification de l’organisme mesures spéciales pour contrôler le risque, telles que :
notifié est 2797. • Recommander des examens de la peau plus
Contre-indications : Traitement fréquents.
Protégé contre les éclaboussures.
Date de fabrication, année XXXX, semaine YY.
par le froid • Exiger des examens de suivi plus fréquents.
• Utiliser une barrière isolante entre le coussinet et
Le personnel médical et les patients doivent être la peau.
Symbole pour dispositifs médicaux CEI 60417- • Prescrire des durées d’application plus courtes,
5031 : Le produit fonctionne sur courant continu. Usage multiple réservé à un seul patient. informés des situations où le traitement par le froid
peut se révéler inapproprié, préjudiciable à une des applications moins fréquentes ou supprimer
affection spécifique ou contre-indiqué, notamment les applications nocturnes.
Symbole pour dispositifs médicaux CEI 60417- les patients souffrant des maladies suivantes : Le VPULSE peut être suffisamment froid pour
5172 : Équipement de classe II. • Diabète entraîner des blessures graves, y compris une
• Urticaire au froid nécrose cutanée complète.
• Cryoglobulinémie
L’humidité excessive au niveau de la zone
Symbole pour dispositifs médicaux CEI 60417- • Maladie de Raynaud
d’application due à un saignement excessif, à la
5570 : Déverrouillage, poignée. • Hémoglobinurie paroxystique a frigore
transpiration ou à la condensation peut augmenter
• Maladies vasospastiques
le risque de blessures graves causées par le froid, y
• Hypersensibilité au froid
compris la nécrose sur toute l’épaisseur.
Symbole pour dispositifs médicaux CEI 60417- • Anomalies de la circulation sanguine locale
5569 : Verrouillage, poignée. • Antécédents de blessures, d’engelures dues au Examinez la peau sous le coussinet de
froid ou de réactions indésirables à l’application traitement par le froid (en soulevant le bord)
locale de froid comme prescrit, en principe toutes les 1 à 2 heures.
Ligne de remplissage minimal du réservoir d’eau. • Patients incohérents en raison d’une anesthésie N’utilisez pas le traitement par le froid VPULSE si un
Étape 1 du remplissage du réservoir d’eau. générale, d’une sédation ou d’un coma pansement, enveloppement, appareillage ou plâtre
• Infection locale des tissus placé sur le coussinet de traitement par le froid
• Chirurgie de la main/du poignet ou du pied/de la empêche les examens de la peau. Cessez l’utilisation
Ligne de remplissage maximal du réservoir de et contactez immédiatement votre médecin si vous
cheville avec polyneuropathie
glace. Étape 2 du remplissage du réservoir d’eau. éprouvez des réactions indésirables, comme une
Notez que vous pouvez utiliser aussi bien des douleur accrue, une sensation de brûlure, une enflure
glaçons que les bouteilles VPULSE préalablement accrue, des démangeaisons, des ampoules, une
congelées pour le traitement par le froid. rougeur accrue, une décoloration, des marques sur la
peau, d’autres changements de l’aspect de la peau
ou toute autre réaction identifiée par votre médecin.
4 sur 23 5 sur 23Faites attention à toute irritation nerveuse et/ Avertissements : Thérapie par Les patients doivent être prudents lorsqu’ils 3. Prescription. Informez le patient du protocole
ou réaction musculaire associée à la sensibilité et à compression appliquent les coussinets de thérapie sur des plaies
ouvertes et écorchées. Au minimum, ces zones
prescrit par le professionnel de santé agréé :
fréquence et durée d’utilisation, durée des
l’irritation de la peau. Le cas échéant, interrompez le
traitement jusqu’à ce que la cause soit déterminée. Si le patient éprouve de la douleur, une enflure, doivent être nettoyées et bandées. pauses entre utilisations, comment et quand
des modifications de la sensation ou des réactions examiner la peau et durée totale du traitement.
N’utilisez PAS le système sans eau, sous peine inhabituelles lors de l’utilisation de la thérapie par Comme pour tous les dispositifs médicaux sur La durée d’application acyclique peut varier
de l’endommager et d’annuler la garantie du compression, il doit cesser d’utiliser la thérapie et ordonnance, le non-respect des instructions du en fonction du patient. Si le patient ne ressent
produit. consulter immédiatement le personnel médical. produit ou le réglage et l’exécution d’applications pas de soulagement de la douleur, le médecin
Une attention particulière doit être portée thérapeutiques sans l’ordre explicite et/ou la peut augmenter la durée de l’application du
aux patients souffrant de neuropathies ou supervision de votre fournisseur de soins de santé traitement par le froid. Au fur et à mesure que la
Contre-indications : Thérapie par de problèmes de viabilité tissulaire (diabète, qualifié peut entraîner de mauvaises performances durée d’application augmente, la fréquence des
du produit et de graves blessures potentielles. Pour examens de la peau doit augmenter.
compression insuffisance artérielle ou veineuse).
toute question d’ordre médical, veuillez consulter
En cas de pulsations ou de palpitations, il se 4. R
isque de blessures. Informez le patient qu’une
Les patients présentant les conditions suivantes ne votre fournisseur de soins de santé.
peut que le brassard soit trop serré. Desserrez mauvaise utilisation peut entraîner de graves
doivent PAS UTILISER la thérapie par compression
immédiatement. blessures cutanées, notamment une nécrose
pneumatique intermittente : N’utilisez que selon les instructions de
cutanée sur toute l’épaisseur de la peau. Insistez
• Preuve par présomptions d’insuffisance cardiaque Pour prévenir le syndrome de loges des votre médecin quant à la fréquence et la durée
sur l’importance de suivre le protocole prescrit,
congestive membres, une attention particulière doit être de l’application, la durée des pauses entre les
d’appliquer correctement le coussinet et
• Thrombose veineuse profonde ou embolie portée aux patients placés en position de lithotomie utilisations, la façon et le moment d’examiner la
d’examiner la peau.
pulmonaire préexistante suspectée/observée en décubitus dorsal pour des durées prolongées. peau et la durée totale du traitement. N’utilisez pas
Cela inclut les patients avec ou sans brassards. ce dispositif si vous n’avez pas reçu d’instructions 5. A
pplication correcte du coussinet. Indiquez
• Thrombose veineuse profonde aiguë
ou si vous ne les avez pas comprises. au patient d’utiliser uniquement les coussinets
(phlébothrombose) suspectée/observée Les patients ne doivent pas marcher avec les de traitement par le froid VPULSE de Breg
• Processus inflammatoire de la phlébite suspecté/ tubes raccordés aux brassards. N’enveloppez PAS les coussinets de conçu pour la partie du corps à traiter ; d’autres
observé
Les brassards utilisés en association avec thérapie de manière à limiter la circulation sang coussinets risquent d’être plus froids, augmentant
• Œdème pulmonaire soupçonné/observé
des appareils de chauffage peuvent provoquer ou de liquide. Vérifiez régulièrement la zone de le risque de blessures graves causées par le
• Embolie pulmonaire soupçonnée/observée
une irritation de la peau. Vérifiez régulièrement traitement. froid, notamment une nécrose cutanée sur
• Inflammations aiguës des veines
l’inconfort du patient, l’élastance et l’irritation de toute l’épaisseur de la peau. Ne couvrez pas le
(thrombophlébite) suspectées/observées
la peau. NE placez PAS de plâtre sur un coussinet. coussinet de traitement par le froid VPULSE avec
• Décompensation cardiaque soupçonnée/
Placer un plâtre sur le coussinet et le jeu de tubes un pansement, enveloppement, appareillage ou
observée Une surveillance étroite est nécessaire lorsque peut restreindre la circulation d’air nécessaire et plâtre qui empêche le patient d’examiner la peau
• Dysrégulation de la pression artérielle cet appareil est utilisé par des patients inconscients gêner le bon fonctionnement. sous le coussinet.
soupçonnée/observée ou en état d’incapacité et par des personnes ayant
• Érysipèle suspecté/observé une mauvaise circulation sanguine. 6. E
xamen de la peau. Demandez au patient
• Carcinome et métastase de carcinome dans le
Lorsque vous utilisez ce système, vérifiez
Protocole de sortie du patient d’examiner la peau qui reçoit le traitement
membre atteint suspectés/observés par le froid selon les instructions du médecin,
• Hypertonie décompensée soupçonnée/observée régulièrement l’endroit où les coussinets sont pour le personnel médical généralement toutes les 1 à 2 heures. Si un
• Maladies inflammatoires ou infectieuses aiguës appliqués sur la peau, comme indiqué. pansement, enveloppement, appareillage ou
de la peau suspectées/observées Suivez ce protocole avant de congédier le patient plâtre sur le coussinet de traitement par le
• Maladie veineuse ou artérielle occlusive Avertissements : Traitement de l’établissement de soins de santé pour une froid VPULSE empêche le patient d’examiner
suspectée/observée par le froid et thérapie par utilisation à domicile. régulièrement la peau sous le coussinet, ne
• Un retour veineux et lymphatique déterminé n’est compression 1. E
xamen du patient. Examinez le patient pour donnez pas le traitement par le froid VPULSE de
Breg à ce dernier.
pas souhaitable déceler toute contre-indication et/ou mise en
• Maladie de Raynaud suspectée/observée Les patients présentant l’un des facteurs garde applicable. Si le patient présente des
de risque cognitifs suivants ne doivent utiliser 7. Interruption. Demandez au patient de cesser
• Mauvaise circulation sanguine périphérique contre-indications, ne lui donnez pas le VPULSE d’utiliser VPULSE de Breg et de contacter
suspectée/observée le VPULSE que sous la supervision directe du de Breg. Si l’un des avertissements s’applique
personnel médical ou d’un soignant, si prescrit immédiatement son médecin agréé s’il éprouve des
• Hypersensibilité au froid suspectée/observée au patient, déterminez la pertinence de réactions indésirables comme une douleur accrue,
• Situations médicales où un retour veineux et par le personnel médical : l’application du VPULSE à ce patient. une sensation de brûlure, une enflure accrue,
lymphatique accru n’est pas souhaitable • Jeunes enfants et personnes âgées des démangeaisons, des ampoules, une rougeur
2. Instructions d’utilisation. Expliquez au patient
• Gangrène de la jambe • Déficiences cognitives accrue, une décoloration, des marques sur la peau
comment utiliser correctement le VPULSE
• Greffe de peau récente • Troubles de la communication ou d’autres changements de l’aspect de la peau.
de Breg. Passez en revue les instructions
• Membre fracturé • Prise de médicaments ayant un effet négatif d’utilisation contenues dans ce document et 8. D
ocumentation. Fournissez au patient une
• Membres insensibles à la douleur sur la capacité mentale apposées sur l’unité avec chaque patient. ordonnance contenant la durée totale du
Si le patient présente l’un des facteurs de risque traitement, la fréquence et la durée des séances
cognitifs ci-dessus, le personnel médical ou le de traitement individuelles et la fréquence des
soignant doit procéder à un examen de la peau. examens de la peau.
6 sur 23 7 sur 23You can also read
