Accuro WoundPro Apex User manual

Negative Pressure Wound Therapy
Owners and Operators Manual
Apex

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Negative Pressure Wound Therapy Owners and Operators Manual
DANGER .............................................................................................................. 4
WARNINGS.......................................................................................................... 4
ADDITIONAL PRECAUTIONS................................................................................ 4
CAUTIONS4
INTRODUCTION.................................................................................................. 5
INDICATIONS FOR USE........................................................................................ 5
CONTRAINDICATIONS FOR USE .......................................................................... 5
PATIENT RISK FACTORS/CHARACTERISTICS TO CONSIDER................................... 6
PRECAUTIONS ..................................................................................................... 7
SYSTEM COMPONENTS....................................................................................... 7
Control Unit................................................................................................ 7
Canister Sets ............................................................................................... 7
Power Supply.............................................................................................. 8
Dressing Kits ............................................................................................... 8
Clamp......................................................................................................... 8
SYSTEM FEATURES ............................................................................................... 8
Control Unit Features.................................................................................. 8
Canister Features ........................................................................................ 8
SYSTEM SPECIFICATIONS .................................................................................... 9
Electrical Specifications ............................................................................... 9
Equipment Symbols.................................................................................... 9
Environmental Conditions .......................................................................... 9
Agency Approvals ....................................................................................... 9
Electromagnetic Emissions ........................................................................ 10
Electromagnetic Immunity........................................................................ 11
SAFETY INSTRUCTIONS ..................................................................................... 13
INSTRUCTIONS FOR USE ................................................................................... 14
Initial Startup ............................................................................................ 14
Programming Changes ............................................................................. 15
Continuous Mode Programming...................................................... 15
Intermittent Mode Programming ..................................................... 15
Runtime Hours Display..................................................................... 16
Canister Changes...................................................................................... 16
Dressing Changes ..................................................................................... 17
DETAILED EXPLANATION OF KEYPAD................................................................. 19
Power Button............................................................................................ 19
Menu Button ............................................................................................ 19
Up Arrow .................................................................................................. 19
Down Arrow ............................................................................................. 19
Canister Light............................................................................................ 19
Alarm Mute............................................................................................... 19
Lock Out................................................................................................... 20
ALARMS ............................................................................................................ 20
Informational Alarms ................................................................................ 20
Low Power ....................................................................................... 20
Canister Full ..................................................................................... 20
Warning Alarms ........................................................................................ 20
Suction Line Blocked ........................................................................ 20
Vacuum Leak.................................................................................... 21
Standby............................................................................................ 21
CLEANING AND MAINTENANCE ........................................................................ 22
General Cleaning Guidelines..................................................................... 22
Cleaning Procedure .................................................................................. 22
STORAGE AND CARE ......................................................................................... 22
WARRANTY........................................................................................................ 23
Table of Contents

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Negative Pressure Wound Therapy Owners and Operators Manual
DANGER
Explosion hazard - Do not use around flammable gases.
Do not use in the presence of flammable gases.
Never drop or insert any object into the openings on the Apex control unit.
WARNINGS
Failure to observe these warnings may cause serious injury or death to the patient.
All instructions and guidelines in this manual and the dressing kits should be read and
followed.
This manual provides general guidelines for the proper use of the WoundPro® Apex NPWT
System. These guidelines do not replace instructions from the patient’s physician. Failure to
obtain and follow instructions from the treating physician could result in injury or death.
Be aware of bone fragments, hardware or staples in the wound bed. These items could
puncture the protective barrier. If the Protective barrier is punctured serious injury or death
could result.
Coming into direct contact with bodily fluids is potentially dangerous. Direct contact could
result in serious illness up to and including death. Follow universal precautions if there is any risk
of coming into contact with the contents in the Apex canister, tubing or dressing.
Do not use the WoundPro® Apex NPWT System if tamper-evident seal is broken or missing.
ADDITIONAL PRECAUTIONS
Care should be taken when using the Apex on patients taking blood thinners or platelet
aggregation inhibitors. Care should also be taken on patients with active bleeding.
Care should be taken when using the Apex on patients with wound hemostasis. Care should
also be taken on patients that have a history of irradiated blood vessels. Care should be taken
on wounds that involve a fistula. Care should also be taken on wounds with sinus tracks and
wounds with tunneling. Care should be taken when using the Apex in close proximity to
blood vessels or organs.
Care should be taken to avoid injury to the patient’s skin where it comes into contact with the
tubing from the dressing.
CAUTIONS
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
Service work is to be done by Accuro Medical authorized personnel only.
Do not immerse or spray any type of liquid directly onto the WoundPro® Apex control unit.
Instead, spray a cloth and wipe down the exterior as described in the cleaning procedure (page
21). The control unit is designed to cover all internal components; however internal components
are not sealed from liquid immersion, over-saturated wipes, or direct spray.
Interrupting Apex therapy for more than two hours may increase the presence of bacteria in
the wound bed. An increase in bacteria may raise the risk of infection. If the Apex therapy is
interrupted for more than two hours remove the old dressing, irrigate the wound, and apply a
new sterile dressing before resuming WoundPro® Apex therapy.

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Negative Pressure Wound Therapy Owners and Operators Manual
Introduction
Thank you for purchasing the WoundPro® Apex Negative Pressure Wound Therapy System
(NPWT).
The Apex offers providers various options for NPWT. We are able to do this by using the
highest quality materials and advanced electronics. The custom battery system enables the
Apex to operate on battery power for 24 hours.
Please take the time to read the contents of this manual before using the system. If you have
questions about any WoundPro®product please call 1-800-669-4757.
Indications For Use
The WoundPro®Apex Negative Pressure Wound Therapy System may promote wound healing,
through the drainage and removal of infectious material and other fluids from the wound
site using continuous and/or intermittent negative pressure. Patients with chronic, acute,
traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic
or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is
intended for use in a healthcare facility only.
Types of Wounds Indicated are:
●Diabetic/Neuropathic ulcers
●Pressure ulcers
●Chronic wounds
●Acute wounds
●Dehisced wounds
Contraindications For Use
The use of the Apex NPWT system is not recommended for patients with any malignancy of
the wound, untreated osteomyelitis, non-enteric or unexplored fistulas, and necrotic tissue
with the presence of eschar.
●The Apex NPWT system may be used after debridement of necrotic tissue and the
complete removal of eschar.
Never use the Apex NPWT system where there are exposed blood vessels, organs, or
exposed bone. Do not place the Apex dressings over anastomosis, sutured vessels, or
exposed nerves.
●In the cases of exposed blood vessels, organs or bone, they must first be covered with
a porous, non-adherent wound contact layer prior to initiating Negative Pressure to the
area.

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Patient Risk Factors/Characteristics
to Consider
Patients at high risk for bleeding and hemorrhage: Certain patients are at high risk of bleeding
complications with or without the use of the Apex NPWT System. Patients that are at an increased
risk of bleeding (which, if uncontrolled, could be potentially fatal) include the following:
●Patients with weakened or friable blood vessels or organs in or around the wound as a
result of, but not limited to:
❍Suturing of the blood vessel/organ
❍Infection – infected wounds should be monitored closely and may require more
frequent dressing changes. The treating physician should determine if Apex NPWT
needs to be discontinued and what treatment steps need to be taken.
❍Trauma
❍Radiation
●Patients without adequate wound hemostasis
●Patients on anticoagulants or platelet aggregation inhibitors
●Patients without adequate tissue coverage over vascular structures.
●Patients with Vascular Anastomosis
●Patients with Osteomyelitis
●Patients with exposed organs, vessels, nerves, tendons, ligaments
●Sharp edges in the wound (i.e. bone fragments) which could puncture protective
barriers, vessels or organs, which could lead to bleeding.
If Apex NPWT has been prescribed for patients with an increased risk for bleeding/hemorrhage,
the patient should be closely monitored by the treating physician. This device should only be
used in a healthcare facility.
If active bleeding develops suddenly or in large amounts during Apex NPWT, immediately stop
therapy (DO NOT REMOVE THE DRESSING), take appropriate measures to stop the bleeding
and seek immediate medical assistance.
800cc Canister: The 800cc canister SHOULD NOT be used on patients with a high risk
of bleeding, or on patients unable to tolerate a large loss of fluid volume. When using this
canister monitoring capability should be taken into account as well as patient risk factor. This
canister is recommended for acute care use only.
Exposed Vessels/Organs and Sharp Edges: If there are any Exposed Vessels, Organs or
Sharp Edges in the wound, they must be completely covered and protected prior to the use of
Apex NPWT. Sharp edges must either be removed or covered prior to treatment.
MRI (Magnetic Resonance Imaging): The Apex NPWT unit is MR unsafe and should never be
taken into an MRI machine. The Apex unit was not designed for this and should be considered a
fire hazard. Replace the Apex Dressing with an approved dressing for use in an MRI machine.
Hyperbaric Oxygen Therapy: The Apex NPWT unit has not been tested for Hyperbaric
Oxygen Therapy and should be considered unsafe for use with Hyperbaric Oxygen Therapy.
Never take the Apex unit into a Hyperbaric Chamber. The Apex unit was not designed for this
and should be considered a fire hazard.