SVED User Manual Rev. D

SVED
®
Wound Treatment System
USER’S MANUAL
P/N: 6702232M • Jan 2013, Rev D
SVED® System User’s Manual Rev D 1/13
CAUTION
This SVED® Wound Treatment System User’s Manual is not a guarantee or warranty. It is intended only
as an operational guide. For additional information and questions, please contact Innovative Therapies,
Inc.’s (ITI) Customer Service department at 1-866-ITI-NPWT (484-6798).
In order for the SVED® Wound Treatment System to provide safe, reliable, and proper performance,
the following conditions must be met. Failure to comply with these conditions will void all pertinent
warranties.
• All assembly, operation, adjustment, modification, maintenance, and/or repair must be carried
out only by qualified personnel authorized by ITI.
• The electrical installation of the room in which the device will be used must comply with
applicable wiring standards and electrical codes.
• The product must be used in accordance with this manual and all associated labeling and the
Instructions for Use.
Notice to Users:
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
As with any prescription medical device, failure to follow product instructions or changing
settings and performing therapy applications without the express direction and/or supervision
of a trained clinical caregiver may lead to improper product performance and the potential for
serious or fatal injury.
II
SVED® System User’s Manual Rev D 1/13
Table of Contents
INTRODUCTION_ __________________________________________________________________ 1-1
Indications________________________________________________________________________________________ 1-1
Contraindications___________________________________________________________________________________ 1-1
Precautions________________________________________________________________________________________ 1-1
Additional Precautions_ _____________________________________________________________________________ 1-1
Safety Tips_ _______________________________________________________________________________________ 1-2
Features_ _________________________________________________________________________________________ 1-3
CARE & CLEANING_ ________________________________________________________________ 2-1
Introduction_______________________________________________________________________________________ 2-1
Protective Equipment_ ______________________________________________________________________________ 2-1
Disposal_ _________________________________________________________________________________________ 2-1
Daily Care and Cleaning_____________________________________________________________________________ 2-1
Weekly Care and Cleaning____________________________________________________________________________ 2-2
AC Adapter Inspection_______________________________________________________________________________ 2-2
PATIENT CARE_____________________________________________________________________ 3-1
Applying the Dressing_______________________________________________________________________________ 3-1
Canister Installation_________________________________________________________________________________ 3-3
Canister Removal___________________________________________________________________________________ 3-4
Dressing Removal_ _________________________________________________________________________________ 3-4
Disposal of Dressings and Canister_____________________________________________________________________ 3-5
OPERATING INSTRUCTIONS_ ________________________________________________________ 4-1
Power ON/OFF_____________________________________________________________________________________ 4-1
Power-On Procedure________________________________________________________________________________ 4-1
Therapy Setting Adjustment__________________________________________________________________________ 4-2
Battery Operation_ _________________________________________________________________________________ 4-4
Alarm Operation_ __________________________________________________________________________________ 4-5
Therapy Selection Lock/Unlock________________________________________________________________________ 4-6
SPECIFICATIONS___________________________________________________________________ 5-1
Symbols_ _________________________________________________________________________________________ 5-2
REPLACEMENT PARTS_ _____________________________________________________________ 6-1
QUESTIONS & INFORMATION________________________________________________________ 7-1
APPENDIX A_______________________________________________________________________ A-I
III
SVED® System User’s Manual Rev D 1/13
1. Introduction
INDICATIONS
The SVED® Wound Treatment System is indicated for patients who would benefit from vacuum assisted
drainage with delivery of topical wound treatment solutions and suspensions over the wound bed.
Types of wounds for which the SVED® Wound Treatment System has been indicated include chronic,
acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps and grafts.
CONTRAINDICATIONS
The SVED® Wound Treatment System is contraindicated for patients with malignancy in the wound,
untreated osteomyelitis, non-enteric and unexplored fistulas, or necrotic tissue with eschar present. Do
not place the ITI Foam Dressing over exposed blood vessels or organs. The ITI Foam Dressings are also
contraindicated for hydrogen peroxide and solutions that are alcohol based or contain alcohol. It is not
recommended to deliver fluids to the thoracic cavity.
PRECAUTIONS
Precautions should be taken for patients with active bleeding, difficult wound hemostasis, or who are
on anticoagulants. When placing the ITI Foam Dressing in close proximity to blood vessels or organs,
take care to ensure that they are adequately protected with overlying fascia, tissue or other protective
barriers. Exposed tendon, nerves or blood vessels should be protected by moving available muscle
or fascia over them or by a layer of synthetic material. Greater care should be taken with respect to
weakened, irradiated or sutured blood vessels or organs. Bone fragments or sharp edges could puncture
a dressing barrier, vessel or organ. Wounds with enteric fistula require special precautions in order to
optimize therapy.
ADDITIONAL PRECAUTIONS
• Defibrillation: Remove the ITI Foam Dressing if defibrillation is required in the area of dressing
placement. Failure to remove the dressing may inhibit electrical current transmission and/or
patient resuscitation.
• Magnetic Resonance Imaging (MRI): The SVED® Wound Treatment Unit is not MRI-compatible.
Do not take into the MRI area.
• Large Canisters: Use of Large Canisters (>500ml) may increase serious risks associated with
excessive fluid loss. Monitor patient status continually. DO NOT USE for infants or other patients
with low fluid volume, nor for patients at high risk of major hemorrhage.
• Hyperbaric Oxygen Therapy (HBO): NEVER allow a device – whether on or off – inside a hyperbaric
chamber. The device must be disconnected from the patient prior to HBO treatment. Refer to the
Clinical Guidance for the Innovative Therapies Wound Treatment Systems for more information
on use with HBO therapy.
• The SVED® Wound Treatment System is intended for use with saline solutions in a physiologic pH
range that can optionally include topical wound treatment solutions.
Sec1:1
SVED® System User’s Manual Rev D 1/13
• Various topical agents, such as hydrogen peroxide, are not intended for extended tissue contact.
If in doubt about the appropriateness of using a solution with the SVED® Wound Treatment
System, contact the solution’s manufacturer.
• Do not apply solutions in conflict with the manufacturer’s instructions for use.
• During irrigation therapy, the ITI Foam Dressing is a closed system and is NOT vented to
atmosphere.
• Do not use where temperature of fluid could cause an adverse reaction, such as a change in
patient’s core body temperature.
• During irrigation therapy, the irrigation bag should be checked periodically to ensure proper
fluid delivery. In addition, when a canister fills with fluid, it should be replaced immediately as
irrigation fluid and wound exudate will not be removed from the dressing once the canister is
full.
SAFETY TIPS
KEEP THERAPY ON
The SVED® Wound Treatment System should be operated at least 22 hours out of every 24 hour period.
Remove the ITI Foam Dressing if therapy is terminated or is off for more than 2 hours in a 24-hour
period.
DRESSING CHANGES
Clean the wound per physician order prior to dressing application. Routine dressing changes should
occur every 48 to 72 hours. Dressing changes for infected wounds should be accomplished more
frequently then 48-72 hours. Always replace with sterile disposables from unopened packages. Follow
established institution protocols regarding clean versus sterile technique.
MONITORING THE WOUND
Inspect the dressing frequently to ensure that the foam is collapsed and that therapy is being
delivered in a consistent manner. Monitor periwound tissue and exudate for signs of infection or other
complications.* Extra care and attention should be given if there are any signs of possible infection or
related complications. Infection can be serious. With or without the SVED® Wound Treatment System,
infection can lead to many adverse complications including pain, discomfort, fever, gangrene, toxic
shock, septic shock, and various other complications. With signs of more serious complications of
infection, discontinue use of the SVED® Wound Treatment System until the serious infection is diagnosed
and properly treated.
DISCOMFORT / ADHERENCE
If patient complains of discomfort during dressing change, consider pre-medication, use of a nonadherent prior to foam placement or irrigation of a topical anesthetic agent such as 1% Lidocaine prior
to dressing removal.
UNSTABLE STRUCTURES
Over unstable body structures such as unstable chest wall or non-intact fascia, use the lowest pressure
setting on the SVED® Wound Treatment Unit.
Sec1:2
SVED® System User’s Manual Rev D 1/13
SPINAL CORD INJURY
In the event a patient experiences autonomic hyperreflexia (sudden elevation in blood pressure or heart
rate in response to stimulation of the sympathetic nervous system), discontinue the use of the SVED®
Wound Treatment System to help minimize sensory stimulation.
BODY CAVITY WOUNDS
Underlying structures must be covered by natural tissues or synthetic materials that form a complete
barrier between the underlying structures and the ITI Foam Dressing.
ITI FOAM DRESSING USE
The ITI Foam Dressings distributed by Innovative Therapies, Inc. are to be used exclusively with the
SVED® Wound Treatment System.
NOTE: All dressing components of the SVED® Wound Treatment System are packaged sterile. The decision
to use clean versus sterile/aseptic technique is dependent upon wound pathophysiology and physician/
clinician preference. All components of the SVED® Wound Treatment System disposable set are latex free.
Be sure to comply with all other CONTRAINDICATIONS and PRECAUTIONS for the SVED® Wound
Treatment System.
* Signs of possible infection may include fever, tenderness, redness, swelling, itching, rash, increased
warmth in the wound area, purulent discharge or a strong odor. Nausea, vomiting, diarrhea, headache,
dizziness, fainting, sore throat with swelling of the mucous membrane, disorientation, high fever (>102°F,
38.8°C), refractory hypotension, orthostatic hypotension, or erythroderma (a sunburn-like rash) may be
added signs of more serious complications of infection.
WARNING: Do not pack the ITI Foam Dressings into any areas of the wound. Forcing dressings in
a compressed manner into any wound is contrary to approved protocols.
FEATURES
Easy-to-use “One Touch” Operation – Therapy can be activated simply with the push of a single
button. Therapy level can be quickly changed by pressing one of three buttons (-70 mmHg, -120 mmHg
and -150 mmHg). Therapy settings can be locked by the caregiver (see “Therapy Selection Lock/Unlock”
Section). Lighted membrane switches clearly indicate current therapeutic setting.
Intermittent Mode – The SVED® Wound Treatment System can be set to operate intermittently (5
minute ON /2 minute OFF cycle). Unit maintains -25 mmHg vacuum during the “OFF” state to prevent
loss of dressing seal and increase patient comfort.
NoiseGuard – Unit is virtually silent in its normal operation increasing patient comfort and
compliance.
PowerGuard – An internal battery provides approximately 12 hours of operation from a single fullcharge. Battery charges while unit is operating with the AC adapter. While running on battery, a lowbattery alarm will “chirp” and the OFF button will begin flashing when remaining capacity of the battery
is less than 20%.
Sec1:3
SVED® System User’s Manual Rev D 1/13
TherapyGuard – Automated alarms for leak/low pressure and full canister. Alarms provide both a visual
and audible indication. Alarms will self-reset once a problem is corrected or can be manually reset by
turning the therapy unit OFF and ON.
SafetyGuard – A unique non-Luer Lock connector is provided for irrigation therapy that will not permit
an accidental connection to a patient’s I.V. line.
I.V. Pole/Bed Hanger Adapter – Pole clamp permits the unit to be mounted to a wide range of standard
I.V. poles: 0.9” to 2” (2.2 to 5.0 cm) in diameter. Stowable bed hangers permit the unit to be hung from a
wide range of hospital bed footboards.
SpeedConnect™ – Six-foot dual-lumen tubing set with adhesive flanges to permit easy connection to
dressing.
Single Patient Use Canister – 300cc canister for irrigation and normal exudating wounds.
CAUTION: Use of Large Canisters (>500ml) may increase serious risks associated with excessive fluid loss.
Monitor patient status continually. DO NOT USE for infants or other patients with low fluid volume, nor for
patients at high risk of major hemorrhage.
Light Weight – The therapy unit weighs only 1.9 Lbs (862 g) and can be easily carried and transported.
Long-life Pump – Diaphragm-type pump with brushless motor increases life expectancy of the unit
and minimizes maintenance requirement.
Sec1:4
SVED® System User’s Manual Rev D 1/13
2. Care & Cleaning
INTRODUCTION
The following instructions are the Innovative Therapies, Inc. (ITI) recommended daily and weekly cleaning
and infection control procedures for the SVED® Wound Treatment System. The Caregiver should review
this manual in its entirety before attempting to the use the product. Carefully read the PRECAUTIONS
and SAFETY TIPS in the INTRODUCTION section before attempting to perform cleaning procedures on
the SVED® Wound Treatment Unit.
PROTECTIVE EQUIPMENT
Universal Safety Precautions should be used to minimize the risk of infection and contact with
contaminated blood or bodily fluids during the dressing changes or disposal, it is important to protect
all exposed skin and mucous membranes. The protective equipment includes:
• Disposable gloves (latex or latex-free).
• Protective eyewear to help prevent splashing of cleaning solutions and/or blood or bodily
fluids.
• Protective mask (to protect the nose and mouth from inadvertent fluid ingress).
• Disposable impervious gown (if splashing of blood or bodily fluids is possible).
DISPOSAL
After patient use, all disposable components of the system should be treated as contaminated. These
include:
• The ITI Foam Dressing, drape, tubing, and connectors.
• The exudate collection canister.
• Suction and irrigation tubing, connectors & clamps.
Dispose of all disposable components in accordance with local, state, and federal regulations and
institution protocols.
NOTE: Cleaning procedures should not be performed when unit is connected to a patient.
Disconnect the unit from the patient and power source before cleaning or servicing.
DAILY CARE AND CLEANING
Perform a visual inspection of the unit. Check for any sign of contamination and ensure that the unit is
functioning properly. If the unit is not operating properly, refer to the Alarm Troubleshooting guide in
the OPERATING INSTRUCTIONS section of this manual or contact ITI to have the unit serviced. If there
are visible signs of contamination or the unit appears dirty, follow the WEEKLY CARE AND CLEANING
instructions below.
Sec2:1
SVED® System User’s Manual Rev D 1/13
WEEKLY CARE AND CLEANING
To help reduce the risk of infection and contact with contaminated blood and bodily fluids please wear
the protective equipment identified above when cleaning the SVED® Wound Treatment Unit.
NOTE: Always follow Universal Safety Precautions. Follow established institution protocols
regarding clean versus sterile technique.
The following cleaning procedure must be performed at least once a week and must be completed
between patients. The SVED® Wound Treatment Unit should be wiped with either a diluted solution
of 5 milliliters bleach in 1 liter of warm water (approximately 1 teaspoon bleach in 1 quart water) or
mild disinfectant. Use a coarse cloth and wring out any excess solution until the cloth is damp and not
dripping. Other cleaning fluids are not recommended as they may damage the finish of the enclosure.
A.C. ADAPTER INSPECTION
The A.C. Adapter should be inspected regularly for damage and/or unusual wear. Replace damaged or
worn Power Supplies immediately. A.C. Adapters are available from ITI.
WA R N I N G
The SVED® Wound Treatment Unit should only be used with the supplied A.C. Adapter. Use of an
incorrectly rated adapter could create a shock hazard for the patient or caregiver.
WA R N I N G
Avoid spilling liquid on any part of the therapy unit. Liquids can cause corrosion when left on
electronic controls, which can lead to failure. Component failure may cause the therapy unit to
operate erratically, possibly causing a potential hazard to the patient or Caregiver.
WA R N I N G
Particular care must be taken when handling undiluted germicide concentrate or chlorine bleach,
including proper shielding of eyes. Always mix by adding concentrated germicide or chlorine
bleach to the water. NEVER intermix germicides or mix germicides with chlorine bleach.
Sec2:2
SVED® System User’s Manual Rev D 1/13
3. Patient Care
It is recommended that all sections of this manual be reviewed prior to using the product. Carefully read
the INDICATIONS, CONTRAINDICATIONS, PRECAUTIONS and SAFETY TIPS in the INTRODUCTION
section before attempting to perform patient care for a patient with the SVED® Wound Treatment
System.
APPLYING THE DRESSING
1. Cleanse wound according to institution protocols or physician order.
2. Debride all necrotic tissue including eschar and hardened slough.
3. Be certain the wound has achieved hemostasis.
4. Visually examine and palpate wound bed to locate any blood vessels or delicate underlying
structure in close proximity.
5. Irrigate wound with normal saline or solution per physician order.
6. Prepare area around wound to permit adhesion of the polyurethane drape.
NOTE: If peri-wound area is excessively moist or oily, a medical-grade liquid adhesive may improve
sealing. For fragile skin, use a skin sealant prior to drape application, or frame the wound with a skin
barrier layer, such as Duoderm® or the ITI SensiSkin Drape. Cut the drape to a size large enough to go
over the foam and the barrier layer only.
7. Take measurements of the wound dimensions and note pathology. Cut the ITI Foam Dressing to
a size that is appropriate for the wound.
NOTE: Do not trim the dressing over or around the wound site to help prevent debris from the foam
dressing from falling into the wound.
8. Place the ITI Foam Dressing in the wound site taking care to avoid contact with the peri-wound
tissue.
WARNING: Do not pack the ITI Foam Dressings into any areas of the wound. Forcing
dressings in a compressed manner into any wound is contrary to approved protocols.
NOTE: The ITI Foam Dressing should cover the entire wound margin, including tunneling and
undermining. However, the ITI Foam should not be in contact with intact skin.
9. Size and trim the ITI Polyurethane Drape to cover dressing plus a 3-5 cm border of intact skin.
(Save the extra drape for later use, if needed). Remove the drape’s release liner and place over
the ITI Foam Dressing and peri-wound.
10. Pat drape material down around the wound site and over the ITI Foam Dressing to ensure
dressing is properly sealed.
Sec3:1
SVED® System User’s Manual Rev D 1/13
11.Cut two 1 cm diameter holes in the top of the drape at both ends of the dressing (see Figure 1).
12.Peel the backing from one of the SpeedConnect™ flanges and place it above one of the holes
made in Step 11. Using the tips of the fingers, press around the top of the SpeedConnect™ to
ensure a good seal to the dressing (see Figure 2).
13. Repeat Step 12 for the second SpeedConnect™ flange (see Figure 3).
To Fluid Collection
Canister
To Fluid Collection
Canister
To Irrigation
ITI Foam®
Dressing
Polyurethane
Drape Material
Figure 1
Figure 2
Figure 3
14.Connect the irrigation-side of the SpeedConnect™ tube with SafetyGuard to the wound
Irrigation Set (see Figure 4 for a complete SVED Wound Treatment Unit set up with irrigation).
NOTE: The solution to be used for wound irrigation should be appropriate for topical
applications (see Appendix A for more information on the suggested types of aqueous wound
therapy solutions). Make sure that the clamp on the Irrigation Tube remains closed until therapy
is started.
15.When irrigation is discontinued, for example while changing the fluid reservoir, place the Tubing
Cap on the irrigation-side of the SpeedConnect™ tube.
16.Proceed to the therapy unit instructions to apply negative pressure wound therapy with
irrigation.
Figure 4
Sec3:2
SVED® System User’s Manual Rev D 1/13
CANISTER INSTALLATION
1.Ensure that an ITI Fluid Collection Canister is properly inserted in the receptacle located on the
side of the therapy unit (see Figure 5). The Canister should “snap” into place and lock. The canister
release button may need to be depressed to permit canister insertion. NOTE: Always use a new
canister with a new patient.
Therapy
SpeedConnectTM
Canister
Release
Canister
Fluid
Collection
Figure 5
Figure 6
2.Inspect the SpeedConnect™ Tube flanges to ensure that they are properly connected to the ITI
Foam Dressing and that the connections are well sealed.
3.Connect the distal end of the SpeedConnect™ Tube with the blue tapered connector to the
Patient port of the Canister (see Figure 6). Gently twist and push the connector on just enough
to secure and seal it. Also, make sure that the clamp on the SpeedConnect™ Tube is open (see
Figure 7).
4.Plug the therapy unit’s A.C. Adapter into a suitable
120 VAC, 60 Hz, 3-prong outlet. Insert the power
plug into the Power Jack on the side of the Therapy
Unit (see Figure 7).
5.Verify the dressing application is correct, the
tubing is connected, the Dressing Suction Tube
clamp is open and the Dressing Irrigation Tube
clamp is closed.
Power
Clamp
6. Begin therapy (see OPERATING INSTRUCTIONS).
Figure 7
Sec3:3
SVED® System User’s Manual Rev D 1/13
CANISTER REMOVAL
1. Press the OFF button to turn the therapy off.
2. Close both tubing clamps (engaged).
3. Remove tubing connector from top of canister.
4. Press canister release button and withdraw canister from bottom of unit.
5.Dispose of canister according to local, state and federal regulations as well as institutional
protocols.
DRESSING REMOVAL
Carefully read the SAFETY TIPS in the INTRODUCTION section of this guide prior to removing the
dressing.
NOTE: Wounds must be carefully monitored at regular intervals. In a non-infected wound, dressings should
be changed every 48 to 72 hours; but no less than 3 times per week, with the frequency of dressing change
determined by the clinician. Infected wounds must be monitored continuously. For infected wounds,
dressings may need to be changed more often than 48-72 hours; the dressing change interval should be
based on a clinical evaluation of the wound condition rather than a fixed schedule.
NOTE: The Canister should be replaced when full (the Canister Full alarm activates) or at least once every
week to minimize the potential for contamination and production of odors.
1. Press the OFF button to turn the therapy off.
2. Close both tubing clamps (engaged).
3.Disconnect SpeedConnect™ Suction and Irrigation tubes. Twisting the tapered connector will
make removing the Suction tube from the Canister easier.
4. Slowly pull drape up and away from skin while gently stretching drape.
NOTE: If the ITI Foam Dressing adheres to the wound during removal, refer to the SAFETY TIPS section
of this manual.
5.Discard disposables in accordance with applicable rules, regulations and infection control protocols,
and always follow Universal Safety Precautions.
Sec3:4
SVED® System User’s Manual Rev D 1/13
DISPOSAL OF DRESSINGS, CANISTER AND OTHER DISPOSABLES
To minimize the risk of infection and contact with contaminated blood or bodily fluids during the
dressing changes or disposal, it is important to protect all exposed skin and mucous membranes. The
protective equipment includes:
• Disposable gloves (latex or latex-free).
• Protective eyewear to help prevent splashing of cleaning solutions and/or blood or bodily
fluids.
• Protective mask (to protect the nose and mouth from inadvertent fluid ingress).
• Disposable impervious gown (if splashing of blood or bodily fluids is possible).
After patient use, all disposable components of the system should be treated as contaminated. These
include:
• The ITI Foam Dressing and drape.
• The exudate collection canister.
• SpeedConnect™ tubing, connectors & clamps.
Dispose of all disposable components in accordance with local, state, and federal regulations and
institution protocols.
Sec3:5
SVED® System User’s Manual Rev D 1/13
4. Operating Instructions
This section contains instructions for setting and adjusting functions of the SVED® Wound Treatment
Unit. This section explains the procedures for activating therapy and the major functions that are
adjusted from the control panel.
Carefully read the PRECAUTIONS and SAFETY TIPS in the INTRODUCTION section before attempting
to operate and adjust the SVED® Wound Treatment Unit.
WA R N I N G
The SVED® Wound Treatment Unit should only be used with the supplied A.C. Adapter. Use of
an incorrectly rated adapter could create a shock hazard for the patient or caregiver. The part
number for the adapter can be found in the REPLACEMENT PARTS section of this manual.
POWER ON/OFF
The ON and OFF buttons are located on the top front of the control panel. The ON and OFF buttons
control the application of power to the therapy unit.
POWER-ON PROCEDURE
1.Verify the dressing application is correct, the
tubing is connected, the Dressing Suction Tube
clamp is open and the Dressing Irrigation Tube
clamp is closed.
OFF (O)
ON (I)
2.Place the therapy unit in an upright position as
level with the wound as possible. The device can
be placed on a table, hung from a footboard or
attached to an I.V. pole using the I.V. Pole/Bed
Hanger adapter.
CAUTION: The I.V. pole clamp should only be
used on poles that are in excess of 0.9” (2.2 cm)
diameter and are securely attached to a bed
frame or suitable stand. To ensure stability of
the therapy unit on the I.V. pole, it should be
clamped no higher than two times the width of
the pole base. The clamp should be tightened to
ensure that the therapy unit cannot slide down
the pole.
3. Hang irrigation bag on the I.V. pole at a level
that is higher than the level of the wound.
Canister
Full
Low
Pressure
Leak
-150mmHg
-125mmHg
-70mmHg
Sec4:1
SVED® System User’s Manual Rev D 1/13
4. Press the ON button. All LED indicators will illuminate for 1 second during the power-on selftest, after which, the ON button will steadily light green.
5.Dressing should collapse indicating the presence of vacuum. Once dressing integrity is verified,
open the Dressing Irrigation Tube and adjust drip to a rate appropriate for desired therapy.
6.Carefully check dressing for vacuum or fluid leaks and repair with additional Polyurethane drape
material as needed.
7.The SVED® Wound Treatment System should be operated at least 22 hours out of every 24 hour
period. Remove the ITI Foam Dressing if therapy is terminated or is off for more than 2 hours in
a 24-hour period.
THERAPY SETTING ADJUSTMENT
CAUTION: Only a physician can prescribe the proper settings and irrigation protocols for the therapy
unit. Failure to follow product instructions or adjusting settings and performing therapy application
without the express direction and/or supervision of your trained caregiver may lead to improper product
performance and the potential for serious or fatal injury.
Negative Pressure Level Adjustment
There are three settings of negative pressure that can be selected: -70 mmHg, -120 mmHg, and -150
mmHg. The negative pressure selector buttons are located on the bottom front of the control panel. Use
these buttons to select the therapy setting that is appropriate for the patient.
1.When the unit is powered-up, the default setting of -120 mmHg is automatically selected (unless
therapy setting has been locked previously by caregiver, see “Therapy Selection Lock/Unlock”
Section).
2. To change the setting, simply press the desired setting button.
3.The setting button will flash indicating the selection has been made and will continue flashing
until the desired negative pressure level has been achieved at which time the button will stay
illuminated.
Intermittent Mode ON/OFF (S/W Ver. 2.57 & Higher)
The SVED® can operate in an intermittent suction mode with a 5 minute “ON” and 2 minute “OFF” cycle.
To turn the intermittent mode on, press and hold the desired setting button then momentarily press the
OFF (0) button. The unit will beep “•—•—“ and the green ON (1) button will begin flashing indicating the
unit is now operating in intermittent mode. Release both buttons.
To turn the intermittent mode off (and return the device to the default continuous mode), repeat the
above steps. The unit will produce a single long beep and the green ON (1) button will steadily illuminate.
The SVED® will remember the mode setting when the power is turned OFF and ON.
During intermittent operation, the SVED® will provide target therapy pressure throughout the “ON” part
of the cycle and approximately -25 mmHg throughout the “OFF” part of the cycle. By maintaining this
lower pressure while the unit is off, the dressing seal is never compromised. This method of applying
intermittent pressure also increases patient comfort.
Sec4:2
SVED® System User’s Manual Rev D 1/13
Therapy Timer (S/W Ver. 2.63 & Higher)
A 7-segment LED indicator is provided for displaying two types of therapy timers. This LED can display
patient usage Therapy Time (resettable) and Total Time accumulated by the device (non-resettable).
The display will use the format: “d: days, H: hours, -: mins” and data will be displayed sequentially on the
single 7-segment LED. When the device is first turned on, the unit’s Total Time is displayed. This timer
cannot be reset and accumulates time as the device is used. After the device has displayed the Total
Time and at any time the device is operating, pressing the ON (“I”) button and -120 mmHg buttons
simultaneously will initiate the display of Therapy Time. To reset the Therapy Time to zero, simply press
and hold the ON (“I”) button and -120 mmHg until the unit beeps three times and the Therapy Time
display indicates “d: 0, H: 00, -: 00”.
NOTE: When the device is turned off, the 7-segment LED will sequentially display the software
version number. For example, software version 2.63 the display will flash “2”, “6”, “3” when power
is shut off.
Alarm Volume Level Control (S/W Ver. 2.63 & Higher)
The volume of the alarm can be adjusted to fit various care settings or patient preferences. To adjust
the alarm volume, press and hold the ON button while simultaneously pressing the yellow -150 mmHg
button to increase the volume, or the -70 mmHg button to decrease the volume. The LED display on the
side of the unit will indicate the volume level (1 to 5). The nominal alarm volume level for the device is 2,
which is generally sufficient for most care settings.
Sec4:3
SVED® System User’s Manual Rev D 1/13
BATTERY OPERATION
NOTE: The SVED® Wound Treatment System is designed to permit use of the product while the internal battery
is charging. The therapy unit will continue to operate properly while charging is taking place.
Average Battery Life
The specified battery life of the SVED® Wound Treatment Unit with a fully charged battery is approximately
12 hours. The actual life is dependant on the integrity of the dressing. A leak in the dressing can reduce
overall battery longevity significantly.
Average Time for Recharging
To ensure the battery has been fully charged, the unit should be connected to an A.C. supply for
approximately 3 hours. After approximately 2 hours of charging, the unit will have achieved 80% of total
battery capacity.
Low Battery Alarm
While running on battery, a low-battery alarm will “chirp” every 10 seconds and the OFF button will
begin flashing when remaining capacity of the battery is less than 20%. Typically, the unit will continue
to operate for approximately 1 hour after the low-battery alarm is activated.
Low Battery Shutoff
If the battery charge falls below a critical level, the unit will shutoff automatically and therapy will be
discontinued. At this point, the unit must be plugged into an A.C. power source for therapy to resume.
Once the A.C. Adapter is plugged in, pressing the ON button will restart the unit.
Recharging the Battery
Plug the power cord from the A.C. Adapter into the power receptacle on the side of the therapy unit.
Plug the A.C. Adapter into a suitable 120 VAC, 60 Hz wall outlet.
When the unit is connected to an AC power source, the GREEN LED below the power receptacle will
illuminate indicating AC power is present and the AMBER LED will illuminate when the battery is
charging.
Once the battery is fully charged, the AMBER LED will extinguish indicating the charge cycle is
complete.
When the SVED® Wound Treatment Unit is disconnected from the AC power source, the device will
automatically switch over to the internal battery and continue to operate without interruption.
Sec4:4
SVED® System User’s Manual Rev D 1/13
ALARM OPERATION
Clearing an Alarm Condition
To clear an alarm condition, turn the therapy unit OFF then ON. The alarm will clear when the power is
cycled.
Alarm Troubleshooting
Alarm Type
Canister
is Full
Low
Pressure/
Dressing
Leaks
Indication
Corrective Action
• Canister Full LED lights
accompanied by an intermittent
audible alarm.
• Turn unit off by pressing the OFF button.
• Remove canister and replace as necessary.
• Unit will continue to alarm until the • Press the ON button to resume therapy.
canister is replaced.
• I f conditions persist, refer unit for servicing as
the internal protective filter may be blocked.
• Low Pressure/Leak LED lights
accompanied by an intermittent
audible alarm.
• Unit will continue to alarm until
the low pressure/leak condition is
corrected or the alarm is cleared.
• Check all tubing connections between the
therapy unit and Dressing.
• Check to ensure the canister is fully seated and
locked. Check for cracks in the canister or lid
separation.
• Pat around drape to check for leaks. If leak is
found, patch with extra drape material.
• Utilizing an approved ITI A.C. Adapter, connect
• The OFF button will flash on and
off accompanied by an intermittent unit to an A.C. power source to provide
operating power and to recharge the internal
audible “chirp” every 10 seconds.
battery.
• The unit will continue to alarm until
Low Battery connected to an A.C. power source.
•When the charge falls below a
critical level, the therapy will be
discontinued.
NOTE: In the event of an emergency, please contact your treating physician, caregiver, or your
local emergency responders.
NOTE: If an Alarm Condition persists and cannot be resolved, please contact ITI for further
assistance.
Sec4:5
SVED® System User’s Manual Rev D 1/13
THERAPY SELECTION LOCK/UNLOCK
The SVED® Wound Treatment Unit is equipped with a therapy locking feature designed to prevent
unauthorized individuals from changing the therapeutic settings inadvertently.
Locking
To lock the unit, press and hold the desired therapy level (-70, -120, -150 mmHg) for three seconds until
three audible beeps are heard. At this point, the unit is locked. Pressing any other therapy level will
result in three beeps with no change in setting. This therapeutic setting will be recalled each time the
unit is powered OFF and ON, and the unit will remain locked until it is unlocked by the caregiver.
Unlocking
To unlock the unit, press and hold the selected therapy button (the lit button) until three audible beeps
are heard. At this point the unit is unlocked and therapy settings can be changed. Additionally, when the
unit is powered OFF and ON, the unit will remain unlocked and will automatically revert to the default
setting of -120 mmHg.
Sec4:6
SVED® System User’s Manual Rev D 1/13
5. Specifications*
SVED® Wound Treatment System
Dimensions_____________________________________ 7.5 x 2.5 x 6.8 in. (19.05 x 6.35 x 17.27 cm)
Weight_______________________________________________________________ 2.1 Lbs (953 g)
Therapy Settings________________________________________________-70, -120 & -150 mmHg
Canister Volume_ _____________________________________________________________300 cc
Medical Equipment with respect to electric shock, fire, and mechanical hazards only in accordance
with UL Std. 60601-1, and CAN/CSA, C22.2 No. 601.1.
IEC Classification
• Medical Equipment
• Equipment not suitable for use in presence of flammable anesthetic mixture with air,
oxygen, or nitrous oxide
• Continuous Operation
• Type B Applied Part
• Class II Internally Powered Equipment
• IPXO
Battery
Duration (Fully Charged)_________________________________________ approximately 12 hours
Electrical
External Power Supply Input_ ______________________________ 100-240 VAC, 50-60Hz, 700 mA
External Power Supply Output___________________________________________15 VDC, 2 Amps
Patient & Enclosure leakage Current_ ___________________________________ < 100 Microamps
Environmental Conditions
Storage Conditions
Temperature Range_ _______________________________________ 10oF (-12oC) to 110oF (43oC)
Relative Humidity Range_____________________________________ 20 – 95% Non-condensing
Atmospheric Pressure Range_________________________________________ 50 kPa to 110 kPa
Operating Conditions
Temperature Range_ __________________________________________ 40oF (4oC) to 90oF (32oC)
Relative Humidity Range_____________________________________ 20 - 75% Non-condensing
Atmospheric Pressure Range_________________________________________ 50 kPa to 110 kPa
Expected useful life of SVED® Wound Treatment Unit________________________________ 3 years
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
* Specifications subject to change without notice.
Sec5:1
SVED® System User’s Manual Rev D 1/13
EXPLANATION OF SYMBOLS
Sec5:2
SVED® System User’s Manual Rev D 1/13
6. Replacement Parts
Description
Part Number
Therapy Unit
SVED® Wound Treatment Unit_ ________________________________________ SVED® User’s Manual_________________________________________________ 6701132
6701132M
A.C. Power Adapter
FRIWO, Model FW7362M/15___________________________________________ 47-9000
Dressings
ITI Small Black Foam Dressing Set (10 per case)_ __________________________ ITI Medium Black Foam Dressing Set (10 per case)_________________________ ITI Large Black Foam Dressing Set (10 per case)_ __________________________ ITI X-Large Black Foam Dressing Set (10 per case)__________________________ ITI White Foam Dressing (10 per case)___________________________________ 47-1702
47-1701
47-1700
47-1703
47-1751
Canisters
Disposable Canister with Gel, 300 cc (10 per case)_ ________________________ Disposable Canister w/o Gel, 300cc (10 per case)__________________________ Disposable Canister with Gel, 500 cc (10 per case)_ ________________________ 47-4000
47-4100
47-4500
Accessories
SVED Bed Bracket_ __________________________________________________ I.V. Pole Adapter for Bed Bracket_ ______________________________________ SVED Carrying Case__________________________________________________ ITI Suction Tubing with SpeedConnect™_________________________________ ITI “Y” Connector____________________________________________________ ITI Polyurethane Drape (10 per pkg.)____________________________________ ITI SensiSkin™ Drape (10 per pkg.)______________________________________ 47-5500
47-5510
47-9500
47-2000
47-2500
47-7000
47-7100
NOTE: In order to assure the highest safety, quality and efficacy of the products, the SVED® Wound
Treatment System should only be used with Innovative Therapies, Inc.’s disposables, and ITI Foam
Dressings should only be used with the SVED® Wound Treatment Units.
Sec6:1
SVED® System User’s Manual Rev D 1/13
7. Questions & Information
For additional information pertaining to the SVED® Wound Treatment System, please contact your local
ITI representative, or:
Innovative Therapies, Inc.
3770 Park Central Blvd. North
Pompano Beach, FL 33064-2225
1-866-ITI-NPWT (484-6798)
www.itimedical.com
For questions or comments regarding the content of this User’s Manual, please contact Innovative
Therapies, Inc. (ITI) at the above address. Please contact ITI Customer Service at 1-866-ITI-NPWT (4846798) for issues concerning the product and its use.
Duoderm® is a trademark of Convatec. All other trademarks designated herein are the property of ITI.
This product is covered by one or more pending patents. Copyright 2013, Innovative Therapies, Inc. All
Rights Reserved Worldwide. (1/13) P/N 6701132M Rev D.
Sec7:1
SVED® System User’s Manual Rev D 1/13
Appendix A. Irrigation Guidelines
Appendix A.1. NPWT with simultaneous irrigation
The SVED or Svedman Wound Treatment System provides NPWT with simultaneous irrigation—
delivering aqueous solutions over the wound bed. Irrigation cleanses all areas in contact with foam:
The wound base and any tunnels or undermined areas. By keeping the wound base moist, irrigation
promotes wound healing. In addition, by cleansing the foam itself, irrigation helps maintain uniform
pressure.
Irrigation is applied through the ITI Irrigation Tubing with SpeedConnect, placed in the same manner a
the ITI Suction Tubing with SpeedConnect. The two SpeedConnects can be in close proximity for small
wounds, or at some distance to each other for large wounds.
Typically, continuous irrigation is applied at a rate of 25 to 30 cc/hr. For intermittent irrigation procedures,
see Appendix A.3. Intermittent irrigation.
Clinicians should carefully investigate indications, contraindications, and usage guidelines before
prescribing any solution. This document is intended to provide general information about topical
irrigation solutions used with wounds. It is not intended to be used as a guide line for prescribing the
solutions.
Tips for using irrigation with ambulatory patients
• Tape together the suction and irrigation tubes.
• As needed, shorten irrigation tubing as follows:
1. Cut tubing with sanitized scissors.
2. Remove the Luer lock connector and cap from the severed tubing end.
3. Insert the Luer lock connector and cap into the working shortened tube.
A:I
SVED® System User’s Manual Rev D 1/13
Appendix A.2. Suggested irrigation solutions
Irrigation
Solution
Type
Mafenide
acetate
(Sulfamylon)
Oxychlorosene
sodium
(Clorpactin)
Sodium
hypochlorite
(Dakins)
Category
Characteristics
Antibacterial agent.
Commonly used to prevent and
treat burn wound infections.
Useful for many gramnegative
and grampositive organisms,
including Pseudomonas and
certain strains of anaerobes.
Activity not altered by the
presence of blood, serum,
leukocytes, or pH variability.
Clinical
Considerations
Administrative
Considerations
Systemically absorbed.
5% solution is typically used.
Patients sensitive to other
sulfonamides, furosemide,
thiazide diuretics, sulfonylureas,
or carbonic anhydrase inhibitors
may be sensitive to this product.
Administer within 24 hours of
mixing.
Does not reduce fungal growth.
Can penetrate non-viable tissue.
Antiseptic/ antimicrobial.
Stable derivative of
hypochlorous acid.
Non-toxic, non-allergenic when
used at recommended strength.
Only effective when in contact
with viable wound base.
Stable for 5 days at room
temperature
Antiseptic/antimicrobial.
Breaks down non-viable tissue.
Effective against bacteria, yeast,
fungi, viruses, spores, and
antibiotic resistant
Is a weak hypochlorite
solution buffered with sodium
bicarbonate
In vivo toxicity is debated,
unclear.
Effective against bacteria, yeast,
fungi, viruses, spores, and
antibiotic resistant organisms.
organisms
Monitor for metabolic acidosis.
Metabolites excreted via
urine—use caution in renalcompromised patients.
No data indicate that solution
is toxic or causes allergic
reactions.
Produced both commercially
and by patients at clinician
direction.
May cause irritation to intact
skin.
Silver nitrate
Antiseptic/antimicrobial.
Effective against broad
spectrum of bacteria and fungi.
Lidocaine
Anesthetic agent.
Wound irrigation solution.
0.4% solution is generally used
for wound disinfection.
0.05% solution is generally
used for wound irrigation or
dressings.
Integrity and potency may
be affected by exposure to
light, heat, and loosely sealed
container.
May cause irritation to intact
skin, especially at stronger
dilutions.
Infrequently used; generally
selected in full thickness burns
in patients who are allergic to
other topical antimicrobials.
Application is painless.
0.5% solution is generally used.
Hypoallergenic, but can pull
electrolytes from base tissue.
Powder must be mixed with
sterile water.
Does not penetrate eschar.
Stains intact skin.
Mixed solution is light sensitive.
May be helpful in reducing pain
with dressing change.
Patients may experience allergic
reaction, toxicity, and other
drug associated side effects.
Irrigation dilution should be
individualized— generally
ranges from 25 cc 1% lidocaine
to 250 cc normal saline
Monitor cardiovascular status
carefully during and after
administration
Sodium chloride
Deliver using 0.22 micron filter.
Does not impact microorganism
viability.
Discard unused fluid within 72
hours of opening container.
Useful for wound bed flushing.
Hypoallergenic, non-toxic.
Generally not used for
continuous irrigation— rather
as local anesthetic prior to
dressing change.
0.9% solution is generally used.
A:II
SVED® System User’s Manual Rev D 1/13
Appendix A.3. Intermittent irrigation
This section addresses intermittent irrigation.
For some care settings—such as outpatient or home care—payors may not compensate for the extra
canisters required for collecting irrigation fluids, or may not pay for fluids and setups not used for IV
administration. In those settings, intermittent irrigation may provide a solution.
The prescribing clinician specifies the volume and frequency of intermittent irrigation.
1.Pour the prescribed amount of irrigation solution into a clean, sterile, disposable container, or
sanitized container.
2. Remove the cap from the end of the Irrigation SpeedConnect.
3.Place the Irrigation SpeedConnect into the container. The irrigation solution will be pulled
through the tubing and into the dressing. Alternatively, a syringe may be used to draw the
fluid and deliver it via the SpeedConnect. The syringe may be refilled to deliver the amount of
irrigation solution prescribed.
4. Replace the cap on the end of the irrigation SpeedConnect.
5. Repeat 2 to 3 times daily or as prescribed.
A:III