Cardinal Health SVED 6701132 User manual

Patient User Manual Cat. 6701132
Cardinal Health™ SVED®

Patient User Manual

Patient User Manual
About Your Cardinal Health SVED device
Your doctor has chosen the Cardinal Health SVED device to remove uid from your wound by using carefully controlled
suction. It is important, however, for you to carefully watch the wound and the Cardinal Health SVED device to make
sure that the Cardinal Health SVED device is working properly. Below is some important information and questions that
you should ask your Healthcare Professional.
Things you need to know about your Cardinal Health SVED device
• Do not allow the Cardinal Health SVED device to get wet. Clamp the tube and disconnect from the canister if you
take a bath or shower.
• Keep the Cardinal Health SVED device plugged in whenever possible to keep the battery fully charged. Always take
the power cord with you when you leave home.
• Keep the Cardinal Health SVED device upright to avoid a false canister full alarm.
• Keep the Cardinal Health SVED device turned on at all times unless there is bleeding from the wound or instructed
by your Healthcare Professional.
• Do not change the settings on the Cardinal Health SVED device unless you are told to do so by your Healthcare Professional.
Things to ask your Healthcare Professional
• How to tell if there is a problem with your Cardinal Health SVED device or dressing.
• What to do if you have a problem or a leak with your dressing.
• What to do if you notice bleeding from the wound.
• What to do if you must take your dressing o.
• What activities you can do while using the Cardinal Health SVED device.
• Who to call if you need help.
• How to take care of your Cardinal Health SVED device.

Patient User Manual
CAUTION: This Cardinal Health™ SVED® PATIENT User Manual is not a guarantee or warranty. It is intended only as
an operational guide. For additional information and questions, please contact the Cardinal Health Customer Service
department at 1.866.484.6798.
In order for the Cardinal Health™ SVED® to provide safe, reliable, and proper performance, the following conditions
must be met. Failure to comply with these conditions will void all pertinent warranties.
• There are no user serviceable components in the Cardinal Health™ SVED®. All assembly, operation, adjustment,
modication, maintenance, and/or repair must be carried out only by qualied personnel authorized by Cardinal Health.
• The electrical installation of the room in which the device will be used complies with the appropriate national
electrical standards.
• The product must be used in accordance with this manual and all associated labeling and the Instructions for Use.
• Any device that does not function as expected must be returned to Cardinal Health.
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.

Patient User Manual
Table of Contents
1. Important User Information ......................................................................................................................................... 4
1.1 Indications ......................................................................................................................................................... 4
1.2 Contraindications .............................................................................................................................................. 4
1.3 Precautions ........................................................................................................................................................ 4
1.4 Additional Precautions ...................................................................................................................................... 4
1.5 Safety Tips ......................................................................................................................................................... 5
2. Introduction to the Cardinal Health™ SVED device ........................................................................................................ 6
2.1 Getting to know the device ................................................................................................................................ 6
2.2 Charging the Battery.......................................................................................................................................... 6
2.3 Changing the Canister ....................................................................................................................................... 8
2.4 Disconnecting the Device ................................................................................................................................ 10
3. Operating Instructions ................................................................................................................................................ 11
3.1 Power ON/OFF ................................................................................................................................................. 11
3.2 Power-up Procedure ........................................................................................................................................ 11
3.3 Alarm Operation .............................................................................................................................................. 12
4. Care and Cleaning ....................................................................................................................................................... 13
4.1 Disposal of Dressings, Canister and Other Disposables...................................................................................... 13
4.2 Cleaning the Device ......................................................................................................................................... 13
4.3 AC Power Adapter Inspection ........................................................................................................................... 14
5. Specications ............................................................................................................................................................. 15
5.1 Symbols ........................................................................................................................................................... 16
5.2 Electromagnetic Compatibility ........................................................................................................................ 17
6. Replacement Parts ..................................................................................................................................................... 19
7. Questions & Information ............................................................................................................................................ 20

4
Patient User Manual
1. Important User Information
1.1 Indications
The Cardinal Health™ SVED® system is an integrated wound management system, indicated for the application of
continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing
by the removal of uids, including wound exudates, irrigation uids, body uids and infectious materials.
The Cardinal Health™ SVED® system is intended for patients with chronic, acute, traumatic, subacute and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic or pressure), aps and grafts.The Cardinal Health™ SVED®
system is intended for use in acute, extended and home care settings.
1.2 Contraindications
The Cardinal Health™ SVED® is contraindicated for patients with malignancy in the wound, untreated osteomyelitis,
non-enteric and unexplored stulas, or necrotic tissue with eschar present. Do not place the Cardinal Health™ NPWT
Dressing over exposed blood vessels or organs.The Cardinal Health™ NPWT Dressings are also contraindicated for
hydrogen peroxide and solutions which are alcohol based or contain alcohol. It is not recommended to deliver uids
to the thoracic cavity.
1.3 Precautions
Precautions should be taken for patients with infected wounds, active bleeding, dicult wound hemostasis, or who
are on anticoagulants.When placing the Cardinal Health™ NPWT 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 stula
require special precautions in order to optimize therapy.
1.4 Additional Precautions
• Debrillation: Remove the Cardinal Health™ NPWT Dressing if debrillation 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 Cardinal Health™ SVED® device is not MRI-compatible. Do not take the
device into the MRI area.
• Hyperbaric Oxygen Therapy (HBO): NEVER allow a device—whether on or o—inside a hyperbaric chamber.
The device must be disconnected from the patient prior to HBO treatment.
• Large Canisters: Use of Large Canisters (>500ml) may increase serious risks associated with excessive uid loss.
Monitor patient status continually.

5
Patient User Manual
• DO NOT USE for infants or other patients with low uid volume, nor for patients at high risk of major hemorrhage.
• During Negative PressureWoundTherapy, the Cardinal Health™ SVED® and Cardinal Health™ NPWT Dressing are a
closed system and are NOT vented to atmosphere.
• During Negative PressureWoundTherapy, when a canister lls with uid, it should be replaced immediately as
uids such as wound exudate will not be removed from the dressing once the canister is full.
1.5 SAFETY TIPS
KEEP THERAPY ON
The Cardinal Health™ SVED® device should be operated at least 22 hours out of every 24 hour period. Contact your
Healthcare Professional if therapy stops or if the device is OFF for more than 2 hours in a 24 hour period.
Your Healthcare Professional will need to change your dressing.
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 wound exudates for signs of active bleeding. 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 Cardinal Health™ SVED® device, 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 the use of the Cardinal Health™ SVED®
device until the serious infection is diagnosed and properly treated.
CARDINAL HEALTH™ NPWT DRESSING USE
Your Healthcare Professional will apply and change your dressings for you.The Cardinal Health™ NPWT Dressings distributed
by Cardinal Health are to be used exclusively with the Cardinal Health™ SVED® device.
NOTE: All dressing components of the Cardinal Health™ NPWT Dressing kit 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 Cardinal Health™ NPWT disposable set are made without natural rubber latex.
Be sure to comply with all other 1.2 CONTRAINDICATIONS and 1.3 PRECAUTIONS for the Cardinal Health™ SVED® device.
* Signs of possible infection may include fever, tenderness, redness, swelling, itching, and rash, increased warmth in the
wound area, sudden increase in pain, 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 periwound induration (a sunburn-like rash) may be added signs of more serious
complications of infection.

6
Patient User Manual
2. Introduction to the Cardinal Health™ SVED® device
2.1 Getting to know the Cardinal Health™ SVED® device
You may not need to use many of the buttons on the device, but it is important that you are familiar with what they are
and their location (see Figure 1).
NOTE: The Cardinal Health™ SVED® device will be virtually silent during normal operation with a well-sealed dressing.
Canister Release
150 mmHg
70 mmHg
120 mmHg
Therapy Timer / Display
Low Pressure / Leak
Battery Charging Port
Power ON
Canister Full
Power OFF
Figure 1
2.2 Charging the Battery
The Cardinal Health™ SVED® device has an internal battery that provides up to 18 hours of operation from a single
full-charge.When the battery is running low, an alarm will sound to let you know you must plug in the device to charge
the battery. See section 3.3 ALARM OPERATION of this manual for AlarmTroubleshooting.
1. Plug the device’s A.C. Adapter into a suitable wall outlet (100-240VAC, 50-60Hz).
2. Insert the power plug into the Battery Charging Port on the side of the device (Figure 2).
3. The device will continue to work when charging.
The Cardinal Health™ SVED® device should only be used with the supplied A.C. Adapter. Use of an incorrectly rated
adapter could create a shock hazard for the patient and caregiver.

7
Patient User Manual
Figure 2
Clamp
Battery Charging Port
Therapy Timer / Display
Additional Battery Information
NOTE: The Cardinal Health™ SVED® is designed to permit use of the product while the internal battery is charging.
The device will continue to operate properly while charging is taking place.
Average Battery Life
The specied battery life of the Cardinal Health™ SVED® device with a fully-charged battery is approximately 18 hours.
The actual life is dependent on the integrity of the dressing. A leak in the dressing can reduce overall battery
longevity signicantly.
Average Time for Recharging
To ensure the battery has been fully charged, the device should be connected to an A.C. supply for approximately
3 hours. After approximately 2 hours of charging, the device 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 ashing
when remaining capacity of the battery is less than 20%.Typically, the device will continue to operate for approximately
1 hour after the low-battery alarm is activated.
Low Battery Shuto
If the battery charge falls below a critical level, the device will shuto automatically and therapy will be discontinued.
At this point, the device 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 device.

8
Patient User Manual
Recharging the Battery
Plug the power cord from the A.C. Adapter into the power connector on the side of the device. Plug the A.C. Adapter into
a suitable 120VAC, 60 Hz wall outlet.
When the device is connected to an AC power source, the GREEN LED below the power connector 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 Cardinal Health™ SVED® device is disconnected from the AC power source, the device will automatically
switch over to the internal battery and continue to operate without interruption.
2.3 Changing the Canister
If the canister lls with uid, an alarm will sound to let you know you must change the canister. Refer to the Alarm
Troubleshooting guide found in the 3.3 ALARM OPERATION section of this manual.
The canister full alarm begins when the canister is 90% full, but the device will continue to work until the canister
completely lls.
1. Clamp the tubing closed (Figure 3).
2. Turn the device OFF by pressing the button.
3. Remove the blue SpeedConnect™ tubing from the top of the canister (Figure 3).Twisting the tapered connector
will make removing the Suction tube from the canister easier.
Figure 3
SpeedConnect™ Tubing Connector
Clamp
Canister