Cardinal Health SVED NPWT User manual

Cardinal Health™
Negative Pressure Wound Therapy SVED®
Patient User Manual

2
Patient User Manual
About Your Cardinal Health™ SVED®
Your doctor has chosen the Cardinal Health™ SVED® to remove uid from your wound by using carefully controlled
suction. It is important, however, for you to carefully watch the wound and the SVED® to make sure that the SVED® is
working properly. Below is some important information and questions that you should ask your healthcare professional.
Things you need to know about your SVED®
• Do not allow the SVED® to get wet. Clamp the tubing and disconnect from the canister if you take a bath or shower.
• Keep the SVED® plugged in whenever possible to keep the battery fully charged. Always take the A.C. Power
Adapter with you when you leave home.
• Keep the SVED® upright to avoid a false Canister Full Alert.
• Keep the SVED® turned on at all times unless there is bleeding from the wound or instructed by your
healthcare professional.
• Do not change the Pressure Settings on the SVED® 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 SVED® 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 SVED®.
• Who to call if you need help.
• How to take care of your SVED®.
This 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 Cardinal Health Customer Service at 1.866.484.6798.
In order for the 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.
• All assembly, operation, adjustment, modication, maintenance, and/or repair must be carried out only by qualied
personnel authorized by Cardinal Health. Unauthorized modication of the SVED device may result in physical hazards,
including delayed therapy, electrocution and re that may lead to injury or death.
• The electrical outlets in the room in which the SVED® is used complies with the appropriate national
electrical standards.
• The SVED® NPWT System must be used in accordance with this manual and all associated labeling and the
Instructions for Use.
• Any SVED® that does not function as expected must be returned to Cardinal Health.
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 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.

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Patient User Manual
Safety and Warnings
Note to healthcare personnel providing training to lay users or caregivers (lay responsible organizations):
Be sure to include all of the warnings below when providing training to lay operators, especially in a home care
environment. Layusers and caregivers should contact Customer Support if there is a change in the performance of the
SVED®. Additionally, lay users should be instructed on proper cleaning procedures to avoid hazards such as electric
shock. Lay users and caregivers should also be trained on inappropriate environments for use (e.g. bathtub).
For guidance on training, please contact Customer Support.
WARNING: Strangulation hazard. Do not leave A.C. Power Adapter cord, tubing or other choking hazards where infants
or young children can become caught. If these objects get wrapped around the neck, strangulation and death can occur.
WARNING: Choking hazard.The SVED® contains small parts, which could become detached and pose a choking hazard.
Some of these components could be inhaled or swallowed by a small child, toddler or infant, which could result in
suocation or death. Keep all parts of the SVED® system out of reach of small children.
WARNING: Do not modify this equipment without authorization from the manufacturer. Modication of this system
could result in physical hazards, including delayed therapy, electrocution and re. These hazards could result in injury
or death.
WARNING: Use only the Cardinal Health™ NPWT Dressing and accessories listed in this manual. Use of other dressings
and accessories can create hazardous situations, including improper therapy or delayed therapy. This could result in
improper healing, damage to the wound area and infection.
CAUTION: Use the SVED® only as described in this user manual. Do not interconnect this SVED® with other devices not
included in this user manual. Failure to comply could result in improper therapy and could result in damage to
the SVED®.
CAUTION: This system is not intended to be used in MRI environments or in the presence of strong magnetic elds.
Do not use this device in any areas with strong magnetic elds. The system contains metal components which could
cause unintended movement.This unintended movement could cause clinician or patient harm due to falling objects
or collisions.
CAUTION: If you are in an environment with pet hair, please use caution when adhering the wound dressing to the
wound site. Pet hair could contaminate the wound site and prevent adhesion of the wound dressing.This could result in
possible infection of the wound or reduced eectiveness of the system.
CAUTION: The SVED® can be used outdoors for short periods of time (not more than 24 hours). Shelter from rain.

Table of Contents
1. Introduction ...................................................................................................................................5
1.1 Indications .......................................................................................................................................................... 5
1.2 Contraindications ............................................................................................................................................... 5
1.3 Precautions ........................................................................................................................................................ 5
1.4 Safety Tips .......................................................................................................................................................... 6
2. Introduction to the SVED® ................................................................................................................7
2.1 Getting to Know the SVED® ................................................................................................................................ 7
2.2 Charging the Battery........................................................................................................................................... 8
2.3 Changing the Canister ........................................................................................................................................ 9
2.4 Disconnecting from the SVED® ......................................................................................................................... 11
3. Operating Instructions ................................................................................................................... 12
3.1 Power ON/OFF .................................................................................................................................................. 12
3.2 Troubleshooting Guide ...................................................................................................................................... 13
4. Care & Cleaning ............................................................................................................................. 14
4.1 Disposal of Used Components ........................................................................................................................... 14
4.2 Cleaning the SVED® .......................................................................................................................................... 14
4.3 A.C. Power Adapter Inspection ......................................................................................................................... 15
5. Symbols Glossary ........................................................................................................................... 16
6. Specications ................................................................................................................................26
6.1 Electromagnetic Compatibility..........................................................................................................................27
7. Questions & Information ................................................................................................................ 29

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1. Introduction
1. Introduction
1.1 Indications
The SVED® Negative PressureWound Therapy (NPWT) 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 SVED® NPWT System is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds,
surgical incisions following sutured or stapled closure, partial-thickness burns, ulcers (such as diabetic
or pressure), aps and grafts.The SVED® NPWT System is intended for use in acute, extended and home care settings.
1.2 Contraindications
The 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 dressings over exposed blood vessels or organs.
The 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 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.
• Debrillation: The dressings must be removed 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 SVED® is not MRI-compatible and cannot be used in the presence
of strong magnetic elds. Do not take the SVED® into the MRI area or any area of high magnetic elds.The SVED®
contains metal components that could cause unintended movement resulting in harm due to falling objects
or collisions.
• Hyperbaric Oxygen Therapy (HBO): NEVER allow a SVED® inside a hyperbaric chamber.The SVED® must be
disconnected from the patient prior to HBO treatment.
• Changes in Performance: If you notice unusual changes in the performance of the system, contact customer
service at 1.866.484.6798.

6
1. Introduction
• During negative pressure wound therapy, the SVED® and dressings are a closed system and are NOT vented
to atmosphere.
• During negative pressure wound therapy, when a canister lls with uid, it should be replaced immediately.
Fluid will not be removed from the dressing once the canister is full.
1.4 Safety Tips
Keep Therapy On
The SVED® 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.
Troubleshooting
If the SVED® alerts or does not seem to operate properly, see 3.2 Troubleshooting.
Monitoring the Wound
Inspect the dressing frequently to ensure that the dressing is collapsed and that therapy is being delivered in a
consistent manner. Monitor wound, canister and tubing for signs of active bleeding. Monitor around your wound
or incision for signs of infection or other complications. Signs of possible infection may include fever, tenderness,
redness, swelling, itching and rash, increased warmth in the wound area, sudden incerease in pain, purulent discharge
or a strong odor. Nausea, vomiting, diarrhea, heacache, dizziness, fainting, sore throat with swelling of the mucous
membrane, disorientation, high fever, refractory hypotension, orhtostatic hypotension, or periwound induration (a
sunburn-like rash) may be added signs of more serious complications of infection. 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®, 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
SVED® until the serious infection is diagnosed and properly treated by your healthcare professional.
NPWT Dressing Use
Your healthcare professional will apply and change your dressings for you.
Monitoring the Tubing/A.C. Power Adapter Cord
Do not allow tubing or A.C. Power Adapter Cord around the neck area.
NOTE: All dressing components of the NPWT Dressing Kit are packaged sterile.The decision to use clean versus sterile/
aseptic technique is dependent upon your healthcare professional’s preference. SVED®, the NPWT Dressing Kits, the
canisters and other accessories are made without natural rubber latex.
Be sure to comply with all other 1.2 Contraindications and 1.3 Precautions for the SVED®.

7
2. Introduction to the SVED®
2. Introduction to the SVED®
2.1 Getting to Know the SVED®
You may not need to use many of the buttons on the SVED®, but it is important that you are familiar with what they are
and their location (see Figure 1).
NOTE: The SVED® will be quiet during normal operation with a well-sealed dressing.
Canister Release Button
Low Pressure / Leak Alert
Battery Charging Port
ON Button
Canister Full Alert
Pressure Settings
OFF Button
Figure 1

8
2. Introduction to the SVED®
2.2 Charging the Battery
The SVED® has an internal battery that provides up to 18 hours of operation from a fully charged battery.
When the battery is running low, an alert will sound to let you know you must plug in the SVED® to charge the battery.
See 3.2 Troubleshooting.
1. Plug the A.C. Power Adapter into a suitable wall outlet (100-240VAC, 50-60Hz).
2. Insert the A.C. Power Adapter into the Battery Charging Port on the left side of the SVED® (Figure 2).
3. When the SVED® is connected to an outlet, the green light next to the Plugged In symbol comes on. If the battery
is charging, the yellow light next to the Battery Charging symbol comes on. Once the battery is fully charged, the
light goes o.
NOTE: If the SVED® is plugged in and green light does not turn on, check to make sure outlet is working properly.
4.The SVED® continues to work when charging.
WARNING: The SVED® must only be used with the supplied A.C. Power Adapter. Use of any other A.C. Power Adapter
or charger could result in physical hazard, including delayed therapy, electrocution and re.These hazards could result
in injury or death.
Figure 2
Battery Charging Port
Plugged In
Battery Charging
Average Battery Life
The specied battery life of the SVED® with a fully-charged battery is up to 18 hours.The actual life is dependent on the
integrity of the dressing. A leak in the dressing can signicantly reduce overall battery longevity.
Average Time for Recharging
To ensure the battery has been fully charged, the SVED® should be connected to an A.C. Power Adaptor for
approximately 3 hours. After approximately 2 hours of charging, the SVED® reaches 80 percent of total battery capacity.

9
2. Introduction to the SVED®
Low Battery Alert
While running on battery, a Low Battery Alert“chirps”every 10 seconds and the OFF button ashes when remaining
capacity of the battery is less than 20 percent (See 3.2 Troubleshooting).Typically, the SVED® continues to operate for
approximately 1 hour after the Low Battery Alert sounds.
If the battery charge gets too low, the SVED® shuts o and the negative pressure wound therapy is stopped. At this
point, the SVED® must be plugged into an outlet using the A.C. Power Adapter for negative pressure wound therapy
to resume. Once the A.C. Power Adapter is plugged in, press the ON button to restart the SVED®.
2.3 Changing the Canister
When the SVED® detects that the canister needs to be changed, a Canister Full Alert sounds.The SVED®
continues to work until the canister completely lls.When the canister is completely full, the SVED® turns o.
To change the canister:
1. Clamp the tubing closed (Figure 3).
2. Turn the SVED® OFF by pressing the OFF button.
3. Remove the blue SpeedConnect™ tubing connector from the top of the canister (Figure 3) by twisting o the
tapered connector.
Figure 3
SpeedConnect™ Tubing Connector
Clamp
Canister

10
2. Introduction to the SVED®
4. To remove the canister, press the Canister Release Button located above the canister, grasp the canister at the
bottom and gently pull downward (Figure 4).
Figure 4
Canister Release
Canister
5. Cap the canister and ask your healthcare professional how to properly dispose of a used canister.
6. To install a new canister, hold the new unused canister at the bottom and slide upwards into the holder.
7. Align the two short ports and press upwards until it“clicks”into place.
8. Reconnect the blue SpeedConnect™ tubing connector to the canister. Gently twist and push the connector on the
open port of the canister just enough to secure and seal it.
9. Turn the SVED® ON by pressing the ON button to resume therapy.
10. Reopen the tubing clamp.