Cardinal Health SVED NPWT Patient User Manual Download Page 6

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1. I

ntr

oduc

tion

•  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 fills with fluid, 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®. 

Summary of Contents for SVED NPWT

Page 1: ...Cardinal Health Negative Pressure Wound Therapy SVED Patient User Manual...

Page 2: ...ctivities 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...

Page 3: ...er Modification of this system could result in physical hazards including delayed therapy electrocution and fire These hazards could result in injury or death WARNING Use only the Cardinal Health NPWT...

Page 4: ...rging 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 2Troubleshooting Guide 13 4 Care Cleaning 14 4 1 Disposal of Used C...

Page 5: ...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 barri...

Page 6: ...e 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 orh...

Page 7: ...s 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 Rele...

Page 8: ...D 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...

Page 9: ...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 SV...

Page 10: ...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...

Page 11: ...t least 22 hours out of every 24 hour period Contactyourhealthcare professionalimmediatelyiftherapyisterminatedorisoffformorethan2hoursina24 hourperiod Your dressing may need to be changed To disconne...

Page 12: ...Health Customer Service at 1 866 484 6798 3 1 POWER ON OFF The ON and OFF buttons are located on the front of the SVED 1 Press the ON button All lights show for 1 second during the power on self test...

Page 13: ...ound replace the canister Open the clamp Once the leak is found and sealed the alert resets the Pressure Setting Button quits flashing and the SVED becomes quiet If alert continues call Cardinal Healt...

Page 14: ...ult in injury or death 4 1 Disposal of Used Components Your healthcare professional should remove your dressings tubings clamps used canisters and any other disposables Ask your healthcare professiona...

Page 15: ...rshouldbeinspectedregularlyfordamage IfyounoticeanydamagetotheA C PowerAdapter callyourhealthcareprofessionalforareplacementtoavoidinterruptionoftherapy WARNING The SVED should only be used with the s...

Page 16: ...and information to be supplied Authorized European Representative Indicates the Authorized Representative in the European Union ISO 15223 1 Clause 5 1 6 Medical devices Symbols to be used with medica...

Page 17: ...l device labels labeling and information to be supplied Humidity Limitation Indicates the range of humidity to which the medical device can be safely exposed ISO 7000 2620 Graphical symbols for use on...

Page 18: ...ice that has been sterilized using irradiation ISO 7000 2502 Graphical symbols for use on equipment ISO 15223 1 Clause 5 2 5 Medical devices Symbols to be used with medical device labels labeling and...

Page 19: ...that intentionally apply RF electromagnetic energy for diagnosis or treatment IEC 60417 5140 Graphical symbols for use on equipment IEC 60878 5140 Graphical symbols for electrical equipment in medical...

Page 20: ...used with medical device labels labeling and information to be supplied Does Not Contain Natural Rubber Latex The medical device or the packaging of the medical device does not contain natural rubber...

Page 21: ...re N1 degree of protection from particles scale of 0 6 and N2 degree of protection from water scale of 0 8 IEC 60529 Degrees of protection provided by enclosures IP Code NOTE When a characteristic num...

Page 22: ...a physician dentist or licensed practitioner 21 CFR Part 801 109 Labeling Prescription devices Directive 93 42 EEC Articles 4 11 12 17 Annex 12 Council Directive 93 42 EEC of 14 June 1993 concerning...

Page 23: ...e programmed or to be programmed duration ISO 7000 5546 Battery check Battery Check To identify the battery condition indicator ISO 7000 0623 This way up ThisWay Up To indicate correct upright positio...

Page 24: ...ermeation of various chemicals per ASTM F739 StandardTest Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact 1 Pair of Gloves 1 Pai...

Page 25: ...uctiscertified underTUV sListingand Classificationservicesand forTUVcertificationsfor CanadaandtheUSA Device Plugged into an Outlet Indicates that device is connected to an external power source Batte...

Page 26: ...AC 50 60Hz 0 8Amp Max External Power Supply Output 15VDC 2Amp Patient Enclosure Leakage Current 100Micro amps SVED Storage Conditions Note Storage and Operation Conditions do not apply to the Addition...

Page 27: ...n meter s 0 01 0 1 1 10 100 0 12 0 38 1 2 3 8 12 0 12 0 38 1 2 3 8 12 0 23 0 73 2 3 7 3 23 The SVED is intended for use in an electromagnetic environment in which radiated RF disturbances are controll...

Page 28: ...RF IEC 61000 4 3 3V rms 150kHz 80MHz 3V m 800MHz 2 5GHz 3V rms 3V m Portable and mobile RF communications equipment should be used no closer to any part of the SVED including cables than the recommend...

Page 29: ...D pleasecontactyourlocalCardinalHealth representative or Call Customer Service at 1 866 484 6798 Cardinal Health Waukegan IL 60085 www cardinalhealth com Alwaysconsultaphysicianandproductinstructionsf...

Page 30: ...0 10 cardinalhealth com 2020 Cardinal Health All Rights Reserved CARDINAL HEALTH the Cardinal Health LOGO SVED SENSISKIN and SPEEDCONNECT are trademarks or registered trademarks of Cardinal Health Pat...

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