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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. Lay users 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 
suffocation 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. 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 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 fields. 

Do not use this device in any areas with strong magnetic fields. 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 effectiveness of the system. 

CAUTION: 

The SVED® can be used outdoors for short periods of time (not more than 24 hours). Shelter from rain.

Содержание SVED NPWT

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

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

Страница 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...

Страница 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...

Страница 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...

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

Страница 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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