background image

17

5. S

ymb

ols

Symbol

Standard/Law  

Reference

Standard/Law Title

Symbol Title/  

Text Reference

Explanatory Text

ISO 15223-1, 
Clause 5.5.1

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

In Vitro 

Diagnostic 

Medical Device

Indicates that a medical 
device is intended to be 
used as an

 in vitro 

diagnostic medical device.

IEC 60601-1, Table 
D.1, Symbol 10

Medical electrical equipment - Part 1: 
General requirements for basic safety 
and essential performance

Caution

Indicates the need for the 
user to consult the 
instructions for use for 
important cautionary 
information such as 
warnings and precautions 
that cannot, for a variety of 
reasons, be presented on 
the medical device itself.

ISO 7000-0434

Graphical symbols for use on equipment

ISO 15223-1, 
Clause 5.3.7

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

Temperature Limit

Indicates the temperature 
limits to which the medical 
device can be safely  
exposed.

ISO 7000-0632

Graphical symbols for use on equipment

ISO 15223-1, 
Clause 5.3.8

Medical devices - Symbols to be used 
with medical 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 equipment

ISO 15223-1, 
Clause 5.3.4

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

Keep Dry

Indicates a medical device 
that needs to be protected 
from moisture.

ISO 7000-0626

Graphical symbols for use on equipment

ISO 15223-1, 
Clause 5.3.1

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

Fragile,  
Handle with Care

Indicates a medical device 
that can be broken or 
damaged if not handled 
carefully.

ISO 7000-0621

Graphical symbols for use on equipment

ISO 15223-1, 
Clause 5.4.2

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

Do Not Reuse

Indicates a medical device 
that is intended for one 
use or for use on a single 
patient during   
a single procedure. 

ISO 7000-1051

Graphical symbols for use on equipment

ISO 15223-1, 
Clause 5.2.6

Medical devices - Symbols to be used 
with medical device labels, labeling and 
information to be supplied

Do Not Resterilize

Indicates that a medical 
device should not be 
resterilized.

ISO 7000-2608

Graphical symbols for use on equipment

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...

Отзывы: