Cardinal Health CATALYST NPWT Скачать руководство пользователя страница 24 | Manualshive

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Cardinal Health CATALYST NPWT Скачать руководство пользователя страница 24

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Standard/Law

Reference

Standard/Law Title

Symbol Title/

Text Reference

Explanatory Text

IEC 60601-1,
Table D.3, Symbol
2

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

Degrees of Ingress
Protection Provided
by Enclosure

Manufacturer-determined
degree of particle and water
ingress where 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 enclo-
sures (IP Code)

NOTE: When a characteristic
numeral is not required to be
specified, it is replaced by the
letter ÒXÓ.

IEC 60529

Degrees of protection provided by enclo-
sures (IP Code)

Degrees of Ingress
Protection Provided
by Enclosure

Protected against solid
foreign objects of 12.5mm
and greater, and against
the effects of continuous
immersion in water.

IEC 60529

Degrees of protection provided by enclo-
sures (IP Code)

Degrees of Ingress
Protection Provided
by Enclosure

Protected against solid
foreign objects of 1.0mm
and greater, and against
the effects of continuous
immersion in water.

IEC 60529

Degrees of protection provided by enclo-
sures (IP Code)

Degrees of Ingress
Protection Provided
by Enclosure

Protected against the
effects of continuous
immersion in water.

IEC 60529

Degrees of protection provided by enclo-
sures (IP Code)

Degrees of Ingress
Protection Provided
by Enclosure

Protected against the
effects of temporary
immersion in water.

IP22

IEC 60530

Degrees of protection provided by enclo-
sures (IP Code)

Degrees of Ingress
Protection Provided
by Enclosure

Protection against the
effects of insertion of fingers
and will not be damaged or
become unsafe when
exposed to vertically or
nearly vertical dripping water.

21 CFR Part
801.1(c)(1)(i)F

Labeling - Medical devices; prominence
of required label statements

Prescription Use
Only

Requires prescription for
sale in the United States
and is used in place of the
statement below:

CAUTION

: Federal law

restricts this device to sale
by or on the order of a
physician, dentist or licensed
practitioner.

21 CFR Part
801.109

Labeling - Prescription devices

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Содержание CATALYST NPWT

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

Страница 2: ...leak with your dressing What to do if you notice bleeding from the wound What to do if you must take your dressing off What activities you can do while using the CATALYST Who to call if you need help...

Страница 3: ...stem 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 Occlusion Detection Dress...

Страница 4: ...ATALYST 7 2 2 Charging the Battery 8 2 3 Changing the Canister 10 2 4 Disconnecting from the CATALYST 12 3 Operating Instructions 13 3 1 On Off 13 3 2Troubleshooting 14 4 Care Cleaning 18 4 1 Disposal...

Страница 5: ...h NPWT Occlusion Detection Dressing or Kendall NPWT Incision Management Dressing over exposed blood vessels or organs The Cardinal Health NPWT Occlusion Detection Dressings and Kendall NPWT Incision M...

Страница 6: ...erash maybeaddedsignsofmoreseriouscomplicationsofinfection Extracareandattentionshouldbe givenifthereareanysignsofpossibleinfectionorrelatedcomplications Infectioncanbeserious Withorwithoutthe CATALYS...

Страница 7: ...Negative PressureWoundTherapy Incision Management Dressing Kit is a wound dressing kit to be used with Cardinal Health Negative PressureWoundTherapy NPWT CATALYST ALLY and ALLYTO GO systems K171499 Th...

Страница 8: ...2 Figure 2 3 When the CATALYST is connected to an outlet the green light next to the Plugged In symbol comes on Figure 3 If the battery is charging the yellow light next to the Battery Charging symbo...

Страница 9: ...e CATALYST reaches 80 percent of total battery capacity Low Battery Alert While running on battery a Low Battery alert chirps every 10 seconds and the OFF Button flashes when remaining capacity of the...

Страница 10: ...anisteriscompletelyfull theCATALYST turnsoff To change the canister 1 Clamp the tubing closed Figure 4 NOTE Only applicable if clamp is present If clamp is not present skip to the next step Figure 4 2...

Страница 11: ...ealthcare 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 ports and pre...

Страница 12: ...e than 2 hours in a 24 hour period Your dressing may need to be changed To disconnect from the CATALYST 1 Clamp the tubing closed Figure 4 NOTE Only applicable if clamp is present If clamp is not pres...

Страница 13: ...e front of the CATALYST Figure 10 OFF Button ON Button Figure 10 1 Press the ON Button All lights show for 1 second during the power on self test When finished the ON Button stays green Figure 11 Figu...

Страница 14: ...alert turn the CATALYST OFF then back ON The alert will clear when the power is cycled WHATYOU SEE HEAR 1 Low Pressure Leak BLINK Push up on bottom of canister Wait 30 seconds BEEP BLINK WHATTO DO 1 I...

Страница 15: ...Canister Full Blockage is fixed BLINK BLINK 9 Wait 1 minute BEEP Call Cardinal Health at 1 866 484 6798 SOLIDLIGHT WHATYOU SEE HEAR BLINK BEEP BLINK Canister Full Blockage First look at the canister t...

Страница 16: ...proceed with the steps below WHATTO DO Turn ON 2 1 Wait 30 seconds If you see If you see hear Canister Full Blockage is fixed Call Cardinal Health at 1 866 484 6798 SOLIDLIGHT BLINK BLINK BEEP Turn OF...

Страница 17: ...w battery fixed WHATYOU SEE HEAR 5 Intermittent Mode WHATTO DO CATALYST makes more noise every 5 minutes when in Intermittent Mode No troubleshooting needed For more information contact your healthcar...

Страница 18: ...fore cleaning The battery provides power when the CATALYST is unplugged so negative pressure wound therapy is not interrupted Clean the CATALYST with a damp soft cloth and a mild soap and water soluti...

Страница 19: ...eling 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 m...

Страница 20: ...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...

Страница 21: ...device 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...

Страница 22: ...for use on equipment IEC 60878 5140 Graphical symbols for electrical equip ment in medical practice ISO 15223 1 Clause 5 3 9 Medical devices Symbols to be used with medical device labels labeling and...

Страница 23: ...ins or Presence of Natural Rubber Latex Indicatesthepresenceof naturalrubberordrynatural rubberlatexasamaterialof constructionwithinthe medicaldeviceorthe packagingofamedicaldevice EN 50419 Marking of...

Страница 24: ...s Protection Provided by Enclosure Protected against solid foreign objects of 1 0mm and greater and against the effects of continuous immersion in water IEC 60529 Degrees of protection provided by enc...

Страница 25: ...ed for Class II equipment according to IEC 61140 ISO 7000 2616 External cord connected External Cord Connected Indicates that device is connected to an external power source ISO 7000 5008 OFF power OF...

Страница 26: ...thetic latex This glove has been tested for resistance to permeation of various chemotherapy drugs per ASTM D6978 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chem...

Страница 27: ...s on how to open pouch 1 Single Glove 1 Single Glove Contains a single glove TUV Listed Productiscertifiedunder TUV sListingandClassifi cationservicesandforTUV certificationsforCanadaand theUSA Device...

Страница 28: ...Hz 0 8Amp Max External Power Supply Output 15VDC 2Amp EnvironmentalConditions Note Storage and Operation Conditions do not apply to the Additional Parts Identified within Section 7 CATALYST Storage Co...

Страница 29: ...r in 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 CATALYST is intended for use in an electromagnetic environment in which radiated RF disturbances are c...

Страница 30: ...1000 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 CATALYST including cables than the recommended s...

Страница 31: ...LYST please contact your local Cardinal Health representative or Call Customer Service at 1 866 484 6798 Cardinal Health Waukegan IL 60085 www cardinalhealth com Alwaysconsultaphysicianandproductinstr...

Страница 32: ...020 Cardinal Health All Rights Reserved CARDINAL HEALTH the Cardinal Health LOGO KENDALL CATALYST TWIST N CONNECT SENSISKIN and SPEEDCONNECT are trademarks or registered trademarks of Cardinal Health...

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