Cardinal Health CATALYST NPWT Patient User Manual Download Page 30

30

 6. Sp

ecific

ations 

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity (IEC 60601-1-2)

Immunity Test

IEC 60601 Test Level Compliance Level

Electromagnetic  

Environment-Guidance

Electrostatic discharge (ESD) IEC 
61000-4-2

±6kV contact
±8kV air

±6kV contact
±8kV air

Floor should be wood, concrete or ceramic tile. If floors 
are covered with synthetic material, the relative humidity 
should be at least 30 percent.

Electrical fast transient/burst

±2kV for power supply lines
±1kV for input/output

±2kV for power supply lines
±1kV for input/output

Mains power quality should be that of a typical  
commercial and/or hospital environment.

Surge
IEC 61000-4-5

±1kV line to line
±2kV line to earth

±1kV line to line
±2kV line to earth

Mains power quality should be that of a typical  
commercial and/or hospital environment.

Voltage dips, short interruptions 
and voltage variations on power 
supply 
IEC 61000-4-11

<5% 

U

T

(>95% dip in 

U

T

) for 0.5 cycle

<5% 

U

T

(>95% dip in 

U

T

) for 0.5 cycle

Mains power quality should be that of a typical  
commercial and/or hospital environment.

40% 

U

T

(60% dip in 

U

T

) for 5 cycles

40% 

U

T

(60% dip in 

U

T

) for 5 cycles

70% 

U

T

(30% dip in 

U

T

) for 25 cycles

70% 

U

T

(30% dip in 

U

T

) for 25 cycles

<5% 

U

T

(95% dip in 

U

T

) for 5 sec.

<5% 

U

T

(95% dip in 

U

T

) for 5 sec.

Power frequency (50/60Hz) 
magnetic field 
IEC 61000-4-8

3A/m

3A/m

Power frequency magnetic fields should be at levels 
characteristic of a typical location in a typical commercial 
or hospital environment.

Note: 

U

T

 is the A.C. mains voltage prior to application of the test level.

Conducted RF IEC 61000-4-6
Radiated 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 CATALYST™ including cables, than the 
recommended separation distance calculated from the equation 
appropriate to the frequency of the transmitter.

Recommend separation distance

  

d

 = 1.2 √

P

d

 = 1.2 √

P

 80MHz to 800MHz 

= 2.3 √

P

 800MHz to 2.5GHz

where 

P

 is the maximum output power rating of the transmitter in watts 

(W) according to the transmitter manufacturer and 

d

 is the recommended 

separation distance in meters (m).
Field strengths from fixed RF transmitters as determined by an 
electromagnetic site survey, 

should be less than the compliance level in 

each frequency range.

ь

Interference may occur in the vicinity of equipment marked with the 
following symbol:

Note 1: At 80MHz and 800MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast and TV 

broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey 
should be considered. If the measured field strength in the location in which the CATALYST™ is used exceeds the applicable RF compliance level above, the CATALYST™ 
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 
CATALYST™. 

ь

 Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Summary of Contents for CATALYST NPWT

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

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

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

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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...

Page 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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