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Storz C-MAC 8401 Series, Instructions For Use Manual

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Storz C-MAC 8401 Series Instructions For Use Manual Download Page 35

Electromagnetic compatibility

Instruction For Use • C-MAC

®

 video laryngoscope 8401xxx, Electronic Module 8401/8402 X, C-MAC

®

 PM 8401

XD • 96076011EN-US • V3.1

35

16 Electromagnetic compatibility

The applied part described in these instructions for use has been tested as a system with the
following basic devices. For relevant electromagnetic compatibility (EMC) information, refer to
‘Electromagnetic Compatibility (EMC) information’ in the instructions for use for these basic
devices:

Basic device

Instructions for use

C-MAC

®

 Monitor 8403 ZX

96076008 D

C-MAC

®

 Pocket Monitor 8403 XD

96076020 D

C-HUB

®

 II 20 2903 20

96206529 D

The EMC warning statements, precautions, notes and Emission/Immunity limits specified in the
instructions for use for the basic devices also apply to the applied part described in these
instructions for use.

Summary of Contents for C-MAC 8401 Series

Page 1: ...Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD en...

Page 2: ...to use or disclose the contents thereof unless express consent is given Publisher KARL STORZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Tel 49 7461 708 0...

Page 3: ...ssories 9 3 7 Damage to the instrument 9 3 8 Damaged products 9 3 9 Allergic reactions 9 4 Product description 10 4 1 Product overview 10 4 2 Packaging symbols 12 4 3 Symbols on the product 12 4 4 Cha...

Page 4: ...V3 1 4 10 Guarantee 27 11 Standards directives and regulations 28 11 1 Standards directives and regulations 28 11 2 Standard compliance 28 12 Disposal 29 13 Technical data 30 14 Fault correction 32 1...

Page 5: ...ined We thus ask that you read these instructions carefully before proceeding to work with the instrument Keep these instructions available for ready reference If the instructions for use are not foll...

Page 6: ...with the airway algorithm in the respective country of application or the official specifications for airway management 2 4 User qualifications Only physicians and medical support staff with a releva...

Page 7: ...y precautions when using the C MAC PM The C MAC PM with C MAC video laryngoscope blade must be used according to the medical rules and procedures recognized for laryngoscopic methods The C MAC PM has...

Page 8: ...ssible imminent risk If this is not avoided it could lead to death or serious injuries CAUTION CAUTION Designates a possible imminent risk If this is not avoided it could lead to minor injuries ATTENT...

Page 9: ...on of IEC 60601 1 Anybody connecting additional equipment to medical electrical equipment is a system configurator and is therefore responsible for the system s compliance with the standard requiremen...

Page 10: ...Product description Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 10 4 Product description 4 1 Product overview...

Page 11: ...eter 8401 AX BX HX with guidance for suction catheter 11 10 12 1 Laryngoscope blade with holder for elec tronic module 2 Electronic module 3 Connecting cable for video monitor 4 Function key for video...

Page 12: ...Serial number 4 4 Charging Unit for C MAC PM WARNING Danger of electric shock Do not touch the patient and the charger plug at the same time For this reason the battery should be recharged outside the...

Page 13: ...Product description Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 13 3 Test for proper operation...

Page 14: ...ing components surface changes or other damage to the medical device limit its life span and may mean that the device can no longer be used for its intended purpose Check the instrument for Mechanical...

Page 15: ...smission 5 2 Initial operation WARNING Optical radiation The optical radiation of the instrument can injure the eyes of patients users and third parties Never look into the light output of a connected...

Page 16: ...off the display After 10 minutes the display of the C MAC PM turns off automatically and must be turned back on again by closing it and reopening it Switching off the Open to intubate OTI display 1 P...

Page 17: ...uction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 17 A B C D 5 2 2 Energy management The battery charge status is shown on the display f...

Page 18: ...es red at the latest For the C MAC PM there is a specially designed bag 8402 YE available which can be ordered as an option see chapter 15 1 Accessories 34 The C MAC PM is also included in a set which...

Page 19: ...image capture 5 is pressed the current image on the monitor is saved on the SD memory card incorporated in the connected Monitor 8403 ZX 6 2 Monitor function keys The monitor is equipped with 4 softke...

Page 20: ...ssembly 1 Unplug the connecting cable from the C MAC monitor connection 2 Push the connecting cable or the C MAC electronic module 2 Fig A from the video laryngoscope or the C MAC PM 12 Fig B out of t...

Page 21: ...ated reprocessing procedures In particular when the tray holder 39501 LC2 is used in a reprocessing machine no further accessories are needed CAUTION Damage to the product To prevent possible damage t...

Page 22: ...trument as soon as possible since encrusted debris can cause irreparable damage Remove major debris using an active cleaner e g tenside based and a disinfected sponge or soft disinfected brush Place i...

Page 23: ...leaning 93 C Steam ster ilization Gas steril ization Hydrogen peroxide sterilization Steris Sys tem 1 C MAC video laryngo scopes X X X C MAC PM 8401 XD X X X X X X Electronic Module 8401 X 8402 X X X...

Page 24: ...ocessing Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 24 Chemically sterilize the C MAC video laryngoscope in dismantled condi...

Page 25: ...oan which must then be returned to KARL STORZ as soon as you receive the repaired device In Germany you can refer repairs directly to KARL STORZ SE Co KG Abt Reparaturservice Take off Gewerbepark 83 7...

Page 26: ...26 9 Limitation of Liability As a supplier of this instrument we consider ourselves responsible for the safety reliability and performance of the instrument only if Assembly extension new adjustments...

Page 27: ...tions of Business of KARL STORZ The medical device must always be sent to your local subsidiary see the section Subsidiaries even during the warranty period Opening of the equipment or performance of...

Page 28: ...XC KXC HXP X XD ZX for 8402 X ZX 8403 ZX Complies with EN 60601 1 EN 60601 2 18 UL 2601 CSA 601 1 Provides Type BF protection when used in conjunction with a KARL STORZ camera control unit with a BF s...

Page 29: ...waste electrical and electronic equipment WEEE At the end of its useful operating life dispose of the unit as electronic scrap Please ask KARL STORZ SE Co KG a KARL STORZ subsidiary or your authorize...

Page 30: ...ology CMOS Resolution 320 x 240 Illumination LED white 1 W Average life cycle Reprocessing cycles 200 Value indicates the number of tested cycles The device s life span may be compromised if the recom...

Page 31: ...dule 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 31 Charging station 8401 XDL Classification IEC Class II Line frequency DC Voltage 5 V Power consumption 2 VA Weight Approx 230 g C MAC PM 8401 XD...

Page 32: ...C MAC PM in as far as it will go Send electronic module C MAC PM or supply unit to KARL STORZ for repair Cloudy picture stripes streaks or similar Telescope of the laryngoscope is soiled Contacts of...

Page 33: ...1 8402 X C MAC PM 8401 XD 96076011EN US V3 1 33 Video stream cannot be played back on the PC moni tor No MPEG 4 Codec installed Install an MPEG 4 Codec on the PC SD memory card cannot be written on SD...

Page 34: ...of water repellent and hard wearing surface material washable the bag contains two compart ments with several holding possibilities for C MAC video laryngoscopes with C MAC Pocket Monitor and for con...

Page 35: ...relevant electromagnetic compatibility EMC information refer to Electromagnetic Compatibility EMC information in the instructions for use for these basic devices Basic device Instructions for use C M...

Page 36: ...ARL STORZ Endoscopy Suomi OY Taivaltie 5 01610 Vantaa Finland Phone 358 0 96824774 Fax 358 0 968247755 E Mail asiakaspalvelu karlstorz fi KARL STORZ SE Co KG Representation Office K stu io st 59 Lenkt...

Page 37: ...8 65 4114 E Mail inquiry karlstorz com hk KARL STORZ Endoscopy Shanghai Ltd Beijing Branch Room 1805 1807 Building B 18F Beijing IFC No 8 Jianguomenwai Street Chaoyang District 100022 Beijing People s...

Page 38: ...Subsidiaries Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 38...

Page 39: ...Subsidiaries Instruction For Use C MAC video laryngoscope 8401xxx Electronic Module 8401 8402 X C MAC PM 8401 XD 96076011EN US V3 1 39...

Page 40: ...KG KARL STORZ SE Co KG Dr Karl Storz Stra e 34 78532 Tuttlingen Postfach 230 78503 Tuttlingen Germany Phone 49 0 7461 708 0 Fax 49 0 7461 708 105 E Mail info karlstorz com www karlstorz com 96076011EN...

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