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  Directive 93/42/EEC on medical devices
  Medical electrical equipment IEC 60601-1
  Medical electrical equipment: Requirements in home healthcare

environment IEC 60601-1-11

  Medical electrical equipment ANSI/AAMI ES 60601-1
  Medical electrical equipment CAN/CSA-C22.2 No. 60601
  Electromagnetic compatibility according to IEC 60601-1-2

Notified Body:

TÜV SÜD Product Service GmbH

Ridlerstraße 65

80339 München, Germany

Manufacturer:

Storz & Bickel GmbH

In Grubenäcker 5-9

78532 Tuttlingen, Germany

10 C O M PL I A N C E W I T H L EG A L A N D

N O R M AT I V E R EQ U I R E M E N T S

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Содержание Mighty Plus MEDIC

Страница 1: ...INSTRUCTIONS FOR USE Read carefully before using the device and save these instructions...

Страница 2: ...1 Intended Use 13 3 2 Side Effects 13 3 3 Contraindications 13 4 Important Information about Cannabinoids 14 5 Commissioning and Operation 15 5 1 Storage and Transport Conditions 15 5 2 Unpacking 15...

Страница 3: ...Settings 22 5 9 Inhalation 22 5 10 End of Inhalation 22 5 11 Disposal of the Dosing Capsules 23 5 12 Automatic Switching Off 23 5 13 Storage 23 6 Cleaning Hygiene 24 6 1 Mouthpiece 24 6 2 Cooling Unit...

Страница 4: ...ries 30 8 Faults 31 8 1 Possible Faults Troubleshooting 31 8 2 Disposal 31 9 Technical Specifications 32 9 1 MIGHTY MEDIC Vaporizer 32 9 2 USB Charger 32 9 3 Technical Requirements for suitable Charge...

Страница 5: ...c USB Charger 3 1 pc USB C Cable USB Type C to USB Type A Plug 4 3 pcs Normal Screen small 3 pcs Coarse Screen small 5 3 pcs Base Seal Ring small 6 1 pc Magazine with 8 Dosing Capsules 7 1 pc Herb Mil...

Страница 6: ...11 6 7 8 1 Filling Chamber 2 Mouthpiece 3 Actual Temperature Display 4 Plus Temperature Button 5 USB C Charging Socket 6 Set Temperature Display 7 Battery Charging Display 8 Filling Chamber Tool 9 ON...

Страница 7: ...al replacement of the batteries and in warranty ca ses please contact our Service Center Storz Bickel GmbH Service Center In Gruben cker 5 9 78532 Tuttlingen Germany Tel 49 74 61 96 97 07 0 e mail inf...

Страница 8: ...ccor ding to IEC 60601 1 CAN CSA C22 2 No 60601 1 and ANSI AAMIES 60601 1 Safety Category II device Please follow these instructions carefully according to IEC 60601 Symbol for the manufacturer the ma...

Страница 9: ...corresponding devices are listed by UL Safety Category II device Air pressure limitation Intermittent operation INT 7 on 30 off Humidity limitation 2 2 Explanation of Symbols of the USB Charger Interf...

Страница 10: ...USB C Cable X Always follow the instructions in these Instructions for Use when using and servicing the device X The Vaporizer is not intended for use with children and adolescents un der 18 years of...

Страница 11: ...damaged by bending crushing or pulling X Do not use multiple sockets and or extension cables Where absolute ly necessary use only products with a quality certificate e g UL IMQ VDE S etc if the stated...

Страница 12: ...ot close cover or obstruct the openings of the Vaporizer during op eration and the cooling phase X Before switching on the Vaporizer ensure that all vapors e g from flam mable cleaning agents and disi...

Страница 13: ...y a physician for use at home in a hospital or doctor s office 3 2 Side Effects There are no known side effects from using the device There are no contraindications specific to the device 3 3 Contrain...

Страница 14: ...allow the use of hemp flowers for medical purposes get a prescription of a certain amount of dried hemp flowers These hemp flowers are delivered either as whole pieces or already ground and have to b...

Страница 15: ...g Chapter 1 1 Scope of Delivery page 5 X Clean the Mouthpiece according to the instructions in Chapter 6 1 Mouth piece page 24 before first use X Check the Vaporizer USB Charger and USB C Cable for ex...

Страница 16: ...to 80 5 4 2 Charging the Battery X Fully charge the battery before first use X Connect the Vaporizer to a USB Charger or computer using the USB C Cable supplied 5 4 3 Explanation of the Battery Charg...

Страница 17: ...ting up of the display Display indication in the second line SLO X Use a more powerful charger 5 4 4 End of Charging Process X When the charging process is finished first disconnect the USB C Cable fr...

Страница 18: ...he Herb Mill X Turn the Herb Mill back and forth 4 5 times 5 7 1 Filling the Dosing Capsule with the Aid of the Magazine Cap X Unscrew the Magazine Cap counter clockwise X Place the Magazine Cap on th...

Страница 19: ...lockwise 5 COMMISSIONING AND OPER ATION X Unscrew the Cooling Unit from the Vaporizer by turning it 90 counter clockwise 5 7 3 Inserting the Dosing Capsule into the Filling Chamber X Insert the Dosing...

Страница 20: ...Basic temperature and booster temperature can be changed individually whereas the superbooster temperature is fixed X Start inhalation at 180 C 356 F X If one temperature level is no longer sufficien...

Страница 21: ...he booster temperature has been reached Booster mode ends automatically 90 seconds after the booster tempera ture has been reached the set temperature is then the basic temperature again 5 8 6 Superbo...

Страница 22: ...y the alveoli and thus enters the bloodstream The effect sets in after about 1 2 minutes and lasts for about 2 4 hours CAUTION High intensity of vapors Irritation of the respiratory tract lungs Reduce...

Страница 23: ...ule after use in household waste as it is a disposable product 5 12 Automatic Switching Off X Three minutes after the last keystroke or the last application the Vaporiz er switches off automatically t...

Страница 24: ...Cooling Unit with Mouthpiece is intended for one person and can be used by that person several times They must be free of deposits Deposits on the inside of the Cooling Unit are caused by steam conden...

Страница 25: ...in isopropyl alcohol remove the cap lock by pulling it up on one side X Unscrew the Cooling Unit base from the Vaporizer by turning it 90 coun terclockwise X Lever out the large Base Seal Ring with Fi...

Страница 26: ...nning water for at least 1 minute X If necessary clean the Cap Lock with warm rinsing water X Let all parts dry completely 6 2 2 2 Cleaning the Cooling Unit and the Filling Chamber Screen with Isoprop...

Страница 27: ...arts for damaged surfaces cracks softening hardening em brittlement contamination or discoloration X Discard damaged parts 6 2 4 Assembling the Cooling Unit CAUTION Plant particles in the Cooling Unit...

Страница 28: ...essed air X Clean the Filling Chamber with a cotton swab soaked in isopropyl alcohol 6 3 2 Removing the Screen X If a Screen is clogged it must be replaced X Press in the Screen using the Filling Cham...

Страница 29: ...as the USB C Cable only when dry or with a damp soft cloth 6 6 Cleaning the Herb Mill and Magazine for Dosing Capsules NOTICE Material damage caused by improper cleaning Damage to the surfaces Do not...

Страница 30: ...Ring Set SKU 11 15 The Set contains all the sealing rings for the Cooling Unit and Filling Chamber Filling Chamber Tool Set SKU 11 19 The various application options of the Filling Chamber Tool are de...

Страница 31: ...ry XAlternatively Operate Va porizer with Supercharger ERR 001 Battery tempera ture is too high XLet the Vaporizer cool down ERR 002 Battery tempera ture is too low XMove the Vaporizer to a warm envir...

Страница 32: ...9 3 Technical Requirements for suitable Chargers X Chargers must comply with USB USBC standard X Only use original Storz Bickel Chargers For general charging a USB charger with at least 5 VDC 2 A 12 W...

Страница 33: ...1 Medical electrical equipment ANSI AAMI ES 60601 1 Medical electrical equipment CAN CSA C22 2 No 60601 Electromagnetic compatibility according to IEC 60601 1 2 Notified Body T V S D Product Service G...

Страница 34: ...roduct Storz Bickel will decide at its own discretion whether to correct a defect covered by warranty law through repair or by delivering a new product to the customer Any warranty claims must be dire...

Страница 35: ...B The MIGHTY MEDIC Vaporizer uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Electroma...

Страница 36: ...at supplies buildings used for domestic purposes provided the following warning is heeded Warning This equipment system is intended for use by healthcare professionals only This equipment system may c...

Страница 37: ...onment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2...

Страница 38: ...nt guidance Mains power quality should be that of a typical commercial or hospital environment If the user of the MIGHTY MEDIC Vaporizer requires continued operation during power mains interruptions i...

Страница 39: ...ipment should be used no closer to any part of the MIGHTY MEDIC Vaporizer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the tran...

Страница 40: ...d people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot b...

Страница 41: ...ion distance according to frequency of transmitter m 0 01 0 12 0 12 0 23 0 73 2 3 7 3 23 0 38 1 2 3 8 12 0 38 1 2 3 8 12 0 1 1 10 100 For transmitters rated at a maximum output power not listed above...

Страница 42: ...r STORZ BICKEL GmbH In Gruben cker 5 9 78532 Tuttlingen Germany Phone 49 7461 969707 0 Fax 49 7461 969707 7 e mail info storz bickel com by STORZ BICKEL GmbH MMAL 30 204 16_en_08 2021 Subject to alter...

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