Vapormed MIGHTY MEDIC Instructions For Use Manual

INSTRUCTIONS FOR USE
Read carefully before using the device
and save these instuctions.
INSTRUCTIONS FOR USE ENGLISH
Table of Contents ................................................ Page
2. Explanation of Symbols,
Safety Recommendations ............................................ 8
4. Important Remarks ..................................................... 14
- Operating Conditions,
5. Commissioning and Operation of the
MIGHTY MEDIC Vaporizer ............................................ 17
5.1. Unpacking ............................................................ 17
5.2. Power Connection ................................................ 17
5.3. Application and Operation ................................... 18
5.4. Charging the Battery ............................................ 18
5.6. Temperature Setting ............................................ 21
5.7. Reset to Default Settings ..................................... 21
5.8. Default Settings .................................................... 21
6.1. Filling the Dosing Capsules ................................. 22
6.2. Inserting the Dosing Capsules ............................ 23
7. The Use of Hemp Flowers (Cannabis Flos) ............... 25
7.1. Preparation ........................................................... 26
7.2. Application and Inhalation ................................... 26
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INSTRUCTIONS FOR USE ENGLISH
1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE
Table of Contents
8. Hygiene ....................................................................... 28
8.1. Disposable Lip Piece for Hygienic Use ............... 29
8.2. Cooling Unit with Mouthpiece .............................. 30
8.3. Cleaning of the Cooling Unit
with Mouthpiece ................................................... 32
8.4. Inspecting/Maintenance of the
9. Disassembly and Assembly of the
MIGHTY MEDIC Cooling Unit .................................... 34
10.1. Cleaning of the MIGHTY MEDIC
Vaporizer and the Power Adapter ........................ 36
10.2. Care and Maintenance,
Storage, Disposal ................................................. 36
10.3. Troubleshooting,
Periodic Safety Checks ....................................... 37
10.4. Technical Specifications ...................................... 39
10.5. Information on Electromagnetic
Compatibility ......................................................... 40
11. Spare Parts and Accessories ...................................... 47
14. Proof of the Annual Safety Checks ............................... 51
............................................... Page
Product Overview:
MI GHTY MEDIC Vaporizer
3 pcs. Lip Piece
1 Set of Spare Seal Rings
Instructions for Use
Power Adapter
Herb Mill
Magazine with
8 pcs. Dosing CapsulesCleaning Brush3 pcs. Spare Screens
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1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE 1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE
MIGHTY MEDIC Vaporizer functional elements:
Filling Chamber
Cooling Unit
Minus Temperature Button
Type Label (on the rear)
ON/OFF Switch
Charging Socket
Filling Chamber Tool (under the Type Label)
Mouthpiece
Actual Temperature Display
Plus Temperature
Set Temperature
Battery Charging Display
Button
Display
Delivery includes MIGHTY MEDIC:
1 pc. MIGHTY MEDIC Vaporizer 1 pc. Instructions for Use 1 pc. Power Adapter 4 pcs. Spare Seal Rings 1 pc. Cleaning Brush 1 pc. Magazine with 8 pcs. Dosing Capsules 1 pc. Herb Mill 3 pcs. Spare Screens 3 pcs. Lip Piece
Please check whether all components have been included. If not, please inform our Service Center.
Operating life:
The MIGHTY MEDIC Vaporizer has an average expected operating life of: – approx. 1,000 operating hours – approx. 5 years
The batteries have an average expected operating life of: – approx. 500 operating hours – approx. 2 years
For exchanging the batteries, please contact our Service Center.
Service
Contact in case of technical problems or questions about the device:
Storz & Bickel Service Center
Tel.: +49-74 61-969707-0 · e-mail: info@vapormed.com For repairs, warranty claims, or disposal, please send the device to
the following address:
Storz & Bickel & Co. KG
Service Center In Grubenäcker 5-9 78532 Tuttlingen, Germany
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2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
Please read the following safety recommendations
thoroughly and carefully
before using the device.
These Instructions for Use are a significant part of the MI GHTY MEDIC Vaporizer and must be pro­vided to the user.
These instructions given in this In­structions for Use must be strictly observed as they are extremely
Explanation of Symbols
Please follow these instructions carefully! (according to IEC 60601: 2005)
Warning !
In order to avoid injuries to persons and damage to the equipment, it is mandatory to observe instructions marked with this symbol.
Note /Tip!
This symbol always gives you technical information or useful tips regarding the MIGHTY MEDIC Vaporizer.
SN
Symbol for serial number - followed by the serial number of the medical product
Symbol for the manufacturer - the manufacturer‘s name and ad­dress are next to the symbol
The medical product was introduced after 13 August 2005. The product may not be disposed of in normal household waste. The X on the trash can indicates the necessity of disposing of this product separately.
The device contains a built-in rechargeable lithium-ion battery that must be discharged before disposal.
important to ensure safety during installation, use and maintenance
of the MIGHTY MEDIC Vaporizer.
Please keep this brochure in a safe
place for future reference.
You may download the current
Instructions for Use for the MIGHTY MEDIC Vaporizer on www.vapormed.com.
IP 22
0123
REF
The MIGHTY MEDIC Vaporizer is protected by an angle of 15° against dropping water (IP 22). The device should nevertheless be
protected against moisture and rain. Do not use in the bathroom or
above water.
EU conformity symbol: A 4-digit number after the CE marking indicates that a notified body is involved in the conformity assessment procedure.
Symbol for order number - followed by the order number of the
corresponding medical product (or part)
Safety tested and production monitored by TUEV SUED according to IEC 60601-1, CAN/CSA C22.2 No. 60601-1 and ANSI/AAMIES 60601-1.
Caution! Hot surfaces! Do not touch metal parts!
Keep away from sunlight
Protect against moisture and humidity
DC (direct current)
Interference may occur in the vicinity of equipment marked with the following symbol.
Temperature limits of ambient temperature
Humidity limitation
9 8
2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
Air pressure limitation
INT: 7 on/ 30 off
The following symbols relate to the power adapter:
intermittent operation
Do not reuse
Safety Category II device
UL Recognized Component Mark: This symbol indicates that the corresponding devices are listed by UL
Restriction on the use of certain hazardous substances in electrical and electronic equipment
Efficiency Level 5 Efficiency of power adapter
Symbol for FCC declaration of conformity (electromagnetic interference approval in the USA)
Equipment with this symbol may only be used in the house (dry surroundings).
Safety Recommendations
The packaging material (plastic bags,
boxes etc.) must be kept out of the reach of children as it is a potential source of danger.
People who require assistance must
be supervised constantly during inhalation. Such persons often underestimate the hazards involved (e.g. strangulation with the power adapter cord), thus resulting in a risk of injury.
The device contains small parts
which can block the respiratory tract and lead to choking. Therefore, make sure that you always keep the MIGHTY MEDIC Vaporizer and the accessories out of the reach of babies and infants.
When charging the battery, use the
power adapter supplied with the Vaporizer only. The use of products from other sources can damage the batter y.
If you have any concerns, ask a spe-
cialist to check whether the electrical system is in accordance with the local safety regulations.
If there are any problems during
operation, immediately pull out the power adapter from the socket.
The power adapter cord must be
unwound over its entire length (avoid rolling up and overlapping the cord). It must not be exposed to any
impacts and must be kept out of the reach of children. Also, it must not be kept near liquids or sources of heat and must not be damaged. Do not wind the power adapter cord tightly, nor pull it over sharp edges and never crush or kink it. If the power adapter cord is damaged, please contact our Service Center to have it replaced. Never try to repair a power adapter cord yourself!
The use of multiple sockets and /or
extension cables is not recommend­ed. However, if this is absolutely necessary, only products with a qual­ity certificate (such as UL, IMQ, VED, +S etc.) may be used, provided the specified power exceeds the power required (A= Ampere) by the devices that are connected.
After use, the Vaporizer must be
placed on a stable, flat surface. To be used only at a sufficient distance away from heat sources (ovens, stoves, fireplaces), and in locations where the ambient temperature can­not drop below +5°C (+41°F). Store the Vaporizer and power adapter in a dry place protected against the ef­fects of weather and out of the reach of children or unqualified persons. It cannot be used in damp locations (such as bathrooms etc.).
11 10
2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
2. EXPLANATION OF SYMBOLS, SAFETY RECOMMENDATIONS
Do not operate the Vaporizer close to
flammable objects such as curtains, tablecloths, or paper.
Keep the Vaporizer and power adapt-
er away from pets (e.g. hamsters, mice) and other animals which could damage the insulation of the power adapter cord.
The Vaporizer and power adapter
may only be repaired by our Service Center. Incorrectly performed repairs without the use of original spare parts can prove dangerous to the user.
Danger to life when opening the
power adapter as live components and connections are exposed.
The Vaporizer must never be re-
paired or transported when the power adapter is plugged in.
The Vaporizer and power adapter
must never be operated when the power adapter cord is faulty.
Do not put any objects into the open-
ings of the device.
Do not leave the Vaporizer unat-
tended while it is being operated. After use, switch off the heater.
The Vaporizer may not be obstructed
while the device is being used, nor while it is cooling down.
Caution! Hot surfaces!
The Filling Chamber is made of
metal; do not touch it when it is hot.
The Dosing Capsule is made of
metal; do not touch it when it is hot.
Before cleaning, disconnect the
power adapter from the socket. The Vaporizer and the power adapter should be cleaned only with a dry cloth - or a damp cloth if absolutely necessary. Never immerse the Va­porizer or the power adapter in water or any other liquid, nor clean it with direct jets of water or steam.
The Vaporizer and the power adapter
must not be used in damp or wet conditions.
The Vaporizer is protected by an an-
gle of 15° against dropping water (IP
22). The device should nevertheless be protected against moisture and rain. Do not use in the bathroom or above water.
Never touch the Vaporizer or power
adapter with wet or damp parts of the body.
Never operate the Vaporizer or power
adapter when it is wet or damp. If the Vaporizer or the power adapter gets wet, it must be checked by our Ser­vice Center for damage to electrical components.
Do not use in an atmosphere with risk
of explosion or ignition.
Never allow the Vaporizer or the
power adapter to be used by children or unqualified persons.
Only use original Storz & Bickel ac-
cessories and spare parts.
The manufacturer is not re­sponsible for any damage
or personal injury caused by inappropriate, incorrect or irre­sponsible use.
3. INTENDED USE
The MIGHTY MEDIC Vaporizer is in-
tended for vaporizing and then inhal­ing cannabinoids from hemp flowers
(cannabis flos). The goal is the application of the ac-
tive ingredients in the human body via the alveoli for the appropriate medical indication.
It is suitable for the temporary inha­lative application of cannabinoids prescribed by a physician for use at home, in a hospital, or doctor’s office.
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4. IMPORTANT REMARKS 4. IMPORTANT REMARKS
The MIGHTY MEDIC Vapor- izer ensures the highly effec-
tive, safe, and fast-acting ap­plication of cannabinoids. The patient must undergo a medical examination before the beginning of treatment.
The MIGHTY MEDIC Vaporizer is not intended for use in children and youth under age 18. Adults may use the de­vice following the Instructions for Use or physician’s instructions.
Due to hygienic reasons, the
MIGHTY MEDIC Vaporizer
may be operated only with at­tached (disposable) Lip Piece on the Mouthpiece (see Chapter 8.1. „Dis­posable Lip Piece for Hygienic Use“ from page 29 onwards).
The device is not to be used, if
the user has respiratory tract
or lung conditions. Depending on the density, the vapor could irritate respiratory tracts or lungs, which can lead to coughing.
The application and inhalation is de­scribed in Chapter 8.2. “Cooling Unit with Mouthpiece” on page 30.
Before every use by another person, the Cooling Unit and the Vaporizer must be cleaned thoroughly (see in­formation on the Cooling Unit and Vaporizer from page 28 onwards).
Please note that damaged or
brittle Lip Pieces are not to be
used.
At a certain dosage, cannabis can have a psychotropic (mind-altering) effect.
Thus, there is a potential for abuse, which governments in nearly all coun­tries of the world counteract with cor­responding laws.
Use only medicinal hemp flowers (cannabis flos) prescribed by your physician and purchased from a phar­macy. Otherwise you may be at risk of breaking the law.
In case of doubt, ask your physician, pharmacist, or the responsible au­thorities about the current laws at your place of residence.
Cannabinoids vaporize at tempera­tures over 180°C (356°F) and then form an aerosol with an average drop­let size (MMAD) of 0.64 µm (microm­eter) that can be inhaled and respired.
The droplets are absorbed in the al­veoli and enter the bloodstream (sys­temic absorption).
When cannabinoids are inhaled, the onset of the effect takes approx. 1-2 min. and the effects last for 2-4 hours.
Our Service Centre is available to an­swer your questions and receive your comments and suggestion concern­ing the MIGHTY MEDIC Vaporizer.
You may download the cur­rent Instructions for Use for the M IGHTY MEDIC Vaporiz-
er on www.vapormed.com. Here you will find the up-to-date information to the current state of research.
If questions occur about the medical use of cannabinoids or cannnabis please contact your doctor, pharma­cist or manufacturer of medical hemp flowers (Cannabis flos).
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4. IMPORTANT REMARKS
Operating Conditions
Ambient conditions in which the specified aerosol characteristics are guaranteed:
+35°C
+5°C
Ambient temperature:
+5°C to +35°C (+41°F to +95°F)
15% - 90%
Relative humidity of ambient air:
15% to 90%
Atmospheric pressure:
700 hPa to 1060 hPa
The device features interference sup­pression acc. to EN 60601-1-2 (see Chapter 10.5. “Information on Electro­magnetic Compatibility“, page 40).
Radiofrequency emitting equipment (e.g. mobile phones) should not be used in the immediate vicinity of the device. In case of doubt, contact qual­ified personnel.
Storage and Transport Conditions
+60°C
-20°C
Ambient temperature:
-20°C to +60°C (-4°F to +140°F)
15% - 90%
Relative humidity:
15% to 90%
Atmospheric pressure:
700 hPa to 1060 hPa
Do not store any parts of the M IG HTY MEDIC Vaporizer in wet rooms (e.g. bathroom) or transport near damp objects.
Extreme fluctuations in ambient tem­perature can lead to condensation and damage the device’s function.
5. COMMISSIONING AND OPERATION OF THE MIGHTY MEDIC VAPORIZER
5.1. Unpacking
The box contains all components as
well as the Instructions for Use. Keep the Instructions for Use for future ref-
erence.
Remove the M IGHTY MEDIC Vapor- izer and the accessories from the box. Immediately after unpacking, check whether the Vaporizer, the accesso­ries, the power adapter and its device plug are all included in the delivery
and work properly.
If you notice any defects, inform the seller or the delivery agent immedi­ate ly.
The packing material (plastic
bags, boxes etc.) must be
kept out of the reach of chil­dren as it is a potential source of dan­ger.
Please dispose of the packing mate­rial in a proper and environmentally friendly manner.
We recommend keeping the original packaging in case it is required later
(transport, Service Centre, etc.).
5.2. Power Connection
Before connecting up the MI GHTY MEDIC Vaporizer, make sure that the
information given on the power adapt­er type label corresponds to the local power supply voltage.
All parts of the electrical system must comply with currently applicable offi­cial regulations.
Place the heated Vaporizer only on a hard, stable surface, and not on any soft or heat-sensitive material.
Take care that the power adapter cord cannot be damaged through kinking, crushing or pulling.
Improper installation may
lead to personal injury or ma­terial damages, for which the
manufacturer cannot be held respon-
sible.
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