Vapormed VOLCANO MEDIC User manual

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

3
Table of Contents ........................................................... Page
1. Product Overview, Scope of Delivery, Service ........................ 6
2. Explanation of Symbols, Safety Recommendations ............... 9
3. Intended Use .......................................................................... 13
4. Important Remarks ................................................................. 14
4.1. Operating Conditions, ................................................... 16
4.2. Storage and Transport Conditions ............................... 16
5. The VOLCANO MEDIC Hot Air Generator ...................... ....... 17
5.1. Unpacking ..................................................................... 17
5.2. Installation ..................................................................... 17
5.3. Operation ...................................................................... 17
5.4. Commissioning ............................................................. 18
5.5. Heating Up .................................................................... 18
5.6. Temperature Setting ..................................................... 19
6. The Use of Dronabinol (THC)
dissolved in Alcohol ................................................................ 20
6.1. The Efficiency of vaporized
Dronabinol (THC) ......................................................... 20
6.2. Preparation ................................................................... 21
6.3. Application .................................................................... 21
6.4. Inhalation from the Valve Balloon ................................. 25
INSTRUCTIONS FOR USE ENGLISH

54
Table of Contents ........................................................... Page
7. The Use of Hemp Flowers (Cannabis Flos) ........................... 27
7.1. The Efficiency of Cannabinoids vaporized
from Hemp Flowers (Cannabis Flos) ........................... 27
7.2. Preparation .................................................................. 30
7.3. Application ................................................................... 30
7.4. Inhalation from the Valve Balloon ............................... 33
8. Accessories: Dosing Capsules and Magazine ...................... 35
8.1. Filling the Dosing Capsules
with ground hemp flowers ............................................. 35
8.2. Filling the Dosing Capsules with Dronabinol .............. 36
8.3. Inserting the Dosing Capsules ..................................... 37
9. Hygiene .................................................................................. 38
9.1. General ........................................................................ 38
9.2. Material Resistance ..................................................... 38
9.3. Disposable MEDIC VALVE Lip Piece
for Hygienic Use ............................................................ 39
9.4. Filling Chamber and Valve Balloon ............................. 40
- Cleaning of the Filling Chamber,
Inspecting/Maintenance of the Filling Chamber,
Reusability of the Filling Chamber,
Reusability of the Valve Balloon, Storage
9.5. Disassembly and Assembly ......................................... 42
- Filling Chamber, Filling Chamber Cap,
Mouthpiece Disassembling the Filling
Chamber Cap, Disassembling the Filling
Chamber, Drying, Assembly of Filling
Chamber Cap, Assembling the Filling Chamber
Table of Contents ........................................................... Page
10. Hot Air Generator .................................................................... 45
10.1. Cleaning ........................................................................ 45
10.2. Care and Maintenance ................................................. 45
10.3. Storage .......................................................................... 46
10.4. In Case of Problems ..................................................... 46
10.5. Disposal ........................................................................ 46
10.6. Troubleshooting ............................................................ 47
10.7. Periodic Safety Checks ................................................ 48
10.8. Technical Specifications .............................................. 48
10.9. Guidance and Manufacturer‘s Declaration –
Electromagnetic Emissions .......................................... 49
11. Spare Parts and Accessories ................................................. 56
12. Declaration of CE Conformity ................................................. 57
13. Warranty, Liability, Repair Service ......................................... 58
14. Proof of the Annual Safety Checks ......................................... 61
INSTRUCTIONS FOR USE ENGLISH INSTRUCTIONS FOR USE ENGLISH

76
Product Overview Delivery includes VOLCANO MEDIC Vaporization System:
1 pc. VOLCANO MEDIC Hot Air Generator
1 pc. Herb Mill (not shown)
1 pc. Instructions for Use (not shown)
2 pcs. Air Filters
1 pc. MEDIC VALVE Filling Chamber
5 pcs. MEDIC VALVE Balloon (standard size 12.5 l) with Mouthpiece
3 pcs. Lip Piece
1 pc. Cleaning Brush (not shown)
6 pcs. Screens
1 pc. Liquid Pad
3 pcs. Filling Chamber Clips (not shown)
1 pc. Cap Ring (not shown)
Please check whether all components have been included.
If not, please inform our Service Center.
1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE 1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE
Liquid Pad
Screen Set
Valve Balloon with
Mouthpiece and
Lip Piece
Filling Chamber
with Cap
Ventilation Slot
“AIR” Button
(Pump)
“HEAT” Button
(Heater)
Plus Temperature
Button
Minus Temperature Button
Set Temperature
Display
Actual Temperature
Display
Air Filter
Air Filter Cap Heater Control Lamp
Hot Air Outlet

98
1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE
Operating life:
The Hot Air Generator and the Filling Chamber
have an average expected operating life of:
- approx. 1,000 operating hours
- max. 5 to 6 years
Service
Contact in case of technical problems or questions about the device:
Storz & Bickel Service Center
Tel.: [phone] · e-mail: [e-mail]
For repairs, warranty claims, or disposal, please send the device to the
following address:
Storz & Bickel GmbH & Co. KG
Service Center
In Grubenäcker 5-9
78532 Tuttlingen, Germany
Please read the following
safety recommendations
thoroughly and carefully
before using the device.
These Instructions for Use are a
significant part of the VOLCANO
MEDIC Vaporization System and
must be provided to the user.
These instructions given in this In-
structions for Use must be strictly
observed as they are extremely
important to ensure safety during
installation, use and maintenance
of the VOLCANO MEDIC Vaporiza-
tion System.
Please keep this brochure in a safe
place for future reference. You
may download the current version
of the Instructions for Use for the
VOLCANO MEDIC Vaporization
System on www.vapormed.com
Explanation of Symbols
SN
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 VOLCANO MEDIC Vaporization System.
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.
Symbol for the manufacturer – the manufacturer‘s name and
address are next to the symbol
Safety Category II device
Symbol for serial number – followed by the serial number of the
medical product.
2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

REF
IP 21
0123
1110
EU conformity symbol
A 4-digit number after the CE marking indicates that a notified
body is involved in the conformity assessment procedure.
Safety tested and production monitored by TUEV SUED according
to IEC 60601-1, CAN/CSA C22.2 No. 60601-1.
Device protected against foreign bodies with a diameter larger
than 12 mm and against vertically falling water drops (according to
IEC 60529).
Symbol for order number – followed by the order number of the
corresponding medical product (or part)
2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS
Contains or presence of phthalate
Air pressure limitation
Caution! Hot surfaces!
Never leave Filling Chamber on the VOLCANO MEDIC Hot Air
Generator.
Keep away from sunlight
Protect against moisture and humidity
Interference may occur in the vicinity of equipment marked with
the following symbol.
Temperature limits of ambient temperature
Humidity limitation
Safety Recommendations
The packaging material (plastic bags,
styrofoam material, 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
cord), so resulting in injury.
The device contains small parts
which can block the respiratory tract
and lead to choking. Therefore, make
sure that you always keep the Hot Air
Generator and accessories out of the
reach of babies and infants.
Before connecting the Hot Air Gen-
erator, make sure that the information
given on the type label on the bottom
side of the Hot Air Generator cor-
responds to the mains supply at the
place of installation.
If there are any problems during
operation, immediately pull out the
power plug from the socket.
The power 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 cord tightly,
nor pull it over sharp edges and never
crush or kink it. If the power cord is
damaged, please contact our Service
Center to have it replaced. Never try
to repair a power cord yourself!
The use of multiple sockets and/or
extension cables is not recommend-
ed. 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.
If you have any concerns, ask a
specialist to check whether the
electrical system is in accordance
with the local safety regulations.
Install the Hot Air Generator on a
stable and dry surface at a sufficient
distance from sources of heat
(oven,stove, fireplace etc.) and in a
place where the ambient tem-
perature cannot drop below +5°C
(+41°F). Store the Hot Air Genera-
tor in a dry place protected against
the effects of weather and out of
the reach of children or unqualified
persons. It must not be installed in
damp locations (such as bathrooms
etc.).
The Hot Air Generator may only be
repaired by our Service Center. In
correctly performed repairs without
the use of original spare parts can-
prove dangerous to the user.
2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

1312
Do not operate the Hot Air Generator
close to flammable objects such as
curtains, tablecloths, or paper.
Keep the Hot Air Generator away
from pets (e.g. hamsters, mice) and
other animals which could damage
the power cord insulation.
Danger to life when opening the Hot
Air Generator as live components
and connections are exposed.
The Hot Air Generator must never
be repaired or transported when the
power plug is plugged in.
To pull the power plug from the
socket, pull the power plug directly,
never pull the power cord.
The Hot Air Generator must never
be operated when the power cord
is faulty.
Do not put any objects into the open-
ings of the device.
Do not leave the Vaporizer unattend-
ed during operation. After use, switch
off the heater and the air pump.
The ventilation slots as well as the
hot air outlet of the Hot Air Genera-
tor may not be closed, obstructed
or blocked while the device is being
used nor while it is cooling down.
Caution! Hot surface!
Do not touch the hot air outlet and the
Filling Chamber when they are hot.
The Filling Chamber may only be
placed on the hot air outlet while
filling the Valve Balloon. After fill-
ing the Valve Balloon, the Filling
Chamber must be removed from the
hot air generator in order to avoid
overheating of the Filling Chamber
(Caution! Hot surface!).
Do not put any body parts or objects
in the hot air stream.
Before cleaning, pull out the po wer
cord from the socket. The Hot Air
Generator should be cleaned only
with a dry cloth - or a damp cloth
if absolutely necessary. Never im-
merse the Hot Air Generator in water
or in other liquids or clean it with a
direct water or steam jet.
The Hot Air Generator must not be
used in damp or wet conditions.
The Hot Air Generator is protected
against falling water drops (IP 21).
The device should nevertheless be
protected against moisture and rain.
Do not use in the bathroom or above
water.
Never touch the Hot Air Generator
with wet or damp parts of the body.
Never put containers containing
liquids on the Hot Air Generator.
2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS
Never operate the Hot Air Genera-
tor when it is wet or damp. If the Hot
Air Generator 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 to be used
by children or unqualified persons.
Only use original Storz & Bickel ac-
cessories and spare parts.
2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS
The manufacturer is not re-
sponsible for any damage
or personal injury caused
by inappropriate, incorrect or irre-
sponsible use.
The VOLCANO MEDIC Vaporization
System is intended for vaporizing
and then inhaling dronabinol (THC)
dissolved in alcohol or 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 medi-
cal indication. It is suitable for the
temporary inhalative application of
cannabinoids prescribed by a physi-
cian for use at home, in a hospital, or
doctor‘s office.
3. INTENDED USE

1514
The VOLCANO MEDIC Va-
porization System ensures
the highly effective, safe, and
fast-acting application of cannabi-
noids. The patient must undergo a
medical examination before the be-
ginning of treatment.
The VOLCANO MEDIC Vaporiza-
tion System 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.
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 Chapters 6.4. and 7.4.
“Inhalation from the Valve Balloon”,
pages 25 and 33.
The Valve Balloon with
Mouthpiece is intended for
only one user and may not be
shared among patients. The Valve
Balloon can be re-used several times,
but only by one person (see Chapter
9. “Hygiene”, page 38).
A new Valve Balloon with Mouthpiece
may be used for a maximum of 2
weeks.
At a certain dosage, cannabis
can have a psychotropic
(mind-altering) effect.
There is thus a potential for abuse,
which governments in nearly all coun-
tries of the world counteract with cor-
responding laws.
Use only medicinal hemp flowers
(cannabis flos) prescribed by your
physician and purchased from a phar-
macy. Otherwise you may be at risk of
breaking the law.
In case of doubt, ask your physician,
pharmacist, or the responsible au-
thorities about the current laws at your
place of residence.
Dronabinol is the international non-
proprietary name for Delta-9-tetrahy-
drocannabinol (THC) which is known
as the most effective cannabinoid for
medical use.
Cannabinoids vaporize at tempera-
tures over 180°C (356°F) and then
form an aerosol with an average drop-
let size (MMAD) of 0.64 µm (microm-
eter) that can be inhaled and respired.
The droplets are absorbed in the al-
veoli and enter the bloodstream (sys-
temic absorption).
When cannabinoids are inhaled, the
onset of the effect takes approx. 1-2
min. and the effects last for 2-4 hours.
4. IMPORTANT REMARKS 4. IMPORTANT REMARKS
For application, a distinction must be
made between the vaporization of
dronabinol (THC) dissolved in alcohol
and the vaporization of cannabinoids
from hemp flowers (cannabis flos).
Our Service Centre is availa-
ble to answer your questions
and receive your comments
and suggestion concerning the VOL-
CANO MEDIC Vaporization System.
If questions occur about the medical
use of cannabinoids or cannnabis
please contact your doctor, pharma-
cist or manufacturer of medical hemp
flowers (Cannabis flos).

1716
4. IMPORTANT REMARKS
4.1. Operating Conditions
Ambient conditions in which the
specified aerosol characteristics are
guaranteed:
4.2. Storage and Transport
Conditions
The device features interference sup-
pression acc. to EN 60601-1-2 (see
Chapter 10. “Hot Air Generator”, page
45).
Radiofrequency emitting equipment
(e.g. mobile phones) should not be
used in the immediate vicinity of the
device. In case of doubt, contact qual-
ified personnel.
Do not store or transport any parts of
the VOLCANO MEDIC Vaporization
System in direct sunlight, wet rooms
(e.g. bathroom) or near damp objects.
Extreme fluctuations in ambient tem-
perature can lead to condensation
and damage the device‘s function.
Atmospheric pressure:
700 hPa to 1060 hPa
Atmospheric pressure:
700 hPa to 1060 hPa
Ambient temperature:
+10°C to +40°C (+50°F to +104°F)
+40°C
+10°C
Ambient temperature:
-20°C to +60°C (-4°F to +140°F)
+60°C
-20°C
Relative humidity of ambient air:
30% to 80%
30% - 80%
Relative humidity:
20% to 80%
20% - 80%
5. THE VOLCANO MEDIC HOT AIR GENERATOR
5.1. Unpacking
The box contains all components as
well as the Instructions for Use. Keep
the Instructions for Use for future ref-
erence.
Take out the accessories and the Hot
Air Generator from the box. Immedi-
ately after unpacking, check whether
the Hot Air Generator, the accesso-
ries, the power cord and the plug are
all included in the delivery and work
properly. If you notice any defects,
inform the seller or the delivery agent
immediately.
The packing material (plastic
bags, styrofoam material,
boxes etc.) must be kept out
of the reach of children as it is a poten-
tial source of danger.
Please dispose of the packing mate-
rial in a proper and environmentally
friendly manner.
We recommend keeping the original
packaging in case it is required later
(transport, Service Center, etc.).
5.2. Installation
Before installing the Hot Air Gen-
erator make sure that the information
given on the type label on the bottom
side of the device corresponds to the
local mains supply data.
All parts of the electrical system must
comply with currently applicable offi-
cial regulations.
Put the Hot Air Generator on a flat and
stable surface.
Take care that the power cord cannot
be damaged through kinking, crush-
ing or pulling.
Improper installation may
lead to personal injury or ma-
terial damages, for which the
manufacturer cannot be held respon-
sible.
5.3. Operation
The Hot Air Generator was
developed for vaporizing the
cannabinoids listed in the in-
structions. Any other use is inappro-
priate and potentially dangerous.
For use and maintenance, the user
must always follow the instructions
given in the Instructions for Use.
If you have any concerns, or if there
are any problems, immediately switch
off the Hot Air Generator and discon-
nect the power plug from the socket.
Do not try to remedy the defect your-
self. Contact our Service Center di-
rectly.
Allow the device to cool down before it
is packed away.

1918
5. THE VOLCANO MEDIC HOT AIR GENERATOR
5.4. Commissioning
Do not leave the device unat-
tended while it is being opera-
ted. Put the Hot Air Generator
on a flat and stable surface.
Check whether the mains voltage cor-
responds to the voltage rating stated
on the device. The power cord and
the plug must be in perfect condition.
Only connect the Hot Air Generator to
a properly installed socket. The man-
ufacturer will not bear any responsibil-
ity whatsoever if this accident preven-
tion measure is not taken.
The device is safely disconnected
from the mains only when the plug is
removed from the socket.
When the power plug is plugged in,
the LED display of the device lights
up briefly. At the same time, an inter-
nal software query is performed. The
green dot on the display shows that
the Hot Air Generator is connected to
the power supply.
5.5. Heating Up
To switch on the heater, push the but-
ton labeled “HEAT”. The set/actual
temperature will light up, signaling
that the heater is switched on. At the
same time, the yellow control lamp
will light up to indicate that the device
is heating up. The upper, red display
shows the actual temperature in the
Filling Chamber with the air pump
switched on, and the lower, green
display shows the desired set tem-
perature. The heating process is com-
pleted when the set value is equal to
the actual value. Heating up can take
up to 5 minutes depending upon the
chosen temperature. After the heating
process is completed, the tempera-
ture is constantly maintained at the
set value. The luminous intensity of
the yellow control lamp corresponds
to the intensity of the heating process.
For technical reasons the
temperature in the Filling
Chamber cannot be meas-
ured during vaporization. During op-
eration the temperature is measured
at the heat exchanger. The display in-
dicates the reference values for the
attached Filling Chamber with the air
pump switched on.
5. THE VOLCANO MEDIC HOT AIR GENERATOR
5.6. Temperature Setting
Plus temperature
button
Minus temperature
button
Actual temperature
display (red)
Set temperature
display (green)
When you press the plus button, the
set value is increased, and when you
press the minus button, the set value
is decreased.
When you briefly tap on the plus or
minus button, the set values are in-
creased or decreased respectively in
1-degree increments.
If you keep the plus or minus button
pressed, the set values start running
continuously in the corresponding di-
rection.
If you simultaneously tap on the plus
button and the minus button, the dis-
play changes from degree Celsius to
degree Fahrenheit and vice versa.
If the actual value is higher
than the set value, you can
speed up the cooling down
process by switching on the air pump.
30 minutes after the last time
a button is pressed, the devi-
ce automatically switches off.
As long as the heater has a substan-
tial amount of residual warmth, the
temperature is displayed until it drops
below +40°C (+104°F).
Then the display turns off, and the
green dot on the display indicates that
the Hot Air Generator is connected to
the mains supply.
The device is safely discon-
nected from the mains only
when the plug is removed
from the socket.

2120
6. THE USE OF DRONABINOL
Use only approved dronabinol (THC)
that is sold to pharmacies for making
up prescriptions.
The pharmacy produces an alcohol
solution according to your physician‘s
prescription (generally 2.5% THC) for
inhalation with the VOLCANO MEDIC
Vaporization System.
6.1. Efficiency of vaporized
Dronabinol (THC)
By following the procedure listed in
the Instructions for Use the systemic
bioavailability of vaporized dronabi-
nol is approximately 40%.
For comparison: The systemic bio-
availability of cannabinoids adminis-
tered orally is below 15%.
When observing the Instructions for Use and with a vaporization temperature of
210°C (410°F) the following reference values are validated in studies:
If dosage is too low increase the amount of dronabinol.
If dosage is too high reduce the amount of dronabinol.
Drug (Filling
Chamber Content)
Dronabinol/THC
(10 mg)
THC: 10 mg approx. 6 mg approx. 4 mg
Cannabinoid
content in drug
Cannabinoid con-
tent in Valve Balloon
after vaporization
with 210°C (410°F)
Cannabinoid
content in blood
stream (systemic
bioavailability)
after inhalation
6. THE USE OF DRONABINOL
Preparation to use the Liquid Pad
When using dronabinol (THC) dis-
solved in alcohol, the Screens in the
Filling Chamber are not needed and
should be removed.
The Liquid Pad is inserted in the Fill-
ing Chamber instead of the lower
Screen.
Applying drops with a pipette
6.2. Preparation
Make sure to use the Mouth-
piece only with attached Lip
Piece before every operation
(see Chapter 9.3. “Disposable MED-
IC VALVE Lip Piece for Hygienic Use”,
page 39)
Turn the Filling Chamber Cap counter-
clockwise in order to remove it from
the Filling Chamber.
Remove Filling Chamber Cap
Dronabinol (THC) dissolved
in oil is not suitable for vapori-
zation and is intended for oral
administration.
6.3. Application
Turn the Filling Chamber upside down
and use a pipette to drop the dronabi-
nol (THC) dissolved in alcohol onto
the center of the bottom of the Liquid
Pad. The Liquid Pad can hold up to
20 drops.
At the beginning of treatment, apply a
maximum of two drops and carefully
increase to the appropriate dosage.
Always follow your doctor‘s recom-
mendations!
Next screw on the Filling Chamber
Cap again.

2322
Please make sure to not overfill the
Liquid Pad. It can contain up to 5
drops.
Dronabinol (THC) is available as an
alcoholic solution.
The advantage of this is that the liquid
is distributed more equally around the
stainless steel wire of the Liquid Pad,
yielding a larger surface area that can
be vaporized.
However, the alcohol must first be
separated from the dronabinol, as al-
cohol should not be inhaled.
Press the “HEAT”button set tempera-
ture to 100°C (212°F) and allow the
device to heat up.
When the temperature has reached
100°C (212°F), place the Filling
Chamber with Cap and Liquid Pad
onto the Hot Air Generator and make
sure it clicks into place.
Then press the “AIR”button to pump
air through the Liquid Pad.
The dronabinol does not vaporize
at this temperature, but the alcohol
evaporates quickly (within 30 sec.).
Since alcohol has a characteristic
odor, you can easily determine by
smelling whether the Filling Chamber
is alcohol free. Dronabinol has nei-
ther odor nor taste.
Suitable for vaporizing small
amounts of dronabinol (THC),
is the Filling Chamber Reduc-
er, which is available as an accessory,
along with the small Liquid Pads and
the Dosing Capsules. The Filling
Chamber Reducer is inserted instead
of the Filling Chamber Cylinder (see
Chapter 9.5. “Disassembling and As-
sembling the Filling Chamber”, page
42).
Either the small Liquid Pad (meas-
urements 15 x 5 mm) or the Dosing
Capsule containing a Liquid Pad
(measurements 13 x 6 mm) are to
be inserted into the Filling Chamber
Reducer.
Screw on Filling Chamber Cap
Insert either a small Liquid Pad directly into
the Filling Chamber Reducer or a Dosing
Capsule equipped with a Liquid Pad
6. THE USE OF DRONABINOL
Separate alcohol
Stretch Valve
Balloon tight
When the Filling Chamber is free of
alcohol, press the “AIR” button again
to switch off the airflow.
The dronabinol, which evaporates
only at higher temperatures – over
157°C (315°F), remains in the Liquid
Pad.
Next remove the Filling Chamber,
press the heat button again and set
the temperature to 210°C (410°F) and
continue heating.
The dronabinol is vaporized in
the first few seconds of filling
the Valve Balloon.
However you should continue filling
the Valve Ballon (approx. 35 sec.) as
the additional air dilutes the aerosol,
which makes inhalation easier, espe-
cially for higher dosages.
When the temperature reaches 210°C
(410°F), place the Filling Chamber
6. THE USE OF DRONABINOL
and then the Valve Balloon on and al-
low them to click in place. This opens
the Valve.
Stretch the Valve Balloon tight before
setting it onto the Filling Chamber so
that when filling, the Valve Balloon
sits upright on the Hot Air Generator.
Press the “AIR”button. The Valve
Balloon will now fill with dronabinol
aerosol.

2524
Remove Valve Balloon with Filling Chamber
Caution! Hot surface!
Do not touch any compo-
nents of the Filling Chamber
(except at the textured grip)
until they have cooled down
after the Valve Balloon has been filled.
Separate the Valve Balloon from the
Filling Chamber. The Valve closes
automatically after separation and the
aerosol in the Valve Balloon cannot
escape.
Detach Valve Balloon from Filling Chamber
Do not leave the Filling Chamber on
the hot air outlet of the VOLCANO
MEDIC when “HEAT” is switched on
– except for separating the alcohol or
filling the Valve Balloon.
Non-observance may cause the Fill-
ing Chamber to overheat and may
cause burns.
Caution! Hot surface!
When the Valve Balloon is filled, press
the “AIR” button and shut off the air
pump and remove the Valve Balloon
together with the Filling Chamber.
To do so, hold the Filling Chamber
Cap at the textured grip.
6. THE USE OF DRONABINOL
6.4. Inhalation from the
Valve Balloon
Attach the Mouthpiece with attached
Lip Piece to the Valve and allow it to
lock in place.
Attach the Mouthpiece with attached Lip
Piece onto the Valve Balloon
Correct position of the Mouthpiece with Lip
Piece on the Valve
Press Mouthpiece against lips to inhale
To inhale, put the Mouthpiece to your
lips and lightly press against the
Mouthpiece with your lips. By doing
As the content of the Valve
Balloon deflates, it may be
completely emptied by
stretching the Valve Balloon taut and
subsequently inhaling the content
6. THE USE OF DRONABINOL
so, the Valve opens and the aerosol
can be inhaled from the Valve Balloon.
As soon as you remove the pressure
from the Mouthpiece, the Valve auto-
matically closes.

Stretch Valve
Balloon tight
2726
The Valve Balloon is not suit-
able for storing the aerosol
for long periods, as it will con-
dense on the interior surface of the
Balloon in time (a few hours).
Inhale the contents of the Valve Bal-
loon within 10 minutes.
Breathing Technique
Inhale only half as much as possible.
Hold your breath a few seconds and
then breathe out slowly.
We recommend consciously concen-
trating on your inhalation. The can-
nabinoid aerosol is absorbed by the
alveoli and into the bloodstream. The
onset of the effect takes approx. 1-2
min.
End of Inhalation
Disconnect the power plug from the
socket after inhalation.
6. THE USE OF DRONABINOL 7. THE USE OF HEMP FLOWERS
Use only standardized, medicinal
hemp flowers (cannabis flos) that
have been tested by licensed produc-
ers for authenticity, purity, and patho-
gens according to the directives of the
competent authorities in your country.
Under no circumstances
should you use cannabis from
the illegal black market or any
other cannabis that has not been sub-
jected to recognised quality controls.
The amount of active ingredients in
these products is generally unknown,
may fluctuate considerably, and they
often contain herbicides, fertilizers,
bacteria, etc.
7.1. The Efficiency of Cannabi-
noids vaporized from Hemp
Flowers (Cannabis Flos)
By following the procedure listed in
the Instructions for Use the systemic
bioavailability of cannabinoids vapor-
ized from hemp flowers is approx. 29-
40%.
For comparison: The systemic bio-
availability of cannabinoids aminis-
tered orally is below 15%.
The following factors determine the
cannbinoid concentration in the Valve
Balloon:
Temperature - Higher vaporiza-
tion temperatures cause a higher
cannbinoid concentration in the
Valve Balloon, lower vaporiza-
tion temperatures cause a lower
cannabinoid concentration in the
Valve Balloon.
Quantity - Higher quantities in the
Filling Chamber cause a higher
cannbinoid concentration in the
Valve Balloon, lower quantities in
the Filling Chamber cause a lower
cannabinoid concentration in the
Valve Balloon.
Quality - Higher cannabinoid
concentrations in the plant mate-
rial cause a higher cannabinoid
concentration in the Valve Balloon,
lower cannabinoid concentrations
in the plant material cause a lower
cannabinoid concentration in the
Valve Balloon.
To obtain a reproducible dosage with
good efficiency, it is recommended to
vaporize small quanitites (100 mg) in
the Filling Chamber at top tempera-
ture (210°C/410°F) in a single Valve
Balloon only.

2928
7. THE USE OF HEMP FLOWERS
After consulting your physician, if your
doctor recommends that you are able
to determine your requirement for
active ingredients yourself (titration),
due to the relatively rapid effect (ap-
prox. 1-2 minutes), you may put higher
quantities cannabis (up to 500 mg)
into the Filling Chamber and vaporize
at lower temperatures.
Thus, you can fill mutiple Valve Bal-
loons with vapors of active ingredients
with a single Filling Chamber filling.
With this method no reproducible
doses are achieved; for this reason,
it is only appropriate for experienced
users.
When observing the Instructions
for Use and with a vaporization tem-
perature of 185°C (365°F) the follow-
ing reference values are validated in
studies:
When observing the Instructions for Use and with a vaporization temperature of
210°C (410°F) the following reference values are validated in studies:
If dosage is too low increase the amount of cannabis.
If dosage is too high reduce the vaporization temperature.
Drug (Filling
Chamber Content)
Bedrocan (100 mg)
Bediol (100 mg)
THC: approx. 19 mg
THC: approx. 6 mg
CBD: approx. 7,5 mg
approx. 8 mg
approx. 3,5 mg
approx. 4,5 mg
approx. 5,5 mg
approx. 2,4 mg
approx. 3 mg
Cannabinoid
content in drug
Cannabinoid con-
tent in Valve Balloon
after vaporization
with 210°C (410°F)
Cannabinoid
content in blood
stream (systemic
bioavailability)
after inhalation
7. THE USE OF HEMP FLOWERS
The charts show the concentration of active ingredients approx. 5 minutes after
the filling of the Valve Balloon. Due to exhalation the actual systematic bioavail-
ability (blood content) is approx. 35% lower than the cannabinoid content in the
Valve Balloon.
Cannabinoid concentration per Balloon Filling at 185°C (365°F) with 250 mg filling quantity
mg
10
8
6
4
2
0
1 2 3 4 5 6 7 8 9 10
Bedrocan (THC)
Bediol (CBD)
Bediol (THC)
Multiple Balloon
Fillings from a single
250 mg sample
Cannabinoid concentration per Balloon Filling at 185°C (365°F) with 500 mg filling quantity
mg
Multiple Balloon
Fillings from a single
500 mg sample
10
8
6
4
2
0
1 2 3 4 5 6 7 8 9 10
Bedrocan (THC)
Bediol (CBD)
Bediol (THC)

3130
Grind the hemp flowers with the en-
closed herb mill. Place a hazelnut-
sized amount in the Herb Mill and
rotate 4-5 times.
Hemp flowers are ground
most easily when they are
cooled or frozen. The fridge or
freezer are suited for storing hemp
flowers.
Depending on the amount of active
ingredients and the recommended
dosage by a physician, fill the Filling
Chamber with ground hemp flowers.
Next screw on the Filling Chamber
Cap again.
Screw on Filling Chamber Cap
7.2. Preparation
Make sure to use the Mouth-
piece only with attached Lip
Piece before every operation
(see Chapter 9.3. “Disposable MED-
IC VALVE Lip Piece for Hygienic Use”,
page 39)
Turn the Filling Chamber Cap counter-
clockwise in order to remove it from
the Filling Chamber.
For consistent and reproduci-
ble dosage with e. g. 100 mg,
use each Filling Chamber
portion only once to fill a Valve Bal-
loon.
Other conditions for a reproducible
dosage are: using standardized can-
nabis, consistent amount, consistent
temperature, consistent Valve Bal-
loon Size (standard size 1.25 l) and
same breathing technique when in-
haling.
7.3. Application
Remove Filling Chamber Cap
Fill Filling Chamber
7. THE USE OF HEMP FLOWERS
Stretch Valve
Balloon tight
Fill the Filling Chamber Reducer with
ground hemp flowers directly or with a filled
Dosing Capsule
Take care that the Screens
are not obstructed with plant
material. To guarantee opti-
mal results, we recommend cleaning
the Screens after each vaporization
cycle with the Cleaning Brush sup-
plied with the device.
Suitable for vaporizing small
amounts of hemp flowers, is
the Filling Chamber Reducer,
which is available as an accessory,
along with the Dosing Capsules.
The Filling Chamber Reducer is in-
serted instead of the Filling Chamber
Cylinder (see Chapter 9.5. „Disas-
sembling and Assembling the Filling
Chamber“, page 42).
The Filling Chamber Reducer can be
filled with ground hemp flowers direct-
ly. Dosing Capsules containing hemp
flowers can be inserted into the Filling
Chamber Reducer as well.
7. THE USE OF HEMP FLOWERS
ture is equal to the set temperature
put the Filling Chamber with Cap on
the Hot Air Generator and allow it to
lock in place. Put the Valve Balloon
on the Filling Chamber and allow it to
lock in place. This will open the Valve.
Before putting the Valve Balloon on
the Filling Chamber, stretch it tight so
that the Valve Balloon is placed verti-
cally on the Hot Air Generator when it
is filled. Press the “AIR” button. The
Valve Balloon will now fill with the can-
nabis aerosol.
Press the “HEAT” button to switch on
the heater. When the actual tempera-

3332
7. THE USE OF HEMP FLOWERS
Remove Valve Balloon with Filling Chamber
Caution! Hot surface!
Do not touch any compo-
nents of the Filling Chamber
(except at the textured grip)
until it has cooled down after
the Valve Balloon has been filled.
Separate the Valve Balloon from the
Filling Chamber. The Valve closes
automatically after separation and the
aerosol in the Valve Balloon cannot
escape.
Separate Valve Balloon from Filling
Chamber
Do not leave the Filling Chamber on
the hot air outlet of the VOLCANO
MEDIC when “HEAT” is switched on
- except for filling the Valve Balloon.
Non-observance may cause the Fill-
ing Chamber to overheat and may
cause burns.
When the Valve Balloon is filled,
switch off the air pump and remove
the Valve Balloon together with the
Filling Chamber.
To do so, hold the Filling Chamber
Cap at the textured grip.
Caution! Hot surface!
7. THE USE OF HEMP FLOWERS
7.4. Inhalation from the Valve
Balloon
Attach the Mouthpiece with attached
Lip Piece to the Valve and allow it to
lock in place.
Press Mouthpiece against lips to inhale
As soon as you remove the pressure
from the Mouthpiece, the Valve auto-
matically closes.
Attach the Mouthpiece with attached Lip
Piece to the Valve Balloon
Correct position of the Mouthpiece with Lip
Piece on the Valve
To inhale, put the Mouthpiece to your
lips and press them lightly against the
Mouthpiece. By doing so, the Valve
opens and the aerosol can be inhaled
from the Valve Balloon.

Stretch Valve
Balloon tight
3534
The Valve Balloon is not suit-
able for storing the aerosol for
long periods, as it will con-
dense on the interior surface of the
Valve Balloon in time (a few hours).
Inhale the contents of the Valve Bal-
loon within 10 minutes.
7. THE USE OF HEMP FLOWERS
When the content of the Valve
Balloon is almost emptied,
you can empty the Balloon
completely by stretching it tight.
Breathing Technique
Inhale only half as much air as pos-
sible. Hold your breath for a few sec-
onds and exhale slowly.
We recommend consciously concen-
trating on you inhalation. The can-
nabinoid aerosol is absorbed by the
alveoli and into the bloodstream. The
onset of the effect takes approx. 1-2
min.
End of Inhalation
Disconnect the power plug from the
socket after inhalation.
Open the Cap of the Filling Chamber
by turning it counterclockwise and
discard the used plant material.
8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE
If necessary, grind the hemp flowers.
Weight out the amount, which is rec-
ommended by the doctor, and fill the
Dosing Capsule by using the Maga-
zine Cap (funnel).
Dosing Capsules with Magazine
With the Dosing Capsules, which are
available as accessories, you can fill
ground hemp flowers or dronabinol
using the Liquid Pads into the Dosing
Capsules in advance and store them
in the Magazine.
This makes usage easy. This way,
patients with fine motor dysfunction
for example, can have their daily dose
pre-filled in Dosing Capsules by the
nursing staff.
8.1. Filling the Dosing Capsules
with ground hemp flowers
Currently, patients in practically all
countries, which 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 be portioned and
weight out by the patient according
to the doctor‘s directive. In case the
hemp flowers are not ground, they
have to be ground with the included
Herb Mill first.
Hemp flowers are ground
most easily when they are
cooled or frozen. The fridge or
freezer are suited for storing hemp
flowers.
The Dosing Capsules can be filled
with e.g. 50, 100 or up to 150 mg
ground hemp flowers per capsule
and be stored in the Magazine as a
reserve.
Dosing Capsule with removed cap

3736
8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE
Dosing Capsule while being filled with
Magazin Cap (funnel) Attaching the Magazine Cap
Dosing Capsule with removed cap and
inserted Liquid Pad
Attach the cap onto the Dosing Cap-
sule. Repeat the filling process until
the desired amount of Dosing Cap-
sules is filled and insert them into the
magazine. The magazine can hold up
to 8 Dosing Capsules.
After filing the Dosing Capsules, at-
tach the Magazine Cap and close it by
turning it clockwise.
8.2. Filling the Dosing Capsules
with Dronabinol
The Dosing Capsules with inserted
Liquid Pad can be filled with up to 5
drops of dronabinol and store them in
the Magazine. Please make sure to
not overfill the Liquid Pad.
8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE
The Dosing Capsule inserted into the Filling
Chamber Reducer
8.3. Inserting the Dosing Capsules
First, the Filling Chamber Reducer,
that is available as an accessory
as well, is to be inserted instead of
the Filling Chamber Cylinder (see
Chapter 9.5. “Disassembling and As-
sembling the Filling Chamber“, page
42), afterwards, insert the Dosing
Capsules into the Filling Chamber
Reducer.
Next screw on the Filling Chamber
Cap again.
Screw on Filling Chamber Cap
The Filling Chamber Reducer
can be filled directly as well
(without a Dosing Capsule),
see Chapters 6.3. and 7.3. “Applica-
tion”, pages 21 and 30.

3938
9. HYGIENE
9.1. General
Caution!
To avoid a health risk – e.g. in-
fection from a contaminated
Filling Chamber or a contaminated
Valve Balloon – the following hygiene
instructions must be followed.
In a physician‘s practice or a in a clinic,
the hygiene requirements of the RKI
(Robert Koch Institute), the BfArM
(German Federal Institute for Drugs
and Medical Devices) or comparable
institutions in your country, have to be
observed.
The VOLCANO MEDIC Vaporization
System is intended for multiple use.
a) Filling Chamber
The Filling Chamber must be
cleaned if there is visible residue
or when a new Valve Balloon is
used.
b) Valve Balloon
The Valve Balloon may be used by
one person only.
Make sure that the equipment is al-
lowed to dry thoroughly after every
cleaning. Condensation or residual
moisture may encourage bacterial
growth. Please note Chapter 9.2. “Ma-
terial Resistance” on this page.
Inspect the component parts of the
Filling Chamber regularly and replace
defective (broken, misshapen, dis-
colored) parts. Replace the Valve Bal-
loon after 70 applications or at least
14 days after the first use.
The Lip Piece of the VOLCANO
MEDIC Vaporization System is
equipped with a check valve.
This check valve reduces the danger of a
potential contamination inside the Valve
Balloon by preventing breathing into the
Valve Balloon.
This ensures that the Valve Balloon can
be re-used several times.
9.2. Material Resistance of the
VOLCANO MEDIC Vaporiza-
tion System
Please ensure that the Mouthpiece,
the Filling Chamber, the Lip Piece and
the Hot Air Generator do not come in
contact with the following chemicals:
organic, mineral and oxidating
acids (min. permissible pH 5.5)
strong bases (max. permissible
pH 10). We recommend using
neutral/enzymatic or slightly
alkaline cleaners.
organic solvents (e.g. aldehyde,
ether, ketone, benzene)
oxidation agents (e.g. hydrogen
peroxide)
halogens (chlorine, iodine, bro-
mine)
aromatic/halogenated hydrocar-
bons
9. HYGIENE
phenol derivatives, amin com-
pounds (in high concentrations)
oils and greases
Clean the parts of the VOLCANO
MEDIC Vaporization System only
with soft brushes, never with metal
brushes or steel wool.
9.3. Disposable MEDIC VALVE
Lip Piece for Hygienic Use
The Lip Piece will be delivered brand
new and in a low-germ, but not fully-
sterile state.
The Lip Piece is equipped
with a check valve. This
check valve reduces the dan-
ger of a potential contamination inside
the Valve Balloon by preventing
breathing into the Valve Balloon.
This ensures that the Valve Balloon
can be re-used several times before
it has to be disposed (see Chapter
9.4. “Reusability of the Valve Balloon”,
page 41).
Valve Balloon with Mouthpiece and Lip
Piece
The Lip Piece is put on the Mouth-
piece, slid until stop and is then ready
for operation.
The Valve Balloon with Mouthpiece
and the Lip Piece may be used by only
one person.
A Lip Piece may be used for max. 4
hours after initial operation if it is un-
damaged and clean. Afterwards, it
must be disposed of in the household
waste and a new Lip Piece must be
used due to hygienic reasons.
Every further use beyond this or the
use of damaged and/or contaminated
products respectively is the user‘s re-
sponsibility.
We assume no liability if this recom-
mendation is ignored.
Please note that damaged or
brittle Lip Pieces are not to be
used.