Vapormed VOLCANO MEDIC Instructions For Use Manual

INSTRUCTIONS FOR USE

Read carefully before using the device and

save these instructions.

INSTRUCTIONS FOR USE ENGLISH

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

3

INSTRUCTIONS FOR USE ENGLISH INSTRUCTIONS FOR USE ENGLISH

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

5 4

1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE 1. PRODUCT OVERVIEW, SCOPE OF DELIVERY, SERVICE

Product Overview

Actual Temperature
Display

Set Temperature
Display

Minus Temperature Button

“HEAT” Button
(Heater)

Air Filter

Air Filter Cap

Screen Set

Valve Balloon with
Mouthpiece and
Lip Piece

Hot Air Outlet

Liquid Pad

Ventilation Slot

Plus Temperature

Button

“AIR” Button

(Pump)

Heater Control Lamp

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.

Filling Chamber

with Cap

7 6

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

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 VOLCANO
MEDIC Vaporization System 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 VOLCANO MEDIC Vaporization System.

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

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.

Safety Category II device

9 8

2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

IP 21

0123

REF

Device protected against foreign bodies with a diameter larger
than 12 mm and against vertically falling water drops (according to
IEC 60529).

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.

Caution! Hot surfaces!
Never leave Filling Chamber on the VOLCANO MEDIC Hot Air
Generator.

Keep away from sunlight

Protect against moisture and humidity

Contains or presence of phthalate

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

Temperature limits of ambient temperature

Humidity limitation

Air pressure 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 cor­responds 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 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.

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 tem­perature cannot drop below +5°C
(+41°F). Store the Hot Air Genera­tor 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 can­prove dangerous to the user.

11 10

2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

2. EXPLANATION OF SYMBOLS, SAFETY
RECOMMENDATIONS

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 Genera­tor 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 fill­ing 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 im­merse 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.

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.

3. INTENDED 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 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.

The manufacturer is not re­sponsible for any damage

or personal injury caused
by inappropriate, incorrect or irre­sponsible use.

13 12

4. IMPORTANT REMARKS

4. IMPORTANT REMARKS

The VOLCANO MEDIC Va-
porization System ensures

the highly effective, safe, and
fast-acting application of cannabi­noids. The patient must undergo a
medical examination before the be­ginning 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 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.

Dronabinol is the international non­proprietary name for Delta-9-tetrahy­drocannabinol (THC) which is known
as the most effective cannabinoid for
medical use.

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.

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 availa­ble 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, pharma­cist or manufacturer of medical hemp
flowers (Cannabis flos).

15 14

4. IMPORTANT REMARKS

5. THE VOLCANO MEDIC HOT AIR GENERATOR

4.1. Operating Conditions

Ambient conditions in which the
specified aerosol characteristics are
guaranteed:

+40°C

+10°C

Ambient temperature:

+10°C to +40°C (+50°F to +104°F)

30% - 80%

Relative humidity of ambient air:

30% to 80%

Atmospheric pressure:

700 hPa to 1060 hPa

The device features interference sup­pression 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 qual­ified personnel.

4.2. Storage and Transport
Conditions

+60°C

-20°C

Ambient temperature:

-20°C to +60°C (-4°F to +140°F)

20% - 80%

Relative humidity:

20% to 80%

Atmospheric pressure:

700 hPa to 1060 hPa

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 tem­perature can lead to condensation
and damage the device‘s function.

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. Immedi­ately after unpacking, check whether

the Hot Air Generator, the accesso­ries, 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 Gen­erator 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 offi­cial regulations.

Put the Hot Air Generator on a flat and
stable surface.

Take care that the power cord cannot

be damaged through kinking, crush­ing or pulling.

Improper installation may

lead to personal injury or ma-

terial damages, for which the
manufacturer cannot be held respon­sible.

5.3. Operation

The Hot Air Generator was
developed for vaporizing the

cannabinoids listed in the in­structions. Any other use is inappro­priate 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 your­self. Contact our Service Center di­rectly.

Allow the device to cool down before it

is packed away.

17 16

5. THE VOLCANO MEDIC HOT AIR GENERATOR

5. THE VOLCANO MEDIC HOT AIR GENERATOR

5.4. Commissioning

Do not leave the device unat-

tended while it is being opera­ted. 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 man­ufacturer will not bear any responsibil­ity whatsoever if this accident preven­tion 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 “H EAT”. 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 tem­perature. The heating process is com­pleted 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 tempera­ture 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 meas­ured during vaporization. During op­eration the temperature is measured
at the heat exchanger. The display in­dicates the reference values for the
attached Filling Chamber with the air
pump switched on.

5.6. Temperature Setting

Actual temperature
display (red)

Minus temperature
button

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 in­creased 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.

Set temperat ure

display (green)

Plus temperature

button

30 minutes after the last time
a button is pressed, the devi­ce 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 discon­nected from the mains only
when the plug is removed

from the socket.

19 18

6. THE USE OF DRONABINOL

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.

When observing the Instructions for Use and with a vaporization temperature of
210°C (410°F) the following reference values are validated in studies:

Drug (Filling
Chamber Content)

Dronabinol/THC
(10 mg)

If dosage is too low increase the amount of dronabinol.
If dosage is too high reduce the amount of dronabinol.

Cannabinoid
content in drug

THC: 10 mg approx. 6 mg approx. 4 mg

6.1. Efficiency of vaporized
Dronabinol (THC)

By following the procedure listed in
the Instructions for Use the systemic
bioavailability of vaporized dronabi­nol is approximately 40% .

For comparison: The systemic bio­availability of cannabinoids adminis­tered orally is below 15%.

Cannabinoid con­tent in Valve Balloon
after vaporization
with 210°C (410°F )

Cannabinoid
content in blood
stream (systemic
bioavailability)
after inhalation

6.2. Preparation

Make sure to use the Mouth­piece only with attached Lip

Piece before every operation
(see Chapter 9.3. “Disposable MED-
IC V ALVE Lip Piece for Hygienic Use”,

page 39)

Turn the Filling Chamber Cap counter­clockwise in order to remove it from

the Filling Chamber.

Remove Filling Chamber Cap

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.

Preparation to use the Liquid Pad

Dronabinol (THC) dissolved
in oil is not suitable for vapori­zation and is intended for oral

administration.

6.3. Application

Turn the Filling Chamber upside down

and use a pipette to drop the dronabi­nol (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!

Applying drops with a pipette

Next screw on the Filling Chamber
Cap again.

21 20

6. THE USE OF DRONABINOL

6. THE USE OF DRONABINOL

Screw on Filli ng Chamber Cap

Suitable for vaporizing small
amounts of dronabinol (THC),

is the Filling Chamber Reduc­er, 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.

Insert either a small Liquid Pad direc tly into
the Filling Chamber Reducer or a Dosing
Capsule equipped with a Liquid Pad

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 al­cohol 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.

Separate alc ohol

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 i s 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

and then the Valve Balloon on and al­low 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.

Stretch Valve

Balloon tight

23 22

6. THE USE OF DRONABINOL

6. THE USE OF DRONABINOL

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.

Remove Valve Balloon with Filling Chamber

Caution! Hot surface!

Do not touch any compo­nents 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 VO LCA NO

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!

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 M outhpie ce with attached Lip
Piece onto the Valve Balloon

Correct posi tion of the Mouthpie ce with Lip
Piece on the Valve

To inhale, put the Mouthpiece to your

lips and lightly press against the
Mouthpiece with your lips. By doing

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 auto­matically closes.

Press Mouthp iece against lips to inhale

As the content of the Valve
Balloon deflates, it may be

completely emptied by
stretching the Valve Balloon taut and
subsequently inhaling the content

25 24

6. THE USE OF DRONABINOL 7. THE USE OF HEMP FLOWERS

Stretch Valve

Balloon tight

The Valve Balloon is not suit­able 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 concen­trating 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.

Use only standardized, medicinal
hemp flowers (cannabis flos) that

have been tested by licensed produc­ers for authenticity, purity, and patho­gens according to the directives of the
competent authorities in your country.

Under no circumstances
should yo u use cannabis fr om

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. 29­40%.

For comparison: The systemic bio­availability 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 vaporiza­tion 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 mate­rial 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 tempera­ture (210°C/410°F) in a single Valve
Balloon only.

27 26

7. THE USE OF HEMP FLOWERS

When observing the Instructions for Use and with a vaporization temperature of
210°C (410°F) the following reference values are validated in studies:

Drug (Filling
Chamber Content)

Bedrocan (100 mg)

Bediol (100 mg)

If dosage is too low increase the amount of cannabis.
If dosage is too high reduce the vaporization temperature.

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 minut es), you may put hig her
quantities cannabis (up to 500 mg)

into the Filling Chamber and vaporize
at lower temperatures.

Thus, you can fill mutiple Valve Bal-

loons wi th vapors of act ive ingredien ts

with a single Filling Chamber filling.

Cannabinoid
content in drug

THC: approx. 19 mg

THC: approx. 6 mg

CBD: app rox. 7,5 mg

Cannabinoid con­tent in Valve Balloon
after vaporization
with 210°C (410°F )

Cannabinoid
content in blood
stream (systemic
bioavailability)
after inhalation

approx. 8 mg

approx. 3,5 mg

approx. 4,5 mg

approx. 5,5 mg

approx. 2,4 mg

approx. 3 mg

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 tem­perature of 185°C (365°F) the follow­ing reference values are validated in

studies:

7. THE USE OF HEMP FLOWERS

Cannabinoid concentration per Balloon Filling at 185°C ( 365°F) with 500 mg filling quantity

10

mg

8

6

4

2

0

1 2 3 4 5 6 7 8 9 10

Cannabinoid concentration per Balloon Filling at 185°C ( 365°F) with 250 mg filling quantity

10

mg

8

6

4

2

0

1 2 3 4 5 6 7 8 9 10

Bedrocan (THC)

Bediol (CBD)

Bediol (THC)

Multip le Ball oon

Filling s from a sin gle

500 mg s ample

Bedrocan (THC)

Bediol (CBD)

Bediol (THC)

Multip le Ball oon

Filling s from a sin gle

250 mg sample

The charts show the concentration of active ingredients approx. 5 minutes after
the filling of the Valve Balloon. Due to exhalation the actual systematic bioavail­ability (blood content) is approx. 35% lower than the cannabinoid content in the
Valve Balloon.

29 28

7. THE USE OF HEMP FLOWERS

7. THE USE OF HEMP FLOWERS

7.2. Preparation

Make sure to use the Mouth­piece only with attached Lip

Piece before every operation
(see Chapter 9.3. “Disposable MED-
IC V ALVE Lip Piece for Hygienic Use”,

page 39)

Turn the Filling Chamber Cap counter­clockwise in order to remove it from

the Filling Chamber.

Remove Filling Chamber Cap

Grind the hemp flowers with the en­closed herb mill. Place a hazelnut­sized 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.

For consistent and reproduci­ble dosage with e. g. 100 mg,

use each Filling Chamber
portion only once to fill a Valve Bal­loon.

Other conditions for a reproducible

dosage are: using standardized can-

nabis, consistent amount, consistent
temperature, consistent Valve Bal­loon Size (standard size 1.25 l) and

same breathing technique when in-

haling.

7.3. Application

Fill Filling Chamber

Next screw on the Filling Chamber

Cap again.

Screw on Filli ng Chamber Cap

Take care that the Screens
are not obstructed with plant

material. To guarantee opti­mal 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 direct­ly. Dosing Capsules containing hemp
flowers can be inser ted into the Filling

Chamber Reducer as well.

Fill the Filling Chamber Reducer with
ground hemp flowers directly or with a fill ed
Dosing Capsule

Press the “HEAT” button to switch on
the heater. When the actual tempera-

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 verti­cally on the Hot Air Generator when it
is filled. Press the “AIR” button. The

Valve Balloon will now fill with the can-

nabis aerosol.

Stretch Valve

Balloon tight

31 30

7. THE USE OF HEMP FLOWERS

7. THE USE OF HEMP FLOWERS

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.

Remove Valve Balloon with Filling Chamber

Caution! Hot surface!

Do not touch any compo­nents 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 VO LCA NO

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.

Caution ! Hot surface!

7.4. Inhalation from the Valve
Balloon

Attach the Mouthpiece with attached

Lip Piece to the Valve and allow it to
lock in place.

Attach the M outhpie ce with attached Lip
Piece to the Valve Balloon

Correct posi tion of the Mouthpie ce 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.

As soon as you remove the pressure

from the Mouthpiece, the Valve auto­matically closes.

Press Mouthp iece against lips to inhale

33 32

7. THE USE OF HEMP FLOWERS

8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE

When the content of the Valve
Balloon is almost emptied,
you can empty the Balloon

completely by stretching it tight.

Stretch Valve

Balloon tight

The Valve Balloon is not suit­able for storing the aerosol for

long periods, as it will con­dense on the interior surface of the
Valve Balloon in time (a few hours).

Inhale the contents of the Valve Bal­loon within 10 minutes.

Breathing Technique

Inhale only half as much air as pos­sible. Hold your breath for a few sec­onds 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.

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

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).

35 34

8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE

8. ACCESSORIES: DOSING CAPSULES AND MAGAZINE

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 As­sembling the Filling Chamber“, page

42), afterwards, insert the Dosing
Capsules into the Filling Chamber
Reducer.

Dosing Capsule while being filled with
Magazin Cap (funnel)

Attach the cap onto the Dosing Cap­sule. Repeat the filling process until
the desired amount of Dosing Cap­sules is filled and insert them into the
magazine. The magazine can hold up
to 8 Dosing Capsules.

Attaching the Magazi ne Cap

After filing the Dosing Capsules, at­tach 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.

Dosing Capsule with removed cap and
inserted Liquid Pad

The Dosing Capsule inserted into the Filling
Chamber Reducer

Next screw on the Filling Chamber
Cap again.

Screw on Filli ng Chamber Cap

The Filling Chamber Reducer
can be filled directly as well

(without a Dosing Capsule),
see Chapters 6.3. and 7.3. “Applica­tion”, pages 21 and 30.

37 36

9. HYGIENE

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 clini c,

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, dis­colored) parts. Replace the Valve Bal-

loon after 70 applications or at least

14 days after the first use.

The Lip Piece of the V OLCAN O
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 Filli ng 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

phenol derivatives, amin com-

pounds (in high concentrations)

oils and greases

Clean the parts of the VO LCA N O
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 pote ntial contamin ation 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 Mouthp iece 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 un­damaged 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 re­sponsibility.

We assume no liability if this recom­mendation is ignored.

Please note that damaged or

brittle Lip Pieces are not to be

used.

39 38

9. HYGIENE

9. HYGIENE

9.4. Filling Chamber and Valve
Balloon

Cleaning the Filling Chamber

Clean your sink and the surround-

ing area.

Disassemble the Filling Chamber

(see Chapter 9.5. “Disassembly
and Assembly” of the Filling Cham­ber, page 42).

Remove stubborn residue inside

the Filling Chamber Cylinder and
cap cylinder (if necessary, with
ethyl alcohol).

Place all component parts of the

Filling Chamber in warm (40-50°C,
104-122°F) soapy water for at
least 5 min. (commercial dish soap
without disinfectants and with as
few additives as possible, used ac­cording to manufacturer‘s recom­mendations, avoiding excessive
foam) and ensure that all parts are
completely covered and contain no
air bubbles.

Use a soft brush (bottle brush)

or a soft, clean cloth to remove
impurities that is used only for this
purpose, never metal brushes or
steel wool. Clean until there are no
visible impurities on the parts.

Remove the parts from the soapy

water and rinse them for at least 1
min. under running water.

Allow the liquid inside to run out

completely and shake any remain­ing water out of the parts. Avoid
any contact with unclean surfaces,
especially the floor.

Do not immerse any plastic
components in ethanol or al-

cohol for longer than an hour.
Extended contact with ethanol or al­cohol can lead to discoloration or em­brittlement of plastic parts.

Note: If the tap water is very hard, re­sulting in the formation of a white film
on the surface of the parts, we recom­mend replacing the Filling Chamber
more frequently.

Possible alternative: The compo­nent parts of the Filling Chamber can
also be cleaned in a dishwasher using
a commercially available dishwasher
detergent.

Put the component parts of
the Filling Chamber in a suit-

able place in the dishwasher.
Small parts (e.g. Filling Chamber
Clips) can be lost or may damage the
dishwasher if improperly placed.

In case of doubt, do not clean the
small parts of the Filling Chamber
(Filling Chamber Clips, Screens) in
the dishwasher.

Inspecting /Maintenance of the
Filling Chamber

After cleaning, check all component
parts of the Filling Chamber for sur­face damage, tears, soften ing or hard­ening, soiling, discoloration, or exces­sive limescale and discard damaged
Filling Chambers.

Then reassemble the Filling Chamber
(see Chapter 9.5. “Disassembling and
Assembling” of the Filling Chamber,
page 42).

Reusability of the Filling Chamber

The Filling Chamber (incl. Screens
and Liquid Pad) is intended for multi­ple use.

It requires no particular hygienic re­processing (see Chapter 9.4. “Clean­ing the Filling Chamber”, page 40).

The Filling Chamber must be cleaned:

if there is residue (condensate) on

the inside of the Filling Chamber,

when a new Valve Balloon and

Mouthpiece is used,

when a new patient uses it.

Before every use, check the Filling
Chamber for damage and wear and tear
(see section “Inspecting/Maintenance
of the Filling Chamber”, page 41). A
defective Filling Chamber or part must
be replaced immediately.

Reusability of the Valve Balloon

The Valve Balloon is intended for mul­tiple uses without hygienical repro­cessing.

It may be used only by one person for
a maximum of 70 times and a maxi­mum of 14 days after the initial use.

Then a new Valve Balloon with Mouth­piece must be used.

Before each vaporization, check from
the outside whether there is any mois­ture (condensation) inside the Valve
Balloon.

If there is any moisture in the Valve
Balloon or if the Valve is damaged, the
Valve Balloon may no longer be used
and must be disposed of with house­hold waste.

41 40

9. HYGIENE

9. HYGIENE

Storage

Store Filling Chamber, Mouthpiece, Lip
Piece and Valve Balloon in a dry, dust­free place away from contamination.

9.5. Disassembly and Assembly

Filling Chamber and Filling Cham­ber Cap

Please allow the Filling Chamber and
the Cap to cool down before disas­sembling them.

All component parts of the Filling
Chamber must be cleaned at the in­tervals prescribed in Chapter 9.4.
“Reusability of the Filling Chamber”,
page 41. Disassemble the Filling
Chamber as follows:

Turn the Filling Chamber Cap coun­terclockwise in order to remove it from
the Filling Chamber.

Remove Filli ng Chambe r Cap

Disassembling the Filling Cham­ber Cap

Use, e.g., the handle of the Cleaning
Brush to press the u pper Screen down
in order to push it out. No Screens are
needed when using dronabinol.

Push out the upper Screen w ith the help of
the Cleaning Brush

Push the cap cylinder downwards out
of the cap housing. At the same time
the cap ring will be stripped off.

Push the cap cylinder ou t of the cap
housing

Disassembling the Filling Chamber

Push the lower Screen or the Liquid
Pad upwards out of the Filling Cham­ber Cylinder.

Push the Filling Chamber Cylinder
upwards out of the Filling Chamber
Housing.

Push the Filling Chamber Cylinder o ut of the
Filling Chamber Housing

When the Filling Chamber Cylinder is
pushed out, the three Filling Chamber
Clips are loosened and fall out of the
Filling Chamber Housing.

Lower Screen

Filling Chamber

Cylinder

Filling Chamber

Housing

Drying

All component parts of the Filling
Chamber must be completely dry be­fore reassembly.

Put all component parts of the Filling
Chamber on a clean, dry, and absor­bent pad and allow them to dry thor­oughly. A hair dryer may be used for
faster drying. Do not dry in wet rooms
(e.g. not in the bathroom).

Assembly of Filling Chamber Cap

Slide the cap cylinder into the cap
housing until it clicks, then pull the cap
ring from above over the cap cylinder
to the cap housing.

When using hemp flowers, push the
upper Screen from below into the cap
cylinder until it clicks into the desig­nated notch.

When using dronabinol solution, the
two Screens are not needed. Only the
Liquid Pad is inserted instead of the
lower Screen.

3 pcs. Filling

Chamber Clip

43 42

9. HYGIENE 10. HOT AIR GENERATOR

Cap Ring

Cap Housing

Cap Cylinder

Upper Screen

The upper Screen has to be placed
carefully into the intended notch. Non­observance may result in plant parti­cles in the Valve Balloon that might be
inhaled subsequently.

Assembling the Filling Chamber

Push the Filling Chamber Cylinder
from above into the Filling Chamber
Housing and allow it to lock in place.

Insert the Filling Chamber Clips in the
openings provided for them in the foot
of the Filling Chamber Housing.

Please ensure that the Filling Cham­ber Clips are placed properly as
shown in the illustration.

Filling Chamber

Cylinder

Filling
Chamber
Housing

Filling
Chamber
Clip

Insert Filling Chamber Clips

Insert the Screen or the Liquid Pad
into the Filling Chamber from above.

Screw Filling Chamber Cap on Filling
Chamber.

10.1. Cleaning

Before maintenance, the device has
to be switched off and the power plug
has to be unplugged.

For home use it is sufficient to clean
the housing of the Hot Air Generator
with a damp cloth. Do not hold the de-

vice under running water.

In a physician‘s office or clinic, the
housing of the Hot Air Generator can
be cleaned and disinfected with a sur­face disinfectant.

The surface disinfectant should be
certified (e.g. VAH/DGHM or FDA
approval or CE marking), be suitable

for disinfecting the Hot Air Generator,
and compatible with the Hot Air Gen­erator (see Chapter 9.2. “Material Re­sistance”, page 38).

Use only a soft clean cloth for wiping.
The cloth may be damp, but not wet.

Prevent liquid from entering the Hot
Air Generator.

The tests for the material resistance
of the Hot Air Generator for surface
disinfection were made using the dis-

infectant “neoform MED Spray” from

Dr. Weigert.

Liquid entering the Hot Air Generator
can damage the electrical parts and
cause malfunctions.

If any liquid does get into the Hot Air
Generator, contact our Service Cent­er immediately.

10.2. Care and Maintenance

Before any maintenance work is done,
the device has to be switched off and
the power plug has to be unplugged.

At the bottom of the Hot Air Generator

is an Air Filter.

The Air Filter must be inspected for

contamination every four weeks by
turning the Air Filter Cap counter­clockwise and removing the Air Filter.

Reassemble

in reverse

order

45 44

10. HOT AIR GENERATOR

10. HOT AIR GENERATOR

10.3. Storage

Store the Hot Air Generator in a dry
place protected against the effects of
weather and out of the reach of chil-

dren or unqualified persons.

10.4. In Case of Problems

Immediately unplug the power cord

and ensure that no one can connect

the Hot Air Generator to the mains

supply again without this being no-

ticed.
If there are any faults in the electron-

ics of the Hot Air Generator VOLC A-

NO MEDIC, you can perform a reset

by pulling out the power plug and
plugging it again after waiting for mini­mum three seconds.

The Hot Air Generator has two inter-

nal fuses (F1 and F2). As these fuses

are used only in case of a defect in

the Hot Air Generator, they can be
replaced only by our Service Center.

Put the Hot Air Generator in the origi-

nal packaging or pack it properly in
other packing material and take it to
our Service Center.

10.5. Disposal

If the Hot Air Generator is irreparably

damaged, please do not simply throw

it away.

As it is made of high quality, complete-

ly recyclable components, it should

be brought to a material recycling
centre in your town or sent to our Ser­vice Center for disposal.

10.6. Troubleshooting

If the device does not function properly when the power plug is connected to the
power socket, please check the Hot Air Generator using the tips in the following
table:

Problem Possible cause/ remedy

No green light signal visible
on the VOLCANO M EDIC
display; no activation of the
heater or pump possible.

No aerosol is formed. Check the set and actual temperature.

The Val ve Balloon does not
fill up.

The device switches of f
(automatic switch-off o f
the VOLCANO MEDIC ).

Plant particles in the Valve
Balloon (when usin g can­nabis flos).

Please make sure that the current is on and that the
fuse (in the mains fuse box) is switched on and is not
defective.

If the Ho t Air Generator still does not function, the inter­nal fuses may have been triggered.

In this case, send the VOLCANO MEDIC Ho t Air Generator
to our Service Cen ter.

Make sure the Filling Chamber and /or Valve Balloon were
correctly attached.

Check w hether dronabinol has been added to the Liquid
Pad or wh ether there is fresh, unus ed cannabis flos in the
Filling Chamber.

Check w hether the pump is tur ned on.
Check w hether the Filling Chamber and /or Valve Balloon

are cor rectly at tached.

No but ton was pressed in the las t 30 minutes – this leads
to automatic swit ch-off. Switch heater or pump on again.

Check w hether the Screen in the Filling Chamber Cap is
clogged or is not inserted into the notch properly.

Check w hether the Filling Chamber was cleaned accord­ing to the Instructions for Use.

47 46

10. HOT AIR GENERATOR 10. HOT AIR GENERATOR

If the preceding tips do not
yield the desired results, or

for any other defects or prob­lems not mentioned here, please pull
the power plug and contact our Ser-

vice Center immediately.

Do not open the Hot Air Gen­erator! Without special tools

and specialized knowledge,
any attempt to open the device will
cause damage to it. Such an attempt

will invalidate the warranty claim.
Do not try to remedy the defect your-

self. Contact directly our Service

Center.

10.7. Periodic Safety Checks

The following safety checks should be

performed at least every 24 months

by a qualified person who has ade­quate training, knowledge, and practi­cal experience to perform these tests.

Inspect the device and accesso-

ries for mechanical and functional
damage.

Inspect the safety labels for leg-

ibility.

Verify that the device functions

properly as described in the
Instructions for Use.

The safet y check is to be rec orded in a
device log and data of control results
are to be documented.

If the device is not functioning prop­erly or fails any of the above tests, the
device has to be repaired.

10.8. Technical Specifications

VOLCANO MEDIC
Vaporization System

Voltage:

220-240 V / 50-60 Hz (alternatively
available with 110-120 V / 50-60 Hz)

The specification is located on the

bottom side of the VOLCANO MEDIC

Hot Air Generator.

Power consumption: 120 VA
Air pump output: 10 VA
Air temperature: adjustable between

approx. 40 - 210°C (104 - 410°F)
Air flow: approx. 12 l/min
Valve Balloon Size:

approx. 12.5 liters

Size of the Hot Air Generator: 20.0 x

18.0 cm (7.9 x 7.1 inch)

Weight of the Hot Air Generator with

power cord, Filling Chamber, and
Valve Balloon with Mouthpiece: ap-

prox. 1.8 kg (3.9 lbs)

Safety category II

Please unplug to disconnect from the

mains current.

Internal fuses F1 and F2: T 1.25 A
(applies to 110-120 V and 220-240 V
devices)

These fuses may be replaced only by
our Service Center.

Subject to technical changes.

Patents and designs:

www.vapormed.com/patents

Manufacturer

Storz & Bickel GmbH & Co. KG
In Grubenäcker 5-9,

78532 Tuttlingen,

Germany

10.9. Information on Electromagnetic Compatibility

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions

The VOLCANO MEDIC Vaporization System is intended for use in the electro-
magnetic environment specified below. The customer or the user of the VOL-
CANO MEDIC Vaporization System should assure that it is used in such an en­vironment.

Electromagnetic environment - guidance Emissions test Compliance

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic emissions
IEC 61000-3-2

Voltage fluctuations/
flicker emissions
IEC 61000-3-3

Group 1

Class B

Class A

Complies

The VOLCANO MEDIC Vaporization
System 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.

The VOLCANO MEDIC Vaporization
System is suitable for use in all
establishments, including domestic
establishments and those directly
connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes.

49 48

10. HOT AIR GENERATOR 10. HOT AIR GENERATOR

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The VOLCANO MEDIC Vaporization System is intended for use in the electro-
magnetic environment specified below. The customer or the user of the VOL-
CANO MEDIC Vaporization System should assure that it is used in such an en­vironment.

Immunity test IEC 60601

Electrostatic
discharge (ESD)
IEC 61000-4-2

Electrical fast
transient/burst
IEC 61000-4-4

Surge
IEC 61000-4-5

test leve l

± 6 kV contact
discharge

± 8 kV air
discharge

± 2 kV for power
supply lines

± 1 kV for input/
output lines

± 1 kV line(s) to
line(s)

± 2 kV line(s) to
earth

Compliance

level

± 6 kV contact
discharge

± 8 kV air
discharge

± 2 kV for power
supply lines

not applicable:
input/output lines
are non-existent

± 1 kV line(s) to
line(s)

± 2 kV line(s) to
earth

Electromagnetic

environment – guidance

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

Mains power quality
should be that of a
typical residential,
commercial or hospital
environment.

Mains power quality
should be that of a
typical residential,
commercial or hospital
environment.

Immunity test IEC 60601

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

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

Note: Uτ is the a.c. mains voltage prior to application of the test level.

test leve l

<5 % Uτ
(>95 % dip in Uτ)
for ½ cycle

40 % Uτ
(60 % dip in Uτ)
for 5 cycles

70 % Uτ
(30 % dip in Uτ)
for 25 cycles

<5 % Uτ
(>95 % dip in Uτ)
for 5 s

3 A/m

Compliance

level

<5 % Uτ
(>95 % dip in Uτ)
for ½ cycle

40 % Uτ
(60 % dip in Uτ)
for 5 cycles

70 % Uτ
(30 % dip in Uτ)
for 25 cycles

<5 % Uτ
(>95 % dip in Uτ)
for 5 s

3 A/m

Electromagnetic

environment – guidance

Mains power quality
should be that of a typical
residential, commercial or
hospital environment. If
the user of the VOLCANO
MEDIC Vaporization
System requires
continued operation
during power mains
interruptions, it is
recommended that the
VOLCANO MEDIC
Vaporization System be
powered from an
uninterruptible power
supply.

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

51 50

10. HOT AIR GENERATOR 10. HOT AIR GENERATOR

Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The VOLCANO MEDIC Vaporization System is intended for use in the electro-
magnetic environment specified below. The customer or the user of the VOL-
CANO MEDIC Vaporization System should assure that it is used in such an en­vironment.

Immunity test IEC 60601

Conducted RF
IEC 61000-4-6

Radiated RF
IEC 61000-4-3

test leve l

3 Vrms
150 kHz to 80
MHz

3 V/m
80 MHz to 2,5
GHz

Compliance

level

3 Vrms

3 V/m

Electromagnetic

environment – guidance

Portable and mobile RF
communications
equipment should be
used no closer to any part
of the VOLCANO MEDIC
Vaporization System,
including cables, than the
recommended separation
distance calculated from
the equation applicable to
the frequency of the
transmitter.

Recommended
separation distance :

d = 1,2 √P

d = 1,2 √P

für 80 MHz bis 800 MHz

d = 2,3 √P
für 800 MHz bis 2,5 GHz

Immunity test IEC 60601

Note 1: At 80 MHz and 800 MHz, 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.

test leve l

Compliance

level

Electromagnetic

environment – guidance

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
survey¹), should be less
than the compliance level
in each frequency
range²).

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

53 52

10. HOT AIR GENERATOR

10. HOT AIR GENERATOR

¹) Field strengths from fixed transmit-

ters, such as base stations for radio

(cellular/cordless) telephones and

land mobile radios, amateur 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 si te survey shou ld be consid ered.
If the measured field strength in the lo-

cation i n which the VOLCANO MEDIC

the applicable RF compliance level
above, the VOLCANO MEDIC Vapori-
zation System should be observed to
verify normal operation. If abnormal

performance is observed, additional

measures may be necessary, such
as re-orienting or relocating the VOL-
CANO MEDIC Vaporization System.

²) Over the frequency range 150 kHz

to 80 MHz, field strengths should be

less than 3 V/m.

Vaporization System is used exceeds

Recommended Separation Distances between portable and mobile
RF Communications Equipment and the VOLCANO MEDIC Hot Air Generator

The VOLCANO MEDIC Hot Air Generator is intended for use in an electromag­netic environment in which radiated RF disturbances are controlled. The customer
or the user of the VOLCANO MEDIC Hot Air Generator can help prevent electro-
magnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the VOLCANO MEDIC
Hot Air Generator as recommended below, according to the maximum output
power of the communications equipment.

Rated maximum
output power of

transmitter

[W]

0,01 0,12 0,12 0,23

0,1

1

10

100

Separation distance according to frequency

150 kHz – 80 MHz

d = 1,2 √P

0,38

1,2
3,8

12

of transmitter [m]

80 MHz – 8 00 MH z

d = 1,2 √P

0,38

1,2
3,8

12

800 MHz – 2,5

d = 2,3 √P

0,73

2,3
7,3

23

For transmitters rated at a maximum

output power not listed above, the

recommended separation distance
d in meters [m] can be determined
using the equation applicable to the

frequency of the transmitter, where P

is the ma ximum output pow er rating of

the transmitter in watts [W] according

to the transmitter manufacturer.

Note 1

At 80 MHz and 800 MHz, the higher

frequency range applies.

Note 2

These guidelines may not apply in all
situations. Electromagnetic propaga-

tion is affected by absorption and re-

flection from structures, objects and

people.

Medical electrical equipment is sub-

ject to special precautions with re­spect to electromagnetic compatibil-

ity. The rel evant verificati on according

to EN 60601-1-2 is available.

55 54

11. SPARE PARTS / ACCESSORIES

12. DECLARATION OF CE CONFORMITY

REF 01 00 M ....................................... VOLCANO MEDIC Vaporization System

REF 05 01 M ................................................... MEDIC VALVE Replacement Set

REF 03 01 M ...................................................... MEDIC VALVE Filling Chamber

REF 03 10 M ................................................ MEDIC VALVE Normal Screen Set

REF 03 11 M ..................................................... MEDIC VALVE Fine Screen Set

REF 03 39 M ...................................... MEDIC VALVE Normal Screen Set, small

REF 03 34 M ........................................................ MEDIC VALVE Liquid Pad Set

REF 06 02 M ..................................................... MEDIC VALVE Wear & Tear Set

REF 03 03 M ....................................... MEDIC VALVE Filling Chamber Housing

with Cap Housing

REF 04 05 M ............................................. MEDIC VALVE Lip Piece Set, 10 pcs.

REF 03 07 M ................................ MEDIC VALVE Filling Chamber with Reducer

REF 03 06 M ....................................... MEDIC VALVE Filling Chamber Reducer

REF 09 32 ....................................................... Magazine with 8 Dosing Capsule

REF 09 33 ............................................................. Dosing Capsule Set, 40 pcs. .

REF 09 36 M ........ MEDIC VALVE Magazine with 8 Dosing Capsule for Liquids

REF 09 38 M .............. MEDIC VALVE Dosing Capsules for Liquids Set, 40 pcs.

REF 03 35 M ..................... MEDIC VALVE Liquid Pad Set for Dosing Capsules

REF 03 37 M ............................................. MEDIC VALVE Liquid Pad Set, small

REF 09 30 .............................................................................................. Herb Mill

REF 01 10 ......................................................... VOLCANO MEDIC Air Filter Set

REF 01 11 ........................................................ VOLCANO MEDIC Air Filter Cap

REF 09 37 ............................................................................. Cleaning Brush Set

All spare parts and other products may be conveniently ordered from

www.vapormed.com.

The devices fulfill the requirements of the following directives and standards:

Medical products: 93/42/EWG
Low Voltage Directive:

73/23/EWG

Electromagnetic Compatibility:

89/336 /EWG

Medical electrical equipment:

IEC 60601-1:2005+A1:2012

UL medical safety testing:

UL 60601-1:2003

Medical electrical equipment:

CAN/CSA-C22.2 No. 601.1-M90

57 56

13. WARRANTY, LIABILITY, REPAIR SERVICE 13. WARRANTY, LIABILITY, REPAIR SERVICE

Warranty

Storz & Bickel GmbH & Co. KG as

seller hereby guarantees the cus-

tomer that the product will be free
from defects in accordance with the

specifications of German law, and

pursuant to our General Terms and
Conditions (GTC), upon which the

purchasing agreement are based. Of
course, Storz & Bickel will only be
subject to a warranty obligation if the
customer has purchased the products
directly from us. If products are pur­chased from third parties, warranty
claims may only be asserted against

these third parties, and Storz & Bickel
cannot provide any information on the
content of such claims.

In clarification, we would like to note
once again here that the warranty
extends only to correcting such initial
defects that exist despite proper han­dling of the product in consideration
of this Instructions for Use and further
information provided to users. Normal
wear or tear to the products is not con­sidered a defect under warranty law. If
the customer has commissioned third
parties with completing maintenance
or repair of the product, or if the cus­tomer uses external products, Storz &
Bickel’s warranty obligations will only
exist if the custom er can prove that the
defect was not caused by use of the
external service or external product.

Storz & Bickel will decide at its own
discretion whether to correct a defect

covered to warranty law through re-

pair or by delivering a new product to
the customer.

Any warranty claims must be di-

rected to Storz & Bickel GmbH, In

Grubenäcker 5-9, 78532 Tuttlingen.

Please send the complete defective
item to us, not disassembled, with in-

voice. Please use external packaging

that would prevent any damage dur­ing transportation.

In order to avoid misunderstandings,
we would like to note that all informa­tion on our products provided in this
Instructions for Use or elsewhere

does not represent any guarantee of

features or durability, unless we have
expressly referred to a guarantee for
such features or durability.

Liability

Storz & Bickel shall be liable for any
damages caused to the customer by
our products in accordance with Ger-

man law and pursuant to our GTC. Un­der said provisions, we are only liable

for damages caused by intentional ac-

tion or gross negligence, unless such
damages involve death, personal

injury, or injury to health, or if the in-

jury is r elated to a cardina l contractual
obligation. In such cases, we will also

be liable to the customer for simple

negligence.

Repair S ervice

In addition to our warranty obligations,
we offer competent repair service to

our customers. We will promptly re-

pair any defective products made by
us after we have informed the custom­er of estimated costs and obtained
customer approval.

Copyright

This document is copyright protected,
and may not be used either in whole
or in part pursuant to Sections 15 et
seqq. UrhG (German Copyright Act)

without prior written approval of Storz
& Bickel.

59 58

13. WARRANTY, LIABILITY, REPAIR SERVICE 14. PROOF OF THE ANNUAL SAFETY CHECKS (SC)

Date SC Finding Comments Signature Name / Title

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

OK
not OK

61 60

Manufacturer and Distributor:

STORZ & BICKEL GMBH & CO. KG

In Grubenäcker 5-9 · 78532 Tuttlingen/Germany

Phone [phone] · Fax [phone]

E-Mail: [e-mail]

© by STORZ & BICK EL GmbH & Co. KG · VMAL-50-213- EN 08-2017 · Subject to a lterations · All r ights reserved