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
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.: +49-74 61-96 97 07-0 · e-mail: info@vapormed.com
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
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