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
5.1. Unpacking ..................................................................... 17
5.2. Installation ..................................................................... 17
5.3. Operation ...................................................................... 17
6. The Use of Dronabinol (THC)
6.1. The Efficiency of vaporized
6.2. Preparation ................................................................... 21
6.3. Application .................................................................... 21
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.: +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.
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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.
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