Area of application The VOLCANO MEDIC Vaporization System is suitable for the temporary inhalative application of cannabinoids prescribed by a physician for use at home, in a hospital, or doctor‘s office. Adults may use the device following the Instructions for Use or physician‘s instructions. Medical device manufacturer with certified quality management As manufacturer of the VOLCANO MEDIC Vaporization System, the company Storz & Bickel GmbH & Co. KG in Tuttlingen, Germany has been an experienced designer of vaporization systems since 2000, and a certified manufacturer of medical devices since September 2009. Vaporization System Indications Cannabis and THC exert a broad spectrum of effects that may be of therapeutic use. Main indications are: • chronic pain, • spasticity and muscle spasms, • anorexia and cachexia, Further indications with less available data or of minor relevance are: Tourette‘s syndrome, attention deficit/ hyperactive disorder (ADHD), posttraumatic stress disorder (PTSD), pruritus, disturbed behaviour in Alzheimer‘s disease, epilepsy, glaucoma, asthma. Information about contraindications, interactions, risks and adverse effects of cannabis and Dronabinol (THC) is available on our website www.vapormed.com and in the Instructions for Use. The VOLCANO MEDIC Vaporization System is marketed exclusively by the company Vapormed GmbH & Co. KG. The Vapormed Service Centre is available to answer your questions and receive your comments and suggestion concerning the VOLCANO MEDIC Vaporization System. Further information as well as the most recent Instructions for Use for the VOLCANO MEDIC Vaporization System is available on our website. This product information is intended exclusively for expert medical personnel. Dosage Tolerated and effective doses show a considerable variation in different patients. In order to avoid strong side effects patients should start with low doses, that is about 1 to 2 mg of inhaled THC and then gradually increase in the following days up to the tolerated and effective dose. Single effective doses may vary between 1 and 15 mg THC. With inhalation, dosing intervals may vary between 2 and 12 hours. VAPORMED GMBH & CO. KG Rote Strasse 1 · 78532 Tuttlingen/Germany Tel. +49-7461-96589-50 · Fax +49-7461-96589-48 info@vapormed.com Detailled information & online shop: www.vapormed.com © by VAPORMED · VMAL-40-002 01-2011 · Subject to alterations · All rights reserved • nausea and emesis Functionality of the VOLCANO MEDIC Vaporization System Certified medical device for the inhalation of cannabinoids The VOLCANO MEDIC Vaporization System is designed to vaporize and subsequently facilitate the inhalation of dronabinol (THC) dissolved in alcohol or cannabinoids from hemp flowers (cannabis flos). The intended purpose is the application of the active ingredients to the human body via the alveoli for the appropriate medical indication. Vaporization ensures the highly effective, safe, and fastacting application of cannabinoids. When cannabinoids are inhaled, the onset of the effect takes approx. 1-2 minutes. The VOLCANO MEDIC Vaporization System resolves two medical-technical problems at the same time: the delivery of cannabinoids from liquid and solid sources. The VOLCANO MEDIC Vaporization System allows, for the first time, the medical inhalation therapy with liquid cannabinoids dissolved in alcohol. In addition, it allows for the inhalation therapy with cannabinoids directly from dried hemp flowers. Until now, the inhalation therapy with cannabinoids was limited to smoking hemp flowers, which is medically questionable. Utilizing the VOLCANO MEDIC Vaporization System, the cannabinoids are solved (vaporized) by heat impact only. Unlike smoking, combustion does not occur. Thus, the development of noxious combustion substances is avoided. The primary advantages of employing inhalation for cannabinoid treatment are the rapid onset of effectiveness and the cost reduction that results from the significantly improved efficiency of the vaporized cannabinoids. The systemic biological availability of inhaled cannabinoids is approximately 29%-40%. For comparison: The systemic bioavailability of cannabinoids administered orally is below 15%. The VOLCANO MEDIC Vaporization System primarily consists of a Hot Air Generator and a detachable Valve Balloon. Due to the independent components, the vaporization process and the inhalation process are separated in time and space. This makes the inhalation very safe for the user, as the patient is not in contact with the heat or the electricity of the Hot Air Generator during inhalation from the Valve Balloon. For the vaporization process, the cannabinoids are placed within the Filling Chamber and are locked in place on the Hot Air Generator. The empty Valve Balloon is placed on top of the Filling Chamber opening the Valve automatically. When the Hot Air Generator reaches the desired temperature, the Pump is switched on and the hot air will stream through the Filling Chamber and initiate the vaporization of cannabinoids. The air/aerosol mixture that is generated is pumped into the Valve Balloon and cools down to the ambient air temperature due to the large surface area of the Valve Balloon. MEDIC VALVE The Mouthpiece of the VOLCANO MEDIC Vaporization System is equipped with a check valve. This check valve reduces the danger of a possible contamination of the interior of the Valve Balloon, as exhaling into the Valve Balloon is prevented. For this reason the Valve Balloon is appropriate for multiple uses. To avoid contamination, the hygienic reprocessing and maintenance of the Mouthpiece are of particular importance. Valve balloon As soon as enough aerosol has filled the Balloon, the Pump is switched off and the Valve Balloon is detached from the Filling Chamber, causing the Valve to closeautomatically. For inhalation, the Mouthpiece is attached to the Valve of the filled Balloon. By gently pressing your lips against the Mouthpiece, the Valve opens and the cannabinoid aerosol can be inhaled. As soon as the pressure is taken off the Mouthpiece, the Valve automatically closes. Mouthpiece 0123 Filling chamber Hot air generator