Between 3-5 million people die annually worldwide due to trauma injuries.

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1 Between 3-5 million people die annually worldwide due to trauma injuries. This is 10% of all deaths. Professional care might not be readily available. Treating wounds is crucial, but just the first step.

2 A trauma injury is a bleeding injury that can lead to the Trauma Triad of Death Reduced Circulation As you bleed the body will circulate less blood around in the body. Temperature Loss This will gradually cool down the injured patient. Increased Bleeding When you cool down too much, the blood cannot form blood clots to stop the bleeding. Hypothermia is the crucial treatable factor.

3 Hypothermia is a condition when the core body temperature drops below 35 celsius. Bleed to death A cold patient is likely to bleed to death during surgery, whereas a warm patient can withstand drastic surgery. A patient must be warm to withstand surgery.

4 The Otivio WARM pulls blood out to the arm, heating it up and sending it back. A second heart The device is placed on the arm (away from the place of injury), and a vacuum pressure pulls blood out to the arm. The blood is then heated with Far Infrared Heat, and sent back into the core of the body. This prepares the patient for surgery and vastly increase the chance of survival. The Otivio WARM is essential to saving patient lives

5 Medical treatment scenario as a service

6 A Actors Injuree Person that has sustained a trauma injury Immediate care person People present at the scene of injury Medical transport personell - Paramedics - Emergency medical technician Emergency room personell - Paramedics - Doctors - Nurses Surgical care - Surgeons - Anesthesists Post surgery - Doctors - Nurses

7 Medical Transport Personell Norwegian Air Ambulance Emergency Room Personell Doctors Without Borders There is little awareness of the importance of Hypothermia treatment among the general public. Today s warming measures is limited to blanket, bubble wrap and thermal blankets, which primarily restricts further heat loss. These products cannot restore the loss of heat in patients There is no pre-hospital non-invasive active warming device for treating and preventing hypothermia on the market today, and the need is huge. - Jan Einar Andersen Thirty percent of casualties die because of hypothermia. Current treatment methods consist of bags of hot water, blankets and etc. There is a huge need for a proper pre-hospital hypothermia device. DWB has only a fraction of the budget compared to the military so the product must be low cost. Furthermore, it must be very easy to use as it will be operated by non-medical personell as well. - Vincent Maure

8 Surgical Care The Norwegian Armed Forces Post-Surgery (Medical Support) Oslo University Hospital Patients that suffer a trauma injury (bleeding injuries) will eventually spiral into the trauma triad of death which will eventually lead to certain death. Passive methods such as blanket, bubble wrap and thermal blankets are incapable of raising the body temperature. In a war situation hypothermia treatment must be initiated at 35º. Patients with a body temperature of 32º or below will die. - Erling Rein Current equipment is huge and bulky (fridge size). Peripheral circulation is usually very poor when dealing with hypothermic patients. The body limits the circulation to preserve heat. Patient warming must happen in a controlled matter, preferably within 1º increase per hour.. There is no point in warming up a limb if the circulation is already reduced. The heat must be applied to the core blood circulation. - Even Enggrav, Liv Berg

9 T Touchpoints Pre-hospital treatment Hospital treatment Injuree Immediate care person 1 ABC treatment 2 Wound treatment Medical transport personell 3 Keep patient warm 4 Improve wound treatment 5 Patient warming treatment Emergency room personell Continue wound treatment Continue warming treatment Prepare for surgery Surgical care 9 10 Perform surgery Expedite warming Post surgery Monitor patient Warming treatment

10 T Touchpoints Workshop

11 Pre-hospital treatment Hospital treatment Injuree Immediate care person 1 ABC treatment 2 Wound treatment Medical transport personell 3 Keep patient warm 4 Improve wound treatment 5 Patient warming treatment Emergency room personell Continue wound treatment Continue warming treatment Prepare for surgery Surgical care Lack of knowledge Service offering 9 10 Perform surgery Expedite warming Post surgery Lack of proper equipment Product offering Monitor patient Warming treatment

12 O Offerings Service Offering Information on Hypothermia for both the general public and health care professionals. Product Offering An easy-to-use product for treating hypothermia designed for everyone. Company Offering The number one provider of Hypothermic treatment services and devices.

13 O Service offerings

14 Trauma Injuries Account for 3-5 million deaths every year. Professional care might not be readily available. Hypothermia How you can save lives This is 10% of all deaths. Treating wounds is crucial but just the first step. Trauma Triad of Death occurs after a trauma injury. Reduced Circulation As you bleed the body will circulate less blood around in the body. Temperature Loss This will gradually cool down the injured patient. Increased Bleeding When you cool down too much, the blood cannot form blood clots to stop the bleeding. Hypothermia is the crucial treatable factor.

15 Hypothermia Occurs when the body temperature drops below 35 A cold patient is likely to bleed to death during surgery, whereas a warm patient can withstand drastic surgery. Increase the risk of bleeding to death. A patient must be warm to withstand surgery. The Otivio WARM Pulls blood out to the arm, heat it up, and sends it back to the body. The device is placed on the arm (away from the place of injury), and a vacuum pressure pulls blood out to the arm. The blood is then heated with Far Infrared Heat, and sent back into the core of the body. Otivio WARM is a second heart. The Otivio WARM is essential to saving patient lives

16 O Product offerings

17 N E Needs & Experiences Service Offering What drives the requirements of the service? Product Offering What drives the requirements of the product? Need based The service serves basic needs (public information on the topic of hypothermia), but should attempt to feel aspirational in its nature and appeal to wants and desires.? 2 Empowering The product - supported by the service - should empower everyone to understand and perform hypothermia treatment.? Hidden need The general public s knowledge on hypothermia in trauma situations is absent. The service must address a hidden need and not an explicitly expressed one. Product requirements The service will educate the product development process, supporting the development of product requirements.! Public information to raise awareness The service must educate the general public on the importance of hypothermia treatment, and convey the importance of such treatment as an addition to the standard rule of ABC first aid treatment. Amateur & Professional The product must be designed in such a way that it can be operated by both amateurs and professional and provide value for both.

18 Trauma Injury Patient is injured and experiences heavy bleeding. Transport time to hospital is more than 1 hour. Vicious Circle Bleeding leads to less circulation, loosing important heat. Apply the product WARM actively heats the blood, reinstates circulation and warms the patient. Safe to operate A cold patient will bleed to death, but a warm patient can undergo immediate surgery. Reduced Circulation Temperature Loss Trauma Triad of Death 1 1h Increased Bleeding Normothermia Hypothermia 3 Warm patient E 30 Body temperature 0 min Death 30 min 60 min Cold patient Experience Time Pre-Hospital Hospital

19 WARM is a novel patient warming system using pulsating vacuum and infrared heat to treat hypothermia.

20 Heating a human body Normothermia Hypothermia Otivio Treatment Normothermia (Normal, 37 body temperature) (Below 35 body temperature) (Below 35 body temperature) (Normalized body temperature)

21 Technology & Placement Spine and back 26% Arm and shoulder Apply pulsating negative pressure By removing 5% of the air inside the container in cycles. 18% Foot Device is placed on a non-injured arm 49% Increase blood flow Pulling blood out from the core of the body to peripheral blood vessels in the skin.

22 User scenario Primary User Drives the esthetic and formal requirements. Will operate the unit. Drives the technical requirements. Life depends upon the function. Secondary User

23 Non-Invasive products to Passive Non-invasive products are often passive products that only offer insulation but no active heating Inefficient Any added heat does not reach the core circulation of blood, and is not transferred the patient

24 Invasive products pressure High risk Invasive products require surgical procedures opening the risk of hemorrhaging and infections Counterproductive Adding IV fluids to a patient with an already low body temperature and blood can worsen the situation.

25 Creating vacuum Manual Pump Peristaltic Pump Membrane Pump Pros Fast Non-electric Affordable Cons Requires manual labor Low accuracy (pressure) Pros Easy to use Simple mechanics Simple maintenance Cons Slow Inefficient Expensive Pros Easy to use Effective Compact form factor Cons Noisy Expensive

26 Power Supply Manual Power Fuel Cell Batteries Pros Power-independent Cons Unstable power current Ineffective Pros Easy to use Great potential Cons Experimental technology Low capacity Requires fuel to rechard Pros Highly effective Stable power current Rechargeable Cons High weight Requires recharge Sensitive to temperatures

27 Heat Source PCM Heat Pads Electric Heating Mat EXO 2 Infrared Radiation Pros Non-electric Affordable Reusable Cons Short duration Low energy capacity Unstable temperature Pros Simple construction Low cost Cons Unstable temperature Non-uniform temperature Heavy Pros Simple rugged construction Uniform temperature Power efficient Cons Higher cost

28 EXO 2 testing Temp 33 C 32 C 31 C 30 C 29 C 28 C Heating of 1L water MAX 33 C 27 C 26 C 1 L Water 25 C 24 C 23 C 22 C Room temp Time 22 C - 33 C t t Hr max Charge Battery pack capacity min Time t t 15 30

29 Principle Structure Concept Directions Exoskeleton Telescope Keystone Granulate

30 From granulate to layers Jamming transition gripping hand Polymer pellets in vacuum bag Sanding paper sandwich Layered PET with Vinyl film.

31 Proof-of-Concept

32 Concept stage 2 Corset Wrap Taco

33 Concept stage 2 Corset Wrap Taco

34 Concept stage 2 Corset Wrap Taco

35 Prototype evolvement 1 2 3

36 Arm & hand antropometrics D:340 D: D: mm 150mm 110mm 55mm 200mm 140mm 110mm 60mm 170mm mm 78.6mm 39mm 95% 50% Min. Max.

37 Hand bed Clay modeling 3D CAD + RP

38 Conformable hand bed

39 Simple printed instructions

40 Usage scenario Product placement Additional warming devices such as blankets are advised used, so controls of the device must be accessible externally. Separate power & control unit Connected with power and air, the external power unit can be placed independently of the main device.

41 Power Unit SHELL VACUUM CHAMBER Two systems The power unit has an air pump serving the Vacuum shell and inner chamber, and power service the EXO2 heating mats.

42 External Power Unit

43 User Sequence Remove from packaging Unfold it Place device on hand Place hand properly

44 Experiences Fold device over hand Close zipper Secure velcro seal

45 Experiences Power on unit Tuck away the power unit Secure cable Heating patient

46 Unique selling points Vacuum Activated Shell Low weight, rigid structure, but foldable. Inexpensive. Molded to arm Minimized air inside the unit means less air to move thus less energy spent. Completely accessible design Opening up the device allows for 100% control of patient hand, ensuring the best possible heat transfer. EXO2 Low weight, low maintenance and high efficiency, no hot spots. Never exceeds set temperature (43 c)

47 Experiences

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