Revolutionary Respiratory Protection

Transcription

1 Revolutionary Respiratory Protection Respirators designed by biomedical engineers for healthcare professionals CleanSpace HALO - HEALTHCARE 2018 INTRODUCTION DR ALEX BIRRELL, CEO ALEX VIRR, CTO CLEANSPACE TECHNOLOGY PTY LTD, SYDNEY AUSTRALIA 1

2 ABOUT CLEANSPACE CLEANSPACE IS A BREAK THROUGH TECHNOLOGY FOR PERSONAL PROTECTION DEVICES & CONSUMABLES FOR HEALTHCARE Smallest PAPR in the market. Compact, lightweight and easy to use. High HEPA protection from a positive pressure respirator Founded by a team of biomedical engineers from ResMed (NASDAQ: RMD. M/Cap US13B. Leader in medical CPAP devices) Respirator Specialist. Patented technology International approvals including NIOSH, CE Mark, ETL (intrinsically safe) Manufacturing in Sydney Australia. Exporting to 30 countries Developed a healthcare respiratory protection solution 2

3 HEALTHCARE RESPIRATOR SYSTEM Respirator systems designed by healthcare professionals for Healthcare Professionals APF 50. Suitable against biohazards and other airborne particulates (0.3microns and above). Protection Easy don & doff. Simple and reliable training. Deployable Minimal parts. No hoses. Small surface area. Streamlined decontamination protocols Personalised equipment options. Adoption CE Mark approval EN12942; Australian/NZ1716; IP rated 66 3

4 CLEANSPACE TECHNOLOGY PROTECTION COMFORT DEPLOYABLE Traditional Respiratory Offerings 80% market Light & simple Protection APF 10 High costs Moisture/CO2 Heat stress Breathing resistance 20% market CLEANSPACE HIGH PROTECTION APF 50 LIGHT & SMALL REDUCE HEAT STRESS MOBILE & PORTABLE LOW TOTAL COST OF OWNERSHIP STATE OF ART DESIGN ( Looks good ) Protection APF 25 Heavy & bulky High costs Large spares inventory Complex Poor equip compatibility 4

5 CLEANSPACE TECHNOLOGY PROTECTION LIGHTWEIGHT SMART Protection Factor 50 (Half) & 1000 (full). Positive mask pressure HEPA/P3 filter efficiency 99.97% filtration efficiency for biohazards (droplets, bacteria and virus) CE Mark Approved (EN12942) and IP Rated 66 water tolerant Durable and reliable - 3 year Warranty Designed and manufactured in Sydney, Australia Lightest (350g) powered respirator in the world Ergonomic compact design for comfort, mobility and portability No waist mounted belts, hoses or cables Clear (good patient interactions) and soft medical grade silicone mask (decontamination) Compatible with hoods, visor/face shields and stethoscopes. Breath responsive fresh airflow (230L/min); no fogging; eliminates heat stress Smart intuitive system with auto-start/stop with long lasting lithium polymer battery (9 hours) Filter and battery alarms Easily disinfected and IP 66 Rated for decontamination practices Low inventory requirements and fast training ID panels for units ID badges for masks PERSONALISED 5

6 PRODUCT COMPARISON CleanSpace HALO PAPR Belt Mounted (Loose) PAPR Helmet (Loose) APR Elastomeric Half APR Disposable N95 APF APF 50 (half) APF 25 APF 25 APF 10 APF 10 Weight (unit inc battery, hoses) 350g 1.5kg 2kg 200g 20g Patient comms Good. Transparent mask Good. Transparent visor Good. Transparent visor Very poor - Intimidating Poor mouth covered Equipment Parts (exc filter) Breathability & comfort Parts (2): Face piece & Battery pack (Unit) Light. Fresh air. No heat. No breathing resistance Parts (4): Head top, hood, Belt, hose, battery pack Heavy. Fresh air. No heat. No breathing resistance Parts (4): Head top, visor, hood and battery pack Bulky. Fresh air. No heat. No breathing resistance Parts (2): face piece & heard harness Hot. Breathing resistance. Fogging. Tight. Hides face Single part Light, Hot. Breathing resistance. Fogging Battery/charge 9 hrs / 2hrs 8 hrs / 4 hrs 8 hrs / 4 hrs NA NA Alarms Yes Yes Yes No No Cleaning Time 10min 20min 20min 15min NA Don/Doff Simple/fast. 2 clicks Complex Complex Simple/fast Simple/fast 6

7 WHAT IS CLEANSPACE? All-in-One Filter, battery, fan all in the one unit No hoses mask fits directly to power unit No wires Internal battery Breath-responsive Motor/fan works hard when you inhale and softly otherwise Constantly maintains mask pressure above atmospheric HEPA Protection 99.97% filtration NIOSH certification exactly the same for a traditional PAPR* Assigned protection factor 50 (half-face) to 1000 (full) Fit factor 500 (NIOSH) to 1000 (CleanSpace) Powered air-purifying respirator but not as you know them! 7

8 DESIGN DRIVERS Sleep Apnea & Healthcare both consumer markets If you can t convince the healthcare worker, you don t have a product improvements from paper mask to elastomeric do not interest the users Non-intimidating appearance important for user adoption Easy use is critical Reduction of heat stress and sweating HEPA-level protection European 2000 fit factor US 500 fit factor An N95 mask 100 fit factor Non-intimidating Design Clear mask Filters off the face Minimal equipment on show 8

9 RESULTS Resolving Elastomeric Issues: Non-threatening & fits with medical professionals No work in breathing; constant flushing of heat, moisture, CO 2 Resolving PAPR issues: All-in-one (no separate battery; no hoses) lightweight (350 gram) Hidden filter (non-intimidating, clean) Quick to don & doff (seconds) Nothing at the waist (minimises contamination) 9

10 REMOVING BARRIERS TO PAPR USE Fit Testing Yes - fit test required (tight fitting PAPR) No it won t be like the fit tests you are doing now Quick, reliable, fails very rare Fit factor of 500 almost impossible to fail Complexity / Never Ready to Use All-in-One No scheduled servicing or parts replacement (other than filters) If it s charged and has a clean filter it s ready Quite forgiving of poor mask selection, stubble, human error 10

11 CONTAMINATION MINIMISED A SYSTEM THAT MINIMISES CONTAMINATION Located away from the contaminated working area Small & compact enough to be worn under Hoods/Visors Low profile masks can be worn under face shields. Compatible with gowns and coveralls Splash-proof disposable cover and hood shields the power unit Away from the face Above the waist X DONNING & DOFFING Few parts and minimal prep or assembly Fast (3 step) donning process (less 10 secs). Simple and effective training and re-training (Intuitive with few parts) Safe and reliable doffing 11

12 CLEANING, DISINFECTION & STORAGE CLEANING & DISINFECTION/STERILIZATION Power Unit IP 66 Rated. System can be worn in decontamination protocols With Cleaning Plug inserted, the unit can be washed down Small surface area easily and reliably wiped down with disinfectant Face piece & head harness Chemical and thermal disinfection and sterilization options (see next page) Medical grade silicone and ABS durable and replaceable Small surface area CHARGING & STORAGE Charged and stored safely in a dedicated container CleanSpace Station (CS3014) Holds and charges 8 units Fits on standard trolleys or shelves for mobile and stationary options Small equipment footprint located close and ready to go BATTERIES & STOCK PILING Equipment can be stored flat or charged for up to 18 months Silicone and materials used can be reliably stored (in recommended conditions) System is quick to commission (minimal equipment checks) Charging is less than 2 hours from flat 12

13 IDENTIFIABLE & PERSONAL Humanise. Personal important for patient care Identify individually issued kit Colour code masks for size (small, medium and large) Mark use in restricted or dedicated areas Signal clean vs contaminated or in-use devices Power Unit ID Panels (Pk 6) CS3013 Mask ID Badges (Pk 8) CS2015 Mask Decal (Pk 2) CS

14 DELIVERING PROTECTION TO HEALTHCARE PROFESSIONALS CleanSpace Systems deliver Higher protection CleanSpace Systems deliver fresh air to reduced heat stress CleanSpace Systems deliver easy, reliable and quick donning CleanSpace Systems deliver safer doffing & disinfection 14

15 THE FUTURE OF RESPIRATORY PROTECTION 15

16 CLEANING & DISINFECTION MASKS & HEAD HARNESS 16

17 CUSTOMER FAQS & ANSWERS CUSTOMER CONCERN CLEANSPACE BENEFIT PRODUCT FEATURES Healthcare professionals are open to technology HOWEVER are constrained on changing their processes. Are there suitable Hoods and accessories? Talking and communication. CleanSpace Halo has been designed to streamline donning/doffing, cleaning, staff training and inventory management. After consultation with Healthcare professionals, CleanSpace has removed unnecessary steps and the need for complex practices. CleanSpace offers a hood with blood/fluid resistant approvals. No fogging and eliminates issues of heat and moisture in the mask. Streamlines the doffing and decontamination steps. CleanSpace s compact design fits with most combinations of Health PPE CleanSpace has clear voice transmission and ability to see the speakers lips and facial features enhancing the communication between wearers Compact. Few parts. One button operating system. Fits over the half mask Blood/Fluid resistant approval Cleaning/Storage Plug. Clear voice transmission Transparent facepiece. Use with Stethoscopes. How do we manage the cleaning, decontamination and sterilisation? How is it different from what we currently do? Do they need to fit test with CleanSpace Halo Unlike head-top mounted PAPRs, CleanSpace Halo works well with stethoscopes. CleanSpace Halo is designed to work with current protocols for cleaning & sterilisation and offers the potential to streamline the process and number of steps. This reduces risks in cross/self contamination and saves time and costs. Non-electrical parts (masks, harness) can be cleaned in industrial washers. Electrical Power Unit: Discuss client s current method CleanSpace Accessories: Disposable cover reduce potential for contamination to improve simplify cleaning. Cleaning/Plug set/ip 66 Wash the power unit. CleanSpace Halo is a tight fitting respirator and the standards recommend fit testing. CleanSpace has VERY HIGH CONSISTENT quantitative fit test results (Portacount Study) even with facial hair. CleanSpace will SUPPORT initial fit testing to demonstrate the CleanSpace protection Few parts & simple design Filter designed to tip out IP Rated 66 Cover to protect unit from splash Medical grade silicone hygienic and easily washed Personalised panels easy identification AirSensit technology maintains a positive pressure in the mask Silicone masks mould to the face 17

18 SUPPORT FOR GLOBAL OPERATIONS 18

19 WORLD CLASS DESIGN & MANUFACTURING ACCREDITATION AWARDS Design and manufacturing certified and audited Quality Management System: ISO 9001 (International) CE Mark, EN12942 (Europe) CDC/NIOSH (USA) AS/NZS1716 (AUSTRALIA/NZ) Intrinsically Safe IECEX, ATEX, CSA/UL (International & North America) IP Rated 66 (International)

20 ASSIGNED PROTECTION FACTORS (APF) CLEANSPACE OFFERS THE HIGHEST PROTECTION OVER DISPOSABLE MASKS (5 TIMES) OR PAPR HOODS (2 TIMES) IN HEALTHCARE Unlike loose fitting hoods, CleanSpace has been tested and approved to protect wearers even if motor/fan is OFF. EN529 (EUROPE) - Type of respirator Disposable Half mask Full face piece Helmet/ hood loose fitting Air-purifying respirator (APR) 30 (D) 30 (D) 400 (D) - Powered air-purifying respirator (PAPR) (D) 500 (D) 100 (D) D - Germany OSHA (USA) - Type of respirator Disposable Half mask / Elastomeric Full face piece Helmet/ hood loose fitting Air-purifying respirator (APR) Powered air-purifying respirator (PAPR) , Tables above outline Assigned Protection Factors (APF) which are the realistic levels of respiratory protection that can be achieved by 95% of properly fitted and trained workers. APFs vary greatly amongst countries 20