Test record CFU measurement Test ID 1130036 Site/Clinic Spijkenisse Objective of the test: To verify that there are < 10 CFU/m3 in the clean air flow area. Type of test: CFU test, Microbial precipitation test Description of test method: Sampling Air sampling CFU-measurement and sedimentation HYCON Agar Strips TC en YM. for reference. Equipment used: RCS High Flow Touch Microbial Air Sampler - Validated according to ISO-14698-1 Air measurements are performed with a device known as an air sampler. This device samples a previously determined quantity of air of between 10 and 1000 liters. By inserting various sterile sampling strips into the device the air can be accurately sampled. The strips are specially prepared in our own laboratories to identify 8 species of bacteria and 18 species of fungi and yeasts. In addition to species assessment, these air samplers and subsequent laboratory testing allow for the determination of amounts of bacteria, fungi and yeasts. On the day of the investigation the air is sampled at a number of locations. At each specified measurement point two samples of air are extracted. The first air sample is drawn over a TC agar strip and the second air sample over an YM agar strip. The first strip is used to measure the number of aerobic (oxygen-demanding) and facultativeanaerobic (oxygen-preferring) bacteria. The second strip is used to measure the number of fungi and yeasts. All plates shall be marked with location of the plate, as A1-C9. The measuring points are in a straight angle from the middle part of the filter at different distances. Altogether 3 x 7 tests shall be done in the following situations: A: At rest - SurgiCube is off, drape is on. B: At rest - SurgiCube is on but no activity, drape is on. C: Operational - SurgiCube is on with simulated surgery, drape is on. In order to get a reference of ambient bacteria conditions, 2 agar strips shall be placed at single locations outside the clean air flow area. The strips shall be exposed during the same time as the ongoing CFU measurements. In addition, one agar strip shall be unexposed and left at the microbiological laboratory for batch control. 1/5 Clinical info
Analysis Both in our laboratory and during the measurement itself the Lab applies relevant norms and standards, as stipulated by the certification council. For the analysis of bacteria an incubation period of 48 hours is required. The incubation of fungi and yeasts takes up to 7 days for initial analysis. If a determination of the samples is required two additional days are needed. LOD (limit of detection) The limit of detection of this sampling and analysis method is 1 CFU/m3 at a required sampling volume of a 1000 Liters. Accreditation (ISO 17025) Bioconsult B.V. is accredited as a Test Laboratory by the Netherlands Accreditation Council (Raad voor Accreditatie) under number L 219 for the qualitative and quantitative investigation of air. Air samples are obtained by using fully certified air samplers able to assess the presence of species, genera or families of micro-organisms as listed in the appendix. This accreditation means that all the criteria of NEN-EN-ISO/IEC 17025:2000 are met. The scope of activities can be found the website of the Accreditation Council (https://www.rva.nl/ ) Setup conditions: Width of filter: 220cm Ventilation: None Temperature: In the winter 20-24ºC and in the summer 23-26ºC are recommended. Relative humidity: Target is between 30% and 70% Pass / Fail criteria: Pass: 10 CFU/m3 in the clean air flow area. Fail: > 10 CFU/m3 in the clean air flow area. Study endpoint: Significance, after 7 samples + 2 ambient reference plates at realistic /simulated surgical procedures. 2/5 Clinical info
Test date 07 august 2015 Test carried out by R.van Elk M. Bot (PhD) Device SurgiCube Number of door openings 3 per sample at Operational Clinic In house People in OR 3 Number of agar strips Type 9 x 3 + 1 Incubation time 2 days 7 days HYCON Agar Strips TC en YM Incubation temp 36ºC for bacteria 25ºC for fungi and yeasts Size of agar plates -- Laboratory Bioconsult Measurement RCS High Flow Duration method Touch Microbial Air Pass/Fail Setup: Sampler Fail > Mean over 10 in clean area 27 samples 3 Batch control samples 3/5 Clinical info
Results summary: A1 Centre 55 cm 69,00 A2 Right 55 cm 80,00 A3 Right 75 cm 94,00 A4 Left 55 cm 75,00 A5 Left 75 cm 64,00 A6 Right 85 cm 70,00 A7 Left 85 cm 63,00 A8 Reference: Post periphery centre + 1.2 m 15,00 Ambient area A9 Reference: Pre periphery centre 1.2 m 24,00 Ambient area Mean A1-A5 76,40 Batch control A 0,00 B1 Centre 55 cm 0,00 B2 Right 55 cm 0,00 B3 Right 75 cm 8,00 B4 Left 55 cm 1,00 B5 Left 75 cm 4,00 B6 Right 85 cm 3,00 B7 Left 85 cm 1,00 B8 Reference: Post periphery centre + 1.2 m 15,00 Ambient area B9 Reference: Pre periphery centre 1.2 m 24,00 Ambient area Mean B1-B5 2,60 Batch control B 0,00 C1 Centre 55 cm 1,00 C2 Right 55 cm 1,00 C3 Right 75 cm 0,00 C4 Left 55 cm 1,00 C5 Left 75 cm 0,00 C6 Right 85 cm 1,00 C7 Left 85 cm 2,00 C8 Reference: Post periphery centre + 1.2 m 15,00 Ambient area C9 Reference: Pre periphery centre 1.2 m 24,00 Ambient area C1-C5 0,60 Batch control C 0,00 4/5 Clinical info
Conclusion: Mean of the SurgiCube: At Rest - shows that there are 2,60 CFU s in the clean air flow area. Mean of the SurgiCube - Operational - shows that there are 0,60 CFU s in the clean air flow area. The SurgiCube filters the air efficiently, passing the criteria for this test, having 10 CFU/m3 in the clean air flow area, in both situations (At Rest and Operational). The clean air flow area is 220cm wide and up to 75cm in depth. The SurgiCube is located in a standard room, that has no other means of ventilation or air conditioning. Measurements at 85cm depth, so 10cm outside the clean air flow area show that the pass criteria are still passed: At Rest: 2 CFU s / Operational: 1,50 CFU s The SurgiCube provides clean air at the clean air flow area and is effectively filtering out airborne particulate matter that can carry microbiological contaminants. We trust that this report has been of service to you, Saferspaces BV Test leader for SurgiCube International Martijn van Amelsfort General Manager Ramón Hilberink 5/5 Clinical info