User Training Record and Checklist
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CLEANING AND DECONTAMINATION GUIDELINES CUBESCAN BIOCON-1100 BLADDER SCANNER COVID-19 We will continue to monitor the situation but at present, our standard cleaning and disinfecting guidance remains unchanged and is as follows. DEFINITIONS Cleaning – a process that physically removes contamination but does not necessarily destroy microorganisms. Cleaning is a necessary pre-requisite to ensure effective disinfection or sterilisation. Decontamination – a process, which removes or nullifies contamination by biomass reduction and thereby prevents microorganisms reaching a susceptible (body) site in sufficient quantities to cause infection. EQUIPMENT PREPARATION Prior to cleaning or decontaminating the CUBEScan BioCon range of bladder scanners ensure that the device is not connected to the mains and is switched off. Care should be taken when handling the probe. Ensure it is not knocked or dropped during the cleaning or decontamination process. IT IS RECOMMENDED TO CHECK THE OPERATION OF THE BLADDER SCANNER AFTER CLEANING AND DECONTAMINATION CLEANING & DISINFECTION – CONSOLE & PROBE Based on the normal use of the CUBEScan BioCon range of bladder scanners and the tissue it contacts during normal use, we recommend low level disinfection is the minimum level required. EXCEPT FOR THE PROBE HEAD, DO NOT IMMERSE IN THE SOLUTION DURING CLEANING AND DISINFECTION See approved list of cleaning solutions in the DISINFECTION section on this document. 1) Turn off the console and unplug the power cord from mains power to prevent the flow of electricity. 2) Ensure your chosen cleaning solution/wipes have not expired. 3) Wear gloves if appropriate for the cleaning solution. 4) Use a paper towel or a soft cloth to wipe the surface clean so that no ultrasound gel, dirt, dust, etc. remain on the probe or console. If required, you may use a soft bristled brush. 5) You may wish to use RO/DI water to thoroughly wipe the console for a minimum of 1 minute. FOLLOW THE CLEANING GUIDELINES FOR YOUR CHOSEN SOLUTION THE DEVICE IS NOW READY FOR USE ON THE PATIENT PRECAUTIONS • • • • • • •
Cleaning is critical to ensure the component is ready for disinfection. Failure to properly clean the device could result in a contaminated instrument after completing the disinfection procedure. Incorrect cleaning and disinfection can permanently damage some or all of the device. Do not use solvents or abrasives such as thinner or benzene on any part of the device for cleaning. Do not use bleach-based (sodium hypochlorite) products for cleaning the LCD. Do not clean the device with a metal or abrasive brush. Scratches can form on the exterior of the device, which may cause damage to the device. Wear protective gloves when cleaning the device. Availability of cleaning and disinfection products varies by country, and Mcube Technology is not able to test the products in every market. Please contact de Smit Medical if you need more information.
DO NOT SPRAY DIRECTLY ONTO THE RECESSED AREAS, CRACKS AND CREVICES OF THE PROBE AND CONSOLE WITH DISINFECTANT SPRAYS
0845 345 4226 - [email protected] - www.desmitmedical.com BioCon-1100 - Cleaning and Decontamination - Page 1 of 2
The BioCon-1100 is intended to contact the patient's abdomen to measure the volume of the bladder. Cleaning and disinfection of the probe and console plays an important role in the safe use of the device. The following table shows the risk management of the probe and console, including the Spaulding's/CDC classification for the minimum required disinfection level. Components
Packaged
Use
Spaulding’s/CDC classification
Clean
Probe head Probe (except head) Console
Nonsterile Nonsterile Nonsterile
Reusable Reusable Reusable
Noncritical Noncritical Noncritical
✔ ✔ ✔
Disinfection level Low High ✔
Probe head COMPATIBILITY The following products have cleaning or germicidal properties and are compatible with the material of the device. Please contact de Smit Medical if you need more information. Metrex® CaviWipes™ Metrex® CaviCide™ Spray
Metrex Metrex
DISINFECTION Disinfectants lists for the probe disinfection The following solutions have demonstrated material compatibility* with BioCon-1100, but they have not been tested for the efficacy. Medline MICRO-KILL Bleach-Free, Alcohol-Free PDI Sani-Cloth® HB (alcohol free) Medline MICRO-KILL+ Disinfection Wipes PDI Sani-Cloth® PLUS (low alcohol) Medline MICRO-KILL One GERMICIDAL ALCOHOL WIPES PDI Sani-Cloth® AF3(alcohol free) Medline MICRO-KILL Bleach GERMICIDAL BLEACH WIPES PDI Super Sani-Cloth® CLOROX Bleach Germicidal Wipes PDI Sani-Cloth® Bleach (alcohol free) CLOROX Hydrogen Peroxide Cleaner Disinfection Wipes CALTECH DISPATCH Clinell Universal wipes/disinfectant wipes Gama Healthcare Ltd * Material compatibility was tested under Mcube Technology’s test conditions. HYDROGEN PEROXIDE VAPOUR 4.9% (DEPROX) Due to the high risk of damage to the surface of the bladder scanner, the BioCon-1100 bladder scanner probe is NOT COMPATIBLE with Hydrogen Peroxide Vapour. The BioCon-1100 is compatible with UV environmental decontamination.
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