BioCon Bladder Scanners Frequently Asked Questions

Q. WHY MALE & FEMALE SETTING? The female setting allows the scanner to compensate for the presence of the uterus. (A very small amount of fluid is held within the uterus - approx. +/- 10ml but varies depending upon condition/medication/number of childbirths etc): BioCon-700 & BioCon-900 BioCon-900-S & 1100

Set to MALE for any adult patient with no uterus. Set to FEMALE for any patient with a uterus. Has the facility to identify patient who has had a hysterectomy (no uterus).

Q. WHAT ABOUT TRANSGENDER PATIENTS? Set to MALE for any adult patient without a uterus. Set to FEMALE for any patient with a uterus. Q. WHAT IS A CHILD? Any patient weighing less than 25kg (55lbs) is suitable for the child setting (includes neonates) as it is a shorter scan depth – 8cm. Ideal for low BMI patients too. Q. WHAT IS THE DIFFERENCE BETWEEN THE CHILD AND ADULT MODE? Scan depth is different between adult & child settings, to accommodate high and low BMI patients: BioCon-700 Adult mode 18cm Child mode 8cm BioCon-900 & 900S & 1100 Adult mode 23cm Child mode 8cm Q. WHAT ABOUT OBESE PATIENTS? For high BMI patients, BioCon bladder scanners have a deep scan depth, see above question. Please note when scanning high BMI patients, greater pressure may need to be applied in order to achieve a reading (depending upon depth of adipose tissue). In certain patients, you may need to lift the ‘apron’ to gain better access to the abdomen. Q. WHAT IS THE BATTERY CAPACITY? A fully charged battery will provide up to 6 hours of continuous scanning. BioCon-700 2400 scans BioCon-900, 900S & 1100 1000 scans The scanner automatically powers down after 7 minutes of inactivity (default setting) to preserve the battery’s charge level. The batteries do not discharge when not in use, they are not on standby. Q. WHAT IS THE BATTERY CHARGE TIME? It will take 4-6 hours to charge the battery to its optimum level, depending on the model. In the unlikely event that the battery is flat, it should be charged for approximately 10 minutes before the scanner is operational again. It is recommended that the scanner is placed on charge before the charge level indicator reaches 1 bar. Q. DOES THE BATTERY NEED TO BE REMOVED FROM THE SCANNER TO BE CHARGED? No. The battery charges whilst in-situ in the scanner and does not have to be removed. BioCon-700 & 1100 Can also be used whilst connected to the mains supply. BioCon-900 & 900S Battery operated only. Q. DO I NEED TO CARRY A SPARE BATTERY? No. The battery capacity and characteristics described above ensure that a spare battery is not required. Integral batteries last (when in normal use) 3 ½ years, therefore possibly a further 1-2 batteries may need to be installed during the bladder scanner’s lifetime.

de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 2 of 7

Q. ARE THERE ANY RECOMMENDED STANDARD SETTINGS? Under the scanner set-up facility (home screen) a variety of scanner settings are user definable. The only settings we recommend for the smooth operation of the scanner are described below under the scan set up section: BioCon setup (images from BioCon-700) IMAGE REVERSE should be ‘OFF’

PRESCAN BladderPoint™

Please note: BladderPoint™ (pink cross) is available on the complete range of MCube bladder scanners. Older models can be upgraded to BladderPoint™ software. Should the scanner be deemed to not function correctly, please check that these standard settings are selected. BioCon-900, 900S & 1100 – settings are pre-set. Speak to your EBME department or local de Smit representative. Also refer to the operator manual. Q. WHAT IS ‘AUTO CORRECTION’? BladderPoint™ with its auto correction tool will ensure that even if your bladder is not centred within the crosshairs, it will still be an accurate scan – as long as the whole bladder is captured within the crosshairs – it will be measured. Example:

Centred Scan Off Centre Current Scan 69ml Current Scan 71ml Q. CAN I DO A TEST MYSELF TO CHECK MY BLADDER SCANNER IS OK? YES. You can undertake a ‘self-diagnostic’ test - this is purely a functional test to undertake, for example, if you have dropped your scanner or probe. This is NOT calibrating your device. Calibration is undertaken by engineers and is a separate test altogether. Older software may not have this feature (upgrades are available). BioCon-700 Within the ‘settings’ window, under ‘GENERAL’ ‘self-diagnostic’ press ‘SCAN’ BioCon-900

Self-diagnostic test within the ‘maintenance’ tab

BioCon-900S & 1100

Self-diagnostic test within the ‘maintenance’ tab and if activated, it may be password protected.

PIN protection (if active) can be deactivated or changed – refer to the EBME department or contact de Smit Medical or refer to the operator manual for instructions. Q. ARE THE BIOCON BLADDER SCANNERS REAL-TIME? Within the ‘pre-scan’ window, you can view a live image of the bladder. This ensures that you can locate the largest/best image for greater accuracy – and to ensure the bladder is fully captured for a ‘centred’ reading. The BioCon bladder scanners read fluid volume only and do this automatically. The scanner settings are fixed. Ultrasound images displayed are to aid bladder location for greater accuracy. de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 3 of 7

Q. CAN I USE MY BLADDER SCANNER FOR PELVIC FLOOR ASSESSMENT? No, although the BioCon bladder scanners provide you with a live image of the bladder, the settings do not allow you to see any fine detail such as seeing the pelvic floor move. NICE Guidelines: 1.3.19 Imaging. Do not use imaging (MRI, CT, X-ray) for the routine assessment of women with urinary incontinence. Do not use ultrasound other than for the assessment of residual urine volume. [2006] 1.6 Assessing pelvic organ prolapse. Do not routinely perform imaging to document the presence of vaginal prolapse if a prolapse is detected by physical examination. [2019] Q. DO I NEED TO LINE UP THE PINK CROSS AND THE VERTICAL GREEN LINE IN PRE-SCAN? No. The pink cross merely confirms the presence of fluid. Within the ‘pre-scan’ window you are able to view a live image of the bladder. You need to be able to visualise the bladder (shown in black), if in any doubt the pink cross confirms you are seeing fluid. As long as the bladder is central in the screen (by aligning the green vertical line down the middle of the bladder) your bladder will be fully captured within the cross hairs (as shown on the results screen). The auto correction tool within BladderPoint™ ensures that even if the bladder is off centre, your readings will be captured (as long as the whole bladder can be seen within the scanning cone). Q. SOMETIMES I SEE A LARGE PINK CROSS, AND OTHER TIMES, A SMALL PINK CROSS? Typically:

Small pink cross indicates small bladder Large pink cross indicates larger bladder

Often, when you see a small pink cross, (indicating very small volumes), you do not get a good view of the bladder, and sometimes the pink cross disappears, (small bladders will sit behind bowels/organs so you cannot always get a good clear image), in this instance, aim the probe (rays) towards the patient’s feet, and press SCAN – if it can see anything, it will give a reading, even if you cannot see the bladder clearly yourself. Bladder volumes of <50ml are not always easy to see or find. If after several attempts you are getting 0ml readings, (and you are aiming it in the general direction of the bladder), you can be satisfied that there is very little fluid remaining in the bladder. Have the patient drink, and re-scan in >10minutes. Typically the adult kidneys will produce approximately 1-2ml/minute (dehydrated patient) or more. Q. CAN THE UNIT BE USED FOR DETERMINING ANYTHING OTHER THAN BLADDER VOLUME? No. The BioCon bladder scanners are only able to read fluid and designed for assessing bladder volume only. Q. HOW IS IT THAT THE SCANNER GIVES A LARGE READING, BUT WHEN CATHETERISED, I GET A SIGNIFICANTLY SMALLER READING? This is not common but can sometimes happen. If it says there is fluid within the abdomen, trust your scanner. Example: the bladder scanner says PVR 400ml, you decide to catheterise – then only mange to drain off 100ml. Scan again after catheterising, you should have approx. 300ml remaining, however you now know that this fluid is not in the bladder. It could be identifying, for example, cyst/bladder diverticulum/ascites/fluid mass. This warrants further investigations to determine what this accumulation of fluid is.

de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 4 of 7

Q. CAN I SCAN A PATIENT WITH A CATHETER IN-SITU? Yes, however, remember the bladder scanner picks up all fluid, so it will also read the volume of saline within the balloon (deduct this from your reading). Q. WHAT IS THE DIFFERENCE BETWEEN THE CURRENT READING AND THE MAX READING DISPLAYED? The current reading displayed is the reading most recently acquired. The max reading displayed is the highest volume captured in a sequence of readings. When printing a record, regardless of the most recent reading captured, it is the max volume and corresponding images that are printed. NB: When capturing pre- and post-void measurements, once the pre-void reading has been taken and recorded it is recommended that the ‘new patient’ touch button is selected to clear the reading ready for the post-void phase to be measured. It is recommended that you do 2 to 3 scans per patient. Monitor the ‘current’ reading to check all scans are giving consistent readings, this will build your confidence and scanning technique. Q. CAN I SCAN A POST-PARTUM PATIENT? Yes. See the results from a study entitled: ‘Reliability of an automatic ultrasound system in the post-partum period in measuring urinary retention’ by Van Os AF, Van Der Linden P. 2006 (https://www.ncbi.nlm.nih.gov/pubmed/16752241). RESULTS: ten additional catheterizations were performed by using bladder scanner, when compared with the number of estimated catheterisations based on clinical indications. Eight women had a residual volume of more than 300ml, of whom two had an indwelling catheter. Using Bland-Altman methods, there was no significant difference in volumes measured by bladder scanner or by catheterisation. Also, there was no significant difference between two observers. Q. DO I HAVE TO MANUALLY REPOSITION THE PROBE BETWEEN DIFFERENT PLANES TO ACHIEVE A MEASUREMENT? No. Once you have located the bladder, the unit automatically calculates the bladder volume. Do not keep moving the probe between scans if you have found a good image of the bladder. Just alter the pressure/contact a little (as you may get a better image) or alter the angle slightly. Positioning the probe midline, approx. 3-5cm above the pubic bone normally finds the bladder easily. 2-3 scans per patient is recommended, to ensure you pick up the largest possible volume. (Monitor ‘current’ versus ‘max’ between scans). Q. CAN ANY KIND OF GEL BE USED? No. To ensure greater accuracy, and to ensure all ultrasound rays transmit through the skin, only ultrasound gel should be used (approximately size of 10p). Any other lubricating gel should be avoided as we cannot guarantee that all the ultrasound rays will be transmitted through the skin, therefore compromising accuracy. To reduce any infection control risk, place the gel directly onto the probe (having first cleaned the probe). Q. HOW MANY SCANNED IMAGES MAY BE STORED ON THE SCANNER’S INTERNAL MEMORY CARD? BioCon-700 BioCon-900/900S BioCon-1100

Internal storage +40 records (depending upon voice annotation used) 4GB external (SD card) – 1400 records Internal storage only - 50 patient records Internal storage only – 1000 patient records

de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 5 of 7

Q. CAN I PASSWORD/PIN PROTECT MY SAVED DATA? BioCon-700 BioCon-700 BioCon-900 BioCon-900S BioCon-1100

Pre-Oct 2020 – PIN protected can be provided as an upgrade (POA) Post-Oct 2020 - PIN protection is provided as standard (activated under setup) Not PIN protected PIN protected if desired (under setup) PIN protected if desired (under setup)

Q. CAN I DOWNLOAD THE SCAN TO MY ELECTRONIC PATIENT RECORDS (EPR)? Yes. All BioCon bladder scanners use HL7 (EPR compatible language) to enable you to connect to the NHS EPR system. Q. DOES THE BIOCON HAVE WIFI CONNECTIVITY? Yes. The BioCon-1100 has a Wi-Fi (CUBEFi) connection from the bladder scanner to the nominated PC using CubePro software to download onto your NHS EPR system. Contact de Smit Medical for more information. Q. WHAT ARE THE MAXIMUM AND MINIMUM READINGS OF THE CUBESCAN BLADDER SCANNERS? The whole BioCon range will display volumes between 0 - 999ml. If a bladder contains more than this the scanner will display 999+ NB: an empty bladder can be difficult to locate and may not be clearly visible on the screen. Q. CAN THE ULTRASOUND PROBE BE IMMERSED IN FLUID? Absolutely not. This may damage the probe and will invalidate any warranties. Refer to our cleaning instructions for compatible cleaning solutions and methods. Q. HOW DO I CLEAN MY BIOCON SCANNER? Please refer to www.desmitmedical.com for the most up to date cleaning and disinfection instructions and materials. Q. HOW MANY PRINTOUTS CAN YOU GET OUT OF A BIOCON BLADDER SCANNER ROLL OF PRINTER PAPER? Based on the Mcube paper roll shipped with each scanner (5 rolls), set to raw image view: approximately 38 scan prints per roll with a warning (red edge print) that there is enough paper left for 4 more printouts. Based on de Smit Medical's paper roll box of 20 rolls (code BC5D-0020(20)) raw image view: approximately 58 scan prints per roll with a warning (red edge print) that there is enough paper left for 4 more printouts. Q. WHAT IS THE MEDICAL SAFETY TESTING CLASS OF THE BLADDER SCANNERS? For a comprehensive guide on all BioCon Bladder Scanners, please contact de Smit Medical. Q. IS THE SCANNER PROBE INTERCHANGEABLE BETWEEN ANOTHER COMPATIBLE SCANNER? BioCon-700 & 1100 BioCon-900 & 900S

No. The probe and scanner are calibrated together and become a matched pair. Recalibration is required if the probe is swapped. NA

Q. HOW OFTEN SHOULD MY BLADDER SCANNER BE CALIBRATED? All BioCon bladder scanners are now calibration free, therefore, no annual calibration is required. However, if your BioCon hasn’t had the latest ‘calibration free’ software installed (updated from Jan 2019) you may still need an annual calibration. The calibration free software is back upgradeable on all units. Contact de Smit Medical to determine your software levels if in doubt.

de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 6 of 7

Q. IS INFORMATION SAVED ON THE SCANNER’S INTERNAL MEMORY CARD ENCRYPTED? BioCon-700

BioCon-900 BioCon-900S/1100

No. However, patient records can only be accessed through the scanner’s internal review function or by uploading the data to a PC and read using the proprietary software supplied with the scanner. If removed from the scanner the memory card is encrypted and cannot be read unless the MCube software is installed on your PC. Yes. Encrypted. Yes. Encrypted and PIN protected (option within set up function).

Q. CAN I SCAN A PATIENT’S BARCODE ID? BioCon-700 BioCon-900 & 900S BioCon-1100

Not able to read a patient barcode. Barcode reader – patient ID & user ID function available – optional at point of order. Barcode reader – patient ID & user ID function available – can be added at any time.

Q. WHAT GS1 INFORMATION IS PROVIDED WITHIN THE BARCODE OF THE SCANNER? The BioCon bladder scanner barcode label identifies the make, model and serial number (barcode formatted to GS1-128).

de Smit Medical Systems Ltd, Bristol Road, Cromhall, South Gloucestershire, GL12 8AX - 0845 345 4226 - [email protected] - www.desmitmedical.com Registered Address: 584 Wellsway, Bath, BA2 2UE - Company Number: 6585345 - VAT Number: GB 935009926 Page 7 of 7