Summary of Contents for BBI SEM Scanner 200
- Page 1 ENGLISH (EU) SEM Scanner 200 (SW V3.60) Instructions for Use OTH-SEM-IFU-MULTI-LANG-0123 Rev D, December 2018...
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Page 2: Table Of Contents
3.6.3. SEM200-008 – Study Population ................... 20 3.6.4. SEM200-008 – Results ......................21 3.7. Recommended SEM Scanner 200 Readings at the Sacrum ..........22 3.8. Recommended SEM Scanner 200 Readings at the Heels ..........24 3.9. Resetting the SEM Scanner 200 .................... 26... - Page 3 ENGLISH (EU) 3.10. Ending SEM Scanner 200 Operation ..................27 3.11. Summary of Action Button Functions ................. 27 Cleaning and Disinfection ........................28 Cleaning and Disinfection Overview ....................28 Scanner Cleaning and Disinfection Instructions ................28 Troubleshooting ............................ 30 Guidance and Manufacturer’s Declaration – Electromagnetic Emissions ........ 31 6.1.
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Page 4: Warnings And Safety Precautions
▪ WARNING: Do not attempt to disassemble or otherwise modify the SEM Scanner 200 as this can result in unintended hazards. The SEM Scanner 200 can only be serviced by the manufacturer (Bruin Biometrics, BBI) or a BBI Authorized Service Center. Please contact your BBI Product Specialist or Customer Service regarding any device that is not functioning correctly. - Page 5 ▪ WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply main with protective earth. ▪ WARNING: To avoid the risk of explosion, the SEM Scanner 200 should not be used in the presence of flammable anesthetic agents.
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Page 6: General
SEM Value of 0.3 to 3.9. SEM is unitless (not an International System of Units measurement). The SEM Scanner 200 displays a (delta) value after a minimum of three (3) SEM Values have been measured. A minimum of four readings were taken to obtain a result during the clinical study described in Section 3.6. -
Page 7: Sem Scanner 200 Device
Action button (turns device on and off and resets readings) Figure . SEM Scanner 200 Top View showing Figure 2. The electrode on the bottom of the SEM Scanner 200 Display and Action Button Figure 3. SEM Scanner 200 Side View... -
Page 8: Sem Scanner 200 Display
Green (middle bars) – correct pressure Yellow (bottom bars) – too soft pressure Status indicator Figure 4. SEM Scanner 200 Display (V3.60) Item Function Action Button Clears SEM readings and turns the Scanner unit ON/OFF. Battery Gauge Battery icon indicating current battery state of charge Calculated difference between the minimum and maximum SEM ... -
Page 9: Additional Sem Scanner 200 Components
ENGLISH (EU) Additional SEM Scanner 200 Components The SEM Scanner 200 ships with an Inductive Charging Mat and wall-mount power supply that is used when charging the device. Figure . Inductive Charging Mat Contraindications Do not use on broken skin. - Page 10 BBI or its authorized service center, unless authorized prior to such service by BBI, (f) that are equipment sold as used, or (g) that are exposed to agents listed in Table 2, below. Table 2 is not an exhaustive list of agents which may compromise the integrity of the SEM Scanner 200.
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Page 11: Table Of Symbols
Instructions are included and must be followed Serial number Drip Proof Equipment-IPX1: The SEM Scanner 200 enclosure provides protection against the harmful effects of the ingress of liquids. (IPX1, per IEC 60529) Caution or warning CE mark in accordance to the European Medical Device Directive... -
Page 12: Operating Instructions
ENGLISH (EU) Operating Instructions 3.1. Unpacking and Inspection After the SEM Scanner 200 is unpacked verify that the scanner has no signs of damage. If there are signs of damage, contact Customer Service. 3.2. Charging the Device The device must be charged before using it for the first time, leave the device on the charging mat for at least 6 hours to completely charge the battery prior to initial use. - Page 13 2. Ensure that the SEM Scanner 200 is OFF by pressing and holding the Action Button for 6 seconds until the display screen is blank. Turn the SEM Scanner 200 upside down (so the electrode is on top) and press it firmly into the cradle on the charging mat (...
- Page 14 4. Figure 7). 5. A blue charging mat indicator light indicates that it is charging the SEM Scanner 200. If the blue light is not illuminated, then the SEM Scanner 200 may not be positioned securely in the cradle. Do not press the Action Button to turn the SEM Scanner 200 on while it is on the charging mat.
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Page 15: Use Of Device
ENGLISH (EU) 3.3. Use of Device The SEM Scanner 200 should be properly cleaned and disinfected after it is used on a patient. The SEM Scanner 200 must be fully dry after cleaning and disinfection prior to use. See Section 4 for detailed cleaning and disinfection instructions. - Page 16 ENGLISH (EU) Figure 9. SEM Scanner 200 Initialization Screen 3.2 It will take approximately 45 seconds for the device to finish initialization and be ready for use. 4. Once initialization is complete, the Status Indicator will display “Ready” (Figure 10).
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Page 17: Acquiring Sem Scanner 200 Readings
No readings will display when the Pressure Indicator shows yellow bars. 3. Confirm a reading has been taken by listening for the SEM Scanner 200 to emit a short audio tone. - Page 18 The display will show a value of zero (0.0) for the SEM Value (see Figure 10 and see Section 3.9). ➢ If the SEM Scanner 200 is not reset to zero (0.0), the ∆ value from the previous evaluation (anatomical location or prior patient) could be used to calculate the ∆...
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Page 19: Displaying An Assessment From A Set Of Readings
SEM Scanner 200. The symbol will display a value when a minimum of three (3) SEM Scanner 200 patient readings are performed. A minimum of four readings were taken to obtain a result during the clinical study described in Section 3.6. -
Page 20: Sem200-008 - Study Population
ENGLISH (EU) 3.6.3. SEM200-008 – Study Population The SEM200-008 (008) clinical study was a prospective, blinded study designed to evaluate the SEM Scanner relative to the current Standard of Care, Visual Skin Assessment (VSA), for identifying patients with skin and tissue at increased risk of developing pressure ulcers at the heels or sacrum. -
Page 21: Sem200-008 - Results
ENGLISH (EU) 3.6.4. SEM200-008 – Results Sensitivity and specificity data presented in Table 4 and Table 5 show how the SEM Scanner 200 compares to visual skin assessment in identifying patients with tissue at risk of developing pressure ulcers at the heels or sacrum. -
Page 22: Recommended Sem Scanner 200 Readings At The Sacrum
The value should be considered in conjunction with other measures of standard of care and clinical judgment. 3.7. Recommended SEM Scanner 200 Readings at the Sacrum The recommended positions for SEM Scanner 200 readings to complete for an assessment of the sacrum is shown in Page 22 of 36... - Page 23 ENGLISH (EU) Figure 12. Readings are taken by moving directionally around the bony prominence to identify healthier tissue and other damaged areas around the bony prominence. For the sacrum, SEM Scanner readings needed for clinical interpretation are taken at six (6) points as shown in Figure 12 and as described below.
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Page 24: Recommended Sem Scanner 200 Readings At The Heels
Table 6. Example of SEM Scanner 200 Readings for Sacrum 3.8. Recommended SEM Scanner 200 Readings at the Heels The recommended positions for SEM Scanner 200 readings to complete for an assessment of the heel is shown in Figure 13. Readings are taken by moving directionally around the bony prominence to identify healthier tissue and other damaged areas around the bony prominence. - Page 25 ENGLISH (EU) For the heel(s), BBI recommends taking SEM Scanner 200 readings at the four (4) points as shown in Figure 13 and described below. Readings at these four points were taken for the clinical study described in Section 3.6. SEM Scanner readings do not need to be taken in numerical sequence.
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Page 26: Resetting The Sem Scanner 200
∆ Calculations High ∆ Table 7. Example of SEM Scanner 200 Readings for the Heel 3.9. Resetting the SEM Scanner 200 To clear (resetting) the sample set and start recording readings for a new sample set, select and hold the Action Button for one second (Figure 14). -
Page 27: Ending Sem Scanner 200 Operation
To end SEM Scanner 200 operation, press and hold the Action Button for approximately 6 seconds until the SEM Scanner screen becomes blank. The SEM Scanner 200 operation is now ended and power is off. 3.11. Summary of Action Button Functions... -
Page 28: Cleaning And Disinfection
ENGLISH (EU) Cleaning and Disinfection Cleaning and Disinfection Overview BBI has conducted testing using Metrex CaviWipes (<20% alcohol), and determined that the low-alcohol-based wipes are capable of cleaning and disinfecting the SEM Scanner against the following 5 micro-organisms with kill times of less than 3 minutes: Mycobacterium terrae •... - Page 29 Figure 15. Clean the Sides of Figure 16. Clean the Top Figure 17. Clean the the SEM Scanner 200 of the SEM Scanner 200 Bottom of the SEM Scanner 200 2. Use the second wipe to completely clean the scanner again for 30 seconds.
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Page 30: Troubleshooting
Troubleshooting Problem Resolution The device does not turn on. Charge the SEM Scanner 200 per Section 3.2 of this Instructions for Use. The device shuts off prior to recording a Charge the SEM Scanner 200 per Section 3.2 of reading. -
Page 31: Guidance And Manufacturer's Declaration - Electromagnetic Emissions
This data is included pursuant to IEC 60601 labelling requirements. The SEM Scanner 200 is intended for use in the electromagnetic environment specified in Table 10. The user of the SEM Scanner 200 should ensure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –... -
Page 32: Electromagnetic Immunity
UT) for dip in UT) for typical commercial or hospital environment. interruptions, 0.5 cycle 0.5 cycle If the user of the SEM Scanner 200 charging and voltage system requires continued operation during 40% UT (60% 40% UT (60% dip variations on... - Page 33 Portable and mobile RF communications IEC 61000-4-6 equipment should be used no closer to any 150 kHz to 80 part of the SEM Scanner 200 system, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
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Page 34: Separation Distance
The SEM Scanner 200 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SEM Scanner 200 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SEM Scanner 200 as recommended below, according to the maximum output power of the communications equipment. -
Page 35: Specifications
SEM Value Range 0.3 to 3.9 SEM Value units SEM Value Repeatability* +/- 0.2 SEM Value units The SEM Scanner 200 should only be stored at temperatures Storage ranging from -4ºF (-20ºC) to 113ºF (45ºC) at 5% to 90% relative humidity (non-condensing). -
Page 36: January
ENGLISH (EU) ©2014 Bruin Biometrics LLC or its affiliates. All rights reserved. Bruin Biometrics, LLC Emergo Europe B. V. 10960 Wilshire Blvd, Suite 950 Prinsessegracht 20 Los Angeles, CA 90024 USA 2514 AP, The Hague Phone: (310) 268-9494 THE NETHERLANDS E-mail: info@bruinbiometrics.com Tel: +31 70 345 8570...