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BBI SEM Scanner 200 Скачать руководство пользователя страница 20

ENGLISH (EU)

Page 20 of 36

OTH-SEM-IFU-

MULTI-LANG-0123 Rev D,

January 2018

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.  In the 008 Study there were 12 unique clinical-trial sites in the United States
and United Kingdom that were included in the study. Each had their own Principal Investigator.
Subjects in the 008-study received standard-of-care interventions for pressure ulcer prevention
and management.  These subjects were at varying risk for developing pressure ulcers (PUs) (as
defined by current risk assessment tools) and thus interventions were given.

According to the study protocol’s inclusion criteria, these patients were defined as being “at

ris

k” if they met one of the following criteria:

•

PU Risk Score

–

Braden < 15; Waterlow ≥ 10; or Norton ≤ 18;

•

Poor mobility; e.g., Braden mobility subscore ≤2; Waterlow mobility subscore >2;
Norton mobility subscore ≤2; or poor mobility according to

clinical judgment (chair- or

bed-bound);

•

Poor nutrition; e.g., Braden nutrition subscore ≤2; Waterlow nutrition subscore >2; or

other indicator of poor nutrition; and/or

•

Medical procedure (e.g., surgery, x-ray, etc.) involving immobility and inability to change
position lasting 4 hours or longer.

Specifically, 182 patients were listed as Intent to Treat (ITT). Of those, 170 Patients were
included in the sensitivity and specificity calculations with 48 pressure ulcers forming across 36
Patients.

Within the 12 sites included in the study, the trials were completed in:

1.

Orthopaedic Trauma: 14% (n=26 subjects)

2.

Medical Surgery: 27% (n=50 subjects)

3.

Long Term Care: 32% (n=58 subjects)

4.

ICU: 9% (n=17 subjects)

5.

Rehab: 4% (n=7 subjects)

6.

Neurologic Care: 8% (n=15 subjects)

7.

Other/Mixed: 5% (n=9 subjects)

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Содержание SEM Scanner 200

Страница 1: ...ENGLISH EU OTH SEM IFU MULTI LANG 0123 Rev D December 2018 SEM Scanner 200 SW V3 60 Instructions for Use...

Страница 2: ...claimer 9 2 9 Table of Symbols 11 3 Operating Instructions 12 3 1 Unpacking and Inspection 12 3 2 Charging the Device 12 3 3 Use of Device 15 3 4 Acquiring SEM Scanner 200 Readings 17 3 5 Displaying a...

Страница 3: ...n Functions 27 4 Cleaning and Disinfection 28 Cleaning and Disinfection Overview 28 Scanner Cleaning and Disinfection Instructions 28 5 Troubleshooting 30 6 Guidance and Manufacturer s Declaration Ele...

Страница 4: ...ING The standard of care should be followed for reducing the risk of developing pressure ulcers Readings from the SEM Scanner 200 can be used to support increased intervention but should never be the...

Страница 5: ...the presence of flammable anesthetic agents CAUTIONS CAUTION Examine the SEM Scanner 200 for damage or sharp edges prior to each use If any damage or sharp edges are found please contact Customer Serv...

Страница 6: ...status SEM Value and SEM Delta SEM The SEM Scanner 200 is pre calibrated The SEM Scanner 200 is provided with a charging mat and power supply for recharging the device unit The SEM Scanner 200 assess...

Страница 7: ...nuary 2018 2 3 1 SEM Scanner 200 Device Action button turns device on and off and resets readings Figure 1 SEM Scanner 200 Top View showing Display and Action Button Figure 2 The electrode on the bott...

Страница 8: ...fference between the minimum and maximum SEM Values in the set of readings taken SEM Display of SEM Value for the last completed reading Pressure Indicator Bars indicating the applied pressure while t...

Страница 9: ...metrics LLC BBI warrants the SEM Scanner 200 against defects in materials and workmanship for three 3 years from the date of purchase from BBI or its subsidiaries This warranty is given only to the or...

Страница 10: ...l to the Warranted Product c that have been used in violation of the BBI Instructions for Use d on which the serial number has been removed or made illegible e that have been modified by anyone other...

Страница 11: ...closure 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 Manufactured By T...

Страница 12: ...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...

Страница 13: ...play Follow the steps below to charge the device 1 Connect the charging mat power adaptor to the power outlet 2 Ensure that the SEM Scanner 200 is OFF by pressing and holding the Action Button for 6 s...

Страница 14: ...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 When...

Страница 15: ...ges or sharp edges and that the electrode is sealed against the base Do not use the device if the electrode seal is broken or any damage or sharp edges are found 3 Turn the SEM Scanner 200 on by press...

Страница 16: ...Rev D January 2018 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 comple...

Страница 17: ...second as indicated with the green bars on the Pressure Indicator The electrode must be in complete contact with the skin to acquire a proper reading No readings will display when the Pressure Indica...

Страница 18: ...to calculate the value on the next anatomical location or patient This will give you a wrong value for that evaluation 9 To minimize skin irritation from exposure to the cleaning and disinfecting age...

Страница 19: ...l will display a value as described in Section 3 5 3 6 1 Interpretation of the Symbol A 0 6 at an anatomical site may suggest the tissue is at lower risk for pressure ulcers A 0 6 at an anatomical sit...

Страница 20: ...tocol s inclusion criteria these patients were defined as being at risk if they met one of the following criteria PU Risk Score Braden 15 Waterlow 10 or Norton 18 Poor mobility e g Braden mobility sub...

Страница 21: ...ble 4 shows 42 anatomical sites in this category True negatives no visible pressure ulcer and a localized SEM delta below 0 6 flat values Table 4 shows 128 anatomical sites in this category False nega...

Страница 22: ...1 Sensitivity and specificity analysis was performed following an analysis rule of 2 of 3 consecutive observations of a SEM delta of 0 6 or above SEM positive or SEM delta less than 0 6 SEM negative...

Страница 23: ...aged 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 SEM Scanner readings...

Страница 24: ...gure 12 SEM Scanner 200 readings over and around sacrum SEM Scanner 200 Readings Sacrum Calculations 3 2 0 High 2 7 5 2 4 2 2 7 1 1 8 4 2 6 6 2 0 Low 1 8 0 9 Table 6 Example of SEM Scanner 200 Reading...

Страница 25: ...ading at that spot The SEM Scanner will produce an SEM reading after only three 3 readings Reading 1 Back of the heel around the calcaneus Avoid placing the SEM Scanner on the achilles tendon Reading...

Страница 26: ...0 3 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...

Страница 27: ...w ended and power is off 3 11 Summary of Action Button Functions Desired SEM Scanner Action Approximate Time to Hold Action Button Result Start Operation 1 second Turns the power on SEM Scanner 200 wi...

Страница 28: ...Escherichia coli Klebsiella pneumoniae The SEM Scanner should never be exposed to the agents listed in the Warranty and Disclaimer section Use of these agents will void the product warranty Scanner Cl...

Страница 29: ...device surface should be fully coated with the wipe solution after the cleaning 4 Allow the device to sit for at least 2 minutes to properly disinfect the device before returning it to storage or usi...

Страница 30: ...nate when the SEM Scanner unit is positioned on the charger Ensure the charging mat is connected to a power source and all cables are securely connected Ensure the SEM Scanner 200 is positioned secure...

Страница 31: ...mpliance Electromagnetic Environment Guidance RF emissions CISPR11 Group 1 The SEM Scanner 200 device uses RF energy only for its internal function Therefore its RF emissions are very low and are not...

Страница 32: ...or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV lines to earth 1 kV line s to line s 2 kV lines to earth Mains power quality should be that of a typical commercial or hospital...

Страница 33: ...ing cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Radiated RF IEC 61000 4 3 3 V m 80 MHz to 2 7 GHz 3 V m Recommended sepa...

Страница 34: ...is listed in Table 12 Separation distance according to frequency of transmitter meters Rated maximum output power of transmitter W 150 kHz to 80 MHz P d 2 1 80 MHz to 800 MHz P d 2 1 800 MHz to 2 7 GH...

Страница 35: ...ty 0 2 SEM Value units Storage The SEM Scanner 200 should only be stored at temperatures ranging from 4 F 20 C to 113 F 45 C at 5 to 90 relative humidity non condensing Operating Conditions The SEM Sc...

Страница 36: ...LC or its affiliates All rights reserved Bruin Biometrics LLC 10960 Wilshire Blvd Suite 950 Los Angeles CA 90024 USA Phone 310 268 9494 E mail info bruinbiometrics com Website www bruinbiometrics com...

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