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EMC Table/Environment

The iCOquit® Smokerlyzer® complies with the Medical Device Directive 93/42/EEC as amended by
2007/47/EC and the Medical Device Electromagnetic Compatibility standard IEC 60601-1-2 and EN
60601-1-2.

WARNING:

Portable RF communications equipment (including peripherals such as antenna cables

and external antennas) should be used no closer than 30 cm (12 inches) to any part of the iCOquit

Smokerlyzer including cables specified by the manufacturer. Otherwise, degradation of the

performance of this equipment could result. This equipment should be moved if necessary, to avoid

interference.

Guidance and manufacturer’s declaration: Electromagnetic Immunity (IEC 60601-1-2)

The iCOquit® Smokerlyzer® is intended for the use in the electromagnetic environment specified below. The

customer or the user of the iCOquit® Smokerlyzer® should assure that it is used in such an environment.

Immunity test

IEC 60601 Test level

Compliance

level

Electromagnetic environment – guidance

Radiated

Immunity

EN61000-4-

3:2006 +

A1:2008 +

A2:2010

IEC61000-4-

3:2006

+A1:2007 +

A2:2010

10V/m (1kHz 80%)

80MHz – 2.7GHz

3V/m (80% 1kHz)

2.7Hz – 6.0GHz

385 MHz 27 V/m

PM 18 Hz

450 MHz 28 V/m

FM 1 kHz sine

710 MHz 9 V/m PM

217 Hz

745 MHz 9 V/m PM

217 Hz

780 MHz 9 V/m PM

217 Hz

810 MHz 28 V/m

PM 18 Hz

870 MHz 28 V/m

PM 18 Hz

930 MHz 28 V/m

PM 18 Hz

1720MHz 28 V/m

PM 217 Hz

1845 MHz 28 V/m

PM 217 Hz

1970 MHz 28 V/m

PM 217 Hz

2450 MHz 28 V/m

PM 217 Hz

5240 MHz 9 V/m

PM 217 Hz

5500 MHz 9 V/m

PM 217 Hz

5785 MHz 9 V/m

PM 217 Hz

Criterion A

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey (*A),

should be less than the compliance level in each

frequency range.

Interference may occur in the vicinity of

equipment marked with the following symbol:

Power

Frequency

Magnetic

Immunity

EN61000-4-

30 A/m

magnetically

sensitive equipment

Criterion A

Power frequency magnetic fields should be at

levels characteristic of a typical location in a typical

home, commercial or hospital environment.

Содержание iCOquit Smokerlyzer

Страница 1: ...User Manual iCOquit Smokerlyzer ...

Страница 2: ...e vapours will damage the carbon monoxide sensor inside the iCOquit CAUTION Do not use hand sanitising products containing alcohol when using the device as this may damage the sensors CAUTION Use of accessories not approved by the manufacturer will invalidate the warranty and may compromise the functionality of the device NOTE Once the iCOquit s battery has become flat the iCOquit will need to be ...

Страница 3: ...tion and Set up 5 User Interface 5 Breath test 8 Using the iCOquit 8 Connecting to an iCOquit device 14 Completing a breath test 15 Interpreting the breath test result 17 Completing the Smoking Habits Questions 18 Navigation drawer menu options 19 Troubleshooting 24 Technical Specification 25 Safety Information 26 Warranty 29 Disposal of Device 29 Responsible Manufacturer and Contacts 29 ...

Страница 4: ... Directive 93 42 EEC Please refer to the Safety Information section of this manual for more information on the compliance of the iCOquit Smokerlyzer Warnings 1 Hands should be washed regularly in accordance with infection control practice 2 Please do not attempt to modify the equipment in any way or use accessories not specified by the manufacturer Any attempt to do so will invalidate the warranty...

Страница 5: ...king The iCOquit can also be used by healthcare professionals with individuals in smoking cessation programmes and research The iCOquit smartphone tablet application will guide the user through the process of providing a breath sample for measurement After the breath test results can be shared via email and social media and stored in a results graph to show progress Instrument Layout 1 Breath samp...

Страница 6: ... to A blue light will flash once to show pairing is complete NOTE This can take up to 5 seconds and will only pair once initiated from within the iCOquit app The device automatically disconnects after 10 seconds of inactivity or when a breath test is complete User Interface Splash Screen The splash screen shall display upon starting the app The splash screen shall disappear once the app has succes...

Страница 7: ...Email Address field 2 Password field 3 Forgotten Password button starts a new forgotten password process 4 Sign In Button starts the authentication process 5 Register button starts the user registration process 1 2 3 4 5 ...

Страница 8: ...escription 3 The second dashboard shows days until quit date or if quit date has been reached it will show number of days smoke free 4 The last dashboard shows amount of money user has saved 5 Results tab will navigate user to results graph 6 Dashboard tab will navigate user to dashboard 7 Breath Test Tab will navigate the user to the first breath test page if it is not the active tab 1 2 2a 3 4 5...

Страница 9: ...ions a If the user already has an account they will need to complete the authentication fields and tap the Sign In Button b If the user is already a user but has forgotten their authentication credentials the user will need to tap the Forgotten Password Button c If the user is not currently a registered user they will need to tap the Register Button 1c 1a 1b ...

Страница 10: ...he user will to provide the email address they completed registration with and then tap the Submit button 2 The 9 digit password reset verification code will have been sent to the users mailbox The user will then need to tap the submit button 1 2 1 ...

Страница 11: ...word has been submitted the app will return to the sign in page Completing the Registration Process 1 The user will need to complete the user profile section of the registration process This will involve a Providing a name b Providing their age Once this has been completed the user will need to tap the Update Button 3 1a 1b ...

Страница 12: ...ted the user will need to tap the Update Button 3 The final section of the registration process is providing details for authentication and consents This will involve a Providing a valid email address b Providing a password for authentication c Agreeing to terms and conditions d Agreeing to the privacy statement Once the user has provided the required information they will need to tap the Continue...

Страница 13: ...ign in using the details registered Tabbed Navigation Pages 1 The tabbed navigation allows navigation between three pages Dashboard Breath Test and Results the selected item will be highlighted as dark blue while the unselected non active items will be grey a To navigate to the Dashboard tap Dashboard The dashboard provides an overview of the users smoking cessation progress 1a 1 ...

Страница 14: ...ne warning and allow the user to start a new breath test by tapping the Continue button c To view historic breath test results the user will need to tap the Results button The results are in date order with the latest reading displayed from the left and oldest reading displayed furthest to right 1b 1c ...

Страница 15: ... Bluetooth scanning phase will show a spinner while searching for a device 2 If an iCOquit device has been found and successfully connected to a tick shall be shown to indicate a successful connection between the smart device and iCOquit 1 2 ...

Страница 16: ...nnect a retry icon shall appear indicating connection has failed but tap the icon to try again Completing a breath test Breath Test Initialisation 1 The first screen prompts the user to initiate the breath test To do this the user will need to tap the New Breath Test Button 3 1 ...

Страница 17: ...ke a deep breath Hold Instructions 3 As prompted onscreen hold your breath until the countdown timer has finished 4 If the 15 second inhalation countdown is unattainable begin exhaling when ready and the device will begin measuring breath sample 2 3 ...

Страница 18: ...on screen exhale Interpreting the breath test result 1 Breath test result interpretation chart a Green Low CO PPM Reading b Yellow Moderate CO PPM Reading c Red High CO PPM Reading Once a breath test has been completed the user will be navigated to this screen where they will see their CO PPM result 4 1 ...

Страница 19: ...they are still an active smoker b Providing how many cigarettes they are actively smoking per day c Providing the duration before the first cigarette of the day d The day they quit or the day they anticipate quitting e The time they quit or the time they anticipate quitting Once the user has completed the questions they should tap the Continue Button 1a 1b 1c 1e 1d ...

Страница 20: ...on Smoker b Light Smoker c Moderate Smoker d Heavy Smoker Navigation drawer menu options 1 The navigation drawer contains seven menu items which can be navigated to upon taping an item in the navigation drawer The menu options are a Dashboard b Manage Profile c iCOquit Smokerlyzer d Frequently Asked Questions e iCOquit Manual f About iCOquit g Delete Account h Sign Out 2 a 1a b c d e f g h ...

Страница 21: ...the form fields Once a user has finished making changes they will need to tap the Update button Edit Smoking Habit Details 1 A user can navigate away by tapping the back button symbol 2 A user can update their smoking habit details by editing the form field Once the user has made their changes they will need to tap the update button 1 2 1 2 ...

Страница 22: ...s screen device details about the connected device will appear These device details include a Connection Status b Device Serial Number c Device UUID d Battery Life Remaining e Firmware Version f Number of tests the device has conducted g iCOquit Activation Date NOTE Once the iCOquit s battery has become flat the iCOquit will need to be disposed of please see disposal guidance in Disposal section o...

Страница 23: ...eb view will appear which will display the iCOquit support web page The user will be able to navigate support articles on the web page within the app About iCOquit page 1 The user can navigate away from the page by tapping the back button symbol 2 Upon navigating to the page the user will be provided with information on the iCOquit 1 2 1 2 ...

Страница 24: ...o confirm that the user wants to delete their account they will need to tap yes else they will need to tap no Upon a user deleting their account all stored data will be removed Sign Out 1 The user can navigate away from the page by tapping the back button symbol 2 Upon navigating to sign out a dialog will appear If the user taps yes this sign the user out and navigate them to the authentication pa...

Страница 25: ...ntal conditions Leave in clean dry area with fresh air free from VOCs for 24hrs If any of these issues persist please contact Bedfont or its distributors Cleaning 1 The iCOquit Smokerlyzer product is moulded with ABS and PC plastic which is easy to keep clean 2 Use a clean damp cloth to wipe the unit over 3 NEVER use alcohol or cleaning agents containing alcohol or other organic solvents as long t...

Страница 26: ...ery is non replaceable Power 3v Lithium ion coin cell T90 response time 30 Seconds Operating temperature 15 35o C Storage Transport Temperature 0 50o C Operating Storage Transport Humidity 10 90 RH non condensing Operating Storage Transport Pressure 912 0 1114 0 mbar Dimensions Less than 150mm long x 30mm diameter Weight Less than 100g Materials Plastic casing ABS and Polycarbonate H2 Cross Sensit...

Страница 27: ...e of safety application in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide Equipment not suitable for use in the presence of flammable mixtures Refer to manual Serial Number Non ionizing electromagnetic radiation CE mark Keep dry Dispose of according to WEEE Serial number Manufacture by and date BF Applied Part whole device Recycling symbol Bedfont logo ...

Страница 28: ...nity test IEC 60601 Test level Compliance level Electromagnetic environment guidance Radiated Immunity EN61000 4 3 2006 A1 2008 A2 2010 IEC61000 4 3 2006 A1 2007 A2 2010 10V m 1kHz 80 80MHz 2 7GHz 3V m 80 1kHz 2 7Hz 6 0GHz 385 MHz 27 V m PM 18 Hz 450 MHz 28 V m FM 1 kHz sine 710 MHz 9 V m PM 217 Hz 745 MHz 9 V m PM 217 Hz 780 MHz 9 V m PM 217 Hz 810 MHz 28 V m PM 18 Hz 870 MHz 28 V m PM 18 Hz 930 ...

Страница 29: ...liance level above the iCOquit should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the iCOquit Emissions test IEC 60601 Test level Compliance level Electromagnetic environment guidance Radiated Emissions EN55011 2016 A1 2017 FCC part 15 Subpart B 30MHz to 1GHz 30MHz to 25GHz Class B The iCOquit is...

Страница 30: ...e warranty is automatically invalidated if the product is repaired altered labels removed or otherwise tampered with by unauthorised personnel or have been subject to misuse neglect or accident Disposal of Device The iCOquit Smokerlyzer must be disposed of responsibly please contact your local Bedfont distributor where you purchased the iCOquit Smokerlyzer or your local authority for details of wh...

Страница 31: ......

Страница 32: ...d Wales Registered No 1289798 Our family innovating health for yours est 1976 Bedfont Scientific Ltd Station Road Harrietsham Maidstone Kent ME17 1JA England Tel 44 0 1622 851122 Fax 44 0 1622 854860 Email ask bedfont com Web www bedfont com Bedfont GmbH Mitterbachweg 18 5081 Anif Austria Tel 43 662 635050 Fax 43 662 635050 50 Email bedfont gmbh bedfont com ...

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