Sm

o

ker

lyzer ®

For use with Micro+ basic

F ormer piCO+

0086

Scientific contributions to health.

www.covita.net | (800)707-5751

 

 

 

 

 

 

 

Contents  

Intended  Use  ......................................................................................................................................  2  

Introduction  ........................................................................................................................................  2  

 

Taking  a  breath  test  ............................................................................................................................   2  

Converting  %COHb  to  %FCOHb ................

......................................................................................  3  

Reviewing  history  ..................................................................................................................

.

....   3  

Changing  date  and  time  .....................................................................................................................   3  

Technical  Specification  .......................................................................................................

.

..........    

4  

Safety  Information  and  Device  Symbols  .............................................................................................  4  

Environment  .......................................................................................................................................  5  

Instrument  Layout  ..............................................................................................................................  5  

Display  and  Device  Symbols  ...............................................................................................................  6  

Warnings  and  Maintenance  ...............................................................................................................  8  

Cleaning  ..............................................................................................................................................  8  

Routine  Maintenance  .........................................................................................................................  9  

Troubleshooting  .................................................................................................................................  9  

Calibration  Procedure  ......................................................................................................................  10  

COdata

+

™  Software  –  connecting  to  the  PC  .....................................................................................  10  

Returns  Procedure  ............................................................................................................................  11  

Spares  ...............................................................................................................................................  11  

Warranty  ..........................................................................................................................................  11  

 

    www.covita.net | (800)707-5751

1  

 

 

Intended  Use  

  The   M icro

+ basic

™  Smokerlyzer®   is   a  breath   carbon   monoxide   monitor  intended  for   multi-­‐patient   use   by  healthcare   professionals   in   smoking   cessation   programmes   and   research.   They   can   also   be   us ed   as   an  indicator  of  carbon  monoxide  poisoning  in  a  healthcare  environment.  

 

Introduction    

Carbon   monoxide   (CO)   is   a   toxic,   odourless,   colourless   and   tasteless   gas.   It   is   formed   by  the  incomplete  combustion  of  organic  material  at  high  temperatures,  with  an  insufficient   oxygen  s u pply.    When   inhaled,   CO   displaces   oxygen   in   the   bloodstream   to   form   carboxyhaemoglobin  (COHb).  This  starves  body  tissue  of  oxygen  restricting  the  body’s  perfor mance  and  causing  health  i m plications.  CO   can   remain   in   the   bloodstream   for   up   to   24   hours,   depending   on   factors   such   as   physical   activity,   sex,  and  inhalation  intensity.  The  half-­‐life  is  about  5  hours.    

CO   (ppm),   carboxyhaemoglobin   (%COHb)   and   foetal   carboxyhaemoglobin   (%fCOHb)   correlation:  

Breath   carbon   monoxide   is   measured   in   parts   per   million   (ppm)   and   blood   carboxyhaemoglobin   is   measured  in  percentages  (%COHb  and  %fCOHb).  The  three  are  compatible  and  convertible:  the  ppm  

CO  reading  relates  to  gas  in  the  lungs  and  on  the  breath  (i.e.  the  amount  of  poisonous  CO  that  has   been  inhaled),  and  the  %COHb  and  %fCOHb  readings  relate  to  the  percentage  of  vital  oxygen  that   has  been  replaced  in  the  bloodstream.    

 

The  Micro

+ basic

™  Smokerlyzer®  displays  CO  ppm,  %COHb  and  %FCOHb.  However  all  devices  on ly d ire ctly   measure   CO   ppm,   the   %COHb   and   %fCOHb   is   a   calculation   based   on   clinical   evidence.   Clinical   research   has   demonstrated   that   a   useful   relationship   between   carbon   monoxide   and   carboxyhaemoglobin  is  obtained  after  a  short  period  of  breath-­‐holding.    

 

The   cut-­‐off   point   between   smoker   and   non-­‐smoker   differs   based   on   local   regulation,  

Bedfont   have  created   cut-­‐off   levels   as   a   guide   only,  see  ‘Traffic  Light  Pre-­‐set   Cut   off   Levels’,  these  can  be  alt ered  

  in-­‐line  with  your  local  regulations  from  the  settings  screen.  

 

Taking  a  breath  test  

1.

Attach  a  breath  sampling  D-­‐piece  and  new  mouthpiece.  

 

2.

Turn  on  the  monitor  by  pressing  the  power  button  once.  

 

 

 

 

 

 

3.

Press  ‘Breath  Test’  symbol  on  screen,  

 

4.

To  cancel  the  breath  test,  press   .   or .  

5.

Inhale  and  hold  breath  for  the  pre-­‐set  15  second  countdown.    

6.

A  beep  will  sound  during  the  last  three  seconds  of  the  countdown.    

7.

Blow  slowly  into  mouthpiece,  aiming  to  empty  lungs  completely.  

8.

The  ppm  and  equivalent  %COHb  levels  will  rise  and  hold  on-­‐screen.  

 

  2  

 

9.

When  the  test  is  finished        will  appear  at  the  bottom  of  the  screen.  

 

10.

If  a  high  reading  has  been  recorded,  you  can  mute  the  sound  by  pressing   .  

 

11.

To  repeat  breath  test,  press    once  to  return  to  the  home  screen  and  repeat  steps  3-­‐8.  

 

 

 

12.

To  save  the  reading  press    and  select  the  relevant  patient  profile.  

13.

Remove  the  D-­‐piece  between  tests  to  purge  sensor  with  fresh  air.  

14.

To  switch  off,  press  and  hold  the  power  button  for  3  seconds,  unit  will  also  power  off  after  2   minutes  of  inactivity  to  save  power.    

 

Converting  %COHb  to  %FCOHb  –  

Refer to the included Maternity Chart to convert the pregant mother's %COHb to

%FCOHb.

   

Reviewing  history  

 

The  Micro

+ basic

™  will  record  every  reading  taken  in  its  history  up  to  150  readings,  to  access  this  press    

  and  then    the  history  will  then  be  shown.  

 

Changing  date  and  time  

Press    and  then    you  can  then  select  either  d-­‐m-­‐y  or  m-­‐d-­‐y  for  the  date  format  and  12h  or  

24h  for  the  time  format.  Dates  and  times  are  then  adjusted  by  selecting  the  number  you  wish  to  

  change  and  pressing   or    to  increase  and  decrease.  Press    to  save  your  settings.  

 

 

 

  3  

 

Traffic  Light  Pre-­‐set  Cut-­‐Off  Levels  

Traffic  light  col o r   Description  

 

Green  

Amber  

1  Red  

2  Red  

3  Red  

3  Red  Flashing  

Non-­‐Smoker  

Borderline  

Reading  (ppm)

0-­‐6  

7-­‐9  

Smoker  –  Low  addicted   10-­‐15  

Smoker  –  Moderately  addicted   16-­‐25  

Smoker  –  Heavily  addicted   26-­‐35  

Smoker  –  Very  heavy  addicted   36+  

Pregnant Smokers

Reading (ppm)*

0-3

4-6

7-10

11-15

16-25

26+

 

To adjust the pre-set cut off levels, press from the settings menu and drag the cut off levels up

      and down to the desired ppm level. These settings will remain until adjusted again.

Technical  Specification  

 

Concentration  Range  (CO)  

Display  

Detection  Principle  

Repeatability  

H

2

 Cross  Interference    

Power  

3  x  AA  (LR6  or  Equivalent)  

Approx.  3  x  AA  Battery  Life    

Micro+ ™ basic  

0-­‐ 15 0ppm  

Full  colo r  touchscreen  

Electrochemical  sensor  

<±5% on consecutive readings

Approx.  1  x  CR2032  Battery  Life  

T

90  

Response  Time    

Operating  Temperature  Range  

Operating/Transport/Storage  Pressure  

Operating  Humidity  

Sensor  Operating  Life  

Sensor  Sensitivity  

Sensor  Drift  

Dimensions  

Weight  

Monitor  Construction  

1  x  CR2032  Lithium  coin  cell  

1,000  uses  on  new  alkaline  batteries  (approx.  

3  min  per  use)  

175,000  hours    

≤30  seconds  

15 -­‐40°C  (storage  0-­‐50°C)  

800-­‐1200mbar  

1 5 -­‐90%non-­‐condensing  (storage  0-­‐95%)  

5  years  –  5  year  warranty  

1ppm  

<5%  per  annum  

Approx.  34  x  75  x  140  mm  

Approx.  200g  (including  batteries)  

Case:  Polycarbonate/ABS  blend  

SteriTouch  anti-­‐Microbial  additive  

D-­‐Piece:  Polypropylene  

 

Safety  Information  and  Device  Symbols  

Degree  of  protection  against  electric  shock  

Type  of  protection  against  electric  shock  

Degree  of  protection  against  ingress  of  liquid  

Degree  of  safety  application  in  the  presence  of  a   flammable  anaesthetic  mixture  with  air,  oxygen   or  nitrous  oxide  

Refer  to  Manual    

Type  BF  applied  part  

Internally  powered  equipment  

IPXO  -­‐  not  protected  against  water  ingress  

Equipment  not  suitable  for  use  in  the   presence  of  flammable  mixtures.  

 

Direct  Current  

CE  Mark    

 

 

 

  4  

 

Type  BF  applied  part  

Dispose  of  according  to  WEEE  

 

 

Serial  Number  

 

Manufacture  by  and  Date  

 

Bedfont  Logo  

 

 

Environment  

 

The   Micro

+ basic

™   Smokerlyzer®   complies   with   the   directive   EN60601-­‐1-­‐2   electromagnetic   compatibility   but   can   be   affected   by   cellular   phones   and   by   electromagnetic   interference  exceeding  the  levels  specified  in  EN50082:1.  This  equipment  should  be  moved  if  n

  eces sary  to  avoid  interference.  

Instrument  Layout  

 

1.

Display  

2.

Power  button  

3.

Breath  sampling  D-­‐Piece™  

4.

D-­‐Piece™  aperture  

5.

Exhaust  port  for  breath  sample  

6.

USB  connector  (for  use  with  COdata  Software)  

7.

Single-­‐use  SteriBreath™  mouthpiece  

8.

Battery  compartment    

9.

Battery  compartment  clip  

10.

Reset  button  

 

 

 

5  

 

Display  and  Device  Symbols  

Description  

Battery  condition:  Full  

Battery  condition:  Low  

Battery  condition:  Empty  

Breath  Test    

Environmental  Test  

Settings  

Patient  Profiles  

View  patient  results  

Inhale  

Hold  Breath  

Countdown  Timer  

Exhale   ppm  Reading    

%COHb  Reading  

Show  %fCOHb  

%fCOHb  Reading  

 

 

 

Micro+ basic ™  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6  

Description  

Ambient  CO  reading  

Home    

Change  D-­‐Piece  

Change  Traffic  Light  Cut-­‐off  Levels  

Save  

Change  Breath  Hold  Time  

History  

Mute  

Change  date/time  

Next  Step  

Countdown  to  Sensor  Change  

Change  Sensor  

 

 

Calibrate  Device  

Attach  Flow  Meter  to  Gas    

Canister  

 

 

 

 

Micro+ basic ™  

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7  

 

 

Description  

Attach  Calibration  Adaptor  to  D-­‐Piece  

Micro+ basic ™  

 

Attach  D-­‐Piece  to  monitor  and  Turn   on  Gas  Flow  

Unit  Calibrating  

Calibration  Successful  

Calibration  Failed  

Retry  Calibration  

Firmware  Version  

6  Month  Calibration  Reminder  

 

 

 

 

 

 

 

 

N/A  =  Not  Available  on  this  device  

 

Warnings  and  Maintenance  

1.

Mouthpieces  should  be  replaced  after  every  use.    

2.

Hands  should  be  washed  regularly  in  accordance  with  infection  control  practice.    

3.

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   and   may   compromise  the  safety  of  the  device.    

4.

Bedfont  will  make  available  upon  request  service  training  to  appropriately  qualified  persons.  

5.

Holding  the  reset  button  down  for  30  seconds  will  perform  complete  device  reset,   this  will  

 

 

 

Cleaning   clear  any  saved  data  and  revert  all  settings  to  the  factory  defaults .  After  performing  a  reset   the  device  will  need  to  have  the  date/time  set  and  be  calibrated  before  it  can  be  used.    

1.

The  Smokerlyzer®  products  are  moulded  with  SteriTouch®  technology  for  optimum  infection   control  and  bacterial  efficacy.  However  Bedfont  recommend  wiping  the  instrument  and  D-­‐ piece   external   surfaces   with   a   product   specifically   developed   for   this   purpose.   Bedfont   provides  instrument  cleaning  wipes.  The  D-­‐Piece  cannot  be  sterilised.  

2.

NEVER   use   alcohol   or   cleaning   agents   containing   alcohol   or   other   organic   solvents   as   long   term  exposure  to  these  vapours  will  damage  the  CO  sensor  inside.    

3.

Under   no   circumstances   should   the   instrument   be   immersed   in   liquid   or   splashed   with   liquid.  

 

 

  8  

 

 

 

Routine  Maintenance  

1.

Replace  batteries  when  indicated  by  the  empty  symbol   .    

2.

Bedfont   recommend   removal   of   the   batteries   when   the   device   is   not   used   for   prolonged   periods  of  time  to  prevent  leakage.  

3.

Replace   breath   sampling   D-­‐piece   every   30   days   or   if   visibly   soiled   or   contaminated.   The  

Micro

+ basic

™   Smokerlyzer®   will   give   a   reminder   during   start-­‐up   when   the   D-­‐piece   should   be   replaced,  see  ‘Change  D-­‐Piece’  symbol.  

4.

The  sensor  should  be  replaced  every  5  years,  60  days  prior  to  the  sensor  change  ‘Countdown   to   sensor   change’   symbol   will   be   shown   with   the   date   on   which   the   sensor   should   be   changed.  This  can  be  ignored  by  pressing    until  the  date  at  which  the  sensor  should  be   changed   arrives,   at   this   point   the   ‘Change   Sensor’   symbol   will   be   shown.   Change   sensor   if   trained  to  by  an  approved  Bedfont  engineer  or  send  to  Bedfont  or  the  local  representative.  

5.

Additional  technical  information  can  be  made  available  on  request;  please  contact  Bedfont   or  its  distributor.  

6.

The   Micro

+ basic

™   Smokerlyzer®   requires   calibration   every   6   months   this   will   be   indicated   by   press  the  

 

Troubleshooting  

 and  follow  instructions  to  calibrate  the  device  or  press    to  ignore.  

 

The  unit  fails  to  turn  on:  

If  the  unit  fails  to  turn  on,  replace  the  batteries.  Ensure  that  the  batteries  are  inserted  the  correct   way  around,  matching  the  symbols  moulded  into  the  plastic.  

 

 

High  readings  recorded  for  reported  non-­‐smoker:  

If   a   breath   test   on   a   non-­‐smoker   gives   an   indication   of   CO   being   present,   it   may   indicate   the   following:  

1.

A  high  ambient  level  of  CO  (possibly  due  to  a  faulty  combustion  appliance  or  exhaust  fumes).  

2.

The  effects  of  passive  smoking.  

3.

The  device  is  contaminated  by  alcohol  or  another  organic  substance.  

4.

The  patient  may  have  a  very  high  level  of  hydrogen  on  their  breath,  which  can  be  generated   in  the  human  digestive  system.  

5.

The  sensor  may  have  drifted  out  of  specification  (see  below).  

 

The  sensor  has  drifted  out  of  specification:  

Smokerlyzer®   products   are   calibrated   before   leaving   coVita ,   however   we   recommend   if   you   suspect   the   instrument   is   reading   incorrectly,   try   the   test   again   with   another   device   if   available   to  get   a   comparison.   Alternatively   you   check   the   function   using   coVita   check   gas   or   send   back   to   coVita .  The  check  gas  required  is   coVita  20ppm  carbon  monoxide  in  air,  procedure  below.  

   

1.

Ensure  the  fine  control  valve  is  in  the  off  position.    

 

2.

Screw  the  fine  control  valve  and  flow  indicator  assembly  to  the  gas  can.  This  is  best  done  by   screwing  the  gas  can  into  the  valve.    

3.

Press  ‘Breath  Test’  symbol  on  screen,   or ,  to  start  a  breath  test.    

 

  9  

 

 

4.

When   prompted   by   the   ‘Exhale’   symbol,   or regulator  and  allow  the  gas  to  flow  at  1  litre  per  minute.  

,   open   the   fine   control   valve   or  

 

5.

Allow  the  gas  to  flow  through  the  instrument  for  the  duration  of  the  test,  again  monitoring   the  rate  of  flow.    

6.

If   the   final   displayed   value   is   less   than   18ppm   or   higher   than   22ppm,   stop   the   test   and   perform  a  calibration  or  send  back  to   coVita  for  a n evaluation.

 

Calibration  Procedure  

1.

Tu r n o n t h e m o n ti o r b y p r e s s i n g t h e p o w e r b u t t o n o n c e

2.

Press

3.

4.

St ar t t h e pr oc e e d c al i b r at i o n p r o c es s , p r e s s i ng th e sy m b o l 5 it m e s an d t h en onc e to

If t h e t e m p e r a t u r e o f t h e m o n it o r is t o o lo w t o c a lib r a t e , t h e b lu e t h e r m o m e t e r w ill b e

5.

sh o w n co n t a ct B e d f o

.

n

Tr y t ® ag o ai n

r yo u r l at e l o ca

r o n c e

l su p p t h e u n i il e r .

t h as w ar m e d u p – if t h is p r o b le m p e r s is t s p le a

If t h e t e m p e r a t u r e o f t h e m o n it o r is t o o h ig h t o c a lib r a t e , t h e r e d t h e r m o m e t e r w ill b e s e sh o w n . T r y a g a in la t e r o n c e t h e u n it h a s c o o le d dow n – if t h is p r o b le m p e r s is t s p le a s e co n t a ct B e d f o n t ® o r yo u r l o ca l su p p il e r .

6.

Once this has been successfully carried out the device will perform a zero; do not apply gas

7.

at this stage

Th e f ri s t st e p o f t h e ca il b r a it o n p r o ce ss w li l b e sh o w n o n scr e e n ; in s t r u c t io n s t o f in is h t h e c a lib r a t io n p r o c e s s f ol l ow th e o n s c re e n

8.

Gas flow should be set to 1.0 litres per minute

9.

A successful calibration will be indicated by the , press to return to the home screen

10.

A failed calibration will be indicated by , press to attempt calibration again – if the problem persists see ‘troubleshooting’ or call your local supplier of Bedfont® products

11.

Return to the home screen by pressing

 

 

COdata

+

™  Software  –  connecting  to  the  PC  

 

Place  one  end  of  the  connection  lead  into  the  USB  socket  on  the  top  of  the  Smokerlyzer®  product,   connecting  the  other  end  to  the  USB  port  on  the  PC.  Before  starting  the  software,  ensure  that  the  

Smokerlyzer®   product   is   connected   to   the   PC   and   switched   on.   Double   click   the   COdata

+

™   icon   on   the  PC  to  start  the  programme.  Refer  to  the  supplied  documentation  for  how  to  operate  COdata

+

™.    

 

 

  10  

 

 

 

 

Returns  Procedure  

If  your  equipment  requires  servicing,  please  contact   coVita  Customer  Service

Department,  before  ret urning  any  goods.    

1.

When  you  have  supplied  the  Customer  Repairs  Department  with  the  monitor  serial  number   and   description   of   the   fault,   you   will   be   issued   with   a   returns/   ticket   number.   Please   state   the   returns/ticket   number   on   the   outside   of   the   box   when   returning   the   monitor,   and   ensure  that  your  full  details,  telephone,  fax  numbers  and  return  address  are  clearly  stated.    

2.

The   product   must   also   be   decontaminated   before   it   is   returned   according   to   your   local   regulations.  Bedfont  can  provide  you  with  a  decontamination  certificate  to  complete,  which   also  needs  to  be  attached  to  the  outside  of  the  box.  Failure  to  do  so  will  result  in  the  product   being  subject  to  Bedfont  decontamination  procedure  and  will  delay  your  service/repair.  

3.

coVita  advise  that  you  use  a  courier  service  when  returning  monitors.  This  enables  you  to   insure  goods  for  loss  or  damage  in  transit.  When  your  goods  are  received,  you  will  be  se nt   an  email  stating  so.    

4.

If  the  device  has  been  returned  for  repair  it  will  then  be  examined  and  you  will  be  sent  an  

‘Engineer’s  Report’  and  a  quotation  for  the  repair,  which  will  include  an  authorisation  form.  

Complete  the  authorisation  form,  and  ensure  that  you  include  the  ‘Official  Purchase  Order  

Number’.   Please   contact   the   Customer   Repairs   Department   if   you   are   unable   to   supply   an  

‘Official  Purchase  Order  Number’.  

5.

If   your   monitor   is   still   in   warranty   and   the   fault   is   covered   by   warranty,   see  ‘Warranty’  section  of  this  manual,   coVita  will  repair  it  and  return  it  to  you  with  an  ‘En ginee r’s  Report’,   free  of  charge plus shipping and handling.

.    

6.

If  you  choose  not  to  proceed  with  the  repair,  a  handling  fee  will  be  charged.  Ensure  that  you   return  the  completed  authori z ation  form  with  an  ‘Official  Purchase  Order  Number’.    

7.

The   equipment   will   be   returned   to   you   as   soon   as   coVita   has   received   all   relevant   paperwork.  A  carriage  fee  will  be  charged  if  the  monitor  is  no  longer  in  warranty.  

 

Spares  

D-­‐PIECE Box  of  12  D-­‐Pieces  (non-­‐sterile)  

STERIBREATH   Bo x  of  250  SteriBreath  Mouthpieces  (non-­‐sterile)  

WIPE S   Pack  of  50  Cleaning  Wipes    

USB-3F

 

Warranty  

USB  Cable  

  coVita warrants   the   Micro

+ ba sic

™   Smokerlyzer®   (excluding   batteries)   to   be   free   of   defects  in  materials  and  workmanship  for  a  period  of  five  years  from  the  date  of  shipment.   coVita ’s  sole  obligation  under  this  warranty  is  limited  to  repairing  or  replacing,  at  its  choice,   any   item  covered  under  this  warranty when  such  an  item  is  returned,  intact  and  prepaid,   to   coVita .   These   warranties   are   automatically   invalidated   if   the   products   are   repaired;   altered,   void   labels   removed   or   otherwise   tampered   with   by   unauthorised   personnel,   or   have  been  subject  to  misuse,  neglect  or  accident.  

Never   dispose   of   any   electronic   instrument   or   batteries   in   domestic   waste.   At   the   end   of   the   product’s  life,  contact   coVita for   trade in credit and/or disposal  instructions.  

 

  11  

www.covita.net | (800)707-5751

Scientific contributions to health.

coVita

212 Cottage Grove Ave Suite C.

Santa Barbara, CA 93101

Tel:

(800) 707-5751

Fax: (800) 721-2377

Email: [email protected]

www.covita.net

© Bedfont Scientific Limited 2012

Issue 3 - March 201 7 , Part No: LAB679_USA

Bedfont Scientific Limited reserves the right to change or update this literature without prior notice.

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