AU659146B2

AU659146B2 - Breath analysis device

Info

Publication number: AU659146B2
Application number: AU16124/92A
Authority: AU
Inventors: Robert James Breakspere; Anthony Porter
Original assignee: Lion Analytics Pty Ltd
Current assignee: Individual
Priority date: 1989-04-03
Filing date: 1992-05-08
Publication date: 1995-05-11
Anticipated expiration: 2010-04-03
Also published as: AU1612492A

Description

ri 2 t*? i 659146 S F Ref: 210228

AUSTRALIA

PATENTS ACT 1990 COMPLETE SPECIFICATION FOR A STANDARD PATENT

ORIGINAL

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r rrt ~+tZL r Name and Address of Applicant: Lion Analytics Pty Ltd 2/10 Salisbury Road Castle Hill New South Wales 2154

AUSTRALIA

at Actual Inventor(s): Address for Service: Invention Title: Anthony Porter and Robert James Breakspere Spruson Ferguson, Patent Attorneys Level 33 St Martins Tower, 31 Market Street Sydney, New South Wales, 2000, Australia Breath Analysis Device t' I The following statement is a full description of this invention, including the best method of performing it known to me/us:r:i u- 4 5845/6 r| -2- The present invention relates to breath analysis devices, and in particular, to a breath analysis device which is capable of passive and direct sampling of an exhaled breath sample.

Police Departments conducting roadside screening of motorists in relation to S breath analysis are currently required by law to require mouthpiece sampling of the breath when requested by the police officers at a random breath testing station. This process involves the officer requesting that a sample of breath be given through a mouthpiece to an instrument, to which the police officer will take appropriate action according to the result. Currently all breath testing is conducted in this way and the Police Departments have a mammoth task in purchasing, distributing, and ultimately disposing of many thousands of mouthpieces each year.

One disadvantage with this is that as a mouthpiece is used for each random breath test, the cost of using such mouthpieces is unnecessary if the motorist has not been drinking or consumed any alcohol in the last few hours.

is The object of the present invention is to provide a breath analysis device which obviates the need to use a mouthpiece on all random breath testing occasions by using "passive" testing which does not require a mouthpiece.

According to one aspect of the present invention there is disclosed a dual breath test analysis device for testing and analysing an exhaled breath sample, said device comprising: a housing; a first test means located in said housing and adapted to enable a first mode of testing to be carried out which includes passive sampling and analysing of an exhaled first breath sample obtained without the use of a mouthpiece for producing a C C ce 25 measurement of said breath sample for determining if a breath alcohol measurement exceeds a predetermined level; and a second test means located in said housing and operable when said first breath sample exceeds said predetermined level, said second test means being configurable, C 5- with a mouthpiece apparatus connectable to said device, to enable a second mode of 73 -3testing to be carried out which includes a direct sampling and analysing of a subsequent breath sample exhaled into and through said mouthpiece apparatus, said second test means including a pressure transducer volumetric measurement system to ensure delivery of a prescribed volume of deep alveolar air from said subsequent breath sample and to generate an accurate measurement of breath alcohol level for persons having a first mode measurement exceeding the predetermined level.

In accordance with another aspect of the present invention there is disclosed a dual breath test analysis device comprising a housing; a first sampling means located in said housing for receiving a (first) exhaled breath without the use of a mouthpiece; a second sampling means located in said housing for receiving a (second) breath exhaled into and through a mouthpiece connectable to said housing; testing means connected to each of said sampling means and being operable in one of a first testing mode and a second testing mode; control means for configuring operation of said device initially in said first ,testing mode to utilize said first sampling means to determine if a breath alcohol level of said first breath exceeds a predetermined level and, if so, then to configure operation of said device in said second mode to prompt connection of said mouthpiece to said housing, to thereby permit said second sampling means to receive said second breath, from which said testing means can determine and display an accurate measurement of a breath alcohol level, said testing means comprising a fuel cell used in each of said K: 4l it modes for providing to said control means an indication of breath alcohol level in said C C breaths, anda volumetric measurement system disposed between said sampling means and said fuel cell for providing a measure of the breath volume exhaled during said i K second breath, said accurate measurement being determined when said volume exceeds a minimum value.

The use of the above eliminates the need to use a mouthpiece for those Smotorists who have not consumed alcohol in recent hours, whereas the remaining small percentage of motorists showing a positive alcohol presence during the passive testing mode will then go through a standard deliverance of a breath sample using a mouthpiece in the direct second mode.

One embodiment of the present invention will now be described with reference to the drawings in which: Fig. 1 is a perspective view of a hand held device of the preferred embodiment; Fig. 2 is a flow diagram of the operation of the device of the preferred embodiment; e oo o

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S 9 5 i 4' O 9 n a s i -4- Fig. 3 is a display table illustrating the different displays of the device of the preferred embodiment; and Fig. 4 is a block diagram of the invention.

The device 1 illustrated in Fig. 1 comprises a hand held housing 2 having a display 3, a push button 4, a sensor (not shown), a sample port 6 (shown in Fig. 4) and a fuel cell 48 (shown in Fig. 4) for testing alcohol content of the sampled breath.

The device 1 uses four AA cells and has automatic power shut-off after five minutes of inactivity. The device is capable of conducting at least 800 passive and direct breath tests on one set of batteries. The display 3 which is an alpha-numeric LCD read out has back lighting for night time use. A microprocessor 52 (shown in Fig. 4) automatically eliminates the read out at pre-programmed time.

The single push-button 4 is provided to select a number of operational modes through multiple actuation. The number of operational modes includes: A. Passive Testing B. Direct Testing with Low Volume Override C. Battery/Testing Life D. Diagnostic Check E. Print Data F. Auto Calibration Mode D, E, and F are supervisory only and provide for mode alterations using an external module.

~The microprocessor 52 shown in Fig. 4 also records both modes of breath testing. The passive test is recorded as either a pass or fail and if a direct test was i conducted after a fail was recorded, the direct test records specific details of date, time, S 25 breath alcohol content, and pass or fail.

a r The print data mode is used to download a stored information onto a printer via a RS232 port. Sufficient capacity is available for the results of two weeks of daily 'i roadside testing.

[N:\IIbccIOO244'SDB I The device is provided with a diagnostic check which provides for ease of servicing and setting up procedures for real time clock and checks of instruments operating parameters, exclusively only through the supervisory mode.

Another mode which requests a supervisory pass word in order to enter the mode of operation which concerns fine tuning of the instrument calibration is the automatic calibration mode. A known simulator solution is used and the instrument is calibrated by pressing the button to correct the span shown on the LCD. This mode provides a calibrator range of t30% and shows a "Out of Service" command if a service is required.

Fuel Cell Response Analysis The output voltage of a fuel cell of this type as a result of receiving a sample of oxidisable gas has been examined (Huck, 1969).

Examples of the response of a tyIpical cell to individual samples of ethyl and methyl alcohols are well documented. The equation that has been proposed is: Vo v(t) k2 [exp (-kit) exp (1) S-1 where kl reaction rate at the electrode (sec k2 discharge rate of the cell (sec and Vo maximum voltage achieved on open circuit.

The determination of kl and k2 by numerical analysis routines can be difficult and iterative procedures can prove to be unstable in functions of this form. However, the amplitude is not of primary interest and so if the following transformation is applied: i v(2t) the following expression is obtained: -6z(t) exp (-kit) exp (3) This function z(t) poses a relatively simple task for analysis. Examining the function at three time values, t, 2t, 4t, yields z(2t) and hence 1 1z(t) 2z(2t) z2(t)] (4) kl -log (4) t 2 The response of several fuel cells to samples of ethyl alcohol and for other alcohols including methyl, butane-l-ol, propane-l-ol was examined. The error in the value of kl obtained for these alcohols showed a trend suggesting a deviation from Equation to include higher orders of kl. However, values of z(t) with the range of alcohols studies showed excellent discrimination for values of t in a particular time range. This was the basis of a technique to show the presence of trace contaminants in a sample of ethyl alcohol.

The device also ensures the delivery of a prescribed amount of deep alveolar air using a pressure transducer volumetric measurement system 50 (shown in Fig. 4) i which ensures that a person delivers a minimum of 1.3 litres of breath when the 2I "instrument is in the direct sampling mode using mouthpiece 42 (shown in Fig. thus 1 enhancing the overall accuracy of the instrument. The microprocessor 52 is incorporated to provide multiple functions which include: t, a) Control of all modes; 2 t b) Actuate the dual pumping systems 46 (shown in Fig. 4); c) Indicate the conditions of operation; C C, d) Record data logging of daily testing; and e) Provide user information and assistance.

Operation of the preferred embodiment is described with reference to Fig. 2.

h ©i The dual breath analysis device is in a standby mode at step 202. In step 204, button 4 [IN\lbcc00244:SDB -7is pressed once to signal the microprocessor 52. Normally, operation proceeds to step 206 where the message "Please Wait" is displayed in display 3 during the power on cycle. However, if the batteries are low, execution continues from step 204 to step 208. In step 208, the message "Change Batteries" is output from microprocessor 52 to display 3. In step 210, the device goes to an auto power off state.

During normal operation, after step 206 is completed, execution continues at step 212 in which the message "Passive Test, Press To Sample" is displayed in display 3. In step 212, a check is made to determine if a single button push 214 or a duable button 248 occurs.

When a single button push 214 is input by button 4, execution continues at step 216. In step 214, a passive sample is taken. In step 216, the microprocessor 52 analyses the result obtained from fuel cell 48. When no alcohol is detected, execution continues at step 218 where the message "Pass" is displayed on display 3. Execution continues from step 218 back to step 212. Otherwise, if alcohol is detected in step .216, execution continues at step 220.

In step 220, the message "Alcohol Present, Set Mouth Piece" is displayed on display 3. At step 222 a check is made to determine if the test subject has supplied a large enough sample, i.e. has 1.3 litres alveolar respiration been measured using pressure transducer 50. When decision block 222 returns yes, execution continues at S 20 step 224. In step 224, the device automatically takes a direct sample and analyses the result. When step 224 returns yes, a message "Over Limit" and the percent blood alcohol content (BAC) is displayed on display 3. When step 224 returns no, the l message "Pass" and the percent BAC are displayed on display 3 in step 224.

S:I When a single button push is detected after either step 242 or 244, execution tl 45t' continues at step 212.

At step 212, when a double button push is detected at step 248, execution continues at step 250. In step 250, the message "Direct Testing, Set Mouth Piece" is displayed on display 3. Execution then continues at step 222. However, if a double [N:\lAibcc]OO244:SDB -8button push is detected after step 250, the back lighting is turned off as described below.

At step 222, if the test subject has not supplied enough of a sample, execution continues at step 226. In step 226, a check is made to determine if this is the subject's second re-test. When decision block 226 returns no, execution continues at step 222.

However, when decision block 225 returns yes, execution continues at step 228.

In step 228, the message "Manual Inject, Press To Sample" is displayed. The bar graph indicates the subjects air pressure. In step 230, a single button push is input to take a sample. In step 240, the sample is analysed. Depending upon the blood alcohol content determined in step 240, execution continues at step 242 or step 244, as described above.

When a double button push is detected in step 252, execution continues at step 254. In step 254, the message "Backlighting Off" is displayed on display 3. When a single button push 256 is detected, execution continues at step 258 in which the message "Backlighting On" is displayed. When a double button push is detected in step 262 execution continues at step 264. Similarly, when a double button push is detected in step 260 after step 254, execution continues at step 264. In step 264, a check is S"made to determine if a single push button has occurred to power off the device. When a single push button is detected in step 266, power to the device is turned off in step 20 270. However when a double button push is detected in step 268, execution continues at step 212.

Fig. 3 illustrates the messages displayed on display 3 during execution of the method described in Fig. 2. In block 302, the standby message "Lion Analytics Dual Screener" displayed in step 202 of Fig. 2. After a single button press 204 is input, S 25 when the batteries are low, the message "Change Batteries" is displayed as shown in block 304.

During non-invasive testing, the following messages are displayed. Block 306 contains the message "Passive Test, Press To Sample" which is displayed in step 212.

Blocks 308, 310 and 312 indicate the messages "Sampling Inject: and the sample 0 N:AIibccJOO244SDB -9number that are displayed on display 3 when each sample is taken in step 214. Block 314 displays the message "Analysing Sample, Please Wait" which is displayed in step 216. If the sample does not contain alcohol, the message "Pass" shown in block 315 is displayed in step 318. The messages "Alcohol Present: Please Wait" displayed in blocks 316 and 318 are displayed in step 220 when the first and second passive testing for blood alcohol content in the first and second sample.

When a double button push is detected in step 248, the time, date, and the number of tests remaining are displayed in blocks 320 and 322. In block 324 the message "Direct Test, Set Mouthpiece" is displayed in step 250. When step 222 returns yes, the message "Volume 1300 ml" is displayed as shown in block 326.

However, if decision block 222 returns no, the message "Volume 0 ml, Retest" is displayed as shown in step 328.

In step 228, the message "Manual Inject, Press To Sample" shown in block 330 is displayed. When a single button push is detected in step 230, the message "Manual Inject" is displayed as shown in block 332. In step 224, the message "Volume 1300 ml, Stop Blowing" as shown in block 334 is displayed. In step 244, the message "Pass BAC 0.000 is displayed as shown in block 336. In step 242, the i? message "Analysing Sample, BAC 0.037 or "Over Limit, BAC 0.050 as shown in block 348 or 340, respectively, for example, can be shown.

20 Blocks 342 and 344 illustrate messages "Please Wait" and "Service Required", respectively, which may be displayed tu an operator.

After step 250, when a double button push is detected in step 252, the message "Backlighting Off" as shown in block 346 is displayed at step 254. After a single button push in step 256, message "Backlight On" is displayed as shown in block 348.

25 After the double button push in either step 260 or 262, the message "Press Once To Power Off" as shown in block 350 is displayed. Blocks 352-360 illustrate alternative messages, "Press Once To Start Print", "Printing", "Press Once To Clear Log", "Log Cleared", and "Please Download", respectively, which can be shown on display 3.

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EC rir; I The foregoing describes only one embodiment of the present invention, and modifications obvious to those skilled in the art can be made thereto without departing from the scope of the present invention.

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Claims

1. A dual breath test analysis device for testing and analysing an exhaled breath sample, said device comprising: a housing; a first test means located in said housing and adapted to enable a first mode of testing to be carried out wiich includes passive sampling and analysing of an exhaled first breath sample obtained without the use of a mouthpiece for producing a measurement of said breath sample for determining if a breath alcohol measurement exceeds a predetermined level; and a second test means located in said housing and operable when said first breath sample exceeds said predetermined level, said second test means being configurable, with a mouthpiece apparatus connectable to said device, to enable a second mode of testing to be carried out which includes a direct sampling and analysing of a subsequent breath sample exhaled into and through said mouthpiece apparatus, said second test means including a pressure transducer volumetric measurement system to ensure delivery of a prescribed volume of deep alveolar air from said subsequent breath sample 1 and to generate an accurate measurement of breath alcohol level for persons having a i i first mode measurement exceeding the predetermined level.

2. The device as claimed in claim 1 further comprising determining means connected to both said first and second test means for determining whether the result of the first mode of testing is recorded as either a pass or a fail, and enabling said second test means after a fail result whereby the second mode of testing is conducted.

3. The device as claimed in claim 1 or 2 wherein said second test means prompts a user of said device to connect said mouthpiece apparatus to said device to 25 permit said second mode of testing. i S c

4. The device as claimed in claim 3 wherein the delivered volume of deep alveolar air is a minimum of 1.3 litres, The device as claimed in ay one of the preceding claims and further T comprisin- a pumping system connected to a fuel cell to pump the prescribed volume of -0 l 1 -12- air into said fuel cell to measure the breath alcohol content of the volume deep alveolar air.

6. The device as claimed in any one of the preceding claims further comprising a microprocessor means connected to a memory means to provide both control and data logging.

7. The device as claimed in claim 6 wherein said microprocessor means comprises part of said first test means and said second test means.

8. A dual breath test analysis device substantially as herein described with reference to Figs. 1 to 3 of the drawings.

9. A method of dual breath analysis substantially as described with reference to Figs. 1 to 3 of the drawings. A dual breath test analysis device comprising a housing; a first sampling means located in said housing for receiving a (first) exhaled breath without the use of a mouthpiece; a second sampling means located in said housing for receiving a (second) breath exhaled into and through a mouthpiece connectable to said housing; V testing means connected to each of said sampling means and being operable in one of a first testing mode and a second testing mode; 20 control means for configuring operation of said device initially in said first testing mode to utilize said first sampling means to determine if a breath alcohol level of said first breath exceeds a predetermined level and, if so, then to configure operation C of said device in said second mode to prompt connection of said mouthpiece to said 1 housing, to thereby permit said second sampling means to receive said second breath, 4ke i 25 from which said testing means can determine and display an accurate measurement of-a- SY'" breath alcohol level, said testing means comprising a fuel cell used in each of said modes for providing to said control means an indication of breath alcohol level in said breaths, a~.tff volumetric measurement system disposed between said sampling means and said fuel cell for providing a measure of the breath volume exhaled during said 0 IFl e- IC~rr -13- second breath, said accurate measurement being determined when said volume exceeds a minimum value.

11. A device as claimed in claim 10, wherein said testing means further comprises a pumping system for supplying said first breath from said sampling means to said fuel cell during said first mode.

12. A device as claimed in any one of claims 10 or 11, further comprising user operable actuator button connected to said control means whereby a user can actuate said control means to configure said testing modes, said control means being connectable to a display for displaying results of said testing modes. DATED this Twenty-fourth Day of February 1995 Lion Analytics Pty Ltd Patent Attorneys for the Applicant SPRUSON FERGUSON cc cc it c C C C c C- C C it cc S t C t f I 1 ABSTRACT A dual breath analysis device having a passive first mode of testing and analysing an exhaled breath sample without the use of a mouthpiece, and a second mode of testing and analysing a second breath sample through a mouthpiece apparatus when the first mode of testing indicates a substantially high level of alcohol in the first breath sample. tt I b 4 o I 4 nas/28y «BI *1 nasI28y