March 5, 1990

Peter Mitchell, President
Vitalograph Medical Instrumentation
8347 Quivira Road
Lenexa, Kansas 66215

Dear Mr. Mitchell:

This is in response to your letters of August 4 to Jeff Spahn, Area Director of our Wichita, Kansas, office and of January 31 to Mr. Gail Brinkerhoff of my staff concerning clarification of some of the requirements relating to spirometry contained in Appendix D to standard 29 CFR 1910.1043 for cotton dust. Please accept our apology for the delay.

As you related, Section I.g. in Appendix D specifies that if a paper record is made, the paper speed must be at least 2 cm/sec. This provision pertains to volume sensing spirometers that do direct mechanical tracing of volume verses time curves on paper. For such spirometers, the paper speed establishes the scale for the axis for plotting the time. The provision does not apply for any other type of spirometer where the paper speed does have any effect on the scale used to plot time for a volume versus time curve.

Section I.j. in Appendix D pertains to field checking of the calibration of spirometers. The volume calibration source should provide a volume displacement of at least 2 liters and should be accurate to within plus or minus 30 milliliters. We agree that the Vitalograph 1-liter Precision Syringe satisfies the displacement requirement if two successive injections are made.

Appendix D contains minimum requirements for spirometry. Employers may follow any American Thoracic Society (ATS) guidelines that are the same as or exceed these requirements.

I appreciate the opportunity to clarify these issues for you. Please contact me if you have further questions.

Sincerely,

Patricia K. Clark,
Director Designate
Directorate of Compliance Programs




October 17, 1989

MEMORANDUM FOR:   THOMAS SHEPICH, DIRECTOR
                  DIRECTORATE OF COMPLIANCE PROGRAMS

FROM:             LEO  CAREY, DIRECTOR OFFICE OF FIELD PROGRAMS

SUBJECT:          Regional Request for Interpretation - Appendix D of 29
                  CFR 1910.1043

Thank you

Attachments



September 13, 1989

MEMORANDUM FOR:   Leo Carey, Director
                 Office of Field Programs

FROM:             Stephen J. Mallinger
                 Acting Regional Administrator

SUBJECT:          Acceptability of Alternative Pulmonary Function Testing Method;
                 29 CFR 1910.1043, Appendix D of the Cotton Dust Standard

Mr. Peter Mitchell, President
Vitalograph Inc.
8347 Quivira Road
Lenexa, Kansas 66215

Dear Mr. Mitchell,

This is in response to your letter of August 4, 1989 to Jeff Spahn, Area Director of the Wichita, KS, Area Office. In your letter you requested clarification as to the acceptability of an alternative pulmonary function testing method to the requirements stated in Appendix D of 29 CFR 1910.1043 of the Cotton Dust Standard. Since the standard permits testing methods which can be shown to be superior, your request will be forwarded to our National Office for their determination. You can expect a direct written response from them. If I may be of further assistance to you on this matter, please do not hesitate to contact me at (816) 426-5861. We appreciate your concern in the area of Occupational Safety and Health.

Sincerely,

Janice P. Barrier ARA/TS



August 10, 1989

MEMORANDUM FOR:   JEFF SPAHN, Acting RA

ATTN:             ARA/TS

MEMORANDUM FROM:  OSCAR J. KWITEROVICH,
                 Acting AD

SUBJECT:          Clarification of OSHA's Standards on Spirometers

Since the person requesting the interpretation is president of a leading manufacturer of spirometers, we find your input is necessary.

Attachment:



August 4, 1989

Mr. Jeff Spahn
216 N. Waco Suite B
Wichita, KS 67201

Dear Mr. Spahn,

I am writing to see if you can assist me in clarification on a number of points regarding the OSHA standards on Spirometry.

Vitalograph Inc. is one of the leading manufacturers of volumetric and flow sensing spirometers and we are based in Kansas.

The queries I require your ruling on are as follows:

1. CALIBRATION:

Your standards state, "the volume calibration source should provide a volume displacement of at least 2 liters and should be accurate to + or - 30 ml."

Vitalograph supplies two syringes. One is a 3 liter volume and the second is a 1 liter volume with a built in valve. This has the advantage of enabling the user to check linearity over the full measuring range at one liter intervals.

Therefore, by pushing in twice you can have a 2 liter calibration. Is this acceptable?

I enclose a brochure for your perusal

2. CLARIFICATION OF PAPER SPEED:

Paragraph "g" of the standards state "If a paper record is made it must have a paper speed of at least 2 cm/sec. and a volume sensitivity of at least 10.0 mm of chart per liter of volume.

Does this apply to only paper records as in our volumetric units (VITALOGRAPH) and a kymograph type system or does it also apply to strip recorders as used on flow sensing spirometers?

3. COTTON DUST STANDARDS:

In a recent communication with Dr. Kuchinski from Cincinnati, she stated that on NIOSH certification courses, they are now incorporating the ATS standards. It was her opinion that those directly covered by the Cotton Dust Standards could use the ATS standards as they were, in many cases more stringent than OSHA. However, she could not say how an inspector for OSHA might respond if the ATS standards were adopted.

I would be grateful of your ruling on this point.

I look forward to receiving your reply in order that we convey the correct information to our customers. If there is any further information you require, please do not hesitate to contact me.

Respectfully,

Peter Mitchell
President


(Attachment)



January 31, 1990

Mr. Gail Brinkerhoff
Dir./Compliance Programmer
OSHA/DOL.
Room 3469
200 Constitution Avenue NW
Washington, DC 20210

Dear Mr. Brinkerhoff,

I am writing in follow up to our telephone conversation of yesterday.

I enclose, as promised, details of our 1 litre syringe and also a copy of the ATS specs.

I also enclose a copy of a letter form Dr. Crappo regarding our Alpha spirometer.

If there is any further way I can be of assistance, please do not hesitate to contact me.

Yours sincerely,

Peter Mitchell
President


enclosure: syringe brochure ATS specs LDS letter



January 23, 1990

Peter Mitchell, President
Vitalograph Medical Instrumentation
8347 Quivira Road
Lenexa, KS 66215

Dear Mr. Mitchell:

The Vitalograph spirometer, model Alpha-1, utilizing computer software labeled "Snowbird Special 1" was tested in our laboratory on 24-27 November 1988. Both static and dynamic testing were performed. Static testing was performed using slow and rapid injections of a 3 liter syringe and the dynamic testing by injecting the 24 standard waveforms using our waveform simulator.

The results of that testing showed the Vitalograph Alpha-1 measured FVC, FEV, and FEF(25-75\) within the criteria recommended by the American Thoracic Society. The Alpha-1 measured each of these parameters correctly on all 24 standard waveforms.

Our testing of the Vitalograph Alpha-1 spirometer therefore indicates that it meets the ATS recommendations for accuracy.

Testing done at the LDS Hospital Pulmonary Laboratory measures spirometer performance against criteria published by the American Thoracic Society. It does not, however, imply any certification or recognition of performance by the ATS.

Sincerely yours,

Robert O. Crapo, M.D.
Medical Director Pulmonary Laboratory