3100B HFOV Operator Manual - CareFusion

3100B HFOV
iii
Revision History
Date Revision Changes
January 1993 A Initial Release
January 1996 B Revisions to meet FDA requirements and 3100B device specification
changes
May 1998 C Performance graphs updated. Performance check procedure updated.
Piston Centering instructions removed. WARNING concerning use in > 28
degrees C added.
October 1998 D Updated addresses & phone numbers. Updated indications for use &
adverse effects. Cautions updated. Added CE mark info. Paw control valve
changed to Pa adjust control valve. Updated treatment strategies. Updated
bias flow, frequency, % inspiratory time and oscillatory pressure amplitude
strategies. Added to non-invasive gas monitoring recommendations.
Updated disease specific variations to general clinical strategies. Updated
suctioning guidelines.
September 1999 E Changed page numbering system. Modified alarm levels adjustment.
Modified Patient Circuit Cal label and instructions. Modified Ventilator
Performance Checks label and instructions. Corrected Mean Pressure
Limit specifications. Removed block diagram. Removed mean pressure
limit instructions. Modified Oscillator subsystems airflow specifications.
Modified WARNING alarms instructions. “Set Max Pa” instructions
updated. Added driver diaphragm lubrication instructions.
January 2001 F Phone numbers corrected. Modified indications for use (removed last
sentence). Modified patient circuit warning. Replaced patient circuit cal.
Label. Updated driver replacement record label. Changed mean pressure
limit to “automatic”. Changed driver replacement hours to 1,500. Updated
figures. Added figure 2.5. Modified figure 3.2. Changed oscillator system
operational life to read “more than 1,00 hours. Changed the lpm values in
chapters 3 and 4. Changed the Warning alarm description. Added low bias
flow note. Modified safety alarms description. Modified figure 4.1.
Removed the words “piston centering” from Mean Pressure Adjust section.
Modified the % Inspiratory Control statement. Modified figure 4.2.
Updated descriptions of “Water Trap Drain Valve” and Hold Down Strap”.
Updated figure 5.3. Updated “start-up” procedure. Changed Maintenance
period to 1,5000 hours. Updated Visual/Audible Alarm table. Updated part
numbers. Updated maintenance procedures for Water Trap, Patient Circuit
and Circuit Calibration. Modified Weaning recommendations.
June 2001 G In Clinical Guidelines Chapter, Changed “Treatment Strategies”,
“Frequency” and “Inspiratory Time” and moved “Mean and Range of
3100B Settings”. Modified “General aspects of Clinical Strategy”, added
“Oxygenation” and modified “Weaning” and Ventilation. Added “Summary
of MOAT II Clinical management Strategies” and “Summary of Weaning
Strategy” from MOAT II Clinical Trial. Removed “Summary of HFOV
Therapeutic Intervention and Rationale”. Modified “Adverse Effects”
September 2001 H Changed 2000 hour Driver Replacement to 1500 hours. Added COPD
and Asthma Caution and Aerosol Warning. Added Inspection of
Diaphragm for Cuts & Tears caution. Modified Indications for Use
statement. Added Chapter 2 Clinical study, re-numbered other chapters.
Simplified manual format to facilitate translation process.
March 2002 J Changed 1500 hour Driver Replacement label and instructions to 4000
hour. Modified list of supplies/replacements. Changed the cooling gas
airflow from 25 lpm to 28 lpm.
767164–101 Rev. R