**Operator\'s Manual**

![](media/image1.png){width="2.8in" height="0.7in"}767164

0601G

**Revision Changes Pages Date**

A Original Release All January 1993

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B Revisions to meet FDA requirements and All January 1996

3100B device specification changes

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C Performance Graphs updated 2.9--2.12 May 1998

Performance Check procedure updated 1.9, 6.5, 6.9

Piston Centering instructions removed 1.9, 2.3, 4.14, 4.15, 6.5,

6.7, 7.13-7.15, 8.2, 8.3

Warning re: use in environments \>28°C added 6.7

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D Addresses and phone numbers updated Ad.1 October 1998

Indications for Use and Adverse Effects updated 1.2

Precautions updated 1.4

CE Mark information added 2.7

Tech. Support phone numbers removed 7.9, 7.11

Pa Control Valve changed to Pa Adjust Control, Pa\
Adjust Valve changed to Pa Control Valve 7.16

Treatment Strategies updated 8.2

Bias Flow, Frequency, % Inspiratory Time, and Oscillatory\
Pressure Amplitude strategies updated 8.3, 8.4, 8.5, 8.6

General Aspects of Clinical Strategy updated 8.6, 8.7, 8.8

Disease-Specific Variations to General Clinical Strategies\
updated 8.10

Non Invasive Gas Monitoring\
recommendations updated 8.11

Suctioning Guidelines updated 8.13

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**Revision Changes Pages Date**

E Changed page numbering system All September 1999

Alarm levels readjust modified 5

Patient Circuit Calibration Procedure Label modified 7

Ventilator Performance Checks Label modified 8

Mean Pressure Limit specifications modified 13

Air Cooling Inlet Flow specifications modified 18, 52

3100B HFOV Block Diagram removed 25

Mean Pressure Limit instructions removed 27, 43, 68, 84, 86, 87

Oscillator Subsystem airflow specifications modified 35

Warning Alarms instructions modified 37, 45

Set Max Pa Alarm instructions modified 44

Patient Circuit Calibration instructions modified 66, 78

Ventilator Performance Check instructions modified 67, 68

Driver Diaphragm Lubrication procedure added 75

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F Corrected the company phone number vii January 2001

Indications of Use section---removed the last sentence 1

Changed the patient circuit warning 2

Replaced the Patient Circuit Calibration Procedure label 7

Updated the Driver Replacement Record Label 10

Changed the driver-replacement hours to 2000 10

Changed the Mean Pressure Limit to "Automatic" 13

Updated Figures 2.1 through Figure 2.4 20--23

Added Figure 2.5 24

Modified figure 3.2 (changed the Y axis from 50 to 60 cm) 31

Changed the oscillator system operational life to read\
"more than 2,000 hours" 32

Changed the LPM values in Section F 34

Changed the warning alarm description 37

Low bias flow rate note added 37

Changed the safety alarms description 37-38

Modified Figure 4.1 42

Removed "Piston Centering" from the fifth paragraph\
under Mean Pressure Adjustment 43

Changed the statement describing the affects of changing\
the "% Inspiratory Control" 45

**Revision Changes Pages Date**

F (cont.) Changed the warning alarm description 45 January 2001

Low Bias Flow Rates note added 46

Modified Figure 4.2 50

Changed the LPM value in item 27 of Chapter 4 52

Modified item 37 of Chapter 4 55

Modified item 42 of Chapter 4 56

Changed the patient circuit warning 61

Modified Figure 5.3 62

Changed the patient circuit warning 66

Changed step 6a of the "Start-up Procedures" 67

Changed steps 7b, 7c, 9, and 10 of the "Start-up Procedures" 68

Changed steps 13, 14, 16, and 17 of the\
"Start-up Procedures" 69

Changed steps 18 and 20 of the "Start-up Procedures" 70

Changed "Emptying the Water Trap" section 74

Changed "Changing the Patient Circuit" 76

Changed "Patient Circuit Calibration" 78

Changed "F. Scheduled Periodic Maintenance" to\
indicated "every 2,000 hours" of operation 82

Updated the "Visual/Audible Alarm Occurring" table 85

Changed the description of part number 771384-102 89

Changed the part number 463202 to 770566 and changed\
its description 90

Added part number 765298 90

Changed item 3 under "Weaning" 96

Removed the first paragraph of Section E 101

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G Changed the section "A. Treatment Strategies" 91 June 2001

Changed "Frequency" and "% Inspiratory Time" 92

Added the section "Mean and Range of 3100B Settings" 92

Changed "General Aspects of Clinical Strategy" 95

Added the section "Oxygenation" 95

Changed "Ventilation" and "Weaning" 96

Removed "Mean and Range of 3100B Settings" and added

"Summary of MOAT II Clinical Management Strategies" and

"Summary of Weaning Strategy from MOAT II Clinical Trial" 97

**Revision Changes Pages Date**

G (cont.) Removed "Summary of HFOV Therapeutic Intervention June 2001

and Rationale" 98

Changed "C. Adverse Effects" 99

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Manufacturer

SensorMedics Corporation

22705 Savi Ranch Parkway

Yorba Linda, California 92887-4645

Telephone: (800) 231 2466

\(714\) 283 2228

FAX: (714) 283 8493

Authorized European Representative

SensorMedics BV

Rembrandtlaan 1b

3723 BG Bilthoven

The Netherlands

Telephone: +31 (30) 2289711

FAX: +31 (30) 2286244

On the Internet at [www.sensormedics.com](../www.sensormedics.com).

Caution: Federal law restricts this device to sale by, or on the order
of a physician.

Caution: Not suitable for use in the presence of flammable anesthetics.

Service of this instrumentation is restricted to factory trained
personnel only.

1 Introduction 1

A. Indications for Use 1

B. Contraindications 1

C. Adverse Effects of the Device on Health 1

D. Warnings 1

E. Precautions 3

F. Explanation of Symbols 6

G. Exterior Labels 7

2 Specifications 13

A. Controls 13

B. Indicators 14

C. Pressure Measurement 15

D. Alarms 16

E. Electrical 17

F. Pneumatic Connections 18

G. Physical 19

H. Performance 20

3 Description of System and Safety Features 25

A. Introduction 25

B. External Air/O2 Blender 25

C. External Humidifier 25

D. Pneumatic Logic and Control 27

Bias Flow 27

Mean Pressure Adjust 27

Patient Circuit Calibration 27

E. Patient Circuit 28

F. Oscillator Subsystem 32

G. Airway Pressure Monitor 34

H. Electronic Control and Alarm Subsystem 35

I. Electrical Power Supply 36

J. Safety Features 37

4 Location and Function of Controls, Indicators, and Connections 41

A. Introduction 41

B. Front and Side Panel -- Control Package 42

C. Rear Panel -- Control Package 50

D. System Column and Patient Circuit 53

5 Assembly and Installation 57

A. Introduction 57

B. Unpacking 57

C. Assembly 57

D. Pre-use Cleaning and Disinfection 64

6 Operational Verification and Start-up Procedures 65

A. Introduction 65

B. Start-up Procedures 66

C. Performance Verification 71

7 Maintenance and Troubleshooting 73

A. Introduction 73

B. Exterior Cleaning 73

C. Operator Maintenance Procedures 73

Emptying the Water Trap 74

Changing the Compressed-gas Inlet Filter Cartridge Elements 74

Changing the Power Failure Alarm Battery 75

Cleaning the Column Lint Filter 76

Changing the Patient Circuit 76

Lubrication of the Driver Diaphragm 76

D. Patient Circuit Calibration 78

E. Other Scheduled Periodic Calibration 78

Control Package DC Power Supply 79

Airway Pressure Monitor Transducer 81

F. Scheduled Periodic Maintenance 82

G. Troubleshooting 82

Special Environmental Considerations 82

Electrostatic Discharge 82

Electromagnetic Interference 83

Troubleshooting Chart 84

H. Supplies and Replacement Parts 89

8 Clinical Guidelines 91

A. Treatment Strategies 91

Adjusting the 3100B's Controls to Execute the Treatment Strategies 91

Therapeutic Objectives 95

General Aspects of Clinical Strategy 95

Summary of MOAT II clinical management strategies 97

Summary of weaning strategy from MOAT II Clinical Trail 98

B. Disease-Specific Variations to General Clinical Strategies 98

Homogeneous Lung Disease Without Significant Air Leak 98

Non-Homogeneous Lung Disease, Air Leak Syndromes, and Airway Disease 98

C. Adverse Effects 99

D. Recommended Monitoring Frequency 100

Arterial Blood Gases 100

Non Invasive Blood Gases (tcO2, tcCO2, and SpO2) 100

Chest X-ray 100

E. Suctioning Guidelines 101

In Index 103

The SensorMedics 3100B is indicated for use in the ventilatory support
and treatment of selected patients 35 kilograms and greater with acute
respiratory failure

The SensorMedics 3100B Oscillatory Ventilator has no specific
contraindications.

In the adult ARDS prospective, non-randomized trial, adverse effects
identified were hypotension, and mucus plugging. Significant adverse
cardiovascular effects were rare in the 30 patients entered into the
study with only one patient exited from the study for hypotension. Only
one patient required re-intubation for narrowing of their endotracheal
tube by mucus encrustment.

In the pediatric randomized trial of the 3100A ventilator, adverse
effects identified were lung overdistention, air leak, and hypotension.
There were no statistical differences in any of the adverse effects as
compared to those reported in the conventionally treated patients with
the exception of hypotension. The HFOV treated group had few but
statistically significant more frequent incidences of hypotension
however, without evidence of serious compromise of cardiovascular
status.

High frequency ventilation, as with conventional positive pressure
ventilation, has inherent risks. These possible adverse effects include:
under/over ventilation, under/over humidification, chronic obstructive
lung disease, necrotizing tracheal bronchitis (NTB), atelectasis,
hypotension, pneumothorax, pneumopericardium, pneumomediastinum,
pneumoperitoneum, and pulmonary interstitial emphysema (PIE). The
reported frequency of these occurrences are similar to conventional
ventilation.

The following Warnings must be read and understood before an attempt is
made to operate the Model 3100B HFOV:

Do not attempt to defeat the proper connection of the ground wire as it
may cause damage to the device or interconnected equipment and could be
injurious to the patient or to those associated with the device use.
This device is factory equipped with a hospital-grade AC power plug.
Grounding reliability can only be assured when connected to a tested
receptacle labeled "Hospital Grade."

Do not operate radio transmitters within 20 feet of this instrument.
This may result in erroneous pressure readings leading to false alarms
and automatic shutdown.

Do not shorten the 30" bias flow tube provided with the patient circuit
as this may reduce the maximum ∆P by allowing the oscillatory pressures
to be attenuated by closer proximity to the volume of the humidifier
canister.

Do not attempt to substitute a circuit configuration from any other
instrument. Use of a non-3100A or a non-3100B circuit can result in
injury to the patient or to the operator, and it may cause damage to the
equipment. The Patient Circuit described in this manual is specifically
designed for patient use with the Model 3100B HFOV.

Only SensorMedics approved lubricants should be used. Use of any other
lubricants could result in damage to the Driver Diaphragm or Bellows
Water Trap Membrane causing ventilator failure or patient injury.

The operational verification and startup procedure (Chapter 6) must be
followed before ventilation of a patient commences. If at any time
during the operational verification and startup procedure any abnormal
function of the Model 3100B HFOV is noted, do not proceed with patient
ventilation as this could cause patient injury or death; immediately
contact SensorMedics Technical Support before proceeding any further.

An audible alarm indicates the existence of a condition potentially
harmful to the patient and should not go unattended. Failure to respond
to alarms could result in injury (including death) to the patient and/or
damage to the ventilator.

Ensure that the cooling fan at the rear of the driver enclosure is
operational.

Under no circumstances should the ventilator be used in the presence of
flammable anesthetics due to the possibility of explosion.

Under no circumstances should a proximal airway gas temperature of 41°C
be exceeded. This could result in injury to the patient\'s airway
membranes.

***Do Not*** use the 3100B ventilator in environments where the ambient
temperature is at or above 84°F (28°C). Use of the ventilator in these
environments will result in extreme reduction in relative humidity in
the patient's airway and possible desiccation of the patient airways.

Failure to comply with the recommended maintenance procedures described
in Chapter 7 could result in injury to the patient or operator or could
result in damage to the equipment.

The following Precautions must be read and understood before an attempt
is made to operate the Model 3100B HFOV:

Follow closely the recommendations contained in Chapter 8, Clinical
Guidelines, regarding the use of chest radiographs to monitor patient
condition. During HFOV, as with all ventilators, the relationship
between improvement in lung compliance, inadvertent increases in lung
volume, increased pleural pressure, and decreased venous return is a
matter of concern, since it may result in decreased cardiac output.

Patient size is an important guideline as to lung volume and anatomical
dead space, as well as the metabolic demand placed on ventilation. While
the maximum displacement volume of the 3100B is approximately 365 ml,
the actual volume delivered to the patient is dependent on power
setting, frequency, endotracheal tube size, and patient respiratory
system compliance. It is recommended that the operator review Section 8
of this manual, "Clinical Guidelines."

The patient\'s tcPCO2 and tcPO2 or SpO2 should be monitored continuously
to insure that blood gases are at the proper level. It is important that
an unrestricted and unobstructed patient airway be maintained during
HFOV. To insure a patent airway, always maintain proper suctioning
procedures as described in the Suctioning Guidelines Section of Chapter
8, Clinical Guidelines. Since only proximal airway pressure is measured,
no alarm will occur in the event of an obstruction or restriction.

Ensure that the stopcock is closed prior to performing a Patient Circuit
Calibration. If the Water Trap Stopcock is left open, Patient Circuit
Calibration (39-43 cmH2O) may not be achievable, and the deliverable Pa
will be reduced.

Deviation from the assembly methods described in Chapter 5, Assembly and
Installation, could damage the Model 3100B, render it mechanically
unstable, or cause it to malfunction. If any questions arise regarding
the assembly procedure, please contact SensorMedics Technical Support
immediately before proceeding.

Care should be taken not to crimp or perforate any of the control or
sensing lines (running to or from the Patient Circuit) during assembly,
operating or cleaning of the ventilator as this will cause malfunction
of the Safety Alarms, Warning Alarms, Caution Alarms, and/or Pressure
Limit Controls.

The driver diaphragm of the 3100B has been coated with a special
lubricant during assembly. Please do not clean the driver diaphragm with
cleaning solvents as it may degrade the materials causing premature wear
of the driver diaphragm.

When connecting the Patient Circuit, make certain that it is properly
supported and oriented by the support arm as described in Chapter 5,
Assembly and Installation. Failure to do so could result in inadvertent
Patient Circuit disconnection due to oscillatory forces or could result
in collection of humidifier condensate in the patient airway.

If the temperature probe is wiped with alcohol, allow the alcohol to
evaporate completely before inserting it into the circuit. A high
residual of alcohol can weaken the acrylic adapter and cause fracturing.

Proper operation of the ventilator must be verified prior to each use.
Refer to Chapter 6, Operational Verification and Startup Procedures. The
alarm functions tested in this procedure verify the capability of the
device to detect and indicate conditions which could have a harmful
effect on the patient.

Touch the outer metal cabinet of the instrument before touching any
other component to avoid possible instrument component damage from
Electrostatic Discharge.

When the ventilator is connected to a patient, it is imperative that
someone be in attendance at all times in order to react to any alarms
and to detect other indications of a problem.

The Inlet Filter Cartridges for the blended gas and the air inputs to
the ventilator must be changed at least every 500 hours of operation as
described in Chapter 7, Maintenance and Troubleshooting. Failure to
replace a Filter Cartridge or substitution of an unauthorized cartridge
could result in injury to the patient and/or damage to the equipment.
Use only SensorMedics Inlet Filter Cartridges.

The filter cartridge body must be screwed back on securely.
Cross-threaded or loose installation will result in leaks and possible
dislodging of the cartridge body. If the cartridge body is dislodged, it
will cause the ventilator to cease functioning.

The cover enclosing the Control Package, Column, or any other portion of
the ventilator must not be removed by the user. To avoid electrical
shock hazard, please refer all service requiring cover removal to a
qualified biomedical equipment service technician.

Recheck and readjust alarm levels after any parameter change has been
made.

Troubleshooting with the 3100B should be done "OFF PATIENT" to avoid any
potentially dangerous situations such as abrupt changes in the Pa.

Do not use extraneous ventilator circuit attachments (such as a suction
port) without a secondary external alarm capable of detecting ventilator
disconnection. Due to their inline pressure characteristics, such
attachments could possibly keep the Pa alarm from detecting an
accidental ventilator circuit disconnection.

Fractional concentration of inspired oxygen should be verified with an
oxygen monitor. Administration of excessive oxygen to a patient may be
harmful. It is imperative that the prescribed gas mixture is delivered
by the blending system.

The Water Trap must be drained at intervals as described in Chapter 7,
Maintenance and Troubleshooting. If the ventilator is operating, leave a
small amount of water at the bottom of the Water Trap container to act
as a flow and pressure seal between the ventilator and the output of the
drain.

To help prevent patient injury due to humidifier malfunction, the use of
a humidifier with the following characteristics is strongly recommended:

Thermally protected heater.

Alarms on over-filled water reservoir.

Alarms on under-filled water reservoir.

Alarms when electrically open or shorted temperature probe detected.

Alarms at probe temperatures \> 41°C.

Alarms when dislodged temperature probe detected.

Do not place on the Control Package of the ventilator any
fluid-containing accessories, accessories that weigh more than ten
pounds, or accessories that extend more than six inches above the
ventilator electronics package or beyond its sides. This could cause
damage to the ventilator, or could cause the ventilator to tip over,
resulting in patient or user injuries and/or damage to the equipment.

Do not overturn the Patient Circuit Calibration screw, as this may cause
damage to the device. When it is nearing its adjustment limit, it will
reach a mechanical stop.

Do not allow liquids to penetrate the air vents of the ventilator as
this may result in machine failure or malfunction.

Do not use a liquid sterilization agent on the outside of the ventilator
as this may cause damage.

The following symbols are used on this device:

![](media/image2.wmf) Circuit Breaker On

![](media/image3.wmf) Circuit Breaker Off

![](media/image4.wmf) Attention, Consult Accompanying Documents

![](media/image5.wmf) Alternating Current / Voltage

![](media/image6.wmf) Equipment of Type B

![](media/image7.wmf) Position Lock---clockwise rotation locks
instrument top. Counter-clockwise rotation unlocks instrument top,
allowing it to be swiveled for best view of front controls and displays.

This section identifies the labels attached to the exterior of the
3100B. All labels are shown at approximately their actual size. Your
system may not have all of the labels listed.

Figure 1.1. Patient Circuit Calibration Procedure Label.

The Patient Circuit Calibration Procedure Label describes the steps
necessary to calibrate the patient circuit to the 3100B. This procedure
is also explained in the Patient Circuit Calibration Section of Chapter
7, Maintenance and Troubleshooting.

![](media/image8.png){width="5.7972222222222225in" height="6.11875in"}

Figure 1.2. Ventilator Performance Checks Label.

The Ventilator Performance Checks Label assists in setting Power, Mean
Pressure Adjust, and Bias flow controls to achieve specific ranges of ∆P
and Pa. These procedures are explained in the Performance Verification
Section of Chapter 6, Operational Verification and Start-up Procedures.

![](media/image9.png){width="3.3097222222222222in"
height="4.104861111111111in"}

Figure 1.3. Blender/Cooling Gas Filter Replacement Record Label.

The Blender/Cooling Gas Filter Replacement Record Label provides a place
to document the 500 hour gas filter changes. For more information, see
the Operator Maintenance Procedures Section of Chapter 7, Maintenance
and Troubleshooting.

> ![](media/image10.png){width="2.902083333333333in"
> height="3.5256944444444445in"}

Figure 1.4. Driver Replacement Record Label.

The Driver Replacement Record Label provides a place to document the
2000 hour replacement of the Oscillator Subassembly. For more
information, see the Scheduled Periodic Maintenance Section of Chapter
7, Maintenance and Troubleshooting.

> **-- WARNING --**
>
> DO NOT OPERATE RADIO-TRANSMITTERS WITHIN 20 FEET OF THIS INSTRUMENT.
> THIS MAY RESULT IN ERRONEOUS PRESSURE READINGS LEADING TO FALSE ALARMS
> AND AUTOMATIC SHUT-DOWN.
>
> **-- SEE OPERATOR'S MANUAL --**

P/N 768559C

Figure 1.5. Radio Frequency Interference Warning Label.

The Radio Frequency Interference (RFI) Warning Label refers to the
possible problems caused by interference from hand-held radio
transmitters. The RFI warning is also discussed in the Troubleshooting
Section of Chapter 7, Maintenance and Troubleshooting.

![](media/image11.png){width="3.1694444444444443in"
height="1.7486111111111111in"}

Figure 1.6. Name Rating Label.

The Name Rating Label lists specific information on each individual
instrument: the Model Name and Number, the Voltage and Current Rating,
the Serial Number, and the instrument's Catalog Part Number. (The
example shown is for the 115V, 7.5A, 60Hz model; your instrument may
have a different rating.)

![](media/image12.png){width="0.7465277777777778in"
height="0.8284722222222223in"}

Figure 1.7. Battery Attachment Label.

The Battery Attachment Label indicates the correct position for the
installed Power Failure Alarm Battery. For directions on changing the
battery, see the Changing the Power Failure Alarm Battery Section of
Chapter 7, Maintenance and Troubleshooting.

![](media/image13.png){width="1.0618055555555554in"
height="0.5930555555555556in"}

Figure 1.8. Battery Specification Label.

The Battery Specification Label indicates the type of Power Failure
Alarm Battery (9V alkaline) that must be used. For directions on
changing the battery, see the Changing the Power Failure Alarm Battery
Section of Chapter 7, Maintenance and Troubleshooting.

0--60 liters per minute (LPM) Continuous, 15-turn control.

2.5 LPM.

±10% of full scale at the following conditions: air or oxygen @ 70°F and
760 Torr.

Approximately 3--55 cmH2O minimum range; Bias Flow dependent. (Refer to
Ventilator Performance Checks in Chapter 6.)

0.1 cmH2O on airway pressure digital meter, 1-turn control.

Non-calibrated control knob.

Automatic.

At 100% power, ∆P \>90 cmH20 max amplitude of proximal airway pressure.

Graduated 10-turn locking dial, not calibrated in % power.

3--15 Hz oscillator frequency.

0.1 Hz on digital meter, 10-turn control.

±5% of full scale.

30--50% of oscillatory cycle.

±1% as read on digital meter.

±5% of full scale.

Oscillator enable/disable.

0--59 cmH2O mean airway pressure.

1 cmH2O.

Within ±2 cmH20.

0--59 cmH2O mean airway pressure.

1 cmH2O.

Within ±2 cmH20.

Inhibits audible alarm function for 45 seconds (±5 seconds).

Resets Pa \>60 cmH2O and \<5 cmH2O alarms if condition has been
corrected; always resets power failure alarm. Resets Max Pa visual
alarm.

Adjusts maximum mean pressure that can be obtained with a specific
Patient Circuit (refer to Chapter 7 for setup procedure).

On/off.

Green LED (Light Emitting Diode) on Start/Stop pushbutton.

Red LED.

Yellow LED on pushbutton.

Red LED.

Red LED.

Red LED.

Red LED.

Red LED (Power Failure / Reset Pushbutton).

Yellow LED.

Yellow LED.

Yellow LED.

Digital meter readout of ∆P to the nearest cmH2O.

Digital meter readout of set % inspiratory time.

Digital meter readout of set oscillator frequency in Hertz.

Digital meter readout of mean airway pressure measurement to the nearest
tenth of a cmH2O.

Digital readout of hours of power applied to the Model 3100B HFOV to
nearest tenth of an hour.

Thumbwheel switch marked in cmH2O.

Thumbwheel switch marked in cmH2O.

3K-Hertz modulated tone.

Visual indication of AC power applied (I/0).

C. Pressure Measurement

--130 to +130 cmH2O airway pressure.

0.1 cmH2O.

Within ±2% of reading or ±2 cmH2O, whichever is greater, assuming
periodic calibration as described in Chapter 7.

20 psig.

Warning

Failure to comply with the recommended maintenance procedures for the
Airway Pressure Monitor as described in Chapter 7 could result in injury
to the patient or operator or could result in damage to the equipment.

Audible and visual indicators, machine intervention.

Indicators activated, oscillator stopped, and dump valve opened when
limit exceeded.

Preset.

±2% of pressure monitor reading or ±2 cmH2O, whichever is greater.

Indicators activated, oscillator stopped, and dump valve opened when
limit exceeded.

Preset to 5 cmH2O.

±2% of pressure monitor reading or ±2 cmH2O, whichever is greater.

Audible and visual indicators, operator intervention.

Indicators activated when set limit exceeded.

0--59 cmH2O.

1 cmH2O.

±2% of pressure monitor reading or ±2 cmH2O, whichever is greater.

Indicators activated when set limit exceeded.

0--59 cmH2O.

1 cmH2O.

±2% of pressure monitor reading or ±2 cmH2O, whichever is greater.

Visual alarm, operator intervention.

Indicator activated when oscillator coil reaches a temperature of 150°C.

±5%.

Indicator activated when battery which operates power failure alarm is
low and must be replaced.

Indicator activated when blended gas or oscillator air cooling source
pressure drops below 30 psig limit.

±5% in source gas mode.

Indicator Activated for 45 seconds when pushbutton pushed.

±5 seconds.

Audible and visual indicators activated when power switch turned off,
power plug unplugged, or insufficient supply voltage within the
electronics package.

Audible and visual indicators activated when patient's airway ∆P falls
below 5 to 7 cmH2O.

Warning

An audible alarm indicates the existence of a condition potentially
harmful to the patient and should not go unattended. Failure to respond
to alarms could result in injury (including death) to the patient and/or
damage to the ventilator.

115 VAC, 7.5A, 60 Hz\
100 VAC, 7.5A, 50 Hz\
220 VAC, 4.0A, 50 Hz\
240 VAC, 4.0A, 50 Hz.

\<100 Microamperes.

Dual electromagnetic circuit breaker.

3-wire grounded hospital-grade plug.

Designed to CSA C22.2 No.125 and UL‑544. Designed to IEC 601-1.

The 3100B Oscillatory Ventilator complies with the Medical Device
Directive, MDD 93/42/EEC, and is labeled with the CE Mark as shown
below.

![](media/image14.png)

Warning

Do not attempt to defeat the proper connection of the ground wire.
Improper grounding may cause damage to the device or interconnected
equipment and could be injurious to patient or to those associated with
the device use. This device is factory equipped with a hospital-grade AC
power plug. Grounding reliability can only be assured when connected to
a tested receptacle labeled "Hospital Grade."

F. Pneumatic Connections

DISS oxygen fitting.

40--60 psig.

60 LPM ±10%.

75 psig ±15% relief valve.

DISS air fitting.

40--60 psig.

25 LPM±10%

75 psig ±15% relief valve.

3/8\" barbed fitting.

5 psig ±15% relief valve.

Coded green, Luer bulkhead.

Coded blue, Luer bulkhead.

Coded red, Luer bulkhead.

Coded white, Luer bulkhead.

All materials used in the construction of the 3100B instrument and its
breathing circuit are non-toxic and pose no safety risk to the patient
or operator.

Height: 53.8\"\
Width: 18.6\"\
Depth: 11.4\"\
Weight: 143 lbs.

5 legs each with 4\" diameter locking wheels, 28\" width across bottom
of pedestal.

Precaution

Do not place on the control package of the ventilator any
fluid-containing accessories, accessories that weigh more than 10
pounds, or accessories that extend more than six inches above the
ventilator electronics package or beyond its sides. This could cause
damage to the ventilator, or could cause the ventilator to tip over,
resulting in patient or user injuries and/or damage to the equipment.

1\. Temperature: 5--28°C

2\. Humidity: 15%--95% (non-condensing)

3\. Certain specific environmental factors such as Electrostatic
Discharge (ESD) and Electromagnetic Interference (EMI) require special
consideration by the operator. For an in-depth discussion of these
factors, see the Troubleshooting section of Chapter 7, Maintenance and
Troubleshooting.

H. 3100B Performance Graphs

![](media/image15.wmf)

Figure 2.1

![](media/image16.png){width="4.697916666666667in"
height="5.458333333333333in"}

Figure 2.2

![](media/image17.png){width="4.864583333333333in"
height="6.2659722222222225in"}

Figure 2.3

![](media/image18.png){width="4.863888888888889in"
height="5.927083333333333in"}

Figure 2.4

![](media/image19.wmf)

Figure 2.5

The system consists of eight subsystems, six included as part of the
Model 3100B and two provided by the user:

1\. External Air/O2 Blender and Oxygen Monitor\
2. External Humidifier

3\. Pneumatic Logic and Control.\
4. Patient Circuit.\
5. Oscillator Subsystem.\
6. Airway Pressure Monitor.\
7. Electronic Control and Alarm Subsystem.\
8. Electrical Power Supply.

Both oxygen and air pressure sources are required as specified in
Chapter 2. These sources feed a user-provided Air/Oxygen Blender. The
air source also provides cooling to the Oscillator Subsystem by means of
a special pneumatic control system. The flow requirements for both the
blender and for the air cooling of the Oscillator Subsystem are
described in Chapter 2.

Precaution

Fractional concentration of inspired oxygen should be verified with an
oxygen monitor. Administration of excessive oxygen to a patient may be
harmful. It is imperative that the prescribed gas mixture is delivered
by the blending system.

It is the responsibility of the user to provide an Oxygen/Air Blender
and Oxygen Concentration Monitor. The blender shall be capable of 60
L/min flow. When used in conjunction, the accuracy shall be ± 3%.
Monitoring should be accomplished at an outlet of the blender in an
unpressurized state.

Although functioning in harmony with the Patient Circuit Subsystem, the
External Humidifier is treated as a separate subsystem because it is
provided by the user. The humidifier that is used must be a heated
humidifier specifically manufactured for pediatric/adult use. It must be
capable of covering a flow range up to 60 LPM. The temperature control
can be either closed or open loop; however, proximal airway gas
temperature must be monitored. Two ports for the temperature probe are
provided on the Patient Circuit. These will be discussed in the next
section.

Warning

Under no circumstances should a proximal airway gas temperature of 41°C
be exceeded. This could result in injury to the patient\'s airway
membranes.

Warning

***Do Not*** use the 3100B ventilator in environments where the ambient
temperature is at or above 84°F (28°C). Use of the ventilator in these
environments will result in extreme reduction in relative humidity in
the patient's airway and possible desiccation of the patient airways.

Precaution

To help prevent patient injury due to humidifier malfunction, the use of
a humidifier with the following characteristics is strongly recommended:

a\. Thermally protected heater.

b\. Alarms on overfilled water reservoir.

c\. Alarms on under filled water reservoir.

d\. Alarms when open or shorted temperature probe is detected.

e\. Alarms at probe temperatures \> 41°C.

f\. Alarms when dislodged temperature probe is detected.

The connection of the humidifier into the Model 3100B HFOV System will
be further described in Chapter 5, Assembly and Installation. Standard
humidifier adapters are required, and two are provided for connecting
the 3/8\" I.D. tubing to and from the humidifier.

The Blender feeds pressurized blended gas to the Model 3100B Pneumatic
Logic and Control Subsystem through an oxygen DISS fitting. Four
pneumatic controls are part of this subsystem:

This control sets the flow of the blended gas that continuously moves
past the patient airway.

This control adjusts the Mean pressure level on which the oscillatory
waveform is superimposed. This Mean pressure along with the oscillatory
waveform characteristics determines the resultant Pa. This control
determines the level of Patient Circuit expiratory limb Control Valve
restriction in the manner described in the Patient Circuit section
below.

This control is a screwdriver adjustment used to set the maximum mean
pressure that can be attained with a particular Patient Circuit under
specified conditions (see Chapter 7, Maintenance and Troubleshooting.)
This control is used only when the Patient Circuit is replaced or the Pa
control valve diaphragm of the existing Patient Circuit is changed. The
control is necessary because the individual elastic and dimensional
characteristics of the Pa control valve diaphragm interact with the
valve control line pressure to determine the control dial maximum
setting.

Precaution

Do not overturn the Patient Circuit Calibration as this may cause damage
to the device. When it is nearing its adjustment limit, it will reach a
mechanical stop.

The range, resolution, and accuracy of the pneumatic controls---and the
characteristics of the various pneumatic connections are described in
Chapter 2. Chapter 4 provides a detailed description of the functions
and use of each control.

Warning

Do not attempt to substitute another circuit configuration as this could
result in injury to the patient and/or the operator, or cause equipment
malfunction. The Patient Circuit described in this manual is
specifically designed for patient use with the Model 3100B HFOV.

The Patient Circuit combines the three elements necessary for
ventilation of the patient using HFOV techniques: bias flow/ Mean
pressure, pressure oscillations, and pressure limiting. The Patient
Circuit is illustrated in Figure 3.1.

![](media/image20.png){width="4.875694444444444in"
height="4.727777777777778in"}

Figure 3.1. Details of Patient Circuit.

During normal operation, humidified, blended bias gas flows into the
continuous flow line from the External Humidifier. This gas flows into
and through the inspiratory limb of the Patient Circuit, through the "Y"
coupler and then into the expiratory limb of the Patient Circuit. While
passing through the "Y" coupler, the fresh gas exchanges oxygen and
carbon dioxide at the ET tube/patient connection.

A proximal airway pressure sensing line made of 1/8\" Tygon tubing runs
from the "Y" coupler to the Airway Pressure Monitor via a white Luer
bulkhead fitting near the Patient Circuit connection. The pressure
signal is processed to determine various pressure measurements and alarm
conditions. The Airway Pressure Monitor and tubing are discussed in a
following section.

The expiratory limb carries the exchanged gas to the Pa Control Valve.
This valve allows two expiratory flow paths. One path is a variable
restriction controlled by the Pa Control Valve control line extending
from the Pneumatic Logic and Control Subsystem via a green Luer bulkhead
fitting near the Patient Circuit connection. The other flow path is a
fixed orifice that requires a minimum bias flow be maintained through
the Patient Circuit to ensure a flow of fresh Bias Gas regardless of the
setting of the Pa Control Valve.

When the Pa Control Valve is changed, it adjusts the mean airway
pressure at the ET tube/patient connection after about five system time
constants have elapsed, but only if the set bias flow and oscillator
characteristics remain unchanged for the same time period. Five time
constants will vary from about one second to as long as 30 seconds. This
time constant varies directly with Pa and inversely with bias flow.

The individual elastic and dimensional characteristics of the Pa Control
Valve diaphragm interact with the valve control line pressure to
determine the control dial maximum setting. The Patient Circuit
Calibration control provides a screwdriver adjustment to set the maximum
mean pressure that can be attained with a particular Patient Circuit
under specified conditions. This control is used only when the Patient
Circuit is replaced or the Pa control valve diaphragm of the existing
Patient Circuit is changed. Refer to Chapter 7, Maintenance and
Troubleshooting, for the complete setup procedure.

The Pressure Limit Valve limits the Pa. When an abnormal condition
exists or when the system mean pressure increases due to an inadvertent
or deliberate control setting change, this valve acts to limit the mean
proximal airway pressure.

Both the Pa Control Valve and the Pressure Limit Valve are mushroom
valves that must be replaced periodically according to the procedures in
Chapter 7, Maintenance and Troubleshooting.

The Dump Valve is activated by the Electronic and Pneumatic Control
Subsystems only when the safety alarms are activated. The safety alarms
are the following:

1\. Pa \> 60 cmH2O

2\. Pa \< 5 cmH2O

The Dump Valve, when activated, will open the entire Patient Circuit to
ambient air. It allows the patient the opportunity to breathe
spontaneously at normal atmospheric pressure when the safety alarms have
been activated. In an emergency situation, the Dump Valve helps to
prevent a decrease in cardiac output due to sustained elevated Patient
Circuit pressure or atelectasis due to a negative Patient Circuit
pressure.

The Dump Valve is a mushroom valve that must be replaced at intervals as
described in Chapter 7.

Two ports are provided for inserting the temperature probe of the
External Humidifier. One is near the patient "Y"; the other is near the
Pressure Limit Valve.

The inspiratory limb acts as the propagation means for the pressure
oscillations generated by the Oscillator Subsystem. A typical airway
pressure oscillatory waveform is illustrated in Figure 3.2.

![](media/image21.png){width="4.848611111111111in"
height="3.589583333333333in"}

Figure 3.2. Typical Oscillatory Proximal Airway Pressure Waveforms With
Dump Valve Activation.

This figure also illustrates the activation of the dump valve due to the
Pa being less than the \<5 cmH2O limit or greater than the 60cmH2O
limit.

To prevent accumulation of water from condensate within the Patient
Circuit and Oscillator Subsystems, a Water Trap drains them through the
Oscillator Compartment. Consult Chapter 7, Maintenance and
Troubleshooting, for details on use of Water Trap.

Precaution

The Water Trap must be drained at intervals as described in Chapter 7,
Maintenance and Troubleshooting.

The function of the controls discussed in the paragraphs above as well
as the function of the safety alarms are discussed further in Chapter 4,
Location and Function of Controls, Indicators, and Connections . The
assembly of the Patient Circuit onto its mounting arm and its connection
to the rest of the HFOV system is discussed in Chapter 5, Assembly and
Installation.

The components of the Oscillator Subsystem are illustrated in Figure
3.3. The design incorporates an electronic control circuit (square-wave
driver) which drives a linear motor which in turn drives a piston
assembly. It is very similar to a permanent magnet speaker.

![](media/image22.png){width="3.3826388888888888in"
height="4.477083333333334in"}

Figure 3.3. Details of Oscillator Subsystems.

One of the major features of the design is that there is no physical
contact between the permanent magnet and the electrical coil which is
suspended by "spiders" within the permanent magnet. This results in a
very efficient frictionless oscillator system with an operational life
of more than 2,000 hours.

When the square-wave driver is of positive polarity, it drives the
electrical coil and the attached piston forward in the direction of the
patient (inspiration). When the polarity is negative, it drives the
electrical coil and the attached piston in the opposite direction
(expiration).

The distance the piston is driven in each direction is determined by the
magnitude of the alternating polarity voltage applied to the electrical
coil, the Patient Circuit pressure encountered by the piston plate, the
piston coil counter-force current, and the frequency of the square wave.
The voltage of the square-wave driver output is controlled by the Power
Control of the Electronic Control and Alarm Subsystem.

There are two mechanical stops which determine the maximum piston
displacement in the full inspiration and full expiration directions. The
maximum stroke of the piston defined by these stops is approximately 365
milliliters.

The % inspiratory time is determined by another control on the
Electronic Control and Alarms Subsystem. This control sets the relative
duration of the successive positive and negative polarity voltages from
the square-wave driver, which is driving the electrical coil and piston.
This control also establishes the counter-force current to overcome the
tendency of the mean airway pressure to displace the piston off center.

As mentioned previously, the displacement of the electrical coil and
piston is determined by the magnitude of the voltage applied to the
electrical coil. The total transit time required for this displacement
is only a matter of milliseconds. Therefore, at the lower oscillation
frequencies, the piston will remain stationery at its full-travel
position for the majority of that particular respiration phase
(inspiratory or expiratory).

As the oscillation frequency increases, the transit time of the
electrical coil and piston to its set full displacement will become a
larger percentage of the total respiratory phase duration. Although
exactly determined by conditions within the Patient Circuit, as
frequency is increased the electrical coil and piston are unable to
complete full displacement before the square-wave driver switches
polarity requiring the travel direction to reverse. Thus, the
displacement amplitude of the oscillator piston will decrease as the
oscillation frequency is increased.

Refer to Chapter 2, Specifications, for details on the range,
resolution, and accuracy of the various control functions affecting the
Oscillator Subsystem. Refer to Chapter 4, Location and Function of
Controls, Indicators, and Connections, for a full description of the use
of these controls.

Because the major portion of the Oscillator Subsystem is a linear motor,
some type of cooling mechanism must be provided for the electrical coil.
The cooling source used in the Model 3100B is air flow obtained from a
standard 50 psig gas wall outlet. A regulator within the Oscillator
Subsystem meters the airflow to a Venturi-type air cooler at 25 LPM,
which then entrains room air at approximately 75 LPM, thus providing 100
LPM of cooling air around the electrical coil.

A thermal cutout circuit has been incorporated into the oscillator to
shut it down in case of overheating caused by a cooling system failure.
Such a failure, if allowed to occur without oscillator shutdown, could
result in the destruction of the oscillator coil\'s support spiders. The
thermal cutout system utilizes a thermistor on the oscillator coil form
to detect temperature rise. Thermal shutdown will occur if coil
temperature exceeds 175°C.

Prior to an oscillator thermal shutdown, the operator is given an
indication that the coil is overheating. A yellow caution LED on the
front panel of the Control Package lights when the coil temperature
reaches approximately 150°C.

The Airway Pressure Monitor is a very key subsystem within the Model
3100B HFOV system. The majority of the safety and warning alarms rely
upon the mean airway pressure determinations of the Airway Pressure
Monitor.

The Airway Pressure Monitor senses the pressure within the Patient
Circuit through 1/8\" tubing running from the "Y" coupler of the Patient
Circuit to the airway pressure monitor transducer. A 500 ml/min trickle
flow of dry gas from the blender flows constantly from the 3100B to the
patient "Y" to keep water vapor from even partially obstructing this
pressure sensing pathway.

Warning

Failure to comply with the recommended maintenance procedures for the
Airway Pressure Monitor as described in Chapter 7 could result in injury
to the patient or operator or could result in damage to the equipment.

The Airway Pressure Monitor processes the instantaneous airway pressure
measurements of its pressure transducer to derive the following:

1\. Mean airway pressure (Pa)

2\. Oscillatory peak minus oscillatory trough pressure (∆P)

Mean Airway Pressure is essentially an arithmetic mean of the airway
pressure measurement. It is obtained by filtering the instantaneous
pressure signal with a DC to 0.5 Hz. low pass filter.

The ∆P reading is obtained by subtracting the oscillatory trough
pressure from the peak pressure.

A detailed list of specifications for the Airway Pressure Monitor is
contained in Chapter 2. A detailed description of the use of its control
and display is contained in Chapter 4.

This subsystem contains the Oscillator Subsystem Controls and the alarm
functions. It consists of various electronic circuits and logic
elements. It integrates information received from the Airway Pressure
Monitor to react in a fashion safest for the patient. It utilizes this
information to orchestrate the activity of the Oscillator Subsystem and
the Pneumatic Logic and Control Subsystem.

The following are the Oscillator Subsystem controls which form a part of
the Electronic Control and Alarm Subsystem:

1\. Power

2\. % Inspiratory Time

3\. Frequency--Hz

4\. Start/Stop

The operation and use of these controls is described in detail in
Chapter 4.

The subsystem also contains the following indicators for reporting on
the Oscillator Subsystem status:

1\. Start/Stop LED

2\. ∆P digital meter

3\. % Inspiratory Time digital meter

4\. Frequency digital meter

The coordination of these indicators with the Oscillator Subsystem
controls is described in detail in Chapter 4.

The following alarm controls and indicators are part of this section:

1\. Max Pa exceeded thumb wheel and LED

2\. Min Pa exceeded thumb wheel and LED

3\. Pa \> 60 cmH2O LED

4\. Pa \< 5 cmH2O

5\. 45-Sec Silence pushbutton and LED

6\. Reset pushbutton

7\. Battery Low LED

8\. Source Gas Low LED

9\. Oscillator Overheated LED

10\. Oscillator Stopped LED

11\. Power Failure LED

The range, resolution, and accuracy of these alarm functions are
described in Chapter 2. A detailed description of the use of these
alarms, controls, and indicators follows in Chapter 4.

The function of the alarms is influenced by inputs from the Airway
Pressure Monitor, Oscillator Subsystem, and Pneumatic Logic and Control
Subsystem.

The Electrical Power Supply converts the AC line voltage to the DC
voltages required to power the Electronic Control and Alarms Subsystem,
the Airway Pressure Monitor, and the Oscillator Subsystem.

Detailed specifications are listed in Chapter 2. Maintenance procedures
are covered in Chapter 7.

The Model 3100B HFOV system has been designed with numerous safety
features both to help avoid patient injury and to protect the equipment
from damage. These safety features are incorporated into the design of
the various subsystems:

1\. Warning Alarms

2\. Safety Alarms

3\. Power Failure Alarm

4\. Oscillator Stopped Alarm

5\. Caution Alarms

6\. Oscillator thermal cutout

7\. Water trapping for condensate

8\. Pressure relief valves to protect the equipment from over-pressure
damage

9\. Oscillator startup logic to prevent application of excessively high
or low oscillatory pressures to patient

The Warning Alarms consist of the Max and Min Pa Exceeded settings and
indicators. In the event that the proximal pressure meets or exceeds the
set Max Pa alarm setting, an audible and visual alarm will occur, and
the ventilator will depressurize the Limit Valve seat pressure. Once the
mean airway pressure falls to a level of 12 (±3) cm H~2~O below the Set
Max Pa setting, the Limit Valve will re-pressurize to its normal
operational state. Should the high mean airway condition persist, the
alarm will repeat until the condition is resolved. Once corrected, the
high Pa visual indicator will remain lit to notify the clinician that
the alarm was violated. Depress the Reset / Power Failure button to
reset the visual indicator. Should the proximal pressure meet or fall
below the Min Pa setting an audible and visual alarm will occur which
will automatically reset after correction of the alarm condition. No
machine action is taken.

 Operating the ventilator with low Bias Flow Rates (\<15 Ipm) and Low
Mean Airway Pressures (\<15 cmH20), with full power (Maximum Amplitude)
may result in a low-pressure dump upon activation of the Max Pa Alarm.

The Safety Alarms consist of Pa \> 60 cmH20 and \< 5 cmH2O alarms. They
are indicated in the same manner as the Warning Alarms described above.
If either of these Pa alarms is activated, the oscillator is stopped
(bias flow continues) and the Dump Valve opens the Patient Circuit to
atmospheric pressure. Either of these alarms can be reset by pressing
the Reset Button once the cause of the alarm condition has been
corrected.

When the Power Failure Alarm is activated, no other machine actions are
taken other than the energizing of a red LED and a 3K-Hertz modulated
tone. The Power Failure Alarm is reset by pushing the Reset button
whether or not the alarm condition (removal of or inadequate power
supply to the Electronic Control and Alarms Subsystem) has been
corrected. To restart the oscillator it will then be necessary to press
the Start/Stop Switch. It is normal for the Battery Low LED to light
when the reset button is pressed.

The Caution Alarms activate a yellow LED only; no audible alarm occurs.
The Caution Alarms are the following: Battery Low, Source Gas Low,
Oscillator Overheated and 45-Sec Silence. The Battery Low or Source Gas
Low and the Oscillator Overheated Caution Alarms are reset only by
correction of the caution condition by the user. The 45-Sec Silence
caution indicator will be illuminated for the duration of the 45-second
alarm silence duration. During this 45-second period, the audible alarm
will be silenced regardless of the alarm condition. All visual alarm
indicators will operate normally.

The Oscillator Stopped Alarm will occur if ∆P is \< 5 to 7 cmH2O. A red
LED and audible 3K-Hz. indication occurs. No action is taken by the
machine and the alarm resets automatically upon correction of the alarm
condition. Note that the oscillator may in fact be operating, but the
resultant ∆P is below 5 to 7 cmH20. If the oscillator is disabled by
pushing the Start/Stop button, the Oscillator Stopped alarm is disabled.

Warning

An audible alarm indicates the existence of a condition potentially
harmful to the patient and should not go unattended. Failure to respond
to alarms could result in injury (including death) to the patient and/or
damage to the ventilator.

Precaution

When the ventilator is connected to a patient, it is imperative that
someone be in attendance at all times in order to react to any alarms
and to detect other indications of a problem.

A thermal cutout safety feature has been incorporated into the
Oscillator Subsystem. This feature shuts down the oscillator if
overheating occurs. If the oscillator were not shut down, such
overheating could result in the destruction of the oscillator coil\'s
support spiders. The thermal cutout system utilizes a thermistor on the
oscillator coil form to detect temperature rise. Thermal shutdown will
occur if coil temperature exceeds 175°C.

Prior to an oscillator thermal shutdown, the operator is given an
indication that the coil is overheating. A yellow caution LED on the
front panel of the Control Package lights when the coil temperature
reaches approximately 150°C.

A Water Trap is incorporated into the Oscillator subsystem, as described
in a previous section, to help eliminate condensate from the Patient
Circuit. This is a safety feature not seen in many conventional
ventilators with a similar water build-up potential. The Water Trap is
easily emptied as described in Chapter 7, Maintenance and
Troubleshooting.

Precaution

The Water Trap must be drained at intervals as described in Chapter 7,
Maintenance and Troubleshooting. If the ventilator is operating, leave a
small amount of water at the bottom of the Water Trap container to act
as a flow and pressure seal between the ventilator and the output of the
drain.

There are also mechanical pressure relief devices to protect the
equipment from damage. A 75 psig mechanical relief valve protects the
"Inlet from Blender" and the "Air Cooling Inlet" connections. The
"Outlet to Humidifier" connection is protected by a 5 psig mechanical
relief valve. These devices function whether the Model 3100B HFOV is
electrically energized or not.

The oscillator will not start unless the controls are used in the proper
sequence and/or set to the proper range. The startup procedure is
described in Chapter 6, Operational Verification and Startup Procedures.

This chapter describes the location, function, and use of each control,
indicator, and connection on the Model 3100B HFOV. They are illustrated
with reference numbers on the illustrations contained within this
chapter. Detailed specifications of the resolution and accuracy of
controls and indicators are contained in Chapter 2. The theory of
operation of the overall Model 3100B system and each of its subsystems
is explained in Chapter 3, Description of System and Safety Features.

Precaution

Proper operation of the ventilator must be verified prior to each use.
Refer to Chapter 6, Operational Verification and Startup Procedures. The
alarm functions tested in this procedure verify the capability of the
device to detect and indicate conditions which could have a harmful
effect on the patient.

B. Front and Side Panel -- Control Package

![](media/image23.wmf){width="7.500694444444444in"
height="4.290277777777778in"}

Figure 4.1. Front Panel Controls and Indicators.

The numbers shown on Figure 4.1 correspond to the numbers on the
following descriptions.

Controls and indicates the rate of continuous flow of humidified blended
gas through the Patient Circuit. The control knob is a 15-turn pneumatic
valve which increases flow as it is turned counterclockwise.

The rate of flow is indicated by a ball float within a rotameter glass
tube graduated from 0 to 60 LPM in 5 LPM increments. The flow is read by
aligning the center of the ball float with the rotameter scale mark
corresponding to the adjusted flow. The maximum achievable rate of flow
is internally limited to 60 LPM.

Adjusts the mean airway pressure (Pa) by controlling the resistance of
the Pa Control Valve. This control is a clockwise increasing 1-turn
pneumatic valve.

The adjustment affected by this control is read on the Mean Pressure
Monitor (8).

Since this control is not a closed-loop control, Pa will change if the
bias flow setting is changed. Increasing the bias flow will increase the
Pa. In addition, since the oscillatory pressure waveform introduced by
the Oscillator Subsystem is nonsymmetrical, adjustment of the oscillator
controls will also vary the Pa.

When adjusted, this control fixes the mean pressure at the ET
tube/patient connection after about five system time constants have
elapsed but only if set bias flow and oscillator characteristics remain
unchanged for the same time period. Five time constants will vary from
about one second to as long as 30 seconds. This time constant varies
inversely with both Pa Control Valve resistance and bias flow setting.

Changes in the following oscillator controls may necessitate
readjustment of the mean pressure to maintain a constant Pa: Frequency,
% Inspiratory Time, Power (and resultant ∆P change).

Frequency affects the Pa adjustment slightly, but at higher frequencies
the amplitude of the oscillator piston movement may be attenuated due to
slew rate limiting. (The transit time of the piston is greater than the
cycle time required by the Frequency adjustment.)

Since the % Inspiratory Time adjustment affects the symmetry of the
oscillatory waveform, it will directly cause a change in the Pa when
readjusted.

A change in the ∆P will cause a change in the percent of the Pa
contributed by any nonsymmetrical oscillatory waveform. Thus, Pa will
change and will need to be readjusted if an unchanged Pa is desired.

With the oscillator off, the Mean Pressure Adjust control is capable of
achieving 41 cmH2O Pa at a Bias Flow of 20 LPM with the patient circuit
calibrated to the system. Pa will generally increase moderately with the
oscillator running.

Refer to Chapter 6, Operational Verification and Startup Procedures, for
an explanation of the Mean pressure setup procedure.

Determines the amount of power that is driving the oscillator piston to
and fro. The Power control is a 10-turn, electrical potentiometer
covering the power range of 0 to 100%. The knob scale is a 10-turn
locking dial that is not calibrated in % power but marked for purposes
of establishing reference points.

The effect of this control is to change the displacement of the
oscillator piston and hence the oscillatory pressure ∆P.

The Power setting interacts with the Pa conditions existing within the
Patient Circuit to produce the resultant ∆P. The ∆P is numerically
displayed on the digital meter adjacent to the Power control. At
extremely high amplitudes (power settings greater than 6) the
oscillatory pressure may significantly contribute to the mean pressure.
Changes to the amplitude will result in changes to the mean airway
pressure and should be compensated for to maintain an unchanged mean
airway pressure.

Refer to Chapter 6, Operational Verification and Startup Procedures, for
a description of the adjustment technique for setting the Power control.

Determines the percent of the oscillator cycle time that the piston is
traveling toward or is at its final inspiratory position. The control is
a 10-turn electrical potentiometer and covers the range of 30 to 50%.
The setting is numerically displayed on the digital meter adjacent to
the control.

Changing the % Inspiratory Time control could have an effect on the
position of the oscillator piston. At higher frequencies, changing the %
Inspiratory Time from at or near 50% toward 30% may decrease the
displacement. This is due to the fact that the shorter inspiratory phase
of the oscillation may not give the piston enough time to travel to its
full deflection.

Since this control affects the symmetry of the oscillatory waveform, it
may affect the Pa or the ∆P.

Sets the oscillator frequency in Hertz. The control knob is a 10-turn,
clockwise increasing, electrical potentiometer covering the range of 3
to 15 Hertz. The set frequency is displayed on the digital meter.

Manually toggles the oscillator between enabled and disabled. If the
green LED on this pushbutton is lit, then the oscillator is enabled and
pressing the pushbutton will disable the oscillator. If the green LED is
not lit, then the oscillator is disabled and depressing the pushbutton
will enable it to start oscillating---assuming the start up procedure
has been properly executed.

This start up procedure will be discussed in Chapter 6. If not done
properly, the system will not allow the oscillator to start. This
prevents the patient from experiencing too high or low a Pa.

Displays the Pa on a digital meter in cmH2O.

Determines the level in cmH2O at which the Max Pa Exceeded Warning Alarm
will be indicated. The Maximum Pa level is set by means of a thumb-wheel
switch covering the range of 0 to 59 cmH2O. A mechanical stop has been
inserted in the tens column of the thumb-wheel switch to prevent the
dial from being turned past the numeral 5.

In the event that the proximal pressure meets or exceeds the set Max Pa
alarm setting, an audible and visual alarm will occur, and the
ventilator will depressurize the Limit Valve seat pressure. Once the
mean airway pressure falls to a level of 12 (±3) cm H~2~O below the Set
Max Pa setting, the Limit Valve will re-pressurize to its normal
operational state. Should the high mean airway condition persist, the
alarm will repeat until the condition is resolved. Once corrected the
high Pa visual indicator will remain lit to notify the clinician that
the alarm was violated. Depress the Reset / Power Failure button to
reset the visual indicator.

 Operating the ventilator with low Bias Flow Rates (\<15 Ipm) and Low
Mean Airway Pressures (\<15 cmH20), with full power (Maximum Amplitude)
may result in a low-pressure dump upon activation of the Max Pa Alarm.

Determines the level in cmH2O at which the Min Pa Exceeded Warning Alarm
will be indicated. The Minimum Pa level is set by means of a thumb-wheel
switch covering the range of 0 to 59 cmH2O. A mechanical stop has been
inserted in the tens column of the thumb-wheel switch to prevent the
dial from being turned past the numeral 5.

The activation of the alarm is indicated by a 3K-Hertz modulated tone
and a red LED which is adjacent to the thumb-wheel switch.

The alarm will reset automatically after correction of the condition.
The audible indicator can be silenced for 45 seconds by pushing the
45-Sec Silence pushbutton.

This alarm does not initiate any machine response other than the
activation of the visual and audible indicators.

The red LED indicates activation of this preset Safety Alarm. It is also
indicated by a 3K-Hertz modulated tone. The alarm is reset only by
pushing the Reset pushbutton after the alarm condition has been
corrected. The 45-Sec Silence pushbutton can be pushed to silence the
audible indicator; however, the red LED indicator will still function
and the Dump Valve will remain open.

When this alarm occurs, the Model 3100B will automatically shut down the
oscillator, but bias flow will continue. The Dump Valve will be open and
will hold the airway pressure to near atmospheric. This protects the
patient from the elevated pressure and allows the patient to breathe
spontaneously. (See the Patient Circuit section in Chapter 3 for further
explanation of this feature.)

Because of the Dump Valve activation, the Pa \< 5 cmH2O Safety Alarm
will also be activated.

After the correction of the condition that triggered the Safety Alarm,
the oscillator startup procedure must be followed for reset. This is
discussed in Chapter 6.

The red LED indicates activation of this Safety Alarm. It is also
indicated by a 3K-Hertz modulated tone. This alarm triggers at a Pa \<5
cmH2O. The alarm will reset after the alarm condition has been
corrected.

The 45-Sec Silence pushbutton can be pushed to silence the audible
indicator; however, the red LED indicator will still function.

When this alarm occurs, the Model 3100B will automatically shut down the
oscillator, but bias flow will continue. The Dump Valve will be
activated and will hold the airway pressure to near atmospheric. This
allows the patient to breathe spontaneously. (See the Patient Circuit
section in Chapter 3 for further explanation of this feature.)

After the correction of the condition that triggered the Safety Alarm,
the oscillator startup procedure must be followed for reset. This is
discussed in Chapter 6.

The red LED indicates loss of electrical power or insufficient or
inadequate electrical power supply. It is accompanied by a 3K-Hertz
modulated audible tone. The following conditions will cause this alarm
to trigger:

a\. Tripping of Model 3100B System circuit breaker.

b\. Turning off Power Switch (29).

c\. Power plug being pulled from wall socket.

d\. Loss of power to the hospital branch line to which the Model 3100B
System is connected.

e\. A failure in the power supply internal to the Model 3100B System.

Once tripped, the alarm indicators (red LED and 3K-Hz modulated tone)
can be reset only by pushing the Reset button (14) even if the power
failure condition has been corrected. Then, the oscillator Start/Stop
Switch must also be pressed to restart the oscillator.

The Power Failure Alarm circuitry is powered by a battery (25) which
will be discussed further in the next section covering operation of
controls, indicators, and connections on the rear panel of the Control
Package.

This momentary pushbutton resets all Safety Alarms and the Power Failure
alarm.

The alarm conditions triggering the \> 60 cmH2O and \< 5 cmH2O Safety
Alarms (11 and 12) must first be corrected before resetting will occur.
Since these alarms cause the Dump Valve to open, Reset must be held in
with the Start/Stop enabled until the Dump Valve closes and airway
pressure builds above the 5 cmH2O Pa level.

The Power Failure alarm (13) will be reset regardless of whether the
alarm condition has been corrected or still exists.

It is normal for the Battery Low LED to light when the reset button is
pressed.

Indicates the Power Failure alarm battery (25) on the rear panel of the
Control Package must be changed as soon as possible to ensure continued
proper operation of the Power Failure alarm.

Indicates the gas pressure at the "Inlet From Blender" or "Air Cooling"
connection has fallen below 30 psig.

Since the Battery Low and Source Gas Low are classified as caution
alarms, yellow LEDs are used, and there is no audible indicator. These
alarms will reset only after the battery has been replaced by a new one
or the source gas pressure increases above 30 psig, respectively.

The user should investigate the cause of the alarm. If the problem is a
loss in blender output pressure, the Warning or Safety Alarms will soon
be activated. If the problem is a loss of oscillator cooling air, the
Oscillator Overheated alarm will soon activate. This alarm can occur due
to plugging of an Inlet Filter Cartridge with dirt. Refer to the
Operator Maintenance Procedures section of Chapter 7 for instructions on
changing the Inlet Filter Cartridges.

The battery will be discussed further in the next section covering the
operation and location of the rear panel controls, indicators, and
connections.

Indicates that the oscillator coil is overheated and has reached
approximately 150°C. Since this is a Caution Alarm, a yellow LED is
used, and there is no audible indicator. This alarm will reset only
after the condition has been corrected. The operator should determine if
the problem is a loss of, or decrease in, cooling gas pressure. This
could be caused by low gas pressure at its source, an occlusion (such as
a kinked tube or plugged Inlet Filter Cartridge) or a loose tube
connection, internal or external. Refer to the Operator Maintenance
Procedures section of Chapter 7 for instructions on changing the Inlet
Filter Cartridges.

Indicates that the oscillator is enabled (Start/Stop pushbutton green
LED lighted) but ∆P \< 5 to 7 cmH2O. A red LED indicator is accompanied
by a 3K-Hertz modulated tone. No machine action is taken other than the
indicators which automatically reset when the condition is corrected.

Activates and indicates the inhibiting of the audible alarm, for a
period of 45 seconds. This control is a lighted pushbutton and indicates
a caution with its yellow LED when pushed. Once activated, the 45-Sec
Silence cannot be reset, but must time out.

Adjusts the maximum mean pressure that can be obtained with a specific
Patient Circuit. This screwdriver adjustment is used to calibrate the
maximum mean pressure after the Patient Circuit is changed or the Pa
Control diaphragm is changed. A full setup procedure is detailed in
Chapter 7, Maintenance and Troubleshooting.

C. Rear Panel -- Control Package

![](media/image24.wmf){width="5.279861111111111in" height="5.75in"}

Figure 4.2. Rear Panel Controls, Indicators, and Connections.

The numbers shown on Figure 4.2 correspond to the numbers on the
following descriptions. Details concerning specific design
characteristics are discussed in Chapter 2.

DISS oxygen fitting for connection to an inline Inlet Filter Cartridge
and then to the External Air/O2 Blender output. The nominal pressure of
the blender output gas should be 50 psig. The Source Gas Low yellow LED
will light if the pressure at the inlet drops below 30 psig ±5%.

This input connection is protected from over-pressure by a 75 psig
mechanical relief valve. More details regarding this protection are
listed in Chapter 2.

Connector which provides bias flow to the inlet of the External
Humidifier. This is a 3/8\" barbed fitting which is over-pressure
protected by a 5 psig mechanical relief valve. The Patient Circuit
assembly procedures associated with this connector are discussed in
Chapter 5.

See Chapter 7.

See Chapter 7.

Indicates the total accumulated time in hours that power has been
applied to the Model 3100B. Detailed specifications of this meter are
discussed in Chapter 2.

A metal cover (fastened by 2 screws) behind which is a 9-volt alkaline
battery. Battery Low LED (15) on front panel indicates when this battery
needs to be changed. It can be replaced by any high quality 9-volt
alkaline battery. Note: remove the 9-volt battery if the instrument is
not intended to be used for a lengthy period.

Locks the Control Package in the rotational position selected by the
user. When this lock is rotated counterclockwise, it allows the rotation
of the Control Package over an arc of nearly 360°. This permits viewing
of the Model 3100B front panel from an angle independent of the Patient
Circuit outlet orientation.

After the desired position has been selected, rotation of the knob in a
clockwise direction will lock the enclosure in the selected position.

Rotation of the knob slightly counterclockwise from fully locked will
apply friction to prevent the enclosure from easily being rotated
without actually fixing it in place.

More on the subject of positioning of controls is discussed in Chapter
5, Assembly.

An Air DISS fitting for connection through an in-line Inlet Filter
Cartridge to hospital air supply which provides the oscillator with
cooling gas. The nominal pressure of the hospital air should be 50 psig
at the required 25 LPM rate. The Source Gas Low yellow LED will light if
the pressure at the inlet drops below 30 psig ±5%.

During normal maintenance as described in Chapter 7, record the reading
on the Elapsed Time Meter for quick reference.

During normal maintenance as described in Chapter 7, record the reading
on the Elapsed Time Meter for quick reference.

D. System Column and Patient Circuit

![](media/image25.png){width="6.426388888888889in"
height="6.067361111111111in"}

Figure 4.3. System Column and Patient Circuit Controls and Connections.

The numbers shown on Figure 4.3 correspond to the numbers on the
following descriptions.

Precaution

Care should be taken not to crimp or perforate any of the control or
sensing lines (running to or from the Patient Circuit) during assembly
or operation of the ventilator as this will cause malfunction of the
Safety Alarms, Warning Alarms, Caution Alarms, and/or Pressure Limit
controls.

Turns power to the Model 3100B System on and off. This power switch also
functions as a circuit breaker in case of a power overload. If the
circuit breaker trips, be sure to locate the problem causing the power
overload before resetting the breaker. This switch is a standard rocker
switch which breaks both sides of the power line as does the built-in
circuit breaker.

Attaches to 1 1/4\" I.D. inspiratory limb of patient circuit and is held
in place by four quarter-turn fasteners.

Green Luer bulkhead fitting for connection to green 1/16\" I.D. tubing
that runs to the control input of the Pa Control Valve on the Patient
Circuit. Consult assembly procedure in Chapter 5 for details on
attachment of this control line to its valve. This line should be
replaced periodically during scheduled preventive maintenance of the
HFOV.

Red Luer bulkhead fitting for connection to red 1/16\" I.D. tubing that
runs to control input of Dump Valve on Patient Circuit. Consult assembly
procedure in Chapter 5 for details on attachment of this control line to
its valve. This line should be replaced periodically during scheduled
preventive maintenance of the HFOV.

White Luer bulkhead fitting for connection to clear 1/8\" I.D. tubing
that runs to the Airway Pressure Port of the Patient Circuit for the
purpose of transmitting the Pa signal to the pressure transducer within
the Control Package. Consult assembly procedure in Chapter 5 for details
on attachment.

Blue Luer bulkhead fitting for connection to blue 1/16\" I.D. tubing
that runs to control input of Pa Limit Valve on Patient Circuit. Consult
assembly procedure in Chapter 5 for details on attachment of the control
line to its valve. This line should be replaced periodically during
scheduled preventive maintenance of the HFOV.

Condensate should drain into the water trap if the Patient Circuit is
positioned properly. There is a small (.025\" diameter) hole at the top
of the water trap to allow air to escape as it fills.

Allows draining of water condensate. Water is drained from the bottom
when the stopcock is opened. The contents of the water trap can be
drained while the Model 3100B is still operating as long as the water
seal between the ventilator and the bottom drain is not broken. This can
be accomplished by always leaving a small amount of water at the bottom
of water trap after draining. Follow the instructions in Chapter 7
regarding cleaning and disinfecting the water trap and valve mechanisms.

Precaution

Ensure that the stopcock is closed prior to performing a Patient Circuit
Calibration. If the Water Trap Stopcock is left open, Patient Circuit
Calibration (39--43 cmH20) may not be achievable, and the deliverable Pa
will be reduced.

Four quarter-turn fasteners that hold the bellows (Oscillator
Compartment) in place in front of the oscillator piston.

For attachment of Patient Circuit. Refer to Chapter 5 for assembly and
adjustment instructions.

The external humidifier is connected between the "Outlet To Humidifier"
on the rear of the Control Package and the Bias Flow Inlet on the
Patient Circuit. In Figure 4.3, the humidifier tubing is shown connected
to the patient circuit without the humidifier inline.

Only the 3/8\" tube supplied with the Patient Circuit should be used.

There are four bulkhead luer fittings on the front of the oscillator
compartment for connection to the three valve caps and pressure sense
port on the patient circuit.

Secures the patient circuit to the Patient Circuit Cradle. This keeps
the circuit in a stable position.

This chapter covers the unpacking, assembly, and installation of the
Model 3100B HFOV prior to operational verification. The Control Package
is shipped already attached to the Column. The assembly of the Patient
Circuit and its attachment to the rest of the ventilator is illustrated
in Figures 5.1 and 5.2.

The Model 3100B HFOV is shipped in one crate, containing the instrument
(pre-assembled control package, column, and pedestal) and several
smaller cartons containing:

1\. Patient Circuit support arm and cradle.

2\. Two complete patient circuits, packaged one to a box.

3\. Humidifier input and output hoses/adapters.

4\. A box of ten spare Inlet Filter cartridges for blended gas and air
inputs.

5\. Operator\'s Manual.

6\. Humidifier mounting bracket adapters.

Precaution

Deviation from the assembly methods described here could damage the
Model 3100B, render it mechanically unstable, or cause it to
malfunction. If any questions arise regarding the assembly procedure,
please contact SensorMedics Technical Support immediately before
proceeding.

Place the pre-assembled Control Package, Column, and Pedestal on a level
floor and lock the locking wheels.

Assemble the Patient Circuit support arm prior to attempting to attach
the Patient Circuit. A flathead screwdriver will be necessary.

Precaution

When connecting the Patient Circuit, make certain that it is properly
supported by the support arm. Failure to do so could result in
inadvertent Patient Circuit disconnection due to oscillatory forces or
could result in collection of humidifier condensate in the patient
airway.

Attach the vertically-adjustable rod to the end of the support arm so
that it will cradle, in its curved end, the main tube of the Patient
Circuit. Tighten the thumbscrew crosspiece to secure it at the height
desired.

The angle of the Patient Circuit can also be controlled by loosening the
thumbscrew on the cradle rod and sliding it either up or down. Once
again, always be certain to retighten the thumbscrew.

![](media/image26.png){width="4.85625in" height="1.6381944444444445in"}

Figure 5.1. Disassembled Patient Circuit.

![](media/image20.png){width="4.875694444444444in"
height="4.727083333333334in"}

Figure 5.2. Details of Patient Circuit.

Assemble the Patient Circuit using Figures 5.1 and 5.2 as a guide.
Connect the Patient Circuit Body to the Bellows/Water Trap Assembly and
snap the three identical caps/diaphragm assemblies onto the three valve
bodies located on the Patient Circuit Body.

Next, attach this assembled Patient Circuit to the face of the
Oscillator Compartment using the four captive T-handle quarter-turn
fasteners.

Precaution

The driver diaphragm of the 3100B has been coated with a special
lubricant during assembly. Please do not clean the driver diaphragm with
cleaning solvents as it may degrade the materials causing premature wear
of the driver diaphragm.

Attach the three color-coded tubes to their corresponding valve caps,
using the following color-coding scheme:

**Color of Line Patient Circuit Attachment Point**

Blue Limit Valve

Green Pa Control Valve

Red Dump Valve

Clear Pa Sensing Port

Note that the differing lengths and color coding of the tubes and the
physical arrangement of the valves within the Patient Circuit minimize
any cross-connection.

Precaution

Care should be taken not to crimp or perforate any of the control or
sensing lines (running to or from the Patient Circuit) during assembly
or operation of the ventilator, as this will cause malfunction of the
Safety Alarms, Warning Alarms, Caution Alarms, and/or Pressure Limit
controls.

Next, attach the 1/8\"-Tygon pressure-sense line (captive to the Patient
Circuit "Y") to the bulkhead Luer fitting marked "Airway Pressure."
Finally, insert the humidifier temperature probe in the tapered-opening
near the patient "Y." Note that an identical such port with a removable
plug in it is located at the opposite end of the Patient Circuit. Always
insert the plug in the unused port.

Precaution

If the temperature probe is wiped with alcohol, allow the alcohol to
evaporate completely before inserting it into the circuit. A high
residual of alcohol can weaken the acrylic adapter and cause fracturing.

Always insert the provided plug into the unused temperature probe port.
Failure to do so will allow a leak of sufficient magnitude that the
minimum Pa necessary to allow the oscillator to start cannot be
achieved.

Use the cradle rod adjustment already described to maintain the proper
Patient Circuit height and angle. The proper angle will allow condensate
to run downward into the Water Trap mounted on the Column.

The 3100B High Frequency Oscillating Ventilator is now ready for
Operational Verification and Start-Up (see Chapter 6).

Warning

Do not attempt to substitute a circuit configuration from any other
instrument. Use of a non-3100A or a non-3100B circuit can result in
injury to the patient or to the operator, and it may cause damage to the
equipment. The Patient Circuit described in this manual is specifically
designed for patient use with the Model 3100B HFOV.

Obtain an External Air/O2 Blender and an External Humidifier for
incorporation into the system as described in Chapter 3. Attach these
devices to the Patient Circuit using the attachment accessories supplied
and using Figures 5.1 and 5.2 as a guide. The following connections must
be made:

**Device Input Connection(s) From Output Connection To**

Air/O2 Blender (a) Hospital Air Control Package rear

DISS connection panel "INLET FROM

\(b\) Hospital Oxygen BLENDER" DISS fitting

DISS connection

Humidifier Control Package rear panel Patient Circuit

"OUTLET TO HUMIDIFIER" Bias Flow Connection

3/8\" barbed fitting 3/8\" nipple fitting

There is an additional connection from the Hospital AIR DISS connection
to the Column DISS Air fitting marked "AIR COOLING."

![](media/image27.wmf){width="3.845138888888889in"
height="3.2256944444444446in"}

> Figure 5.3. Rear Panel Connections.

Warning

Do not shorten the 30\" bias flow tube provided with the patient
circuit, as this may reduce the maximum ∆P by allowing the oscillatory
pressures to be attenuated by closer proximity to the volume of the
humidifier canister.

Precaution

The inlet filter cartridges for the blended gas and the air inputs to
the ventilator must be replaced at least every 500 hours of operation as
described in Chapter 7, Maintenance and Troubleshooting. Failure to
replace a filter cartridge or substitution of an unauthorized cartridge
could result in injury to the patient and/or damage to the equipment.
Use only SensorMedics P/N 463110 cartridges (P/N 767163 box of 10).

Find a convenient power outlet for connection to the Model 3100B with a
minimum rating compatible with the HFOV power ratings described in
Chapter 2.

The Model 3100B HFOV system is now ready for operational verification.

Warning

Do not attempt to defeat the proper connection of the ground wire.
Improper grounding may cause damage to the device or interconnected
equipment and could be injurious to the patient or to those associated
with the device use. This device is factory equipped with a
hospital-grade AC power plug. Grounding reliability can only be assured
when connected to a tested receptacle labeled "Hospital Grade."

Precaution

Proper operation of the ventilator must be verified prior to each use.
Refer to Chapter 6, Operational Verification and Start-up Procedures.

Warning

Do not operate radio transmitters within 20 feet of this instrument.
This may result in erroneous pressure readings leading to false alarms
and automatic shut-down.

The 3100B requires no preliminary cleaning before initial use. The
Patient Breathing Circuit components, though clean, are not shipped
sterile. If desired, the circuit body may be disinfected before using
according to the instructions in the "Changing the Patient Circuit"
section of Chapter 7, Maintenance and Troubleshooting.

This chapter covers the proper operational verification and ventilation
start-up methods for the Model 3100B HFOV.

 See Chapter 5 for instructions on unpacking, assembly, and
installation of the Model 3100B HFOV prior to operational start-up and
verification.

Warning

The operational verification and start-up procedure must be followed
before ventilation of a patient commences. If at any time during the
operational verification and start-up procedure any abnormal function of
the Model 3100B HFOV is noted, do not proceed with patient ventilation
as this could cause patient injury or death; immediately contact
SensorMedics Technical Support before proceeding any further.

Precaution

Proper operation of the ventilator must be verified prior to each use.
The alarm functions tested in this procedure verify the capability of
the device to detect and indicate conditions which could have a harmful
effect on the patient.

Precaution

Touch the outer metal cabinet of the instrument before touching any
other component to avoid possible instrument component damage from
Electrostatic Discharge.

Warning

Do not operate radio transmitters within 20 feet of this instrument.
This may result in erroneous pressure readings leading to false alarms
and automatic shut-down.

1\. Connect the source gases to the Model 3100B HFOV System:

a\. Oxygen line to the External Air/O2 Blender oxygen input fitting

b\. Air line to the External Air/O2 Blender air input fitting and the
oscillator "Air Cooling" input connector.

c\. External Air/O2 Blender output to the Control Package rear panel
oxygen DISS fitting labeled "Inlet from Blender."

2\. Connect Patient Circuit and External Humidifier to the Model 3100B
using the assembly procedures described in Chapter 5.

Warning

Do not attempt to substitute a circuit configuration from any other
instrument. Use of a non-3100A or a non-3100B circuit can result in
injury to the patient or to the operator, and it may cause damage to the
equipment. The Patient Circuit described in this manual is specifically
designed for patient use with the Model 3100B HFOV.

Precaution

When connecting the Patient Circuit, make certain that it is properly
supported by the support arm as described in Chapter 5, Assembly and
Installation. Failure to do so could result in inadvertent patient
circuit disconnection due to oscillatory forces or could result in
collection of humidifier condensate in the patient airway.

3\. Connect all color-coded Patient Circuit Control Lines and the clear
Pressure Sense Line to their proper locations on the Patient Circuit as
described in Chapter 5.

Precaution

Care should be taken not to crimp or perforate any of the control or
sense lines (running to or from the Patient Circuit) during assembly or
operation of the ventilator as this will cause malfunction of the Safety
Alarms, Warning Alarms, Caution Alarms, and/or Pressure Limit controls.

4\. Block off or obstruct the ET connection port on the Patient Circuit
using the #1 rubber stopper accessory provided.

5\. Turn on the Main Power Switch (the green LED on the Start/Stop
pushbutton should be off). Some of the alarm LED\'s will be lit when
power is first turned on.

Warning

An audible alarm indicates the existence of a condition potentially
harmful to the patient and should not go unattended. Failure to respond
to alarms could result in injury, including death, to the patient and/or
damage to the ventilator.

Precaution

Ensure that the stopcock is closed prior to performing a Patient Circuit
Calibration. If the Water Trap Stopcock is left open, Patient Circuit
Calibration (39--43 cmH20) may not be achievable, and the deliverable Pa
will be reduced.

Warning

Ensure that the cooling fan at the rear of the driver enclosure is
operational.

6\. Calibrate the patient circuit calibration, to the system. (These
instructions are also located on a label on the side of the Control
Package).

a\. Turn on source gas pressure and establish Bias Flow at 20LPM. Be
sure to read the flow at the center of the ball, looking level at the
flow meter.

b\. Set Max Pa Alarm to 59 cmH2O.

c\. Set Mean Pressure Adjust control to Max (full CW).

d\. Push in and hold RESET while observing the Mean Pressure digital
readout. It is normal for the Battery Low LED to light when the reset
button is pressed.

e\. Adjust the Patient Circuit Calibration on the right side of the
control package to achieve a Pa of 39 to 43 cm H2O. Do not overturn; if
the specified pressure can not be achieved, locate the leak.

f\. Release the RESET button; the Battery Low LED should turn off.

Precaution

Do not overturn the Patient Circuit Calibration as this may cause damage
to the device. When it is nearing its adjustment limit, it will reach a
mechanical stop.

7\. Perform the Ventilator Performance Check "Off Patient Only" section.
(These instructions are also located on a label on the top of the
Control Package).

a\. Insert stopper in Patient Circuit "Y" and turn on both gas sources.

b\. Set BlAS FLOW for 30 LPM.

c\. Set Max Pa Alarm to 35 cmH2O.

d\. Pressurize system by pressing and holding RESET, and ADJUST for a
mean Pressure of 29-31 cmH2O.

e\. Set FREQUENCY to 6, % I-Time to 33, and press START/STOP to start
the oscillator.

f\. Set POWER to 6.0.

g\. When a stable ∆P reading is obtained, verify that the ∆P and Pa
readings are within the range specified for your corresponding altitude
(see Figure 6.1).

8\. Depress the START/STOP button to stop the oscillator.

9\. With Mean Pressure Adjust and/or Bias Flow adjustment, achieve a
mean airway pressure within 2 cmH2O of the desired level. Ensure that
the Bias Flow is sufficient (see Chapter 8).

10\. Verify the function of the thumb-wheel switches for "Set Max Pa"
and "Set Min Pa" alarms by setting the Max thumb wheel just below the
established Mean pressure, and by setting the Min thumb wheel just above
the established Mean pressure.

11\. Set these thumb-wheel alarm switches to their desired settings.
This is generally 2--5 cmH20 above (Max thumb-wheel) and below (Min
thumb wheel) the established Mean pressure.

12\. With fingers and thumb(s), squeeze closed the 1/8\" clear Pressure
Sense tubing on the patient circuit to verify operation of the "Pa \> 60
cmH2O" alarm.

13\. Depress the RESET button until the "Pa \< 5 cmH2O" LED is
extinguished to reestablish the mean airway pressure.

14\. Again, squeeze the pressure sense tubing on the patient circuit and
observe the pressure at which the Mean Pressure display limits.

15\. Position the ventilator for connection to the patient. Loosen the
Position Lock control and adjust the angle of the Control Package for
the best view and access relative to the patient. Retighten the Position
Lock.

16\. Set the desired % oxygen, Mean Pressure, and ∆P for the patient. ∆P
will affect the Pa depending on ratio of Flow Rate/Pa. The lower the
ratio, the stronger the effect.

Precaution

Fractional concentration of inspired oxygen should be verified with an
oxygen monitor. Administration of excessive oxygen to a patient may be
harmful. It is imperative that the prescribed gas mixture is delivered
by the blending system.

17\. Remove the Patient Circuit stopper. Adjust the External Humidifier
to establish the desired gas temperature at the patient airway
temperature port. Connect the Patient Circuit to the patient ET tube.

Warning

Under no circumstances should proximal airway gas temperature of 41°C be
exceeded. This could result in injury to the patient\'s upper airway
membranes.

Warning

***Do Not*** use the 3100B ventilator in environments where the ambient
temperature is at or above 84°F (28°C). Use of the ventilator in these
environments will result in extreme reduction in relative humidity in
the patient's airway and possible desiccation of the patient airways.

Precaution

When the ventilator is connected to a patient, it is imperative that
someone be in attendance at all times in order to react to any alarms
and to detect other indications of a problem.

18\. Push the Reset pushbutton until the "Pa \< 5 cmH2O" LED is
extinguished to reestablish Mean Pressure.

19\. Set the Power control for the desired ∆P (see Chapter 8).

20\. Readjust the Frequency, % Inspiratory Time, Power, Mean Pressure,
and Bias Flow as needed during patient ventilation.

Warning

Under no circumstances should the ventilator be used in the presence of
flammable anesthetics due to the possibility of explosion.

Precaution

Do not place on the Control Package of the ventilator any
fluid-containing accessories, accessories that weigh more than 10
pounds, or accessories that extend more than six inches above the
ventilator electronics package or beyond its sides. This could cause the
ventilator to tip over, resulting in patient or user injuries and/or
damage to the equipment.

C. Performance Verification

![](media/image8.png){width="6.7in" height="6.910416666666666in"}Figure
6.1. Ventilator Performance Checks.

The two graphs shown in Figure 6.1 are intended to guide the operator in
setting Power, Mean Pressure Adjust, and Bias Flow controls, and to help
ascertain that the 3100B is performing in a typical fashion without
problems.

The left graph indicates the approximate setting of the Power control
required to achieve a specific ∆P pressure. The right graph illustrates
the Bias Flow required to achieve a range of Mean pressures with the
single-turn Mean Pressure Adjust control.

In establishing a specific Mean pressure, find the required Bias Flow
that will allow the Mean pressure to be adjusted above and below that
desired. Set the Mean Pressure Adjust control to approximately "twelve
o\'clock" and set the Bias Flow as indicated on the graph, to a level
which puts the desired Pa level in its mid-range. When the system is
operating, whether ON or OFF Patient, the settings of the controls
relative to the pressures being developed and displayed, will quickly
give an indication that the system performance is nominal.

This chapter covers the Model 3100B maintenance and troubleshooting
procedures with which the operator and service technician should be
acquainted.

 SensorMedics or its official representative will make available upon
request such circuit diagrams, component part lists, descriptions,
calibration instructions or other information which will assist
***factory-qualified*** technical personnel to repair those parts of the
equipment which are classified as repairable. If you are interested in
factory training, please contact the SensorMedics Service Department for
scheduling and pricing of our biomedical training classes.

Warning

Failure to comply with the recommended maintenance procedures described
in this chapter could result in injury to the patient or operator or
could result in damage to the equipment.

When surface cleaning of the 3100B is desired, we recommend using a weak
disinfectant liquid to wipe down the exterior of the instrument. Do not
spray liquid cleaners directly on the exterior surface; spray the
cleaning cloth and wring it nearly dry before wiping. ***Do not*** allow
liquids to drip into the instrument.

 Do not use alcohol or sterilization liquids on the exterior surface of
the 3100B.

 Do not use abrasive cleaners or solvents on the exterior surface of
the 3100B.

The operator maintenance procedures are the following:

Emptying the Water Trap.

Changing the Compressed-gas Inlet Filter Cartridge Elements.

Changing the Power Failure Alarm battery.

Cleaning the Column Lint Filter.

Changing the Patient Circuit.

Lubricating the driver diaphragm.

The Water Trap must be emptied as described below.

Precaution

The Water Trap must be drained at intervals. If the ventilator is
operating, leave a small amount of water at the bottom of the Water Trap
container to act as a flow and pressure seal between the ventilator and
the output of the drain.

Opening the stopcock on the bottom of the water trap will open the
drain. The contents of the water trap should be emptied into a
disposable cup or a container which can be subsequently disinfected.

When the Model 3100B is not operational, the Water Trap container can be
completely emptied.

Precaution

Ensure that the stopcock is closed prior to performing a Patient Circuit
Calibration. If the Water Trap Stopcock is left open, Patient Circuit
Calibration (39--43 cm H20) may not be achievable, and the deliverable
Pa will be reduced.

The 0.1 micron Inlet Filter Cartridges are placed at the input of both
the Inlet From Blender DISS oxygen fitting and the Air Cooling Inlet
DISS air fitting. Their purpose is to capture any dirt particles or
moisture before entry into the Model 3100B HFOV.

Precaution

The Inlet Filter Cartridges for the blended gas and the air inputs to
the ventilator must be replaced at least every 500 hours of operation as
described in this chapter. Failure to replace a Filter Cartridge or
substitution of an unauthorized cartridge could result in injury to the
patient and/or damage to the equipment. Use only SensorMedics cartridges
(P/N 767163 box of 10).

The recommended minimum change interval is every 500 hours of operation.
However, the level of contaminants in the gas lines of your hospital may
be higher than normal. If the Model 3100B HFOV is used for the first
time at a new location within your hospital, Filter Cartridges should be
checked for flow-limiting contaminants after 100 hours of operation, and
then after 300 hours of operation, to determine whether or not a 500
hours of operation change interval is appropriate.

A Filter Cartridge which has been allowed to accumulate flow limiting
contaminants will cause the gas supply pressure at the particular DISS
fitting to drop. Eventually, the Source Gas Low alarm will trigger.
Refer to Chapter 4 for a description of this alarm indication.

The procedure for changing a cartridge is as follows:

1\. Turn off and disconnect both the air and oxygen source gas lines.

2\. Unscrew body of inlet filter.

3\. Remove old cartridge.

4\. Install new cartridge. (A box of 10 spare cartridges, part number
767163, is shipped with the Model 3100B as an accessory.)

5\. Screw filter back together.

6\. Record the Elapsed Time Meter reading on the rear of the 3100B.

Precaution

The filter cartridge body must be screwed back on securely.
Cross-threaded or loose installation will result in leaks and possible
dislodging of the cartridge body. If the cartridge body is dislodged, it
will cause the ventilator to cease functioning.

When the yellow Battery Low LED Caution Alarm on the front panel of the
Control Package is lighted, the problem is the Power Failure Alarm
battery. It should be changed as soon as possible. Access to this
battery is gained through the access door on the rear panel. A good
quality 9 volt alkaline battery should be used.

After each patient, inspect and clean the lint filter in the Column of
the Model 3100B HFOV. Remove the filter element from its holder on the
column rear. Shake dirt out, wash it in warm sudsy water, dry it out and
replace it in the holder. Failure to perform this procedure will
eventually cause a significant restriction of air cooling flow to the
oscillator square-wave driver. This could lead to overheating of the
driver and eventual malfunction of the oscillator.

Change the Patient Circuit with the same frequency as your
institution\'s policy requires for conventionally-ventilated patients.
Dispose of the three snap-off Cap/Diaphragms and the Bellows/Water Trap
Assembly; ***these items absolutely cannot be reused***. The Patient
Circuit Body is intended for single-patient use.

Due to the high power settings which may be encountered, the cap
diaphragms of the patient circuit should be changed at least every three
days. Failure to do so may cause mean airway pressure instability.

Precaution

The driver diaphragm of the 3100B has been coated with a special
lubricant during assembly. Please do not clean the driver diaphragm with
cleaning solvents as it may degrade the materials causing premature wear
of the driver diaphragm.

The oscillating mechanism of the 3100B ventilator consists of a linear
motor which drives a piston assembly. Due to the loads which can be
placed on the piston assembly, the driver diaphragm must be lubricated
every 500 hours of operation. This maintenance procedure will reduce
wear on the driver diaphragm and prolong its operational life.

1\. Turn off the ventilator and remove the patient circuit.

2\. Utilizing a lint free cloth or towel, wipe the surface of the driver
diaphragm to remove any contaminants and any residual lubricant.

3\. Use a cotton tipped applicator or the finger of a gloved hand, to
apply a thin film of SensorMedics approved lubricant to the entire
surface of the driver diaphragm (Figure 7.1).

4\. Record the Elapsed Time Meter reading on the rear of the 3100B.

![](media/image28.png){width="4.86875in" height="4.093055555555556in"}

Figure 7.1. Driver Diaphragm Lubrication.

Warning

Only SensorMedics approved lubricants should be used. Use of any other
lubricants could result in damage to the Driver Diaphragm or Bellows
Water Trap Membrane causing ventilator failure or patient injury.

Precaution

The Driver Diaphragm of the SensorMedics 3100B must be lubricated every
500 hours of use as described in this chapter. Failure to lubricate the
Driver Diaphragm may result in premature wear of the diaphragm, which
could result in failure of the driver mechanism.

***Before*** use on a patient, each patient circuit must be calibrated
to the Model 3100B by following this procedure:

1\. Insert the stopper in the Patient Circuit "Y" and turn on the Bias
Flow gas.

2\. Set Max Pa Alarm to 59 cmH2O.

3\. Rotate the Mean Pressure ADJUST control to "Max."

4\. Adjust the Bias Flow to 20 LPM.

5\. Depress and hold RESET (Oscillator OFF).

6\. Observe the Mean Pressure display and adjust the Patient Circuit
Calibration screw for a reading of 39--43 cmH2O.

Precaution

Do not over adjust the Patient Circuit Calibration screw. Over
adjustment may cause damage to the device. The screw will reach a
mechanical stop when it is at the adjustment limit. DO NOT FORCE THE
SCREW PAST THIS STOP!

There are two other functions within the Model 3100B HFOV which require
periodic calibration:

1\. Control Package DC Power Supply.

2\. Airway Pressure Monitor Transducer Calibration.

Maintenance of accurate calibration of these functions is extremely
important to the proper function of the Model 3100B HFOV. If at any
time, a calibration discrepancy exists that cannot be solved by the
normal calibration procedures described below, do not attempt to treat a
patient with the HFOV. Call SensorMedics immediately for assistance.

The calibration interval for these functions is tracked on the Elapsed
Time Meter (24) on the Rear Panel of the Control Package. A calibration
must be performed at least every 2,000 hours or when a discrepancy is
noticed. An National Bureau of Standards traceable digital voltmeter and
a National Institute of Standards and Technology traceable pressure
measurement transducer are required for proper calibration of the Power
Supply and the Airway Pressure Monitor.

To assure accurate setup, all periodic calibrations must be done with
the Model 3100B HFOV at room temperature and prior to extensive
operation of the oscillator. If the oscillator is warm due to previous
operation, allow a non-operating cool-down interval of at least one hour
before commencing calibration.

Precaution

The cover enclosing the Control Package, Column, or any other portion of
the ventilator must not be removed by the user. To avoid electrical
shock hazard, please refer all service requiring cover removal to a
qualified biomedical equipment service technician.

The calibration procedure for the Control Package DC Power Supply is as
follows:

1\. Turn off Power to the 3100B HFOV and unplug unit from AC receptacle.

2\. Remove the rear column cover.

3\. Plug the 3100B HFOV back into receptacle and turn on Power.

4\. Refer to Figure 7.2 to locate screwdriver potentiometer settings R9,
R57, and R82 for the DC Power Supply. It is located immediately below
the oscillator drive electronics.

![](media/image29.png){width="4.743055555555555in"
height="3.7020833333333334in"}

Figure 7.2. Power Supply Adjustment Potentiometers.

5\. Connect the negative lead of a digital voltmeter to the +5V Com
terminal of the DC Power Supply.

6\. Connect the positive lead of the digital voltmeter to the +5V
terminal of the DC Power Supply.

 If adjustments are necessary, remove the front column cover.

7\. If necessary, adjust R9 for a reading of +5 volts ±0.25 volts on the
digital voltmeter.

8\. Connect the negative lead of the voltmeter to the ±15V Com terminal.

9\. Connect the positive lead of the voltmeter to the -15V terminal.

10\. If necessary, adjust R57 for a reading of -15 volts ±0.75 volts.

11\. Connect the positive lead of the voltmeter to the +15V terminal.

12\. If necessary, adjust R82 for a reading of +15 volts ±0.75 volts.

13\. When calibration has been completed, replace the column covers.

The calibration procedure for the Airway Pressure Monitor Transducer is
as follows:

1\. Locate the pressure transducer ZERO and SPAN screwdriver adjustable
controls on the rear panel of the Control Package below the battery
compartment (see Figure 4.2). Have a suitably-small screwdriver
available to make any necessary adjustments.

2\. Attach a digital readout type pressure transducer meter to the
bottom "leg" of a 1/8\" "T" fitting. Attach one of the "arms" of the "T"
fitting directly to the pressure sense fitting of the patient "Y."
Attach the 3100B\'s 1/8\" Tygon pressure sense tubing directly to the
other "arm" of the "T" fitting.

3\. Plug the end of the patient circuit "T" with a #1 rubber stopper.
Turn on the bias-flow gas pressure, press reset until the Pa comes up,
and create a mean pressure of 40--45 cmH2O (as read on the transducer
meter) by using the Mean Pressure and Bias Flow controls (as explained
in the Start Up Procedures section of Chapter 6).

4\. Remove the #1 stopper and adjust the ZERO control on the rear panel
until the Mean Pressure Monitor digital readout matches the pressure
transducer meter reading within ±0.2 cmH2O. This reading is typically
between 0.2 and 0.3 cmH2O.

5\. Replace the #1 stopper, press reset until the Pa comes up, and
re-establish the 40--45 cmH2O mean pressure reading on the transducer
meter as explained in Step 3, above.

6\. Adjust the rear-panel SPAN control until the Mean Pressure Monitor
reading matches the pressure transducer meter within ±0.2 cmH2O.

7\. If the SPAN control requires no adjustment, the calibration
procedure is now complete. But if the SPAN control required
readjustment, steps 4,5, and 6 must be repeated (typically twice) until
both the near-zero level and the 40--45 cmH2O levels match within
±0.2cmH2O.

8\. The pressure transducer calibration procedure is now complete. It
has been adjusted finer than its "±2% of reading or ±2.0 cmH2O"
specification to allow for minor changes before the next required
calibration in 2,000 operating hours.

There are two other scheduled maintenance intervals suggested by
SensorMedics, based on accelerated life testing data and clinical usage
history. These are:

1\. Every 2,000 operating hours have the Oscillator Subassembly
("Driver") replaced with a new or rebuilt unit which has new diaphragms
and support spiders (the parts subject to flexure fatigue). This
replacement must be done by a factory trained technician.

2\. Every 8,000 operating hours have the 3100B HFOV returned to a
factory authorized service location for a complete overhaul. This
overhaul will include the scheduled Oscillator Subassembly replacement
plus the replacement of all other parts subject to usage wear and aging
(e.g., solenoid valves, regulators, plastic tubing, and cooling fans).

This section is intended to assist the operator in identifying and
correcting any apparent malfunctions of the 3100B System. For
assistance, the SensorMedics Technical Support Department can be reached
24 hours a day, 7 days a week.

Excessive amounts of dust and lint in the area around the 3100B can
cause malfunctions due to blockage of the cooling fan input at the base
of the instrument. We recommend keeping the instrument environment as
clean and well-ventilated as possible, along with the normal maintenance
of the cooling fan filter as described earlier in this chapter.

The 3100B is designed and tested to withstand normal to high amounts and
occurrences of Electrostatic Discharge (ESD)ESDElectrostatic Discharge.
Under certain circumstances, however, it is still possible for ESD to
cause component damage to the 3100B. ESD takes place when a person has
built up enough static electricity on their body and clothing that a
"shock" occurs when they touch something conductive, like metal or
another person. This can damage instrument components if the charge is
of sufficient strength. To avoid this, especially during conditions of
extremely low humidity when the levels of ESD are generally high, touch
the outer metal cabinet of the instrument before touching any other
component.

The 3100B is also designed and tested to withstand normal amounts and
occurrences of Electromagnetic Interference (EMI) EMI. Under certain
circumstances, however, it is possible for EMI to effect the components
of the system. EMI consists of electromagnetic waves from one electronic
device interfering with the function of another electronic device. These
waves can be radiated through the air or conducted through electrical
wiring. Likely causes of troublesome EMI in the hospital setting include
(but are not limited to) MRI systems, lasers, diathermy equipment,
cauterizers, transmitting computers, and hand-held radio transmitters.

Operation of radio transmitters (e.g., walkie-talkies, cellular phones,
etc.) within 20 feet of the instrument may cause erroneous pressure
readings, which can lead to false alarms and automatic shut-down. These
erroneous pressure readings are not due to fluctuations in the actual
pressure but are the effect of EMI on the components of the measurement
circuits. Once the disturbance stops, the reading returns to normal. If
the condition of interference is strong enough, and lasts long enough,
the \>60cmH2O or the \<5 cmH2O alarms may be triggered, which will cause
the dump valve to open and the oscillator to stop. Once the EMI
disturbance has stopped or has been removed, press the reset switch to
restart the oscillator. The situation can generally be remedied by
locating the offending device and then distancing it at least 20 feet
away.

In addition to the ***radiated*** EMI described above, ***conducted***
EMI can also cause the same problems by disturbing the AC power line.
Typical devices which can exhibit this phenomenon are personal computers
and other devices that rely on high speed switching electronics. This
sort of interference can be difficult to locate if there are many such
devices in the immediate vicinity. Without expensive electronic
detection equipment the only means available to locate the offending
device is to power down the surrounding systems one at a time until the
interference is removed.

It is important to note that ***radiated*** interference from hand-held
radio transmitters is the most common, and sources such as these should
be isolated first. The majority of devices used in a hospital
environment have been checked for conducted emissions and only through a
malfunction of the device is there likely to be an interference problem.

The following chart should be used as a guide in correcting problems
that may arise in the use of the 3100B. For problems not covered by this
list, or for any questions or concerns, call the SensorMedics Technical
Support Department.

Precaution

Troubleshooting with the 3100B should be done ***"OFF PATIENT"*** to
avoid any potentially dangerous situations such as abrupt changes in the
Pa.

Visual / Audible Alarm Occurring

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Displayed Pa | Patient at high Pa and    | Bias Flow rate possibly   |
| \> 60 cmH2O  | spontaneously breathing.  | insufficient, re-adjust   |
| Alarm        |                           | Pa using higher flow.     |
|              | Obstruction in expiratory | Also, consider clinical   |
|              | limb.                     | status of patient.        |
|              |                           |                           |
|              | Obstruction in pressure   | Replace patient circuit.  |
|              | sense line.               |                           |
|              |                           | Replace patient circuit.  |
|              | Interference from a radio |                           |
|              | transmitter.              | Remove source of          |
|              |                           | interference.             |
+--------------+---------------------------+---------------------------+
| Displayed Pa | Patient spontaneously     | Bias Flow rate possibly   |
| \> Set Max   | breathing.                | insufficient, re-adjust   |
| Pa           |                           | Pa using higher flow.     |
| Thumbwheel   | Improper setting of       | Also, consider clinical   |
| Alarm        | thumb-wheel switch.       | status of patient.        |
|              |                           |                           |
|              | Obstruction in expiratory | Change setting.           |
|              | limb.                     |                           |
|              |                           | Replace the patient       |
|              | Obstruction in pressure   | circuit.                  |
|              | sense line.               |                           |
|              |                           | Replace the patient       |
|              | Patient circuit           | circuit.                  |
|              | temperature rise.         |                           |
|              |                           | Check and correct circuit |
|              | Interference from a radio | temperature.              |
|              | transmitter.              |                           |
|              |                           | Remove the source of      |
|              |                           | interference.             |
+--------------+---------------------------+---------------------------+

Visual / Audible Alarm Occurring (cont.)

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Displayed Pa | Patient spontaneously     | Bias Flow rate possibly   |
| \< Set Min   | breathing.                | insufficient, re-adjust   |
| Pa           |                           | Pa using higher flow.     |
| Thumbwheel   | Improper setting of       | Also, consider clinical   |
| Alarm        | thumb-wheel switch.       | status of patient.        |
|              |                           |                           |
|              | Improper setting of Pa    | Change setting.           |
|              | adjust or flow meter.     |                           |
|              |                           | Change setting.           |
|              | Patient circuit           |                           |
|              | temperature drop.         | Check and correct circuit |
|              |                           | temperature.              |
|              | Leak in patient circuit   |                           |
|              | or humidifier.            | Eliminate leak or replace |
|              |                           | circuit.                  |
|              | Cap diaphragm leak.       |                           |
|              |                           | Replace cap diaphragm.    |
|              | Interference from a radio |                           |
|              | transmitter.              | Remove source of          |
|              |                           | interference.             |
+--------------+---------------------------+---------------------------+
| Displayed Pa | Improper setting of Pa    | Change setting.           |
| \< 5 cmH2O   | adjust or flow meter.     |                           |
| Alarm        |                           | Eliminate leak or replace |
|              | Leak in humidifier or     | circuit.                  |
|              | patient circuit,          |                           |
|              | including patient         | Replace cap diaphragm.    |
|              | disconnect.               |                           |
|              |                           | Remove source of          |
|              | Cap diaphragm leak.       | interference.             |
|              |                           |                           |
|              | Interference from a radio | Close Water Trap Stopcock |
|              | transmitter.              |                           |
|              |                           |                           |
|              | Open Water Trap Stopcock  |                           |
+--------------+---------------------------+---------------------------+
| Oscillator   | Power setting too low and | Adjust setting for        |
| Stopped with | ∆P is less than or equal  | desired ∆P.               |
| no other     | to 7 cm H2O.              |                           |
| alarm        |                           | Call SensorMedics         |
| occurring    | Oscillator Failure.       | Service.                  |
+--------------+---------------------------+---------------------------+

Visual / Audible Alarm Occurring (cont.)

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Source Gas   | Input pressure less than  | Check input gas lines.    |
| Low Alarm    | 30 psi, either from       |                           |
|              | blender or cooling air.   | Replace filters.          |
|              |                           |                           |
|              | Input filter needs        | Replace supply lines.     |
|              | replacement.              |                           |
|              |                           | Call SensorMedics         |
|              | Flow restriction in gas   | Service.                  |
|              | supply lines.             |                           |
|              |                           |                           |
|              | Internal leak.            |                           |
+--------------+---------------------------+---------------------------+
| Battery Low  | Battery voltage less than | Replace battery.          |
| Alarm        | optimal.                  |                           |
|              |                           | Properly reconnect        |
|              | Battery disconnected.     | battery.                  |
+--------------+---------------------------+---------------------------+
| Oscillator   | No cooling gas flow.      | Assure cooling gas supply |
| Overheated   |                           | hose is attached.         |
| Alarm        | Oscillator overheated due |                           |
|              | to poor cooling gas flow. | Check cooling gas flow    |
|              |                           | for blocked filter        |
|              | Oscillator overheated due | element or restricted     |
|              | to mechanical failure of  | supply hose---replace if  |
|              | oscillator subsystem.     | necessary.                |
|              |                           |                           |
|              |                           | Call SensorMedics         |
|              |                           | Service.                  |
+--------------+---------------------------+---------------------------+

Failure During Checkout

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Reset /      | AC power removed from     | Check line cord. If okay, |
| Power        | system or main power      | check other equipment on  |
| Failure      | interruption.             | same outlet. If other     |
|              |                           | equipment okay, possible  |
|              | Internal power supply     | internal fault. Contact   |
|              | failure.                  | SensorMedics Service.     |
|              |                           |                           |
|              |                           | To start oscillator after |
|              |                           | correcting problem, apply |
|              |                           | power to system, press    |
|              |                           | and hold "RESET" to       |
|              |                           | establish Pa, and then    |
|              |                           | press Stop/Start switch.  |
|              |                           |                           |
|              |                           | Call SensorMedics         |
|              |                           | Service.                  |
+--------------+---------------------------+---------------------------+

Failure During Checkout (cont.)

Condition Possible Causes Possible Remedies

+--------------+---+---------------------------+---+---------------------------+
| Failure to   | L |                           |   | Eliminate leak or replace |
| meet Patient | e |                           |   | patient circuit.          |
| Circuit      | a |                           |   |                           |
| Calibration  | k |                           |   | Set flow meter to 20 LPM, |
|              | i |                           |   | sighting on center of     |
|              | n |                           |   | ball.                     |
|              | p |                           |   |                           |
|              | a |                           |   | Close Water Trap Stopcock |
|              | t |                           |   |                           |
|              | i |                           |   | Call SensorMedics         |
|              | e |                           |   | Service.                  |
|              | n |                           |   |                           |
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|              | d |                           |   |                           |
|              | j |                           |   |                           |
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|              | n |                           |   |                           |
|              | t |                           |   |                           |
|              | . |                           |   |                           |
+--------------+---+---------------------------+---+---------------------------+
| Failure of   | I |                           |   | Perform Patient Circuit   |
| Ventilator   | n |                           |   | Calibration.              |
| Performance  | c |                           |   |                           |
| Check---Pa   | o |                           |   | Adjust flow to center of  |
| out of range | r |                           |   | ball.                     |
| (LOW)        | r |                           |   |                           |
|              | e |                           |   | Use appropriate altitude  |
|              | c |                           |   | range for your facility.  |
|              | t |                           |   |                           |
|              | P |                           |   | Call SensorMedics         |
|              | a |                           |   | Service.                  |
|              | t |                           |   |                           |
|              | i |                           |   |                           |
|              | e |                           |   |                           |
|              | n |                           |   |                           |
|              | t |                           |   |                           |
|              | C |                           |   |                           |
|              | i |                           |   |                           |
|              | r |                           |   |                           |
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|              | k |                           |   |                           |
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|              | 2 |                           |   |                           |
|              | 0 |                           |   |                           |
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|              | a |                           |   |                           |
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|              | l |                           |   |                           |
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|              | a |                           |   |                           |
|              | i |                           |   |                           |
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|              | u |                           |   |                           |
|              | r |                           |   |                           |
|              | e |                           |   |                           |
|              | . |                           |   |                           |
+--------------+---+---------------------------+---+---------------------------+
| Failure of   |   | Incorrect Patient Circuit | P |                           |
| Ventilator   |   | Calibration.              | e |                           |
| Performance  |   |                           | r |                           |
| Check---Pa   |   | Center of flow meter ball | f |                           |
| out of range |   | not used to make 20 LPM   | o |                           |
| (HIGH)       |   | adjustment.               | r |                           |
|              |   |                           | m |                           |
|              |   | Incorrect altitude range  | P |                           |
|              |   | being used.               | a |                           |
|              |   |                           | t |                           |
|              |   | Internal Failure.         | i |                           |
|              |   |                           | e |                           |
|              |   |                           | n |                           |
|              |   |                           | t |                           |
|              |   |                           | C |                           |
|              |   |                           | i |                           |
|              |   |                           | r |                           |
|              |   |                           | c |                           |
|              |   |                           | u |                           |
|              |   |                           | i |                           |
|              |   |                           | t |                           |
|              |   |                           | C |                           |
|              |   |                           | a |                           |
|              |   |                           | l |                           |
|              |   |                           | i |                           |
|              |   |                           | b |                           |
|              |   |                           | r |                           |
|              |   |                           | a |                           |
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|              |   |                           | i |                           |
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|              |   |                           | u |                           |
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|              |   |                           | a |                           |
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|              |   |                           | . |                           |
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|              |   |                           | U |                           |
|              |   |                           | s |                           |
|              |   |                           | e |                           |
|              |   |                           | a |                           |
|              |   |                           | p |                           |
|              |   |                           | p |                           |
|              |   |                           | r |                           |
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|              |   |                           | r |                           |
|              |   |                           | y |                           |
|              |   |                           | o |                           |
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|              |   |                           | f |                           |
|              |   |                           | a |                           |
|              |   |                           | c |                           |
|              |   |                           | i |                           |
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|              |   |                           | i |                           |
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|              |   |                           | y |                           |
|              |   |                           | . |                           |
|              |   |                           |   |                           |
|              |   |                           | C |                           |
|              |   |                           | a |                           |
|              |   |                           | l |                           |
|              |   |                           | l |                           |
|              |   |                           | S |                           |
|              |   |                           | e |                           |
|              |   |                           | n |                           |
|              |   |                           | s |                           |
|              |   |                           | o |                           |
|              |   |                           | r |                           |
|              |   |                           | M |                           |
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|              |   |                           | i |                           |
|              |   |                           | c |                           |
|              |   |                           | s |                           |
|              |   |                           | S |                           |
|              |   |                           | e |                           |
|              |   |                           | r |                           |
|              |   |                           | v |                           |
|              |   |                           | i |                           |
|              |   |                           | c |                           |
|              |   |                           | e |                           |
|              |   |                           | . |                           |
+--------------+---+---------------------------+---+---------------------------+

Failure During Checkout (cont.)

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Failure of   | Bias Flow tubing from     | Use Bias Flow tubing      |
| Ventilator   | humidifier to circuit has | supplied with circuit and |
| Performance  | been cut to less than     | do not shorten.           |
| Check---∆P   | 30\", or tubing not       |                           |
| out of range | supplied with patient     | Set Power to 6.           |
| (LOW)        | circuit being used.       |                           |
|              |                           | Bypass humidifier for     |
|              | Power not set at 6.       | performance check, then   |
|              |                           | re-attach.                |
|              | Compression               |                           |
|              | characteristics of        | Call SensorMedics         |
|              | humidifier allowing ∆P to | Service.                  |
|              | drop.                     |                           |
|              |                           |                           |
|              | Internal Failure.         |                           |
+--------------+---------------------------+---------------------------+
| Failure of   | Oscillator not warmed up. | Allow Oscillator to warm  |
| Ventilator   |                           | up for 5 minutes.         |
| Performance  | Incorrect altitude range  |                           |
| Check---∆P   | being used.               | Use appropriate altitude  |
| out of range |                           | range for your facility.  |
| (HIGH)       | Internal Failure.         |                           |
|              |                           | Call SensorMedics         |
|              |                           | Service.                  |
+--------------+---------------------------+---------------------------+

Unexplained Operation

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Oscillator   | Drastic change in Pa due  | Re-establish Pa and make  |
| shuts down   | to over-aggressive        | any small adjustments to  |
| and Dump     | control change using the  | Pa using Flow-meter       |
| Valve opens  | Pa Adjust.                | Adjust. Note: see         |
| during       |                           | Clinical Guidelines       |
| operation    | ET Tube has become        | chapter for minimum flow  |
|              | disconnected.             | requirements.             |
|              |                           |                           |
|              | Radio Frequency           | Reconnect ET Tube.        |
|              | Interference.             |                           |
|              |                           | Locate and distance       |
|              |                           | offending device.         |
+--------------+---------------------------+---------------------------+
| Oscillator   | To restart oscillator, Pa | Reduce power and increase |
| will not     | must first be \>5 cmH2O,  | Pa to target level using  |
| restart      | but in order to achieve   | flow meter and Pa Adjust  |
| after        | Pa \>5 cmH2O, oscillator  | Control---then increase   |
| temporary    | must be on.               | power while keeping Pa on |
| d            |                           | target by adjusting flow  |
| isconnection |                           | meter or Pa control valve |
| (such as for |                           | down.                     |
| routine      |                           |                           |
| suctioning). |                           |                           |
+--------------+---------------------------+---------------------------+

Unexplained Operation (cont.)

Condition Possible Causes Possible Remedies

+--------------+---------------------------+---------------------------+
| Pa           | Water collecting at Pa    | Adjust circuit height for |
| unst         | Control Valve.            | better draining.          |
| able---jumps |                           |                           |
| by 2--3      | Patient spontaneously     | Bias Flow rate possibly   |
| cmH2O        | breathing.                | insufficient; re-adjust   |
|              |                           | Pa using higher flow.     |
|              | Worn or defective cap     | Also, consider clinical   |
|              | diaphragm.                | status of patient.        |
|              |                           |                           |
|              | Internal Failure.         | Replace cap diaphragms.   |
|              |                           |                           |
|              |                           | Call SensorMedics         |
|              |                           | Service.                  |
+--------------+---------------------------+---------------------------+
| Humidifier   | Excessive heat from       | Ensure cooling gas is     |
| not          | driver                    | connected. Try different  |
| operating    |                           | source connection for     |
| properly     | Room temperature \> 84°F  | cooling gas.              |
|              |                           |                           |
|              |                           | Decrease room             |
|              |                           | temperature.              |
+--------------+---------------------------+---------------------------+
| Pa jumping   | Worn or improperly seated | Replace cap diaphragms.   |
| by \> 5      | cap diaphragm.            |                           |
| cmH2O when   |                           | Call SensorMedics         |
| trying to    | Internal Failure.         | Service.                  |
| adjust with  |                           |                           |
| Pa Adjust    |                           |                           |
| Valve.       |                           |                           |
+--------------+---------------------------+---------------------------+
| Oscillator   | Cap diaphragm defective.  | Replace cap diaphragm.    |
| making a     |                           |                           |
| squeaking    |                           |                           |
| sound        |                           |                           |
+--------------+---------------------------+---------------------------+

Parts and Supplies can be ordered by calling the SensorMedics Customer
Service Department. The Customer Service Representative can answer
questions concerning correct parts configurations and prices.

**Description**

3100B Patient Circuit Body (Flex Circuit with Heated Wire--Box of 4)

3100A Patient Circuit Body (Box of 4)

Cap/Diaphragm Set (Box of 4)

Bellows/Watertrap (Box of 4)

Gas Filter Cartridge Element (Package of 10)

Connecting Tube Assembly (8\" length, blue)

Connecting Tube Assembly (8\" length, green)

Connecting Tube Assembly (26\" length, red)

Connecting Tube Assembly (36\" length, red, for use with 771384-102
patient circuit)

Humidifier Tubing

Column Lint Filter Element

Hold Down Strap, Patient Circuit

Adjustable Cradle with Collar, Patient Circuit

Mounting Bracket, Humidifier, 77mm (RCI ConchaTherm)

Mounting Bracket, Humidifier, 30mm (Fisher and Paykel)

Lubricant

![](media/image30.png){width="4.85625in" height="2.19375in"}

Figure 7.3. Patient Circuit Parts.

The clinical guidelines described below reflect the strategies and
applications developed during the course of the Multicenter Oscillatory
ARDS Trial (MOAT II) Prospective Randomized Control Trial.

A recently published trial by the National Institutes of Health ARDS
network, comparing a "lung protective" strategy of lower tidal volumes
(\< 6 ml/kg) and plateau pressures (\< 30 cm H~2~O) with a higher tidal
volume strategy, reported an absolute mortality reduction of 9%. High
frequency oscillatory ventilation (HFOV) is an alternative method of
ventilation, which theoretically achieves the goals of lung protective
ventilation. HFOV achieves gas exchange by applying a constant mean
airway pressure, higher than that usually applied during conventional
ventilation. Thus, HFOV allows maintenance of alveolar recruitment while
potentially avoiding both the cyclic closing and opening of alveolar
units as well as the high peak airway pressures that occur with
conventional ventilation techniques.

The strategies are easy to implement because, for most clinical
situations, only two of the 3100B\'s five controls are employed: mean
airway pressure and oscillatory pressure amplitude (∆P). The other
three, Bias Flow, Frequency and % Inspiratory Time, are rarely changed
during the course of treatment, as explained below.

A continuous flow of fresh, humidified gas from a standard humidifier
and Air/Oxygen blender is a fundamental requirement for replenishing
oxygen and removing carbon dioxide from the patient circuit. In most
applications the flow rate should be set at not less than 20 l/min.
However, the effect of increasing this control is relatively benign
unless exceptionally high oscillatory amplitudes are required. In these
cases, bias flow should be higher to insure that the patient circuit
clearance flow is greater than the patient's oscillatory flow. If the
bias flow is inadequate, the patient circuit\'s effective dead space
will increase and diminish the ventilation affect being sought by
increasing the oscillatory amplitude (∆P). Additionally, when operating
the ventilator at high oscillatory amplitudes it may be necessary to
increase the flow to maintain mean airway pressure. Although changes in
Bias Flow will cause changes in Pa, in practice a flow rate of 20--40
l/min is typical.

If signs of carbon dioxide retention persist, increase the bias flow in
increments of 5 l/min as frequently as every 15 minutes. Remember that
the Pa Adjust control will have to be turned counterclockwise to
compensate for the increased flow, and maintain the desired Pa.

For adult applications the typical starting frequency is 5Hz. In
patients who present with refractory hypercapnia with maximal
oscillatory amplitude, the frequency is then decreased incrementally to
improve ventilation.

For most therapeutic situations, 33% has been found to be effective for
most patients. This control typically does not change during the course
of treatment.

As for the adjustment of inspired oxygen concentration (FIO2), the basic
strategy employed with the 3100B is the same as in conventional
ventilator strategy---wean the concentration lower, as tolerated.

Having addressed these seldom-changed controls and the approach to FIO2
management, it is time to turn attention to the two controls at the
heart of the strategy for patient management with the 3100B: mean airway
pressure and oscillatory pressure amplitude (∆P).

The table below summarizes the ranges of control settings employed
during the MOAT II Clinical Trial.

  ----------------------------- ------------- ------------ ---------------
  **Mean and Standard Deviation                            
  of 3100B Settings from MOAT                              
  II Clinical Trial**                                      

                                Mean                       
                                (Standard                  
                                Deviation)                 

  Patient Weight (kg)           78 (25)                    

                                24 hours      48 hours     72 hours

  FiO~2~                        0.51 (0.15)   0.52 (0.17)  0.51 (0.15)

  Mean Pa (cm H~2~O)            29 (6)        28 (6)       28 (6)

  Frequency (Hz)                4.7 (0.7)     4.7 (0.7)    4.5 (0.9)

  Amplitude (cm H~2~O)          66 (14)       65 (13)      66 (17)
  ----------------------------- ------------- ------------ ---------------

Mean airway pressure changes are accomplished by a single-turn control
that varies the inflation of a mushroom valve which, in turn, increases
the resistance to the exit of the bias flow from the expiratory limb of
the patient circuit. The management of mean airway pressure is
fundamental to controlling oxygenation. Increases in mean airway
pressure increase lung volume and therefore alveolar surface area. At
any given level of oscillatory pressure amplitude (∆P), oxygenation is
usually improved by increasing the mean airway pressure, and vice versa.
Disease-specific strategies for the manipulation of mean airway pressure
will be described below.

Pa will show small fluctuations with temperature and humidity changes.
The operator should be ready to make minor adjustments to Pa as the
circuit temperature rises and falls as it may, for instance, when a
humidifier canister is filled with fresh water.

Changes in the oscillatory pressure amplitude (∆P) are accomplished with
the ten-turn "Power" control, which adjusts the electrical current level
applied to the driving coil of the linear motor that displaces the
diaphragm-sealed piston. As the piston is displaced rapidly forward and
backward in a nearly square-wave pattern by the square-wave current in
the driving coil, high-amplitude pressures fluctuations are
symmetrically superimposed on the level of mean airway pressure
previously established in the patient circuit as described above (at a
%Insp Time of 50%).

Although the 3100B is capable of generating oscillatory pressure higher
than 90 cmH20 peak-to-peak at the proximal endotracheal tube attachment
point of the patient-circuit wye, no such pressures are developed in the
trachea. This is because the respiratory system impedance (of which the
endotracheal tube is the dominant element) greatly attenuates these high
frequency pressure waves and at the same time distorts their wave shape
into a nearly triangular pattern. For instance, at 3 Hz and a compliance
of 19 ml/cmH2O, the losses are:

95% 5.0 mm ET tube

91% 7.0 mm ET tube

84% 9.0 mm ET tube

Hence, in the clinical setting a larger ET tube will result in greater
distal pressure waveforms and a greater reduction in arterial PCO2.

To further clarify this oscillatory pressure amplitude phenomenon,
consider the following example. A patient with a compliance of 19
ml/cmH2O is attached to the 3100B\'s patient circuit with a 5.0 mm ET
tube. The 3100B is operating at 3 Hz, 33% Inspiratory Time, a mean
airway pressure of 25 cmH2O and a ∆P of 90 cmH2O. Hence, the peak
proximal airway pressure has a peak of 70 cmH2O and a low of minus 20
cmH2O, while the tracheal airway pressure has a peak of approximately 28
cmH2O and a low of 22 cmH2O because of the 95% attenuation caused by
this size ET tube at 3 Hz. With the 19 ml/cmH2O compliance, this distal
∆P of 6 cmH2O creates a high-frequency tidal volume of 114 ml in a lung
held at a nearly-constant, well-inflated level by the 25 cmH2O mean
airway pressure.

At a given mean airway pressure and frequency, the sole mechanism by
which ventilation (carbon dioxide removal) is achieved is the
high-frequency tidal volume created by the oscillatory pressure swings
(∆P). Hence, as the "Power" control is increased, the piston
displacement increases, the ∆P increases, the tidal volume increases,
and ventilation increases.

Although the great majority of patients can be ventilated with this
straightforward method of adjusting ∆P upwards to counter a high PaCO2
level, there are some patients who require an even larger ∆P. When this
is the case, the strategy is to take advantage of the
frequency-dependent nature of the attenuation caused by the ET tube. As
the frequency is reduced, the attenuation diminishes and a larger distal
∆P occurs, resulting in an increase in delivered tidal volume. Reducing
the frequency in 1 Hz increments---is generally sufficient to control
persistently high PaCO2 levels. In some patients, the frequency may have
to be reduced to 3Hz.

Assuming that peak alveolar pressure is the causative factor in airway
rupture, the principle advantage of HFOV over conventional ventilation
is its ability to maintain adequate ventilation and oxygenation at lower
peak alveolar pressures. Because ventilation is so readily achieved with
relatively low oscillatory pressure amplitudes, patients can be managed
at higher mean airway pressures while simultaneously operating at lower
peak alveolar pressures than conventional ventilators. This capability
serves to improve oxygenation by increasing alveolar recruitment and
reinflation of atelectatic lung spaces, and thereby improving
ventilation/perfusion matching. Hence, the therapeutic objectives in
using the 3100B are to take maximum advantage of these unique
characteristics.

The strategy for the MOAT II clinical trial identified an oxygenation
goal of a SpO~2~ ≥ 88%, with maintenance of mean airway pressure until
FiO2 could be reduced to ≤ 0.60. The target PaCO~2~ expected was between
40-70 mm Hg, although a higher PaCO~2~ was tolerated providing the pH
was \> 7.15.

Precaution

Patient size is an important guideline as to lung volume and anatomical
dead space, as well as the metabolic demand placed on ventilation. While
the maximum displacement of the 3100B is approximately 365 ml, the
actual volume delivered to the patient is dependent on power setting,
frequency, endotracheal tube size, and patient respiratory system
compliance.

The performance charts in Section 2 of this manual can be used as a
guide to these relationships, but they may vary somewhat with individual
patients and instruments.

Mean airway pressure (Pa) was set 5 cm H~2~O greater than the Pa during
conventional ventilation (CMV) immediately prior to transition to HFOV.
Target oxygenation parameters were; pulse oximetry (SpO~2~) ≥ 88%, with
fraction of inspired oxygen (FiO~2~) ≤ 0.60. Once the patient was
stabilized on HFOV, the FiO~2~ was reduced to ≤ 0.60 as long as SpO~2~
was ≥ 88%.

An open lung strategy was used to optimize oxygenation on HFOV by
increasing mean airway pressure. If an FiO~2~ \> 0.60 was required to
maintain SpO~2~ ≥ 88%, the Pa was increased in increments of 2 to 3 cm
H~2~O every 20 to 30 minutes to a maximum of 45 cm H~2~O. As oxygenation
improved, the FiO~2~ was reduced to maintain SpO~2~ ≥ 88%. Once FiO~2~ ≤
0.50, Pa was decreased in 1 to 2 cm H~2~O decrements at 4 to 6 hour
intervals, as long as SpO~2~ remained within the target range.

Initial oscillatory amplitude (∆P) was titrated to chest wall vibration.
∆P was subsequently titrated to achieve a PaCO~2~ within the target
range of 40 to 70 mm Hg and maintain pH \> 7.15. If the pH was \< 7.15,
the power setting was increased up to a maximum of "10" in order to
increase ∆P in increments of 10 cm H~2~O. If adequate ventilation could
not be achieved at maximum pressure amplitude, the following
interventions were used in sequence:

1\. Reduce respiratory frequency in 1 Hz steps to a minimum of 3 Hz.

2\. Deflate the endotracheal tube cuff followed by restoration of the Pa
by adjusting the Pa controls or bias flow (if Pa was already at maximum
setting).

Patients were weaned from HFOV back to CMV when FiO~2~ ≤ 0.50 and Pa was
≤ 24 cm H~2~O with SpO2 ≥ 88%. For transition back to CMV, the
conventional ventilator was set in the pressure control mode with peak
inspiratory pressure adjusted to achieve a delivered tidal volume of 6
-- 10 ml/kg of actual body weight, PEEP 10 cm H2O, and 1:1 I:E ratio.
These settings were designed to achieve a Pa of close to 20 cmH~2~O
(approximating the Pa on HFOV just prior to changing to CMV).

Summary of MOAT II Clinical Management Strategies

+-----------+------------------+---------------------------------------+
| **M       |                  |                                       |
| anagement |                  |                                       |
| S         |                  |                                       |
| trategy** |                  |                                       |
+-----------+------------------+---------------------------------------+
| Target    |                  |                                       |
| SpO2 ≥88  |                  |                                       |
|           |                  |                                       |
| Target    |                  |                                       |
| PaCO~2~   |                  |                                       |
| 40-70 mm  |                  |                                       |
| Hg        |                  |                                       |
+-----------+------------------+---------------------------------------+
|           | Initial Setting  | Continued Management                  |
+-----------+------------------+---------------------------------------+
| Pa        | CMV Pa +5 cm     | Increase Pa to achieve the            |
|           | H~2~O            | oxygenation goal (45 cm H~2~O         |
|           |                  | maximum)                              |
+-----------+------------------+---------------------------------------+
| Amplitude | Visible chest    | Adjust the amplitude to achieve the   |
|           | movement         | PCO~2~ goal.                          |
+-----------+------------------+---------------------------------------+
| Frequency | 5 Hz             | If the amplitude is maximized,        |
|           |                  | decrease the frequency by 1Hz         |
|           |                  | increments until the ventilation goal |
|           |                  | is reached.                           |
|           |                  |                                       |
|           |                  | If Frequency = 3 Hz, deflate ETT cuff |
+-----------+------------------+---------------------------------------+
| FiO2      | As Needed        | Maintain Pa until FiO~2~ \< 0.60      |
|           |                  | (SpO2\>88%)                           |
+-----------+------------------+---------------------------------------+
| Insp.     | 33%              |                                       |
| Time %    |                  |                                       |
+-----------+------------------+---------------------------------------+

  --------------- ------------- ------------- ------------- ----------------
  **Weaning from                                            
  HFOV**                                                    

  Transition to                                             
  CMV when:                                                 
  FiO2\< .50                                                
  **and** Pa \<                                             
  24 cmH~2~O                                                

                  Tidal Volume  I:E Ratio     PEEP          Mode

  Initial CMV     6-10 cc/Kg    1:1           10 cmH~2~O    Pressure Control
  Settings                                                  
  --------------- ------------- ------------- ------------- ----------------

B. Disease-Specific Variations to General Clinical Strategies

The primary pulmonary diagnoses which are associated with this pattern
of lung disease are: pneumonia and acute respiratory distress syndrome.

For these diagnoses, follow the general strategies outlined previously
in this chapter.

The primary diagnoses in this group of illnesses are: pulmonary
interstitial emphysema (PIE), and severe recurrent pneumothoraces. The
major pathophysiologic processes are: persistent leak of gas from the
airways and alveoli into the interstitium of the lung or into the
pleural space, and trapping of gas within the lung.

For these diagnoses, also follow the general strategies outlined above,
but with the following important changes in emphasis and pressure
levels:

1\. When FIO2 is above 0.6, place equal emphasis on weaning mean airway
pressure lower, even if it means accepting higher PaCO2 levels and lower
PaO2 levels, in order to further reduce the peak inflation pressure and,
thus, the risk of gas trapping and recurrent air leak.

2\. Initiate therapy at a lower frequency to provide a longer expiratory
time and, thus, further reduce the risk of gas trapping.

3\. Following resolution of air leak, revert to general strategies.

High frequency ventilation, as with conventional positive pressure
ventilation, has inherent risks. These possible adverse effects include:
under/over ventilation, under/over humidification, chronic obstructive
lung disease, necrotizing tracheal bronchitis (NTB), atelectasis,
hypotension, pneumothorax, pneumopericardium, pneumomediastinum,
pneumoperitoneum, and pulmonary interstitial emphysema (PIE).

The table below summarizes the adverse events reported during the MOAT
II Clinical Trial and demonstrates that within this study there was no
increase in the occurrence of the listed adverse effects with HFOV when
compared to conventional mechanical ventilation.

  --------------------------------------------- ------------ ------------
  Summary of reported adverse events during                  
  MOAT II Clinical Trial                                     

                                                HFOV         CMV

  Number of patients                            75           73

  Intractable hypotension failure               0%           3%

  Oxygenation failure                           5%           8%

  Respiratory acidosis failure                  5%           8%

  Air leak developed or worsened                9%           12%

  Mucous plugged ET Tube                        5%           4%
  --------------------------------------------- ------------ ------------

Precaution

Follow closely the recommendations contained in this Chapter regarding
the use of chest radiographs to monitor patient condition. During HFOV,
as with all ventilators, the relationship between improvement in lung
compliance, inadvertent increases in lung volume, increased pleural
pressure, and decreased venous return is a matter of concern, since it
may result in decreased cardiac output.

Precaution

The patient\'s tcPCO2 and tcPO2 or SpO2 should be monitored continuously
to insure that blood gases are at the proper level. It is important that
an unrestricted and unobstructed patient airway be maintained during
HFOV. To insure a patent airway, always maintain proper suctioning
procedures as described in the Suctioning Guidelines Section of Chapter
8, Clinical Guidelines. Since only proximal airway pressure is
monitored, no alarm will occur in the event of an obstruction or
restriction.

The recommended minimum frequency for monitoring the key pulmonary
status parameters is the following:

1\. 45--60 minutes after initiation of HFOV therapy to correlate to
transcutaneous values

2\. Every 2 hours for 8 hours

3\. Every 4 hours for 16 hours

4\. Every 8--12 hours depending on institution policy during treatment

5\. Within 1 hour after major setting change, or as clinically indicated

1\. Continuously. This may alert the clinician to subtle changes in the
patients ventilatory status that may not be detectable by auscultation
or physical exam.

1\. Within 4 hours of start of use

2\. Every 12 hours next 24 hours

3\. Every 24 hours next 5 days

4\. Every 48 hours next 8 days

5\. Every week thereafter

6\. Whenever lung over inflation is suspected

The need to suction during HFOV use should be determined based on
institution policy and clinical signs, just as with CV. The Multi-Center
Studies found no difference in the frequency of suctioning between the
HFOV and CV patients. However, some have observed that more frequent
suctioning becomes indicated during the treatment of the sickest
patients, especially after they have stabilized.

Precaution

Do not use extraneous ventilator circuit attachments (such as a suction
port) without a secondary external alarm capable of detecting ventilator
disconnection. Due to their inline pressure characteristics such
attachments could possibly keep the Pa alarm from detecting an
accidental ventilator circuit disconnection.

The correct steps for disconnection and reconnection of the patient are
as follows:

1\. Press the Alarm Silence. All the audio alarms will be inactive for
45 seconds. Note the settings for Pa and Power setting.

2\. Disconnect patient. This should allow the \<5 cmH2O Pa alarm to open
the dump valve and stop the oscillator.

3\. Perform suctioning using your institution's standard technique.

4\. Reconnect patient.

5\. Press and hold RESET. Once the Pa rises above 5 cmH2O, the
oscillator will restart. Readjust Power and Mean Pressure until Pa and
∆P are at the levels noted in step 1.

If the oscillator does not restart (or starts and then stops), first
turn the power down to a setting between 2 and 3; then, while holding
the reset switch, adjust the Pa to the desired level using the flow
meter. Next, while monitoring the Pa, turn the power up to achieve the
desired amplitude and adjust the flow meter as necessary to maintain the
desired Pa.

A

Adverse Effects, 1

Adverse Effects, Potential, 98

Air Cooling Inlet Fitting, 51

Air Leak Syndromes, 98

Airway Disease, 98

Airway Pressure Monitor, 34

Airway Pressure Monitor Transducer Calibration, 80

Alarm, 15

Alarm Battery, Power Failure, 50

Alarm Subsystem, 35

Alarm, Battery Low, 85

Alarm, Oscillator Overheated, 85

Alarm, Pa \< 5 cmH2O, 84

Alarm, Pa \< Set Min Pa Thumbwheel, 84

Alarm, Pa \> 60 cmH2O, 83

Alarm, Pa \> Set Max Pa Thumbwheel, 83

Alarm, Source Gas Low, 85

Alarms, 16

Arterial blood gases, 95

Arterial Blood Gases, 99

Assembly, 56

atelectasis, 98

B

Battery Attachment Label, 12

Battery Compartment, 50

Battery Low Alarm, 85

Battery Low Indicator, 14, 47

Battery Specification Label, 12

Battery, Power Failure Alarm, Changing, 74

Bellows Fasteners, 54

Bias Flow, 90

Bias Flow Control, 13, 27

Blender, 61

Blender, External Air/O2, 25

Blender/Cooling Gas Filter Replacement Record, 51

Blender/Cooling Gas Filter Replacement Record Label, 9

blood gases, Arterial, 95

Blood Gases, Arterial, 99

Bulkhead Luer Fittings, 55

C

Calibration, Airway Pressure Monitor Transducer, 80

calibration, patient circuit, 66

Calibration, Patient Circuit, 77

Calibration, Periodic, Scheduled, 77

Calibration, Power Supply, 78

Caution Alarms, 16, 38

Changing the Compressed-gas Inlet Filter Cartridge Elements, 73

Changing the Patient Circuit, 75

Changing the Power Failure Alarm Battery, 74

Chest X-Ray, 100

Children, Large, Adults Special Considerations, 94

circuit breaker, 53

Circuit, Patient, 28

Cleaning and Disinfection, Pre-use, 63

Cleaning the Column Lint Filter, 75

Cleaning, Exterior, 72

Clinical Guidelines, 90

Clinical Strategy, General Aspects, 94

color-coded tubes, 59

Column Lint Filter, Cleaning, 75

Compartment, Battery, 50

Compressed-gas Inlet Filter Cartridge Elements, Changing, 73

Connections, Gas, 18

Connections, Location and Function, 40

Connections, Rear Panel, 61

connections, tubing, 61

Contraindications, 1

Controls, 13

Controls, Location and Function, 40

Cradle, Patient Circuit, 54

D

Delta P, 35

Delta P Control, 43

Delta P Indicator, 15

Dimensions, 19

Disconnection and Reconnection during Suctioning, 100

Disease-Specific Variations to General Clinical Strategies, 98

Drain Valve, Water Trap, 54

Driver Diaphragm, Lubrication, 75

Driver Lubrication Record Label, 9

Driver Replacement Record, 51

Driver Replacement Record Label, 10

Dump Valve, 30

Dump Valve Control, 53

E

Effects, Adverse, 1

Elapsed Time Indicator, 15

Elapsed Time Meter, 50

Electrical Power Supply, 36

Electrical Specifications, 17

Electromagnetic Interference (EMI), 82

Electronic Control and Alarm Subsystem, 35

Electrostatic Discharge (ESD), 81

EMI (Electromagnetic Interference), 82

Emptying the Water Trap, 73

Environmental and Operational Conditions, 19

Environmental Considerations, 81

Explanation of Symbols, 6

Exterior Cleaning, 72

F

Filter Cartridge Elements, Compressed-gas Inlet, Changing, 73

FIO2, 91

Flow, Bias, 90

Forty-five Sec Silence Pushbutton, 48

Frequency, 91

Frequency Control, 13, 44

Frequency Indicator, 15

G

Gas Connections, 18

General Clinical Strategies, Disease-Specific Variations, 98

Graphs, Performance, 20

H

Hold Down Strap, 55

Homogeneous Lung Disease, 98

Humidifier, 61

Humidifier Tubing, 54

Humidifier, External, 25

Humidity, 19

hypotension, 98

I

Indications for Use, 1

Indicators, 14

Indicators, Location and Function, 40

Inlet Fitting from Blender, 50

Inspiratory Time Control, 13

Inspiratory Time, Percent, 91

Installation, 56

Interference, Electromagnetic, 82

Introduction, 1

L

Labels, Exterior, 7

Leakage Current, 17

Lint Filter, Column, Cleaning, 75

Lubrication, Driver Diaphragm, 75

M

Maintenance, 72

Maintenance Procedures, Operator, 72

Maintenance, Periodic, Scheduled, 81

Mean Airway Pressure, 35, 92

Mean Airway Pressure Indicator, 44

Mean and Range of 3100A Settings, 96

Mean Pressure Adjust, 13, 27, 42

Mean Pressure Limit, 13

Mean Pressure Monitor, 15

mechanical relief valves, 39

Monitoring Frequency, Recommended, 99

Multi-Center Controlled Trials, 90

Multi-Center Studies, 100

N

Name Rating Label, 11

necrotizing tracheal bronchitis (NTB), 98

Non-Homogeneous Lung Disease, 98

O

Operational and Environmental Conditions, 19

Operational Verification, 64

Operator Maintenance Procedures, 72

Oscillator Compartment (Bellows), 53

Oscillator Enabled Indicator, 14

Oscillator Overheated Alarm, 85

Oscillator Overheated Indicator, 14, 48

Oscillator Stopped Alarm, 38

Oscillator Stopped Indicator, 14, 48

Oscillator Subassembly Replacement, 81

Oscillator Subsystem, 32

Oscillatory Pressure Amplitude, 92

Outlet Fitting to Humidifier, 50

overhaul, complete, scheduled, 81

Overload Protection, 17

Oxygenation, Management, 95

P

Pa \< 5 cmH2O Alarm, 84

Pa \< 5 cmH2O Indicator, 46

Pa \< Set Min Pa Thumbwheel Alarm, 84

Pa \<20% of, 14

Pa \> 60 cmH2O Alarm, 83

Pa \> 60 cmH2O Indicator, 45

Pa \> Set Max Pa Thumbwheel Alarm, 83

Pa \>50 cmH2O Indicator, 14

Pa Control Valve, 29

Pa Control Valve Control, 53

Pa Limit Valve Control, 53

Pa Sense Fitting, 53

Parts, 88

Patient Circuit, 28, 52

patient circuit calibration, 66

Patient Circuit Calibration, 77

Patient Circuit Calibration Control, 14, 27, 48

Patient Circuit Calibration Failure, 86

Patient Circuit Calibration Procedure Label, 7

Patient Circuit Cradle, 54

Patient Circuit, Changing, 75

Percent Inspiratory Time, 91

Percent Inspiratory Time Control, 43

Percent Inspiratory Time Indicator, 15

Performance Check, Ventilator, 67

Performance Graphs, 20

Performance Verification, 70

Periodic Calibration, Scheduled, 77

Periodic Maintenance, Scheduled, 81

Pneumatic Connections, 18

Pneumatic Logic and Control, 27

pneumomediastinum, 98

pneumonia, 98

pneumopericardium, 98

pneumoperitoneum, 98

pneumothoraces, severe recurrent, 98

pneumothorax, 98

Position Lock Control, 50

Potentiometers, Power Supply, 79

Power Control, 13, 43

Power Failure Alarm, 38

Power Failure Alarm Battery, 50

Power Failure Alarm Battery, Changing, 74

Power Failure Indicator, 14, 46

Power Indicator, 15

Power Requirements, 17

Power Supply, 36

Power Supply Calibration, 78

Power Switch, 53

Precautions, 3

Pressure Limit Valve, 29

Pressure Specifications, 15

Pressure Transducer Span Adjustment, 50

Pressure Transducer Zero Adjustment, 50

Pre-use Cleaning and Disinfection, 63

proximal airway pressure sensing line, 29

pulmonary interstitial emphysema (PIE), 98

R

Radio Frequency Interference (RFI) Warning Label, 11

radio transmitters, 82

Rear Panel Connections, 61

Rear Panel, Control Package, 49

Reset / Power Failure, 85

Reset Button, 14

Reset Pushbutton, 47

respiratory distress syndrome, 98

S

safety alarms, 30

Safety Alarms, 16, 37

Safety and System Features, Description, 25

Safety Features, 37

Safety Standards, 17

Scheduled Periodic Calibration, 77

Scheduled Periodic Maintenance, 81

Set Max Pa Alarm Thumbwheel, 13

Set Max Pa Control, 44

Set Max Pa Exceeded Indicator, 14

Set Max Pa Thumbwheel, 15

Set Min Pa, 45

Set Min Pa Alarm Thumbwheel, 14

Set Min Pa Exceeded Indicator, 14

Set Min Pa Thumbwheel, 15

Silence Control, 45-Sec, 14

Silence Indicator, 45-SEC, 14

Source Gas Low Alarm, 85

Source Gas Low Indicator, 14, 47

Span Adjustment, Pressure Transducer, 80

Specifications, 13

square-wave driver, 32

Standards, Safety, 17

Start/Stop Control, 13, 44

Start-up Procedures, 64, 65

Strap, Hold Down, 55

Strategies, Treatment, 90

Suctioning Guidelines, 100

Supplies, 88

System and Safety Features, Description, 25

System Column, 52

T

Technical Support Department, 81

Temperature, 19

Therapeutic Intervention and Rationale, HFOV, Summary, 97

Therapeutic Objectives, 94

thermal cutout circuit, 34

thermal cutout safety system, 39

Treatment Strategies, 90

Troubleshooting, 72, 81

Troubleshooting Chart, 83

tubes, color-coded, 59

tubing connections, 61

Tubing, Humidifier, 54

U

Unpacking the Instrument, 56

V

Ventilation, Management, 94

Ventilator Performance Check, 67

Ventilator Performance Check Failure, 86

Ventilator Performance Checks Label, 8

Verification, Operational, 64

W

Warning Alarms, 16

Warnings, 1

Water Trap, 31, 39, 54

Water Trap Drain Valve, 54

Water Trap, Emptying, 73

Weaning, 95

Wilford Hall Medical Center, 90

X

X-Ray, Chest, 100

Z

Zero Adjustment, Pressure Transducer, 80