TSI/Alnor 4073, 4072, 4075, 4078, 4076 User manual

CERTIFIER® FA

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980436, REVISION L

FEBRUARY 2017

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Caution

TSI flowmeters are not medical devices under FDA 510(k) and in no
situation should be used for human measurements.

LIMITATION OF WARRANTY AND LIABILITY (effective April 2014)

Seller warrants the goods, excluding software, sold hereunder, under normal use and
service as described in the operator's manual, to be free from defects in workmanship and
material for 12 months, or if less, the length of time specified in the operator's manual,
from the date of shipment to the customer. This warranty period is inclusive of any statutory
warranty. This limited warranty is subject to the following exclusions and exceptions:

a. Hot-wire or hot-film sensors used with research anemometers, and certain other

components when indicated in specifications, are warranted for 90 days from the date
of shipment;

b. Pumps are warranted for hours of operation as set forth in product or operator’s

manuals;

c. Parts repaired or replaced as a result of repair services are warranted to be free from

defects in workmanship and material, under normal use, for 90 days from the date of
shipment;

d. Seller does not provide any warranty on finished goods manufactured by others or on

any fuses, batteries or other consumable materials. Only the original manufacturer's
warranty applies;

e. This warranty does not cover calibration requirements, and seller warrants only that

the instrument or product is properly calibrated at the time of its manufacture.
Instruments returned for calibration are not covered by this warranty;

f. This warranty is VOID if the instrument is opened by anyone other than a factory

authorized service center with the one exception where requirements set forth in the
manual allow an operator to replace consumables or perform recommended
cleaning;

g. This warranty is VOID if the product has been misused, neglected, subjected to

accidental or intentional damage, or is not properly installed, maintained, or cleaned
according to the requirements of the manual. Unless specifically authorized in a
separate writing by Seller, Seller makes no warranty with respect to, and shall have no
liability in connection with, goods which are incorporated into other products or
equipment, or which are modified by any person other than Seller.

The foregoing is IN LIEU OF all other warranties and is subject to the LIMITATIONS stated
herein. NO OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR

PARTICULAR PURPOSE OR MERCHANTABILITY IS MADE. WITH RESPECT TO
SELLER’S BREACH OF THE IMPLIED WARRANTY AGAINST INFRINGEMENT, SAID
WARRANTY IS LIMITED TO CLAIMS OF DIRECT INFRINGEMENT AND EXCLUDES
CLAIMS OF CONTRIBUTORY OR INDUCED INFRINGEMENTS. BUYER’S EXCLUSIVE
REMEDY SHALL BE THE RETURN OF THE PURCHASE PRICE DISCOUNTED FOR

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REASONABLE WEAR AND TEAR OR AT SELLER’S OPTION REPLACEMENT OF
THE GOODS WITH NON-INFRINGING GOODS.

TO THE EXTENT PERMITTED BY LAW, THE EXCLUSIVE REMEDY OF THE USER
OR BUYER, AND THE LIMIT OF SELLER'S LIABILITY FOR ANY AND ALL LOSSES,
INJURIES, OR DAMAGES CONCERNING THE GOODS (INCLUDING CLAIMS BASED
ON CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) SHALL
BE THE RETURN OF GOODS TO SELLER AND THE REFUND OF THE PURCHASE
PRICE, OR, AT THE OPTION OF SELLER, THE REPAIR OR REPLACEMENT OF
THE GOODS. IN THE CASE OF SOFTWARE, SELLER WILL REPAIR OR REPLACE
DEFECTIVE SOFTWARE OR IF UNABLE TO DO SO, WILL REFUND THE
PURCHASE PRICE OF THE SOFTWARE. IN NO EVENT SHALL SELLER BE LIABLE
FOR LOST PROFITS, BUSINESS INTERRUPTION, OR ANY SPECIAL, INDIRECT,
CONSEQUENTIAL OR INCIDENTAL DAMAGES. SELLER SHALL NOT BE
RESPONSIBLE FOR INSTALLATION, DISMANTLING OR REINSTALLATION COSTS
OR CHARGES. No Action, regardless of form, may be brought against Seller more than
12 months after a cause of action has accrued. The goods returned under warranty to
Seller's factory shall be at Buyer's risk of loss, and will be returned, if at all, at Seller's
risk of loss.

Buyer and all users are deemed to have accepted this LIMITATION OF WARRANTY AND
LIABILITY, which contains the complete and exclusive limited warranty of Seller. This
LIMITATION OF WARRANTY AND LIABILITY may not be amended, modified or its terms
waived, except by writing signed by an Officer of Seller.

Service Policy

Knowing that inoperative or defective instruments are as detrimental to TSI as they are
to our customers, our service policy is designed to give prompt attention to any
problems. If any malfunction is discovered, please contact your nearest sales office or
representative, or call TSI's Customer Service department at [phone] / (1) 651
490-2811 (USA and International) or TSI Instruments in UK at: [phone].

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Contents

1 INTRODUCTION ........................................................................... 1

1.1 Parts List ............................................................................. 3

1.2 Glossary .............................................................................. 6

2 SETUP ........................................................................................... 7

3 OPERATION ............................................................................... 13

3.1 Power Up .......................................................................... 13

3.2 Keypad Functions ............................................................. 14

3.3 Displaying Test Measurements ........................................ 14

3.4 Measurements .................................................................. 15

3.4.1 Flow Rate .............................................................. 15

3.4.2 Peak Flow Rate ..................................................... 16

3.4.3 Volume .................................................................. 16

3.4.4 Minute Volume ...................................................... 16

3.4.5 Stacked Volume .................................................... 17

3.4.6 Oxygen Concentration .......................................... 17

3.4.7 Low Pressure ........................................................ 17

3.4.8 Peak Pressure ....................................................... 18

3.4.9 Peep Pressure....................................................... 18

3.4.10 Breath Rate ........................................................... 18

3.4.11 I:E Ratio ................................................................. 18

3.4.12 I Time .................................................................... 19

3.4.13 Absolute Pressure ................................................. 19

3.4.14 Oxygen Concentration .......................................... 19

3.5 Required Pre-test Calibrations .......................................... 20

3.5.1 Low-Pressure Transducer Zero Calibration .......... 20

3.5.2 Oxygen Sensor Calibration ................................... 20

3.6 Breathing Cycles and Trigger Levels ................................ 21

3.6.1 Inhalation and Exhalation Timing .......................... 21

3.6.2 Flow Trigger Levels ............................................... 21

3.7 Display Information ........................................................... 22

4 TROUBLESHOOTING ................................................................ 25

5 MAINTENANCE .......................................................................... 29

5.1 Replacing the Batteries (as required) ............................... 29

5.2 Replacing the Oxygen Sensor (yearly) ............................. 29

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5.3 Cleaning (as required) ....................................................... 29

5.4 Factory Calibration (yearly) ............................................... 30

5.5 Return Procedure .............................................................. 30

6 SPECIFICATIONS....................................................................... 31

6.1 Physical ............................................................................. 31

6.2 Environmental ................................................................... 31

6.3 Power ................................................................................ 31

6.4 Test Measurements .......................................................... 31

6.5 Calibration Requirements.................................................. 33

6.6 Compliance and Approvals ............................................... 33

List of Figures

Figure 1. The Certifier
Figure 2. Certifier

Figure 3. Connecting the Controller Module to a Flow Module ..... 7

Figure 4. Connecting the Bacteria Filters to the Flow Modules .... 8

Figure 5. Attaching Pressure Tubing to the High Flow Module ..... 9

Figure 6. Attaching the Oxygen Sensor to the High Flow

Module ......................................................................... 10

Figure 7. Installing a Flow Module into the Test Circuit .............. 11

Figure 8. Certifier® FA Test System Installed in an Oxygen

Concentrator Circuit .................................................... 12

Figure 9. Controller Module Keypad ............................................ 14

®

FA Test System ....................................... 2

®

FA Test System Parts ..................................... 3

List of Tables

Table 1. Certifier

Table 2. Keypad Functions and Operation .................................. 14

Table 3. Screen Displays ............................................................. 22

Table 4. Troubleshooting the Certifier

Table 5. Cleaning Recommendations ......................................... 29

iv

®

FA Test System Parts List ............................... 4

®

FA Test System ............ 25

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1 Introduction

The Certifier® Flow Analyzer (FA) Test System allows you to test
respiratory care or other devices. This portable tester makes it simple
to test flows, volumes, pressures, oxygen concentration, and breath
timing. The Certifier® FA Test System is designed for institutional,
home care, field service, and laboratory settings.

Certifier® FA Test System components include:

 Controller module:

The keypad and display allow you to select test measurements
and units for display. The controller module connects to a high or
Low Flow module.

 High Flow module:

Measures air or 100% oxygen (O2) over a range of flows from 0
to 300 standard liters per minute (SLPM).

 Low Flow module:

Measures air, 100% O2, or 100% nitrous oxide (N2O) over a
range of flows from 0.01 to 15 SLPM with greater accuracy than
the High Flow module at low flow rates.

 Oxygen sensor:

Used with the High Flow module, allows the High Flow module to
measure O2 concentration and other measurements for any
mixture of air and O2.

You can connect or disconnect the flow modules and oxygen sensor
at any time during normal operation without interrupting tester
operation. Four AA batteries power the test system. The test system
conserves power by automatically turning off if none of the keys are
pressed for 15 minutes. See Section 3.1 to disable this feature.

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2

Controller
module

Low Flow
module

High Flow
module

Oxygen
sensor

Figure 1. The Certifier® FA Test System

WARNING

 To avoid the risk of explosion, do not use in the presence of

flammable anesthetic gases.

 Only qualified and trained service technicians are authorized to

service the Certifier® FA Test System. Use only factory-approved
parts and procedures to service the device.

CAUTION

 To avoid inaccurate test readings, do not obstruct tubing or inlet

or exhaust ports, and always use dry gas.

 To avoid damage to the Certifier® FA Test System components,

always use bacteria filters upstream of the flow modules, and
always cap flow module ports when not in use.

 TSI flowmeters are not medical devices under FDA 510(k) and in

no situation should be used for human measurements.

1: Introduction

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3

1.1 Parts List

Carefully unpack the test system components from the shipping
container. Check the individual parts against the packing list and
notify TSI immediately if anything is missing or damaged. Table 1
summarizes the Certifier® FA Test System components and part
numbers shown in Figure 2.

Figure 2. Certifier® FA Test System Parts

1: Introduction

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4

Table 1. Certifier® FA Test System Parts List

Item

no.

Description

Part
no.

Qty

High Flow standard kit (part no. 4070)

1

Controller module

4078

1 2 High Flow module

4071

1

3

Bacteria filter, 22-mm x 22-mm
male/female, for use with High Flow
module (single use)

1602341

1

4

Soft carrying case (holds Certifier® FA Test
System and accessories)

1319289

1

5

Adapter, 15-mm ID x 22-mm OD

1102093

1 6 Airway pressure fitting with screen

1611330

1

7

Adapter, 22-mm x 6-mm (for interfacing
High Flow module to Low Flow filter, for
use with oxygen concentrator)

1102091

2

8

Pressure tubing, 1/8-in. ID x 1/4-in. OD x
48-in. length, silicone

3002053

1

9

Mounting bracket (includes mounting
bracket, screws, and Velcro strap)

1040044

1

10

Pocket driver (used to remove/install the
controller module battery cover)

3012034

1
11

AA batteries (not shown)

NA

4

12

Certifier® FA Test System Operator’s
Manual (not shown)

1980436

1

1: Introduction

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1: Introduction

5

Table 1. Certifier® FA Test System Parts List (cont)

Item

no.

Description

Part
no.

Qty

Low Flow standard kit (part no. 4075)

1

Controller module

4078

1

13

Low Flow module

4074

1

14

Bacteria filter, barbed fittings, for use with
Low Flow module (single use)

1040045

1 4 Soft carrying case (holds Certifier® FA Test

System and accessories)

1319289

1 9 Mounting bracket (includes mounting

bracket, screws, and Velcro strap)

1040044

1

10

Pocket driver (used to remove/install the
controller module battery cover)

3012034

1
11

AA batteries (not shown)

NA

4

12

Certifier® FA Test System Operator’s
Manual (not shown)

1980436

1

High Flow module kit (optional) (part no. 4076)

2

High Flow module

4071

1

3

Bacteria filter, 22-mm x 22-mm
male/female, for use with High Flow
module (single use)

1602341

1

5

Adapter, 15-mm ID x 22-mm OD

1102093

1 6 Airway pressure fitting with screen

1611330

1

7

Adapter, 22-mm x 6-mm (for interfacing
High Flow module to Low Flow filter, for
use with oxygen concentrator)

1102091

2

8

Pressure tubing, 1/8-in. ID x 1/4-in. OD x
48-in. length, silicone

3002053

1 9 Mounting bracket (includes mounting

bracket, screws, and Velcro strap)

1040044

1

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6

Table 1. Certifier® FA Test System Parts List (cont)

Item

no.

Description

Part
no.

Qty

Low Flow module kit (optional) (part no. 4072)

13

Low Flow module

4074

1

14

Bacteria filter, barbed fittings, for use with
Low Flow module (single use)

1040045

1 9 Mounting bracket (includes mounting

bracket, screws, and Velcro strap)

1040044

1

Oxygen sensor kit (optional) (part no. 4073)

15

Oxygen sensor

2917019

1

16

Threaded tee

1313118

1

17

Cable, 8-in. length

1303741

1

Other accessories (optional)

18

Hard shell carrying case (holds
Certifier® FA Test System and
accessories)

1319288

1

1.2 Glossary

Refer to manual: see Certifier® FA Test System Operator’s
Manual for important information.

Safety approvals for Canada by Underwriter’s Laboratories
Inc. (UL).

These labels, terms, and symbols appear on the Certifier® FA Test
System:

See Section 3.7 for definitions of symbols and abbreviations that
appear on the Certifier® FA display.

1: Introduction

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Controller
module

Flow

module

2 Setup

Follow these steps to set up the Certifier® FA Test System:

CAUTION

To avoid damage to the Certifier® FA Test System components,
always use bacteria filters upstream of the flow modules, and always
cap flow module ports when not in use.

1. Connect the controller module to a flow module (Figure 3).

To remove the cable, pull its locking connector (not the cable)
from the controller module.

Figure 3. Connecting the Controller Module to a Flow Module

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2. Attach the bacteria filter to the flow module (Figure 4).

Controller
module

High Flow module
(note flow direction)

Low Flow module
(note flow direction)

High Flow filter

Low Flow
filter

Install the bacteria filter to the flow module inlet or upstream of all
Certifier® FA Test System components. Make sure the filter is in
the correct orientation by aligning the filter’s flow arrow with the
direction of the flow, ensuring that the filter’s inlet indicator
(labeled “INLET”, “I”, or other) faces upstream of the flow module,
or that the outlet indicator (label “Patent side”, “Outlet” or other)
faces towards the flow module.

Figure 4. Connecting the Bacteria Filters to the Flow Modules

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3. High Flow module only: install pressure tubing (Figure 5).

Pressure
tubing

High Flow module

Attach one end of the pressure tubing to the low-pressure port on
the flow module, and the other to the pressure port in the circuit.

Figure 5. Attaching Pressure Tubing to the High Flow Module

2: Setup 9

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4. High Flow module only: install the oxygen sensor (optional,

High Flow module

Threaded tee

Oxygen
sensor

Oxygen sensor

cable

Figure 6).

Plug the oxygen sensor cable into the High Flow module and
oxygen sensor. Turn the cable collar to secure the cable to the
oxygen sensor. Use the threaded tee to install the oxygen sensor
into the circuit. The oxygen sensor can only connect to the High
Flow module.

Figure 6. Attaching the Oxygen Sensor to the High Flow Module

10 2: Setup

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5. Install the flow module into the test circuit (Figure 7, Figure 8).

Ventilator

Align the flow direction of the flow module and filter with the
direction of flow through the circuit.

Figure 7. Installing a Flow Module into the Test Circuit

2: Setup 11

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Oxygen
Concentrator

Figure 8. Certifier® FA Test System Installed in an Oxygen

Concentrator Circuit

12 2: Setup

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3 Operation

3.1 Power Up

Pull the protective caps from the flow module ports before powering
up. Do not apply pressure to the flow module at power up (this
ensures accurate low-pressure transducer zero calibration).

Press the I/O (on/off) key on the controller module to power up the

Certifier® FA Test System (the controller module powers all of the
attached Certifier® FA Test System components). At power up, the
controller module shows information in this sequence:

1. All LCD segments light (about two seconds).

NOTE: If battery voltage is below the minimum operating level,
the battery symbol lights and the controller module will turn off.

2. Firmware revision shown (about two seconds).

3. Controller module verifies connection and correct operation of the
flow module and oxygen sensor (if installed). If the oxygen

sensor is installed, the controller module will display a
symbol.

4. Default measurements displayed:

High Flow module: flow (top line), low pressure (bottom line).
Low Flow module: flow (top line), respiratory rate (bottom line).

CAUTION

 To ensure accurate measurements, wait about one minute for the

Certifier® FA Test System to warm up. If environmental conditions
have changed significantly, more time may be necessary.

 To avoid damage to the Certifier® FA Test System components,

always use bacteria filters upstream of the flow modules, and
always cap flow module ports when not in use.

 If liquid has penetrated any of its components, do not use, and

return to the factory for calibration.

The test system conserves battery life by automatically turning off if
none of the keys are pressed for 15 minutes. To override the
automatic turn off, press the GAS SELECT key with the I/O key when
turning on. The will appear while the software revision is
displayed during power up if the automatic turn off is disabled.

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3.2 Keypad Functions

Top line

select key

Bottom line

select key

ON/OFF

key

DISPLAY
UNITS key

GAS SELECT

key

Backlight

on/off key

Table 2. Keypad Functions

Key

Primary Function

Top line select

Selects the measurement shown on the

top line of the display.

Bottom line select

Selects the measurement shown on the

bottom line of the display.

ON/Off

Turns the system on (I) or off (O).

DISPLAY UNITS

Selects the unit of measure for

measurements.

GAS SELECT

Selects the supply gas type for the
Certifier

®

FA.

Backlight on/off

Turns the controller module display

backlight on or off.

Table 2 summarizes the primary functions of the Certifier® FA Test
System keypad (Figure 9).

Figure 9. Controller Module Keypad

3.3 Displaying Test Measurements

Follow these steps to display test measurements:

1. Set up the Certifier® FA Test System and install it into the circuit.

2. Press the I/O (on/off) key to power up the system.

14 3: Operation

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3. Once power up is complete, press the Top line select and
Bottom line select keys to select the measurements to be

displayed. See Section 3.4, Measurements, for details on each
parameter.

You can change the display selections and connect or disconnect the
flow module or oxygen sensor at any time during normal operation.

 If you disconnect the flow module, the controller module display

is blank.

 If you disconnect the oxygen sensor, the sensor symbol and any

oxygen-related measurements are not shown on the display.

 Normal operation and display resume about one second after

reconnection.

NOTE: The Certifier® FA Test System automatically updates
measurements that are recalculated at every breath. The Certifier®
FA Test System uses a threshold flow to determine the beginning and
end of each breath. The threshold flow calculated from the last three
breaths, is updated at each breath, and then is applied to the
following breath. Breath measurement displays begin after two full
breaths.

CAUTION

To avoid damage to the Certifier® FA Test System components,
always use bacteria filters upstream of the flow modules, and always
cap flow module ports when not in use.

3.4 Measurements

Measurements on Top Line of Display

The following parameters are displayed on the top line of the display.

The Top Line Select key is used to scroll through parameters by
momentarily pressing and then releasing the key.

3.4.1 Flow Rate

The flow rate can be displayed on the top line of control module
display. Units of standard liters per minute, indicated by “SLPM”, and
actual liters per minute, indicated by “LPM”, can be selected using the
DISPLAY UNITS key. For the High Flow module air, O2, and air/O2
mixture (when oxygen sensor is attached) can be selected using the
GAS SELECT key. For the Low Flow module air, O2, and N2O can be
selected using the GAS SELECT key.

3:Operation 15

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3.4.2 Peak Flow Rate

Maximum flow rate during the inhalation cycle of a breath can be
displayed on the top line of the control module display. Units of
standard liters per minute, indicated by “PEAK SLPM”, and actual
liters per minute, indicated by “LPM”, can be selected using the
DISPLAY UNITS key. See Section 3.7, Display Information, for
definitions of these units of measure. For the High Flow module air,
O2, and air/O2 mixtures can be selected using the GAS SELECT key.
For the Low Flow module air, O2, and N2O can be selected using the
GAS SELECT key.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

3.4.3 Volume

Volume that occurs during the inhalation cycle of a breath can be
displayed on the top line of the control module display. Units of
actual liters, indicated by “ATP L”; standard liters, indicated by “STP
L”; or liters at body temperature and pressure saturated, indicated by
“BTPS L” can be selected using the DISPLAY UNITS key. See
Section 3.7, Display Information, for definitions of these units of
measure. For the High Flow module air, O2, and air/O2 mixture can
be selected using the GAS SELECT key. For the Low Flow module
air, O2, and N2O can be selected using the GAS SELECT key.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

3.4.4 Minute Volume

Minute volume calculated from the inhalation cycle of the last breath
and breath rate can be displayed on the top line of the control module
display. Units of “MINUTE VOL ATP L” (actual liters), “MINUTE VOL
STP L” (standard condition liters), or “MINUTE VOL BTPS L” (liters at
body temperature and pressure saturated) can be selected using the
DISPLAY UNITS key. See Section 3.7, Display Information, for
definitions of these units of measure. For the High Flow module air,
O2, and air/O2 mixture can be selected using the GAS SELECT key.
For the Low Flow module air, O2, and N2O can be selected using the
GAS SELECT key.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

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3.4.5 Stacked Volume

Total volume over a displayed number of inhalation cycles can be
displayed on the top line of the control module display with the
number of inhalation cycles displayed on the bottom line of the
display. Units of actual liters, indicated by “ATP S L”; standard liters,
indicated by “STP S L”; or liters at body temperature and pressure
saturated, indicated by “BTPS S L” can be selected using the
DISPLAY UNITS key. See Section 3.7, Display Information, for
definitions of these units of measure. For the High Flow module air,
O2, and air/O2 mixture can be selected using the GAS SELECT key.
For the Low Flow module air, O2, and N2O can be selected using the
GAS SELECT key.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

3.4.6 Oxygen Concentration

When the oxygen sensor is attached to the High Flow module the
oxygen concentration “%O2” can be displayed on the top line of the
control module display. Oxygen concentration can also be displayed
on the bottom line of the display, see Section 3.4.14.

Daily calibrations need to be done on the oxygen sensor. See
Section 3.5.2 for instructions on oxygen sensor calibration.

NOTE: The symbol will appear on the display when the oxygen
cable is attached.

Measurements on Bottom Line of Display

The following parameters are displayed on the bottom line of the
display. The Bottom line select key is used to scroll through
parameters by momentarily pressing and then releasing the key.

3.4.7 Low Pressure

Gauge pressure from the low-pressure port of the High Flow module
can be displayed on the bottom line of the control module display.
Select units of “cmH2O” or “mmHg” by pressing and holding the
DISPLAY UNITS key for at least three seconds.

For best results check the zero on the low pressure transducer before
measurements. See Section 3.5.1 for instructions on zeroing the
pressure transducer.

3:Operation 17

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NOTE: For distinguishing low pressure from absolute pressure, the
resolution for low pressure is in 0.1 cmH2O or mmHg and absolute
pressure measurement (Section 3.4.13) is displayed in resolution of
1 mmHg.

3.4.8 Peak Pressure

Peak gauge pressure from the low-pressure port of the High Flow
module during the inhalation cycle can be displayed on the bottom
line of the control module display. Select units of “PEAK cmH2O” or
“PEAK mmHg” by pressing and holding the DISPLAY UNITS key for
at least three seconds.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

For best results check the zero on the low pressure transducer before
measurements. See Section 3.5.1 for instructions on zeroing the
pressure transducer.

3.4.9 Peep Pressure

Positive end expiratory pressure (PEEP) from the low-pressure port
of the High Flow module can be displayed on the bottom line of the
control module display. Select units of “PEEP cmH2O” or “PEEP
mmHg” by pressing and holding the DISPLAY UNITS key for three
seconds.

For best results check the zero on the low pressure transducer before
measurements. See Section 3.5.1 for instructions on zeroing the
pressure transducer.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

3.4.10 Breath Rate

The breaths per minute (BPM) can be displayed on the bottom line of
the control module display.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

3.4.11 I:E Ratio

The ratio of the inhalation time and exhalation time (I:E RATIO) can
be displayed on the bottom line of the control module display.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

18 3: Operation

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NOTE: The inhalation time is defined as the time of positive
inhalation flow and does not include the breath hold time. If the vents
inhalation time includes the inhalation pause time, the Certifier® FA’s
I:E ratio will not match the vents I:E ratio.

3.4.12 I Time

The inhalation time (I TIME) can be displayed on the bottom line of
the control module display.

NOTE: A valid flow cycle must occur for this value to be displayed.
See Section 3.6, Breathing Cycles and Trigger Levels, for details.

NOTE: The inhalation time is defined as the time of positive
inhalation flow and does not include the breath hold time. If the vents
pause inhalation time includes a pause time, the Certifier® FA’s I time
will not match the vents I time.

3.4.13 Absolute Pressure

The absolute pressure in the flow tubes can be displayed on the
bottom line of the control module display in units of “mmHg”.

NOTE: For distinguishing absolute pressure from low pressure, the
resolution for absolute pressure measurement is displayed in a
resolution of 1 mmHg and low pressure (Section 3.4.7) is displayed
in a resolution of 0.1 cmH2O or mmHg.

3.4.14 Oxygen Concentration

When the oxygen sensor is attached to the High Flow module, the
oxygen concentration “%O2” can be displayed on the bottom line of
the control module display. Oxygen concentration can also be
displayed on the top line of the display. See Section 3.4.6.

Daily calibrations need to be done on the oxygen sensor. See

Section 3.5.2 for instructions on oxygen sensor calibration.

NOTE: The symbol will appear on the display when the oxygen

cable is attached.

3:Operation 19

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3.5 Required Pre-test Calibrations

3.5.1 Low-Pressure Transducer Zero Calibration

The Certifier® FA Test System automatically performs a low-pressure
transducer zero calibration at power up. Check the low pressure zero
by disconnecting the pressure tubing from the flow module before
each low-pressure measurement after initial power up to ensure the
most accurate readings. If low pressure is not reading zero, perform
the following steps to zero the transducer.

1. Disconnect the pressure tubing from the flow module to expose
the flow module to ambient air.

2. Momentarily press the Bottom line select key until low pressure

(see Section 3.4.7) is shown on the display.

3. Press and hold the Bottom line select key for 2 to 3 seconds.

The display shows ZERO to indicate that the zero calibration is in
progress.

4. When ZERO is no longer displayed, the low-pressure transducer
zero calibration is complete.

NOTE: The barometric pressure transducer does not require a zero
calibration.

3.5.2 Oxygen Sensor Calibration

Follow these steps daily and following an altitude change or sensor
replacement to calibrate the oxygen sensor:

1. Power up the Certifier® FA Test System with the High Flow
module and oxygen sensor attached, then allow about one
minute to warm up. The oxygen sensor symbol flashes if the
controller module detects the sensor needs calibration or has
expired.

2. Momentarily press the Top line select or Bottom line select key

to show %O2 on the display.

3. Press and hold the GAS SELECT key for 2 to 3 seconds. Expose

the oxygen sensor to room air when you see 21.0 %O2 and CAL
on the display. The 21% calibration is complete when 100.0 %O2
lights up on the top line and CAL flashes on the display. This can
take several minutes while the oxygen concentration and sensor
stabilize.

4. Expose the oxygen sensor to 100% oxygen of at least 5 liters per

minute. Press and release the GAS SELECT key to begin the

100% calibration. CAL stops flashing when the 100% calibration
begins.

20 3: Operation

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5. If the calibration is successful, CAL disappears and the O2
concentration is shown on the display. This can take several
minutes while the oxygen concentration and sensor stabilize.

6. If the calibration is not successful (oxygen sensor symbol
continues to flash, no O2 concentration is shown), repeat the
calibration. If the repeated calibration is not successful, replace
the oxygen sensor and repeat.

7. Expose the oxygen sensor to room air. The Certifier® FA Test
System is ready to use when the %O2 reading returns to
approximately 21%.

3.6 Breathing Cycles and Trigger Levels

The Certifier® FA uses flow rate to trigger the beginning and the end
of a ventilator’s inhalation cycle.

3.6.1 Inhalation and Exhalation Timing

At the beginning of the inhalation cycle the flow rate must be above
the trigger flow rate for at least 0.25 milliseconds. If this time is less
than 0.25 milliseconds, the Certifier® FA considers this part of the
exhalation cycle. When a valid inhalation cycle is ending and the flow
rate goes below the trigger level, the flow rate must remain below the
trigger level for at least 0.25 milliseconds, otherwise, this period is
included in the inhalation cycle.

If testing of ventilator pressure modes is needed, a test lung must be
used to ensure that a long enough flow delivery time is generated. If
there is not enough volume in the breathing circuit, the pressure can
be generated in less than 0.25 milliseconds.

3.6.2 Flow Trigger Levels

The default trigger level is automatically set on power up at the 20%
point from the minimum flow to the peak flow. For example, if the
maximum flow rate is 80 L/min and the minimum flow is 5 L/min, then
the trigger flow rate is set to (80 L/min – 5 L/min) x 20% + 5 L/min =
20 L/min. The 20% auto trigger level will work for most ventilators,
but some manufactures may instruct you to select a different trigger
level.

A 10% of the peak flow rate and trigger can also be selected. The
10% auto trigger does not use the minimum flow rate in calculating
the trigger level; zero is assumed for the minimum flow rate. In the
above example the trigger level would be 80 L/min x 10% = 8 L/min.

Manually set trigger levels can also be used. Trigger can be
manually set at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 17, 20, 22, 24, 30,
35, or 40 L/min.

3:Operation 21

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Follow these steps to view or adjust the flow trigger level.

Table 3. Screen Displays

Display

Meaning

- - -

An out-of-range measurement.

Oxygen sensor symbol: indicates presence of
oxygen sensor. Flashes to indicate that sensor must
be calibrated or replaced.

Low battery voltage symbol: indicates that batteries
should be replaced.

%O2

Oxygen concentration can be displayed on either
line if High Flow module and oxygen sensor are
attached.

AIR

Air supply gas, selected using the GAS SELECT

key (when High Flow or Low Flow module is
attached).

AIR O2

Mixed air and oxygen supply gas, selected using the

GAS SELECT key (when High Flow module and

oxygen sensors are attached).

1. Momentarily press the Top line select key until volume

parameter is on the display, see Section 3.4.3.

2. Press and hold the Top line select key until the “trig” appears on

the bottom of the display.

3. The trigger value will appear on the top line of the display which
will be one of the following: “20 PEAK” (20% Auto trigger),
“1 LPM”, “2 LPM”, “3 LPM”, “4 LPM”, “5 LPM”, “6 LPM”, “7 LPM”,
“8 LPM”, “9 LPM”, “10 LPM”, “12 LPM”, “15 LPM”, “17 LPM”,
“20 LPM”, “22 LPM”, “25 LPM”, “30 LPM”, “40 LPM”, or
“10 PEAK” (10% Auto trigger).

4. To adjust the value, press and release the Top line select or
Bottom line select to scroll through the list of values in step 3.

After 3 seconds the new trigger level will be set and the interface
module will return to displaying volume.

NOTE: The default value of 20% auto trigger is restored once the
controller module is turned off.

3.7 Display Information

Table 3 describes information that can appear on the controller

module screen.

22 3: Operation

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Table 3. Screen Displays (cont.)

Display

Meaning

ATP

Atmospheric temperature and pressure: a condition
of volume measurement. The Certifier® FA Test
System calculates the ATP value by applying the
actual gas temperature and pressure to the STP
measurement.

BPM

Breaths per minute: a unit of respiratory rate. Can
be displayed on the bottom line (either High Flow or
Low Flow module attached).

BTPS

Body temperature and pressure, saturated: a
condition of volume measurement. The Certifier®
FA Test System calculates a BTPS value by
compensating the STP measurement for BTPS
conditions (37 °C (98.6 F), ambient pressure,
100% relative humidity).

CAL 100%

O2

Oxygen sensor calibration in progress (during
exposure to 100% O2).

CAL 21% O2

Oxygen sensor calibration in progress (during
exposure to room air).

cmH2O

Centimeters of water: a unit of pressure.

I TIME

Inspiratory time (in seconds). Can be displayed on
the bottom line (either High Flow or Low Flow
module attached).

I:E RATIO

Ratio of inspiratory time to expiratory time, can be
displayed on the bottom line (when High Flow or
Low Flow module is attached).

L

Liter: a unit of volume.

LPM

Liters per minute: a unit of flow. The Certifier® FA
Test System calculates the LPM value by applying
the actual gas temperature and pressure to the
SLPM measurement.

MINUTE VOL

Minute volume: an estimate of exhaled volume for
the next 60 seconds, based on the current breath.
Can be displayed on the bottom line (when High
Flow or Low Flow module is attached).

mmHg

Millimeters of mercury: a unit of pressure.

N2O

100% nitrous oxide supply gas, selected using the

GAS SELECT key (if Low Flow module is attached).

3:Operation 23

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24 3: Operation

Table 3. Screen Displays (cont.)

Display

Meaning

O2

100% oxygen supply gas, selected using the GAS
SELECT key (when High Flow or Low Flow module

is attached).

PEAK

Peak flow or pressure. Peak flow can be displayed
on top line (when High Flow or Low Flow module is
attached). Peak pressure can be displayed on
bottom line (if High Flow module is attached).

PEEP

Positive end expiratory pressure: the minimum
pressure measured in the circuit throughout the
breath cycle. Can be displayed on the bottom line (if
High Flow module attached).

REV

Software revision level, displayed at power up.

S

Stacked volume: a cumulative volume measurement
for consecutive breaths. The top line shows the
cumulative volume and the bottom line shows the
number of consecutive breaths.

SEC

Seconds, a unit of time for I TIME measurements.

SLPM

Standard liters per minute: a unit of flow. The
Certifier® FA Test System measures flows in SLPM.
Standard conditions are defined as 21.1 C (70 F)
at 101.3 kPa (14.7 psia).

STP

Standard temperature and pressure: a condition of
volume measurement. The Certifier® FA Test
System measures volumes at STP. Standard
conditions are defined as 21.1 C (70 F) at

101.3 kPa (14.7 psia).

VOL

Volume: the exhaled volume for the most recent
breath. Can be displayed on the top line (either High
Flow or Low Flow module attached).

ZERO

Low-pressure transducer zero calibration in
progress.

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Table 4. Troubleshooting the Certifier® FA Test System

Symptom

Possible Cause

Corrective Action

Controller module
won’t turn on, or
turns on and off.

Batteries are
depleted or installed
backwards.

Check that batteries
are installed correctly.
Replace batteries.

Measurements
aren’t displayed
even though
controller module
is on.

Flow module isn’t
connected to
controller module.

Connect flow module to
controller module.

‘---‘ is shown on
display.

Measurement is out
of range.

Check range for
displayed
measurement, and only
make measurements
within that range.

Flow rate does
not read zero
when no gas
flowing
(Especially when
set to N2O).

Meter was not
purged with gas
displayed on the
controller.

Purge meter with gas
displayed on controller
or press gas select key
to change to desired
gas.

Unable to
disconnect flow
module from
controller module.

Pulling on the cable
rather than the
connector.

Pull the locking
connector (not the
cable) to disengage
connector lock.

Can’t display
%O2.

Oxygen sensor not
connected. Look for
oxygen sensor

symbol, .

Connect oxygen sensor
cable to High Flow
module and oxygen
sensor.

4 Troubleshooting

Table 4 lists the symptoms, possible causes, and recommended

corrective actions for problems you may encounter with the
Certifier® FA Test System. If the symptom is not listed, or if none of
the recommended corrective actions solves the problem, please
contact TSI Customer Support at [phone] or 651-490-2811.

25

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Table 4. Troubleshooting the Certifier® FA Test System (cont.)

Symptom

Possible Cause

Corrective Action

Can’t select
AIR O2 mixtures.

Oxygen sensor not
connected. Look for
oxygen sensor

symbol, .

Connect oxygen sensor
cable to High Flow
module and oxygen
sensor.

Volume, minute
volume, peak
flow, peak
pressure, PEEP,
respiratory rate,
or I:E ratio
measurement
isn’t updated.

Less than two
consecutive full
breaths have been
supplied to flow
module, or flow is
not supplied as a
breathing waveform.

Bias flow is greater
than auto trigger
level.

Inhalation cycle is
less than 0.25
milliseconds

Testing pressure
mode on ventilator
and no test lung
attached.

Wait for at least two
consecutive full breaths
to be supplied to the
flow module.

Ensure that flow is
supplied as a breathing
waveform.

Manually set flow
trigger level.

Certifier® FA cannot
measure shorter than

0.25 millisecond flow
delivery.

Use a test lung so that
at least 0.25
milliseconds of flow
delivery is generated to
generate pressure.

Can’t change
measurement
units.

Measurement isn’t
displayed while
changing units.

Press the Top line

select or the Bottom
line select key to

display measurement,
then press the

DISPLAY UNITS key to

change units.

Can’t zero low­pressure
transducer.

Transducer is
connected to a
pressure source.

Disconnect pressure
tubing from flow
module, then zero low­pressure transducer.

Can’t zero
barometric
pressure
transducer.

Barometric pressure
transducer does not
require a zero
calibration.

Resume normal system
operation.

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Table 4. Troubleshooting the Certifier® FA Test System (cont.)

Symptom

Possible Cause

Corrective Action

Oxygen sensor
calibration takes
longer than 5
minutes.

21% oxygen and/or
100% oxygen not
supplied for
calibration.

Flow of 100%
oxygen is too low.

Verify that calibration
gases are 21% oxygen
and 100% oxygen and
repeat calibration.

Increase flow of 100%
oxygen to at least
5 SLPM and repeat
calibration.

Oxygen sensor
calibration fails.

21% oxygen and/or
100% oxygen not
supplied for
calibration.

Oxygen sensor is
expired.

Verify that calibration
gases are 21% oxygen
and 100% oxygen and
repeat calibration.

Replace oxygen
sensor.

4:Troubleshooting 27

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Table 5. Cleaning Recommendations

Component

Cleaning

 Controller module

 Flow modules

 Carrying cases

 Oxygen sensor

 Oxygen sensor cables

Clean exterior as required with a clean
cloth and isopropyl alcohol, hydrogen
peroxide (3%), or ammonia (15%).

 Tee

 Adapters

Steam autoclave after contact with any
non-sterile breathing circuit
components, and discard if any damage
is visible.

 Single use filters (high

and Low Flow
modules)

Discard after contact with any non­sterile breathing circuit components or if
damage is visible.

5 Maintenance

5.1 Replacing the Batteries (as required)

Replace the batteries when the low battery voltage symbol is
displayed or instrument will not power up.

1. Turn off the controller module.

2. Use the pocket driver tool (supplied) to loosen the screw that
holds the battery cover on the controller module back panel.

3. Remove the old batteries from the battery compartment, and
install new batteries noting the polarity indicators.

4. Reinstall the battery cover and tighten the screw to hold the cover
to the controller module.

5.2 Replacing the Oxygen Sensor (yearly)

The oxygen sensor will function for one year of normal operation if
use begins before the expiration date. Replace the oxygen sensor
every year of normal use, or if the sensor cannot be calibrated or
sensor readings are erratic.

5.3 Cleaning (as required)

Table 5 summarizes recommended cleaning methods for

Certifier® FA Test System components.

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Dimensions

Controller module: 13.2 cm x 7 cm x 3.3 cm (5.2 in. x 2.8 in. x 1.3 in.).

High Flow module: 18 cm x 6.6 cm x 4 cm (7.1 in. x 2.6 in. x 1.6 in.).

Low Flow module: 12.7 cm x 5.1 cm x 2.8 cm (5.0 in. x 2.0 in. x 1.1 in.).

Flow
connectors

High Flow module:

 flow inlet: 22-mm female ISO taper.

 flow outlet: 22-mm male ISO taper.

Low Flow module:

 flow inlet: 0.25-in. barb.

 flow outlet: 0.25-in. barb.

Weight

Approximately 1.36 kg (3 lb) for the standard kits.

Temperature

Operating: 5 to 40 C (41 to 104 F). 15 to 80% relative humidity from
5 to 31 C decreasing linearly to 15 to 50% relative humidity at 40 C.

Storage: -40 to 70 C (-40 to 158 F) at 10 to 95% relative humidity.

Atmospheric
Pressure

Operating: 57.1 to 106 kPa (8.28 to 15.37 psia).

Storage: 50 to 106 kPa (7.25 to 15.37 psia).

Conditions

Indoor Use
Operating Altitude up to 4000 m (13,000 ft)
Pollution degree I or II

Battery life

15 to 20 hours.

Battery type

Four commercially available AA batteries.

Measurement

High Flow Module

Low Flow Module

Flow and Peak Flow

Range

0 to 300.0 SLPM.

0.01 to 15.00 SLPM.

Accuracy

Air and oxygen:  2% of reading
or  0.075 SLPM, whichever is
greater.

Air/oxygen mixtures:  4% of
reading or  0.1 SLPM, whichever
is greater.

Air and oxygen:  2% of
reading or  0.010 SLPM,
whichever is greater.

Nitrous oxide:  4% of reading
or  0.025 SLPM, whichever is
greater.

6 Specifications

NOTE: Specifications are subject to change without notice.

6.1 Physical

6.2 Environmental

6.3 Power

6.4 Test Measurements (see notes at end of section)

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32 6: Specifications

Measurement

High Flow Module

Low Flow Module

Pressure drop

Maximum between inlet and
outlet ports at 101.3 kPa (14.7
psia) including filter: 0.50 cmH2O
at 20 SLPM, 1.50 cmH2O at 50
SLPM, 5.0 cmH2O at 100 SLPM,

30.0 cmH2O at 300 SLPM.

Maximum between inlet and
outlet ports at 101.3 kPa (14.7
psia) including filter: 4 cmH2O
at 2 SLPM, 16 cmH2O at 5
SLPM, 45 cmH2O at 10 SLPM,
85 cmH2O at 15 SLPM.

Volume

Range

0.01 to 10.0 L STP.

0 to 9.999 L STP.

Accuracy

Air and oxygen:  2% of reading
plus 0.020 L STP

Air/oxygen mixtures:  4% of
reading plus 0.020 L STP.

Air and oxygen:  2% of
reading or  0.010 L STP,
whichever is greater.

Nitrous oxide:  4% of reading
or  0.010 L STP, whichever is
greater.

Minute Volume

Range

0 to 99.00 L STP.

0 to 9.999 L STP.

Accuracy

 7% of reading.

 7% of reading.

Stacked Volume

Range

0 to 99.00 L STP.

0 to 9.999 L STP.

Accuracy

Air and oxygen:  2% of reading
plus 0.020 L STP

Air/oxygen mixtures:  4% of
reading plus 0.020 L STP.

Air and oxygen:  2% of
reading or  0.010 L STP,
whichever is greater.

Nitrous oxide:  4% of reading
or  0.010 L STP, whichever is
greater.

Inspiratory Time

Range

0.25 to 60.00 seconds.

0.25 to 60.00 seconds.

Accuracy

 0.01 seconds.

 0.01 seconds.

I:E Ratio

Range

1:100.0 to 100.0:1.

1:15.0 to 15.0:1.

Accuracy

 5% of reading.

 5% of reading.

Respiratory Rate

Range

0.5 to 120.0 breaths per minute.

0.5 to 120.0 breaths per
minute.

Accuracy

 5% of reading.

 5% of reading.

Low Pressure

Range

-25.0 to 150.0 cmH2O.

(-18.4 to 110 mmHg)

Not applicable.

Accuracy

 0.75% of reading or
 0.20 cmH2O (0.15 mmHg),

whichever is greater.

Not applicable.

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Measurement

High Flow Module

Low Flow Module

Peak & PEEP Low Pressure

Range

0 to 150.0 cmH2O.

(0 to 110 mmHg)

Not applicable.

Accuracy

 0.75% of reading or  0.20
cmH2O (0.15 mmHg), whichever
is greater.

Not applicable.

Barometric Pressure

Range

375 to 1500 mmHg.

375 to 1500 mmHg.

Accuracy

 8 mmHg.

 8 mmHg.

Oxygen Concentration

Range

0 to 100.0% O2.

Not applicable.

Accuracy

 2% O2 at daily calibration
conditions.

Not applicable.

NOTES

1. Standard conditions are defined as 21.1 C (70 F) and 101.3 kPa (14.7 psia).

2. Flow and volume accuracy is applicable in SLPM or STP mode only.

3. The temperature of the gas and the ambient air must be within  10 C ( 18 F) of
each other and the gas must be less than 30% relative humidity at 21. 1 C (70 F).

4. Flow and volume accuracy de-rating:  0.075% of reading per 1 C (1.8 F) away
from 21.1 C (70 F);  0.015% of reading per 1.03 kPa (0.15 psia) above 101.3 kPa
(14.7 psia);  0.022% of reading per 1.03 kPa (0.15 psia) below 101.3 kPa (14.7
psia);  0.07% of reading per 1% relative humidity above 30% relative humidity.

6.5 Calibration Requirements

Flow modules

Factory calibration every year for normal use under normal
conditions using the filter(s) provided.

Controller module

No calibration required.

Oxygen sensor

Daily, following sensor replacement or as required.

Complies with these
standards:

 CAN/CSA-C22.2 No. 1010. 1-92: Canadian Standard for the

Safety of Electrical Equipment for Measurement, Control
and Laboratory Use, Part 1.

 EN 55011 (1991) Class B, CISPR 11 (1990) Class B, FCC

(CFR 47, Part 15) Class B: Emissions, Radiated and
Conducted.

 EMC Directive 89/336/ECC, EN 61326-1 (1997 plus

Amendment A1 1998), IEC 1000-4-2 (1995), EN 61000-4-2,
IEC 1000-4-3 (1995), EN 61000-4-3: Immunity.

6.6 Compliance and Approvals

6: Specifications 33

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