TSI Instruments CERTIFIER FA PLUS Operator's Manual

CERTIFIER® FA PLUS

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980560, REVISION L

JULY 2018

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CERTIFIER® FA PLUS

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980560, REVISION L

JULY 2018

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Copyright  TSI Incorporated / 2010-2018 / All rights reserved.
Address

TSI Incorporated / 500 Cardigan Road / Shoreview, MN 55126 / USA

Fax No.

[phone]

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 February 2015)

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 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

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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 (800) 680­1220 / (1) 651 490-2860 (USA and International) or TSI Instruments in UK at: [phone].

Trademarks

Certifier® is a registered trademark of TSI Incorporated.

ii Certifier® FA Plus Test System

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CONTENTS

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

1.1 Parts List ......................................................................................................... 2

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

1.2.1 Symbols on Display ............................................................................ 6

2 SETUP AND OPERATION ..................................................................................... 11

2.1 Keypad Functions ......................................................................................... 14

2.2 Power up ....................................................................................................... 15

2.3 Display Navigation ........................................................................................ 15

2.3.1 Measurement Selection .................................................................... 18

2.3.2 Graph Measurement Selection ......................................................... 19

2.3.3 Available Measurement Parameters ................................................. 20

2.3.4 Gas Conditions Selection Box .......................................................... 22

2.3.5 Averaging Setup Menu ..................................................................... 23

2.3.6 Breath Trigger Types ........................................................................ 24

2.3.7 Flow Triggering ................................................................................. 25

2.3.8 Saving/Loading Configurations ......................................................... 26

2.3.9 Print/Save Button .............................................................................. 27

2.3.9.1 Waveform Logging ..................................................................... 28

2.3.9.2 Continuous Logging ................................................................... 28

2.3.10 Setup Key ......................................................................................... 29

2.3.10.1 Advanced Features .................................................................... 30

2.3.10.1.1 Configuration Import/Export .................................................. 30

2.3.10.1.2 Format Settings ..................................................................... 31

2.4 Required Pre-test Calibrations ..................................................................... 32

2.4.1 Low Flow Module .............................................................................. 32

2.4.1.1 None required ............................................................................ 32

2.4.2 High Flow Module ............................................................................. 32

2.4.2.1 Zeroing the Flow Direction Sensor ............................................ 32

2.4.2.2 Low-Pressure and High-Pressure Transducer Zeroing ............. 32

2.4.2.3 Oxygen Sensor Calibration ........................................................ 33

3 TROUBLESHOOTING ........................................................................................... 35

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4 MAINTENANCE ...................................................................................................... 39

4.1 Recharging the Batteries (as required) ......................................................... 39

4.2 Replacing the Oxygen Sensor ...................................................................... 39

4.3 Cleaning (as required) ................................................................................... 39

4.4 Factory Calibration (recommended yearly) ................................................... 40

4.5 Return Procedure .......................................................................................... 40

5 SPECIFICATIONS ................................................................................................... 41

5.1 Physical ......................................................................................................... 41

5.2 Environmental ............................................................................................... 41

5.3 Power ............................................................................................................ 41

5.4 Data Transfer and Storage ............................................................................ 42

5.5 Test Measurements (See notes at end of section. See Table 3 for

symbol definitions.) ....................................................................................... 42

5.6 Calibration Recommendations ...................................................................... 45

5.7 Compliance and Approvals ........................................................................... 45

APPENDIX A DATA FILE FORMATS ......................................................................... 47

LIST OF FIGURES

Figure 1. Certifier® FA Test System High Flow Standard Kit (4080) ............................... 2

Figure 2. Certifier® FA Test System Low Flow Module Kit (4082) ................................... 4

Figure 3. Certifier® FA Test System Oxygen Sensor Kit (4073) ...................................... 4

Figure 4. Certifier® FA Test System Extra Battery and Charger Kit (1208061) ............... 5

Figure 5. Interface Module ............................................................................................... 7

Figure 6. Back of Interface Module .................................................................................. 8

Figure 7. High Flow Module (arrow on module indicates positive flow direction) ........... 9

Figure 8. Low Flow Module .............................................................................................. 9

Figure 9. Oxygen Sensor Kit ............................................................................................ 9

Figure 10. Connecting the Interface Module to a Flow Module ..................................... 11

Figure 11. Installing a Flow Module into the Circuit for Measuring Bi-directional

Flow (flow direction Arrow should be towards test lung) .............................. 12

Figure 12. Test Circuit for Bi-Directional Flow ............................................................... 13

Figure 13. Removing Coupling ....................................................................................... 14

Figure 14. Interface Module Keypad .............................................................................. 14

Figure 15. Example of Parameter Screen ...................................................................... 15

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Figure 16. Example of Graph Screen ............................................................................ 15

Figure 17. Parameter Screen Features ......................................................................... 16

Figure 18. Graph Screen Features ................................................................................ 17

Figure 19. Measurement Selection Screen ................................................................... 18

Figure 20. Graph Measurement Selection Screen ........................................................ 19

Figure 21. Parameter Definitions ................................................................................... 21

Figure 22. Gas Conditions Selection Box ...................................................................... 22

Figure 23. Averaging Setup Menu ................................................................................. 23

Figure 24. Trigger Options Menu .................................................................................. 24

Figure 25. Configuration Save Screen .......................................................................... 26

Figure 26. Print/Save Options Screen ........................................................................... 27

Figure 27. Add Comments Screen ................................................................................ 27

Figure 28. Setup Menu .................................................................................................. 29

Figure 29. Advanced Function Menu ............................................................................ 30

Figure 30. Format Settings Screen ............................................................................... 31

LIST OF TABLES

Table 1. Certifier® FA Test System Parts List ................................................................. 3

Table 2. Keypad Functions ............................................................................................ 14

Table 3. Parameters (parameter list changes depending on module attached) ........... 20

Table 4. Troubleshooting the Certifier® FA Test System ............................................... 35

Table 5. Cleaning Recommendations ........................................................................... 39

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Interface Module

The keypad and touch screen display allow you to select test
measurements and units for display. The Interface Module
connects to the High or Low Flow Module.

High Flow Module

Measures air, oxygen (O2), nitrogen (N2) and carbon dioxide
(CO2) flow rate over a range of 0 to 300 standard liters per
minute (0 to 40 standard L/min for CO2). A 150 PSI (10 Bar)
gauge transducer, a barometric pressure transducer, and a
150 cm H2O differential pressure transducer are also in the
High Flow Module.

Low Flow Module

Measures air, O2, N2, CO2 and nitrous oxide (N2O) flow rate
over a range of 0.01 to 20 standard L/min 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.

1 Introduction

The Certifier® Flow Analyzer (FA) Test System is a multi-functional pneumatic tester
designed specifically for the medical industry. Specific measurements for ventilator
testing are programmed and include flows, volumes, pressures, oxygen concentration,
and breath timing. The Certifier® FA Plus Test System is designed for hospital, home
care, field service, and laboratory settings.

Certifier® FA Test System components include:

You can connect or disconnect the flow modules and oxygen sensor at any time during
normal operation without interrupting the operation of the instrument.

Lithium-Ion batteries or an AC adapter can be used to power the test system.

WARNING

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

gases.

 Only TSI qualified and trained service technicians are authorized to service the

Certifier® FA Test System.

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Caution

1 2 3 6 4 5 7 8 9

10

11

12

13

14

15

19

17

16

18

 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.

 The Certifier FA Plus is not a medical device under the Medical Device Directive or

FDA 510(k) and in no situation should be used for human measurements.

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 1, 2, and 3.

Figure 1. Certifier® FA Test System High Flow Standard Kit (4080)

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Table 1. Certifier® FA Test System Parts List

Item
No.

Description

Replacement
Part Number

Quantity

High Flow Standard Kit (part number 4080)

1 1

Interface Modulea

4088

1

2 2

High Flow Moduleb

4081

1

3 3

Bacteria filter, 22-mm  22-mm male/female, for use
with High Flow Module

1602341

1

4 7

Adapter, 22-mm  6-mm (for interfacing High Flow
Module to Low Flow filter)

1102091

2

5 5

Adapter, 15-mm ID  22-mm OD

1102093

1

6

Airway pressure fitting with screen

1611330

1

7 9

Pressure tubing, silicone, 1/8-in. ID  ¼-in. OD 
48-in. (3.2 mm ID  6.4 mm OD  122 cm)

3002053

1

8

Velcro strap for use on High Flow Module

2913133

1

9

Adapter, high pressure port

1611221

1

10

Cable, flow module

1040219

1

11 4

Soft carrying case

1319289

1

12

Power supply 90/260 VAC to +12 VDC

2613237

1

13

Stylus

1319420

2

14

Certifier® FA Test System Operator’s Manual

1980560

1

15

Battery—Lithium-Ion SBL-160

1208056

1

16

Connector, four types:
AC NORTH AM./IEC320, right angle
AC EURO/IEC320, right angle
AC UK/IEC320 fuse, right angle
AC AUST/IEC320, right angle

1302013
1302014
1302015
1302025

1
1
1
1

17

SD flash memory card

1500108

1

18

Protective Rubber boot for Interface module

6001503

1

19

Computer Cable—USB standard A to mini B

1303754

1

a

If ordering a 4088 for replacement, items 10 through 19 are included.

b

If ordering a 4081 for replacement, items 3 through 9 are included

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4

Item
No.

Description

Replacement
Part Number

Quantity

Low Flow Module Kit (optional—part number 4082)

20

Low Flow Module

4082

1

21

Bacteria filter, for use with Low Flow Module

1602342

1

22

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

1040044

1

23

Coupling, 38 inch tube

1601180

1

24

Adapter, 38 inch tube to 38 inch barb

1601179

1

20

21

22

23

24

25

26

27

Figure 2. Certifier® FA Test System Low Flow Module Kit (4082)

Figure 3. Certifier® FA Test System Oxygen Sensor Kit (4073)

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Item
No.

Description

Replacement
Part Number

Quantity

Oxygen sensor kit (optional—part number 4073)

25

Oxygen sensor

2917019

1

26

Threaded tee

1313118

1

27

Oxygen sensor cable

1303741

1

Item
No.

Description

Replacement
Part Number

Quantity

Extra Battery and Charger Kit (optional kit – part number 1208061)

28

Battery—Lithium-Ion SBL-160

1208056

1

29

Battery Charger kit

1208059

1

Other accessories (optional)

Printer Cable—USB mini A to standard B

1303860

28

29

Figure 4. Certifier® FA Test System Extra Battery and Charger Kit (1208061)

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1.2 Glossary

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

CE marking of European Conformity for the Low Voltage Directive (LVD)
and the Directive for Electromagnetic Compatibility (EMCD).

WEEE Directive Label (Waste Electrical and Electronic Equipment). (Item
must be recycled properly.)

Warning symbol. Touch symbol for explanation.

Flow module is working in unidirectional mode. The module is not detecting
a significant amount of negative flows. When testing ventilators,
unidirectional flow is used when the flow module is connected to the To
Patient line

Flow module is in bi-directional flow mode. For ventilators bi-directional flow
is used when the module is between the Y fitting and the test lung.

Battery status symbol. This symbol will indicate how much the battery
charge is left. When no bars are showing instrument will shut off within
minutes.

Battery charging symbol.

>

Start graph or start displaying data on main parameter screen.

||

Pause graph or pause data being displayed on main parameter screen

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

1.2.1 Symbols on Display

See Available Measurement Parameters in Table 3 for definitions of measurement
symbols and abbreviations that appear on the Certifier FA+ display.

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Touch Screen Display

Key Pad

Stylus

Figure 5. Interface Module

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Module B Connector

(not used)

Module A Connector

USB Connector

SD Card Slot

DC

Power

Input

Flip Out Stand

Battery Cover

Wrist Strap

Figure 6. Back of Interface Module

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Figure 7. High Flow Module

Figure 8. Low Flow Module

Figure 9. Oxygen Sensor Kit

Coiled Cable Connector

High Pressure

(150 PSIG, 10 bar)

Low Pressure (150 cmH2O

differential)

Use “+” port for airway

pressure.

Coiled Cable Connector

TTL Trigger Input

Oxygen Sensor

Connector

(arrow on module indicates positive flow direction)

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2 Setup and Operation

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

Caution

To avoid damage to the Certifier

filters upstream of the flow modules, and always cap flow module ports when not

in use.

1. Install battery if not already installed. Connect AC adapter to DC power source
connector if desired. The battery will charge in the instrument when the AC adapter
is plugged in. Fully charge the battery overnight before using with battery alone.

2. Install SD flash memory card into card slot on top of the interface module. This step
is necessary only if planning to log data.

3. Connect the Interface Module to a flow module (Figure 10). To remove the cable,
pull its locking connector (not the cable) from the Interface Module.

®

FA Test System components, always use bacteria

Figure 10. Connecting the Interface Module to a Flow Module

Refer to the manufacturers test procedure for the device under test for
specific instructions on where to connect the Certifier® FA Plus flow module.
The manufacturer of the device under test will also specify which operating
parameters to test.

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4. Install the flow module into the test circuit. Align the flow direction arrow on the flow
module with the positive direction of flow through the circuit; for ventilator testing the
arrow should point towards the test lung or away from the “To Patient” port on the
ventilator.

Figure 11. Installing a Flow Module into the Circuit for Measuring

Bi-directional Flow

(flow direction Arrow should be towards test lung)

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N o t e

If using a test lung with a built in restrictor or a separate restrictor, place the airway
pressure fitting at least 15 cm of the 22 mm tubing between the restrictor and the flow
module. If this is not done, the flow direction sensor may not work properly.

Figure 12. Test Circuit for Bi-Directional Flow

2: Setup and Operation 13

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The low flow module is
used for testing oxygen
concentrators and other
low flow devices. It is not
designed for testing
ventilators.

The low flow module
includes a push-to-fit tube
fitting. To install, push
tubes into coupling. To
remove fittings, press or
pry ring towards the
coupling body with a small
screwdriver while pulling
coupling away from flow
module.

Figure 13. Removing Coupling

Table 2. Keypad Functions

Figure 14.

Interface Module Keypad

Key

Primary Function

On/OFF key

Zeroing Key—Press this key to zero the

high and low pressure transducers.

Print/Save Key—Press this key to print
and/or save data. See Print/Save section
(pg. 27) in this manual for more
information.

Press this key to switch between the
Parameter Screen and Graph Screen.

Press this key to perform setup on the
instrument.

2.1 Keypad Functions

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Figure 15. Example of Parameter Screen

Figure 16. Example of Graph Screen

2.2 Power up

If the device under test is running and creating flow or pressure, temporarily remove the
flow module from the test circuit during power up. This allows the flow direction sensor
on the high flow module to auto calibrate.

Press the I/O (on/off) key on the Interface Module to power up the Certifier® FA Plus
Test System (the Interface Module powers all of the attached Certifier FA Test System
components). At power up, the Interface Module shows information in this sequence
below. After this, return the flow module into the test circuit.

1. Logo screen appears on display for several seconds.

2. One of two types of screens will appear on the display: Graph Screen or
Parameter Screen (see Figures 15 and 16).

3. Wait 1 minute for pressure transducers and flow sensor to warm-up.

4. Perform the pre-test calibrations described in Section 2.4.

5. Perform test per the device manufactures procedure (or other appropriate
procedure).

If the AC adapter is plugged into the instrument, the battery charging symbol will
appear on the display.

2.3 Display Navigation

The main two screens are the Parameter Screen and the Graph Screen.

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By touching on the active areas of the Parameter Screen, you can change the

Stops/Starts

data acquisition

configuration of the display by choosing which parameters to monitor, units of
measure, gas calibration, gas conditions, averaging, and triggering. You can also
save the display configuration to a file or load a previously saved configuration.

Figure 17. Parameter Screen Features

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By touching on the active areas of the Graph Screen, you can change the

Stops/Starts

graph

Y-axis setup

Y-axis setup

X-axis setup

configuration of the display by choosing which parameters to plot on the Graph,
units of measure, gas calibration, gas conditions, averaging, triggering, x and y axis
scale. You can also save the display configuration to a file or load a previously
saved configuration.

Figure 18. Graph Screen Features

2: Setup and Operation 17

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2.3.1 Measurement Selection

 To add a parameter to the

Parameter Screen, touch the
parameter and then touch the
right direction arrow. The
available parameters change
depending on what module is
attached.

 To remove a parameter from

the Parameter Screen, touch
the parameter and then touch
the left direction arrow.

 To move a parameter higher

on the Parameter Screen,
touch the parameter and then
use the up and down direction
arrows.

Figure 19. Measurement Selection Screen

 To change the gas calibration used, touch the gas dropdown list and select the

desired gas.

Note: If the gas selection Air/O2 Mixture is selected but no oxygen sensor is

plugged into the Model 4081 high flow module, then the high flow module
will use the internal air calibration only. No corrections for oxygen
concentration will be made if the oxygen sensor is not plugged into the
flow module.

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2.3.2 Graph Measurement Selection

 To add a parameter to Graph,

touch the parameter on the left
and then touch the top right
direction arrow. Only two
parameters can be graphed at
one time. The available
parameters change depending
on what module is attached.

 To remove a parameter from

the graph, touch the parameter
and then touch the top left
direction arrow.

 To change the gas calibration

used, touch the gas dropdown
list and select the desired gas.

Figure 20. Graph Measurement Selection Screen

 To add a parameter to the label section below the graph, touch the parameter and

then touch the bottom right direction arrow. Only four parameters can be in this
section.

 To remove a parameter from the Parameter Screen, touch the parameter and then

touch the bottom left direction arrow.

 After clicking OK, a prompt will appear to enter the units of measurement.

Note: Up to two parameters may be graphed simultaneously; whereas up to four

parameters may be viewed simultaneously on the Graph page.

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Flow Rate. “Q” is used on the
Graph Screen.

High pressure transducer
(4081 only)

Peak Flow Rate—Peak Inhaled
Flow Rate. “Qpeak” is used on
the Graph Screen.

Absolute pressure in flow tube.
If flow tube open to
atmosphere, then this is also
the barometric pressure

Minimum Flow Rate—In Bi­Directional Mode this is the
Negative of the Peak Exhaled
Flow Rate. “Qmin” is used on
the Graph Screen.

Oxygen concentration (with
both 4081 and 4073 only)

Inhaled tidal volume

Temperature of gas (accurate
for flows above 5 L/min)

Exhaled tidal volume (4081
only)

Frequency—Breath rate

V

Real-time volume (graphing
only)

Inspiratory time

Inhaled minute tidal volume

Inspiratory pause time (4081
only)

Low pressure transducer—
Airway pressure (4081 only)

Inspiratory time including the
pause time

Peak Inspiratory pressure (4081
only)

Expiratory time

Peak End Expiratory Pressure
(4081 only)

I to E ratio

Mean Airway Pressure (4081
only)

I to E ratio which includes
inspiratory pause time

Minimum low Pressure (4081
only)

Time of day

Delta low pressure—Delta
airway pressure (4081 only)

2.3.3 Available Measurement Parameters

Table 3. Parameters (parameter list changes depending on module attached)

2: Setup and Operation 20

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I:E = t

E

/ t

I

I:E

IP

= t

E

/ t

I+P

f = 1

/ (t

I+P

+ t

E

)

MV = V

TI

 f

Figure 21. Parameter Definitions

2: Setup and Operation 21

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2.3.4 Gas Conditions Selection Box

Figure 22. Gas Conditions Selection Box

STP

Standard Temperature and Pressure. The gas flow rate and volumes are

displayed in terms of what the gas flow rate and volume would be if the gas
was 21°C and 1 atmosphere (101.3 kPa) of pressure.

ATP

Actual Temperature and Pressure. The gas flow rate and volumes at the
actual temperature and pressure of the gas.

BTPS

Body temperature and Pressure Saturated. The gas flow rate and

volumes are displayed in terms of what the gas flow rate and volume would
be if the gas was changed to 37°C, the actual pressure, and also saturated
with water vapor.

BTPD

Body temperature and Pressure Dry The gas flow rate and volumes are

displayed in terms of what the gas flow rate and volume would be if the gas
was changed to 37°C, but maintaining the actual pressure.

STPxx

User defined Standard Conditions. The gas flow rate and volumes are

displayed in terms of what the gas flow rate and volume would be if the gas
was at the conditions entered in the boxes to the right.

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2.3.5 Averaging Setup Menu

Figure 23. Averaging Setup Menu

Number of
Breaths
Averaged

All breath parameters are averaged over the selected number of
breaths.

Second
Average for
Real-Time
Values

All displayed transducer measurements are averaged over the
selected number of seconds. Transducer measurements include:
flow, low pressure, high pressure, absolute pressure, oxygen
concentration, and temperature.

2: Setup and Operation 23

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2.3.6 Breath Trigger Types

This screen defines how the start of the inspiratory breath cycle and the expiratory
breath cycle are detected. Under most circumstances, it is recommended that the auto­trigger be used.

Figure 24. Trigger Options Menu

Flow Rate

Start and end of the breath is determined by the specified flow rate. If
Auto-Triggering is selected, instrument tries to determine trigger
levels. In some cases you may need to manually select the flow rates
by looking at the flow waveform on the Graph Screen.

Pressure

Start and end of the breath is determined by the specified pressure
levels. Positive slope changed through the first value is used for the
start of inspiratory and a negative slope through the second value is
used for the start of expiratory.

Note: This trigger type is intended to give advance users additional

setup options for special circumstances, such as achieving
basic breath measurements from high frequency ventilators or
other setups in which flow rate or auto triggering are non-ideal.

TTL

Start and end of the breath is determined by a TTL voltage signal
given at the connector on the High Flow Module labeled “Trigger
Input”. This is only available for the 4081 High Flow Module. The
connector is a 3.5 mm mono audio jack plug.

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2.3.7 Flow Triggering

The auto-trigger feature for flow rate is internally established as 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 auto trigger flow rate is set to (80 L/min – 5 L/min)
x 20% + 5 L/min = 20 L/min. If auto-triggering is not providing reasonable results,
consider using either manual flow or manual pressure triggering. To use manual flow
triggering, select the flow radio button and uncheck the "Auto-Triggering" checkbox.
Similarly, to use manual pressure triggering, select the pressure radio button. For a
breath to be detected, trigger settings must be set appropriately for the waveform of
interest. There are two suggested methods for determining the appropriate start and
end trigger values: 1) switch the Certifier FA Plus Test System to the graphing screen
and observe the flow or pressure readings at the start and the end of inspiration and 2)
observe the flow and pressure wave form from the ventilator being tested. For robust
flow and pressure triggering always set the "End Trigger" level lower than the "Start
Trigger". For example, a manual flow trigger setting may be +5 L/min for a start trigger
and -5 L/min for an end trigger setting. These numbers can be optimized based upon
your specific application.

2: Setup and Operation 25

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2.3.8 Saving/Loading Configurations

Configuration is saved

under current name and

location

Figure 25. Configuration Save Screen

Configuration of the values displayed, gas, conditions, triggering, and graph setup can
be saved and recalled. This allows the user to save configurations for different
equipment.

See section 2.3.10.1 to learn how to transfer configuration files from one instrument to
another using the SD memory card.

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2.3.9 Print/Save Button

If the Print/Save button is pressed
while viewing the Parameter
Screen, the "Print/Save Options"
screen will appear. By selecting
the various options on this screen
you will be able to:

 Print the current data record

without saving to a file.

 Print the current data record

and also save it to a file in a
single operation.

 Save the current data record

to a file without printing.

Figure 26. Print/Save Options Screen

 Select Waveform logging function. This feature saves 15 seconds of "raw"

flowmeter data at a rate of 1 millisecond/reading to a file (requires an SD Flash
memory card).

 Select Continuous logging function. This mode logs the Parameter Screen data

into a file at intervals of approximately 1 second until you command the logging to
stop (requires an SD Flash memory card).

When printing or saving, you can
add custom comments to your
data by selecting the Add
Comments option. When that
option is selected, an on-screen
keyboard appears, allowing you to
enter your comment text.

If the Print/Save button is pressed
while viewing the Graph Screen,
you will be able to Save the
currently displayed Graph data to a
file to either the built-in Internal
Memory or to an SD Flash card
inserted into the SD Card slot. You
cannot print the Graph or the
Graph data and you cannot print or
save a screen shot of the graph.

Figure 27. Add Comments Screen

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To retrieve data from the Certifier test system, simply connect the device to a PC using
an USB standard A to mini-B cable. Use the Setup function “Select Mass Storage
Target” (see section 2.3.10 “Setup Key”) to choose whether the host PC will access the
Certifier test system’s built-in memory, or an SD Flash card inserted in the card slot of
the Certifier test system.

All data files exported from Certifier test system use the ASCII character set and
"comma separated value" (CSV) format. This is a format that most spreadsheet and
database applications can import. See Advanced Features Menu for selecting file
delimeters other than commas.

2.3.9.1 Waveform Logging

The Waveform Logging feature logs 15 seconds of raw flowmeter data into a file on a
SD Flash card. The logging rate is about once per millisecond. The data is exported into
“comma separated value” (CSV) format, readable by many common spreadsheet and
database applications. See Advanced Features Menu for selecting file delimeters other
than commas.

The Waveform logging feature requires an SD Flash card.

To initiate Waveform logging:

 Press the Print/Save button on the Certifier test system keypad.

 Select Waveform from the Logging Features section.

 You may choose to Add Comments if you would like to annotate the data.

 Click OK, add comments (if selected) and name the file.

 The Certifier test system will collect 15 seconds of flowmeter waveform data and

then save it into the file.

Access the data by connecting the Certifier test system to a host computer via USB, or
by removing the SD Flash card from the Certifier test system and inserting it into a card
reader attached to a host computer.

2.3.9.2 Continuous Logging

The Continuous Logging feature will log snapshots of the same data being displayed on
the Certifier Parameter Screen and log it into a file on an SD Flash card. The logging
rate is once per second. Only data displayed on the Certifier Parameter Screen will be
logged. See section 2.3 on how to add or remove parameters. The data is exported into
“comma separated value” (CSV) format, readable by many common spreadsheet and
database applications. See Advanced Features Menu for selecting file delimeters other
than commas.

The Continuous logging feature requires an SD Flash card.

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To initiate Continuous logging:

Figure 28. Setup Menu

Oxygen Sensor
Calibration

See required pre-test section of this manual.

Set Time/Date

Sets the current time and date.

Touch Screen
Calibration

Calibrates the touch screen of the interface module. Follow the
instructions on the display.

Lock Touch
Screen

Disables the touch screen once the Setup Menu is closed. To
enable the touch screen, press the Setup button.

 Press the Print/Save button on the Certifier test system keypad.

 Select Continuous from the Logging Features section.

 You may choose to Add Comments if you would like to annotate the data.

 Click OK, add comments (if selected) and name the file.

 The Certifier test system will continue to log data until the Print/Save button is

pressed again or until the SD Flash card fills up.

Access the data by connecting the Certifier test system to a host computer via USB, or
by removing the SD Flash card from the Certifier test system and inserting it into a card
reader attached to a host computer.

Note: If the pause button was pressed prior to continuous logging, a slight delay may

be noticed in the start of the data acquisition.

2.3.10 Setup Key

2: Setup and Operation 29

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Lock
Configuration

Disables the saving of configurations. The user will be able to load
existing configurations and change the current configuration, but not
save it.

Advanced
Features

See Section 2.3.10.1 for a complete list of advanced features which
can be accessed through this menu.

About Device

Displays information about the Certifier Interface Module and any
connected flow module.

Select Mass
Storage Target

When the Certifier test system is connected to a host computer via
USB interface, it appears to the host as a "mass storage" device,
similar to a "memory stick" or “thumb drive”. This function allows
you to select whether the host can access the Certifier's Internal
Memory or an SD Flash memory card. The Certifier test system
supports SD flash cards up to 1 GB in size. Restart the Certifier
whenever a change if made when selecting between internal flash
RAM and SD flash card.

2.3.10.1 Advanced Features

Figure 29. Advanced Function Menu

2.3.10.1.1 Configuration Import/Export

This feature enables you to both download and upload configuration files to and from
the SD card. This is convenient when multiple Certifier FA+ units are in use where the
configuration files from one unit can be transferred to multiple Certifier units. This
eliminates the need to generate configuration files for each instrument.

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This feature requires an SD card to be inserted in the instrument. If it is desired to view

Different formats of the date can be
selected from this menu. This information
is used in the file save mode as part of the
filename and also stored internally within
the file.

Different data delimeters used in the file
save function can be selected through this
menu. This allows for greater flexibility for
importing data in different regions of the
world.

Figure 30. Format Settings Screen

the configuration file on a PC, be sure the Select Mass Storage Device setting is
configured to SD card as mentioned in section 2.3.10.

Press Export button to export the configuration file to the SD card.

Press Import to import the configurations from the SD card.

Notes about exporting configuration files:

 All data is saved to a single file called CertifierConfigurations.dat. If this file already

exists on the SD card, it will be overwritten each time the Export command is
executed.

 It is not possible to generate a user-selectable filename for the exported

configurations.

Notes about importing configuration files:

 Importing a configuration which already exists under the same name in the Certifier

memory will cause the configuration in memory to be overwritten.

 Importing a configuration file will not erase existing configuration files which already

exist in memory but under a different configuration name.

 This feature is not designed for creating configuration files on a PC. The feature is

primarily designed to transfer configuration files from one instrument to another.

2.3.10.1.2 Format Settings

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Caution

 To ensure accurate measurements, wait 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

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.

®

FA Test System components, always use

2.4 Required Pre-test Calibrations

2.4.1 Low Flow Module

2.4.1.1 None required

2.4.2 High Flow Module

2.4.2.1 Zeroing the Flow Direction Sensor

The model 4081, High Flow Module, has a sensor that is used to detect the direction of
flow. This sensor will normally auto-zero if there is no flow for a fraction of a second. If it

is unable to do this at power-up or at least every 10 minutes, a appears on the
screen. Touch the symbol on the display for an explanation of the warning. To manually
zero the direction sensor, remove the High Flow Module from the flow source and cover
one end of the flow tube for a couple of seconds.

2.4.2.2 Low-Pressure and High-Pressure Transducer Zeroing

Check the Low-pressure transducer zero and a High pressure transducer zero by
disconnecting the pressure tubing from the flow module before each pressure
measurement after initial power up to ensure the most accurate readings. If the low or
high pressure is not reading zero, perform the following steps to zero the transducers.

1. Disconnect the pressure tubing from the low and high pressure ports.

2. Press the key.

3. “Pressure Transducers Zeroing” appears on the display for one second. If the
transducers do not see a steady pressure or near zero pressure, an error appears.

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

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2.4.2.3 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, allow one minute to warm up.

2. Press the key and select the “Oxygen Calibration” box on the display. Follow
the directions on the screen. Note that either an “air only” or an “air and 100%
oxygen” calibration can be done. The two point air/100% oxygen calibrations
provide the best accuracy.

Note: The numeric value displayed during the stabilization process does not

necessarily represent the actual oxygen concentration. This numeric
stabilization value is there for you to determine if it is changing or not. Once
the reading stops changing then it is time to advance to the next step in the
oxygen sensor calibration process.

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Symptom

Possible Cause

Corrective Action

Interface Module won’t
turn on, or turns on
and off.

Batteries are depleted or
not installed.

Connect AC adapter or install
charged batteries.

Measurements are not
displayed even though
Interface Module is
turned on.

Flow module is not
connected to Interface
Module.

Connect flow module to Interface
Module. If connected, disconnect
and then reconnect.

Measurements are not
changing or graph is
not updating.

Pause button was
pressed.

Press the Play button at the
top of the screen.

“OOR” 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 or
CO2).

Meter was not purged
with gas displayed on the
Interface Module.

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

Unable to disconnect
flow module from
Interface Module.

Pulling on the cable
rather than the connector.

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

3 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 solve the problem,

Table 4. Troubleshooting the Certifier® FA Test System

35

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Symptom

Possible Cause

Corrective Action

Volume, minute
volume, peak flow,
peak pressure, PEEP,
respiratory rate, or I:E
ratio measurements
are not updated or
incorrect.

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

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

Auto-trigger not optimized
for current waveform.

Ensure that flow is supplied as a
breathing waveform.

Manually set flow trigger level.

Airway restrictor causing
flow disturbance next to
flow module.

Use the TSI Airway pressure
fitting which contains the screen
between the flow module and
the test lung (see Figure 12).

Flow condition causing
oscillations in the
waveform.

Minimize length of tubing
between the test lung and the
airway pressure fitting.

I:E ratio or I time
readings do not
appear correct.

It is possible the
inspiratory pause function
is turned on inside the
ventilator.

Select the I time parameter T

I+P

and ratio parameter I:EIP to be
on the display when the
inspiratory pause feature is
activated on the ventilator. See
section 2.3.3 for a description of
the difference between TI and
T

I+p

.

Another option is to turn off the
inspiratory pause feature on the
ventilator.

Cannot zero low­pressure or high
pressure transducer.

Transducer is connected
to a pressure source.

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

Cannot zero
barometric pressure
transducer.

Barometric pressure
transducer does not
require a zero calibration.

Resume normal system
operation.

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Symptom

Possible Cause

Corrective Action

Oxygen sensor
calibration fails.

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

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

Oxygen sensor is
expired.

Replace oxygen sensor.

Non-steady flow or tidal
flows used.

Use constant flow rates to
supply calibration gas.

Pressure trigger gives
erroneous results.

Pressure signal supplied
to high-flow module not
correct.

Change source of pressure
signal.

Pressure trigger optimized for
use with high-frequency
ventilators.

Host computer not
able to view internal
memory or SD flash
memory.

Certifier test system was
not restarted after
selecting mass storage
target location.

Turn Certifier off and then on
again.

3: Troubleshooting 37

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Component

Cleaning

 Interface 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 non-sterile breathing
circuit components or if damage is visible.

4 Maintenance

4.1 Recharging the Batteries (as required)

The batteries can be charged internally by connecting the AC adapter or they can be
charged externally with the optional battery charger. The fastest charging method is to
charge the battery in the instrument with the instrument turned off. The Certifier FA Plus
uses SBL-160, Lithium Ion Batteries, which are available from many battery supply
houses or TSI. Charging time is approximately 4 to 6 hours.

4.2 Replacing the Oxygen Sensor

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

4.3 Cleaning (as required)

Table 5 summarizes recommended cleaning methods for Certifier® FA Test System
components.

Table 5. Cleaning Recommendations

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4.4 Factory Calibration (recommended yearly)

Certifier® FA Test System flow modules are designed for one year of normal use
following each factory calibration.

If the test system has been dropped or liquid has penetrated any of its components,

do not use, and return to the factory for calibration.

Recalibrated flow modules come with a certificate of calibration and a summary of
performance before and after the calibration. A factory calibration consists of pressure
transducer calibration over the full range of pressures and calibration over the full range
of flows. All calibration datum are stored in the flow modules, so the Interface Module
does not require calibration. Therefore, it is not necessary to return the Interface
Module for factory calibration.

Follow the steps in Section 4.5 below to return Certifier® FA Test System flow modules
for factory calibration.

4.5 Return Procedure

Follow these steps to return Certifier® FA Test System flow modules for factory
calibration:

1. Obtain a Return Material Authorization (RMA) number using our online RMA form at
ntact one of the following offices to make service arrangements.

2. Package the flow modules carefully to avoid damage during shipping.

NOTE: It is not necessary to return the Interface Module for factory calibration.

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Dimensions

Interface module: 17.3 cm  10.5 cm  4.5 cm

(6.8 in.  4.1 in.  1.8 in.)
High Flow Module: 15 cm  6.7 cm  6.1 cm (5.9 in.  2.7 in.  1.4 in.).
Low Flow Module: 12.7 cm  5.1 cm  2.8 cm

(5.0 in.  2.0 in.  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: 3/8-in.
 Flow outlet: 3/8-in.

Weight

Approximately 0.7 kg (1.5 lb), interface with high flow module and
cable.

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 90% relative humidity,
non-condensing

Atmospheric
Pressure

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

Storage: 15000 meters

Conditions

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

Battery Life

3 to 6 hours typical

Battery Type

Lithium-Ion SBL160

AC Adapter

12 VDC 1A Minimum

5 Specifications

NOTE: Specifications are subject to change without notice.

5.1 Physical

5.2 Environmental

5.3 Power

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5.4 Data Transfer and Storage

Internal Memory

1 MB (500 typical records)

External Memory

SD Flash Card. Supports up to 1 GB cards.

Measurement

High Flow Module

Low Flow Module

Flows

Range

-200 to +300.0 SLPM air,
oxygen, and nitrogen

-40 to +40 SLPM carbon
dioxide

0 to 300 air/oxygen mixture

0.01 to 20.00 SLPM air, oxygen,
nitrogen, carbon dioxide, and
nitrous oxide

Accuracy

Air and oxygen: ±2% of reading
or ±0.075 standard L/min,
whichever is greater

Nitrogen and carbon dioxide:
±3% of reading or ±0.075
standard L/min, whichever is
greater

Air/Oxygen mixture: ±4% of
reading or ±0.100 standard
L/min, whichever is greater

Air and oxygen: ±2% of reading or
±0.010 standard L/min, whichever is
greater

Nitrogen and carbon dioxide: ±3%
of reading or ±0.010 standard
L/min, whichever is greater

Nitrous oxide: ±4% of reading or
±0.025 standard L/min, whichever is
greater

Volumes

Range

0.01 to 10 L STP

0 to 10 L STP

Accuracy

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

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

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

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

5.5 Test Measurements (See notes at end of section. See Table 3 for symbol definitions.)

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5: Specifications 43

Measurement

High Flow Module

Low Flow Module

Volumes

Range

0.01 to 10 L STP

Not applicable

Accuracy

Air and oxygen: 3% of reading
plus 0.030 L

Air/oxygen mixtures: 4% of
reading plus 0.040 L STP

Not applicable

Minute Volume

Range

0.01 to 100 L STP

0 to 10 L STP

Accuracy

3% of reading

3% of reading

Times

Range

0.04 to 30 seconds

0.04 to 30 seconds

Accuracy

2% of reading or 0.01
seconds, whichever is greater

2% of reading or 0.01 seconds,
whichever is greater

I:E Ratios

Range

1:100.0 to 100.0:1

1:100.0 to 100.0:1

Accuracy

4% of reading typical

4% of reading typical

Respiratory Rate

Range

1 to 1500 breaths per minute

1 to 1500 breaths per minute

Accuracy

2% of reading or 0.1 BPM,
whichever is greater

2% of reading or 0.1 BPM,
whichever is greater

Low Pressures

Range

-25.0 to 150.0 cmH2O
(-18.4 to 110 mmHg)

Not applicable

Accuracy

0.5% of reading or
0.15 cmH2O (0.15 mmHg),

whichever is greater

Not applicable

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Measurement

High Flow Module

Low Flow Module

High Pressure

Range

-10 to 150.0PSIG
(-0.7 to 10 bar)

Not applicable

Accuracy

1% of reading or 0.1 PSI
(7 mbar), whichever is
greater.

Not applicable

Absolute Pressure

Range

375 to 1200 mmHg
(500 to 1600 mbar)

375 to 1500 mmHg
(500 to 2000 mbar)

Accuracy

8 mmHg (11 m bar)

8 mmHg (11 mbar)

Oxygen Concentration

Range

21 to 100%

Not applicable

Accuracy

2% concentration

Not applicable.

Temperature

Range

5 to 40°C

5 to 40°C

Accuracy

1°C When flow rates are
above 2 L/min

1°C When flow rates are above
2 L/min

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Measurement

High Flow Module

Low Flow Module

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 at these standard conditions (see note 1).

3. For the High Flow Module 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).

For the Low Flow Module the temperature of the gas and the ambient air must be
within 5C (9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.
The Low Flow Module has an additional flow rate accuracy de-rating of 0.0003
standard L/min per 1C (1.8F) and 1 kPa away from 21.1C (70F) and 101.3kPa.

5.6 Calibration Recommendations

Flow
Modules

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

Interface
Module

No calibration required.

Oxygen
Sensor

Check Daily, calibrate as needed.

Complies
with these
standards:

 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.

5.7 Compliance and Approvals

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Appendix A Data File Formats

Parameter Screen Single Sample and Continuous Logging Data
Format

Raw Text Example:

Filename:,\NV1FLASH\EXAMPLE.csv
Comments:,Custom comments here
Configuration:,*Current Configuration
Module A Model:,4081
Module A SN:,40810705010
Trigger Type:,Flow Rate
Start Trigger:,Auto
End Trigger:,Auto
Module A Conditions:,STP
Module A Gas:,AIR
Data Section:,,Module A,Module A,Module A
,,Flow Rate,Low Pressure,PEEP Pressure
Date,Time,L/Min,cmH2O,cmH2O
27/12/2007,12:03:20,0.00,-0.256,0.000

47

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As Formatted By spreadsheet application:

Filename:

\NV1FLASH\EXAMPLE.csv

Comments:

Custom comments here

Configuration:

*Current Configuration

Module A
Model:

4081
Module A SN:

40810705010

Trigger Type:

Flow Rate

Start Trigger:

Auto

End Trigger:

Auto

Module A
Conditions:

STP
Module A Gas:

AIR Data Section:

Module A

Module A

Module A

Flow Rate

Low
Pressure

PEEP

Pressure

Date

Time

L/Min

cmH2O

cmH2O

27/12/2007

12:03:20

-19.2

-0.256

0

Notes:

 When Continuous logging is used, each additional reading is given on a separate,

appended text line.

 Parameter value columns are formatted in the same order that they have been

configured on the display screen.

Parameter Screen Waveform Logging Data Format

Waveform Logging collects a 15-second snapshot of “raw” data from the connected
flow module. An example of the data collected in waveform logging is shown below.

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Raw Text Example (waveform logging):

Appendix A Data File Formats 49

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Graph Screen Data Format

The Graph Display data is formatted as 2 (1 parameter on Graph) or 3 (2 parameters
on Graph) columns of text. The first column is the X axis (relative time), the second and
third columns will contain the Graph data.

X Q L/Min P cmH2O
Total graph time: 10 seconds.
0 -0.421556 0.673527

0.041 -0.197457 0.678888

0.082 -0.095008 0.693449

0.123 -0.043302 0.699908

0.1639 -0.027286 0.712823

0.2049 -0.027088 0.723274

0.2459 -0.022927 0.730932

0.2869 -0.019958 0.736425

0.3279 -0.019294 0.738421

0.3689 -0.022878 0.740417

0.4098 -0.024059 0.744878

0.4508 -0.030267 0.744917

0.4918 -0.034957 0.747344

0.5328 -0.040919 0.74523

0.5738 -0.046022 0.740886

0.6148 -0.04976 0.749106

0.6557 -0.049111 0.743039

0.6967 -0.049844 0.742413
[up to 244 data points]

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