TSI Incorporated Certifier FA Plus Operator's Manual

CERTIFIER® FA PLUS

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980560, REVISION J

FEBRUARY 2016

CERTIFIER® FA PLUS

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980560, REVISION J

FEBRUARY 2016

U.S. & INTERNATIONAL TSI Instruments Ltd. (UK)
Sales and Customer Service: Sales and Customer Service:

[phone] / [phone] [phone]

Fax: Fax:

[phone] [phone]

Copyright  TSI Incorporated / 2010-2016 / 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)
(For country-specific terms and conditions outside of the USA, please visit www.tsi.com.)

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

i

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) 874­2811 / (1) 651 490-2811 (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

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 ......................................................................................... 15

2.2 Power up ....................................................................................................... 16

2.3 Display Navigation ........................................................................................ 17

2.3.1 Measurement Selection .................................................................... 20

2.3.2 Graph Measurement Selection ......................................................... 21

2.3.3 Available Measurement Parameters ................................................. 22

2.3.4 Gas Conditions Selection Box .......................................................... 24

2.3.5 Averaging Setup Menu ..................................................................... 25

2.3.6 Breath Trigger Types ........................................................................ 26

2.3.7 Flow Triggering ................................................................................. 27

2.3.8 Saving/Loading Configurations ......................................................... 28

2.3.9 Print/Save Button .............................................................................. 29

2.3.9.1 Waveform Logging ..................................................................... 30

2.3.9.2 Continuous Logging ................................................................... 31

2.3.10 Setup Key ......................................................................................... 32

2.3.10.1 Advanced Features .................................................................... 33

2.3.10.1.1 Configuration Import/Export .................................................. 33

2.3.10.1.2 Format Settings ..................................................................... 34

2.4 Required Pre-test Calibrations ..................................................................... 35

2.4.1 Low Flow Module .............................................................................. 35

2.4.1.1 None required ............................................................................ 35

2.4.2 High Flow Module ............................................................................. 35

2.4.2.1 Zeroing the Flow Direction Sensor ............................................ 35

2.4.2.2 Low-Pressure and High-Pressure Transducer Zeroing ............. 35

2.4.2.3 Oxygen Sensor Calibration ........................................................ 36

3 TROUBLESHOOTING ........................................................................................... 37

iii

4 MAINTENANCE ...................................................................................................... 41

4.1 Recharging the Batteries (as required) ......................................................... 41

4.2 Replacing the Oxygen Sensor ...................................................................... 41

4.3 Cleaning (as required) ................................................................................... 41

4.4 Factory Calibration (recommended yearly) ................................................... 42

4.5 Return Procedure .......................................................................................... 42

5 SPECIFICATIONS ................................................................................................... 43

5.1 Physical ......................................................................................................... 43

5.2 Environmental ............................................................................................... 43

5.3 Power ............................................................................................................ 43

5.4 Data Transfer and Storage ............................................................................ 44

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

symbol definitions.) ....................................................................................... 44

5.6 Calibration Recommendations ...................................................................... 47

5.7 Compliance and Approvals ........................................................................... 47

APPENDIX A DATA FILE FORMATS ......................................................................... 49

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 .......................................................................................... 10

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 .............................................................................. 15

Figure 15. Example of Parameter Screen ...................................................................... 17

iv Certifier

®

FA Plus Test System

Figure 16. Example of Graph Screen ............................................................................ 17

Figure 17. Parameter Screen Features ......................................................................... 18

Figure 18. Graph Screen Features ................................................................................ 19

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

Figure 20. Graph Measurement Selection Screen ........................................................ 21

Figure 21. Parameter Definitions ................................................................................... 23

Figure 22. Gas Conditions Selection Box ...................................................................... 24

Figure 23. Averaging Setup Menu ................................................................................. 25

Figure 24. Trigger Options Menu .................................................................................. 26

Figure 25. Configuration Save Screen .......................................................................... 28

Figure 26. Print/Save Options Screen ........................................................................... 29

Figure 27. Add Comments Screen ................................................................................ 30

Figure 28. Setup Menu .................................................................................................. 32

Figure 29. Advanced Function Menu ............................................................................ 33

Figure 30. Format Settings Screen ............................................................................... 34

LIST OF TABLES

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

Table 2. Keypad Functions ............................................................................................ 15

Table 3. Parameters (parameter list changes depending on module attached) ........... 22

Table 4. Troubleshooting the Certifier® FA Test System ............................................... 37

Table 5. Cleaning Recommendations ........................................................................... 41

Contents v

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vi Certifier

®

FA Plus Test System

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:
 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.

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.

1

2

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)

Certifier® FA Plus Test System

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, 18-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

1: Introduction 3

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)

Certifier® FA Plus Test System

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

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

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

1: Introduction 5

6

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.

Certifier® FA Plus Test System

Touch Screen Display

Key Pad

Stylus

Figure 5. Interface Module

1: Introduction 7

Certifier® FA Plus Test System

8

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

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

Coiled Cable Connector

Figure 7. High Flow Module

(arrow on module indicates positive flow direction)

Figure 8. Low Flow Module

1: Introduction 9