TSI Instruments CERTIFIER FA Bedienungsanleitung

CERTIFIER®FA

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980436, REVISION L

FEBRUARY 2017

Biomedica l Test

Inst r u m entat i o n

CERTIFIER®FA

TEST SYSTEM

OPERATOR’S MANUAL

P/N 1980436, REVISION L

FEBRUARY 2017

U.S. & INTERNATIONAL TSI Instruments Ltd. (UK)

Sales and Customer Service: Sales and Customer Service:

(800) 874-2811 / +1(651) 490-2811 +44 (0) 1494 459200

Fax: Fax:

+1(651) 490-3824 +44 (0) 1494 459700

trademark of TSI Incorporated

Address

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

Fax No.

(651) 490-3824

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)

(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 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) 874-2811 / (1) 651

490-2811 (USA and International) or TSI Instruments in UK at: +44 (0) 1494 4 59200.

iii

Contents

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

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

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

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

3OPERATION...............................................................................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

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

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

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

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

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

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

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

6SPECIFICATIONS.......................................................................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®FA Test System.......................................2

Figure 2. Certifier®FA Test System Parts.....................................3

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

List of Tables

Table 1. Certifier®FA Test System Parts List ...............................4

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

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

Table 4. Troubleshooting the Certifier®FA Test System ............25

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

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 O2concentration 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.

1: Introduction

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 notmedical devices under FDA 510(k) and in

no situation should be used for human measurements.

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