TSI Certifier FA User manual
Biomedical Test
Instrumentation
®
Certifier
FA
Test System
Operator’s Manual
April 2008
P/N 1980436, Rev. F
Biomedical Test
Instrumentation
®
Certifier
FA
Test System
Operator’s Manual
April 2008
P/N 1980436, Rev. F
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
Copyright©TSI Incorporated / 2001–2008 / All rights reserved. Certifier® is a registered
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. Seller warrants the goods sold
hereunder, under normal use and service as described in the operator's manual, shall
be free from defects in workmanship and material for twelve (12) months, or 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:
a. 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.
b. 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.
c. 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.
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 NO EVENT SHALL SELLER BE LIABLE FOR
ANY SPECIAL, 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.
Contents
INTRODUCTION...........................................................................1
1
1.1 Parts List .............................................................................3
1.2 Glossary .............................................................................. 6
2 SETUP........................................................................................... 7
3 OPERATION ...............................................................................13
3.1 Power Up ..........................................................................13
3.2 Keypad Functions .............................................................14
3.3 Displaying Test Measurements ........................................14
3.4 Measurements ..................................................................15
3.4.1 Flow Rate ..............................................................15
3.4.2 Peak Flow Rate ..................................................... 16
3.4.3 Volume ..................................................................16
3.4.4 Minute Volume ......................................................16
3.4.5 Stacked Volume ....................................................17
3.4.6 Oxygen Concentration ..........................................17
3.4.7 Low Pressure ........................................................17
3.4.8 Peak Pressure.......................................................18
3.4.9 Peep Pressure.......................................................18
3.4.10 Breath Rate ...........................................................18
3.4.11 I:E Ratio.................................................................18
3.4.12 I Time .................................................................... 19
3.4.13 Absolute Pressure.................................................19
3.4.14 Oxygen Concentration .......................................... 19
3.5 Required Pre-test Calibrations.......................................... 19
3.5.1 Low-Pressure Transducer Zero Calibration.......... 19
3.5.2 Oxygen Sensor Calibration ...................................20
3.6 Breathing Cycles and Trigger Levels................................21
3.6.1 Inhalation and Exhalation Timing.......................... 21
3.6.2 Flow Trigger Levels...............................................21
3.7 Display Information ...........................................................22
4 TROUBLESHOOTING................................................................25
5 MAINTENANCE..........................................................................29
5.1 Replacing the Batteries (as required) ...............................29
5.2 Replacing the Oxygen Sensor (yearly) ............................. 29
v
5.3
Cleaning (as required).......................................................29
5.4 Factory Calibration (yearly) ...............................................30
5.5 Return Procedure..............................................................30
6 SPECIFICATIONS.......................................................................31
6.1 Physical .............................................................................31
6.2 Environmental ...................................................................31
6.3 Power ................................................................................31
6.4 Test Measurements ..........................................................31
6.5 Calibration Requirements..................................................33
6.6 Compliance and Approvals ...............................................33
List of Figures
Figure 1. The Certifier® 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.........................................................................
Figure 7. Installing a Flow Module into the Test Circuit ..............11
Figure 8. Certifier® FA Test System Installed in an Oxygen
Concentrator Circuit ....................................................
Figure 9. Controller Module Keypad............................................14
10
12
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
vi
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
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 (O
to 300 standard liters per minute (SLPM).
Low Flow module:
Measures air, 100% O
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 O
mixture of air and O
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
®
FA Test System is designed for institutional,
) over a range of flows from 0
2
, or 100% nitrous oxide (N2O) over a
2
concentration and other measurements for any
2
.
2
3.1 to disable this feature.
1
Controller
module
Low Flow
module
Oxygen
sensor
High Flow
module
Figure 1. The Certifier
®
FA Test System
WARNING:
To avoid the risk of explosion, do not use in the presence of
flammable anesthetic gases.
Only qualified and trained service technicians are authorized to
service the Certifier® FA Test System. Use only factory-approved
parts and procedures to service the device.
CAUTION:
To avoid inaccurate test readings, do not obstruct tubing or inlet
or exhaust ports, and always use dry gas.
To avoid damage to the Certifier® FA Test System components,
always use bacteria filters upstream of the flow modules, and
always cap flow module ports when not in use.
TSI flowmeters are not medical devices under FDA 510(k) and in
no situation should be used for human measurements.
2
1: Introduction
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.
summarizes the Certifier
numbers shown in
®
FA Test System components and part
Figure 2.
Table 1
Figure 2. Certifier
1: Introduction
®
FA Test System Parts
3
Table 1. Certifier
®
FA Test System Parts List
Item
no.
Description
Part
no.
Qty
High Flow standard kit (part no. 4070)
1 Controller module 4078 1
2 High Flow module 4071 1
3 Bacteria filter, 22-mm x 22-mm
1602341 1
male/female, for use with High Flow
module (single use)
4 Soft carrying case (holds Certifier® FA Test
1319289 1
System and accessories)
5 Adapter, 15-mm ID x 22-mm OD 1102093 1
6 Airway pressure fitting with screen 1611330 1
7 Adapter, 22-mm x 6-mm (for interfacing
1102091 2
High Flow module to Low Flow filter, for
use with oxygen concentrator)
8 Tube junction connector, 22-mm x 22-mm 1102094 1
9 Pressure tubing, 1/8-in. ID x 1/4-in. OD x
3002053 1
48-in. length, silicone
10 Mounting bracket (includes mounting
1040044 1
bracket, screws, and Velcro strap)
11 Pocket driver (used to remove/install the
3012034 1
controller module battery cover)
12 AA batteries (not shown) NA 4
13 Certifier® FA Test System Operator’s
1980436 1
Manual (not shown)
4
1: Introduction
Table 1. Certifier
®
FA Test System Parts List (cont)
Item
no.
Description
Part
no.
Qty
Low Flow standard kit (part no. 4075)
1 Controller module 4078 1
14 Low Flow module 4074 1
15 Bacteria filter, barbed fittings, for use with
1040045 1
Low Flow module (single use)
4 Soft carrying case (holds Certifier® FA Test
1319289 1
System and accessories)
10 Mounting bracket (includes mounting
1040044 1
bracket, screws, and Velcro strap)
11 Pocket driver (used to remove/install the
3012034 1
controller module battery cover)
12 AA batteries (not shown) NA 4
13 Certifier® FA Test System Operator’s
1980436 1
Manual (not shown)
High Flow module kit (optional) (part no. 4076)
2 High Flow module 4071 1
3 Bacteria filter, 22-mm x 22-mm
1602341 1
male/female, for use with High Flow
module (single use)
5 Adapter, 15-mm ID x 22-mm OD 1102093 1
6 Airway pressure fitting with screen 1611330 1
7 Adapter, 22-mm x 6-mm (for interfacing
1102091 2
High Flow module to Low Flow filter, for
use with oxygen concentrator)
8 Tube junction connector, 22-mm x 22-mm 1102094 1
9 Pressure tubing, 1/8-in. ID x 1/4-in. OD x
3002053 1
48-in. length, silicone
10 Mounting bracket (includes mounting
1040044 1
bracket, screws, and Velcro strap)
1: Introduction
5
Table 1. Certifier
®
FA Test System Parts List (cont)
Item
no.
Description
Part
no.
Low Flow module kit (optional) (part no. 4072)
14 Low Flow module 4074 1
15 Bacteria filter, barbed fittings, for use with
1040045 1
Low Flow module (single use)
10 Mounting bracket (includes mounting
1040044 1
bracket, screws, and Velcro strap)
Oxygen sensor kit (optional) (part no. 4073)
16 Oxygen sensor 2917019 1
17 Threaded tee 1313118 1
18 Cable, 8-in. length 1303741 1
Other accessories (optional)
19 Hard shell carrying case (holds
Certifier
®
FA Test System and
1319288 1
accessories)
1.2 Glossary
These labels, terms, and symbols appear on the Certifier® FA Test
System:
Refer to manual: see Certifier
Manual for important information.
CE marking of European Conformity for the Low Voltage
Directive (LVD) and the Directive for Electromagnetic
Compatibility (EMCD).
®
FA Test System Operator’s
Qty
Safety approvals for Canada by Underwriter’s Laboratories
Inc. (UL).
See Section
appear on the Certifier
3.7 for definitions of symbols and abbreviations that
®
FA display.
6
1: Introduction
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