4070 Certifier Flow Analyzer Ventilator Test System User Manual

: June 10, 2024
: Certifier

Table of Contents

4070 Certifier Flow Analyzer Ventilator Test System
CertifierTM FA Test System
Product Usage Instructions
Introduction
Operation
- Breathing Cycles and Trigger Levels
Troubleshooting
Maintenance
Specifications
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4070 Certifier Flow Analyzer Ventilator Test System

CertifierTM FA Test System

The CertifierTM FA Test System is a product developed and sold by TSI. It is used to test whether a room or space meets the required air balance and airflow standards. The system consists of a flow hood or capture hood, which is used to measure the air volume flow rate, an electronic meter with a display, and a software program that allows the user to view and analyze the data collected during the test.

Product Usage Instructions

Before using the CertifierTM FA Test System, carefully read and understand the operator’s manual.
Ensure that the flow hood or capture hood is clean and free from debris.
Connect the flow hood or capture hood to the electronic meter.
Turn on the electronic meter and ensure that it is properly calibrated.
Start the software program on your computer and select the appropriate test settings.
Place the flow hood or capture hood in the desired location and take your measurements. Record your results and analyze the data collected using the software program.

Please note that TSI flow meters are not medical devices under FDA 510(k) and should not be used for human measurements. Additionally, this product has certain limitations and exclusions in its warranty and liability, as described in the operator’s manual. If you have any questions or concerns about the CertifierTM FA Test System, please contact TSI’s sales and customer service team.

Thank you for your TSI® instrument purchase. Occasionally, TSI® releases information on software updates, product enhancements and new products. By registering your instrument, TSI® will be able to send this important information to you.
http://register.tsi.com

As part of the registration process, you will be asked for your comments on TSI products and services. TSI’s customer feedback program gives customers like you a way to tell us how we are doing.

CAUTION: TSI flow meters 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. P umps 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 800-680-1220 / (1) 651 490-2860 (USA and International) or TSI Instruments in UK at: +44 (0) 1494 4 59200.

Trademarks
TSI and the TSI logo are registered trademarks of TSI Incorporated in the United States and may be protected under other country’s trademark registrations. Certifier is a trademark of TSI Incorporated.

Introduction

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

Certifier™ FA Test System components include:

Controller module:
The keypad and display allow you to select test measurements and units for display. The controller module connects to a high or Low Flow module.
High Flow module:
Measures air or 100% oxygen (O2) over a range of flows from 0 to 300 standard liters per minute (SLPM).
Low Flow module:
Measures air, 100% O2, or 100% nitrous oxide (N2O) over a range of flows from 0.01 to 15 SLPM with greater accuracy than the High Flow module at low flow rates.
Oxygen sensor:
Used with the High Flow module, allows the High Flow module to measure O2 concentration and other measurements for any mixture of air and O2.

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

Figure 1. The Certifier™ FA Test System

WARNINGS

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.

CAUTIONS

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® flow meters ARE NOT medical devices under FDA 510(k) and in no situation should be used for human measurements.

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

4070-Certifier-Flow-Analyzer-Ventilator-Test-System-
fig-2

Table 1. Certifier™ FA Test System Parts List

Item no.	Description	Part no.	Qty

High Flow standard kit (part no. 4070)
1| Controller module| 4078| 1
2| High Flow module| 4071| 1
3| Bacteria filter, 22-mm x 22-mm male/female, for use with High Flow module (single use)| 1602341| 1
4| Soft carrying case (holds Certifier™ FA Test System and accessories)| 1319289| 1
5| Adapter, 15-mm ID x 22-mm OD| 1102093| 1
6| Airway pressure fitting with screen| 1611330| 1
7| Adapter, 22-mm x 6-mm (for interfacing High Flow module to Low Flow filter, for use with oxygen concentrator)| 1102091| 2
8| Pressure tubing, 1/8-in. ID x 1/4-in. OD x 48-in. length, silicone| 3002053| 1
9| Mounting bracket (includes mounting bracket, screws, and Velcro strap)| 1040044| 1
10| Pocket driver (used to remove/install the controller module battery cover)| 3012034| 1
11| AA batteries (not shown)| NA| 4
12| Certifier™ FA Test System Operator’s

Manual (not shown)

| 1980436| 1
Item no.| Description| Part no.| Qty
---|---|---|---
Low Flow standard kit (part no. 4075)
1| Controller module| 4078| 1
13| Low Flow module| 4074| 1
14| Bacteria filter, barbed fittings, for use with Low Flow module (single use)| 1040045| 1
4| Soft carrying case (holds Certifier™ FA Test System and accessories)| 1319289| 1
9| Mounting bracket (includes mounting bracket, screws, and Velcro strap)| 1040044| 1
10| Pocket driver (used to remove/install the controller module battery cover)| 3012034| 1
11| AA batteries (not shown)| NA| 4
12| Certifier™ FA Test System Operator’s

Manual (not shown)

| 1980436| 1
High Flow module kit (optional) (part no. 4076)
2| High Flow module| 4071| 1
3| Bacteria filter, 22-mm x 22-mm male/female, for use with High Flow module (single use)| 1602341| 1
5| Adapter, 15-mm ID x 22-mm OD| 1102093| 1
6| Airway pressure fitting with screen| 1611330| 1
7| Adapter, 22-mm x 6-mm (for interfacing High Flow module to Low Flow filter, for use with oxygen concentrator)| 1102091| 2
8| Pressure tubing, 1/8-in. ID x 1/4-in. OD x 48-in. length, silicone| 3002053| 1
9| Mounting bracket (includes mounting bracket, screws, and Velcro strap)| 1040044| 1
Item no.| Description| Part no.| Qty
---|---|---|---
Low Flow module kit (optional) (part no. 4072)
13| Low Flow module| 4074| 1
14| Bacteria filter, barbed fittings, for use with Low Flow module (single use)| 1040045| 1
9| Mounting bracket (includes mounting bracket, screws, and Velcro strap)| 1040044| 1
Oxygen sensor kit (optional) (part no. 4073)
15| Oxygen sensor| 2917019| 1
16| Threaded tee| 1313118| 1
17| Cable, 8-in. length| 1303741| 1
Other accessories (optional)
18| Hard shell carrying case (holds Certifier™ FA Test System and accessories)| 1319288| 1

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

Refer to the manual: see Certifier™ FA Test System Operator’s Manual for important information. Safety approvals for Canada by Underwriter’s Laboratories Inc. (UL). See Section 3.7 for definitions of symbols and abbreviations that appear on the Certifier™ FA display.

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

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

Connect the controller module to a flow module To remove the cable, pull its locking connector (not the cable) from the controller module.
Attach the bacteria filter to the flow module
Install the bacteria filter to the flow module inlet or upstream of all Certifier™ FA Test System components. Make sure the filter is in the correct orientation by aligning the filter’s flow arrow with the direction of the flow, ensuring that the filter’s inlet indicator
(labeled “INLET”, “I”, or other) faces upstream of the flow module, or that the outlet indicator (label “Patent side”, “Outlet” or other) faces towards the flow module.
High Flow module only: install pressure tubing Attach one end of the pressure tubing to the low-pressure port on the flow module, and the other to the pressure port in the circuit.
High Flow module only: install the oxygen sensor (optional,
Plug the oxygen sensor cable into the High Flow module and oxygen sensor. Turn the cable collar to secure the cable to the oxygen sensor. Use the threaded tee to install the oxygen sensor into the circuit. The oxygen sensor can only connect to the High Flow module.
Install the flow module into the test circuit ( Align the flow direction of the flow module and filter with the direction of flow through the circuit.

Operation

Power Up
Pull the protective caps from the flow module ports before powering up. DO NOT apply pressure to the flow module at power up (this ensures accurate low- pressure transducer zero calibration).
Press the I/O (on/off) key on the controller module to power up the Certifier™ FA Test System (the controller module powers all of the attached Certifier™ FA Test System components). At power up, the controller module shows information in this sequence:

All LCD segments light (about two seconds).
NOTICE: If battery voltage is below the minimum operating level, the battery symbol lights and the controller module will turn off.
Firmware revision shown (about two seconds).
Controller module verifies connection and correct operation of the flow module and oxygen sensor (if installed). If the oxygen sensor is installed, the controller module will display a symbol.
Default measurements displayed:
High Flow module: flow (top line), low pressure (bottom line). Low Flow module: flow (top line), respiratory rate (bottom line).
CAUTIONS
To ensure accurate measurements, wait about one minute for the Certifier™ FA Test System to warm up. If environmental conditions have changed significantly, more time may be necessary.
To avoid damage to the Certifier™ FA Test System components, always use bacteria filters upstream of the flow modules, and always cap flow module ports when not in use.
If liquid has penetrated any of its components,
DO NOT use, and return to the factory for calibration.

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

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

Table 2. Keypad Functions

4070-Certifier-Flow-Analyzer-Ventilator-Test-System-
fig-11

Displaying Test Measurements
Follow these steps to display test measurements:

Set up the Certifier™ FA Test System and install it into the circuit.
Press the I/O (on/off) key to power up the system.
Once power up is complete, press the Top line select and Bottom line select keys to select the measurements to be displayed. See Section 3.4, Measurements, for details on each parameter.

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

If you disconnect the flow module, the controller module display is blank.
If you disconnect the oxygen sensor, the sensor symbol and any oxygen-related measurements are not shown on the display.
Normal operation and display resume about one second after reconnection.

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

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

Measurements
Measurements on Top Line of Display
The following parameters are displayed on the top line of the display.

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

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

Peak Flow Rate

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

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

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

NOTICE: A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.
Minute Volume: Minute volume calculated from the inhalation cycle of the last breath and breath rate can be displayed on the top line of the control module display. Units of “MINUTE VOL ATP L” (actual liters), “MINUTE VOL STP L” (standard condition liters), or “MINUTE VOL BTPS L” (liters at body temperature and pressure saturated) can be selected using the DISPLAY UNITS key. See Section 3.7, Display Information, for definitions of these units of measure. For the High Flow module air, O2, and air/O2 mixture can be selected using the GAS SELECT key. For the Low Flow module air, O2, and N2O can be selected using the GAS SELECT key.

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

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

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

Oxygen Concentration
When the oxygen sensor is attached to the High Flow module the oxygen concentration “%O2” can be displayed on the top line of the control module display. Oxygen concentration can also be displayed on the bottom line of the display, see Section 3.4.14. Daily calibrations need to be done on the oxygen sensor. See Section 3.5.2 for instructions on oxygen sensor calibration.

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

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

Low Pressure: Gauge pressure from the low-pressure port of the High Flow module can be displayed on the bottom line of the control module display.
Select units of “cmH2O” or “mmHg” by pressing and holding the DISPLAY UNITS key for at least three seconds.
For best results check the zero on the low pressure transducer before measurements. See Section 3.5.1 for instructions on zeroing the pressure transducer.

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

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

NOTICE: A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.
For best results check the zero on the low pressure transducer before measurements. See Section 3.5.1 for instructions on zeroing the pressure transducer.

Peep Pressure: Positive end expiratory pressure (PEEP) from the low- pressure port of the High Flow module can be displayed on the bottom line of the control module display. Select units of “PEEP cmH2O” or “PEEP mmHg” by pressing and holding the DISPLAY UNITS key for three seconds. For best results check the zero on the low pressure transducer before measurements. See Section 3.5.1 for instructions on zeroing the pressure transducer.

NOTICE: A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.
Breath Rate: The breaths per minute (BPM) can be displayed on the bottom line of the control module display.
NOTICE: A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.

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

NOTICES:

A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.
The inhalation time is defined as the time of positive inhalation flow and DOES NOT include the breath hold time. If the vents inhalation time includes the inhalation pause time, the Certifier™ FA test system’s I:E ratio will not match the vents I:E ratio.

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

NOTICES

A valid flow cycle must occur for this value to be displayed. See Section 3.6, Breathing Cycles and Trigger Levels, for details.
The inhalation time is defined as the time of positive inhalation flow and does not include the breath hold time. If the vents pause inhalation time includes a pause time, the Certifier™ FA test system’s I time will not match the vents I time.

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

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

Oxygen Concentration
When the oxygen sensor is attached to the High Flow module, the oxygen concentration “%O2” can be displayed on the bottom line of the control module display. Oxygen concentration can also be displayed on the top line of the display. See Section 3.4.6. Daily calibrations need to be done on the oxygen sensor. See Section 3.5.2 for instructions on oxygen sensor calibration.Daily calibrations need to be done on the oxygen sensor. See Section 3.5.2 for instructions on oxygen sensor calibration.

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

Required Pre-test Calibrations

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

Disconnect the pressure tubing from the flow module to expose the flow module to ambient air.
Momentarily press the Bottom line select key until low pressure (see Section 3.4.7) is shown on the display.
Press and hold the Bottom line select key for 2 to 3 seconds. The display shows ZERO to indicate that the zero calibration is in progress.
When ZERO is no longer displayed, the low-pressure transducer zero calibration is complete.

NOTICE: The barometric pressure transducer DOES NOT require a zero calibration.

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

Power up the Certifier™ FA Test System with the High Flow module and oxygen sensor attached, then allow about one minute to warm up. The oxygen sensor symbol flashes if the controller module detects the sensor needs calibration or
has expired.
Momentarily press the Top line select or Bottom line select key to show %O2 on the display.
Press and hold the GAS SELECT key for 2 to 3 seconds. Expose the oxygen sensor to room air when you see 21.0 %O2 and CAL on the display. The 21% calibration is complete when 100.0 %O2 lights up on the top line and CAL flashes on the display. This can take several minutes while the oxygen concentration and
sensor stabilize.
Expose the oxygen sensor to 100% oxygen of at least 5 liters per minute. Press and release the GAS SELECT key to begin the 100% calibration. CAL stops flashing when the 100%calibration begins.
If the calibration is successful, CAL disappears and the O2 concentration is shown on the display. This can take several minutes while the oxygen concentration and sensor stabilize.
If the calibration is not successful (oxygen sensor symbol continues to flash, no O2 concentration is shown), repeat the calibration. If the repeated calibration is not successful, replace the oxygen sensor and repeat.
Expose the oxygen sensor to room air. The Certifier™ FA Test System is ready to use when the %O2 reading returns to approximately 21%.

Breathing Cycles and Trigger Levels

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

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

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

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

A 10% of the peak flow rate and trigger can also be selected. The 10% auto trigger does not use the minimum flow rate in calculating the trigger level; zero is assumed for the minimum flow rate. In the above example the trigger level would be 80 L/min x 10% = 8 L/min. Manually set trigger levels can also be used. Trigger can be manually set at 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 17, 20, 22, 24, 30, 35, or 40 L/min.

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

Momentarily press the Top line select key until volume parameter is on the display, see Section 3.4.3.
Press and hold the Top line select key until the “trig” appears on the bottom of the display.
The trigger value will appear on the top line of the display which will be one of the following: “20 PEAK” (20% Auto trigger),
“1 LPM”, “2 LPM”, “3 LPM”, “4 LPM”, “5 LPM”, “6 LPM”, “7 LPM”, “8 LPM”, “9 LPM”, “10 LPM”, “12 LPM”, “15 LPM”, “17 LPM”,
“20 LPM”, “22 LPM”, “25 LPM”, “30 LPM”, “40 LPM”, or
“10 PEAK” (10% Auto trigger).
To adjust the value, press and release the Top line select or Bottom line select to scroll through the list of values in step 3. After 3 seconds the new trigger level will be set and the interface module will return to displaying volume.

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

Display Information: Table 3 describes information that can appear on the controller module screen.

Table 3. Screen Displays

Display Meaning

CAL 100% O2| Oxygen sensor calibration in progress (during exposure to 100% O2).
CAL 21% O2| Oxygen sensor calibration in progress (during exposure to room air).
cmH2O| Centimeters of water: a unit of pressure.
I TIME| Inspiratory time (in seconds). Can be displayed on the bottom line (either High Flow or Low Flow module attached).
I:E RATIO| Ratio of inspiratory time to expiratory time, can be displayed on the bottom line (when High Flow or Low Flow module is attached).
L| Liter: a unit of volume.
LPM| Liters per minute: a unit of flow. The Certifier™ FA Test System calculates the LPM value by applying the actual gas temperature and pressure to the SLPM measurement.
MINUTE VOL| Minute volume: an estimate of exhaled volume for the next 60 seconds, based on the current breath. Can be displayed on the bottom line (when High Flow or Low Flow module is attached).
mmHg| Millimeters of mercury: a unit of pressure.
N2O| 100% nitrous oxide supply gas, selected using the

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

O2| 100% oxygen supply gas, selected using the GAS SELECT key (when High Flow or Low Flow module is attached).
PEAK| Peak flow or pressure. Peak flow can be displayed on top line (when High Flow or Low Flow module is attached). Peak pressure can be displayed on bottom line (if High Flow module is attached).
PEEP| Positive end expiratory pressure: the minimum pressure measured in the circuit throughout the breath cycle. Can be displayed on the bottom line (if High Flow module attached).
REV| Software revision level, displayed at power up.
Display Meaning

S| Stacked volume: a cumulative volume measurement for consecutive breaths. The top line shows the cumulative volume and the bottom line shows the number of consecutive breaths.
SEC| Seconds, a unit of time for I TIME measurements.
SLPM| Standard liters per minute: a unit of flow. The Certifier™ FA Test System measures flows in SLPM. Standard conditions are defined as 21.1 °C (70 °F) at 101.3 kPa (14.7 psia).
STP| Standard temperature and pressure: a condition of volume measurement. The Certifier™ FA Test System measures volumes at STP. Standard conditions are defined as 21.1 °C (70 °F) at

101.3 kPa (14.7 psia).

VOL| Volume: the exhaled volume for the most recent breath. Can be displayed on the top line (either High Flow or Low Flow module attached).
ZERO| Low-pressure transducer zero calibration in progress.

Troubleshooting

Table 4 lists the symptoms, possible causes, and recommended corrective actions for problems you may encounter with the
Certifier™ FA Test System. If the symptom is not listed, or if none of the recommended corrective actions solves the problem, please contact TSI® Customer Support at 800-680-1220 or 651-490-2860.

Table 4. Troubleshooting the Certifier™ FA Test System

4070-Certifier-Flow-Analyzer-Ventilator-Test-System-
fig-14

Symptom	Possible Cause	Corrective Action
Cannot select AIR O2 mixtures.	Oxygen sensor not connected. Look for oxygen
sensor symbol, .	Connect oxygen sensor cable to High Flow module and oxygen

sensor.
Volume, minute volume, peak flow, peak pressure, PEEP, respiratory rate, or I:E ratio measurement is not updated.| 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.

Ensure that flow is supplied as a breathing waveform.

| Bias flow is greater than auto trigger level.| Manually set flow trigger level.
| Inhalation cycle is less than 0.25 milliseconds.| Certifier™ FA test system cannot measure shorter than

0.25 millisecond flow delivery.

| Testing pressure mode on ventilator and no test lung attached.| Use a test lung so that at least 0.25 milliseconds of flow delivery is generated to generate pressure.
Cannot change| Measurement is not| Press the Top line
measurement| displayed while| select or the Bottom
units.| changing units.| line select key to
| | display measurement,
| | then press the
| | DISPLAY UNITS key to
| | change units.
Cannot zero low-| Transducer is| Disconnect pressure
pressure| connected to a| tubing from flow
transducer.| pressure source.| module, then zero low-
| | pressure transducer.
Cannot zero| Barometric pressure| Resume normal
barometric| transducer does not| system operation.
pressure| require a zero|
transducer.| calibration.|
Symptom| Possible Cause| Corrective Action
---|---|---
Oxygen sensor calibration takes longer than

5 minutes.

| 21% oxygen and/or

100% oxygen not supplied for calibration.

| Verify that calibration gases are 21% oxygen and 100% oxygen and repeat calibration.
| Flow of 100% oxygen is too low.| Increase flow of 100% oxygen to at least

5 SLPM and repeat calibration.

Oxygen sensor calibration fails.| 21% oxygen and/or

100% oxygen not supplied for calibration.

| Verify that calibration gases are 21% oxygen and 100% oxygen and repeat calibration.
| Oxygen sensor is expired.| Replace oxygen sensor.

Maintenance

Replacing the Batteries (as required)
Replace the batteries when the low battery voltage symbol is displayed or instrument will not power up.

Turn off the controller module.
Use the pocket driver tool (supplied) to loosen the screw that holds the battery cover on the controller module back panel.
Remove the old batteries from the battery compartment, and install new batteries noting the polarity indicators.
Reinstall the battery cover and tighten the screw to hold the cover to the controller module.

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

Cleaning (as required)
Table 5 summarizes recommended cleaning methods for Certifier™ FA Test System components.

Table 5. Cleaning Recommendations

Component Cleaning

§ Controller module

§ Flow modules

§ Carrying cases

§ Oxygen sensor

§ Oxygen sensor cables

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

§ Adapters

| Steam autoclave after contact with any non-sterile breathing circuit components, and discard if any damage is visible.
§ Single use filters (high and Low Flow modules)| Discard after contact with any non- sterile breathing circuit components or if damage is visible.

Factory Calibration (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 controller module DOES NOT require calibration. Therefore, it is not necessary to return the controller module for factory calibration. Follow the steps in Section 5.5 to return Certifier™ FA Test System flow modules for factory calibration.

Return Procedure
Follow these steps to return Certifier™ FA Test System flow modules for factory calibration:

Contact one of the following offices to make service arrangements and obtain a Service Request number or use our online Service Request form at tsi.com/service.
Package the flow modules carefully to avoid damage during shipping.

NOTICE: It IS NOT necessary to return the controller module for factory calibration.

Specifications

Specifications are subject to change without notice.

Physical

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

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

---|---
Atmospheric Pressure| Operating: 57.1 to 106 kPa (8.28 to 15.37 psia).

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

Conditions| Indoor Use

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

Power

Battery life	15 to 20 hours.
Battery type	Four commercially available AA batteries.

Test Measurements (see notes at end of section)

Measurement	High Flow Module	Low Flow Module

Flow and Peak Flow
Range| 0 to 300.0 SLPM.| 0.01 to 15.00 SLPM.
Accuracy| Air and oxygen: ± 2% of reading or ± 0.075 SLPM, whichever is greater.

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

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

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

Measurement	High Flow Module	Low Flow Module
Pressure drop	Maximum between inlet and outlet ports at 101.3 kPa (14.7 psia)

including filter: 0.50 cmH2O at 20 SLPM, 1.50 cmH2O at 50

SLPM, 5.0 cmH2O at 100 SLPM,

30.0 cmH2O at 300 SLPM.

| Maximum between inlet and outlet ports at 101.3 kPa (14.7 psia) including filter: 4 cmH2O at 2 SLPM, 16 cmH2O at 5

SLPM, 45 cmH2O at 10 SLPM,

85 cmH2O at 15 SLPM.

Volume
Range| 0.01 to 10.0 L STP.| 0 to 9.999 L STP.
Accuracy| Air and oxygen: ± 2% of reading plus 0.020 L STP

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

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

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

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

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

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

(-18.4 to 110 mmHg)

| Not applicable.
Accuracy| ± 0.75% of reading or

± 0.20 cmH2O (0.15 mmHg),

whichever is greater.

| Not applicable.
Measurement| High Flow Module| Low Flow Module
---|---|---
Peak & PEEP Low Pressure
Range| 0 to 150.0 cmH2O.

(0 to 110 mmHg)

NOTES

Standard conditions are defined as 21.1 C (70 F) and 101.3 kPa (14.7 psia).
Flow and volume accuracy is applicable in SLPM or STP mode only.
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).
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.

Calibration Requirements

Flow modules| Factory calibration every year for normal use under normal conditions using the filter(s) provided.
---|---
Controller module| No calibration required.
Oxygen sensor| Daily, following sensor replacement or as required.

Compliance and Approvals

Complies with these standards:| ·          CAN/CSA-C22.2 No. 1010. 1-92: Canadian Standard for the Safety of Electrical Equipment for Measurement, Control and Laboratory Use, Part 1.
---|---
| ·          EN 55011 (1991) Class B, CISPR 11 (1990) Class B, FCC (CFR 47, Part 15) Class B: Emissions, Radiated and Conducted.
| ·          EMC Directive 89/336/ECC, EN 61326-1 (1997 plus Amendment A1 1998), IEC 1000-4-2 (1995), EN 61000-4-2, IEC 1000-4-3 (1995), EN 61000-4-3: Immunity.

TSI Incorporated – Visit our website www.tsi.com for more information.

CONTACT

USA Tel: +1 800 680 1220
UK Tel: +44 149 4 459200
France Tel: +33 1 41 19 21 99
Germany Tel: +49 241 523030
India Tel: +91 80 67877200
China Tel: +86 10 8219 7688
Singapore Tel: +65 6595 6388

U.S. & INTERNATIONAL

Sales and Customer Service: 800-680-1220 / +1(651) 490-2860
Fax: +1(651) 490-3824
TSI Instruments Ltd. (UK)
Sales and Customer Service: +44 (0) 1494 459200
Fax: +44 (0) 1494 459700

U.S. & International

Address: TSI Incorporated 500 Cardigan Road Shoreview MN 55126-3996 USA
Tel: 800-680-1220 /+ 1(651) 490-2860
Fax: 1(651) 490-3824
E-mail: technical.services@tsi.com
Website: www.tsi.com/

United Kingdom

Address: TSI Instruments Ltd.
Tel: (44) 1494 459200
Fax: 44) 1494 459700
E-mail: tsiuk@tsi.com

Germany

Address: TSI GmbH
Tel: + 49 241-52303-0
Fax: + 49 241-52303-49
E-mail: tsigmbh@tsi.com

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4070 Certifier Flow Analyzer Ventilator Test System

CertifierTM FA Test System

Product Usage Instructions

Introduction

Operation

Breathing Cycles and Trigger Levels

Display Meaning

Troubleshooting

Maintenance

Component Cleaning

Specifications

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