4093 Anesthesia Sensor Kit

CertifierTM Anesthesia Sensor Kit

Model 4093

User Manual

P/N 6017331, Revision A September 2023

www.tsi.com

List of Components

Anesthesia Sensor Kit (Model 4093)

• Anesthesia Sensor Cell (with DB9 connector cable) – Part
  Number: 130386

• Convertor, DB9 Serial to USB-A – Part Number: 130402

• Anesthesia Airway Adapter, Adult/Pediatric – Part Number:
  130403

Optional Accessory

Anesthesia Airway Adapter, Infant – Part Number: 130404

Multi-Gas Anesthetic Analyzer

Principle of Operation: The measurement of CO2, N2O, and
anesthetic agents in gas mixtures is based on the fact that
different gas components absorb infrared light at specific
wavelengths. A beam of infrared light is directed through the gas
flow in the anesthesia sensor adapter. As the beam passes through
the adapter, some of the light is absorbed by the gas mixture. The
amount of absorbed light is measured by a miniaturized spectrometer
which incorporates multiple light filters and an infrared detector
that converts the light beam to an electrical signal and then a
digital value. The ratio of light measured through the filters is
used to calculate the gas concentration.

Available Measurements

that specific agent will be displayed).
CO2| Concentration of carbon dioxide as a percentage.
N2O PATM| Concentration of nitrous oxide as a percentage.

Connecting the Anesthesia Sensor

To connect the anesthesia sensor, follow these steps:

1. Ensure that the power to the analyzer is turned off.

2. Locate the DB9 connector cable on the anesthesia sensor
   cell.

3. Connect the DB9 connector cable to the corresponding port on
   the analyzer.

4. Ensure that the connection is secure.

Touchscreen Operation

Module Card:

The touchscreen operation is performed using the module card.
Insert the module card into the designated slot on the
analyzer.

Selecting Measurements:

To select measurements, follow these steps:

1. Ensure that the analyzer is turned on and connected to the
   anesthesia sensor.

2. On the touchscreen, navigate to the measurement selection
   screen.

3. Using the touchscreen, select the desired measurement(s).

4. The selected measurements will be displayed on the screen.

Zeroing the Anesthesia Sensor

Zeroing Procedure:

To zero the anesthesia sensor, follow these steps:

1. Ensure that the analyzer is turned on and connected to the
   anesthesia sensor.

2. On the touchscreen, navigate to the zeroing screen.

3. Follow the on-screen instructions to initiate the zeroing
   process.

4. Wait for the zeroing process to complete.

Status LED

The analyzer is equipped with a status LED that indicates the
current status of the device. Refer to the user manual for the
meaning of different LED states.

Messages and Errors

Refer to the user manual for a list of messages and errors that
may be displayed on the analyzer’s screen and their corresponding
meanings.

Troubleshooting

Refer to the user manual for troubleshooting guidelines and
solutions to common issues that may arise during the use of the
anesthesia sensor kit.

Maintenance

Cleaning:

Regular cleaning of the anesthesia sensor kit is recommended to
ensure accurate measurements and optimal performance. Follow the
cleaning instructions provided in the user manual.

CertifierTM Anesthesia Sensor Kit
Model 4093
User Manual
P/N 6017331, Revision A September 2023
www.tsi.com

Contents
CONTENTS …………………………………………………………………………………….. 2
LIST OF COMPONENTS………………………………………………………………….. 3 Anesthesia Sensor Kit (Model 4093) ………………………………………. 3 Optional Accessory ………………………………………………………………. 3
MULTI-GAS ANESTHETIC ANALYZER……………………………………………. 4 Principle of Operation …………………………………………………………… 4
AVAILABLE MEASUREMENTS ………………………………………………………. 4
CONNECTING THE ANESTHESIA SENSOR ……………………………………. 5
TOUCHSCREEN OPERATION…………………………………………………………. 6 Module Card………………………………………………………………………… 6 Selecting Measurements ………………………………………………………. 7
ZEROING THE ANESTHESIA SENSOR …………………………………………… 9 Zeroing Procedure ……………………………………………………………….. 9
STATUS LED ………………………………………………………………………………… 11
MESSAGES AND ERRORS …………………………………………………………… 12
TROUBLESHOOTING……………………………………………………………………. 13
MAINTENANCE …………………………………………………………………………….. 14
CLEANING ……………………………………………………………………………………. 14
SPECIFICATIONS………………………………………………………………………….. 15 Measurements …………………………………………………………………… 15 Gas Concentration Conversion…………………………………………….. 16 Electrical and Environmental ……………………………………………….. 16 Physical Characteristics ………………………………………………………. 16 General …………………………………………………………………………….. 17 Airway Adapters …………………………………………………………………. 18 Effects from Water Vapor Partial Pressure on Gas Readings …… 18 Interfering Gas Vapor Effect ………………………………………………… 19

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CertifierTM Anesthesia Sensor Kit Model 4093

List of Components

Anesthesia Sensor Kit (Model 4093)

Material Description

Part Number

Anesthesia Sensor Cell (with DB9 connector cable)

130386

Image

Convertor, DB9 Serial to USB-A

130402

Anesthesia Airway Adapter, Adult/Pediatric

130403

Optional Accessory
Description
Anesthesia Airway Adapter, Infant

Part Number
130404

Image

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Multi-Gas Anesthetic Analyzer
The anesthesia sensor is a mainstream gas analyzer that works in conjunction with the TSI® CertifierTM Plus or CertifierTM Pro test systems to measure real-time gas concentrations of CO2, N2O, and anesthetic agents Halothane, Enflurane, Isoflurane, Sevoflurane, and Desflurane.
Principle of Operation
The measurement of CO2, N2O, and anesthetic agents in gas mixtures is based on the fact that different gas components absorb infrared light at specific wavelengths. A beam of infrared light is directed through the gas flow in the anesthesia sensor adapter. As the beam passes through the adapter, some of the light is absorbed by the gas mixture.
The amount of absorbed light is measured by a miniaturized spectrometer which incorporates multiple light filters and an infrared detector that converts the light beam to an electrical signal and then a digital value. The ratio of light measured through the filters is used to calculate the gas concentration.

Available Measurements

Symbol Description

AA1

Anesthetic agent as a percentage of concentration (if detected, that specific agent will be displayed).

CO2

Concentration of carbon dioxide as a percentage.

N2O PATM

Concentration of nitrous oxide as a percentage.
Atmospheric pressure displayed in units cmH2O, kPa, Pa, hPa, mbar, mmHg, inH2O, or psi.

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CertifierTM Anesthesia Sensor Kit Model 4093

Connecting the Anesthesia Sensor
The anesthesia sensor is connected to the USB-A port of the CertifierTM flow analyzer which provides power and user control from its instrument display.
An airway adapter is inserted into the sensor module which can then connect to the test circuit. There are two types of airway adapters that can be used with the anesthesia sensor: adult/pediatric and infant.
Follow the steps below to setup the anesthesia sensor:
1. Attach an airway adapter to the anesthesia sensor. The adapter will click when properly seated.

2. Connect the anesthesia sensor cable to either USB-A port on the CertifierTM flow analyzer using the supplied DB-9 serial to USB converter.
3. Power on the CertifierTM instrument and configure the anesthesia sensor measurements.
4. Wait a minimum of 30 seconds then perform the zeroing procedure.
5. The green status LED on the anesthesia sensor illuminates when the sensor is ready for use.
6. Connect the attached airway adapter to the anesthesia test circuit.
7. Position the anesthesia sensor with the status LED pointing upwards.

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CAUTION
· DO NOT run anesthetic agents through CertifierTM flow modules/channels.
Use of the anesthesia sensor with CertifierTM Flow Analyzers is for testing purposes only and should not be used for human measurements.
Touchscreen Operation
Once the anesthesia sensor is connected to the CertifierTM flow analyzer, a module card will be generated at the top of the dashboard for the connected sensor.
Module Card
The module card will display the model number of the connected sensor (IRMA AX+) and the anesthetic agent detected by the anesthesia sensor. If no anesthetic agent is detected, the module card will display “No Agent.”
Press the IRMA AX+ module card to view and edit settings for the anesthesia sensor.

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CertifierTM Anesthesia Sensor Kit Model 4093

The manufacturer (Masimo®) and serial number (ex. 914990) of the anesthesia sensor are displayed in the heading of the module card dialog screen.

Three different levels of oxygen concentration can be selected based on the oxygen percentage present in the gas flowing through the anesthesia sensor.
If an anesthetic agent is detected, it will be displayed in this dialog screen. “No Agent” will be displayed if the sensor does not detect an anesthetic agent.
NOTICE
Anesthetic agents cannot be selected by the user but instead are automatically detected by the anesthesia sensor.
Selecting Measurements
From the Parameter screen, access the measurement selection screen by pressing on any of the currently displayed measurement symbols, readings, or units of measurement, or by pressing the pencil icon in the right navigation bar.

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Press the (+) ADD tile to select an additional measurement, or press the measurement symbol of a currently selected measurement to change that measurement parameter.
Once pressed, a list of available measurements will be displayed in alphabetical order. If more than one module is connected, a letter (ex. M, A, B) will indicate which module the measurement is coming from. The letter “M” is used to indicate measurements coming from the Masimo® anesthesia sensor module. Swipe up and down to scroll through the list options then tap to select.
Press the orange X button in the right navigation bar at any time to disregard all changes and return to the Parameter screen. Press the green checkmark button in the right navigation bar to save changes and returns you to the Parameter screen.

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CertifierTM Anesthesia Sensor Kit Model 4093

Zeroing the Anesthesia Sensor
Zeroing should be performed every time the airway adapter is replaced, or whenever an offset in gas values or an unspecified gas accuracy message is displayed.
Before proceeding with the zeroing procedure, allow 30 seconds for warm up after powering on the anesthesia sensor or after changing the adapter. The green LED on the sensor will be blinking for approximately 5 seconds while zeroing is in process.
Zeroing Procedure
Zeroing is performed by snapping a new airway adapter on the anesthesia sensor without connecting to the test circuit and then using the CertifierTM flow analyzer to transmit a zero reference command to the anesthesia sensor.
NOTICE The presence of ambient air (0% CO2) in the airway adapter is of crucial importance for a successful zeroing. No span zeroing is required.
Press the flow module card for the anesthesia sensor.
On the anesthesia sensor module card, select the ZERO button.

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Expose the anesthesia sensor to ambient air and press CONFIRM.
A dialog screen will appear while the anesthesia sensor goes through the zeroing process. It takes approximately 5­10 seconds to zero the anesthesia sensor.

A message will be displayed once the zeroing process has completed. Press DONE to return to the previous screen.

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CertifierTM Anesthesia Sensor Kit Model 4093

Status LED
The status LED provides visual indication of the anesthesia sensor status and illuminates in different colors depending on the state of the device.
NOTICE
Without an airway adapter connected, the status LED will not illuminate.

The status LED is located above the airway adapter inlet on the front of the anesthesia sensor device.

LED Steady green light Blinking green light Steady blue light Steady red light Blinking red light

Status Anesthesia sensor OK Zeroing in progress Anesthesia agent present Anesthesia sensor error Check airway adapter

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Messages and Errors
Descriptions of active messages or errors from the anesthesia sensor can be viewed in the Active Warnings and Errors screen on the CertifierTM display. The following table lists the common anesthesia sensor related messages, their possible cause, and the next steps.

Message
No adapter (check adapter)
Replace adapter (check adapter)

Possible Cause
An airway adapter is not installed.
The airway adapter should be replaced.

Next Steps
Connect an airway adapter to the sensor.
Replace the airway adapter.

Ambient pressure out of range (unspecified accuracy)
Temperature out of range (unspecified accuracy)
Software error (gas sensor error)

Ambient pressure measurement is outside of operating range.
The internal temperature is outside of the operating range.
Sensor software error.

Verify operating conditions according to the specifications. If normal, replace the sensor.
Verify operating conditions according to the specifications. If normal, replace the sensor.
If persistent, replace the sensor.

Hardware error

Sensor hardware

(gas sensor error) error.

If persistent, replace the sensor.

Factory calibration The sensor’s factory If persistent, replace

lost/missing (gas calibration is lost or the sensor.

sensor error)

missing.

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CertifierTM Anesthesia Sensor Kit Model 4093

Troubleshooting
The table below lists the symptoms, possible causes, and recommended corrective actions for problems that may be encountered while operating the anesthesia sensor.
If the symptom is not listed or if none of the recommended corrective actions solve the problem, contact technical support at [email protected] or customer support at 800-680-1220 or 651-490-2860 for assistance.

Symptom
Measurement values are not displaying.

Possible Cause
Anesthesia sensor requires a power cycle.

Status LED is dark (indicator is off).
Status LED is steady red.

Sensor is not plugged into CertifierTM flow analyzer or there is an internal error.
Sensor requires a power cycle or has an internal error.

Gas readings from the sensor are questionable.

Sensor is not connected correctly to the test circuit or the test circuit is leaking.

Gas readings from Sensor may need to

the sensor are

be zeroed.

questionable.

Corrective Action
Disconnect and reconnect the sensor to the CertifierTM flow analyzer.
Verify the sensor is connected to the CertifierTM flow analyzer.
Disconnect and reconnect the sensor to the CertifierTM flow analyzer.
Disconnect and reconnect sensor to test circuit and check the test circuit for leaks.
Zero the anesthesia sensor.

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Maintenance
Once a year it is recommended to perform a gas span check on the anesthesia sensor with a reference instrument or with calibration gas.
To do an operational check on the anesthesia sensor: 1. Connect an airway adapter to the anesthesia sensor. 2. Connect the anesthesia sensor to the CertifierTM flow analyzer and
power on the instrument. 3. Verify that the anesthesia sensor status LED displays a steady
great light. 4. Breathe briefly into the anesthesia sensor airway adapter and verify
that a CO2 values are displayed on the CertifierTM flow analyzer.
Cleaning
To clean the anesthesia sensor: 1. Remove the airway adapter. 2. Wipe each of the sensor’s outer surfaces, paying attention to
crevices and hard to reach areas, until the surfaces are free of any visible residue using one of the following solutions: a. A cloth moistened with 70% isopropyl alcohol b. A quaternary ammonium chloride solution wipe c. A soft bristled brush as needed. 3. Repeat the above cleaning step using a fresh cloth or wipe. 4. Allow the sensor to thoroughly dry before using again.
The surfaces of the anesthesia sensor have been tested to be chemically resistant to the following disinfections/solutions: 70% Isopropyl alcohol 70% Ethyl alcohol Quaternary ammonium chloride solution wipes Cidex® Plus (3.4% glutaraldehyde) 0.5% sodium hypochlorite (1:10 bleach to water solution) Accelerated hydrogen peroxide
NOTICE
The airway adapters are not intended to be cleaned.

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CertifierTM Anesthesia Sensor Kit Model 4093

CAUTION
DO NOT immerse the anesthesia sensor in any liquid and never saturate the sensor completely with any disinfection solution.
DO NOT apply excessive pressure on the IR-windows.

Specifications

Measurements
Standard Conditions
The following measurement specifications are valid with no drift for dry single gases at 22 ±5 °C and 1013 ±40 hPa.

Gas

Range*

Accuracy

CO2

0 to 15 vol%

±(0.2 vol% +2% of reading)

15 to 25 vol% Unspecified

N2O

0 to 100 vol% ±(2 vol% +2% of reading)

HAL, ISO, ENF 0 to 8 vol% 8 to 25 vol%

±(0.15 vol% +5% of reading) Unspecified

SEV

0 to 10 vol% 10 to 25 vol%

±(0.15 vol% +5% of reading) Unspecified

DES

0 to 22 vol%

±(0.15 vol% +5% of reading)

22 to 25 vol% Unspecified

*All gas concentrations are reporting in units of volume percent and may be translated into mmHg or kPa by using the reported atmospheric pressure.

All Conditions
The following measurement specifications are valid with no drift for all specified environmental conditions except for interference specified in the sections Interfering Gas Vapor Effect and Effects from Water Vapor Partial Pressure on Gas Readings.

Gas CO2 N2O Agents**

Accuracy ±(0.3 kPa +4% of reading) ±(2 kPa +5% of reading) ±(0.2 kPa +10% of reading)

**The accuracy specification for the anesthesia sensor is not valid if more than two agents are present in the gas mixture. If more than two agents are present, an alarm will be set.

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Gas Concentration Conversion
Gas concentration is reported in units of volume percent. The concentration is defined as: %gas = (partial pressure of gas component)/(total pressure of gas component)*100.

Note that the total pressure of the gas mixture is estimated by measuring the actual atmospheric pressure (range 525 to 1200 hPa) in the sensor probe.

Electrical and Environmental

Item

Specification

Power Supply

4.5 to 5.5 VDC
1.4 W (normal operation @ 5V) < 2.0 W (power surge @ 5V can last up to 300 ms when entering measurement mode from sleep mode or during start-up)

Operating Temperature 10 °C to 40 °C (50 °F to 104 °F)

Storage/Transport Temperature

-40 °C to 70 °C (-40 °F to 158 °F)

Operating Humidity

< 50 hPa H2O (non-condensing) (68% RH at 40 °C)

Storage/Transport Humidity

10% to 95% RH (non-condensing) (95% RH at 40oC)

Operating Atmospheric 525 to 1200 hPa (525 hPa corresponding to

Pressure

an altitude of 5211m/17,100 feet)

Storage/Transport

500 to 1200 hPa (500 hPa corresponding to

Atmospheric Pressure an altitude of 5572m/18,280 feet)

Compliance

EN ISO 80601-2-55:2018, EN 60601-1-2:2015, EN ISO 5356-1:2015, MDD 92/42/EEC

Physical Characteristics

Item Dimensions Weight Cable Length Expected Service Life

Specification 38 x 37 x 34 mm (1.49 x 1.45 x 1.34 in.) < 25 g (< 0.05 lbs.) 2.5 m ±0.1 m (98 in. ±4 in.) 5 years

*Excluding cable.

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CertifierTM Anesthesia Sensor Kit Model 4093

General

Item

Specification

Data update frequency 20 Hz

Compensation

Automatic pressure, temperature and full spectral interference correction.

Calibration

Zeroing recommended when changing airway adapter, no span calibration is required.

Warm-up time

< 20 seconds (agent identification enabled and full accuracy)

Rise time* (@ 10 l/min)

CO2 90 ms N2O 300 ms HAL, ISO, ENF, SEV, DES 300 ms

Primary agent threshold

0.15 vol%. When an agent is identified, concentrations will be reported even below 0.15 vol% as long as apnea is not detected.

Agent identification time

< 20 seconds (typically < 10 seconds)

Automatic agent detection

Primary agent

Analyzer system response time**

< 1 second

Recovery time after defibrillator test

Unaffected

Drift of measurement accuracy

No drift

Surface temperature at Maximum 46 °C (115 °F) ambient temperature of 23 °C (73.4 °F)

Compliance

EN ISO 80601-2-55:2018, EN 60601-1-2:2015, EN ISO 5356-1:2015

*Measured at 10 l/min with gas concentration steps corresponding to 30% of total measuring range for each gas.
**Measured according to EN ISO 80601-2-55.

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Airway Adapters
Item Disposable adult/pediatric Disposable infant

Specification
Adds less than 6 ml dead space. Pressure drop less than 0.3 cm H2O @ 30 L/min.
Adds less than 1 ml dead space. Pressure drop less than 1.3 cm H2O @ 10 L/min.

Effects from Water Vapor Partial Pressure on Gas Readings
The effects of water vapor are illustrated by the examples in the following table. The two columns on the right show the relative error in displayed concentrations when adding or removing water vapor from the gas mixture, and referencing the measurement to dry gas conditions at actual temperature and pressure (ATPD) or saturated conditions at body temperature (BTPS).

The table illustrates that the gas concentrations at body temperature saturated (BTPS), are 6.2% lower than the corresponding concentrations in the same gas mixture after removal of all water vapor (ATPD).

Temp (oC) 10 20
25

RH (%) 20 20 0

P (hPa) 1013 1013
1013

H2O part. Press. (hPa)
2
5
0 (ATPD)

Err rel (%) 0 0
0

Err rel ATPD (%)
-0.2
-0.5
0

Err rel (%) BPTS
6.0
5.7
6.2

25

23

25

50

1013 7.3 1013 16

0

-0.7 5.5

0

-1.6 4.6

30

80

1013 42

0

37

100

1013 63 (BTPS) 0

37

100

700 63

0

-4.1 2.0 -6.2 0 -9.0 -2.8

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CertifierTM Anesthesia Sensor Kit Model 4093

Interfering Gas Vapor Effect

Gas or Vapor N2O 3 HAL 3

Gas Level
60 vol%
4 vol%

CO2 – 12 – 1

Agents – 1 – 1

N2O – 1 – 1

ENF, ISO, SEV 3 5 vol%

– 1

– 1

– 1

DES 3

15 vol% – 1

– 1

– 1

O2 4

100 vol% – 1 2

– 1

– 1

Note 1: Negligible interface, effect included in the measurement specifications. Note 2: For probes not measuring N2O or O2 the concentrations shall be set from the
host. The anesthesia sensor does not measure O2. Note 3: According to EN ISO 80601-2-55 standard. Note 4: In addition to the EN ISO 80601-2-55 standard.

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

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

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

P/N 6017331 Rev A ©2023 TSI Incorporated Printed in U.S.A.

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