TSI 4093 Sensor Kit User Manual

TSI 4093 Sensor Kit

Product Information

Specifications

• Product Name: Certifier™ Anesthesia Sensor Kit
• Model: 4093
• User Manual: P/N 6017331, Revision B February 2024
• Website: www.tsi.com

Product Usage Instructions

Principle of Operation
The Certifier™ Anesthesia Sensor Kit (Model 4093) is a multi-gas anesthetic analyzer that measures various anesthesia-related parameters.

Available Measurements:
The sensor can measure multiple gas concentrations and provide valuable data for anesthesia monitoring.

Connecting the Anesthesia Sensor
Ensure the sensor is securely connected to the appropriate port on the monitoring equipment.

Touchscreen Operation

• Insert the module card into the designated slot.
• Use the touchscreen to navigate and select desired measurements.

Zeroing the Anesthesia Sensor
Follow the zeroing procedure outlined in the manual to calibrate the sensor for accurate readings.

Status LED
The status LED provides visual feedback on the operating status of the sensor.

Maintenance
Regular cleaning and maintenance of the sensor are essential for optimal performance. Follow the cleaning instructions provided in the manual.

FAQ

• Q: Can the anesthesia sensor be used in MRI environments?
  A: No, the anesthesia sensor is not designed for MRI environments.

• Q: What should be done if moisture pooling is observed on the airway adapter?
  A: When moisture pooling is observed, ensure the airway adapter is positioned vertically and consider changing it if necessary, especially when using heated humidifiers.

Certifier™ Anesthesia
Sensor Kit
Model 4093
User Manual
P/N 6017331, Revision B
February 2024

Warnings, Cautions, and Notes

Operation

WARNING
When operated in conjunction with TSI® Certifier™ flow analyzers, the anesthesia sensor is used for testing purposes only and should not be used for human measurements.

CAUTION
Read the user manual, accessories directions for use, all precautionary information, and specifications before use.

Safety

WARNING

• Anesthesia sensor should only be used for the purpose and in the manner described in this manual.
• DO NOT adjust, repair, open, disassemble, or modify the sensor. Damage to the device may result in degraded performance.
• The anesthesia sensor not intended to be in patient contact.
• The anesthesia sensor is not designed for MRI environments.

NOTICE

• Disconnect the device from power by removing the device cable connection from the Certifier™ flow analyzer.
• Use and store the sensor in accordance with specifications.

Performance

WARNING

• Use only airway adapters manufactured by Masimo®.
• No modification of the probe or airway adapters is allowed.
• Light transmission can be affected by and moisture pooling on the airway adapter XTP™ windows. When using heated humidifiers special care should be paid to position the airway adapter in a vertical position and to change airway adapter if necessary.
• Use of this equipment adjacent to or stacked with other equipment should be avoided as it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating properly.
• Make sure the anesthesia sensor is used in the electromagnetic environment specified in this manual.
• Use of high-frequency electrosurgical equipment in the vicinity of the sensor may produce interference and cause incorrect measurements.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the sensor including cable. Otherwise, degradation of the performance of the sensor could result.
• Incorrect zeroing of the anesthesia sensor will result in false gas readings.
• Use of accessories and cables other than those specified or provided could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
• Replace the airway adapter if rainout/condensation occurs inside the airway adapter.

CAUTION
DO NOT operate the anesthesia sensor outside of the specified operating environment.

Cleaning and Service

WARNING
To avoid electric shock, always physically disconnect the anesthesia sensor and any electrical connections before cleaning.

CAUTION

• NEVER submerge the sensor in water or any other liquid solution this may cause permanent damage to the sensor.
• DO NOT apply excessive pressure on the IR-windows.
• NEVER saturate the anesthesia sensor completely with any disinfection solution.
• Only perform maintenance procedures specifically described in the manual; otherwise, return the sensor for servicing. Improper maintenance may result in damage to the internal parts. Damage to internal parts may result in no or inaccurate readings.
• DO NOT clean the sensor with any chemical other than those specified in this manual. These substances may affect the device’s materials and damage internal parts.
• The anesthesia sensor and airway adapters are non-sterile devices. DO NOT submerge the sensor or airway adapters in any cleaning solution or attempt to sterilize by autoclave, irradiation, steam, gas, ethylene oxide or any other method. This will seriously damage the device.
• DO NOT use undiluted bleach (5% – 5.25% sodium hypochlorite) or any cleaning solution other than those recommended in this manual. Permanent damage to sensor may occur if other unspecified solutions are used.

NOTICE
The presence of ambient air (0% CO2) in the airway adapter is of crucial importance for a successful Zeroing. Special care should be taken to avoid breathing near the airway adapter before or during the Zeroing procedure.

Compliance

WARNING
Any changes or modifications not expressly approved by Masimo® shall void the warranty for this equipment and could void the user’s authority to operate the equipment.

CAUTION

• Disposal of Product: Comply with local laws in the disposal of the device and/or its accessories.
• Airway adapters shall be disposed of in accordance with local regulations for bio hazardous waste.
• For FCC compliance information, refer to Masimo’s operator’s manual.

NOTICE
Use the anesthesia sensor in accordance with the environmental specifications stated in this operator’s manual.

List of Components

Anesthesia Sensor Kit (Model 4093)

Optional Accessory

Multi-Gas Anesthetic Analyzer
The anesthesia sensor is a mainstream gas analyzer that works in conjunction with the TSI® Certifier™ Plus or Certifier™ 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

specific agent will be displayed).
CO2| Concentration of carbon dioxide as a percentage.
N2O| Concentration of nitrous oxide as a percentage.
PATM| Atmospheric pressure displayed in units cmH2O, kPa, Pa, hPa, mbar, mmHg, inH2O, or psi.

Connecting the Anesthesia Sensor
The anesthesia sensor is connected to the USB-A port of the Certifier™ 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 Certifier™ flow analyzer using the supplied DB-9 serial to USB converter.
3. Power on the Certifier™ 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.

CAUTION

• DO NOT run anesthetic agents through Certifier™ flow modules/channels.
• Use of the anesthesia sensor with Certifier™ 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 Certifier™ 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.

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

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

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

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.

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.

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 Certifier™ 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.

The presence of ambient air (0% CO2) in the airway adapter is of crucial importance for a successful zeroing. No span zeroing is required. The presence of ambient air (0% CO2) in the airway adapter is of crucial importance for a successful zeroing. No span zeroing is required.

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 5–10 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.

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.

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 Certifier™ display. The following table lists the common anesthesia sensor related messages, their possible cause, and the next steps.

airway adapter to the sensor.
Replace adapter (check adapter)| The airway adapter should be replaced.| Replace the airway adapter.
Ambient pressure out of range (unspecified accuracy)| Ambient pressure measurement is outside of operating range.| Verify operating conditions according to the specifications. If normal, replace the sensor.
Temperature out of range (unspecified accuracy)| The internal temperature is outside of the operating range.| Verify operating conditions according to the specifications. If normal, replace the sensor.
Software error (gas sensor error)| Sensor software error.| If persistent, replace the sensor.
Hardware error (gas sensor error)| Sensor hardware error.| If persistent, replace the sensor.
Factory calibration lost/missing (gas sensor error)| The sensor’s factory calibration is lost or missing.| If persistent, replace the sensor.
Motor speed out of bounds| Sensor is exposed to excessive movement or vibrations.| Ensure sensor is used in a controlled environment where it is not subject to excessive movement/vibration.
Message| Possible Cause| Next Steps
---|---|---
Agent identifications and concentrations are unreliable| The sensor has detected something that is not necessarily one of the agents we are measuring.| e.g., Isopropanol vapors can be incorrectly identified as Halothane which will result in this alarm.
N2O outside specified range| Measured N2O concentration < 0 vol% or > 100 vol% most likely caused by poor zeroing.| Perform zeroing.
CO2 outside specified range| CO2 level above 15 vol% Specified range:

0–15 vol% ±(0.2 vol%

+2% of reading)

| Check that supplied CO2 gas concentration is within our specified range.
At least on agent outside specified accuracy range| One of the supplied agents is outside our specified accuracy range.| Check that supplied AA gas concentration is within our specified range.
Zero reference calibration required| Inaccurate zero reference.| Perform zeroing.

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 technical.services@tsi.com or customer support at 800-680-1220 or 651-490-2860 for assistance.

to the Certifier™ flow analyzer.
Status LED is steady red.| Sensor requires a power cycle or has an internal error.| Disconnect and reconnect the sensor to the  Certifier™ flow analyzer.
Gas readings from the sensor are questionable.| Sensor is not connected correctly to the test circuit or the test circuit is leaking.| Disconnect and reconnect sensor to test circuit and check the test circuit for leaks.
Gas readings from the sensor are questionable.| Sensor may need to be zeroed.| Zero the anesthesia sensor.

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 Certifier™ 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 Certifier™ 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 cloth moistened with 70% isopropyl alcohol
   • A quaternary ammonium chloride solution wipe
   • 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.

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.

0 to 15 vol%
15 to 25 vol%

| ±(0.2 vol% +2% of reading) 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%
22 to 25 vol%

| ±(0.15 vol% +5% of reading) 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.

**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.

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

≤ 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 Pressure| 525 to 1200 hPa (525 hPa corresponding to an altitude of 5211m/17,100 feet)
Storage/Transport Atmospheric Pressure| 500 to 1200 hPa (500 hPa corresponding to 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

General

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 ambient temperature of 23 °C (73.4 °F)| Maximum 46 °C (115 °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.

Airway Adapters

than 0.3 cm H2O @ 30 L/min.
Disposable infant| 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 ( o C)

|

RH (%)

|

P

(hPa)

| H 2 O part. Press. (hPa)|

Err rel (%)

| Err rel ATPD (%)| Err rel (%) BPTS
---|---|---|---|---|---|---
10| 20| 1013| 2| 0| -0.2| 6.0
20| 20| 1013| 5| 0| -0.5| 5.7
25| 0| 1013| 0 (ATPD)| 0| 0| 6.2
25| 23| 1013| 7.3| 0| -0.7| 5.5
25| 50| 1013| 16| 0| -1.6| 4.6
30| 80| 1013| 42| 0| -4.1| 2.0
37| 100| 1013| 63 (BTPS)| 0| -6.2| 0
37| 100| 700| 63| 0| -9.0| -2.8

Interfering Gas Vapor Effect

Gas or Vapor| Gas Level| CO 2| Agent| N 2 O
---|---|---|---|---
N2O 4| 60 vol%| – 1 2| – 1| – 1
HAL 4| 4 vol%| – 1| – 1| – 1
ENF, ISO, SEV 4| 5 vol%| – 1| – 1| – 1
DES 4| 15 vol%| – 1| – 1| – 1
Xe (Xenon) 4| 80 vol%| -10% of reading 3| – 1| – 1
He (Helium) 4| 50 vol%| -6% of reading 3| – 1| – 1
Metered dose inhaler propellants 4| Not for use with metered dose inhaler propellants
C2H5OH (Ethanol) 4| 0.3 vol%| – 1| – 1| – 1
C3H7OH (Isopropanol) 4| 0.5 vol%| – 1| – 1| – 1
CH3COCH3 (Acetone) 4| 1 vol%| – 1| – 1| – 1
CH4 (Methane) 4| 3 vol%| – 1| – 1| – 1
CO Carbon monoxide 5| 1 vol%| – 1| – 1| – 1
NO Nitrogen monoxide 5| 0.02 vol%| – 1| – 1| – 1
O2 Oxygen 5| 100 vol%| – 1 2| – 1| – 1

Note 1: Negligible interface, effect included in the measurement specifications “Accuracy, all conditions” above.
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: Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO2 readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO2 and 50 vol% Helium, the actual measured CO2 concentration will typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.
Note 4: According to EN ISO 80601-2-55 standard.
Note 5: In addition to the EN ISO 80601-2-55 standard.

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.

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P/N 6017331 Rev B ©2024 TSI Incorporated Printed in U.S.A.

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