(212 days)
None
No
The summary describes a device that measures and displays gas concentrations in real-time using standard sensor technology. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies.
No
The device is used for monitoring airway gases and anesthetic agents during anesthesia and/or assisted respiration; it does not provide therapy itself.
No
The device is a monitoring device that measures gases in real-time during anesthesia and assisted respiration. While the information it provides can be used to inform clinical decisions, its primary purpose is not to diagnose a disease or condition, but rather to monitor physiological parameters.
No
The device description explicitly lists hardware components: AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board, and Communication Board. It is an independently powered unit that interfaces with a patient monitor.
Based on the provided information, the Gas Module 3 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "monitoring of airway gases during anesthesia and/or assisted respiration." This involves measuring gases directly from the patient's airway, which is a physiological measurement, not a test performed on a sample taken from the body.
- Device Description: The device measures gases in "real-time, breath-by-breath." This further reinforces that it's a direct measurement of physiological processes.
- Lack of Sample Analysis: IVD devices typically analyze samples (blood, urine, tissue, etc.) to provide diagnostic information. This device is measuring gases in the airway, not analyzing a biological sample.
Therefore, the Gas Module 3 falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Product codes
BZK
Device Description
The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.
The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).
The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.
The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing:
EMC and Electrical Safety - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754), Mindray conducted additional Electromagnetic Compatibility and Electrical Safety testing on the subject device. The testing provides an evaluation of the EMC and electrical safety of the subject devices relevant to each of the modifications since clearance of the predicate Gas Module SE. The Electromagnetic Compatibility and Electrical Safety testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012* Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Performance Testing - Bench - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754). Mindray conducted functional and system level testing on the subject devices. The testing provides an evaluation of the performance of the subject devices relevant to each of the modifications since clearance of the Gas Module SE. The functional and system level testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject device meets following consensus standards.
ISO 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the subject Gas Module 3 was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Key results: The testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device. The CO2 rise time for subject device is smaller than the predicate device. The smaller rise time means the device can detect the variety of the concentration of the gas with greater sensitively. No clinical risks or safety issues were introduced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement range:
CO2: 0 to 10%
O2: 0 to 100%
N2O: 0 to 100%
DES: 0 to 18%
SEV: 0 to 8%
ENF: 0 to 5%
ISO: 0 to 5%
HAL: 0 to 5%
awRR: 2 to 100 rpm
Full accuracy:
CO2 accuracy: ± 0.1% @ 0 - 1%; ± 0.2% @ 1 - 5%; ± 0.3% @ 5 - 7%; ± 0.5% @ 7 - 10%; Unspecified @ > 10%
O2 accuracy: ± 1% @ 0 - 25%; ± 2% @ 25 - 80%; ± 3% @ 80 - 100%
N2O accuracy: ± 2% @ 0 – 20%; ± 3% @ 20 – 100%
DES accuracy: ± 0.1% @ 0 - 1%; ± 0.2% @ 1 - 5%; ± 0.4% @ 5 - 10%; ± 0.6% @ 10 - 15%; ± 1% @ 15 - 18%; Unspecified @ > 18%
SEV accuracy: ± 0.15% @ 0 - 1%; ± 0.2% @ 1 - 5%; ± 0.4% @ 5 - 8%; Unspecified @ > 8%
ENF accuracy: ± 0.15% @ 0 - 1%; ± 0.2% @ 1 - 5%; Unspecified @ > 5%
ISO accuracy: ± 0.15% @ 0 - 1%; ± 0.2% @ 1 - 5%; Unspecified @ > 5%
HAL accuracy: ±0.15 % @ 0 - 1%; ±0.2 % @ 1 - 5%; Unspecified @ > 5%
Rise time:
CO2 rise time:
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).
0
October 24, 2018
Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, 518057 CN
Re: K180788
Trade/Device Name: Gas Module 3 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK Dated: September 19, 2018 Received: September 24, 2018
Dear Yanhong Bai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180788
Device Name Gas Module 3
Indications for Use (Describe)
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Gas Module 3 is provided below.
| Device Common Name: | Spirometer, Monitoring (W/wo Alarm) |
|---|---|
| Device Proprietary Name: | Gas Module 3 |
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD. |
| Mindray Building, Keji 12th Road South, | |
| Hi-tech Industrial Park, Nanshan, | |
| Shenzhen, 518057, P. R. China | |
| Tel: +86 755 8188 8998 | |
| Fax: +86 755 2658 2680 | |
| Contact: | Ms. Yanhong Bai |
| Manager Regulatory Affairs | |
| Shenzhen Mindray Bio-medical Electronics Co., LTD. | |
| Mindray Building, Keji 12th Road South, | |
| High-tech Industrial Park, Nanshan, Shenzhen | |
| 518057, P.R. China | |
| Tel: +86 755 81885635 | |
| Fax: +86 755 26582680 | |
| E-mail: baiyanhong@mindray.com | |
| Date Prepared: | October 23, 2018 |
| Classification Regulation: | 21 CFR 868.1850, Class II, Monitoring spirometer |
| Panel: | Anesthesiology |
4
| Primary | ||||
|---|---|---|---|---|
| Product Code | Regulation Number | Panel | Regulation description | Device Common Name |
| BZK | 21 CFR 868.1850 | Anesthesiology | Monitoring spirometer | Spirometer, Monitoring (W/wo Alarm) |
Classification Regulation, Classification Name and Product Codes:
Primary Predicate Device: K062754 - GAS MODULE SE; DATASCOPE CORP.
Indications for Use:
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Device Description:
The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.
The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).
The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.
The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.
Non-clinical testing:
EMC and Electrical Safety - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754), Mindray conducted additional Electromagnetic Compatibility and Electrical Safety testing on the subject device. The testing provides an evaluation of the EMC and electrical safety of the subject devices relevant to each of the modifications since clearance of the predicate Gas Module SE. The Electromagnetic Compatibility and Electrical Safety testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ●
5
A2:2010/(R)2012* Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Performance Testing - Bench - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754). Mindray conducted functional and system level testing on the subject devices. The testing provides an evaluation of the performance of the subject devices relevant to each of the modifications since clearance of the Gas Module SE. The functional and system level testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject device meets following consensus standards.
- ISO 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the subject Gas Module 3 was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Substantial Equivalence:
Comparison of Indications - The indication for use of the subject device (Gas Module 3) is identical to that of the predicate device (Gas Module SE), with only the device name changed. The minor change to the indication for use does not change the fundamental intended use of the Gas Module 3.
Comparison of Technological Characteristics - The table below compares the key technological feature of the subject device to the primary predicate device (Gas Module SE, K062754). The features in gray are the main features that have been modified since their previous clearances.
Device Comparison Table
6
| Feature | Predicate Device
(K062754) | Subject Device | Comparison analysis |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Gas Module SE | Gas Module 3 | |
| Indications for
Use | The indications for use
for the Gas Module SE
include monitoring of
airway gases, during
anesthesia and/or
assisted respiration. The
intended environment of
use is the anesthesia
department, including the
Operating Room (OR)
and post anesthesia care
units (PACU), etc. | The indications for use for
the Gas Module 3 include
monitoring of airway gases
during anesthesia and/or
assisted respiration. The
intended environment of
use is the anesthesia
department, including the
Operating Room (OR) and
post anesthesia care units
(PACU), etc. | Same
The indication for use of
the subject device (Gas
Module 3) is identical to
that of the predicate
device (Gas Module SE),
with only the device
name changed. |
| Power supply | Multi-voltage power
supply, source 100-
240VAC, 50-60Hz. | Multi-voltage power
supply, source 100-
240VAC, 50-60Hz. | Same |
| User interface | Operation is controlled
by a connected patient
monitor via Mindray DS
USA proprietary
communication protocol
by a RS232 connector. | Operation is controlled by a
connected patient monitor
via Mindray DS USA
proprietary communication
protocol by a RS232
connector. | Same |
| Measured
gases | CO2, O2, N2O and
Anesthetic agents
(Halothane, Isoflurane,
Sevoflurane, Desflurane
and Enflurane). | CO2, O2, N2O and
Anesthetic agents
(Halothane, Isoflurane,
Sevoflurane, Desflurane
and Enflurane). | Same |
| Measured
parameters | Patient inspired/expired
gas concentration and
respiration rate. | Patient inspired/expired gas
concentration and
respiration rate. | Same |
| Warm-up time | 2 minutes to operation
with CO2, O2 and N2O. 5
minutes to operation of
anesthetic agents. 30
minutes for full
specification. | 45 seconds to operation
with CO2, O2, N2O and
anesthetic agents. 10
minutes for full
specification. | Similar, warm-up time
improved in Gas Module 3. |
| Sampling rate | The sampling system
takes care of drawing a
gas sample to analyzers
at a fixed rate
(200 $\pm$ 20ml/min). | 200 $\pm$ 20ml/min with larger
size water trap.
120 $\pm$ 12ml/min with smaller
sizewater trap. | Same - The flow rate for
larger size water trap is the
same. The option to use a
new smaller size water trap
is introduced which support
a flow rate of 120ml/min,
which may provide
enhanced gas management
for smaller sized patients. |
| Gas sampling
accessories | Water trap
Sampling line | Adult/Pediatric Water trap
Neonate Water trap
Adult/Pediatric Sampling
line
Neonate Sampling line | The water trap and
sampling line is changed
from Datex-Ohmeda to
Artema Technology. |
7
8
| Adapter, Straight
Adapter, Elbow | Adapter, Straight
Adapter, Elbow | In Gas Module SE, there is
one water trap (PN: 0202-
00-0129) and one sample
line (PN: 0683-00-0451-10)
for all patient types (Adult,
Pediatric and Neonate) with
the sample line flow rate
setting 200ml/min.
In Gas Module 3, there is
one water trap (PN: 0202-
00-0182-10) and sample
line (PN: 0683-00-0525-25)
for adult and pediatric
patient with the sampling
flow rate setting
200ml/min. And a small
size water trap (PN: 0202-
00-0181-10) and sample
line (PN: 0683-00-0524-25)
is introduced for the flow
rate 120ml/min, which is an
enhancement for neonate
patients.
The adapter is the same. |
| ------------------------------------- | ------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
9
| Measurement
range | CO2:
O2:
100%
N2O:
DES:
SEV:
ENF:
ISO:
HAL:
awRR:
rpm | 0 to 15%
0 to 100%
0 to 100%
0 to 20%
0 to 8%
0 to 6%
0 to 6%
0 to 6%
4 to 60
rpm | CO2:
O2:
N2O:
DES:
SEV:
ENF:
ISO:
HAL:
awRR:
rpm | 0 to 10%
0 to 100%
0 to 100%
0 to 18%
0 to 8%
0 to 5%
0 to 5%
0 to 5%
2 to 100 | Although the measurement range of CO2, DES, ENF, ISO and HAL for subject device is small than the predicate device, the difference in the measurement range of these gases for the subject device is insignificant in for the clinical use.
The awRR measurement range for the subject device is wider than the predicate device.
The awRR measurement range of the subject device has been tested using the test apparatus in figure 201.101 of ISO80601-2-55, and the test result meets the specification. |
|----------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Full accuracy | CO2 accuracy: | $\pm$ (0.2% + 2% of reading) | CO2 accuracy: | $\pm$ 0.1% @ 0 - 1%
$\pm$ 0.2% @ 1 - 5%
$\pm$ 0.3% @ 5 - 7%
$\pm$ 0.5% @ 7 - 10%
Unspecified @ > 10% | The CO2 measurement accuracy is now specified in different ranges. These accuracies in different ranges meet the requirements of ISO 80601-2-55. |
| | O2 accuracy: | $\pm$ (1% + 2% of reading) | O2 accuracy: | $\pm$ 1% @ 0 - 25%
$\pm$ 2% @ 25 - 80%
$\pm$ 3% @ 80 - 100% | The O2 measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55 |
10
| N2O accuracy: $\pm$ (1% +
2% of reading) | N2O accuracy:
$\pm$ 2% @ 0 – 20%
$\pm$ 3% @ 20 – 100% | The N2O measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges continue to meet the
requirements of ISO 80601-
2-55. |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DES accuracy: $\pm$ (0.15% + 5% of
reading) | DES accuracy:
$\pm$ 0.1% @ 0 - 1%
$\pm$ 0.2% @ 1 - 5%
$\pm$ 0.4% @ 5 - 10%
$\pm$ 0.6% @ 10 - 15%
$\pm$ 1% @ 15 - 18%
Unspecified @ > 18% | The DES measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges still meet the
requirements of ISO 80601-
2-55. |
| SEV accuracy: $\pm$ (0.15%
- 5% of reading) | SEV accuracy:
$\pm$ 0.15% @ 0 - 1%
$\pm$ 0.2% @ 1 - 5%
$\pm$ 0.4% @ 5 - 8%
Unspecified @ > 8% | The SEV measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges continue to meet the
requirements of ISO 80601-
2-55. |
| ENF accuracy: $\pm$ (0.15% - 5% of reading) | ENF accuracy:
$\pm$ 0.15% @ 0 - 1%
$\pm$ 0.2% @ 1 - 5%
Unspecified @ > 5% | The ENF measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges continue to meet the
requirements of ISO 80601-
2-55. |
| ISO accuracy: $\pm$ (0.15% +
5% of reading) | ISO accuracy:
$\pm$ 0.15% @ 0 - 1%
$\pm$ 0.2% @ 1 - 5%
Unspecified @ > 5% | The ISO measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges continue to meet the
requirements of ISO 80601-
2-55. |
l
11
| | HAL accuracy: ±(0.15% + 5% of reading) | HAL accuracy:
±0.15 % @ 0 - 1%
±0.2 % @ 1 - 5%
Unspecified @ > 5% | The Hal measurement
accuracy is now specified in
different ranges. These
accuracies in different
ranges continue to meet the
requirements of ISO 80601-
2-55. |
|------------|----------------------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rise time | CO2 rise time: