(224 days)
No
The device description details a mechanical and electronic system for oxygen concentration based on pressure swing adsorption and breath detection, with no mention of AI or ML algorithms for control or analysis.
Yes
The device is described as providing "an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy," which directly treats a medical condition.
No
This device is a portable oxygen concentrator, which provides oxygen therapy to patients, rather than diagnosing a condition.
No
The device description clearly outlines a physical hardware device (compressor, sieve beds, valves, etc.) that produces oxygen, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "patients requiring high concentrations of oxygen on a supplemental basis." This describes a therapeutic use, delivering oxygen directly to the patient's respiratory system.
- Device Description: The description details the mechanical process of concentrating oxygen from ambient air and delivering it to the patient via a cannula. This is a physical process for patient treatment, not a diagnostic test performed on a sample from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, disease, or condition based on the analysis of a sample.
- Using reagents or other substances to perform a test on a sample.
The device is a medical device used for treatment, specifically oxygen therapy, rather than for diagnosis.
N/A
Intended Use / Indications for Use
The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
Product codes
CAW
Device Description
The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its operation with air being pulled into the external air intake filter. This filtered air enters the compressor via a suction resonator and fine filter. Pressurized air then exits the compressor. Next, an electronic valve system directs the air into one of two tubes that contain molecular sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the nitrogen from the air as it is pushed through the sieve beds, this process is called pressure swing adsorption (PSA). As one tube is generating the product gas, the other is being purged of the adsorbed nitrogen. After passing through the oxygen storage tank, the rate of product gas being delivered to the patient is set by a restricting orifice and pulse dose valve based upon detection of a breath. It then passes through a fine particle filter and thru a sensor that detects the oxygen concentration of the product gas before it exits the device through a fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
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)
Bench Tests were performed for:
- Basic Safety and Essential Performance of Oxygen Concentrators (ISO 80601-2-69:2014) - Pass
- Basic Safety and Essential Performance of Oxygen-Conserving Equipment (ISO 80601-2-67:2014) - Pass
- Basic Safety and Essential Performance of Medical Electrical Equipment (IEC 60601-1:2006 + A1:2013) - Pass
- Electromagnetic Disturbances – requirements and tests (IEC 60601-1-2:2015) - Pass
- Usability Engineering to Medical Devices (IEC 62366-1:2015 + AC:2016) - Pass
- Alarm Systems in Medical Electrical Equipment (IEC 60601-1-8:2007) - Pass
- Usability (IEC 60601-1-6:2010) - Pass
- Medical Devices used in a Home Healthcare Environment (IEC 60601-1-11:2015) - Pass
- Safety Requirements for lithium batteries used in portable applications (IEC 62133-2:2017) - Pass
- Exposure to RFID Readers (AIM 7351731:2017) - Pass
Biocompatibility Tests were performed for:
- Biological Evaluation of Breathing Gas Pathways (ISO 18562-1:2017) - Pass
- Emissions of Particulate Matter (ISO 18562-2:2017) - Pass
- Emissions of Volatile Organic Compounds (ISO 18562-3:2017) - Pass
- Biological Evaluation of Medical Devices (ISO 10993-1:2009 + AC:2010) - Pass
- Cytotoxicity Tests (ISO 10993-5:2009) - Pass
- Skin Sensitization / Irritation Tests (ISO 10993-10:2010) - Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nidek Medical Products, Inc. Olivia Mullen Compliance/ Regulatory Affairs 3949 Valley East Industrial Drive Birmingham, Alabama 35217
Re: K192693
Trade/Device Name: Nuvo Nano Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: May 1, 2020 Received: May 1, 2020
Dear Olivia Mullen:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192693
Device Name
Nuvo Nano Portable Oxygen Concentrator
Indications for Use (Describe)
The Nuvo Nano Portable Oxygen Concentrator is for prescription use by patients requiring high concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
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
Image /page/3/Picture/0 description: The image shows the logo for NIDEK Medical. The word "NIDEK" is written in large, blue, sans-serif font. Below the word "NIDEK" is the word "Medical" written in a smaller, italicized, gray font. There is a horizontal line below the word "NIDEK".
5 510(k) Summary
| 510(k) Summary | This summary of 510(k) safety and effectiveness is made in accordance
with the requirements of 21 CFR 807.92. |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Nidek Medical Products, Inc.
3949 Valley East Industrial Drive
Birmingham, AL 35217, USA
Phone - 205.856.7200
Fax - 205.856.0533 |
| Contact Person | Olivia Mullen
Compliance / Regulatory Affairs
omullen@nidekmedical.com
Phone - 205.856.7200 ext 220
Fax - 205.856.0533 |
| Date Submitted | 07 May 2019 |
| Trade Name | Nuvo Nano Portable Oxygen Concentrator |
| Common Name | Oxygen Concentrator |
| Classification Name | Generator, Oxygen, Portable |
| Regulation Number | 21 CFR 868.5440 |
| Prior PMA Submission | No, there has not been a submission for the Nuvo Nano from Nidek
Medical Products, Inc. |
| Equivalent Legally
Marketed Device | Respironics SimplyGo Mini Oxygen Concentrator
K111885 |
| Description | The Nuvo Nano Portable Oxygen Concentrator (Nano POC) begins its
operation with air being pulled into the external air intake filter. This
filtered air enters the compressor via a suction resonator and fine filter.
Pressurized air then exits the compressor. Next, an electronic valve
system directs the air into one of two tubes that contain molecular
sieve (sieve beds). The molecular sieve adsorbs (physically attracts) the
nitrogen from the air as it is pushed through the sieve beds, this
process is called pressure swing adsorption (PSA). As one tube is
generating the product gas, the other is being purged of the adsorbed
nitrogen. After passing through the oxygen storage tank, the rate of
product gas being delivered to the patient is set by a restricting orifice
and pulse dose valve based upon detection of a breath. It then passes
through a fine particle filter and thru a sensor that detects the oxygen
concentration of the product gas before it exits the device through a |
4
Description (cont.) fire-resistant outlet. Once the product gas leaves the device, it travels to the patient via oxygen tubing and a cannula inserted in the nose. The Nano POC offers the user multiple options to power the device; a detachable lithium ion battery, replaceable by the patient, and an external AC/DC power supply. The device will charge the lithium ion battery when the battery and power supply are both attached. The device operates from 100V to 240V and at 50/60Hz. The device is approximately 8.3″ wide by 3.5″ deep by 6.5″ high (21.6cm x 8.9cm x 16.5cm). The device weighs about 4.7 pounds (2.1 kg) including the battery. The device provides an intermittent supply of oxygen enriched gas at a concentration between 87% and 96% to patients requiring longterm oxygen therapy without the higher cost of bottled oxygen. The device produces a product pressure of less than 170 kPa (25 psig) and flow is set by a controller that delivers pulsed flow rates nominally equivalent to continuous flow rates of 1 to 5 LPM. The device provides pulsed dose delivery of oxygen to the user through a selection of 5 settings; setting 1 delivering the least and setting 5 delivering the greatest amount of oxygen enriched product gas. Oxygen pulse volume per minute is controlled electronically by monitoring the user's breath rate and therefore adjusting bolus volume to deliver the same amount of oxygen per minute to the user. The device does not contain, nor does it produce, any latex, phthalates, harmful chemicals, animal tissue, blood components, or radioactive materials that the user or patient could physically contact. The user has short term surface contact with the device (PC + ABS cabinet and PET HMI overlay), but the nasal cannula has contact with the face for the duration of the treatment. The product gas also has prolonged contact with the respiratory airways. The device is not invasive nor implanted. The device is not life supporting, life sustaining, sterile, or radioactive. The device does not incorporate a medical substance, animal tissue or blood component. The device is reusable and should be used as often as prescribed, for the duration prescribed. Smoking cigarettes while undergoing treatment, especially during treatment, is a contraindication to the intended purpose of the device. Nidek Medical Products, Inc.
The Nano POC is for prescription use by patients requiring high Intended use concentrations of oxygen on a supplemental basis. It is small, portable, and is capable of continuous use in the home, institutional, and travel / mobile environments.
warns against the use of oil or grease, using the device around an open
flame, and using the device without a prescription from a doctor.
5
| Predicate Device | Proposed Device | |
|---|---|---|
| Trade Name | Philips Respironics SimplyGo Mini | Nidek Medical Nuvo Nano |
| Model Number | SimplyGo Mini | 855 |
| 510(k) submitter | Respironics, Inc. | Nidek Medical Products, Inc. |
| 510(k) number | K111885 | K192693 |
| Common Name | Oxygen Concentrator | Oxygen Concentrator |
| Classification Name | Generator, Oxygen, Portable | Generator, Oxygen, Portable |
| FDA Product Code | CAW | CAW |
| Regulation Number | 21 CFR 868.5440 | 21 CFR 868.5440 |
| Intended Use | The Philips Respironics SimplyGo Mini | |
| Portable Oxygen Concentrator is for | ||
| prescription use by patients requiring high | ||
| concentrations of oxygen on a supplemental | ||
| basis. It is small, portable, and is capable of | ||
| continuous use in the home, institutional, | ||
| and travel / mobile environments. | The Nuvo Nano Portable Oxygen | |
| Concentrator is for prescription use by | ||
| patients requiring high concentrations of | ||
| oxygen on a supplemental basis. It is small, | ||
| portable, and is capable of continuous use in | ||
| the home, institutional, and travel / mobile | ||
| environments. | ||
| Comparison | ||
| Statement | The proposed device has the same classification information and intended | |
| use as the predicate device. | ||
| General | ||
| Power Supply | Lithium Ion Battery | |
| AC Power (100 to 240 VAC, 50/60Hz) | ||
| DC Power (12-16 VDC) | Lithium Ion Battery | |
| AC Power (100 to 240 VAC, 50/60Hz) | ||
| Battery Options | Standard Battery | |
| Extended Battery | Standard Battery | |
| Watt-hour Rating | 97.9 Wh (per standard battery) | 99 Wh |
| Battery Duration | Up to 4.5 hours (setting 2 at 20 BPM – | |
| standard battery) | Up to 4 hours | |
| Battery Charge | ||
| Time | 4 hours (max recharge for std battery) | Not more than 4 hours |
| Expected Service | ||
| Life | 5 years – device and accessories | 5 years – Nano System |
| 1 year – Molecular Sieve Beds | ||
| 500 cycles - Battery | ||
| Dimensions | 9.4 in x 8.3 in x 3.6 in (std battery) | 8.3 in x 3.5 in x 6.5 in |
| Weight | 5.0 lbs (std battery) | 4.7 lbs |
| Classification | ||
| IEC Class II Internally Powered | ||
| Equipment | IEC Class II Internally Powered | |
| Equipment | ||
| Type BF Applied Part | Type BF Applied Part | |
| IP22 | IP22 | |
| Comparison | ||
| Statement | The proposed device has similar general specifications as the predicate | |
| device. |
Predicate Device Comparison
6
Predicate Device Comparison
| Predicate Device | Proposed Device | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Technology | Pressure Swing Adsorption (PSA) | Pressure Swing Adsorption (PSA) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| User Interface | Capacitive Touch Screen | 2.8 inch (7.1 cm) color LCD with | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| membrane switch controls | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Comparison | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Statement | The proposed device has similar technology to the predicate device. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Performance | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Specifications | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Average Oxygen | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Content | At least 87% at all settings (maximum of | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 96%) | 87% to 96% at all settings | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inspiratory Trigger | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sensitivity | ≤ 0.2 cm H2O | ≤ 0.12 cm H2O | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Breathing Frequency | Up to 40 BPM | 10 to 40 breaths per minute | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Flow Control Settings | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| and Pulse Volumes | 1 2 3 4 5 Breath Rate Pulse Volumes (mL) 15 11.0 22.0 33.0 44.0 55.0 20 11.0 22.0 33.0 44.0 50.0 25 8.8 17.6 26.4 35.2 40.0 30 7.3 14.7 22.0 29.3 33.3 35 6.3 12.6 18.9 25.1 28.6 40 5.5 11.0 16.5 22.0 25.0 per ISO 80601-2-67 | 1 2 3 4 5 Breath Rate Pulse Volumes (ml) 10 21 42 63 84 100 15 14 28 42 58 66.7 20 10.5 21 31.5 42 50 25 8.4 16.8 25.2 33.6 40 30 7 14 21 28 33.3 35 6 12 18 24 28.6 40 5.3 10.5 15.8 21 25 ±15% at Standard Temperature and Pressure, dry (STDP)* | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| ± 25% over the rated environmental range |
- STDP is 101.3kPa at an operating temperature of 20°C, dry | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Sound Level | 43 dBA typical at setting 2
49 dBA typical at setting 5 | | 49 dBA (on setting 2) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Altitude Capability | Up to 10,000 ft | | 0 to 10,000 ft/3048 m | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Storage Temperature | -4 to 140 F/-20 to 60 C | | -4 to 158 F/-20 to 70 C | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Operating
Temperature | 41 to 95 F/5 to 35 C | | 41 to 104 F/5 to 40 C | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Relative Humidity | 15% to 93% | | 10% to 90% | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Alarms/Alerts | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | No breath / High Breath Rate | | No breath detected | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Low Oxygen Concentration | | Low O2 concentration
(at