(129 days)
No
The summary mentions "interpretation software" for ECG but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe training or test data sets typically associated with AI/ML development. The interpretation is described as supporting the physician and providing "partial quantitative information," not an automated diagnosis.
No.
The device is used to measure and record physiological parameters (lung function and ECG), not to directly treat a condition or disease.
Yes
The device measures inspiratory and expiratory lung function parameters (spirometry) and a 12-channel surface electrocardiogram (ECG), which are both used to assess and evaluate a patient's medical condition. The "Intended Use" explicitly states it's a "medical device to measure inspiratory and expiratory lung function parameters" and that the interpretation software "is intended to support the physician in evaluating the ECG in terms of morphology and rhythm," indicating its role in diagnosis.
No
The device description explicitly states it is a "portable device, which can collect spirometry and ECG data" and mentions wired and wireless spirometry sensors, a battery-powered wireless sensor unit, and a charging station. These are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The MasterScope WSSU measures inspiratory and expiratory lung function parameters (spirometry) and surface electrocardiograms (ECG). These are measurements taken directly from the patient's body, not from samples in vitro (outside the body).
The device is clearly described as a medical device for measuring physiological parameters directly from the patient.
N/A
Intended Use / Indications for Use
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope/MasterScope ECG represent partial quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.
It can be used by physicians in the office or hospital.
The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.
Product codes
BTY, DPS
Device Description
The MasterScope is a portable device, which can collect spirometry and ECG data.
With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph).
The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station.
With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use.
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights).
MasterScope provides automated and secure data transmission to a centralized data base.
The measured data is saved into the MasterScope software and can be read out at any time.
A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet.
The MasterScope WSSU is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Possible Configurations:
MasterScope will be delivered in the following configurations:
- MasterScope WSSU:
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) o
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) O and ECG Amplifier
- MasterScope ECG: .
- o Notebook with ECG Amplifier
- pulmonary functions a)
- Measurement with pneumotachograph ●
- Slow spirometrv ●
- Forced spirometry ●
- Flow-Volume and Volume- Time Loop, pre/post tests
- . Trending capabilities
- . Patient Incentive animations
- b) ECG functions
- Simultaneous acquisition of the 12 standard leads ●
- Storage of 10 seconds of acquired ECG signal ●
- Digital filters for base-line drift and mains interference suppression
- Interpretation program Hanover ECG System (HES) providing the following additional ● information:
- Representatives templates of each lead including markers on fiducially points .
- Summary of mean measurements ●
- Rhythm Analysis statements ●
- Signal noise detection and information ●
- . Specific findings on QRS complex
- Conduction statements ●
- QRS T diagnostic statements
- Arrhythmia monitoring detection .
- Heart Rate Variability ●
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
Adults and children aged 4 years and older.
Intended User / Care Setting
Physicians in the office or hospital.
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)
The following practices were followed and monitored for development of the MasterScope WSSU
- . The device was developed and tested according to GMP Standard Operating Procedures for Medical Devices.
- . Software verification and validation was done in accordance with IEC 62304 Ed.1.1:2015.
- . Risk analysis of the MasterScope and WSSU was performed according to ISO 14971:2007.
- Tests were performed to confirm that the MasterScope WSSU meets the . recommendations for accuracy and precision for Spirometry of the American Thoracic Society (ATS) according to ATS/ERS standards 2005.
- The electrical safety testing was performed according to IEC 60601-. 1:2012 to demonstrate conformance with the requirements for basic safety and essential performance.
- . The Electro Magnetic Compatibility testing was performed according to IEC 60601-1-2:2014.
- . The FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" from 2013 was considered for the 3G/BT/WIFI functions and all requirements are fulfilled.
- Human Factors/Usability Engineering validation according to IEC 62366-1: . 2015. IEC 60601-1-6:2013. and the FDA Guidance "Applying Human Factors and Usability Engineering to Medical Devices" from 2016 demonstrated the safety and efficacy of the device.
- . Material Certification provided to support Biocompatibility evaluation in accordance with ISO 10993-1:2009 and ISO 18562-1:2017.
- . The FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" from 2014 has been considered in the device design and all requirements are fulfilled.
- The electrical safety testing for ECG was performed according to IEC . 60601-2-25:2011 to demonstrate conformance with the requirements for basic safety and essential performance of electrocardiographs
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
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 28, 2021
eResearchTechnology GmbH Margit Kohlen Design Assurance Engineer Sieboldstrasse 3 Estenfeld, Bavaria 97230 Germany
Re: K202754
Trade/Device Name: MasterScope WSSU Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive pulmonary-function value calculator Regulatory Class: Class II Product Code: BTY, DPS Dated: December 15, 2020 Received: December 21, 2020
Dear Margit Kohlen:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Rachana Visaria, Ph.D. 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)
Device Name
Indications for Use (Describe)
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/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. Below the text is the tagline "Confidence at every turn".
GENERAL INFORMATION
| 1 | Type of Submission |
|---|---|
| Traditional 510(k) Submission | |
| Submission date: 01/28/2021 | |
| 2 | Submitter |
| Name: eResearchTechnology GmbH | |
| Address: Sieboldstrasse3 | |
| D-97230 Estenfeld | |
| Germany | |
| Contact person in Germany: | |
| (Official Correspondent) Margit Kohlen | |
| Address: eResearchTechnology GmbH | |
| Sieboldstrasse 3, 97230 Estenfeld | |
| Germany | |
| Phone: +49 9305 720 6376 | |
| FAX: +49 9305 720 60 | |
| E-mail margit.kohlen@ert.com | |
| Contact person in the U.S.: Mingzi Deng | |
| Address: eResearchTechnology | |
| 1818 Market Street, Suite 1000 | |
| Philadelphia, PA 19103 | |
| Phone/Fax: 215-2825588 | |
| E-mail mingzi.deng@ert.com | |
| 3 | Establishment Registration Number |
| 3008505660 | |
| 4 | Common Name or Classification Name |
| Predicted pulmonary-function value calculator | |
| (CFR 868.1890, Product Code BTY) | |
| Electrocardiograph (CFR 870.2340, Product Code DPS) | |
| 5 | Trade Name |
| MasterScope WSSU | |
| 6 | Device Classification |
| This is a Class II device |
4
510(k) Summary
Image /page/4/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, with the top section being light green and the bottom two sections being dark blue. Below the text "ERT" is the tagline "Confidence at every turn".
7 Classification Panel
73 Anesthesiology Part 868 (Code BTY) 74 Circular System Devices, ECG Part 870 (Code DPS)
8 Reason for Premarket Notification
New option to an existing eResearchTechnology device
9 Legally predicate marketed device
MasterScope / MasterScope ECG / MasterScope CT Code BTY, DPS K082539
Reference device
SpiroSphere K173937 Code BTY
10 Predicate Device Company
eResearchTechnology GmbH
Device Description 11
The MasterScope is a portable device, which can collect spirometry and ECG data.
With the option Spirometry, inspiratory and expiratory lung function measurements can be performed with a wired sensor (Digital Handle USB) or wireless spirometry sensor unit (WSSU Bluetooth). Both spirometry sensors work with a pneumotach (Lilly Type Pneumotachograph).
The Wireless Spirometry Sensor Unit is battery-powered and can be charged with a dedicated charging station.
With the option ECG, a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use.
The interpretation software is intended to support the physician in evaluation the ECG in terms of morphology and rhythm.
The MasterScope software allows protocol-driven workflows and can be customized for use in clinical trials (e.g. individual access rights).
MasterScope provides automated and secure data transmission to a centralized data base.
5
Image /page/5/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn."
The measured data is saved into the MasterScope software and can be read out at any time.
A printer can be connected with the notebook and all needed data can be printed. Moreover it is possible to transfer data by USB, Wifi, and Ethernet.
The MasterScope WSSU is powered from 100 - 240V / 50 - 60Hz wall outlets. No energy is transferred to the patient.
Possible Configurations:
MasterScope will be delivered in the following configurations:
- MasterScope WSSU:
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) o
- Notebook with Wireless Spirometry Sensor Unit (incl. Charging Station) O and ECG Amplifier
- MasterScope ECG: .
- o Notebook with ECG Amplifier
- pulmonary functions a)
- Measurement with pneumotachograph ●
- Slow spirometrv ●
- Forced spirometry ●
- Flow-Volume and Volume- Time Loop, pre/post tests
- . Trending capabilities
- . Patient Incentive animations
- b) ECG functions
- Simultaneous acquisition of the 12 standard leads ●
- Storage of 10 seconds of acquired ECG signal ●
- Digital filters for base-line drift and mains interference suppression
- Interpretation program Hanover ECG System (HES) providing the following additional ● information:
- Representatives templates of each lead including markers on fiducially points .
- Summary of mean measurements ●
- Rhythm Analysis statements ●
- Signal noise detection and information ●
- . Specific findings on QRS complex
- Conduction statements ●
- QRS T diagnostic statements
- Arrhythmia monitoring detection .
- Heart Rate Variability ●
6
Image /page/6/Picture/1 description: The image shows the logo for ERT. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.
12 Intended Use Statement
MasterScope WSSU is a medical device to measure inspiratory and expiratory lung function parameters. With the option ECG a 12-channel surface electrocardiogram (ECG) can be measured and recorded. It is not intended for intracardial use. Automatic interpretation of the ECG is not possible for pediatric patients with an age below 16 years and for pacemaker patients.
A qualified physician has to reassess all MasterScope/MasterScope ECG measurements. An interpretation by MasterScope/MasterScope ECG is only significant if it is considered in connection with other clinical findings. ECG interpretation statements made by the MasterScope/MasterScope ECG represent partial quantitative information on the patient's cardiovascular conditions and no therapy or drugs can be administered based solely on the interpretation statements.
It can be used by physicians in the office or hospital.
The MasterScope spirometry and ECG application is intended to measure adults and children aged 4 years and older. The patients must be able to understand and perform instructions of the physician.
13 Required Components
Notebook (MasterScope Software) Instruction for Use
MasterScope WSSU:
- Wireless Spirometry Sensor Unit (WSSU) ●
- . Pneumotach with Mouthpiece (ERT PT)
- Charging Station (WSCS) with Power Supply (medical grade) ●
- Calibration syringe (manufacturer Vyaire) ●
- Nose clips (manufacturer Quosina)
MasterScope ECG:
- ECG Amplifier ●
- . ECG electrodes (manufacturer AMBU or Welch Allyn)
7
Image /page/7/Picture/1 description: The image shows the ERT logo. The logo consists of a circular graphic on the left and the text "ERT" on the right. The circular graphic is divided into three sections, colored light green, light blue, and dark blue. Below the text "ERT" is the tagline "Confidence at every turn" in a smaller font.
14 Summary Table of Comparison
Comparison with MasterScope CT (K082539) and SpiroSphere (K173937)
The Sensor Unit used in MasterScope WSSU device is cleared under SpiroSphere (K173937). The Sensor Unit is supplied in its final finished form and is identical to the reference predicate device.
| Pulmonary Function Comparison | |||
|---|---|---|---|
| Predicate Device | |||
| MasterScope CT (K082539) | Reference Device | ||
| SpiroSphere | |||
| (K173937) | MasterScope WSSU | ||
| Indications | |||
| for Use | The MasterScope / MasterScope | ||
| ECG is intended to be used for | |||
| measurement and data collection | |||
| of lung function parameters. The | |||
| system performs cooperation- | |||
| dependent flow volume | |||
| measurements. Mostly it will be | |||
| used for COPD and Asthma | |||
| patients. | |||
| In addition it is intended for | |||
| measuring a 3/6- or 12-channel | |||
| surface electrocardiogram (ECG) | |||
| of a patient. The acquired ECG | |||
| can be recorded and displayed on | |||
| the screen or printed on paper. 12- | |||
| channel ECG's are analysed | |||
| automatically and suggestions for | |||
| the interpretation of the 12-channel | |||
| ECG can be made by the software. | |||
| MasterScope / MasterScope ECG | |||
| can be used for non interpretive | |||
| applications for patients with an | |||
| age of 4 years and older and a | |||
| weight of 20 kg or higher. | |||
| MasterScope / MasterScope ECG | |||
| is intended for use in routine ECG | |||
| recording by trained physicians in | |||
| the office or hospital. MasterScope | |||
| / MasterScope ECG is not | |||
| intended for intracardial use. | |||
| Automatic interpretation of the | |||
| ECG is not possible for pediatric | |||
| patients with an age below 16 | |||
| years and for pacemaker patients. | |||
| MasterScope CT (Clinical Trial | |||
| version) incorporates the identical | |||
| measurements. In addition it offers | The SpiroSphere is a | ||
| compact device to | |||
| measure inspiratory and | |||
| expiratory lung function | |||
| parameters in adults and | |||
| children aged 4 years | |||
| and older. | |||
| It can be used by | |||
| physicians in the office | |||
| or hospital. | MasterScope is a medical | ||
| device to measure | |||
| inspiratory and expiratory | |||
| lung function parameters. | |||
| With the option ECG a 12- | |||
| channel surface | |||
| electrocardiogram (ECG) | |||
| can be measured and | |||
| recorded. It is not intended | |||
| for intracardial use. | |||
| Automatic interpretation of | |||
| the ECG is not possible for | |||
| pediatric patients with an | |||
| age below 16 years and for | |||
| pacemaker patients. | |||
| A qualified physician has to | |||
| reassess all | |||
| MasterScope/MasterScope | |||
| ECG measurements. An | |||
| interpretation by | |||
| MasterScope/MasterScope | |||
| ECG is only significant if it | |||
| is considered in connection | |||
| with other clinical findings. | |||
| ECG interpretation | |||
| statements made by the | |||
| MasterScope/MasterScope | |||
| ECG represent partial | |||
| quantitative information on | |||
| the patient's cardiovascular | |||
| conditions and no therapy | |||
| or drugs can be | |||
| administered based solely | |||
| on the interpretation | |||
| statements. | |||
| It can be used by | |||
| physicians in the office or | |||
| hospital. | |||
| Pulmonary Function Comparison | |||
| Predicate Device | |||
| MasterScope CT (K082539) | Reference Device | ||
| SpiroSphere | |||
| (K173937) | MasterScope WSSU | ||
| workflow control elements to | |||
| restrict the use of the equipment | |||
| (e.g. individual access rights are | |||
| defined for different user roles like | |||
| investigator, doctor, study nurse, | |||
| trainer and service personnel). | |||
| The interpretation software is | |||
| intended to support the physician | |||
| in evaluation the ECG in terms of | |||
| morphology and rhythm. | |||
| A qualified physician has to | |||
| reassess all MasterScope / | |||
| MasterScope ECG measurements. | |||
| An interpretation by MasterScope / | |||
| MasterScope ECG is only | |||
| significant if it is considered in | |||
| connection with other clinical | |||
| findings. ECG interpretation | |||
| statements made by the | |||
| MasterScope / MasterScope ECG | |||
| represent partial qualitative and | |||
| quantitative information on the | |||
| patient's cardiovascular condition | |||
| and no therapy or drugs can be | |||
| administered based solely on the | |||
| interpretation statements. | |||
| The MasterScope / MasterScope | |||
| ECG / MasterScope CT is powered | |||
| from 100 - 240V / 50 - 60Hz wall | |||
| outlets. No energy is transferred to | |||
| the patient. | The MasterScope | ||
| spirometry and ECG | |||
| application is intended to | |||
| measure adults and | |||
| children aged 4 years and | |||
| older. The patients must be | |||
| able to understand and | |||
| perform instructions of the | |||
| physician. | |||
| Patient | |||
| population | Adults and children 4 years and | ||
| older | Adults and children 4 | ||
| years and older | Adults and children 4 years | ||
| and older | |||
| Operation | |||
| principle | - Measurement of inspiratory and | ||
| expiratory flows and volumes | |||
| with pneumotach transducer |
- Calculation of lung function
parameters - Results are displayed and
stored, they can be printed and
exported | - Measurement of
inspiratory and
expiratory flows and
volumes with
pneumotach
transducer - Calculation of lung
function parameters
Results are displayed
and stored, they can be
printed and exported | - Measurement of
inspiratory and expiratory
flows and volumes with
pneumotach transducer - Calculation of lung
function parameters
Results are displayed and
stored, they can be printed
and exported |
| Measure-
ments | FEV1, FVC, PEF, FEF25-75, VC,
IC, ERV and others acc. to ATS* | FEV1, FVC, PEF,
FEF25-75, VC, IC, ERV
and others acc. to ATS* | FEV1, FVC, PEF, FEF25-
75, VC, IC, ERV and others
acc. to ATS* |
| Pulmonary Function Comparison | | | |
| | Predicate Device
MasterScope CT (K082539) | Reference Device
SpiroSphere
(K173937) | MasterScope WSSU |
| | Measuring Range - PEF: 0 to +/- 16 L/s
- FEV1 and FVC: 0.1 to 8 L | Measuring Range
- PEF: 0.1 to 16 L/s
- FEV1 and FVC: 0.1 to
8 L | Measuring Range - PEF: 0.1 to 16 L/s
- FEV1 and FVC: 0.1 to 8
L |
| Performanc-
e Specifica-
tions | Accuracy - PEF:
0 to 14 L/s: +/- 5%/0.2 L/s - FEV1 and FVC:
0.5 to 8 L: +/- 3%/0.05 L | Accuracy - PEF:
0,1 to 16L/s: ±10% of
reading or +/-0,3 L/s - FEV1 and FVC:
0,1 to 8 L: ± 3% of
reading or +/- 0,050 L
Instantaneous flow:
0.1 - 14 L/s: ± 5% or 0.2
L/s | Accuracy - PEF: 0.1 to 16 L/s: +/-
10% of reading or +/- 0,3
L/s - FEV1 and FVC: 0.1 to 8
L: +/- 3% of reading or +/-
0,050 L
Instantaneous flow:
0.1 - 14 L/s: ± 5% or 0.2 L/s |
| | Resolution - PEF: 10 mL/s
- FEV1 and FVC: 1 mL | Resolution
- PEF: