(336 days)
Not Found
No
The document describes a standard fetal and maternal monitor and does not mention any AI or ML capabilities. The performance studies listed are standard device validations, not AI/ML model performance evaluations.
No
The device is described as a monitor that non-invasively or internally monitors physiological parameters (such as FHR, uterine activity, maternal vital signs). There is no indication that it treats or cures any condition.
Yes
This device monitors various physiological parameters (FHR, TOCO, DECG, IUP, MECG, NIBP, MSpO2, TEMP) of pregnant women and fetuses. While it doesn't provide a direct diagnosis, the continuous monitoring of these parameters during antepartum examination, labor, and delivery is crucial for trained personnel to identify potential issues and make clinical decisions, thus serving a diagnostic function in the broader sense of assessing health status and identifying deviations from normal. It facilitates Non-Stress testing, which is a diagnostic tool.
No
The device description explicitly states it is a "bedside fetal and maternal monitor" and lists various hardware components and sensors (ultrasound transducer, TOCO transducer, DECG, IUPC, NIBP sensor, SpO2 sensor, temperature sensor) used for data acquisition. Performance studies also include electrical safety and electromagnetic compatibility testing, which are relevant to hardware.
Based on the provided information, 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 Fetal & Maternal Monitor described here is a device that monitors physiological parameters of the pregnant woman and fetus externally or internally using sensors and transducers. It does not analyze samples taken from the body.
- Parameters Measured: The parameters measured (FHR, TOCO, FM, AFM, DECG, IUP, MECG, NIBP, MSp02, TEMP) are all physiological measurements taken directly from the patient, not from in vitro samples.
Therefore, the device falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
Product codes (comma separated list FDA assigned to the subject device)
HGM, HGL, DSI, DRT, DXN, FLL, DQA, DPS
Device Description
The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.
The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.
The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:
Fetal heart rate (FHR)
Tocodynamometry (TOCO) for external monitoring of uterine contractions .
Fetal Movement (FM)
Automated Fetal Movement (AFM)
Direct ECG (DECG) for internal monitoring of fetal heart rate
. Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
. Maternal ECG (MECG)
. Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
. Temperature (TEMP) for monitoring maternal temperature
The following table summarizes the fetal and maternal physiological parameters measured by each fetal monitor.
Mo: F3, F2, F6, F9, F6 Express, F9 Express
Measurement: F3, F2, F6, F9, F6 Express, F9 Express
Single-FHR: √, √, √, √, √, √
Dual-FHR: √, √, √, √, √, √
TOCO: √, √, √, √, √, √
FM: √, √, √, √, √, √
AFM: √, √, √, √, √, √
DECG/IUP: Opt, Opt, Opt, Opt, ×, Opt
MECG: ×, ×, ×, ×, √, √
NIBP: ×, ×, ×, ×, √, √
MSpO2: ×, ×, ×, ×, √, √
TEMP: ×, ×, ×, ×, √, √
NOTE: √ = Standard; Opt = Optional; × = Not Available
The following features are available for the F6/F9 and F6/F9 Express bedside fetal and maternal monitors:
Basic parameters: FHR, TOCO, Event Mark, AFM
. Dual FHR monitoring
Internal parameters: IUP/DECG ●
FHR limit alarm
Software for data transmission to PC
Quick printing for stored waveform ●
Lithium battery for continuous operation ●
Maternal ECG, Sp02, NIBP, and temperature monitoring ●
Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3) ●
The following features are available for the F2/F3 bedside fetal monitors:
Basic parameters: FHR, TOCO, Event Mark, AFM ●
Dual FHR monitoring
Internal parameters: IUP/DECG
FHR limit alarm
Software for data transmission to PC
Quick printing for stored waveform ●
Lithium battery for continuous working ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Pregnant women from the 28th week of gestation.
Intended User / Care Setting
Trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
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)
Software validation per the FDA's Guidance for Industry and FDA Staff, "Guidance for . the Content of Premarket Submissions for Software Contained in Medical Devices."
. Electrical safety testing per IEC 60601-1
. Electromagnetic compatibility testing per IEC 60601-2
Evaluation of NIBP sensor ●
Evaluation of ultrasound transducer ●
The results of all completed performance testing were acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 884.2740 Perinatal monitoring system and accessories.
(a)
Identification. A perinatal monitoring system is a device used to show graphically the relationship between maternal labor and the fetal heart rate by means of combining and coordinating uterine contraction and fetal heart monitors with appropriate displays of the well-being of the fetus during pregnancy, labor, and delivery. This generic type of device may include any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, 884.2700, and 884.2720. This generic type of device may include the following accessories: Central monitoring system and remote repeaters, signal analysis and display equipment, patient and equipment supports, and component parts.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 5, 2018
Edan Instruments, Inc % Alice Yang Regulatory Engineer Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089
Re: K173042
Trade/Device Name: Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express; Fetal Monitor: Models F2, F3 Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM, HGL, DSI, DRT, DXN, FLL, DQA, DPS Dated: September 20, 2017 Received: September 28, 2017
Dear Alice Yang:
This letter corrects our substantially equivalent letter of August 30, 2018.
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 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.
1
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 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.html; 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 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,
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173042
Device Name Fetal & Maternal Monitor Model: F6, F6 Express, F9, F9 Express
Indications for Use (Describe)
F6/F9 Fetal & Maternal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K173042
Device Name Fetal Monitor Model: F2, F3 Fetal Monitor
Indications for Use (Describe)
F3/F2 Fetal Monitor is intended for non-invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Prepared in accordance with the requirements of 21 CFR Part 807.92
| Submitter: | Edan Instruments, Inc
#15 Jinhui Road,Jinsha Community,
Kengzi Sub-District, Pingshan District,
Shenzhen, 518122 P.R.China.
Tel.: (0755) 28340011
Fax: +1 (408) 418-4059 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alice Yang |
| Date Prepared: | August 30, 2018 |
| Device Name and
Classification: | Device Name: Fetal & Maternal Monitor
Model: F6, F6 Express, F9, F9 Express
Common Name: Fetal & Maternal Monitor
Classification Name:
884.2740 Perinatal monitoring system and accessories
Product Codes:
HGM (system, monitoring, perinatal)
DSI (detector and alarm, arrhythmia)
DRT (monitor, cardiac (incl. cardiotachometer & rate alarm))
DXN (system, measurement, blood-pressure, non-invasive)
FLL (thermometer, electronic, clinical)
DQA (oximeter)
DPS (electrocardiograph) |
| | Device Name: Fetal Monitor
Model: F2, F3
Common Name: Fetal Monitor
Classification Name
884.2740 Perinatal monitoring system and accessories
Product codes:
HGM (system, monitoring, perinatal)
HGL (transducer, ultrasonic, obstetric)
Regulatory Class: Class II |
| Predicate Device(s): | 1. Fetal & Maternal Monitor, F9 Express, Edan Instruments, Inc.,
K150901 (Primary for F6, F6 Express, F9, F9 Express)
2. Fetal Monitor, F3, Edan Instruments, Inc., K102140 (Primary for F2 and F3)
3. Patient Monitor, iM20, Edan Instruments, Inc., K152552
(Secondary) |
| | The predicate devices have not been subject to a design related
recall. |
5
Device Description:
The subject devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices may be used antepartum as well as during labor and delivery. The submission seeks clearance for several devices and their accessories, which were modified since their last 510(k) clearance.
The subject devices of the present submission include the F2/F3 and F6/F9 fetal monitors as well as the F6/F9 Express, which provide both fetal and maternal monitoring capabilities.
The fetal and maternal physiological parameters that are supported by the EDAN bedside monitors are as follows:
- Fetal heart rate (FHR)
- Tocodynamometry (TOCO) for external monitoring of uterine contractions .
- Fetal Movement (FM) ●
- Automated Fetal Movement (AFM) ●
- Direct ECG (DECG) for internal monitoring of fetal heart rate
- . Intrauterine pressure catheter (IUP) for internal monitoring of uterine contractions
- . Maternal ECG (MECG)
- . Noninvasive blood pressure (NIBP) was added to F6/F9 Express in this submission
- Maternal Sp02 (MSp02) for monitoring pulse rate (PR) .
- . Temperature (TEMP) for monitoring maternal temperature
The following table summarizes the fetal and maternal physiological parameters measured by each fetal monitor.
| Mo
del
| Measurement | F3 | F2 | F6 | F9 | F6 Express | F9 Express |
|---|---|---|---|---|---|---|
| Single-FHR | √ | √ | √ | √ | √ | √ |
| Dual-FHR | √ | √ | √ | √ | √ | √ |
| TOCO | √ | √ | √ | √ | √ | √ |
| FM | √ | √ | √ | √ | √ | √ |
| AFM | √ | √ | √ | √ | √ | √ |
| DECG/IUP | Opt | Opt | Opt | Opt | × | Opt |
| MECG | × | × | × | × | √ | √ |
| NIBP | × | × | × | × | √ | √ |
| MSpO2 | × | × | × | × | √ | √ |
| TEMP | × | × | × | × | √ | √ |
| NOTE: √ = Standard; Opt = Optional; × = Not Available |
The following features are available for the F6/F9 and F6/F9 Express bedside fetal and maternal monitors:
- Basic parameters: FHR, TOCO, Event Mark, AFM
- . Dual FHR monitoring
- Internal parameters: IUP/DECG ●
- FHR limit alarm
- Software for data transmission to PC
- Quick printing for stored waveform ●
- Lithium battery for continuous operation ●
- Maternal ECG, Sp02, NIBP, and temperature monitoring ●
- Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3) ●
6
The following features are available for the F2/F3 bedside fetal monitors:
- Basic parameters: FHR, TOCO, Event Mark, AFM ●
- Dual FHR monitoring
- Internal parameters: IUP/DECG
- FHR limit alarm
- Software for data transmission to PC
- Quick printing for stored waveform ●
- Lithium battery for continuous working ●
Indications for Use:
F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):
F6/F9 Fetal & Maternal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6/F9 Fetal & Maternal Monitor provides Non-Stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
F6 Express/F9 Express Fetal & Maternal Monitor (hereinafter called F6 Express/F9 Express):
F6 Express/F9 Express Fetal & Maternal Monitor is intended for monitoring physiological parameters of pregnant women during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
F6 Express/F9 Express Fetal & Maternal Monitor is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. In addition, it provides a solution for maternal vital signs monitoring.
F3/F2 Fetal Monitor is intended for non-invasive and invasive monitoring of fetus during antepartum examination, labor and delivery. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.
The monitor provides non-stress testing for pregnant women from the 28th week of gestation. It can externally monitor the FHRs using ultrasound and uterine activity via a TOCO transducer. Alternatively, it can internally monitor one of the FHRs with DECG and uterine activity with an IUPC.
7
Comparison between the subject F9 series and the previously cleared F9 Express
| Item | F6 / F6 Express/ F9 / F9 Express | F9 Express | Comparison |
|---|---|---|---|
| Manufacturer | Edan Instruments, Inc. | Edan Instruments, Inc. | |
| K# | K174042 | K150901 | |
| Intended use | F6/F9 Fetal & Maternal | ||
| Monitor is intended for | |||
| non-invasive and invasive | |||
| monitoring of fetus during | |||
| antepartum examination, | |||
| labor and delivery. It is | |||
| intended to be used only by | |||
| trained and qualified | |||
| personnel in antepartum | |||
| examination rooms, labor | |||
| and delivery rooms. | |||
| F6/F9 Fetal & Maternal | |||
| Monitor provides Non- | |||
| Stress testing for pregnant | |||
| women from the 28th week | |||
| of gestation. It can | |||
| externally monitor the | |||
| FHRs using ultrasound and | |||
| uterine activity via a | |||
| TOCO transducer. | |||
| Alternatively, it can | |||
| internally monitor one of | |||
| the FHRs with DECG and | |||
| uterine activity with an | |||
| IUPC. | |||
| F6 Express/F9 Express | |||
| Fetal & Maternal Monitor | |||
| is intended for monitoring | |||
| physiological parameters | |||
| of pregnant women during | F6/F9 Fetal & Maternal | ||
| Monitor is intended for | |||
| non-invasive and invasive | |||
| monitoring of fetus during | |||
| antepartum examination, | |||
| labor and delivery. It is | |||
| intended to be used only by | |||
| trained and qualified | |||
| personnel in antepartum | |||
| examination rooms, labor | |||
| and delivery rooms. | |||
| F6/F9 Fetal & Maternal | |||
| Monitor provides | |||
| Non-Stress testing for | |||
| pregnant women from the | |||
| 28th week of gestation. It | |||
| can externally monitor the | |||
| FHRs using ultrasound and | |||
| uterine activity via a | |||
| TOCO transducer. | |||
| Alternatively, it can | |||
| internally monitor one of | |||
| the FHRs with DECG and | |||
| uterine activity with an | |||
| IUPC. | |||
| F6 Express/F9 Express | |||
| Fetal & Maternal Monitor | |||
| (hereinafter called F6 | |||
| Express/F9 Express): | |||
| F6 Express/F9 Express | |||
| Fetal & Maternal Monitor | |||
| is intended for monitoring | |||
| physiological parameters | |||
| of pregnant women during | Same | ||
| antepartum | |||
| examination, | |||
| labor and delivery. It is | |||
| intended to be used only by | |||
| trained and qualified | |||
| personnel in antepartum | |||
| examination rooms, labor | |||
| and delivery rooms. | |||
| F6 Express/F9 Express | |||
| Fetal & Maternal Monitor | |||
| is intended for providing | |||
| Non-Stress testing or fetal | |||
| monitoring for pregnant | |||
| women from the 28th week | |||
| of gestation. In addition, it | |||
| provides a solution for | |||
| maternal vital signs | |||
| monitoring. | antepartum examination, | ||
| labor and delivery. It is | |||
| intended to be used only by | |||
| trained and qualified | |||
| personnel in antepartum | |||
| examination rooms, labor | |||
| and delivery rooms. | |||
| F6 Express/F9 Express | |||
| Fetal & Maternal Monitor | |||
| is intended for providing | |||
| Non-Stress testing or fetal | |||
| monitoring for pregnant | |||
| women from the 28th week | |||
| of gestation. In addition, it | |||
| provides a solution for | |||
| maternal vital signs | |||
| monitoring. | |||
| Electrical Safety | |||
| Anti-electric-shock | |||
| degree: | FHR1, FHR2, TOCO, FM, | ||
| IUP: BF; | |||
| SpO2, NIBP: BF | |||
| (Defibrillator-proof); | |||
| DECG:CF; | |||
| ECG, TEMP: CF | |||
| (Defibrillator-proof); | |||
| FTS-3: FHR1, FHR2, | |||
| TOCO: BF | |||
| (Defibrillator-proof). | FHR1, FHR2, TOCO, FM, | ||
| IUP: BF; | |||
| SpO2, NIBP: BF | |||
| (Defibrillator-proof); | |||
| DECG: CF; | |||
| ECG, TEMP: CF | |||
| (Defibrillator-proof). | |||
| FTS-3: FHR1,FHR2, | |||
| TOCO: BF | |||
| (Defibrillator-proof). | Same | ||
| Degree of safety of | |||
| application in the | |||
| presence of | |||
| flammable gas: | Equipment not suitable for | ||
| use in presence of | |||
| flammable gases | Equipment not suitable for | ||
| use in presence of | |||
| flammable gases | Same | ||
| Degree of Protection | |||
| against Harmful | |||
| Ingress of Water | Main Unit: | ||
| IPX1, protected against | |||
| vertically falling water | |||
| drops (provided recorder | |||
| drawer is shut and the | |||
| monitor is not mounted on | |||
| the wall vertically) | Main Unit: | ||
| IPX1, protected against | |||
| vertically falling water | |||
| drops (provided recorder | |||
| drawer is shut and the | |||
| monitor is not mounted on | |||
| the wall vertically) | Same | ||
| US/TOCO Transducers: | |||
| IPX8, protected against the | |||
| effects of continuous | |||
| emersion in water | |||
| FTS-3: | |||
| Base station: IPX1 | |||
| (protected against | |||
| vertically falling water | |||
| drops) | |||
| Transducers: IPX8 | |||
| (Protected against the | |||
| effects of continuous | |||
| immersion in water 1.1m | |||
| deep for 24 hours) | US/TOCO Transducers: | ||
| IPX8, protected against the | |||
| effects of continuous | |||
| emersion in water | |||
| FTS-3: | |||
| Base station: IPX1 | |||
| (protected against | |||
| vertically falling water | |||
| drops) | |||
| Transducers: IPX8 | |||
| (Protected against the | |||
| effects of continuous | |||
| immersion in water 1.1m | |||
| deep for 24 hours) | |||
| Working mode: | Continuous running | ||
| equipment | Continuous running | ||
| equipment | Same | ||
| FHR (F6 / F6 Express/ F9 / F9 Express) | |||
| Technique: | Pulse Doppler with | ||
| autocorrelation processing | Pulse Doppler with | ||
| autocorrelation processing | Same | ||
| Pulse Repetition | |||
| Frequency: | 2 KHz | 2 KHz | Same |
| Effective Radiating | |||
| Area: | 942 mm² ± 15%( F9/F9 | ||
| Express/ FTS-3, 12 | |||
| ultrasound crystals) | |||
| 628 mm² ± 15%( F6/F6 | |||
| Express, 8 ultrasound | |||
| crystals) | |||
| 549.5 mm²± 15%( F6/F6 | |||
| Express /FTS-3, 7 | |||
| ultrasound crystals) | 942 mm² ± 15%( F9/F9 | ||
| Express /FTS-3, 12 | |||
| ultrasound crystals) | |||
| 628 mm² ± 15%( F6/F6 | |||
| Express, 8 ultrasound | |||
| crystals) | Different | ||
| TOCO (F6 / F6 Express/ F9 / F9 Express) | |||
| TOCO Range: | 0-100 | 0-100 | Same |
| Resolution: | 1 | 1 | Same |
| DECG (F6 / F9 / F9 Express) | |||
| Technique: | Peak-peak detection | ||
| technique | Peak-peak detection | ||
| technique | Same | ||
| Heart Rate Counting | |||
| Range: | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | Same |
| IUP (F6 / F9 / F9 Express) | |||
| Pressure Range: | $0 ~ 100mmHg(0.0~13.3 kPa)$ | $0 ~ 100mmHg(0.0~13.3 kPa)$ | Same |
| Sensitivity: | $5uV/V/mmHg$ | $5uV/V/mmHg$ | Same |
| Resolution: | $1mmHg (0.1 kPa)$ | $1mmHg (0.1 kPa)$ | Same |
| Zero Mode: | Automatic (TOCO value becomes zero or below lasting for 30 seconds) / Manual | Automatic (TOCO value becomes zero or below lasting for 30 seconds)/ Manual | Same |
| MECG (F6 Express / F9 Express) | |||
| Heart Rate Range | 30-240BPM | 30-240BPM | Same |
| Defibrillator Protection | YES | YES | Same |
| HR averaging method | Heart rate is computed by averaging the 12 most recent RR intervals. | Heart rate is computed by averaging the 12 most recent RR intervals. | Same |
| SpO2 (F6 Express/ F9 Express) | |||
| Measuring Range: | 50% ~ 100% | 50% ~ 100% | Same |
| Resolution: | 1% | 1% | Same |
| Pulse Rate Measurement Range: | 30-240BPM | 30-240BPM | Same |
| Pulse Rate Measuring Accuracy: | $\pm 3BPM$ | $\pm 3BPM$ | Same |
| Emitted light energy |