SD5 & SD6 Ultrasonic Tabletop Doppler

K153475 · Edan Instruments, Inc. · KNG · Jan 29, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K153475
• Device Name: SD5 & SD6 Ultrasonic Tabletop Doppler
• Applicant: Edan Instruments, Inc.
• Product Code: KNG · Obstetrics/Gynecology
• Decision Date: Jan 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2660
• Device Class: Class 2

Indications for Use

The SD5 Ultrasonic TableTop Doppler (hereinafter called "SD5") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices. The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability.

Device Story

Hand-held tabletop Doppler device for non-invasive fetal heart rate (FHR) monitoring. Uses 2 MHz or 3 MHz ultrasound probes to transmit acoustic energy to maternal abdomen; reflected ultrasound from fetal heart and blood flow is received by probe and converted to electrical signals. Main unit performs digital processing of waveform data for display on LED screen; audio signals routed to speaker. SD5 uses wired connection; SD6 uses Bluetooth for signal transfer. Powered by AC mains or internal Ni-MH battery; probes powered by internal Lithium battery. Used in hospitals, clinics, and private offices by clinicians to assess fetal well-being and viability. Output provides real-time FHR data to assist clinical decision-making during pregnancy and labor.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, biocompatibility evaluation (ISO 10993-1), electrical safety, EMC, and software verification/validation.

Technological Characteristics

Tabletop Doppler system. Materials: shell of probe and wire jacket identical to K150901. Sensing: Doppler shift of ultrasound (2 MHz/3 MHz). Power: AC (100-240V) or Ni-MH battery (main unit); Lithium battery (probes). Connectivity: Wired (SD5), Bluetooth (SD6). Safety: Class I, Type BF applied parts. Standards: IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993-1, IEC 62304.

Indications for Use

Indicated for detection of fetal heart rate from early gestation through delivery, general indication of fetal well-being, and verification of fetal heart viability in pregnant patients. Used by healthcare professionals (nurses, midwives, ultrasound technicians, physician assistants) via prescription.

Regulatory Classification

Identification

A fetal ultrasonic monitor is a device designed to transmit and receive ultrasonic energy into and from the pregnant woman, usually by means of continuous wave (doppler) echoscopy. The device is used to represent some physiological condition or characteristic in a measured value over a period of time (e.g., perinatal monitoring during labor) or in an immediately perceptible form (e.g., use of the ultrasonic stethoscope). This generic type of device may include the following accessories: signal analysis and display equipment, electronic interfaces for other equipment, patient and equipment supports, and component parts. This generic type of device does not include devices used to image some relatively unchanging physiological structure or interpret a physiological condition, but does include devices which may be set to alarm automatically at a predetermined threshold value.

Predicate Devices

• SD5&SD6 Ultrasonic Tabletop Doppler (K102138)

Reference Devices

• F9 Fetal & Maternal Monitor (K150901)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2016

Edan Instruments, Inc. % Ms. Queena Chen Regulatory Engineer 3/F - B, Nanshan Medical Equipments Park Nanhai Road 1019# Shenzhen, Guangdong 518067 CHINA

Re: K153475

Trade/Device Name: SD5 & SD6 Ultrasonic Tabletop Doppler Regulation Number: 21 CFR 884.2660 Regulation Name: Fetal ultrasonic monitor and accessories Regulatory Class: II Product Code: KNG Dated: November 30, 2015 Received: December 2, 2015

Dear Ms. Chen:

This letter corrects our substantially equivalent letter of January 29, 2016. 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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

Device Name

SD5&SD6 Ultrasonic Tabletop Doppler

Indications for Use (Describe)

The SD5 Ultrasonic TableTop Doppler (hereinafter called "SDS") and SD6 Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be used by health care professionals including registered nurses, midwives, ultrasound technicians, and physician assistants, by prescription in hospitals, clinics and private offices.

The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability.

Type of Use (Select one or both, as applicable)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |

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## Diagnostic Ultrasound Indications for Use Ultrasonic Tabletop Doppler SD5

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|--------------------------------|-------------------|---|-----|-----|----------------|--------------------|------------------|
| General | Specific | B | M | PWD | CWD | Colour Doppler | Combined (Specify) | Other* (Specify) |
| Ophthalm | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal | Small Organ (Specify) | | | | | | | |
| Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P=previously licensed Additional Comments:

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System: Ultrasonic Tabletop Doppler SD5

Transducer: 2 MHz CW fetal probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | Other*<br>(Specify) |
|----------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour<br>Doppler | Combined<br>(Specify) | |
| Ophthalm<br>ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal | Small Organ (Specify) | | | | | | | |
| Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P=previously licensed

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System: Ultrasonic Tabletop Doppler SD5

Transducer: 3 MHz CW fetal probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalm<br>ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P=previously licensed

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## Diagnostic Ultrasound Indications for Use Ultrasonic Tabletop Doppler SD6

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalm<br>ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal | Small Organ (Specify) | | | | | | | |
| Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P=previously licensed

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System: Ultrasonic Tabletop Doppler SD6

Transducer: 2 MHz CW fetal probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|----------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalm<br>ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal | Small Organ (Specify) | | | | | | | |
| Imaging<br>& Other | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | |
| | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P=previously licensed

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System: Ultrasonic Tabletop Doppler SD6

Transducer: 3 MHz CW fetal probe

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application | | Mode of Operation | | | | | | |
|-----------------------------|--------------------------------|-------------------|---|-----|-----|-------------------|-----------------------|---------------------|
| General | Specific | B | M | PWD | CWD | Colour<br>Doppler | Combined<br>(Specify) | Other*<br>(Specify) |
| Ophthalm<br>ic | Ophthalmic | | | | | | | |
| | Fetal | | | | P | | | |
| | Abdominal | | | | | | | |
| | Intra-operative<br>(Specify) | | | | | | | |
| | Intra-operative (Neuro) | | | | | | | |
| | Laparoscopic | | | | | | | |
| | Pediatric | | | | | | | |
| Fetal<br>Imaging<br>& Other | Small Organ (Specify) | | | | | | | |
| | Neonatal Cephalic | | | | | | | |
| | Adult Cephalic | | | | | | | |
| | Trans-rectal | | | | | | | |
| | Trans-vaginal | | | | | | | |
| | Trans-urethral | | | | | | | |
| | Trans-esoph.<br>(Non-Card.) | | | | | | | |
| | Musculo-skel<br>(conventional) | | | | | | | |
| | Musculo-skel<br>(superficial) | | | | | | | |
| | Intra-luminal | | | | | | | |
| | Other (Specify) | | | | | | | |
| | Cardiac Adult | | | | | | | |
| Cardiac | Cardiac Pediatric | | | | | | | |
| | Trans-Esoph. (Cardiac) | | | | | | | |
| | Other (Specify) | | | | | | | |
| Peripheral<br>Vessel | Peripheral vessel | | | | | | | |
| | Other (Specify) | | | | | | | |

N = new indication; P=previously licensed

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# 510(k) Summary

## Prepared in accordance with the requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 3/F-B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen, 518067 P.R. China |
| | Tel.: [phone] |
| | Fax: [phone] |
| Contact Person: | Queena Chen |
| Prepare date: | 2015-11-30 |
| 2. Device name<br>and classification: | Device Name: Ultrasonic Tabletop Doppler |
| | Model: SD5, SD6 |
| | Classification Name:<br>21 CFR 884.2660 Fetal ultrasonic monitor and accessories |
| | Product code: KNG<br>Regulatory Class: Class II |
| 3. Reason for<br>Submission | Technology Change. |
| 4. Predicate<br>Device(s): | SD5&SD6 Ultrasonic Tabletop Doppler / K102138 / Edan Instruments, Inc. |
| 5. Device<br>Description: | The SD5&SD6 Ultrasonic Tabletop Doppler is a hand-held device for non-invasive measurement and display of fetal heart rate utilizing the principle of Doppler shift of an ultrasound. The ultrasound is transmitted from the probe to patient body (maternal abdominal wall), and moves through biophysical objects. The acoustic ultrasound is reflected by blood and moving objects such as the fetal heart. The reflected ultrasound is received by the probe and is converted into electric signals. The waveform data are applied to the CPU for all the digital processing on LED Display, operation keys. The audio signal is taken off for the routing to the speaker to generate the analogue signals before digital processing. The system is compatible with 2 MHz or 3 MHz for fetal heart rate. The signal acquired can be transferred to SD5 by wired method, and by Bluetooth to SD6.<br>The main unit can be powered by main supply (100 V-240 V~) or Ni-MH Battery (7.2 V/2000 mAh). And transducers are powered by 3.7 V/800 mAh Lithium Battery only. |

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The SD5 Ultrasonic TableTop Doppler (hereinafter called "SD5") and SD6 6. Indications for Ultrasonic TableTop Doppler (hereinafter called "SD6") are intended to be Use: used by health care professionals including registered nurses, practical nurses, midwives, ultrasound technicians, and physician assistants, by prescription from licensed physicians in hospitals, clinics and private offices.

> The 2 MHz and/or 3 MHz obstetrical probes are indicated for the detection of fetal heart rate from early gestation thru delivery and as a general indication of fetal well being. They can also be used to verify fetal heart viability.

## 7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

| Item | SD5/SD6 | SD5/SD6 | Comparison<br>Result |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Manufacturer/K# | EDAN Instruments/<br>K102138 | Current Submission | --- |
| Intended Use/Indications for Use | | | |
| Intended<br>Use/Indications for<br>Use | The SD5 Ultrasonic<br>TableTop Doppler<br>(hereinafter called “SD5”)<br>and SD6 Ultrasonic<br>TableTop Doppler<br>(hereinafter called “SD6”)<br>are intended to be used by<br>health care professionals<br>including registered nurses,<br>practical nurses, midwives,<br>ultrasound technicians, and<br>physician assistants, by<br>prescription from licensed<br>physicians in hospitals,<br>clinics and private offices.<br>The 2 MHz and/or 3 MHz<br>obstetrical probes are<br>indicated for the detection of<br>fetal heart rate from early<br>gestation thru delivery and as<br>a general indication of fetal<br>well being. They can also be<br>used to verify fetal heart<br>viability following patient<br>trauma.<br>The 4 MHz, 5 MHz and/or 8<br>MHz vascular probes are<br>indicated for the detection of<br>blood flow in veins and<br>arteries for assisting in the<br>detection of peripheral<br>vascular disease. | The SD5 Ultrasonic TableTop<br>Doppler (hereinafter called<br>“SD5”) and SD6 Ultrasonic<br>TableTop Doppler (hereinafter<br>called “SD6”) are intended to be<br>used by health care professionals<br>including registered nurses,<br>practical nurses, midwives,<br>ultrasound technicians, and<br>physician assistants, by<br>prescription from licensed<br>physicians in hospitals, clinics<br>and private offices.<br>The 2 MHz and/or 3 MHz<br>obstetrical probes are indicated<br>for the detection of fetal heart rate<br>from early gestation thru delivery<br>and as a general indication of fetal<br>well being. They can also be used<br>to verify fetal heart viability. | Different |
| Operation characteristic | | | |
| Mode of operation | Continuous operation | Continuous operation | Same |
| Physical Specifications | | | |
| Dimensions | Main Unit: 265 mm x 155<br>mm x 180 mm | Main Unit: 265 mm x 155 mm x<br>180 mm | Same |
| Weight | Main Unit: 1.7 kg (with<br>battery and probe) | Main Unit: 1.7 kg (with battery<br>and probe) | Same |
| Display: | Effective display area: 62.0<br>mm (W) x 44.0mm(H)<br>Number of characters:<br>128*64 Dots<br>Dot size: 0.39 mm (W) x<br>0.55 mm (H)<br>Dot pitch: 0.44 mm (W) x<br>0.60 mm (H) | Effective display area: 62.0 mm<br>(W) x 44.0mm(H)<br>Number of characters: 128*64<br>Dots<br>Dot size: 0.39 mm (W) x 0.55<br>mm (H)<br>Dot pitch: 0.44 mm (W) x 0.60<br>mm (H) | Same |
| Environmental Specifications | | | |
| Working | Temperature: + 5 °C ~ + 40°C<br>( +41°F ~ +104°F)<br>Relative Humidity: 25% RH<br>~ 80% RH (non-condensing)<br>Atmospheric Pressure: 86<br>kPa~106 kPa | Temperature:0°C ~ + 40°C<br>(+32°F ~ +104°F)<br>Relative Humidity: 15% RH ~<br>95% RH (non-condensing)<br>Atmospheric Pressure: 86 kPa ~<br>106 kPa | Different |
| Transport and<br>Storage | Temperature: -20°C ~ +55°C<br>(-4°F ~ +131°F)<br>Relative Humidity: 25% RH<br>~ 93% RH (non-condensing)<br>Atmospheric Pressure: 70<br>kPa~106 kPa | Temperature: -20°C ~ +55°C (-4°F<br>~ +131°F)<br>Relative Humidity: 15% RH ~<br>95% RH (non-condensing)<br>Atmospheric Pressure: 70 kPa ~<br>106 kPa | Same |
| Safety Classifications | | | |
| Anti-electric Shock<br>Type | Class I equipment with<br>internal power supply | Class I equipment with internal<br>power supply | Same |
| Anti-electric Shock<br>Degree | Type B applied parts | Type BF applied parts | Different |
| Degree of Protection<br>against Harmful<br>Ingress of Water | Main Unit: Ordinary<br>equipment (Sealed equipment<br>without liquid proof)<br>Probe: IPX4 | Main Unit: Ordinary equipment<br>(Sealed equipment without liquid<br>proof)<br>Probe: IPX4…