Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express

K150901 · Edan Instruments, Inc. · HGM · Jul 1, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150901
• Device Name: Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express
• Applicant: Edan Instruments, Inc.
• Product Code: HGM · Obstetrics/Gynecology
• Decision Date: Jul 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.2740
• Device Class: Class 2

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 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.

Device Story

Fetal & Maternal Monitor (F6, F6 Express, F9, F9 Express) performs non-invasive/invasive monitoring of fetal heart rate (FHR) and uterine activity; maternal vital signs (ECG, SpO2, NIBP, temperature) included in Express models. Inputs: ultrasound (FHR), TOCO transducer (uterine activity), DECG/IUPC (internal monitoring), and maternal sensors. Device uses pulse Doppler with autocorrelation for FHR and peak-peak detection for ECG. Output: real-time waveforms and numerical data displayed on LCD; quick printing for stored waveforms. Used in antepartum/labor/delivery rooms by trained clinicians. Data transmission to Central Nursing System supported. Benefits: continuous monitoring of fetal/maternal status during labor and delivery to support clinical decision-making.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, biocompatibility evaluation (ISO 10993-1), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2). Acoustic output measured per NEMA UD-2 and IEC 62359.

Technological Characteristics

LCD display; rechargeable Lithium-ion battery; AC/DC power. Sensing: Pulse Doppler (1.0MHz) for FHR, TOCO for uterine activity, ECG/SpO2/NIBP/Temp sensors for maternal monitoring. Connectivity: Wired/wireless (FTS-3) to Central Nursing System. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-27, IEC 60601-2-37, ISO 80601-2-61, ISO 80601-2-56. Software: Moderate level of concern.

Indications for Use

Indicated for pregnant women from the 28th week of gestation for non-invasive and invasive fetal monitoring (FHR, uterine activity) and maternal vital signs monitoring (ECG, SpO2, NIBP, temperature) during antepartum examination, labor, and delivery. Intended for use by trained personnel in clinical settings.

Regulatory Classification

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.

Predicate Devices

• Edan Instruments, Inc., Fetal & Maternal Monitor/F9 Express (K100797)
• Philips Medical Systems, Inc./Avalon CTS cordless Fetal Transducer System (K023931)

Reference Devices

• EDAN Central Nursing System (K100358)

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

July 1, 2015

Edan Instruments, Inc. % Doug Worth Sr. Dir. Us RA/QA Edan Medical 1200 Crossman Ave, Suite 200 Sunnyvale, California 94089

Re: K150901

Trade/Device Name: Fetal & Maternal Monitor, models F6, F6 Express Regulation Number: 21 CFR 884.2740 Regulation Name: Perinatal monitoring system and accessories Regulatory Class: Class II Product Code: HGM Dated: March 27, 2015 Received: April 3, 2015

Dear Mr. Worth:

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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/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,

# Benjamin R. Fisher -S

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

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# Indications for Use

510(k) Number (if known) K150901

Device Name

Fetal & Maternal Monitor, models F6, F6 Express, F9, F9 Express

Indications for Use (Describe)

F6/F9 Fetal & Maternal Monitor (hereinafter called F6/F9):

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. Alternally 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.

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

| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
|----------------------------------------------|---------------------------------------------|
|----------------------------------------------|---------------------------------------------|

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# 510(K) Summary

# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

| 1. Submitter: | Edan Instruments, Inc<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen,<br>518067 P.R. China<br>Tel: [phone]<br>Fax: [phone] |
|-----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person:<br>Preparing date: | Queena Chen<br>June 29, 2015 |
| 2. Device name and<br>classification: | Device Name: Fetal & Maternal Monitor, models F6, F6 Express,<br>F9, F9 Express (hereinafter called F series)<br>Classification Name/ Product code:<br>884.2740 Perinatal monitoring system and accessories/ HGM<br>Regulatory Class: Class II |
| 3.Premarket<br>Notification Class III<br>Certification and<br>Summary | Not applicable, the subject device is Class II. |
| 4. Predicate Device(s): | 1) Edan Instruments, Inc., Fetal & Maternal Monitor/F9 Express<br>/K100797.<br>2) Philips Medical Systems, Inc./Avalon CTS cordless Fetal<br>Transducer System/K023931 |
| 5. Reason for<br>Submission | Modification for previous cleared product Fetal & Maternal<br>Monitor, models F6, F6 Express, F9, F9 Express. |
| 6. Pre-Submission,<br>IDE | Not applicable, there is no prior submission. |
| 7. Device Description: | F series Fetal & Maternal Monitor, including F6, F6 Express,<br>F9, F9 Express which provides the following primary features<br>that can be available for the multiple configurations:<br>• Basic parameters: FHR, TOCO, Event Mark, AFM<br>• Dual FHR monitoring<br>• Internal parameters: IUP/DECG<br>• FHR limit alarm |

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• Software for data transmission to PC, which means the subject device can be connected to Central Nursing System provided by EDAN, which has been cleared by K100358.

- Quick printing for stored waveform
- Lithium battery for continuous working
- · Maternal ECG monitoring
- · Maternal SpO2 monitoring
- · Maternal NIBP
- · Maternal temperature monitoring
- Used with FTS-3 Fetal Telemetry System (hereinafter called FTS-3)

The above is the maximum configuration for F series Fetal & Maternal Monitor, the user may select different measurement parameters in according with their requirements, which is also show in the following table.

| Model | F6 | F9 | F6<br>Express | F9<br>Express |
|-------------------------------------------------------|-----|-----|---------------|---------------|
| Measurement | | | | |
| Single-FHR | √ | √ | √ | √ |
| Dual-FHR | √ | √ | √ | √ |
| TOCO | √ | √ | √ | √ |
| FM | √ | √ | √ | √ |
| AFM | √ | √ | √ | √ |
| DECG/IUP | Opt | Opt | × | Opt |
| MECG | × | × | √ | √ |
| NIBP | × | × | √ | √ |
| MSpO2 | × | × | √ | √ |
| TEMP | × | × | √ | √ |
| NOTE: √ = Standard; Opt = Optional; × = Not Available | | | | |

#### 8. 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.

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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.

#### 9. Predicate Device Comparison

The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters items, detailed comparison information can be found in the following tables.

| Item | F6 / F6 Express/ F9 / F9 Express | F9 Express | Substantial Equivalence (SE) |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Manufacturer | Edan Instruments, Inc. | Edan Instruments, Inc. | / |
| K# | N/A | K100797 | / |
| Intended use | The 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. It is not intended for use in intensive care units, operating rooms or for home use. F9 Express fetal & maternal monitor is intended for providing | The 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. It is not intended for use in intensive care units, operating rooms or for home use. F9 Express fetal & maternal monitor is intended for providing | Same |
| | Non-Stress testing or fetal<br>monitoring for pregnant<br>women .In addition, it<br>provides a solution for<br>maternal vital signs<br>monitoring. | Non-Stress testing or fetal<br>monitoring for pregnant<br>women. In addition, it<br>provides a solution for<br>maternal vital signs<br>monitoring. | |
| Electrical Safety | | | |
| Anti-electric-shock<br>degree: | FHR1, FHR2, TOCO,<br>FM, IUP: BF;<br>SpO2, NIBP: BF<br>(Defibrillator-proof);<br>DECG:CF;<br>ECG, TEMP: CF<br>(Defibrillator-proof);<br>FTS-3: FHR1, FHR2,<br>TOCO: BF<br>(Defibrillator-proof). | FHR1, FHR2, TOCO, FM,<br>IUP: BF;<br>SpO2, NIBP: BF<br>(Defibrillator-proof);<br>DECG: CF;<br>ECG, TEMP: CF<br>(Defibrillator-proof). | Different |
| Degree of safety of<br>application in the<br>presence of<br>flammable gas: | Equipment not suitable<br>for use in presence of<br>flammable gases | Equipment not suitable for<br>use in presence of<br>flammable gases | Same |
| Working mode: | Continuous running<br>equipment | Continuous running<br>equipment | Same |
| FHR | | | |
| Technique: | Pulse Doppler with<br>autocorrelation processing | Pulse Doppler with<br>autocorrelation processing | Same |
| Pulse Repetition<br>Frequency: | 2 KHz | 2 KHz | Same |
| Pulse Duration: | 92 μs | 92 μs | Same |
| Ultrasound<br>Frequency: | 1.0MHz±10% | 1.0MHz±10% | Same |
| Spatial-Peak<br>Temporal Average<br>Intensity: | Ispta < 100 mW/cm2 | Ispta < 100 mW/cm2 | Same |
| FHR Range: | 50 bpm-240 bpm | 50 bpm-240 bpm | Same |
| Resolution: | 1 bpm | 1 bpm | Same |
| Accuracy: | ±1 bpm(F9)<br>±2 bpm(F6,FTS-3) | ±1 bpm(F9)<br>±2 bpm(F6) | Same |
| TOCO | | | |
| TOCO Range: | 0%-100% | 0%-100% | Same |
| Resolution: | 1%/ | 1%/ | Same |
| ECG | | | |
| Technique: | Peak-peak detection<br>technique | Peak-peak detection<br>technique | Same |
| Heart Rate<br>Counting Range: | 30 bpm ~ 240 bpm | 30 bpm ~ 240 bpm | Same |
| Heart Rate<br>Resolution: | ±1 BPM | ±1 BPM | Same |
| Input Impedance: | >10ΜΩ (Differential,)<br>>20ΜΩ (Common Mode) | >10ΜΩ (Differential,)<br>>20ΜΩ (Common Mode) | Same |
| Countable Input<br>Signal Range: | 20uV-3mV peak-to-peak | 20uV-3mV peak-to-peak | Same |
| Pressure Range: | 0~100mmHg | 0~100mmHg | Same |
| Sensitivity: | 5uV/V/mmHg | 5uV/V/mmHg | Same |
| Resolution: | 1% | 1% | Same |
| Zero Mode: | Automatic / Manual | Automatic / Manual | Same |
| Heart Rate Range | 30-240BPM | 30-240BPM | Same |
| Heart Rate<br>Resolution | ±1 BPM | ±1 BPM | Same |
| Input Signal Range | ±8 mV PP | ±8 mV PP | Same |
| Defibrillator<br>Protection | YES | YES | Same |
| Tall T-wave<br>Rejection | 1.2mV(12mm) | 1.2mV(12mm) | Same |
| HR averaging<br>method | Heart rate is computed by<br>averaging the 12 most<br>recent RR intervals. | Heart rate is computed by<br>averaging the 12 most<br>recent RR intervals. | Same |
| Accuracy and<br>Response to<br>Irregular Rhythm | Ventricular bigeminy:<br>80bpm±1bpm<br>Slow alternating<br>ventricular bigeminy:<br>60bpm±1bpm<br>Rapid alternating<br>ventricular bigeminy:<br>120bpm±1bpm<br>Bidirectional systoles:<br>91bpm±1bpm | Ventricular bigeminy:<br>80bpm±1bpm<br>Slow alternating<br>ventricular bigeminy:<br>60bpm±1bpm<br>Rapid alternating<br>ventricular bigeminy:<br>120bpm±1bpm<br>Bidirectional systoles:<br>91bpm±1bpm | Same |
| Response time to<br>Change in HR | HR range: 80bpm ~<br>120bpm<br>Range: 7s ~ 8s (average:<br>7.5s)<br>HR range: 80bpm ~<br>40bpm<br>Range : 7s ~ 8s (average:<br>7.5s) | HR range: 80bpm ~<br>120bpm<br>Range: 7s ~ 8s (average:<br>7.5s)<br>HR range: 80bpm ~ 40bpm<br>Range : 7s ~ 8s (average:<br>7.5s) | Same |
| SpO2 | | | |
| Measuring Range: | 50% ~ 100% | 50%~100% | Same |
| Resolution: | 1% | 1% | Same |
| | | | |
| Measuring<br>Accuracy<br>(EDAN): | $90\% \sim 100\% \pm 2\%$<br>$70\% \sim 90\% \pm 4\%$<br>$< 70\%$<br>unspecified | $90\% \sim 100\% \pm 2\%$<br>$70\% \sim 90\% \pm 4\%$<br>$< 70\%$<br>unspecified | Same |
| Measuring<br>Accuracy<br>(Nellcor): | $70\% \sim 100\% \pm 2\%$<br>$< 70\%$<br>unspecified | $70\%~100\% \pm 2\%$<br>$< 70\%$<br>unspecified | Same |
| Pulse Rate<br>Measurement<br>Range: | 30-240BPM | 30-240BPM | Same |
| Pulse Rate<br>Measuring<br>Accuracy: | $\pm$ ulse | $\pm$ ulse | Same |
| Emitted light<br>energy | < 15 mW | < 15 mW | Same |
| NIBP | | | |
| Blood Pressure<br>Range | Systolic<br>pressure:40mmHg ~<br>270mmHg Diastolic<br>pressure:10mmHg ~<br>215mmHg | Systolic pressure:40mmHg<br>~ 270mmHg Diastolic<br>pressure:10mmHg ~<br>215mmHg | Same |
| Measuring<br>Accuracy: | $\le 8mmHg$ | $\le 8mmHg$ | Same |
| Cuff Pressure<br>Protection | 300mmHg | 300mmHg | Same |
| TEMP | | | |
| Channel: | 1 | 1 | Same |
| Measurement<br>Range: | 0 °C ~ 50 °C | 0 °C ~ 50 °C | Same |
| Accuracy: | 0°C ~ +25°C (+32°F ~<br>+77°F): $\pm$ 0.2°C<br>( $\pm$ 0.36°F)<br>+25°C ~ +45°C (+77°F ~<br>+113°F): $\pm$ 0.1°C<br>( $\pm$ 0.18°F)<br>+45°C ~ +50°C (+113°F ~<br>+122°F): $\pm$ 0.2°C<br>( $\pm$ 0.36°F) | 0°C ~ +25°C (+32°F ~<br>+77°F): $\pm$ 0.2°C<br>( $\pm$ 0.36°F)<br>+25°C ~ +45°C (+77°F ~<br>+113°F): $\pm$ 0.1°C<br>( $\pm$ 0.18°F)<br>+45°C ~ +50°C (+113°F ~<br>+122°F): $\pm$ 0.2°C<br>( $\pm$ 0.36°F) | Same |
| Printer | | | |
| Paper width: | 152mm (GE), 150mm<br>(PHILIPS) | 152mm (GE), 150mm<br>(PHILIPS) | Same |
| Effective printing<br>width: | 110mm (American<br>Standard)<br>120mm (International | 110mm (American<br>Standard)<br>120mm (International | Same |

#### Comparison between the subject F9 series and the previous cleared F9 Express

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| | Standard) | Standard) | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------|
| FHR printout<br>width: | 70mm (American<br>Standard)<br>80mm (International<br>Standard) | 70mm (American<br>Standard)<br>80mm (International<br>Standard) | Same |
| FHR scaling: | 30bpm/cm (American<br>Standard)<br>20bpm/cm (International<br>Standard) | 30bpm/cm (American<br>Standard)<br>20bpm/cm (International<br>Standard) | Same |
| TOCO printout<br>width: | 40mm | 40mm | Same |
| TOCO scaling: | 25%/cm | 25%/cm | Same |
| Standard Speed<br>(Real-Time<br>Traces ): | 1 cm/min, 2 cm/min, 3<br>cm/min | 1 cm/min, 2 cm/min, 3<br>cm/min | Same |
| Paper: | Z-fold, thermosensitive<br>(compatible with GE and<br>PHILIPS record papers) | Z-fold, thermosensitive<br>(compatible with GE and<br>PHILIPS record papers) | Same |
| <b>Physical Specification</b> | | | |
| Screen | LCD | LCD | Same |
| Screen Diagonal: | F9 Express / F9 :<br>12.1"<br>F6 Express / F6 :<br>10.1" | F9 Express / F9 :<br>12.1"<br>F6 Express / F6 :<br>10.1" | Same |
| Power Supply: | AC or battery | AC or battery | Same |
| Operating Voltage: | a.c.100 V-240 V | a.c.100 V-240 V | Same |
| Line Frequency: | 50/60 Hz | 50/60 Hz | Same |
| Pmax : | 1.0A-0.5A | 1.0A-0.5A | Same |
| Battery : | Rechargeable Lithium-ion<br>Battery | Rechargeable Lithium-ion<br>Battery | Same |
| Dimensions: | 347mm × 330mm ×<br>126mm | 347mm × 330mm ×<br>126mm | Same |
| Weight: | F6: Approx. 5.3 kg<br>F6 Express: Approx. 6.1<br>kg<br>F9: Approx. 5.5 kg<br>F9 Express: Approx. 6.3<br>kg<br>FTS-3:<br>1.8 kg | F6: Approx. 5.3 kg<br>F6 Express: Approx. 6.1<br>kg<br>F9: Approx. 5.5 kg<br>F9 Express: Approx. 6.3<br>kg | Same |
| Operating<br>Temperature: | 5 °C ~ 40 °C | 5 °C ~ 40 °C | Same |

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| Transport/ Storage<br>Temperature: | -20 °C ~ 55 °C | -20 °C ~ 55 °C | |
|-----------------------------------------------|-------------------------------------------------…