MEDIBLU ECG SYSTEM

K233266 · Mediblu Medical, LLC · DPS · Jun 12, 2024 · Cardiovascular

Device Facts

• Record ID: K233266
• Device Name: MEDIBLU ECG SYSTEM
• Applicant: Mediblu Medical, LLC
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 12, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals. Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Story

Mediblu ECG System (models ME3, ME6P, ME12P, ME15P) acquires, displays, and records ECG signals from adult and pediatric patients using body surface electrodes. Device amplifies and filters signals; displays waveforms on integrated LCD; records via thermal printer; stores data in internal memory. Operated by physicians or trained healthcare professionals in clinical settings. Provides automated measurements (e.g., HR, PR interval, QRS duration, QT/QTC, axes) and interpretive statements on an advisory basis to assist clinicians in diagnosing heart disease. Benefits include standardized diagnostic data collection and rhythm analysis.

Clinical Evidence

Bench testing only. Performance verified against AAMI EC11 standards for system error, frequency response, and signal reproduction. No clinical data presented.

Technological Characteristics

12-lead (ME3, ME6P, ME12P) or 15-lead (ME15P) ECG acquisition. Sampling rate 8000Hz. Input impedance ≥2.5-30 MΩ. CMRR >89-115 dB. TFT LCD screens (5" to 12.1"). Rechargeable lithium battery power. Thermal printer. Safety: IEC60601-1 Class I, Type CF. Connectivity: Optional IEEE 802.11b/g/n/a wireless.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition via body surface electrodes for heart disease analysis and diagnosis. Intended for use in hospitals or healthcare facilities by doctors and trained healthcare professionals.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• iE 15 (K123816)
• iE 3 (K132758)
• iE 6 (K132758)
• Digital Electrocardiograph, iE300 (K160092)
• iE 12 (K122712)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

June 12, 2024

Mediblu Medical LLC % Jorge Millan Biomedical Director Sigma Biomedical 490 Sawgrass Corporate Parkway Suite 130 Sunrise, Florida 33325

Re: K233266

Trade/Device Name: Mediblu ECG System Models ME3, ME6P, ME12P, ME15P Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: Mav 8, 2024 Received: May 13, 2024

Dear Jorge Millan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Jennifer W. Shih -S

Jennifer Shih Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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#### Indications for Use

510(k) Number (if known) K233266

Device Name Mediblu ECG System Models ME3. ME6P, ME12P, ME15P

#### Indications for Use (Describe)

The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The carded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healtheare facilities by doctors and/or trained healthcare professionals.

| Type of Use ( <i>Select one or both, as applicable</i> ) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="padding-left:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## Submitter Information

| Submitter | Mediblu Medical LLC<br>3016 NW 82 Ave Doral, FL-USA- 33122 |
|------------------|------------------------------------------------------------|
| Contact: | Jorge Millan, PhD |
| Telephone number | [phone] |
| E-mail | [e-mail] |
| Date prepared: | June 11, 2024 |

## Subject Device Name

| Trade/Proprietary Name: | Mediblu ECG System Models ME3, ME6P, ME12P, ME15P |
|-------------------------|---------------------------------------------------|
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |

## Predicate Devices

| Predicate Device: | iE 15 |
|--------------------|-----------------------------------------|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K123816 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |

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| Predicate Device: | iE 3, iE 6 |
|--------------------|-----------------------------------------|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K132758 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |

| Predicate Device: | Digital Electrocardiograph, iE300 |
|--------------------|-----------------------------------------|
| Sponsor | Biocare Bio-medical Equipment Co., Ltd. |
| 510(K) | K160092 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |
| Predicate Device: | iE 12 |
| Sponsor | Shenzhen Biocare Electronics Co., Ltd. |
| 510(K) | K122712 |
| Regulation Number: | 870.2340 |
| Regulation Name: | Electrocardiograph |
| Product Code: | DPS |
| Class | II |
| Panel | Cardiovascular |

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#### Device Description

The Mediblu ME3 Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

The Mediblu ME6P Digital Electrocardiograph is intended to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

The Mediblu ME12P Digital Electrocardiograph is designed to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

The Mediblu ME15P Digital Electrocardiograph is designed to acquire, display and record ECG signals from adult and pediatric patients through body surface ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

#### Indications for Use:

The Digital Electrocardiograph ME3 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

The ME6 is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Digital Electrocardiographs ME12P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

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Digital Electrocardiograph ME15P is intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall he used in healthcare facilities by doctors and/or trained healthcare professionals.

#### Predicate Device Comparison

#### ME3 Comparison

| Name/510K #<br>Owner | Subject Device<br>ME3/K233266<br>Mediblu | Predicate Device<br>E300/K160092<br>Biocare | Comparison |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications forUse | The Digital Electrocardiograph ME3 is<br>intended to acquire ECG signals from<br>adult and pediatric patients through<br>body surface ECG electrodes. The<br>electrocardiograph is only intended to<br>be used in hospitals or healthcare<br>facilities by doctors and trained<br>healthcare professionals. The<br>cardiogram recorded by the<br>electrocardiograph can help users to<br>analyze and diagnose heart disease. The<br>proposed device has analysis feature,<br>however the ECG with measurements<br>and interpretive statements is offered to<br>clinician on an advisory basis only. | The Digital Electrocardiograph iE300 is<br>intended to acquire ECG signals from<br>adult and pediatric patients through<br>body surface ECG electrodes. The<br>electrocardiograph is only intended to<br>be used in hospitals or healthcare<br>facilities by doctors and trained<br>healthcare professionals. The<br>cardiogram recorded by the<br>electrocardiograph can help users to<br>analyze and diagnose heart disease.<br>The proposed device has analysis<br>feature, however the ECG with<br>measurements and interpretive<br>statements is offered to clinician on an<br>advisory basis only. | Same |
| Dimensions | 281mm x 191mm x 59mm | 281mm x 191mm x 59mm | Same |
| Net Weight | 1.3 kg | 1.3 kg | Same |
| Lead | Standard 12-lead | Standard 12-lead | Same |
| AcquisitionMode | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×<br>4+1R, 3/2 | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×<br>4+1R, 3/2 | Same |
| Record Format | Auto, Manual, Upload | Auto, Manual, Upload | Same |
| Display Format | 3 × 4, 3 × 4+1R, 6 × 2, 6 × 2+1R, 12 ×<br>1 | 3 × 4, 3 × 4+1R, 6 × 2, 6 × 2+1R, 12 × 1 | Same |
| Rhythm Time | 30~300s waveforms acquisition for rhythm<br>analysis | 30~300s waveforms acquisition forrhythm<br>analysis | Same |
| Measurement<br>Parameters | Ventricular Rate, PR Interval, QRS Time<br>Limit, QT/QTC Interval, P/QRS/TAxis,<br>RV5/SV1 Amplitude and RV5+SV1<br>Amplitude | Ventricular Rate, PR Interval, QRS Time<br>Limit, QT/QTC Interval, P/QRS/TAxis,<br>RV5/SV1 Amplitude and Same RV5+SV1<br>Amplitude | Same |
| Filters | AC Filter<br>Baseline Wander FilterEMG Filter | AC Filter<br>Baseline Wander Filter<br>EMG Filter | Same |
| Input CIR Current | <0.1 μ A | <0.1 μ Α | Same |

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| Input Impedance | ≥30 MΩ (10Hz) | ≥30 MΩ (10Hz) | Same |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Time Constant | ≥3.2 s | ≥3.2 s | Same |
| Frequency<br>Response | 0.01 Hz~250 Hz | 0.01 Hz~250 Hz | Same |
| Noise Level | ≤12.5 μ Vp-v | ≤12.5 μ Vp-v | Same |
| Sensitivity<br>Threshold | 20 μ Vp-v | 20 μ Vp-v | Same |
| Sensitivity | Auto, 0.625 mm/mV, 1.25<br>mm/mV, 2.5 mm/mV, 5 mm/mV, 10/5<br>mm/mV, 10mm/mV, 20/10mm/mV, 20<br>mm/mV, and 40 mm/mV | Auto, 0.625 mm/mV, 1.25 mm/mV,<br>2.5 mm/mV, 5 mm/mV, 10/5mm/mV, 10<br>mm/mV, 20/10mm/mV, 20 mm/mV,and<br>40 mm/mV | Same |
| Sensitivity | 10 mm/mV ± 2% | 10 mm/mV ± 2% | Same |
| CalibrationVoltage | 1 mV±3 % | 1 mV±3 % | Same |
| Accuracy of inputsignal<br>reproduction | Using the method described in<br>4.2.7.1 of AAMI EC11 to test the overall<br>system error, which is within<br>±5%;Using method A and D described in<br>4.2.7.1 of AAMI EC11 to test frequency<br>response. Because of sampling<br>characteristics and the asynchronism<br>ECG machine, digital systems may produce<br>a noticeable modulating effect from one<br>cycle to the next, particularly in pediatric<br>physiologic, shall be clearly described in the be clearly described<br>operator's and service manuals. | Using the method described in<br>4.2.7.1 of AAMI EC11 to test the overall<br>system error, which is within<br>±5%;Using method A and D described in<br>4.2.7.1 of AAMI EC11 to test frequency<br>response. Because of sampling characteristics<br>and the asynchronism between sample rate<br>between sample rate and signal rate of the and signal rate of the ECG machine, digital<br>systems may produce a noticeable<br>modulating effect from one cycle to the next,<br>particularly in pediatric recordings. This<br>recordings. This phenomenon, which is not phenomenon, which is not physiologic, shall<br>in the operator's and service<br>manuals. | Same |
| CMRR | >115 dB | >115 dB | Same |
| Patient Leak<br>Current | < 10 μA | <10 μA | Same |
| Sampling rate | 8000Hz | 8000Hz | Same |
| Display on LCD | 5-inch TFT LCD screen | 5-inch TFT LCD screen | Same |
| Safety<br>Classification | IEC60601-1, Class I, TypeCF | IEC60601-1, Class I, Type CF | Same |
| AC Power Supply | 100 V-240V, 50 Hz /60 Hz, 80 VA | 100 V-240V, 50 Hz /60 Hz, 80 VA | Same |
| DC Power Supply | Rechargeable lithium battery, 11.1 V/<br>2600mAh.In environment temperature<br>25 °C± 5 °C and with the machine<br>turning off, the charging time is not<br>more than 2 hours to charge the battery<br>to 90%. In environment temperature 25<br>°C± 5 °C, the continuous working time<br>is not less than 3 hours while the ECG<br>deviceis<br>continuously printing. | Rechargeable lithium battery, 11.1 V/<br>2600mAh. In environment temperature 25<br>°C± 5 °C and with the machine turning<br>off, the chargingtime is not more than 2<br>hours to charge the battery to 90%. In<br>environment temperature 25 °C± 5°C, the<br>continuous working time is not less than 3<br>hours while the ECGdevice is continuously<br>printing. | Same |

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## 510 (k) Summary

# ME6 Comparison

| Name / 510K #<br>Owner | Subject Device<br>ME6 / K233266<br>Mediblu | Predicate Device<br>iE6 / K132758<br>Biocare | Comparison |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications forUse | The ME6 is intended to acquire ECG<br>signals from adult and pediatric patients<br>through body surface ECG electrodes.<br>The obtained ECG records can help users<br>to analyze and diagnose heart disease.<br>Digital Electrocardiographs shall be used<br>in healthcare facilities by doctors and/or<br>trained healthcare professionals. | The intended use of the iE6<br>electrocardiograph is to acquire ECG<br>signals from adult and pediatric patients<br>through body surface ECG electrodes.<br>The obtained ECG records can help users<br>to analyze and diagnose heart disease.<br>Digital Electrocardiographs shall be used<br>in healthcare facilities by doctors and/or<br>trained healthcare professionals. | Same |
| Dimensions | 257 mm × 291 mm × 106 mm | 257 mm × 291 mm × 106 mm | Same |
| Net Weight | 2.5 kg | 2.5 kg | Same |
| Leads | Standard 12-lead | Standard 12-lead | Same |
| Acquisition<br>Mode | Simultaneous 12-lead<br>Acquisition | Simultaneous 12-lead<br>Acquisition | Same |
| Record Format | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×<br>4+1R (3-channel)<br>3 × 4,3 × 4+1R,3 × 4+3R,6 × 2,6<br>× 2+1R (6-channel, Standard leads) 6 × 1,<br>3×2 | 1 × 12, 1 × 12+1R, 3 × 4, 3 ×<br>4+1R (3-channel)<br>3 × 4,3 × 4+1R,3 × 4+3R,6 × 2,6<br>× 2+1R (6-channel, Standardleads) 6 × 1,<br>3×2 | Same |
| Record Mode | Auto, Manual, Upload (3-<br>channel)<br>Auto, Manual, Upload, Cycle,Trigger<br>(6-channel) | Auto, Manual, Upload (3-<br>channel)<br>Auto, Manual, Upload, Cycle,Trigger<br>(6-channel) | Same |
| Lead Format | Standard leads: 3 × 4, 3 × 4+1R,6 × 2,<br>6×2+1R, 12×1<br>6-channel, Nehb lead: 6 × 1, 3 ×<br>2 | Standard leads: 3 × 4, 3 × 4+1R,6 × 2,<br>6×2+1R, 12×1<br>6-channel, Nehb lead: 6 × 1, 3 × 2 | Same |
| Rhythm Time | 30~300s waveforms acquisitionfor<br>rhythm analysis | 30~300s waveforms acquisitionfor<br>rhythm analysis | Same |
| Measurement<br>Parameters | Standard leads:HR, PR Interval, QRS<br>duration, QT/QTC Interval, P/QRS/T<br>Axis, RV5/SV1 voltage and RV5+SV1<br>voltage<br>Nehb lead: HR, PR interval, P<br>duration, T duration, QRS duration,<br>QT/QTC interval,<br>P/QRS/T axis, P amplitude | Standard leads:HR, PR Interval, QRS<br>duration, QT/QTC Interval, P/QRS/T Axis,<br>RV5/SV1 voltageand RV5+SV1 voltage<br>Nehb lead: HR, PR interval, Pduration, T<br>duration, QRS duration, QT/QTC interval,<br>P/QRS/T axis, P amplitude | Same |
| Filters | AC Filter<br>Baseline Wander FilterEMG<br>Filter | AC Filter<br>Baseline Wander FilterEMG<br>Filter | Same |
| Input CIR<br>Current | ≤0.1 μ A | ≤0.1 μ A | Same |
| Input Impedance | ≥2.5 M $\Omega$ | ≥2.5 M $\Omega$ | Same |
| Time Constant | ≥3.2 s | ≥3.2 s | Same |
| Frequency<br>Response | 0.05 Hz~250 Hz | 0.05 Hz~250 Hz | Same |
| Noise Level | ≤15 μ Vp-v | ≤15 μ Vp-v | Same |
| Sensitivity<br>Threshold | 20 μ Vp-v | 20 μ Vp-v | Same |
| Sensitivity | Auto, 1.25 mm/mV, 2.5 mm/mV,<br>5 mm/mV, 10 mm/mV, 20<br>mm/mV, 40 mm/mV,<br>10/5 mm/mV, 20/10 mm/mV | Auto, 1.25 mm/mV, 2.5 mm/mV,<br>5 mm/mV, 10 mm/mV, 20<br>mm/mV, 40 mm/mV,<br>10/5 mm/mV, 20/10 mm/mV | Same |
| Standard<br>Sensitivity | 10 mm/mV ± 2% | 10 mm/mV ± 2% | Same |
| Calibration<br>Voltage | 1 mV±5 % | 1 mV±5 % | Same |
| Accuracy of input<br>signal reproduction | Using the method described in<br>4.2.7.1 of AAMI EC11 to test theoverall<br>system error, which is within ±5%;<br>Using method A and D described in<br>4.2.7.1 of AAMI EC11 to test frequency<br>response.<br>Because of sampling characteristics and<br>the asynchronism between sample<br>rate and signal rate of the ECG machine,<br>digital systems may produce a<br>noticeable modulating effect from one<br>cycle to the next, particularly in pediatric<br>recordings. This phenomenon, which is<br>not physiologic, shall be clearly described<br>in the operator's and service manuals. | Using the method described in<br>4.2.7.1 of AAMI EC11 to test the overall<br>system error, which is within ±5%;<br>Using method A and D described in 4.2.7.1<br>of AAMI EC11 to test frequency response.<br>Because of sampling characteristics and the<br>asynchron…