Who is the manufacturer of MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. filed the 510(k) submission for MESI mTablet ECG Diagnostic System, MESI mTablet ECG (K223670).

What is the FDA product code for MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

DPS. It is classified under 21 CFR 870.2340 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MESI mTablet ECG Diagnostic System, MESI mTablet ECG?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MESI mTablet ECG Diagnostic System, MESI mTablet ECG

K223670 · Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. · DPS · Jul 28, 2023 · Cardiovascular

Device Facts

Record ID	K223670
Device Name	MESI mTablet ECG Diagnostic System, MESI mTablet ECG
Applicant	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Product Code	DPS · Cardiovascular
Decision Date	Jul 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2340
Device Class	Class 2
Attributes	Pediatric

Intended Use

The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.

Device Story

Portable 12-lead resting ECG system; acquires, displays, and stores cardiac signals from adult/pediatric patients. Input: 10 electrodes measuring heart muscle depolarization. Transformation: Signal acquisition via Bluetooth transmission to MESI mTABLET unit; Glasgow algorithm provides automated diagnostic interpretation. Output: ECG waveforms and analytical statements displayed on tablet. Used in professional clinical environments by trained healthcare personnel for spot-checking. Physician reviews output to make clinical judgments. Benefits: Enables rapid cardiac screening and diagnostic support in clinical settings.

Clinical Evidence

No clinical data is required to determine substantial equivalence. Bench testing only.

Technological Characteristics

12-lead resting ECG system; 10.1" color IPS screen (1280x800); Bluetooth 2.1+EDR wireless connectivity. 24-bit A/D conversion; 19-bit resolution. Hardware pacemaker detection with convolution digital filtering. Powered by rechargeable Li-Polymer battery. IP44 protection. Disposable electrodes (ISO 10993-1 compliant). Software includes Glasgow algorithm for interpretation. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, and ANSI/AAMI EC53.

Indications for Use

Indicated for adult and pediatric patients to evaluate and diagnose cardiac function via 10-electrode ECG measurement. For use in professional clinical environments by trained healthcare personnel.

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

CARDIOLINE HD+ (K150289)

Reference Devices

touchECG (K160746)
MESI mTABLET ABI (K201046)

Related Devices

K233521 — QT ECG (QTERD100) · QT Medical, Inc. · Dec 6, 2023
K142288 — MAC 800 Resting ECG Analysis System · Ge Medical Systems China Co., Ltd. · Dec 3, 2014
K173830 — MAC VU360 Resting ECG Analysis System · Ge Medical Systems Information Technologies, Inc. · Sep 18, 2018
K220795 — QT ECG · QT Medical, Inc. · Sep 26, 2022
K233266 — MEDIBLU ECG SYSTEM · Mediblu Medical, LLC · Jun 12, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. July 28, 2023 MESI, Development of Medical Devices, Ltd; MESI, D.O.O. % Elaine Duncan President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082 Re: K223670 Trade/Device Name: MESI mTablet ECG Diagnostic System, MESI mTablet ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: June 23, 2023 Received: June 27, 2023 Dear Elaine Duncan: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ 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/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223670 Device Name MESI mTABLET ECG #### Indications for Use (Describe) The MESI mTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare personnel. The MESI mTABLET ECG provides information regarding the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | <div> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ # 510(k) Summary | Submitted on behalf of: | MESI D.O.O | |-------------------------|----------------------------------------------------------------------| | Date Prepared: | July 28, 2023 | | Address: | Lesloskova cesta 11A, 1000 Ljubijana Slovenia, Europe | | Telephone: | +386 1 620 34 87 + 386 8 2015 32 95 | | Submitted by: | Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 | | Telephone: | 715-549-6035 | | CONTACT PERSON: | Elaine Duncan, MSME, RAC, FAIMBE President, Paladin Medical, Inc. | | Trade name | MESI mTABLET ECG | | Common name | 12-lead resting wireless ECG system | | Classification name | Cardiac Electrophysiology, Diagnostics, and Monitoring Devices | | Device classification | Class II | | Product classification | 870.2340 | | Product code | DPS | | Classification panel | Cardiovascular | {4}------------------------------------------------ ### DEVICE DESCRIPTION The MESI mTABLET ECG portable 12 lead resting ECG system is intended to screen cardiac abnormalities. The MESI mTABLET ECG System acquires, permits viewing and storing signals from adult and pediatric patients. The MESI mTABLET ECG is one of several variations of the company's MESI mTABLET system portfolio. MESI mTABLET ECG is intended to measure heart activity by ten electrodes placed on the patient body which measure miniscule electrical activity generated by heart muscle depolarizations. This activity is captured and displayed on the MESI mTABLET UNIT. The MESI mTABLET ECG supports acquisition of 10 seconds signal or manual mode with acquisition up to 5 minutes. The MESI mTABLET ECG provides analytical statements when configured with the appropriate options. It also comes with Glasgow algorithm for automatic interpretation which offers dagnostic opinion is not intended to constitute professional advice, diagnosis or treatment, or be a substitute for professional judgment. ## INDICATIONS FOR USE: The MESI mTABLET ECG is indicated for use on adult or pediatic patients, to evaluate and diagnose patient cardiac function. MESI mTABLET ECG is intended to measure heart activity by ten (10) electrodes placed on the patient's body which measure mimiscule electrical activity generated by the heart muscle depolarizations. The MESI mTABLET ECG is solely used in professional clinical environment by trained healthcare persomel. The MESI mTABLET ECG provides information the patient's cardiac function. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician. ## PREDICATE DEVICE and EQUIVALENCE: The MESI mTABLET ECG has a similar indication for use and intended use as the CARDIOLINE HD+ predicate device (K150289), manufactured by Cardioline S.p.A. In addition, the MESI mTABLET ECG is equivalent to the reference device "touchECG" (K160746) that is intended to be used in conjunction with CARDIOLINE HD+ device (K150289) that acquires the ECG signal and transmits it. The "touchECG is a software medical device provided on a CD support. The touch ECG employs the Glasgow Algorithm for interpretation. The MESI mTABLET ECG is intended for spot-checking use. Additionally, the MESI mTABLET ABI (K201046), manufactured by MESI D.O.O serves as a reference device to the basic technology of the tablet communication and several similar components, such as charging unit. Indeed, the MESI mTABLET ECG uses the same tablet device and charging plate as MESI mTABLET ABI, cleared under 510(k) number K201046. {5}------------------------------------------------ | Substantial Equivalence Determination Table | | | | | | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device | CARDIOLINE HD+ | touchECG | MESI mTABLET ABI | MESI mTABLET ECG | Equivalence of features & characteristics | | 510(k) Number | K150289 | K160746 | K201046 | K223670 | | | Manufacturer | Cardioline S.p.A. Predicate | Cardioline S.p.A Reference | MESI D.O.O. Reference | MESI D.O.O. Subject Device | | | Indications for Use / Intended use | HD+ is a physiological ECG acquisition module. HD+ transmits wireless, via Bluetooth to a PC or Tablet, the data acquired, without making any analysis or filtering on the data acquired. HD+ acquires 12-lead ECG waveforms meeting the standards for clinical and diagnostic applications (AAMI, ANSI, AHA, ACC) and offers full ECG acquisition. HD+ is designed to acquire and transmit a high quality ECG data allowing the patient to be free to moving (without cable connected to the processing unit). The HD+ transmits the acquired physiological signals in real-time to a computer/device where a compatible application is installed. All data acquired are sent via Bluetooth to a receiver that it can be a PC, tablet or device capable of receiving BT | touchECG is designed to check and diagnose cardiac function. However, a physician must validate the results of the analysis run by the ECG. touchECG is intended for use in hospitals, clinics and outpatient departments of any size. It is suited for use by health professional in emergencies (ambulances). touchECG is intended to be used in conjunction with CARDIOLINE HD+ device. The device analyzes, displays and prints out electrocardiograms. The ECG's are acquired from CARDIOLINE HD+ device. The device interprets the data for review by a physician. The device must be used by a physician or by health professionals on behalf of an authorized doctor in clinical facilities. It is not intended as the only means for determining the diagnosis. The device's | The MESI MTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). MESI MTABLET ABI is intended for the rapid measurement of ankle- brachial pressure index (ABI) and pulse volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy. MESI MTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI MTABLET ABI is intended to be used to spot- check patients. The MESI MTABLET ABI provides information | The MESI MTABLET ECG is indicated for use on adult or pediatric patients, to evaluate and diagnose patient cardiac function. MESI MTABLET ECG is intended to measure hearth activity by ten (10) electrodes placed on the patient's body which measure miniscule electrical activity generated by the heart muscle depolarizations. The MESI MTABLET ECG is solely used in professional clinical environment by trained healthcare personnel for spot- checking. The MESI MTABLET ECG provides information regarding the patient's | EQUIVALENT; MESI MTABLET ECG has same indication for use as the Cardioline and is also tablet and bluetooth based. Both can use 12 lead ECG electrodes Both are indicated for adult and pediatric patients. MESI MTABLET ECG uses the same technological platform as the MESI mTABLET ABI. | | | The ECG is transmitted verbatim to the receiving system, without LSB or sampling adjustment. It is up to the receiving system/application to perform the necessary processing such as (but not limited to) LSB scaling, signal filtering, Resting ECG analysis etc. The device HD+ is intended to be used on adult and on all pediatric patients. The device is intended for use by qualified, trained nurses and physicians operating in hospitals, clinics and medical practices. | analysis is only significant if used together with an additional analysis by the physician and by an assessment of all the patient's important data. The device can be used on adults patients. The device must not be used as a physiological monitoring of vital signs. touchECGis intended to be used in conjunction with CARDIOLINE HD+ device (K150289 that acquires the ECG signal and transmits it. touchECG is a software medical device provided on a CD support | The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician. | physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician. | | | Dimensions / weight | Dimensions: 115 x 65 x 15 mm Weight: < 90 grams (including batteries) | The device installs on any PC, tablet or notebook with the minimum requisites shown below: Operating System - Windows 7, Windows 8.1, Windows 10 Processor - Intel I5 or higher RAM - 4GB or more Free space on Hard Disk - 3GB or more. Monitor - 640 x 480 pixel or more Bluetooth - Bluetooth 2.1 +EDR Printer - Laser (colour/BW) Printing paper: A4, Letter Interpretation Algorithm: Glasgow algorithm Additional applications - Email application which supports the EML format (only required for the email File | MESI mTABLET UNIT Width: 199 mm (7,83 inches), Depth: 278mm (10,95 inches), Height: 53mm (2,08 inches), Weight: 757grams MESI mTABLET WI-FI DOCKING UNIT Width: 176 mm (6,93 inches), Depth: 126 mm (4,96 inches), Height: 40 mm (1,57inches), Weight: 717grams MESI TUBELESS CUFF UNIT (4x): Width: 40 mm (1.57 inches) Depth: 40 mm (1.57 inches) Height: 150 mm (5.91 inches) Weight: 286 g | MESI mTABLET UNIT Width: 199 mm (7,83 inches), Depth: 278mm (10.95 inches), Height: 53mm (2,08 inches), Weight: 757grams MESI mTABLET WI- FI DOCKING UNIT Width: 176 mm (6,93 inches), Depth: 126 mm (4,96 inches), Height: 40 mm (1,57inches), Weight: 717grams MESI ECG UNIT: Width: 40 mm (1.57 inches) Depth: 40 mm (1.57 inches) Height: 125 mm (5.31 | MESI mTABLET dimensions IDENTICAL TO THE MESI mTABLET ABI Dimensional differences between MESI TUBELESS CUFF UNIT and MESI ECG UNIT due to internal hardware differences are insignificant | | | | Upload feature) It prints out in the following formats: standard or Cabrera 3, 3+1, 3+3, 6 or 12 channel in automatic mode, and 3, 6 or 12 printout channels of the rhythm strip. | MESI LARGE CHARGING PLATE UNIT: Width: 400 mm (15.75 inches), Depth: 200 mm (7.87 inches), Height: 38 mm (1.49 inches), Weight: 675 grams | inches) Weight: 220 g MESI LARGE CHARGING PLATE UNIT: Width: 400 mm (15.75 inches), Depth: 200 mm (7.87 inches), Height: 38 mm (1.49 inches), Weight: 675 grams | | | Power Supply | 2x AAA standard 1,5 V batteries | Intrinsic to add on system | MESI mTABLET UNIT AC/DC adaptor: FW8030M/05(FRIWO) Input: 100-240 V~; 50-60 Hz Output: 5 Vdc; 5000 mA Battery type: RechargeableLithium- Polymer battery(LP6058110) Capacity: 8800 mAh, Battery operation: more than 8 hours MESI TUBELESS CUFF UNIT Battery type: Rechargeable Lithium-Polymer battery, Capacity: 1240 mAh Examinations per battery charge: > Power Supply 2x AAA standard 1,5 V batteries Intrinsic to add on system MESI mTABLET UNIT | MESI mTABLET UNIT AC/DC adaptor: FW8030M/05(FRIWO) Input: 100-240 V~; 50-60 Hz Output: 5 Vdc; 5000 mA Battery type: RechargeableLithium- Polymer battery(LP6058110) Capacity: 8800 mAh, Battery operation: more than 8 hours MESI ECG UNIT Battery type: Rechargeable Lithium-Polymer battery, Capacity: 1240 mAh Examinations per battery charge: > 2000 Charge time for depleted battery: approximately 2 hours (minimum charge time for 1 automatic mode ECG: 10 minutes) MESI LARGE CHARGING PLATE UNIT AC/DC adaptor: FW8030M/05 | IDENTICAL TO THE MESI mTABLET ABI | | Display | LCD color touch screen | various | AC/DC adaptor: FW8030M/05(FRIWO) Input: 100-240 V~; 50-60 Hz Output: 5 Vdc; 5000 mA Battery type: RechargeableLithium- Polymer battery(LP6058110) Capacity: 8800 mAh, Battery operation: more than 8 hours MESI TUBELESS CUFF UNIT Battery type: Rechargeable Lithium-Polymer battery, Capacity: 1240 mAh Examinations per battery charge: > MESI mTABLET UNIT AC/DC adaptor: FW8030M/05(FRIWO) Input: 100-240 V~; 50-60 Hz Output: 5 Vdc; 5000 mA Battery type: RechargeableLithium-Polymer battery(LP6058110) Capacity: 8800 mAh, Battery operation: more than 8 hours MESI ECG UNIT Battery type: Rechargeable Lithium-Polymer battery, Capacity: 1240 mAh IDENTICAL TO THE MESI mTABLET ABI | (FRIWO FOX30-XM) Input: 100-240 V~; 50- 60 Hz Output: 5 Vdc / 5000 mA | IDENTICAL TO THE MESI mTABLET ABI | | | | | 10,1" color IPS screen with 1280x800 resolution | 10,1" color IPS screen with 1280x800 resolution | | | Applied parts in contact with the patient | Disposable electrodes, clamps | NONE | 2x tubeless arm cuffs 2x ankle cuffs | Disposable electrodes | The user supplies the disposable electrodes | | Materials in contact with the patient | Not specified | NONE | ARM CUFFS: TPU coated PU leather – outside layer Nylex based PU leather - inside layer TPU bladder | Requires user to supply disposable electrodes: Adhesive: Medical grade pressure sensitive adhesive Foam: | MESI mTABLET ECG uses disposable electrodes, which meet ISO 10993-1. Not supplied by MESI. | | | | | | cell; Connector: stainless steel | | | Bench Testing | Applied parts: CF RF emissions: Group 2, Class B Compliant with standards: EC 60601-1 IEC 60601-1-2 IEC 60601-2-25 ETSI EN 300 328 ETSI EN 301 489 -1 ETSI EN 301 489 -17 ETSI EN 300 440 -2 FCC CFR47 Part 15 (US) | Defibrillation Protection Overload Tolerance Requirements for mplitude measurements Interval Measurements Requirements for interval measurements on biological ECGs Indication of Inoperable ECG Leads Minimum Lead Configuration Wilson Leads Input Impedance Required Gains Common Mode Rejection Line Filter Response Noise Level Channel Crosstalk High Frequency Response Low Frequency Response Linearity and Dynamic Range Sampling and Amplitude Quantization Record Identification Patient Identification Recording Speed Time and Amplitude Ruling Use with Cardiac Pacemakers | Type of protection against electric shock: Class II Applied parts: BF SoftWare classification: Class B RF emissions: Group 1, Class B Compliant with standards: EN 60601-1:2006/A1:2013 EN 60601-1-2:2015 EN 60601-1- 6:2010/A1:2015 EN 80601-2-30:2010 EN ISO 15223-1:2016 EN 303 446-1:2017 EN 62366:2008 EN 62304:2006/A1:2015 EN ISO 10993- 1:2009/AC:2010 EN ISO 14971:2012 IEEE/ANSI C63.27-2017 | Type of protection against electric shock: Class II Applied parts: CF SoftWare classification: Class B RF emissions: Group 1, Class B Compliant with standards: EN 60601- 1:2006/A1:2013 EN 60601-1- 6:2010/A1:2015 EN 60601-2-25:2015 EN 62304:2006/A1:2015 EN 62366:2008 EN 60601-1-2:2015 EN ISO 15223-1:2016 EN 1064:2005/A1:2007 EN 303 446-1:2017 EN ISO 14971:2012 EN ISO 10993- 1:2009/AC:2010 IEEE/ANSI C63.27- 2017 | MESI mTABLET ECG meets more ECG standards and better RF emisson compliance than Cardioline HD+. EMC and safety test reports are available in the Section 17 - Bench Testing. Test reports: T223-0126-20 60601-1 T251-0146-20 60601- 1-2 T223-0127-20_60601- 1-6 T223-0122-20 60601- 2- 25 F2P27871A-03E | | Temperature and humidity range | Working environment: Temperature between +10 and +40 °C inclusive, Relative humidity between 25 and 95 % inclusive (without condensation), Atmospheric pressure between 700 and 1060 mbar Transport and storage environment: | | Working environment: 10° to 40°C, relative air humidity: 25 to 85% Transport and storage environment: | Working environment: 10° to 40°C, relative air humidity: 25 to 85% Transport and storage environment: -15° to 50°C (<1 month) / | IDENTICAL TO THE MESI mTABLET ABI | | | Temperature between -10 e +40°C inclusive Relative humidity between 25 and 95 % inclusive (without condensation) Atmospheric pressure between 500 and 1060 mbar inclusive | Adults | -15° to 40°C (<3 month) / -15° to 25°C (<12 month) Relative humidity: 25 to 85% (no condensation) IP42 protection | -15° to 40°C (<3 month) / -15° to 25°C (<12 month) Relative humidity: 25 to 85% (no condensation) IP44 protection | IDENTICAL TO THE CARDIOLINE HD+ | | Target population | Adults and pediatric patients | Adult | Adult | Adults and pediatric patients | IDENTICAL TO THE CARDIOLINE HD+ | | Where used | Clinical environment…