ECG recorder,portable,w/access

GENERAL DESCRIPTION
Multichannel, interpretive electrocardiograph, including printer.

INTENDED USE
Electrocardiographs detect the electrical signals associated with cardiac activity and produce an ECG, a graphic record of the voltage versus time. They are used to diagnose and assist in treating some types of heart disease and arrhythmias. Electrocardiographs differ from ECG monitors, which provide a continuous real-time display of the ECG waveform and other physiologic measurements on a screen and warn of potentially life-threatening or precursor rhythms. Electrocardiographs are used to diagnose cardiac abnormalities, determine a patient's response to drug therapy, and reveal trends or changes in heart function. Multichannel electrocardiographs record and display signals from two or more leads simultaneously.

TECHNICAL SPECIFICATIONS
ECG analysis and full interpretation (rhythm and events), real-time and manual interpretation.
Three (3) or more recording channels.

SIGNAL ACQUISITION
Simultaneous 12 lead acquisition ( aVR, aVL, aVF, I, II, III and V1 - V6) derived from 10 electrodes (RA, LA, RL, LL, V1 - V6).
Arrythmia and ST elevation detection.
Minimum gain/sensitivity settings include 2.5, 5, 10 and 20 mm/mV.
Lead switching, either manual, automatic or both (manual and auto options).
Adjustable trace speeds include 5, 10 (and/or 12.5), 25 and 50 mm/s.
Minimum HR range 30 – 300 bpm with rhythm analysis.
Minimum guaranteed diagnostic frequency response of 0.05 – 150 Hz.
Common Mode Rejection Ratio (CMRR) at 60 Hz > 105 dB or better.
Calibration signal of 1 mV, manual and/or automatic.
Selectable/adjustable filters for baseline drift, muscle artefacts, mains power.
Pacemaker detection.
Accuracy of input signal reproduction ± 5 % or ± 40 μV, whichever is greater.
Input impedance > 50 MΩ.
Internal noise level < 12.5 µV peak-to-peak.
Automatic baseline centring.
Defibrillation fluctuation/overload protection.
Baseline recovery < 5 s after defibrillation.
AC fluctuation protection.

RECORDER AND PRINTER
Minimum of 3 recording channels.
Recorder display includes date/time, patient data and heart rate and basic settings.
Capable of displaying one group of at least three channels simultaneously.
Recorder waveform display includes lead marker and timing marker.
Integrated/built-in printer.
Capable of printing user selected number of channels.
Capable of printing one group of at least three channels simultaneously.
Paper speeds include 5, 10 (or 12.5), 25 and 50 mm/s.
Compatible with Z-fold paper and optionally with roll paper also (indicate compatibility).

DATA INPUT/OUTPUT, STORAGE AND ALARMS
Integrated alpha-numeric keyboard.
Patient data input fields include name, age, height and weight, gender.
Backlit Liquid Crystal Display (LCD) display screen, minimum of 12.7 cm (5 inches) diagonally.
Capable of internally storing a minimum of 10 waveforms for later retrieval, printing and/or transmission.
Expandable storage for additional waveforms if required, via USB.
Capable of exporting waveform data and reports, via USB or LAN.
Visual alarms for patient connection (lead faults), heart rate, printer and paper errors, and system errors.
Automatic self-test at start up.

POWER PROVISIONS
Built-in rechargeable lithium-ion battery.
Minimum battery operating time is 100 ECG exams or 4 hours of continuous recording.
Automatic switch to battery in case of power failure, automatic recharge on connection to mains.
Maximum battery charging time to full charge is 8 hours.
Power requirements: 100 - 240 Volts - 50/60 Hz.
Designed for frequent and easy dismount and disinfection with hospital-grade products.

SUPPLIED WITH
Instructions for assembly, use and maintenance in English, French and Spanish.
1 x Plastic protective dustcover.
1 x Patient cable.
2 x full sets of chest electrodes.
2 x full sets of limb electrodes.
1 x supply of 960 Z-folded sheets suitable for the unit. (if accepts Z-folded sheets), or 5 x supply of rolls suitable for the unit (if the unit accepts rolls).
3 x bottle of 100 ml of ECG conductive gel.
1 x spare rechargeable battery pack.

ESTIMATED LIFE SPAN
Five years.

WARRANTY
Two years from shipping date.

ENVIRONMENTAL CONDITIONS
- Operating conditions: 5°C – 40°C / 25% - 85% RH.
- Storage conditions: -20°C - 40°C / 25% - 95% RH.
- Atmospheric pressure: 860 ~ 1060 hPa.

WEIGHT AND VOLUME
Weight: 10.00 kg.
Volume: 80.00 dm³.

ESTIMATED DELIVERY LEAD TIME
120 days

INSTALLATION REQUIREMENTS
This product does not require assembly or installation.

TRAINING REQUIREMENTS
User training prior to utilization is recommended.

MAINTENANCE/USER REQUIREMENTS
As per user and service manuals.

RELATED PRODUCTS
S0002058, Defibrillator,AED,w/access
S0002059, Defibrillator,basic,w/access

COMPONENT OF A KIT
No part of a kit.

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

CLASSIFICATION
Classified either under EU MDD 93/42/ECC, or under EU MDR 2017/745 as Class IIa device

SAFETY & PRODUCT STANDARDS
- IEC 60601-1:2005 + A1:2012(E) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.
- IEC 60601-2-25:2011 Medical Electrical Equipment – Part 2-25: Particular requirements for the safety of electrocardiographs.

NOMENCLATURE
- GMDN code: Electrocardiograph, professional, multichannel (16231)
- UMDNS code: Electrocardiographs, Multichannel, Interpretive (16231)