ELECTROCARDIOGRAPH (Schiller AT-1 G2), portable, 3 ch+ACC
STD
EEMDECGE4--
Valid Article
Account code:
60100
HS Code:
901890
Last Updated on:
07/11/2024, 18:35:41
C0205 - Cardiac diagnostic devices
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
ELECTROCARDIOGRAPH, portable, Schiller AT-1 G2
Definition
Apparatus allowing to record and to report on a support the cardiac activity . It enables the diagnosis of cardio-vascular diseases.
The new model Schiller AT-1 G2 replaces the previous model Schiller AT-1.
Synonym
ECG
Specifications
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Quality standards
EN 60601-2-25, 2015, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
Technical specifications
- Screen
- LCD color screen
- Resolution: 800 x 480 dots, 5 "
- Printer
- High resolution printer with thermal print head; 8 points / mm (amplitude axis); 20 points / mm (time axis) @ 25 mm / s
- Graph paper: thermoreactive, folded accordion, width 80 mm; thermo-reactive, width 80 mm
- Speed: 5/25/50 mm / s; (for resting ECG: 25/50 mm / s)
- Sensitivity: 5/10/20 mm / mV; (for resting ECG: 10 mm / mV)
- Display of the ECG
- The ECG is displayed on a surface of 108 x 65 mm.
- Speed: 5/25/50 mm / s
- Sensitivity: 5/10/20 mm / mV
- Interfaces
- ECG cable interface
- Equalization of potential; 1 USB
- The CARDIOVIT AT-1 G2 may be exposed to the following interference without malfunctioning
- Static discharge up to ± 8 kV, ± 15 kV air
- Energy in the radio frequency range up to 10 V / m (80 to 3000MHz)
- In the vicinity of HF wireless telecommunication equipment fields, from 9 to 28V / m (385-5785 MHz), for details, see table on page 47.
- magnetic field of 30 A / m, 50 Hz
- Patient input
- Fully floating and insulated, protected against defibrillation (with original SCHILLER patient cable only)
- Configuring screen leads
- Derivations: Standard 12 tracks
- Status: Display of selected leads (3 x4); Condition of the filters; Source of food ; Derivations; Adhesion of the electrodes; Heart rate (HR); Date and hour ; Patient number
- Filters
- Myogram filter (muscle tremor): Set to 25, 40, 150, 250 Hz (250 Hz = filter disabled)
- Notch Filter: Non-distorted suppression of 50 or 60 Hz superimposed sinusoidal interference using Adaptive Digital Filtering
- Recorded data: List of all ECG recording conditions (date, time, filter); Results of ECG measurements (intervals, amplitudes, electric axes)
- With optional ETM interpretation program: Medium Complexes; ECG Interpretation Guide for Adults and Children
- Operating conditions
- Operating temperature: 10 to 40°C
- Relative humidity: 20 to 90% (without condensation)
- May be used at an altitude up to 2000 m
- Power supply
- Voltage 100 - 240 VAC, max. 0.75 A (115 V) - 0.4 A (230 V), 50/60 Hz
- Max. Power consumption 30 W
- Built-in rechargeable battery for network-independent use
- Lead acid gel battery 12V, 2.0 Ah
- Battery autonomy: 4 hours of normal use without printing
- Battery life: 4 years under normal conditions of use
- Charging time: 90%: approx. 4 hours when the device is off
Dimensions
285 x 189 x 61 mm, approx. 1,94 kg with recording paper
Supplied with the Article
- 10-lead patient cable with banana plugs
- Power cable
- Electrode gel tube (50 ml)
- Precordial electrodes
- Limbs electrodes
- Ream of thermo-reactive, z-folded recording paper
- Instructions leaflet
- Dust cover
Instructions for use
- See: 1.8. SOP ECG
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Precautions for Use
- When used or stored, the apparatus must be protected from humidity, dust, direct sunlight or any other heat source
- Avoid contact with steam or liquids containing acids which could cause irreversible damages to this apparatus
- Do not install the equipment in the neighbourhood of radiography units
- Contact your biomedical officer in order to see the need to protect the apparatus with a double conversion UPS (see related articles below).
Storage
- Storage temperature: 5 to 50°C
- Transport temperature: -10 to 50°C
- Moisture during storage / transport: 10 to 95% (non-condensing)
- Air pressure during storage / Transport: 500 to 1060 hPa
MSF requirements
Lightweight, compact and autonomous apparatus
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