FDA certificate

Features:
Simultaneous 12-lead ECG creation
6/12 standard and Cabrera leads
7’’ inch backlight graphic LCD touch screen operation and display
12 ECG channels and one rhythm curve on the display
Reliable, high-resolution 6-channel thermal printer
manual, automatic report and printing
12 lead analysis and diagnosis program
Arrythmia program with QRS classification and statistics
Large storage capacity 500 records patient case
Built-in clock and calendar
PC Software connection
Complete PC software package for further ECG data process and management
Powerful clinical application and diagnosis Mode:
standard 12-lead ECG
custom 12-lead ECG
ventricular late potentials
heart rate variability
Vector ECG
time vector ECG
FECG
HFECG
QTD
PC software support various printing format by laser printer on A4 paper
6/12 channel ECG displaying on PC
PC can be connected to a network system
ECG wave form speed on the display: 5, 6.25,10,25, 50, mm/sec
Sensitivity: 1/4, 1/2 ,1, 2,4 cm/mV
High-resolution high quality thermal printer head
min 8/40 points/mm resolution on the time axis
Thermal roll paper
ECG record data: date, time and patient identification code
ECG measurement: intervals, amplitudes, electric axis
averaged ECG complexes
diagnosis recommendation
rhythm curve with QRS classification and statistics
ECG amplifier:
frequency response 0,05Hz-150 Hz, +0/-3dB
input noise max.: 20μVpp
CMRR 100dB
DC tolerance ±320mV DC
Input impedance 20 Mohm
Input signal range ± 8mV
Digital conversion data
Sampling rate is 800Hz/channel
A/D conversion min.13 bit, 2,5 μV/bit on the input
General technical data
Electrical Power
AC: 220V±10%, 50Hz/60Hz
Rechargeable battery type is NiMh
2 hours charging time with smart quick-charger for battery
Operating time with rechargeable batteries is 3 hours continuous monitoring or 45 minutes printing
Battery operating mode
Environmental Conditions
Transportation Temperature:-20℃~+50℃
Relative Humidity:10%~95%
Atmospheric Pressure:700hPa~1060hPa
Storage Temperature:-20℃~+50℃
Relative Humidity:10%~95%
Atmospheric Pressure:700hPa~1060hPa
Operation Temperature:5℃~+40℃
Relative Humidity:25%~80%
Atmospheric Pressure:700hPa~1060hPa
Safety data
Patient leakage current : 10 μA or less
Electric shock protection class “I”, “CF” according to IEC 601-1
Defibrillator protection: both cable & Machine hardware protection
Accessories :
10-pole patient cable with electrode
ECG carrying Trolley with drawer (SS made)
Certificates
Quality Standards
ISO9001
ISO13485
CMD
CCC
Design Standards
EN60601-1 & EN60601-1-2
EN60601-2-25 & EN60601-2-51
EN60601-1-4 & EN62304
EN ISO13485 & EN ISO10993-1
CE Declaration
ZQ-1206 has been assessed with respect to
the conformity assessment procedure
described in Article 11.3.a and Annex II
excluding section 4 (Module H) of Council
Directive 93/42/EEC on Medical Devices,
as amended, and found to comply.