Hospital professional Equipment small size Patient Monitor device

1.1 Safety Classifications

Item Specification
MDD classification Class IIb
Anti-electroshock degree Class I equipment with internal power supply
Anti-electroshock degree TEMP/SpO2/NIBP: BF
ECG/RESP: CF
Explosion proof level Ordinary equipment,without explosion proof
Harmful liquid proof degree IPX1
Working system Continuous running equipment
Equipment type Portable

1.2 Applicable Standards

Medical Device Directive 93/42/EEC
EN60601-1:2005 or IEC60601-1:2005, Medical Electrical Equipment, Part 1: General Requirements for Safety
EN60601-1-1 or IEC60601-1-1, Medical Electrical Equipment, Part 1-1: General Requirements for Safety, Collateral Standard: Safety Requirements for Medical Electrical Systems
IEC60601-1-4, Medical Electrical Equipment, Part 1-4: General Requirements for Safety, Collateral Standard: Programmable Electrical Medical Systems
IEC60601-2-49, Medical Electrical Equipment, Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment
IEC 60601-1-2:2007, Electromagnetic Compatibility, Medical Electrical Equipment
ISO 21647:2009, Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors

1.3 Environment

Temperature
Working 0 ~ 40 ℃
Storage -20 ~ 50 ℃
Humidity
Working 15 % ~ 90 %
Storage 15 % ~ 90 % (no coagulation)
Atmospheric pressure
Working 86.0 kPa ~ 106.0kPa;
Storage 86.0 kPa ~ 106.0kPa

1.4 Lead mode

5 Leads: RA,LA,LL,RL,V; Lead mode: I, II, III, AVR, AVL, AVF, V
1.11.4 Gain
×2.5mm/mV, ×5.0mm/mV, ×10mm/mV, ×20mm/mV
1.11.5 Sweep speed
12.5mm/s, 25mm/s, 50mm/s

1.5 Heart rate

Measure range
Adult 15 ~ 300 bpm
Neonatal/Pediatric 15 ~ 350 bpm
Accuracy ±1%