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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%
| Electrode offset potential | 300mV |
| Diagnostic Mode | >90 dB |
| Monitor Mode | >110 dB |
| Surgery Mode | >110 dB |
| Surgery | 1 ~ 20 Hz |
| Monitor | 0.5 ~ 40 Hz |
| Diagnostic | 0.05 ~ 130 Hz |
| Differential Input Impedance | > 5 M ohm |
| 1.7 Sensitivity | > 200 μV P-P |
| Measure range | Adult 15 ~ 300 bpm |
1. OEM/ODM service : Darppon offers OEM/ODM service for distributor to establish long term business relationship.
2. Warranty :Darppon offers 18 months free after-sale service for customers, and be responsible for life-time repair.
3. Technical support:Darppon offers professional engineers for customers on the technical support, and response within 12 hours
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