Masimo Rad-G User Manual

39296/9527H-0320
12
Display Indicators
ITEM DESCRIPTION
Display Update Rate 1 second
Type TFT LCD
Pixels 320 dots x 240 dots
Compliance
EMC COMPLIANCE
IEC 60601-1-2:2007, Class B
EN/ISO 80601-2-61:2011, Clause 202.6.2.3, 20 V/m
SAFETY STANDARDS COMPLIANCE
ANSI/AAMI ES 60601-1:2005
CAN/CSA C22.2 No. 60601-1
IEC 60601-1:2005
IEC 62366
IEC 60601-1-6
IEC 60601-1-11
EN/ISO 80601-2-61:2011
EQUIPMENT CLASSIFICATION PER IEC 606011
Type of Protection
Class II (AC power)
Internally powered (Battery power)
Degree of Protection of Electrical
Shock
Defibrillation proof BF-Applied Part
Protection against harm from
liquid ingress
IP22, Protection from ingress of particulates >
than 12.5 mm and protection against vertically
falling water drops when enclosure is tilted at
15 degrees.
Mode of Operation Continuous operation
Guidance and Manufacturer’s Declarations - Electromagnetic Emissions
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an environment.
EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT  GUIDANCE
RF Emissions
CISPR 11
Group 1
ME Equipment uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
RF Emissions
CISPR 11
Class B
Suitable for use in all establishments, including domestic environments and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.
Harmonic Emissions
IEC 61000-3-2
Class A
Voltage fluctuations/ Flicker
emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer’s Declarations - Electromagnetic Immunity
The ME Equipment is intended for use in the electromagnetic environment specified below.
The customer or the user of the ME Equipment should assure that it is used in such an environment.
IMMUNITY TEST
IEC 60601
TEST LEVEL
COMPLIANCE LEVEL
ELECTROMAGNETIC
ENVIRONMENT  GUIDANCE
Electrostatic
discharge (ESD)
IEC 61000-4-2
+6 kV contact
+8 kV air
+6 kV contact
+8 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/ burst
IEC 61000-4-4
+/- 2 kV for power lines +/- 2 kV for power lines
Mains power quality should be that of a typical commercial or hospital environment.
+/- 1 kV for input/
output lines
+/- 1 kV for input/
output lines
Surge
IEC 61000-4-5
+/-1 kV line(s) to
line(s)
+/-1 kV line(s) to line(s)
Mains power quality should be that of a typical commercial or hospital environment.
+/- 2 kV line(s) to earth +/- 2 kV line(s) to earth
Voltage dips, short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
100% dip in mains
voltage for 0.5 cycle
100% dip in mains
voltage for 0.5 cycle
Mains power quality should be that of a typical commercial or hospital environment.
60% dip in mains
voltage for 5 cycle
60% dip in mains
voltage for 5 cycle
30% dip in mains
voltage for 25 cycle
30% dip in mains
voltage for 25 cycle

Masimo Rad-G Specifications

General

Type	Handheld Pulse Oximeter
Ingress Protection	IP22
Operating Temperature	5°C to 40°C
Storage Temperature	-20°C to 60°C
SpO2 Range	0% to 100%
Pulse Rate Range	25 – 240 bpm
Battery Type	Rechargeable Lithium-ion
Connectivity	Bluetooth
Perfusion Index Range	0.02% to 20%
PVI Range	0% - 100%
Humidity	10% to 95% (non-condensing)