Unimed External Sidestream ETCO2 Sensor

Model C300 CO2 Module - SPECIFICATIONS

Carbon Dioxide Monitoring:

Mode of Sampling

Side-stream

Principle of Operation

Non-dispersive infrared (NDIR) single beam optics, dual

wavelength, no moving parts.

Initialization Time

Capnogram displayed in less than 4 seconds, At an ambient temperature of 25° C, full specifications within 2 minutes.

CO2 Measurement Range

0 to 152 mmHg, 0 to 20.0% 0 to 20 kPa (Barometric Pressure supplied by module and mmHg reading is auto-calculated)

CO2 Calculation Method

BTPS (Body Temperature Pressure Saturated)

CO2 Response Time

<4 seconds - includes transport time and rise time

CO2 Resolution

0.1 mmHg 0 to 69 mmHg 0.25 mmHg 70 to 152 mmHg

CO2 Accuracy *

0 - 40 mmHg ± 2 mmHg

41 - 150 mmHg ± 10 % of reading

Above 80 breath per minute ± 10%of reading
* NOTE: Gas temperature at 25° C.

CO2 Stability

Short /long Term Drift: Drift shall not exceed 1 mmHg maximum. Module will auto run zero calibration when drift exceed 1 mmHg.

CO2 Noise

RMS noise of the module shall be less than or equal to 0.25 mmHg at 5% CO2

Sampling Rate

100 Hz

Respiration Rate Range

2 to 150 breaths per minute (BPM)

Respiration Rate

Accuracy

1% of reading, ± 1 breath

Calibration ETCO2 Calculation Method:

No routine user calibration required.
Peak of the expired CO2 waveform

Inspired CO2 Measurement

Range: 3 to 50 mmHg
Method: lowest reading of the CO2 waveform in the previous Breath

Compensations

need compensations for:
Expired O2, Balance gas (N2, N2O, He) and Anesthetic Agents
Compensations for barometric pressure has been finished by module itself.

Physical Characteristics and Host Interface

Physical characteristics

Module weight is less than 186g Module Size: <76mm(wide)
*38mm(high)* 108mm(deep)
Cable length – 48.88 cm (unless otherwise specified)

Data Interface

RS-232, bi-directional, 19200 baud, standard N-8-1

Module Interconnection

Standard- Lemo Redel 8-pin plastic, Material PSU
Module Plug: PAB.M0.8GL.AC39GZ
Bend Relief: GMA.1B.030.DA
Host Receptacle: PKB.M0.8GL.LA
Custom configurations available upon request.
Pinout:
1 VA 5.0V
2 SHIELD Shield return
3 DGND Digital return
4 VSRC 5.0V
5 TxD Serial data from C300
6 RxD Serial data from Host
7 AGND Analog return
8 NC

Model C300 CO2 module Voltage requirements

The C300 Module relies solely on the host system for power.
The host system shall provide the following:
VA:+5.00 VDC 5.0%;
70 mA (350 mW)typ (Steady-state); 240 mA (1.2 W) max
(Offset calibration ). Ripple not to exceed 50.0 mV
VSRC: DC Output Voltage:+5 V
Output Current: 40 mA .
Power interface must conform to IEC 60601-1

Power Rating

Total System Power:
Offset calibration:<1.1 W
Steady-state < 0.5 W

Model C300 CO2 module - SPECIFICATION

Temperature and Humidity

Operating: 0 to 50°C, 10 to 90% RH, non-condensing
Storage: -40 to 60°C, 10 to 90% RH, non-condensing

Atmospheric Pressure

Storage: 400-800 mmHg

Protection against electric shock

The module does not provide electrical isolation for enclosure leakage current, patient risk circuit, or patient auxiliary current. It is the responsibility of the 11 Host System to ensure that the power supply conforms to applicable standards - Recommend IEC 60601-1 Type BF.

Mode of operation

Model C300 CO2 module is rated for continuous use.
No marking is required.

Category AP/APG

AP - This device is not suitable for use in the presence of a flammable anesthetic mixture with air or nitrous oxide

Water Resistance

IPX4 - Splash-proof - Module only (When gas dryer line is inserted into the gas-in receptacle)

Shock Impact

IEC TR 60721-4-7 Class 7M3 (designed to withstand environments subject to significant vibrations or high
shock levels)
EN60068-2-27 Shock
EN60068-2-64 Random Vibration

Radiated emissions

Host system dependent, designed to meet the requirements of EN55011 - CISPR 11 Class B 30 MHz to 1000 MHz

Electrostatic discharge immunity

Host system dependent, designed to meet the requirements of IEC 61000-4-2 (2001-04) 6 kV conducted 8 kV air discharge

Radiated immunity

Host system dependent, designed to meet the requirements of IEC 61000-4-3 (2002-03) 80 MHz to 2.5 GHz, 20 V/m

Immunity to conducted disturbances induced by RF fields

Host system dependent, designed to meet the requirements of IEC 61000-4-6 (2001-04)

Mechanical:

Mechanical strength

Cable Strain Relief, resistance to pull-out: Cable strain (bend) relief system for the module enclosure shall withstand a pull of 30 pounds without failure to either the cable or the enclosure. Cable Strain Relief, flexibility: The connector strain relief system shall withstand 10,000 bend cycles. Connector Retention Force: The average retention force of the standard connector when pulling on the cable shall be 90 Newtons (20 pounds).

Regulatory

Regulatory Designed to meet the following:
IEC 60601-1
IEC 60601-1-2
EN55011
CISPR 11 Class B (Radiated and Conductive Emissions)
IEC 61000-4-2 Electrostatic Discharge Immunity
IEC 61000-4-3 Radiated Immunity
Designed to comply with the following:
93/42/EEC (MDD CE Marking)