MORPHEUS M

Anaesthesia Unit

Code: OM3.S5

Rev. 7: dated 10/01/2019

INTENDED USE The MORPHEUS M is an anaesthesia unit and it can be used on adult, children
and newborn patients.

The MORPHEUS M is suitable for administration of Oxygen - Air - Nitrous

Oxide - Halothane - Enflurane - Isoflurane - Sevoflurane - Desflurane mixtures.

GENERAL The MORPHEUS M anaesthesia unit is completed with:

DESCRIPTION  mechanic gas mixing system,
 electronic lung ventilator with 12” TFT color display,
 valves group: open, semi-closed, closed, heated, with soda lime absorber,
 SIARETEX rapid connection device, Selectatec compatible for 2 vaporizers,
 gas supply group,
 gas analysis system (optional function).

TECHNICAL DATA

Structure Light aluminum alloy and plastic moulds

Wheels Pivoting antistatic wheels, diameter 100 mm (2 with brakes)

Drawer No. 3 full extension drawers

Cylinder support No. 2 vertical cylinders supports, on the back side (for cylinders up to 10 litres
capacity) and round rubber pads

Support for 2 vaporizers On horizontal guide (SIARETEX rapid connection device, Selectatec compatible
for 2 vaporizers)

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Auxiliary power supply No. 1 SCHUKO 220 Vac outlet (max. 6 A)
outlets

Work shelf lighting 12Vdc by led

Dimensions 71 x 77 x 138 (L x P x H) cm (without monitor).

Weight 72 kg (without accessories)

Environmental conditions  Temperature from 10 to 40°C

 Relative humidity from 10 to 90% non-condensing

GAS MIXING SYSTEM

It has the function to regulate the capacity and the concentration of gas mixture
(Air, O2, N2O) as well as to deliver it to the anaesthetic gas vaporizer.
It allows to select the mixture to be delivered (Air - O2, or N2O - O2) and the O2
enrichment for delivered mixture in case of emergency.
The anaesthesia module includes a device which guarantees a minimum
concentration of 25% oxygen in all conditions (MIX-LIFE device).

The three pressure gauges on the front panel allow the continuous control of
medical gas feeding pressure coming from the gas pipelines system.

Oxygen rotameter Scale: 0.1 - 15 L/min.

Resolution: 0.1 L/min up to 1 L/min and 1 L/min up to 15 L/min
Accuracy:  10% of read value or:  1% of end scale whichever is the worse
case.

Nitrous oxide rotameter Scale : 0.2 - 12 L/min.

Resolution: 0.1 L/min up to 1 L/min and 0.5 L/min up to 12 L/min
Accuracy:  10% of read value or:  1% of end scale whichever is the worse
case.

Air rotameter Scale: 0.1 - 15 L/min.

Resolution: 0.1 L/min up to 1 L/min and 1 L/min up to 15 L/min
Accuracy:  10% of read value or:  1% of end scale whichever is the worse
case.

Low flows oxygen Scale 0.1 - 1 L/min.

rotameter
Resolution: 0.05 L/min
Accuracy:  10% of read value or:  1% of end scale whichever is the worse
case.

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Low flow nitrous oxide Scale: 0.1 - 1 L/min.
rotameter
Resolution: 0.05 L/min
Accuracy:  10% of read value or:  1% of end scale whichever is the worse
case.

Medical gas supply OXYGEN

 Pressure included between 280 kPa and 600 kPa (2,8 – 6 bar)
 Max. required flow 90 L/min.

NITROUS OXIDE
 Pressure included between 280 kPa and 600 kPa (2,8 – 6 bar)
 Max. required flow 15 L/min.

MEDICAL COMPRESSED AIR

 Pressure included between 280 kPa and 600 kPa (2,8 – 6 bar)
 Max. required flow 90 L/min.

Gauges No. 3 on front panel (O2 - N2O - AIR ), scale 0 - 6 bar

Alarms Lack or low oxygen pressure with consequent cut-off of nitrous oxide delivery

Safety devices AGAINST THE ADMINISTRATION OF HYPOXIC MIXTURES MIX-LIFE: it

always guarantees a minimum concentration of 25 % oxygen on mixtures which
includes nitrous oxide.

IN CASE OF LACK OR LOW OXYGEN PRESSURE CUT-OFF: audible alarm

with immediate cut-off of nitrous oxide delivery.

AGAINST OVERPRESSURE IN FLOWMETER BOX: Safety valve calibrated at

0.8 bar for the protection of the glass rotameters.

IN CASE OF LACK OR COMPRESSED AIR LOW PRESSURE: All the devices

(gas feeding) supplied by compressed air are automatically supplied by oxygen.

AGAINST THE SIMULTANEOUS DELIVERY OF AIR AND N2O: Selection by

membrane key on the flowmeter front panel.

Control for activation of Setting of MANUAL modalities on ventilator (MAN) with automatic deviation of
exit of fresh gas for fresh gas to the manual system of anaesthesia unit valves group, or to a TO-
manual ventilations AND-FRO circuit with visual indicator.
Automatic deactivation of manual ventilation systems directly by ventilator
control.

O2 emergency by-pass By apposite membrane key on the front shelf, max flow 35 L/min.

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IN gas sockets on gas  No. 3 sockets for distribution system (O2 - N2O - AIR)
supply group
 No. 2 sockets for cylinder (O2 - N2O)

OUT gas sockets on gas  No. 1 sockets for O2

supply group
 No. 1 sockets O2 - AIR for active scavenger feeding

 No. 1 fresh gas connector for external use for ex. TO AND FRO (selectable
by apposite membrane key on the front shelf - AUX).

Other  Socket for recycle of exhaust monitor gas

 Connection for anaesthetic gas scavenging (optional device: active type, or
passive type)

BREATHING SYSTEM

Compact system with automatic connections, easy dismountable and

autoclavable.
It allows the ventilation in modality: real open circuit, semi-closed circuit, closed
circuit at low flows.
The system also allows the spontaneous and manual ventilation in case of
anaesthesia unit breakdown or machine off.
Top special CO2 absorber canister of 1,5 Kg with rapid connection: this allows
canister replacement also during interventions (the canister is autoclavable and
reusable).
The recycling system is a selective type, hence the soda lime and fresh gas
consumption are reduced to the minimum.
The heated valves group reduces the condensation and heats the fresh gas.
The transition from one ventilation modality to another is completely controlled by
the ventilator without any user’s action on valves group.

LUNG VENTILATOR

User’s interface 12” TFT high resolution colour display with membrane keyboard and encoder

Control modality Electronic by microprocessor

Dead space Automatic

compensation system

Automatic compensation Automatic compensation of atmospheric pressure on measured pressure: present

of atmospheric pressure (max. 5000 mt)

Flow generation Electronic system

Gas feeding  Medical compressed Air or Oxygen supply with pressure included between
280 kPa and 600 kPa (2,8 – 6 bar)

 OPTIONAL. Turbine driven: independent from the gas supply system (in this
case it’s necessary a pneumatic Oxygen supply only).

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Self-Test Primary test: at anaesthesia unit’s start-up, a control test of Turbine presence,
Medical Gas Supply presence, INSP and EXP flow sensors operation, pressure
sensor, patient circuit losses, back-up battery state, oxygen cell, integrity of
audible alarm is automatically performed. This test takes around 15 seconds.
Tests on demand: the anaesthesia unit has a tests on demand which is
activated by the user in the ventilator menu. This subtest permits to verify the
dead space and losses or to perform the oxygen cell calibration.

Ventilation modalities  APCV

 APCV-TV

 PSV

 APNEA BACK-UP

 SIMV ( Volumetric +PS; SPONT )

 VC/VAC

 VC/VAC BABY ( integrated NEONATAL ventilation mode )

 MANUAL

Breathing rate From 4 to 120 bpm (step 1 bpm)

I:E Ratio 1:1, 1:1.5, 1:2, 1:3, 2:1, 3:1

Inspiratory time From 0.2 to 5 sec.

Inspiratory pause From 0 to 60% of inspiratory time

SIMV rate From 1 to 119 bpm

Tidal volume From 5 to 1500 ml (< 50ml: step 1ml / 50-100ml: step 5ml / >100ml step 10ml)

Minute volume From 1 to 30 liters

Airways pressure limit From 6 to 60 cmH2O

(PLIM)

Support pressure (PS) From 5 to 60 cmH2O

PEEP OFF, 3 to 30 cmH2O (step 1 cmH2O)

Inspiratory Flow (FLOW) Selectable ramp from 10 to 80 L/min (step 10 L/min)

Oximeter Minimum resolution 1% - Automatic calibration procedure

Bronchomanometer -20 to 80 cmH2O

Flow trigger From OFF, 1 to 15 L/min (step 1 L/min)

Pressure trigger From -1 to -9 cmH2O under the PEEP level

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Safety Electronic and mechanical limit of airways pressure; Self-diagnosis system

Alarms  Low / High Airways Pressure, Low / High Breathing Rate, Low / High O2
Concentration, Low / High Tidal Volume, Electric Power Supply
 Apnoea, Low Battery, Low Gas Supply, Disconnected Patient Circuit, Can-
Bus Failure

Flow sensor Internal to the valves group, by magnetic perturbance, reusable.

Measured parameters  PAW; PEEP; Rate; I:E; FiO2; Vte; ExpMV

 MAP; Pplateau; Tpause; Ti; Te; Fi; Fe; Cs; Ri;

Ventilation Curves CURVES: Pressure - Flow - Volume

LOOPs: Volume / Pressure and Flow / Volume
Measurement RANGE: automatic

Trend Scale and 72 hours trend period setting

Foreseen Trends: PAW; PEEP; VTe; ExpMV; Rate

Events Memory storage up to 100 events per machine including the alarms.

GAS ANALYSIS - (Optional Function)

Gas analysis Integrated software for analysis of CO2, O2, N2O, AG automatic identification, MAC.

Mainstream device  IRMA AX+ (CO2, N2O, primary and secondary agents, HAL, ISO, ENF, SEV,
DES).
 IRMA CO2 (CO2)

Sidestream device  ISA AX+ (CO2, N2O, Agents)

 ISA CO2 (CO2)

 ISA OR+ (CO2, N2O, Agents, O2)

Technical Consult the relevant technical data sheets for mainstream and sidestream modules.
characteristics

ELECTRIC POWER SUPPLY

Electric power supply 100 ÷ 240Vac / 45 ÷ 60Hz

Maximum power 120 Watt

Back-up battery 12Vdc - 3 Ah Pb battery which guarantees an autonomy of around 120 minutes

Charging time Around 10 hours

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NORMS

The device complies with the essential requirements and it is realized according
0476 to the references of the Annex II of 93/42/EEC Medical Devices Directive.

Class and type according Class I Type B

to IEC 601-1

Class according to 93/42 Class IIb

EEC Directive

Electromagnetic Conform to the requirements of the EN 60601-1-2: 2015 and following

compatibility (EMC)

Norms DIR. 93/42/CEE (2007); EN 60601-1 :2006/A1 :2011/A1 :2013; EN 60601-1-2

:2015; IEC 601-1-6:2013; IEC 601-1-8:2012; EN 62304:2006/AC:2008; ISO
10993-1:2009; IEC 62353:2014; EN 60601-2-13:2006; ISO 80601-2-13:2011;
ISO 15223-1:2016; DIR. 2011/65/CE; D.Lgs 49/2014; ISO 14971:2012; EN ISO
4135:2001

ACCESSORIES

Standard accessories  User’s Manual

 O2 supply hose
 N2O supply hose
 Air supply hose
 O2 cylinder supply hose
 N2O cylinder supply hose
 Top Special CO2 absorber canister (no. 1 / canister with metal cover)
 O2 cell
 Patient circuit - Manual ventilation KIT
 Adult Mapleson C adult patient circuit
 Electric power supply cable

Optional accessories See current export price list

SIARE applies the UNI EN ISO 13485:2016 Quality System and 93/42 EEC Dir.ve.

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.

Via Pastore, 18 - Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel: +39 051 969802 - Fax: +39 051 969366
E-mail: [email protected] - http://www.siare.it

Morpheus_M_te_rev7 7/7
 NEPTUNE 12”
Multi-Parametric Monitor
Code: A56.NT
Rev: V2.2 - 09/11/2018

APPLICABLE STANDARDS
EN 60601-1 (1995), EN 60601-1 (2006), EN 601-1-1 (2001), EN 60601-1-2 (2007), EN 60601-1-8 (2007),
EN 60601-2-26 (2003), IEC 60601-2-26 (2012), EN 60601-2-27 (2006), IEC 60601-2-27 (2011),
EN 60601-2-30 (2000), IEC 80601-2-30 (2009), EN 60601-2-34 (2000), IEC 60601-2-34 (2011),
EN 60601-2-49 (2001), IEC 60601-2-49 (2011), EN 1041 (2008), EN 980 (2008), EN 1060-1 (2009),
EN 1060-3 (2009), EN 12470-4 (2009), AAMI ISO 81060-2 (2009), ISO 9919 (2005), ISO 80601-2-61
(2011), ISO 21647 (2004), ISO 80601-2-55 (2011), ISO 10993-1 (2003), ISTA 1A (2001)

CLASSIFICATION
Class I, Type CF for all modules (except Multi-gas, NIBP and CSM/BFA
Protection against electroshock
modules that are BF) (based on IEC 60601-1).
Mode of operation Continues operation equipment
Harmful liquid proof degree IPX1
Method of sterilization and
Refer to user’s manual.
disinfection
Not suitable for use in the presence of a flammable anaesthetic mixture
Safety of anesthetic mixture
with air or with oxygen or nitrous oxide.

DISPLAY
NEPTUNE LED COLOR 800  600, 12”
Waveforms ECG, SPO2, IBP1, IBP2, RESP/GAS, EEG (Freezable), C.O.
Numeric Parameters HR, PVCs, ST, SPO2, PR, NIBP (SYS, DIA, MAP), IBP1(SYS, DIA,
MAP), IBP2 (SYS, DIA, MAP), RR, T1, T2, DT, EtCo2, FiCo2, AWRR,
EtN2O, FiN2O, EtO2, FiO2, EtAA, FiAA, CSI/BFI, BS%, EMG%, SQI%,
C.O, Alarm Limits.
Operation Method Membrane/Keys and rotary knob, Touch Screen

ECG (for 12 wire optional)

Selectable 3 , 5 or 10 wires
For 3 wire: I, II, III
Leads
For 7 wire : I, II, III, V, aVR, aVF, aVL
For 12 wire : I, II, III, V, aVR, aVF, aVL , C2, C3, C4, C5, C6

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Dynamic Range  5 mV
Lead Off Current < 90 nA
Gain 4, 2, 1, 1/2, 1/4, Auto
Calibration 1mV, 0.5 sec
“MONITOR” ( 0.5 - 24 Hz )
Filters “NORMAL” ( 0.5 - 40 Hz )
“EXTENDED” ( 0.05-100 Hz)
CMRR > 98 dB
Internal Noise < 30 µV RTI
Input Impedance > 5 MΩ
Duration : 40 to 120 msec
QRS Detection Amplitude : 0.25 to 5 mV for Adult/Pediatric
0.2 to 5 mV for Neonate
15 - 300 BPM for adult/pediatric
Heart Rate Range
15 - 350 BPM for neonate
Accuracy 1% or 2 BPM
Tall T-Wave Reject up to 1.2 mV Amp.
Duration : 0.1 - 2 msec
Amp: ±2 to ± 700 mV (without over/undershoot)
Reject from heart rate counter
Re-insert into ECG to display on screen
Pacer Detection/Rejection Ineffective pace rejection: HR:0, Pace: 60
HR:60, Pace:60
HR:30, Pace:80
Beside rejection of atrial paces preceed ventricular paces by 150 or 250
ms
Protection Defibrillator and Electrosurgery
Standards ANSI/AAMI EC-13, EN 60601-2-27

ANALOG OUTPUT
Signals ECG
Maximum delay ≤30 ms
Output range ±5V
Signal gain 1000 (1V/mV)
Gain accuracy ± 20 mV
Maximum offset ± 50 mV
“MONITOR” ( 0.5 - 24 Hz )
ECG bandwidth “NORMAL” ( 0.5 - 40 Hz )
“EXTENDED” ( 0.05-100 Hz)
Amplitude: 5 V (nominal)
Pacemaker pulses
Duration: 5 ms

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ECG range -5 to 5 mV
Output impedance 249 Ω ± 5%
Data rate 400 samples/sec
Standards ANSI/AAMI EC-13

ARRHYTHMIA ANALYSIS
ASYS, VFIB, VTAC, RUN, AIVR, COUPLET, BIGEMINY, TRIGEMINY,
Type
TACHY, BRADY, AFIB, PAUS, FREQUENT PVCs
Rapid Learning: only 20 seconds required for recognition of dominant
Learning
rhythm.
Method Real time arrhythmia detection with innovative feature.
Capability of storing the latest 150 ARR event. (waveform and
Memory
Parameters)

ST ANALYSIS
Display resolution 0.01 mV
Measurement Range -2mv to +2mv
Alarm Range -2mv to +2mv
Features User Adjustable Isoelectric and ST point trending of ST values
Update period 5 Sec.

NIBP
Measurement method Oscillometric

Measurement mode Manual/Automatic/Stat

Measurement time 20-25 sec (excluding cuff pressurization time)

Adult: SYS 30 ~ 255 mmHg
DIA 15 ~ 220 mmHg
MAP 20 ~ 235 mmHg

Neonate: SYS 30 ~ 135 mmHg

Measurement Range DIA 15 ~ 110 mmHg
MAP 20 ~ 125 mmHg

Pediatric: SYS 30 ~ 240 mmHg

DIA 15 ~ 220 mmHg
MAP 20 ~ 230 mmHg
Pressure Transducer accuracy 3 mmHg full range
Initial Inflation Target Adult 150 mmHg, Pediatric 140mmHg, Neonate 85 mmHg
Overall System Efficacy Meet ANSI/AAMI SP-10/2002
Memory 500 Records

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SPO2 Masimo ( Rainbow set Optional )

Method 2 Wave length pulse wave type

SpO2 0 – 100 %
SpMet 0 – 99.9 %
SpCO 0 – 99 %
SpHb 0 – 25.0 g/dL
Range
SpOC 0 – 35.0 ml/dL
PR 25 – 240 bpm
PI 0 – 20.0 %
PVI 0 – 100 %
Oxygen Saturation

During no motion conditions:

- Adult/Pediatric: 2% (SPO2 70 ~ 100%)
- Neonate: 3% (SPO2 70 ~ 100%)

During motion conditions:

- Adult/Pediatric/Neonate: 3% (SPO2 70 ~ 100%)

During low perfusion conditions:

- Adult/Pediatric/Neonate: 2% (SPO2 70 ~ 100%)

Pulse Rate

During no motion conditions:

Accuracy - Adult/Pediatric/Neonate: 3bpm (PR 25 ~ 240)

During motion conditions:

- Adult/Pediatric/Neonate: 5bpm (PR 25 ~ 240)

During low perfusion conditions:

- Adult/Pediatric/Neonate: 5bpm (PR 25 ~ 240)

Carboxyhemoglobin Saturation
- Adult/Pediatric: 3% (1 - 40)

Methemoglobin Saturation
- Adult/Pediatric/Neonate: 1% (1 – 15)

Total Hemoglobin
- Adult/Pediatric: 1g/dL (8 – 17) g/dL

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 SpO2 1%
SpCO 1.0 %
SpMet 0.1 %
SpHb 0.1 g/dL
Resolution
PI 0.1%
PVI 1%
SpOC 0.1 ml/dL

PR 1 BPM

Please note that pulse-oximetry method (SPO2) is compared to laboratory spectroscopy of sample blood
(SaO2). This method measures precision of SPO2 measurement using statistical analysis. Therefore,
measurement precision is reliable for at least two third of measurements.

TEMPERATURE
Probe Type YSI 400 Compatible
Range 0 - 50 C
Accuracy  0.2 C

RESPIRATION
Method Impedance
Base Resistance 250 -1250 Ohm
Dynamic Range 0.2 - 2 Ohm
Breath Rate Range 0 - 253 BrPM
Accuracy ±2% or 2 BrPM

IBP ( Optional )
Channel 2 (Up to 4)
SYS -50 ~ 300 mmHg
Measurement Range DIA -50 ~ 300 mmHg
MAP -50 ~ 300 mmHg
Pressure Filter 8Hz, 16Hz, 22Hz selectable
Press Sensor Sensitivity 5 μV / V / mmHg
Press Sensor Impedance 300 ~ 2500 Ohm
Resolution 1 mmHg
Accuracy 2 % or 2mmHg (each one is greater) without transducer

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Multi-gas / Mainstream ( Optional )
Power supply 4.5-5.5 VDC, max 1.4W
Method Infrared absorption
Measuring mode Mainstream
IRMA Harmful Liquid Proof Degree IPX1
Et and Fi Parameters
Fi and ET are displayed after one breath and have a continually updated breath average.
IRMA CO2 CO2, CO2 waveform
CO2, N2O, Anaesthesia Agent (HAL, ISO, ENF, SEV, DES),
IRMA AX+
5 selectable waveform, Automatic identification, MAC

3-10 channel NDIR type gas analyzer measuring at

Sensor head
4-10µm. pressure, temperature and full spectral interference correction.
Sensor Dimension (W×D×H) IRMA CO2/AX+: 38×37×34mm
Sensor weight <25g (cable excluded)
Calibration No routine calibration required
Concentrations reported in less than 10s, full accuracy with in 10s for IRMA
Warm-up time
CO2, 20s for IRMA AX+
IRMA CO2: 0 to 40C
Operating temperature
IRMA AX+: 10 to 40C
IRMA CO2: -40 to 75C
Storage and transportation temperature
IRMA AX+: -20 to 75C
Operating humidity 10 to 95% RH, non-condensing
Storage and transportation humidity 5 to 100% RH, condensing
Operating atmospheric pressure IRMA CO2/AX+: 525 to 1200hPa
Storage and transportation pressure 500 to 1200hPa
Surface temperature Max 50ºC / 122ºF

CO2 ≤ 90ms
Rise time (@10 l/min) N2O ≤ 300ms
HAL, ISO, SEV, ENF, DES≤ 300ms

Delay time ≤ 140ms

Primary agent threshold 0.15% V
Secondary agent threshold 0.2% +10% of total agent concentration
Agent identification time < 20 seconds
Total system response time < 1 second

Respiration rate 0~150BrPM

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Accuracy specifications-during standard conditions

Measuring range
Gas Accuracy
CO2 AX+

0-15% 0-10% ±(0.2%ABS+2%REL)

CO2 10-15% ±(0.3%ABS+2%REL)

15-25% 15-25% Unspecified

N2O - 0-100% ±(0.2%ABS+2%REL)

- 0-8% ±(0.15%ABS+5%REL)
HAL, ISO, ENF
8-25% Unspecified
- 0-10% ±(0.15%ABS+5%REL)
SEV
10-25% Unspecified
- 0-22% ±(0.15%ABS+5%REL)
DES
22-25% Unspecified

Accuracy specification-during all condition

CO2 ±(0.3%ABS or ±4%REL)

N2O ±(2%ABS or ±5%REL)

Single agent ±(0.2%ABS or ±10%REL)

Dual agent ±(0.2%ABS or ±10% of total agent concentration)

Note 1 : The accuracy specification is valid for all specified environment conditions, and includes effects from the following
interfering gases : N2O, HAL, ISO, ENF, SEV, DES, Ethanol, Isopropyl alcohol, Acetone, Methane, He.
See Appendix IV for effects from water vapour partial pressure on gas reading.

Note 2: The accuracy specification is not valid if more than two gas for IRMA AX+ are in the gas mixture.

Interfering gas and vapour effects

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 Gas or vapour Gas level CO2 Agents N2O
IRMA CO2 IRMA AX+
4) 1 & 2)
N2O 60 vol% - - 1 & 2) - 1) - 1)
HAL 4) 4 vol% - 1) - 1) - 1) - 1)
ENF, ISO, SEV 4) 5 vol% +8% of reading 3) - 1) - 1) - 1)
DES 4) 15 vol% +12% of reading 3) - 1) - 1) - 1)
Xe (Xenon) 4) 80 vol% -10% of reading 3) - 1) - 1)
He (Helium) 4) 50 vol% -6% of reading 3) - 1) - 1)
Metered does inhaler Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 vol% - 1) - 1) - 1) - 1)
C3H7OH (Isopropanol) 4) 0.5 vol% - 1) - 1) - 1) - 1)
CH3COCH3 (Acetone) 4) 1 vol% - 1) - 1) - 1) - 1)
CH4 (Methane) 4) 3 vol% - 1) - 1) - 1) - 1)
CO (Carbon monoxide) 5) 1 vol% - 1) - 1) - 1) - 1)
NO (Nitrogen monoxide) 5) 0.02 vol% - 1) - 1) - 1) - 1)

Note 1 : Negligible interference, effect included in the specification “ Accuracy all conditions” above.

Note 2 : For probes not measuring N2O the concentrations shall be set from host according to the instructions. (IRMA CO2
dose not measure N2O. IRMA AX+ dose not measure O2.)
Note 3 : Interference at indicated gas level. for example, 50 vol% Helium typically decreases the CO2 readings by 6%. This
means that if measuring on a mixture contaning 5.0 vol% CO2 and 50 vol% Helium, the measured CO2 concentration will
typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.

Note 4 : According to the EN ISO 21647:2004 standard.

Note 5 : In addition to the EN ISO 21647:2004 standard.

Sample Rate 20 Hz / channel

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Multi-Gas / Sidestream ( Optional )
4.5-5.5 VDC
ISA CO2: <1.4 W (normal op.), <1.8 W (peak @ 5 VDC)
Power supply
ISA AX+: <1.6 W (normal op.), <2.0 W (peak @ 5 VDC)
ISA OR+: <2.0 W (normal op.), <2.4 W (peak @ 5 VDC)
Method Infrared absorption
Measuring mode Sidestream
Et and Fi Parameters
Fi and ET are displayed after one breath and have a continually updated breath average.
ISA CO2 CO2, CO2 waveform
CO2, O2, N2O, Anaesthesia Agent (HAL, ISO, ENF, SEV, DES), 5
ISA OR+ selectable waveform, Automatic agent identification, MAC
ISA AX+ CO2, N2O, Anaesthesia Agent (HAL, ISO, ENF, SEV, DES), 5 selectable
waveform, Automatic agent identification, MAC
Automatic agent identification ISA OR+/AX+: primary and secondary agent.
Sensor head 2-9 channel NDIR type gas analyzer measuring at 4-10µm.
ISA CO2/AX+: 33x78×49mm
Sensor Dimension (W×D×H)
ISA OR+: 49×90×100mm
ISA CO2/AX+: 130g (including cable)
Sensor weight
ISA OR+: 400g (including cable)
No span calibration is required for the IR bench. An automatic zero reference
Calibration
calibration is performed at startup and then every 24 hours.
Compensation
Automatic compensation for pressure and temperature.
ISA CO2
Manual compensation for broadening effects on CO2.
Automatic compensation for pressure, temperature and broadening effects on
ISA OR+/AX+
CO2.

Warm-up time

ISA CO2 <10 seconds (concentrations reported and full accuracy)

<20 seconds (concentrations reported, automatic agent identification enabled and
ISA OR+/AX+
full accuracy)
ISA CO2: 0 to 50C
Operating temperature
ISA OR+ /AX+: 5 to 50C
Storage temperature -40 to 70C
<4 kPa H2O
Operating humidity
(non-condensing) (95 % RH at 40C)
5 to 100 %RH
Storage humidity
(condensing) (100 % RH at 40C)
Operating atmospheric pressure 52.5 to 120 kPa (corresponding to a max altitude of 4572 m/15000 feet)
Storage atmospheric 20 to 120 kPa
Typical rise time at 50 l/min sample flow

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 CO2  200 ms ( 250 ms for ISA OR+ / AX+)
N2O  350ms
Agents  350ms
O2  450ms

0.15 V%. When an agent is identified, concentrations will be reported even

Primary agent threshold (ISA OR+/AX+)
below 0.15 V%
Secondary agent threshold (ISA OR+/AX+) 0.2 V% +10% of total agent concentration
Agent identification time (ISA OR+/AX+) <20 seconds (Typically <10 seconds)
Total system response time < 3 second (with 2m sampling line)
Sampling flow rate 50 ± 10 ml/min
Respiration rate 0 ~ 150BrPM
Accuracy specifications-during standard conditions

Gas Measuring Range Accuracy

0~15% ±(0.2 V% +2% of reading)
CO2
15~25% Unspecified
N2O 0-100% ±(2 V% +2% of reading)
0-8% ±(0.15 V%+5% of reading)
HAL, ISO, ENF
8-25% Unspecified
0-10% ±(0.15 V% +5% of reading)
SEV
10-25% Unspecified
0-22% ±(0.15 V% +5% of reading)
DES
22-25% Unspecified
O2 0-100% ±(1 V% +2% of reading)

Accuracy specification-during all condition

CO2 ±(0.3 kPa + 4% of reading)

N2O ±(2 kPa + 5% of reading)
Agents ±(0.2 kPa + 10% of reading)
O2 ±(2 kPa + 2% of reading)

Note 1: The accuracy specification is valid for all specified environment conditions.

Note 2: The accuracy specification is not valid if more than tow agents are present in the gas mixture. If more than tow
agents are present, an alarm will be set.

Interfering gas and vapour effects

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 Gas or vapour Gas level CO2 Agents N2O
IRMA CO2 IRMA AX+/OR+
N2O 4) 60 vol% - 2) - 1) - 1) - 1)
HAL 4) 4 vol% - 1) - 1) - 1) - 1)
ENF, ISO, SEV 4) 5 vol% +8% of reading 3) - 1) - 1) - 1)
DES 4) 15 vol% +12% of reading 3) - 1) - 1) - 1)
Xe (Xenon) 4) 80 vol% -10% of reading 3) - 1) - 1)
He (Helium) 4) 50 vol% -6% of reading 3) - 1) - 1)
Metered does inhaler Not for use with metered dose inhaler propellants
propellants 4)
C2H5OH (Ethanol) 4) 0.3 vol% - 1) - 1) - 1) - 1)
C3H7OH (Isopropanol) 4) 0.5 vol% - 1) - 1) - 1) - 1)
CH3COCH3 (Acetone) 4) 1 vol% - 1) - 1) - 1) - 1)
CH4 (Methane) 4) 3 vol% - 1) - 1) - 1) - 1)
CO (Carbon monoxide) 5) 1 vol% - 1) - 1) - 1) - 1)
NO (Nitrogen monoxide) 5) 0.02 vol% - 1) - 1) - 1) - 1)
O2 5) 100 vol% - 2) - 2) - 1) - 1)

Note 1 : Negligible interference, effect included in the specification “ Accuracy all conditions” above.

Note 2 : Negligible interference with N2O/O2 concentrations correctly set, effect included in the specification “ Accuracy all
conditions” above.
Note 3 : Interference at indicated gas level. for example, 50 vol% Helium typically decreases the CO2 readings by 6%. This
means that if measuring on a mixture contaning 5.0 vol% CO2 and 50 vol% Helium, the measured CO2 concentration will
typically be (1-0.06) * 5.0 vol% = 4.7 vol% CO2.

Note 4 : According to the EN ISO 21647:2004 standard.

Note 5 : In addition to the EN ISO 21647:2004 standard.

Sample Rate 20 Hz / channel

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CSM ( Optional )
EEG sensitivity ±400µV
Noise <2µVp-p <0.4µV RMS, 1-250 Hz
CMRR >140dB
Input impedance >50MΩ
Sample rate 2000 samples/sec (14 bits equivalent)
CSI and update 0-100. Filter 6-42Hz, 1sec. update
EMG 0-100 logarithmic. Filter 75-85 Hz, 1 sec. update
BS% 0-100%. Filter 2-42 Hz, 1 sec. update
Digital output Wireless to CSM card in monitor (ISM 2.4GHz)
Wireless range Up to 10 meters
Display size 1.3" x 0.7"
Alarms High/low with user selectable limit
Artifact rejection Automatic
Sensor impedance range 0-10kOhm / measurement current 0.01µA
Battery Rechargeable NiMH or 9V Alkaline (6AM6/IEC: 6LR61/ANSI: 1604A)
Supply current 30Ma (typical)
30h (stand alone)
Max. battery lifetime-Alkaline
18h (transmitting wireless)
Battery recharge time 4 Hours (CSMX04 Only)
Weight 4.6 ounces (130 g) with battery
Dimensions 4.6×2.7×1.2”
Internal power supply Class II, type BF, continuous use Sensors
Classification
Danmeter Neuro Sensors
Cable length 77” with 14” split
Mounting options Velcro strip l.7x0.9"
Memory Data recording 18 hours
Temperature 50-104°F
CSM module Environment -
Rel. humidity 30~75%
Operation
Air pressure 700-1060 hPa
Temperature 50-104°F *
Rel. humidity 30-95%
CSM module Environment-
Air pressure 700-1060hPa
Transport and storage

*If transport without sensors:-4 -158°F

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BFA ( Optional )
EEG sensitivity ±450µV
Noise <2µVp-p <0.4µV RMS, 0.25-250 Hz
CMRR >140dB
Input impedance >50MΩ
Sample rate 1000 samples/sec (16 bits equivalent)
Brain Function Index (BFI) 0-100 Filter 1-47Hz, 1sec. update

EMG 0-100 Filter 30-47 Hz, 1 sec. update

BSR 0-100 Filter 2-47 Hz, 1 sec. update

Signal Quality Index (SQI) 0-100 1 sec. update

EEG Waveform ±250µV, user-adjustable, 5 sec
Alarms Auditory and visual, user-adjustable limits
Artifact rejection Automatic

Sensor impedance measurement 0-30 kOhm / Manual-Automatic / Measurement current 0.06µA

Power supply 5 VDC

Power Consumption Less than 0.5 W
Weight / Dimensions 100 gr / 111×64×25 mm
Classification Class I, type BF, continuous use
Sensors Ambu Neuro Sensors
Cable length 195 cm / 77” with 35 cm / 14” split
Memory Data recording (96 hours)
Trend BFI/EMG/SQI/BS, 10 sec. update
Temperature 5-40°C
Environment - Operation Rel humidity 20~96%
Altitude -200~3000m

CARDIAC OUTPUT ( Optional )

Method Right Heart Thermodilution

Range 0.5 - 18 l/min
Resolution 0.01 l/min
Reproducibility ±3%

RECORDER ( Optional )

Model Thermal Printer

Printing Speed 6, 12.5, 25, 50 mm/sec
Paper 58mm by 100 foot roll

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ALARM
Sources Error messages, All other parameter limits
Alarm On/Off Selectable for all parameters

Alert Blinking on Display, Volume Selectable Audio Alarms, Light indicator

TREND
HR, PVCs, ST, AFIB, SPO2, RR, T1, T2, IBP1 (SYS, DIA, MAP),
IBP2 (SYS, DIA, MAP), IBP3 (SYS, DIA, MAP), IBP4 (SYS, DIA,
Sources
MAP), EtCo2, FiCo2, AWRR (sidestream, mainstream), EtN20,
FiN2O, EtO2, FiO2, EtAA, FiAA (ISO, DES, ENF, HAL, SEV)
Trend Time Save 96 Hours
Trend Time Interval 15, 30, 45 Min, 1, 2 and 4 Hours
Resolution 1 sec

INPUT/OUTPUT
Network Reliable TCP/IP Protocol Ethernet LAN with RJ45 Interface and WIFI5
Connection VGA connector, External alarm, Wired remote control

GENERAL
Safety Based on IEC 60601-1, Class I
Protection Against Electro surgery and Defibrillator (Except BFA/CSM)
AC Power 100 - 240 VAC, 50/60 Hz , Ip: 0.9 - 0.4 A

Sealed Lead Acid, Lithium Polymer

Rechargeable, 12 V, 1.2 AH 11.1V, 4.3AH
Internal Battery
Charge Time Maximum 2 Hours Maximum 8 Hours
Usage More than 1 Hour 1 More than 6 Hours

DC Power Plug 12-14 VDC, Max. 3A (without Recorder) - Max.6 A (with Recorder)
Dimension: 347 (W) 309 (H) 142 (D)
Physical Specification
Weight with Lithium polymer battery : 5.0 Kg

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ENVIRONMENTAL
Operating: 5 to 40 C
Temperature
Storage & Transport: -20 to 60 C
Operating: 20-90 % (Noncondensing)
Humidity
Storage & Transport: 10-95 % (Noncondensing)
Altitude -200 to 3000 m

ACCESSORIES
 Operator’s manuals
 Power cable 220 Vac (SHUKO-VDE)
 Battery fuses (2)
 ECG : ECG Patient Cable
 TEMP : TEMP Probe, Skin, Adult mod. FMT400AS
 NIBP : Spiral-extension hose with adult cuff - 25×33cm
 SpO2 extension cable (mt 3,0)
 Masimo finger sensor > 30kg (mt 0,80)

SIARE applies the UNI EN ISO 13485:2004 Quality System and the 93/42 EEC.

SIARE ENGINEERING INTERNATIONAL GROUP s.r.l.

Via Pastore , 18 - Località Crespellano, 40053 Valsamoggia (BO), ITALY
Tel : +39 051 969802 - Fax : +39 051 969366 / Email : [email protected] - http://www.siare.it

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