Chapter 11

Product Specification
 Parameters Abbreviatio Units Range Resolution
n
Respiratory rate RR b/min 1 to 100 1
Oxygen FiO2 % 21 to 100 1
Positive End PEEP cmH2O 0 to 50 1
Expiratory/Pressure
Tidal Volume VT mL 15 to 2000 5 for < 50
10 for >50 < 1000
50 for >1000
Inspiratory Time Tinsp sec 0.1 to 10 0.05 for < 1.0
0.1 for >1.0
Inspiratory Pause Time Tpause % 0 to 70 5
Trigger Sensitivity PTrig cmH2O OFF, 0.5 to 10 0.1 for < 2.0
0.5 for > 2.0
Trigger Sensitivity FTrig L/min OFF, 0.5 to 15 0.1 for < 2.0
0.5 for > 2.0
Inspiratory Pressure PInsp cmH2O 1 to 80 1
Pressure Support Psupport cmH2O 1 to 80 1
Apnea Time Tapnea sec 5 to 60 1
Flow Pattern Fpattern -NA- Square, Acceleration -NA-
& Deceleration
Pressure Slope Pslope -NA- Slow, Medium & Fast -NA-
Expiratory Trigger Exp Trig % flow 5 to 80 5
Maximum Inspiratory Time Tinsp max sec 0.1 to 10 0.05 for < 1.0
0.1 for >1
Safety Features
Apnea backup ventilation.
Single gas ventilation when one of the gases fails.
Software controlled pressure limit function.
Sub ambient valve for emergency air intake.
Mechanical pressure relief valve for additional
safety. Built-in battery backup for around 3 hours.

Technical Specifications
Alarms / Alerts / Indications
Audible and Visual
Respiratory Rate - Low & High
Tidal Volume - Low & High
Minute Volume - Low & High
PEEP - Low & High
FiO2 - Low & High
Peak Inspiratory Pressure - Low & High
Power Failure - Alarm
Mains / Battery Operation - Indication / Change over
Alarm Battery charge Status - Indication
Low Battery - Indication / Alarm with status
Apnea Backup - Alarm
Inverse I:E Ratio - Alert
Supply Gas Failure - Alarm
Circuit Leak - Alarm

Technical Features
Dimensions (L x H x B)
Weight
Gas Supply
bar) Battery Backup Time
Charging Time
operation) Power Supply
- 65 x 140 x 53 cm
- 42 kg. Approx (Stand Option)
60 kg. Approx (Compressor Option)
- 40 to 87 psi (2.75 to 6
- >3 Hours
- 10 hours (charges automatically during mains
- 100-240V AC 50/60 Hz
59
Power Consumption - 80 watts (Typical)

60
Modes of Ventilation
Volume control - A/CMV-VC, SIMV-VC, CPAP-VC
Pressure control - A/CMV-PC, SIMV-PC, CPAP-PC
Non-Invasive - NIV-PC

Monitored Parameters
Peak Airway Pressure, Mean Airway Pressure, Plateau Pressure, PEEP, Inspired Tidal Volume, Expired
Tidal Volume, Spontaneous Minute Volume , Expired Minute Volume, Spontaneous Respiratory Rate, Total
Respiratory Rate, Compliance, FiO2, I:E Ratio, Compliance, Resistance, Time Constant, Peak Expiratory
Flow

Additional Features
Pressure Sensing - Proximal (Optional)
Peak Flow Rate - 180 L/min
100% O2 for 3 mins - For Pre & Post suction maneuver
Ventilation Standby - To conserve gas during suction /
Standby
Built-in Nebuliser - For Drug Administration, Volume Inspiration compensated and FiO2
Corrected Inspiration Hold - To Monitor & Calculate Lung mechanics
Expiration Hold - To Monitor total PEEP
Real Time Waveforms - To show flow, pressure and volume waveform against
time Loops - Pressure vs Volume & Flow vs Volume
Freeze Waveforms - To facilitate closer study
Key Lock - To lock the front panel for patient’s
protection Alarm Silence / Reset- To mute audible alarm for 2 mins
Waveform Scale - Fixed, automatic scaling

Patient History
Details available - All parameters / modes set and changed, all alarms set and
violated Record - 2000 events
Trends for 24 hrs - Mean airway pressure
(Selectable one at a time) Expired Minute
Volume
Total Respiratory Rate
FiO2
Spontaneously breathed minute volume
Compliance

Operating Conditions
Temperature - 10 to 40 0C (operating),
-35 to 70 0C (storage)
Humidity - 10 to 95% non-condensing
(operating) 10 to 95% non-
condensing (storage)
Altitude - Up to 3000m (9843 ft) above sea level

Standards of Certification
Developed in accordance with IEC 60601-1, IEC 60601-1-2:2014 (4th Edition), IEC 60601-1-6, IEC 60601-
1-8, ISO 80601-2-12, IEC 62304:2006, EN ISO 14971:2012

Electro Magnetic Compatibility Information and Manufacturer’s Declaration

Electromagnetic Compatibility:
The ventilator is suitable for use in the electromagnetic environment specified in the table below. You
must ensure that it is used in such an environment.
Emission Test Compliance level Electromagnetic Environment -
Guidance
Radiated Emission CISPR 11 Class A, Group1 plus
The SKANRespiro / SKANRespiro does not
use any RF energy for its internal function.
Therefore, its RF emissions are very low & are
not likely to cause any interference in nearby
electronic equipment.
Conducted Emission CISPR 11 Class A, Group1
Harmonic Distortion IEC 61000-3-2 Class A The ICU ventilator is suitable for use in
Voltage fluctuations / flicker emissions Clause 5 hospitals.
IEC 61000-3-3
Electromagnetic Compatibility (EMC) Specifications
Take special precautions regarding electromagnetic compatibility (EMC) when using medical electrical equipment.
You must operate your ICU ventilator according to the EMC information provided in this book.
Portable and mobile radio frequency (RF) communications equipment can affect medical electrical equipment.

WARNING
Using accessories other than those specified may result in increased electro magnetic emission or decreased
electromagnetic immunity of the equipment.

Compliant with EMC Standards

SKANRespiro / SKANRespiroplus and its accessories listed in the section comply with the requirements of
IEC 60601-1-2:2014.

WARNING
The ventilator should not be used next to or stacked with other equipment. If you must stack the ventilator, you
must check that normal operation is possible in the necessary configuration before you start ventilating patients.

Electromagnetic Immunity
The ventilator is suitable for use in the specified electromagnetic environment. The user must ensure
that it is used in the appropriate environment as described below.

Immunity Test IEC 60601- Complian Electromagnetic

1-2 ce Environment
Test Level Level Guidance
Electrostatic ±8 kV contact ±8 kV contact Floors should be wood, concrete, or ceramic tile. If
discharge (ESD) IEC ±15 kV air ±15 kV air floors are covered with synthetic material, the relative
60601-1-2: humidity should be at least 30%
2014(Table 7)
ISO 80601-2-12
202.6.2.1.10
EN 61000-4-3:2006
+A2:2010
Electrical fast ± 2 kV 100 kHz ±2kV for Mains power quality should be that of a typical
transient / burst IEC repetition frequency power supply commercial and/or hospital environment
60601-1-2: lines
Ed:4 2014-02
IEC 61000-4-4
Surge IEC 60601-1- ±2kV AC Power ±2kV AC Power Mains power quality should be that of a typical
2: ±0.5kV, ±0.5 kV, ±1kV commercial and/or hospital environment
Ed:4 2014-02 ±1 kV differential differential mode
IEC 61000-4-5 mode ±0.5kV,±1kV,±2kV
±0.5 kV, ±1kV, ±2kV common mode
common mode
Radiated 3 V/m 80MHz - 2.7 3 V/m Mains power quality should be that of a typical
Susceptibility IEC Ghz (Unmolulated commercial and/or hospital environment
60601-1-2: 2014 RMS) Recommended separation distances:
(Table 4, Table 9) 27V/m d= 1.2
ISO 80601-2-12 28V/m d= 1.2 √P 80 MHz to 800 MHz:
202.6.2.1.10 9V/m d= 2.3 √P 800 MHz to 2.5 GHz:
EN:6100-4-3:2016 where P is the maximum output power rating of the
+A2:2010 28V/m transmitter in watts(W) according to the transmitter
manufacturer & d is the recommended separation
2
28V/m distance in metres (m). Field strengths from fixed RF
transmitters, as determined by an electromagnetic
28V/m site survey, should be less than the compliance level
9V/m in each frequency range.
ab

Interference may occur in the vicinity of equipment

marked with the following symbol:
Minimum separation distances for higher IMMUNITY
LEVELS shall be calculated using the following
equation: E = 6/d √P
Where P is the maximum power in W, d is the
minimum separation distance in m, and E is the
IMMUNITY TEST LEVEL in V/m.
Minimum separation distances is 0.3m for proximity
fields.
Conducted RF 3 V h), 0.15 MHz 3 V h), 0.15MHz Mains power quality should be that of a typical
Immunity IEC 60601- to 80 MHz to 80 MHz commercial and/or hospital environment.
1-2: 6 V h) in ISM band 6Vh) in ISM Portable and mobile RF communications equipment
Ed:4 2014-02 between 0.15 MHz band between should be used no closer to any part of the ventilator,
IEC 61000-4-6 and 80 MHz j) 0.15MHz and including cables, than the recommended separation
80 % AM at 1 kHz 80 MHz j) 80% distance calculated from the equation applicable to the
3V/m and 6V ISM AM at 1kHz frequency of the transmitter.
band -All PATIENT 3V/m and 6V
COUPLED ISM
cables shall be tested band - All
through EM clamp PATIENT
COUPLED
cables shall be
tested through
EM clamp
 Immunity Test IEC 60601- Compliance Electromagnetic Environment
1-2 Level Guidance
Test Level
Voltage dips, Short Dips: Dips: Mains power quality should be that of aoftypical
the mo
interruptions & 0 % UT; 0.5 cycle g) 0 % UT; 0.5 cycle commercial and / or hospital environment. If the user
equipment
voltage variations on At 0°, 45°, 90°, 135°, g) nitor requires continuedatoperation
the mon during
power input lines 180°, 225°, 270° and At 0°, 45°, 90°, power mains equipment i s
IEC 60601-1-2: 2014 315°q) 135°, interruptions, it is recommended th i tor is
(Table 5) 0 % UT; 1 cycle & 70 180°, 225°, 270° equipped with an internal battery or is powered from
ISO 806010-2-12 % UT; 25/30 cycles and 315°q) an uninterruptible power supply.
202.6.2.10 h) Single phase: at 0% UT; 1cycle &
IEC 61000-4-11 0° Short Interruption 70% UT; 25/30
0% UT; 250/300 cycles h)
cycle h) Single
phase:at0°
Short
Interruption
0%
UT;250/300
cycle h)
Power frequency 30 A/m 30 A/m Power frequency magnetic fields should be at levels
(50/60Hz) characteristic of a typical location in a typical
magnetic Field commercial and / or hospital environment.
IEC 60601-1-2: 2014
(Table 4)
ISO 80601-2-12
202.6.2.10.10
EN 61000-4-5: 2010
UT is the a.c. mains voltage prior to application of the test level. At 80 MHz and 800MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflections from
structures, objects and people.

Recommended Separation Distance

WARNING
In the following table, P is the maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer and d is the recommended separation distance in meter (m). Portable and mobile RF
communications equipment should be used no closer to any part of the ventilator, including cables, than the
recommended separation distance calculated from the equation appropriate for the frequency of the transmitter.
“Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less
than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked
with this symbol:
IEC 60601- Complian Electromagnetic Environment
Immunity Test 1-2 ce Guidance
Test Level Level
Conducted RF 3 V RMS 3 V RMS Recommended separation distance: d = 1.2 √P
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF IEC 3 V/m 3 V/m Recommended separation distance: 80 MHz to 800 MHzd =
61000-4-3 80 MHz to 2.7 GHz 1.2 √P 800 MHz to 2, 5 GHz d = 2.3 √P
2.0 to 2, 3 GHz for short range radio d = 7.0 √P
Field strengths from fixed transmitters, such as base stations for radio (cellular, cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site
survey should be considered. If the measured field strength in the location in which the ventilator is used
exceeds the applicable RF compliance level above, the ventilator should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the ventilator. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.

Recommended separation distances from portable and mobile RF communication equipment

The ICU ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or user of the ventilator can help prevent electromagnetic interference by maintaining a
minimum distance between portable and mobile RF communications equipment and the ventilator as
recommended below, according to the maximum output power of the communications equipment. “In the
following table, P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and dis the recommended separation distance in meter (m).
Frequency of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5
GHz
Equation d = 1.2 √P d = 1.2 √P d = 2.3 √P
Rated max. output power Separation distance Separation distance Separation
of transmitter distance
0.01 W 0.1 (0.4) m 0.1 (0.4) m 0.2 (0.7) m
 0.1 W 0.4 (1.1) m 0.4 (1.1) m 0.7 (2.2) m
1W 1.3 (3.5) m 1.3 (3.5) m 2.3 (7.0) m
10 W 3.8 (11.1) m 3.8 (11.1) m 7.3 (22.1) m
100 W 12.0 (35.0) m 12.0 (35.0) m 23.0 (70.0) m

WARNING
Do not expose the equipment to x-ray or strong magnetic fields (MRI).