DATA SHEET VENTILATION SERVO-i UNIVERSAL

HIGHLIGHTS
For all patient categories - available in two editions Intuitive user interface Designed for cost-efficiency Flexible placement Modular interchangeable plug-in units Enables Heliox delivery NAVA - improved synchrony and unique monitoring capabilities For invasive as well as non invasive ventilation The Open Lung Tool - Lung recruitment with Dynamic Compliance and etCO2. Available in MR and Transport editions for continuity of ventilatory care

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SERVO-i VENTILATOR FAMILY SERVO-i UNIVERSAL

SERVO-i Configurations The SERVO-i Ventilator family consists of four congurations: Infant Adult UBE UEE Universal Basic Edition Universal Extended Edition Standard Configuration Options Not applicable

UBE NIV NAVA

UEE

NAVA Heliox Nasal CPAP NIV PC NIV PS Bi-Vent Y Sensor Measuring CO2 Analyzer Nebulizer Alarm output connector Open Lung Tool

The SERVO-i Ventilator family addresses the very different requirements of neonatal, pediatric and adult needs from a single ventilation platform. All four congurations are the same ventilator, equipped with different functions. They can be customized and upgraded with different options for future needs. (SERVO-i Adult and SERVO-i Infant can also be upgraded to SERVO-i Universal.) The same ventilator can be used at the bedside, during transport* and in the MR-room* facilitating training, operation and maintenance, increasing efciency and exibility.

Automode SIMV (PRVC) + PS PRVC VS SIMV (VC) + PS VC SIMV (PC) + PS PC PS/CPAP All patient category software
KEY TO ABBREVIATIONS

SERVO-i Universal is an intensive care ventilator for all patient categories and is available in two editions - Basic and Extended, the latter featuring a wide range of modes and functions as standard.

NAVA NIV SIMV PRVC VS VC PS PC CPAP

*An agreement with MAQUET must be signed, see conditions in the SERVO-i MR declaration (Order no. 66 71 670) and the Interhospital Transport Declaration (Order no. 66 64 721) respectively.

Neurally Adjusted Ventilatory Assist Non-invasive ventilation Synchronized Intermittent Mandatory Ventilation Pressure Regulated Volume Control Volume Support Volume Control Pressure Support Pressure Control Continuous Positive Airway Pressure

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

The system - General The device complies with requirements of Medical Device Directive 93/42/EEC. Classication: Standards: Class I equipment. According to IEC/EN 60 601-1. IEC/EN 60 601-1 (Type B). IEC/EN 60 601-2-12. EN 794-1. IP 20 According to IEC/EN 60601-1-2 (Edition 2:2001). According to IEC/EN 60601-1-2.

Non-operating conditions Impact: Peak acceleration: 15 g. Pulse duration: 6 ms. Number of impacts: 1000. 25 to +60 C (13 to 140 F) < 95%

Storage temperature: Storage Relative Humidity:

Storage Atmospheric Pressure: 470 to 1060 hPa

IP classification Emission: Immunity- Extended test to 30 v/m:

Power supply Power supply, automatic range 100 120 V AC 10%, 50 selection: 60 Hz, or 220 240 V AC 10%, 50 60 Hz. Plug-in battery module: Battery backup: Two battery modules are delivered with the ventilator. Up to six battery modules can be included. Rechargable, 12 V, 3.5 Ah each. Approximately 3 h/battery. At least 3 h, when using six batteries. 12.0 V 15.0 V DC, 10 A At 100 120 V: 2 A, 190 VA, 140 W. At 220 240 V: 1 A, 190 VA, 140 W.

Electromagnetic compatibility (EMC):

The 'EMC Declaration, Information to the Responsible Organization' is available from MAQUET. Battery capacity: Patient range: Adult, all ventilation modes: Infant, invasive ventilation: Infant, NAVA + NIV NAVA: Infant, NIV PS+PC: Infant, Nasal CPAP: Weight: 10 - 250 kg 0.5 - 30 kg 0.5 - 30 kg 3 - 30 kg 0.5 - 10 kg External 12 V DC: Max power consumption: Recharge time: Battery backup time:

Operating conditions Operating temperature: Relative humidity: Atmospheric pressure: Lowest pressure in breathing system: +10 to +40C 15 to 95% non-condensing 660 to 1060 hPa 400 cmH2O

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

The ventilator - General Dimensions: User Interface: Patient Unit: Weight: Method of triggering: Max. operating pressure: Bias ow: Adult: Infant:

User interface (See dimensional drawings page 15) W 355 x D 53 x H 295 mm W 300 x D 205 x H 415 mm Approximately 20 kg (Patient Unit 15 kg, User Interface 5 kg) Flow and pressure Approximately 115 cmH2O 2 l/min 0.5 l/min Inspiratory channel Pressure drop: Internal compressible factor: Max. 6 cmH2O at a ow of 1 l/s Max. 0.1 ml/cmH2O Microprocessor controlled valve 0 to 3.3 l/s 0 to 0.55 l/s Weight: Attachment: Approximately 5 kg Can be attached to the mobile cart, a table, rail or pole (15 30 mm diameter).

Screen Type: Size: Viewing area: TFT-LCD module 31 cm (12.1) diagonal 246.0 x 184.5 mm

Gas supply Inlet gas pressure Air/O2: 200 650 kPa / 2.0 6.5 bar / 29 94 PSI

Gas delivery system: Inspiratory ow range: Adult: Infant:

Connection standards available: AGA, DISS, NIST, or French standard. Unavailable gas/loss of gas pressure: The ow from an unavailable gas (air or O2) is automatically compensated for so that the patient gets the preset volume and pressure.

Expiratory channel Pressure drop: Internal compressible factor: PEEP regulation: Rise time, expiratory ow measurement: Expiratory ow range: Max. 3 cmH2O at a ow of 1 l/s Max. 0.1 ml/cmH2O Microprocessor controlled valve <12 ms for 10 90 % response at ow of 0.05 3.2 l/s 0 to 3.2 l/s

Patient system gas connectors Conical ttings: Gas exhaust port: Male 22 mm / female 15 mm. In accordance with ISO 5356-1. Male 30 mm cone

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Alarms Airway pressure (upper): Adult, invasive ventilation: Adult, Non Invasive Ventilation: Infant, Invasive ventilation: Infant, Non Invasive Ventilation Expired minute volume (Upper alarm limit): Adult: Infant: Expired minute volume (Lower alarm limit): Adult: Infant: 0.5 40 l/min 0.01 20 l/min 0.5 60 l/min 0.01 30 l/min 16 - 120 cmH2O 16 - 40 cmH2O 16 - 90 cmH2O 16 - 40 cmH2O

Alarms Battery: Limited battery capacity: 10 min. No battery capacity: less than 3 min. Low battery voltage.

End-tidal CO2 (upper and lower 0.5 20%. 4 100 mm Hg. limit): 0.5 14 kPa. Leakage out of range in NIV: Technical: Autoset (alarm limits) specication: High airway pressure: Yes. Described in the Users manual. Yes. Described in the Users manual. Invasive ventilation, controlled modes only. Mean peak pressure +10 cmH2O or at least 35 cmH2O. Expiratory minute volume + 50%. Expiratory minute volume 50%.

Upper minute volume: Lower minute volume:

It is possible to permanently silence this alarm (an option with Infant version only) No patient effort (Apnea) alarm Adult: Infant 15 45 s 5 45 s

Upper respiratory frequency: Breathing frequency + 40%. Lower respiratory frequency: Breathing frequency 40%. High end expiratory pressure: Mean end expiratory pressure + 5 cmH2O. Low end expiratory pressure: Mean end expiratory pressure 3 cmH2O. Upper end tidal carbon End tidal carbon dioxide dioxide concentration (etCO2): concentration + 25%. Lower end tidal carbon End tidal carbon dioxide dioxide concentration (etCO2): concentration 25%.

Automatic return to support mode on patient triggering No consistent patient effort: Respiratory frequency: High end expiratory pressure: Low end expiratory pressure: Yes, described in User's manual 1 160 breaths/min 0 55 cmH2O 0 47 cmH2O. Note. Setting the alarm to 0 (zero) is equal to alarm off. Set PEEP level + 15 cmH2O exceeded for more than 15 seconds. Set value 5 vol% or 18 vol% Below 200 kPa / 2.0 bar / 29 PSI and above 650 kPa / 6.5 bar / 94 PSI

High continuous pressure:

O2 concentration: Gas supply:

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Ventilation Modes Invasive ventilation Controlled ventilation: PC VC PRVC Optional with Universal Basic Edition

Ventilation modes Non-invasive Ventilation (optional) NIV PC NIV PS Nasal CPAP

Ventilation modes - NAVA (Optional) Supported ventilation: PS/CPAP VS Optional with Universal Basic Edition NIV NAVA Combined ventilation: SIMV (VC) + PS: SIMV (PC) + PS: SIMV (PRVC) + PS Comes with the corresponding controlled ventilation mode Comes with the corresponding controlled ventilation mode Comes with the corresponding controlled ventilation mode (optional with Universal Basic Edition) Pressure controlled ventilation on two independently adjustable levels, allowing unrestricted spontaneous breathing on both levels. (Optional) Control mode: VC <> Support mode: VS Control mode: PC <> Support mode: PS Control mode: PRVC <> Support mode: VS Optional with Universal Basic Edition NAVA Neurally Adjusted Ventilatory Assist via endotracheal tube or tracheostomy Neurally Adjusted Ventilatory Assist via non-invasive patient interfaces

Waveform and loop presentations Real time waveforms - up to 4 waveforms can be displayed simultaneously: Pressure Flow Volume CO2 Edi Loops: Volume / Pressure* *A reference loop and three overlaying loops can be displayed. *Displayed simultaneously with Open Lung Tool graphical trends, if requested. Requires SERVO-i CO2 Analyzer option Requires SERVO-i NAVA option

Bi-Vent

Automode

Flow / Volume*

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Displayed Monitoring Breathing frequency: Spontaneous breaths per minute (RRsp): Peak Airway Pressure: Mean Airway Pressure: Pause Airway Pressure: End Expiratory Pressure: CPAP Pressure: Inspired Tidal Volume: Expired Tidal Volume: Inspired Minute Volume: Expired Minute Volume: Leakage fraction in NIV (%): Ti/Ttot: I:E ratio: Total PEEP: Edi peak: Edi min: O2 Concentration (measured): CO2 End tidal concentration (etCO2): CO2 Minute elimination (CO2): MVe sp / MVe: Spontaneous Exp. Minute Volume (MVe sp): value Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Trended value* Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No Yes Yes Yes Yes Yes Yes No Yes Service log: Log function Event log: Monitoring End Expiratory Flow: Static Compliance: Dynamic Compliance: Inspiratory Resistance Expiratory Resistance Elastance Time Constant P0.1: Work of Breathing patient: Work of Breathing ventilator Shallow Breathing Index (SBI) Supply pressure (O2 and air): Battery remaining time: Barometric pressure:

Displayed value Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes

Trended value* Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes No No No

Alarms. Ventilator settings. Apnea periods. Immediate functions. Technical alarms. Test results. Preventive maintenance. Service history. Conguration log.

Tidal CO2 elimination (VTCO2): Yes

*Stored trend values for up to 24 hours

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Parameter settings Parameter: Inspiratory tidal volume (ml): Inspiratory minute volume (l/min): Apnea, time to alarm (s): Automode Trigger timeout (s): PC/PS above PEEP (cmH2O) PC/PS above PEEP in NIV (cmH2O) PEEP (cmH2O) PEEP in NIV (cmH2O) CPAP pressure (cmH2O): CMV frequency (breaths/min): SIMV frequency (breaths/min): Breath cycle time, SIMV (s): PHigh (cmH2O) THigh (s): TPEEP (s): PS above PHigh (cmH2O):

Setting range: Infant 2 350 0.3 20 5 45 3 15 Adult 100 4000 0.5 60 15 45 7 12

Parameter settings Parameter: O2 concentration (%): I:E ratio: TInsp (s): NAVA level (cmH2O/V): Edi trigger sensitivity (V): TPause (s): Flow trigger sensitivity level (fraction of bias ow): Insp. rise time (% of breath cycle time): Insp. rise time (s):

Setting range: Infant 21 100 1:10 4:1 0.1 5 0 - 15 0.1 2.0 0 1.5 0 100% Adult 21 100 1:10 4:1 0.1 5 0 - 15 0.1 2.0 0 1.5 0 30 0 100% -20 0 0 20 0 0.4 1 70 10 70 5 30

0 (80 -PEEP) 0 (120 -PEEP) 0 (32 - PEEP) 0 (32 - PEEP) 0 50 2 20 2 20 4 150 1 60 0.5 15 0.2 10 0.2 10 0 50 2 20 4 150 1 60 1 15 0.2 10 0.2 10

TPause (% of breath cycle time): 0 30

Press. trigg sensitivity (cmH2O): -20 0 0 20 0 0.2

Insp. cycle off (% of peak ow): 1 70 Insp. cycle off in NIV (% of peak 10 70 ow): Nebulizer time (min): 5 30

(PEEP + 1) 50 (PEEP + 1) 50

0 (80 - PHigh) 0 (120 PHigh)

Backup settings Parameter: Inspiratory tidal volume (ml): PC above PEEP (cmH2O) PC above PEEP in NIV CMV frequency (breaths/min): I:E ratio: TInsp (s):

Setting range: Infant 2 350 Adult 100 4000

5 (80 -PEEP) 5 (120 -PEEP) 5 (32 -PEEP) 5 (32 -PEEP) 4 150 1:10 4:1 0.1 5 4 150 1:10 4:1 0.1 5

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Parameter: Oxygen breaths: Start breath:

Setting range 100% for 1 minute Initiation of 1 breath (In SIMV mode initiation of 1 mandatory breath) Insp. or exp (0 30 seconds) 2 minute silence and reset of latched alarms On/Off Automode On/Off

Non-invasive Ventilation (optional) Max. leakage compensation level Adult Infant, NIV: Infant, Nasal CPAP: Leakage overrange detection: Disconnect detection: Disconnect flow: Low High 65 l/min 25 l/min 15 l/min Automatic Automatic Configurable 7.5 l/min - 40 l/min (Adult) - 15 l/min (Infant) Deactivates disconnect detection Manual, or automatic via bias ow

Pause hold: Alarm silence/reset: Compliance compensation: Automode (optional with Universal Basic Edition): Backup ventilation

Servo Ultra Nebulizer (optional): Nebulizer On/Off Backup On/Off

Suction Support Pre oxygenation time: Post oxygenation time: Suction phase time: Adjustable oxygen level: Max. 2 min Max. 1 min No maximum level 21 100 %

Disabled

Connect detection:

Saving of data Recording of current waveform 20 seconds of data will be and parameter values: recorded (10 seconds before and 10 seconds after activation).

Communication/Interface Serial port: RS-232C - isolated. For data communication via the Communication Interface Emulator (CIE).

Network connection (optional): MIB (Medical Information Bus) monitor connection Data transfer (optional): Screen picture transfer (optional) Via Ventilation Record Card Via Ventilation Record Card

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Open Lung Tool (OLT) (optional with Universal Basic Edition) Three simultaneous graphical trends, presented breath-by-breath: 1. EIP and PEEP (End Inspiratory Pressure and Positive End Expiratory pressure). VTi and VTe (Inspiratory and Expiratory Tidal volume). C dyn i and VTCO2*

NAVA (optional) Standards: IEC/EN 60601-1 (Type CF, defibrillator proof) Size: Edi module: Edi catheter cable: 154 x 90 x 21 mm Length: 2 m

2.

3.

(Dynamic inspiratory Compliance [= VTi/(EIP PEEP)] and Tidal CO2 elimination*). * Requires SERVO-i CO2 Analyzer option. Values stored breath by breath: Up to 21.600 breaths. Cursor function: A cursor can be moved with the main rotary dial or via the touch screen. When moving it along the graph, the numeric parameter values valid for that actual moment will be shown. Time resolution of the x-axis can be selected in ve different steps. Hours and minutes (when values are measured).

Weight - Edi module: Power source - Edi module supply voltage: Parameters:

0.25 kg Powered from SERVO-i. <3 W at 12 V (normal operation) Edi waveform Edi leads waveforms NAVA estimated pressure waveform (Pest) 6 Fr, length 49 cm 6 Fr, length 50 cm 8 Fr, length 100 cm 8 Fr, length 125 cm 12 Fr, length 125 cm 16 Fr, length 125 cm

Edi catheters:

Zoom function:

Time marking:

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

SERVO-i CO2 Analyzer (optional) Standard: EN 864, ISO 9918. IEC/EN 60601-1 (Type BF, defibrillator proof) Size: CO2 Analyzer Module: Sensor: Weight: CO2 Analyzer Module: Sensor: Airway adapter: Connectors and cables: CO2 Analyzer Module: Sensor: Power source: CO2 Analyzer Module supply Powered from the SERVO-i. voltage: Power consumption: 8 W at 12 V, during warm up. 6.5 W at 12 V, during normal operation. Powered from the CO2 Analyzer Module. 15-pole D-sub female connector. 20-pole, 2.4 m cable. 0.45 kg 18 g 10 g 154 x 90 x 43 mm 32.0 x 42.4 x 21.6 mm

SERVO-i CO2 Analyzer Performance Measuring method: Parameters: Mainstream, dual-wavelength, non-dispersive infrared. Capnogram. CO2 End tidal concentration (etCO2). CO2 Minute elimination ( CO2). Tidal CO2 elimination (VTCO2). Measuring range: 0 to 100 mm Hg CO2 partial pressure. 0 to 13.3 kPa CO2 partial pressure. 0 to 13.2% CO2 volume (at a barometric pressure of 1013 hPa). <25 ms (10 to 90% step response). 30 s to initial CO2 indication, max. 5 min to full specication. Automatic. Values supplied from the SERVO-i Ventilator System. Automatic. Values supplied from the SERVO-i Ventilator System. 87 Hz <5 ml <0.5 ml

Step response time: Warm-up time: Oxygen concentration compensation: Barometric pressure compensation: Digitizing rate: Airway adapter dead space: Adult: Infant:

Sensor:

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Y Sensor measuring (optional) Size: Y Sensor Module: Y sensor adult: Y sensor infant: Weight: Y Sensor Module: Y sensor adult: Y sensor infant: Sensor material: Tubing: Power source Y Sensor Module supply voltage: 0.4 kg 10.5 g 7.5 g Makrolon polycarbonate. 2.0 m. Medical grade PVC. Powered from the SERVO-i. <5 W at 12 V (normal operation). 154 x 90 x 43 mm Length 84 mm Length 51 mm

Servo Ultra Nebulizer (optional) Weight: Dimensions: Connection cable length: Approx. 125 g H 105 mm x L 108 mm x W 60 mm 2.0 m

Nebulizer T-piece connections: Inlet/outlet: 22/15 mm outer/inner diameter and 22 mm inner diameter, ISO standard. Pediatric patient tubes: Adapters 22/10 mm outer diameter and 15/10 mm outer diameter. Internal volume: Particle size (water): 60 ml Mass Median Diameter (MMD) = approximately 4.0 m, measured distally in endotracheal tube 8 mm inner diameter. Ultrasonic generator frequency: 2.4 MHz

Y sensor measuring Performance Measuring method: Parameters: Fixed orice, differential pressure. Airway pressure. Airway flow. Inspiratory and expiratory volumes. 2 to 180 l/min 0.125 to 40 l/min

Output from nebulizer (water) Min. 0.1 ml water/min at 0.1 l minimum water ux: gas ow/s. Min. 0.3 ml water/min at 0.5 l gas ow/s. Min. 0.5 ml water/min at 1.0 l gas ow/s (Adult only). Buffer liquid: Max. medication temperature: Volume, medication cup: Noise level: Sterile water 55 C (131 F) Max. 10 ml Max. 50 dBA, measured at 0.3 m distance.

Measuring range: Adult: Infant: Airway adapter dead space: Adult: Infant: < 9.0 ml < 0.45 ml

Aeroneb Nebulizer Systems (optional) See separate data sheets.

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

SERVO-i Mobile Cart (optional) Weight: Dimensions: 20 kg H 1015 mm x L 640 mm x W 560 mm (see dimensional drawing below)

Gas trolley (optional) Max load: Docking: 2x10 kg bottles Dockable to SERVO-i Mobile Cart. Dockable to a separate wall clamp.

SERVO-i Drawer kit (optional) Weight: Dimensions: 4.5 kg H 240 mm x L 210 mm x W 300 mm

Compressor Mini (optional) See separate data sheet.

Alarm output connector (optional) Connector: SERVO-i Holder (optional) Weight: Dimensions: 3.5 kg H 352 mm x L 247 mm x W 159 mm (see dimensional drawing below) Ratings: 4-pole Modular connector Max 40 V DC, Max 500 mA, Max 20 W

Service Regular maintenance: Once every 12 months or at least after 5000 operating hours.

SERVO-i Shelf Base (optional) Weight: Dimensions: 1.2 kg H 29 mm x L 205 mm x W 159 mm (see dimensional drawing below) Note For inaccuracies and more detailed technical specications please refer to the Users manual.

ORDERING INFORMATION Gas cylinder restrainer (optional) Max load: 2 x 5-liter bottles SERVO-i, Ventilator and accessories: See separate information: SERVO-i, Version 5.0 System Flow Chart (Order no: 66 70 102).

SERVO-i IV Pole (optional) Max load (total): 6 kg

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TECHNICAL SPECIFICATIONS SERVO-i UNIVERSAL

Dimensional drawings SERVO-i on Mobile Cart SERVO-i Holder

SERVO-i (patient unit) on SERVO-i Holder

SERVO-i Shelf Base

Maquet Critical Care AB Rntgenvgen 2 SE-171 54 Solna, Sweden Phone: +46 (0) 8 730 73 00 www.maquet.com
GETINGE GROUP is a leading global provider of products and systems that contribute to quality enhancement and cost efficiency within healthcare and life sciences. We operate under the three brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. GETINGE provides solutions for infection control within healthcare and contamination prevention within life sciences. MAQUET specializes in solutions, therapies and products for surgical interventions and intensive care.

For local contact: Please visit our website www.maquet.com

Maquet Critical Care AB 2010. All rights reserved. MAQUET reserves the right to modify the design and specifications contained herein without prior notice. Order No. 66 70 105 Printed in Sweden 100601 10 English Data Sheet