Data sheet This document is intended to provide information to an international audience outside of the US.
2 Critical Care Key features For adult and pediatric patients A ventilator system designed to operate in a variety of hospital ventilatory care settings Alarm output connector for external alarm (optional) Supports invasive ventilation and the option non-invasive ventilation (NIV) with leakage compensation High level of sensitivity to your patient s efforts - Precise gas delivery system - Extreme speed in sensing and regulation Diagnostic trend tools ensure accurate time and detail recording for up to 24 hours after an event Volume/Pressure and Flow/Volume loops Simple to operate and learn - Large color display with clear graphic presentation - Intuitive user interface - Select between touch screen, direct access knobs or dial - Fast and simple start up procedure e.g. automated pre-use check with user configurable default ventilator settings - Suction support - Previous mode functionality - High-resolution pressure, flow and volume waveforms Simple to maintain and clean - ne-piece interchangeable part for cleaning - Extended maintenance interval (5000 hours) - Maintenance information given via graphical user interface Reliable - Battery backup (60 minutes) - Apnea backup - Direct access knobs for vital settings - Enhanced alarm system Uninterrupted bedside quality ventilatory treatment during intra-hospital transportation with Mobile cart Can be mounted on both ceiling pendant and shelf n-consumable and maintenance-free ultrasonic 2 sensor, alternative to consumable 2 cell SERV-s configurations Standard configuration ptions Bi-Vent/APRV n-invasive ventilation (NIV) Lung mechanics PRVC (incl. SIMV (PRVC) + PS) VC (incl. SIMV (VC) + PS) PC (incl. SIMV (PC) + PS) PS/CPAP Key to abbreviations NIV n-invasive ventilation PRVC Pressure Regulated Volume Control SIMV Synchronized Intermittent Mandatory Ventilation VC Volume Control PC Pressure Control PS Pressure Support CPAP Continuous Positive Airway Pressure Key to abbreviations NIV n-invasive ventilation PRVC Pressure Regulated Volume Control SIMV Synchronized Intermittent Mandatory Ventilation VC Volume Control PC Pressure Control PS Pressure Support CPAP Continuous Positive Airway Pressure
Critical Care 3 The system - general perating conditions Classification: The device complies with requirements and classification IIb of Medical Device Directive 93/42/EEC. CE Mark tified Body number: 0123. Class I equipment. According to IEC/EN 60 601-1. perating temperature: Relative humidity: Atmospheric pressure: Lowest pressure in breathing system: +10 to +40ºC 15 to 95% non-condensing 660 to 1060 hpa 400 cmh 2 Standards: A-weighted sound pressure level (L pa ) IP classification Electromagnetic compatibility (EMC): IEC 60601-1: 2005 IS 80601-2-12:2011 IS 80601-2-55: 2011 <41 db, measured at 1 m distance. IP 21 According to limits specified in IEC 60601-1-2:2007. n-operating conditions Impact: Storage temperature: Storage Relative Humidity: Storage Atmospheric Pressure: Peak acceleration: 15 g. Pulse duration: 6 ms. Number of impacts: 1000. 25 to +60º C ( 13 to 140º F) < 95% 470 to 1060 hpa The 'EMC Declaration, Information to the Responsible rganization' is available from Maquet. Patient range: General Instructions for use Legal manufacturer ther products Patient weight 10 250 kg Please carefully read the user s manual Maquet Critical Care AB See separate data sheets. Contact your local Maquet supplier for more information. Power supply Power supply, automatic range selection: External 12 V DC: Battery capacity: Battery backup time: Battery recharge time: Max power consumption: 100 120 V AC ±10%, 50 60 Hz, or 220 240 V AC ±10%, 50 60 Hz. 12.0 V 15.0 V DC, 10 A Rechargeable, 12 V, 7 Ah At least 1 h Approximately 6 h At 100 120 V: 2 A, 190 VA, 140 W. At 220 240 V: 1 A, 190 VA, 140 W.
4 Critical Care The ventilator - general Dimensions: User Interface and Patient Unit: User Interface: Patient Unit: Weight: Method of triggering: Max. operating pressure: Bias flow: Gas supply Inlet gas pressure Air/ 2 : Connection standards available: Unavailable gas/loss of gas pressure: (See dimensional drawings page 9.) W 380 x D 300 x H 520 mm W 355 x D 53 x H 295 mm W 380 x D 300 x H 210 mm Approximately 18 kg Flow and pressure Approximately 115 cmh 2 2 l/min 200 600 kpa / 2.0 6.0 bar / 29 87 PSI AGA, DISS, NIST, or French standard. The flow from an unavailable gas (air or 2 ) is automatically compensated for so that the patient gets the preset volume and pressure. Patient system gas connectors Conical fittings: Male 22 mm / female 15 mm. In accordance with IS 5356-1. Gas exhaust port: Inspiratory channel Pressure drop: Internal compressible factor: Gas delivery system: Inspiratory flow range: Male 30 mm cone Max. 6 cmh 2 at a flow of 1 l/s Max. 0.1 ml/cmh 2 Microprocessor controlled valve 0 to 3.3 l/s Expiratory channel Pressure drop: Internal compressible factor: PEEP regulation: Rise time, expiratory flow measurement: Expiratory flow range: Screen Type: Size: Viewing area: Max. 3 cmh 2 at a flow of 1 l/s Max. 0.1 ml/cmh 2 Microprocessor controlled valve <12 ms for 10 90 % response at flow of 0.05 3.2 l/s 0 to 3.2 l/s TFT-LCD module 31 cm (12.1 ) diagonal 246.0 x 184.5 mm Ventilation modes Invasive ventilation Controlled ventilation: PC VC Can be configured with alternative flow patterns - VC with flow adaptation, - VC without flow adaptation, - VC with decelerating flow PRVC Supported ventilation: PS/CPAP Combined ventilation: SIMV (PC) + PS SIMV (VC) + PS SIMV (PRVC) + PS Bi-Vent/APRV ptional, pressure controlled ventilation on two independently adjustable levels, allowing unrestricted spontaneous breathing on both levels. Ventilation modes n-invasive ventilation (optional) NIV PC NIV PS
Critical Care 5 Alarms Airway pressure (upper): Invasive ventilation: n-invasive ventilation: Expired minute volume (Upper alarm limit): Expired minute volume (Lower alarm limit): 16 120 cmh 2 16-70 cmh 2 0.5-60 l/min 0.5 40 l/min patient effort (Apnea) alarm 15 45 s Automatic return to support mode on patient triggering consistent patient effort Respiratory frequency: High end expiratory pressure: Low end expiratory pressure: High continuous pressure: 2 concentration: Gas supply: Battery: Leakage out of range in NIV:, described in User's manual 1 160 breaths/min 0 55 cmh 2 0 47 cmh 2. te. Setting the alarm to 0 (zero) is equal to alarm off. bstruction leading to constant high airway pressure (>PEEP +15 cmh 2 ) during: > 2 breaths or 5 seconds, whichever is greater, 15 ±1.5 s if less than 2 breaths are triggered Set value ±5 vol% or 18 vol% Below 200 kpa / 2.0 bar / 29 PSI and above 600 kpa / 6.0 bar / 87 PSI Limited battery capacity: 10 min. battery capacity: less than 3 min. Low battery voltage.. Described in the User s manual. Alarms Autoset alarm limits specifications: High airway pressure: Upper minute volume: Lower minute volume: Upper respiratory frequency: Lower respiratory frequency: High end expiratory pressure: Low end expiratory pressure: Monitoring Breathing frequency: Spontaneous breaths per minute (RRsp): Peak airway pressure: Mean airway pressure: Pause airway pressure: End expiratory pressure: Inspired tidal volume: Expired tidal volume: Inspired minute volume: Expired minute volume: Leakage fraction in NIV (%): Invasive ventilation, controlled modes only Mean peak pressure +10 cmh 2 or at least 35 cmh 2. Expiratory minute volume + 50%. Expiratory minute volume 50%. Breathing frequency + 40%. Breathing frequency 40%. Mean end expiratory pressure + 5 cmh 2. Mean end expiratory pressure 3 cmh 2. Displayed value Trended value* Technical:. Described in the User s manual. Ti/Ttot: I:E ratio: Total PEEP**: Switch to backup (b/min) Backup (%/min)
6 Critical Care Monitoring 2 concentration (measured): MV e sp / MV e : Displayed value Trended value* Parameter: Inspiratory tidal volume (ml): Inspiratory minute volume (l/min): Setting range: 100 2000 0.5 60 Spontaneous exp. minute volume (MV e sp): Apnea, time to alarm (s): PC/PS above PEEP (cmh 2 ) 15 45 0 (120 - PEEP) End expiratory flow: Static compliance**: PC/PS above PEEP in NIV (cmh 2 ) 0 (62 - PEEP) Dynamic compliance**: PEEP (cmh 2 ): 0 50 Inspiratory resistance**: PEEP in NIV (cmh 2 ): 2 20 Expiratory resistance**: CMV frequency (breaths/min): 4 100 Elastance**: SIMV frequency (breaths/min): 1 60 Time constant**: Breath cycle time, SIMV (s): 1 15 P0.1 measurement**: P High (cmh 2 ): (PEEP+1) 50 Work of breathing patient**: T High (s): 0.2 30 Work of breathing ventilator**: T PEEP (s): 0.1 10 Shallow Breathing Index (SBI)**: 2 concentration (%): 21 100 Supply pressure ( 2 and air): I:E ratio: 1:10 4:1 Battery remaining time: T Insp (s): 0.1 5 Barometric pressure: T Pause (% of breath cycle time) 0 30 * Stored trend values for up to 24 hours Flow trigger sensitivity level: 0-10 ** ptional Press. trigg sensitivity (cmh 2 ): -20 0 Insp. rise time (% of breath cycle time): 0 20 Insp. rise time (s): 0 0.4 End inspiration (% of peak flow): 1 70 End inspiration in NIV (% of peak flow): 10 70 xygen breaths: 100% for 1 minute Start breath: Initiation of 1 breath (In SIMV mode initiation of 1 mandatory breath) Pause hold: Insp. or exp (0 30 seconds)
Critical Care 7 Parameter: Setting range: Suction support Alarm silence/reset: Compliance compensation: Backup ventilation: 2 minute silence and reset of latched alarms n/ff n/ff Pre oxygenation time: Post oxygenation time: Suction phase time: Adjustable oxygen level: Max. 2 min Max. 1 min maximum level 21 100 % Waveform and loop presentations Real time waveforms - up to 3 waveforms can be displayed simultaneously: Pressure Flow Volume Loops: Volume / Pressure Flow / Volume Communication/Interface Serial port: RS-232C - isolated. For data communication via the Communication Interface Emulator (CIE). Alarm output connector (optional) Connector: 4-pole Modular connector Ratings: Max 40 V DC, Max 500 ma, Max 20 W Log function Event log: Alarms. Ventilator settings. Apnea periods. Immediate functions. n-invasive ventilation (optional) Leakage compensation level: Inspiratory, up to 200 l/min Expiratory, up to 65 l/min Leakage overrange detection: Automatic Service log: Technical alarms. Test results. Preventive maintenance. Service history. Configuration log. Disconnect detection: Disconnect flow: Low: High: Disabled Automatic Configurable 7.5 l/min 40 l/min Deactivates disconnect detection Backup settings Parameter: Setting range: Connect detection: Manual, or automatic via bias flow Inspiratory tidal volume (ml): 100-2000 PC above PEEP (cmh 2 ) 5 (120 - PEEP) Service PC above PEEP in NIV CMV frequency (breaths/min): 5 - (62 PEEP) 4 100 Regular maintenance: nce every 12 months or at least after 5000 operating hours. I:E ratio: 1:10 4:1 T Insp (s): 0.1 5 te: For inaccuracies and more detailed technical specifications please refer to the User s manual.
8 Critical Care SERV-s Mobile cart (optional) Weight: 25 kg Dimensions: H 828 mm (with handles 1.051 mm) x L 644 mm x W 538 mm (see dimensional drawing) Gas cylinder restrainer (optional) Max load: 2 x 5-liter bottles Compressor Mini (optional) See separate data sheet. SERV-s Shelf base (optional) Weight: 0.1 kg Dimensions: H 8 mm x L 160 mm x W 60 mm (see dimensional drawing) Aerogen nebulizer systems (optional) See separate data sheets.
Critical Care 9 rdering information SERV-s, Ventilator and accessories: See separate information: System Flow Chart (rder no: 66 70 112). Dimensional drawings SERV-s on Mobile cart SERV-s on Shelf base 828 mm 1053 mm 1363 mm 210 mm 295 mm 520 mm 538 mm 644 mm 380 mm 300 mm Mobile cart SERV-s Shelf base SERV-s 60 mm 828 mm 1053 mm 8 mm 538 mm 644 mm 160 mm
Productsmay be pending regulatory approvals to be marketed in your country. Contact your Maquet representative for more information. This document is intended to provide information to an international audience outside of the US. Manufactured: Maquet Critical Care AB Röntgenvägen 2 171 54 Solna, Sweden Phone: +46 (0) 10 335 73 00 www.maquet.com Getinge Group is a leading global provider of innovative solutions for operating rooms, intensive-care units, hospital wards, sterilization departments, elderly care and for life science companies and institutions. With a genuine passion for life we build quality and safety into every system. ur unique value proposition mirrors the continuum of care, enhancing efficiency throughout the clinical pathway. Based on our first-hand experience and close partnerships, we are able to exceed expectations from customers improving the every-day life for people, today and tomorrow. Maquet Critical Care AB 2016. All rights reserved. Maquet reserves the right to modify the design and specifications contained herein without prior notice. rder. 66 70 115 Data sheet Printed in Sweden 160318 Rev: 15 English