DATA SHEET. ANESTHESIA SYSTEM FLOW-i

Transcription

1 DATA SHEET ANESTHESIA SYSTEM FLW-i

2

3 2 FLW-i Critical Care FLW-i General System model C20 C30 C40 Base system weight (depending on configuration) Dimensions of base plate Approx. 138 kg/ 304 lbs 692 x 985 mm (27.2" x 38.8") Approx. 143 kg/ 315 lbs 692 x 985 mm (27.2" x 38.8") Approx. 140 kg/ 309 lbs 406 x 897 mm (16.0" x 35.3") Measured over table-top and grips Height (1 drawer) Height (2 drawers) Height (3 drawers) Drawers Vertical shafts for optional horizontal rails Wheels Working surface/writing table Additional writing table Reading lamp N/A 860 mm/ 33.9" 1030 mm/ 40.6" 2-3 (1 lockable) 4 Four wheels (diameter 150 mm/ 5.9") with separate brakes mm (32.9" ") Adjustable N/A N/A 1 (lockable) 4 Four wheels (diameter 150 mm/ 5.9") with separate brakes 632 mm/ 24.9" Approx. 420 x 600 mm (16.5" x 23.6") 397 mm x 250 mm (15.6" x 9.8") Adjustable LED light integrated into the display arm 802 mm/ 31.6" N/A 1-2 (1 lockable) 4 Three wheels (diameter 50 mm/ 2.0")

4 Critical Care FLW-i 3 FLW-i Display Type Size Placement Viewing area Waveforms Trends LED touch screen, complete with 11 membrane switches and one rotary knob 432 mm x 295 mm (17.0" x 11.6") Attached to display arm 15", 1024x768 pixels with a palette of 512 colors Up to 6 waveforms, user configurable Graphic display, 1 to 24 hour resolution Numeric display, 1 to 60 minute resolution Environment Ambient temperature Battery perating conditions +15 o C to +35 o C (+60 o F to +95 o F) (Desflurane: +15 o C to +30 o C, +60 o F to +85 o F) +15 o C to +35 o C (+60 o F to +95 o F) Non-operating conditions -25 o C to +60 o C (-15 o F to +140 o F) +5 o C to 40 o C (40 o F to 104 o F) Relative humidity (non-condensing) Atmospheric pressure 15% to 95% 700 hpa 1060 hpa < 95% 470 hpa to 1060 hpa

5 4 FLW-i Critical Care FLW-i Maximum load Accessory/ption C20, MAX LAD (KG/LBS) C30, MAX LAD (KG/LBS) C40, MAX LAD (KG/LBS) Additional writing table Drawer Patient monitor mounting position Auxiliary 2 & Suction module mounting position 13.5/30 2.5/ /30 2.5/ /30 2.5/5.5 Parameter box support arm Working surface/writing table 4 vertical shafts Horizontal rails for hanging accessories Additional arm Backup Gas Rack (incl. full gas cylinders) 20/44 5 kg/ 11 lbs per shaft 3/6.6 12/26 34/75 5 kg/ 11 lbs per shaft 3/6.6 12/26 34/75 5 kg/ 11 lbs per shaft 3/6.6 12/26 N/A Extra backup gas holder (incl. full gas cylinder) Top shelf Vaporizer holder Universal bracket 13/29 20/44 4/8.8 30/66 13/29 20/44 4/8.8 30/66 12/26 20/44 4/8.8 N/A Universal bracket (C20) 30/66 N/A N/A Cable support arm 0.5/ / /1.1

6 Critical Care FLW-i 5 FLW-i Standards - Safety and Functionality Safety Electromagnetic compatibility Respiratory gas monitoring Usability Cleaning Classification according to IEC : Class I equipment: Type B equipment: Continuous operation: Classification according to EU Medical Directive 93/42/EEC: The anesthesia system is classified as IIb. Classification according to IEC Ingress Protection Rating (IP) IEC (Class 1, Type B), IEC , IEC , IEC , IEC , IEC 62304, IS , IS , IS , IS , IS 5360:2006 IEC IS IEC 62366, IEC , IEC according to the type of protection against electrical shock according to the degree of protection against electrical shock according to the mode of operation (not applicable to the lift, 10% duty cycle) IPX1

7 6 FLW-i Critical Care FLW-i Power supply Mains power Mains power Power consumption (C30) Power consumption (patient monitor and maximum auxiliary configuration) Mains fuse Lift fuse Patient monitor Battery Type Capacity perating time Charging time Auxiliary power outlets (option) Power outlet Type of electrical outlet 3 x IEC outlets 1 x IEC patient monitor power cable 3 x 15A NEMA 5-15R (ption) V, V, AC 50-60Hz 560 VA (auxiliary power outlet not included) 1250 VA 2x4A (230V)/2x8A (110V) 1A (230V)/2A (110V) 1A (230V)/2A (110V) Sealed acid-lead rechargeable 38 Ah Approx. 90 minutes Approx. 6 hours All auxiliary outlets and the patient monitor outlet are connected to an isolation transformer. Voltage depends on mains power supply Max load from each outlet 2A (230V)/4A (110V) 1A (230V)/2A (110V) 2A-1A-1A (110V) Max load total 2A (230V)/4A (110V) 1A (230V)/2A (110V) 2A-1A-1A (110V)

8 Critical Care FLW-i 7 FLW-i Gas supply inlets and gas outlets Central gas Supply pressure inlet Air/ 2 /N kpa/ bar/ PSI Hospital central gas supply must be able to deliver a flow of at least 60 l/min at a supply pressure of 2.8 bar (280 kpa, 41 PSI) Connection standards Maximum levels: Maximum inlet gas temperature Gas supply outlets 2 outlet Air outlet Backup gas supply (option) Air AGA DISS NIST French standard H 2 < 7 g/m 3 il < 0.5 mg/m 3 Chlorine must not be detectable <35 o C (<95 o F) 2 H 2 < 20 mg/m 3 Dependent on central gas supply pressure or cylinder inlet pressure Dependent on central gas supply pressure or cylinder inlet pressure Pin Index cylinders (5l) Electronically measured cylinder pressure, Quick-release system for docking and release Weight and size (backup gas rack) Approx. 20 kg / 44 lbs excluding gas cylinders, 322 mm x 846 mm x 291 mm (12.7" x 33.3" x 11.5") (WxHxD) Cylinder configuration (backup gas rack) Max 2 cylinders: 2 /N 2 or 2 /Air Weight (backup gas holder) Approx. 13 kg / 29 lbs including gas cylinder Cylinder configuration (backup gas holder) N 2, 2 Cylinder pressure, 2 /Air Max. 20,000 kpa / 200 bar / 2900 PSI Cylinder pressure, N 2 Max. 8,000 kpa / 80 bar / 1160 PSI Cylinder safety valve opening pressure Air/ 2 and N kpa/6.5 bar/94 PSI All gases and anesthetic agents must conform to the European and American Pharmacopeia.

9 8 FLW-i Critical Care FLW-i Anesthesia gas scavenging (AGS) Type Scavenging flow utlet connections Passive system (including a flow indicator) integrated into the system Minimum 25 l/min, or 10 l/min over the set minute volume, whichever is greater. 30 mm IS taper DISS EVAC 12.7 mm / ½" in hose Barb 25 mm / 1" Barb AGA EVAC WAGD-to-Vacuum connector 22 mm out. diam. connector and 22 mm int. diam. connection tube Fresh gas flow Gas mix Fresh gas flow range Fresh gas 2 /air Flow (numerical/bargraph) Fresh gas 2 /N 2 Flow (numerical/bargraph) Preset 2 concentration 2 Flush Air/ 2 Electronic Servo controlled 2 /N 2 Electronic Servo controlled MAN = l/min AUT = l/min (FGF delivery depending on set MV) AFG = l/min Selectable Selectable Air/ 2 21% - 100% ±5% 2 /N 2 28% 100% ±5% Approx. 50 l/min 2 cmh 2 expiratory resistance when APL is set to SP

10 Critical Care FLW-i 9 FLW-i Breathing system Type System volume (incl. absorber, without patient tubings and manual breathing bag) Maximum volume allowed for patient tubings and optional equipment forming part of the circle system Drive gas C 2 absorber Patient tube connections Type of material (breathing circuit system) System compliance (volume of gas lost due to internal compliance - manual mode only) Internal resistance Manual ventilation Electronic APL valve AFG - Additional Fresh Gas utlet (option) Type Emergency backup ventilation Emergency APL valve 2 emergency flow Circle system with Volume Reflector Approx. 2.9 l 3000 ml 2 Volume Absorbent material 22/15 mm IS cone PPSU (Polyphenylsulphone). Approx. 3 ml/cmh 2 6 cmh 2 at a flow of 1 l/s Approx. 0.7 l Sofnolime Spontaneous breathing (SP) and adjustable pressure up to 80 cmh 2 22 mm coaxial/15 mm conical outlet connections Pneumatic powered SW controlled (from control panel) SP - 80 cmh l/min

11 10 FLW-i Critical Care FLW-i Ventilator Type Patient range Ventilation modes Tidal volume (VT) Tidal volume setting range Inspiratory pressure (Pressure controlled modes) Pneumatic powered Servo controlled Neonatal to Adult Manual/Bag AFG (option) Volume Control (VC) Pressure Control (PC) Pressure Support (PS, option) Pressure Regulated Volume Control (PRVC, option) Synchronized Intermittent Mandatory Ventilation (SIMV, option) ml ±10% of actual value or 10 ml, whichever is greater Infant range: ml, resolution 1 ml Adult range: ml, resolution 10 ml cmh 2 ± 15% or ± 2 cmh 2, whichever is greater Inspiratory pressure setting range Compressible volume compensation Inspiratory flow Breathing frequency I:E (VC, PC) PEEP Trigger Inspiratory pause (VC) Infant range: 0-80 cmh 2, resolution 1 cmh 2 Adult range: cmh 2, resolution 1 cmh 2 Yes Maximum 3.3 l/s (200 l/min) ±1 breaths/minute 1:10-4: cmh 2 Flow / Pressure 0 to 30% or s

12 Critical Care FLW-i 11 FLW-i Respiratory monitoring Administered breaths Loops ±1 breath/minute Flow Volume Volume Pressure Additional display options include having a reference loop and/or the last two loops shown together with the real-time loop Inspiratory Minute Volume Expiratory Minute Volume Inspiratory Tidal Volume Accuracy Insp. Tidal Volume l/min ±15% or ±15 ml multiplied by the breathing frequency, whichever is greater l/min ±15% or ±10 ml multiplied by the breathing frequency, whichever is greater ml ±4 ml (5-20 ml range) ±15% or 15 ml, whichever is greater ( ml range) Expiratory Tidal Volume Accuracy Exp. Tidal Volume ml ±4 ml (5-20 ml range) ±15% or 10 ml, whichever is greater ( ml range) Mean Airway Pressure Peak Airway Pressure End Expiratory Airway Pressure Airway Pressure Airway pressure accuracy (applicable to all pressure measurements) cmh cmh cmh 2-30 to 140 cmh 2 ±5% of actual value or ±2 cmh 2, whichever is greater

13 12 FLW-i Critical Care FLW-i Alarms Airway pressure: High Expiratory Minute Volume: High Expiratory Minute Volume: Low Excessive leakage (automatic mode only) Continuous APL pressure (manual mode only) High continuous pressure Regulated Pressure Limited (PRVC mode only) PEEP: High PEEP: Low Respiratory Rate: High Respiratory rate: Low Apnea (manual mode only) Long apnea (manual mode only) Backup ventilation Check breathing circuit Battery operation - battery capacity unknown Limited battery capacity No battery capacity Water trap missing/replace water trap cmh l/min l/min The difference between the maximum and minimum pressures during inspiration is too low Activated when the measured airway pressure exceeds predefined values for more than 15 seconds. Predefined values depend on current APL setting. The measured airway pressure is above set PEEP + 15 cmh 2 for more than 15 seconds. Permissible pressure limits pre-set tidal volume 0-55 cmh cmh B/min and FF B/min and FF 5-45 s. and FF No breath detection for up to 120 s Pressure controlled administered breath detected in pressure support backup mode due to time out of the backup respiratory rate parameter. Activated when inspiratory and expiratory pressures fail to meet preset requirements Connection error; unable to estimate battery time. Less than 18 minutes left of battery operation. Less than 3 minutes left of battery operation. The gas analyzer has detected that a water trap replacement is needed

14 Critical Care FLW-i 13 FLW-i Gas alarms Lower limit setting range Upper limit setting range Inspiratory 2 concentration alarm Expiratory 2 concentration alarm Inspiratory C 2 concentration alarm Expiratory C 2 concentration alarm 18-99% 10-99% and FF % and FF 23-99% and FF 13-99% and FF % and FF % and FF Inspiratory AA concentration alarm Expiratory AA concentration alarm Agent mixture: MAC > 3 High continuous MAC Agent mixture Insp N 2 : High % and FF (IS) % and FF (SEV) % and FF (DES) % and FF (IS) % and FF (SEV) % and FF (DES) % (IS) % (SEV) % (DES) % and FF (IS) % and FF (SEV) % and FF (DES) The MAC of the secondary agent is 0.6 and the total MAC value is 3 Measured MAC exceeds time limit: MAC > 2.2; from starting a New Case, until 15 minutes after the first vaporizer activation. MAC > 1.8 otherwise 1 The second agent is MAC 0.6 and the total MAC value is <3 Inspiratory N 2 gas supply >80% 1. In order to reflect time lag owing to pharmacokinetics between alveolar concentration and the target organ brain concentration, the high continuous MAC alarm activation and deactivation are delayed.

15 14 FLW-i Critical Care FLW-i Vaporizer Agents Type Weight (full) Dimensions (mm / inch.) Capacity Residual capacity Setting range Accuracy Filling system Vaporizer filling speed verfill protection Tank liquid level Agent usage tracking Isoflurane, Sevoflurane and Desflurane Electronic Injector Approx. 3.2 kg / 7.1 lbs 70 x 215 x 178 (2.8" x 8.5" x 7.0") 300 ml 30 ml (triggering the low level alarm) Isoflurane 0, 0.3-5%, FF Sevoflurane 0, 0.3-8%, FF Desflurane 0, %, FF ±15% of set value or ±5% of maximum possible user setting (whichever is greater) Isoflurane Maquet filling adapter Sevoflurane Quik Fil and Maquet filling adapter Desflurane SAFE-FIL TM Approx. 4 ml/s verfilling prevention systems built into the vaporizer ptical and electronic Individual agent usage for each of the last 20 patient cases Total agent usage since last user reset

16 Critical Care FLW-i 15 FLW-i Patient gas analyzer Measuring technology Warm-up time 2 Agents, C 2, N 2 IS standard accuracy Paramagnetic sensor IR sensor Within 60 s Sampling flow Measured parameters Resp. rate Respiration rate measurement accuracy Gas measuring range Inspiratory and End-Tidal 2 Concentration Inspiratory and End-Tidal C 2 Concentration Inspiratory and End-Tidal N 2 Concentration Inspiratory and End-Tidal Agent Concentration Automatic AA identification Full accuracy 200 ml/min (Return to circuit) breaths/minute <60 breaths/minute >60 breaths/minute Within 10 minutes ± 1 breath/minute Unspecified % N % C % Isoflurane 0-5% Sevoflurane 0-8% Desflurane 0-18% Yes Yes Yes Yes Yes. Agent mixtures are displayed containing a Primary and Secondary agent (classification depending on relative agent concentration)

17 16 FLW-i Critical Care FLW-i Patient suction and auxiliary 2 module (option) Weight Patient suction supply pressure (Air) Auxiliary 2 supply pressure Auxiliary 2 flow range Max. vacuum (suction) Max. suction flow Approx. 2.2 kg / 4.9 lbs kpa/3-6.5 bar/44-94 PSI kpa/3-6.5 bar/44-94 PSI 0-10 l/min -90 kpa when gas supply is 6.5 bar 90 l/min when gas supply is between 5.0 and 6.5 bar Misc. optional equipment Vaporizer holder Weight Weight including full vaporizer Dimensions Universal bracket for C20 Weight Maximum load EVAC Restrictor Weight Dimensions Manual breathing bag support arm Weight Maximum load Approx. 0.8 kg / 1.8 lbs Approx. 4.0 kg 8.8 lbs 90 x 220 x 215 mm / 3.5" x 8.7" x 8.5" (W x H x L) Approx. 1.5 kg / 3.3 lbs 30 kg / 66 lbs Approx. 60 g / 2 oz 32 x 48 x 48 mm / 1.3" x 1.9" x 1.9" (W x H x L) Approx. 1.0kg / 2.2 lbs 1.0 kg / 2.2 lbs External communication Serial ports USB Video out Ethernet 2 x RS232 FCI protocol 1 1 VGA 1 Network connection for service use The products may be pending regulatory approvals to be marketed in your country. Contact your MAQUET representative for more information.

18 Critical Care FLW-i 17 FLW-i DIMENSINAL DRAWINGS (SHWING C20 MDEL) 22 cm cm cm 39.0 C20: cm C30: cm C20: C30: C20: cm C30: cm 43 cm cm 15.7 C20: C30: cm cm 34.5

19 18 FLW-i Critical Care FLW-i DIMENSINAL DRAWING (SHWING C40 MDEL). Several ceiling pendant solutions are available. The minimum height requirement of the pendant interface is 56.0 cm / 22.0" relative to the floor level when using a ceiling pendant cm 22.0

20 Maquet Critical Care AB All rights reserved. MAQUET reserves the right to modify the design and specifications contained herein without prior notice. rder No DATA SHEET Printed in Sweden Rev: 07 English Maquet Critical Care AB Röntgenvägen 2 SE Solna, Sweden Phone: +46 (0) For local contact: Please visit our website GETINGE GRUP 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, interventional cardiology and intensive care.