MAQUET
FLOW-i 4.7 Datasheet Rev 01 April 2019
Datasheet
16 Pages
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Page 1
Datasheet Flow-i Anesthesia Machine System version 4.7
This document is intended to provide information to an international audience outside of the US.
Contents
Technical specifications ...3 General ...3 Display ...3 Environment ...4 Maximum load ...4 Standards – safety and functionality ...5 Power supply ...5 Gas supply inlets and gas outlets ... 6 Anesthetic Gas Scavenging System (AGSS) ... 6 AGC parameters (option) ...7 AGC ventilation parameters (option) ...7 Recruitment maneuvers (option) ...7 Fresh gas flow ...8 Breathing system ...8 Ventilator ... 9 Respiratory monitoring ... 9 Respiratory monitoring (continued) ...10 Alarms ...10 Gas alarms ... 11 Vaporizer ... 11 Patient gas analyzer ...12 Patient suction and auxiliary O2 module (option) ...12 Misc. optional equipment ...13 External communication ...13 Ordering information ...13 Dimensional drawings ...14 C20 and C30 models ...14 C40 model ...14
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GE TINGE • FLOW- I
Flow-i Anesthesia Machine Technical specifications
General
Display
GE TINGE • FLOW- I
System model
C20
C30
C40
Base system weight (out of the box weight)
Appr. 138 kg/304 lbs
Appr. 140 kg/309 lbs
Appr. 140 kg/309 lbs
Dimensions of base plate
692 985 mm (27.2" × 38.8")
692 × 985 mm (27.2" × 38.8")
406 × 897 mm (16.0" × 35.3") Measured over table-top and grips
Height (1 drawer)
N/A
835–1025 mm (32.9"–40.4”) Adjustable
632 mm/ 24.9"
Height (2 drawers)
860 mm/ 33.9"
N/A
802 mm/ 31.6"
Height (3 drawers)
1030 mm/ 40.6"
N/A
N/A
Drawers
2–3 (1 lockable)
1 (lockable)
1–2 (1 lockable)
Vertical shafts for optional horizontal rails
4
4
4
Wheels
Four wheels (diameter 150 mm/5.9") with separate brakes
Four wheels (diameter 150 mm/5.9") with separate brakes
Three wheels (diameter 50 mm/2.0")
Working surface/writing table
Appr. 420x600 mm (16.5" × 23.6")
Additional writing table
397 mmx250 mm (15.6" × 9.8")
Reading lamp
Adjustable LED light integrated into the display arm
Type
LED touch screen, complete with 11 membrane switches and one rotary knob
Size
432 mm × 295 mm (17.0" × 11.6")
Placement
Attached to display arm
Viewing area
15", 1024 × 768 pixels with a palette of 512 color
Waveforms
Up to 6 waveforms, user configurable
Trends
• Graphic display, 1 to 24 hour resolution • Numeric display, 1 to 60 minute resolution
3
Environment
Maximum load
Environment
Operating conditions
Non-operating conditions
Ambient temperature
+15 C to +35 C (+60oF to +95oF) (Desflurane: +15oC to +30oC, +60oF to +85oF)
-25oC to +60oC (-15oF to +140oF)
Battery
+15oC to +35oC (+60oF to +95oF)
+5oC to 40oC (40oF to 104 oF)
Relative humidity (non-condensing)
15% to 95%
<95%
Atmospheric pressure
700 hPa–1060 hPa
470 hPa–1060 hPa
Accessory/option
C20, max load (kg/lbs)
C30, max load (kg/lbs)
C40, max load (kg/lbs)
Additional writing table
5/11
5/11
5/11
Drawer
5/11
5/11
5/11
Patient monitor mounting position
13.5/30
13.5/30
13.5/30
Auxiliary O2 & Suction module mounting position
2.5/5.5
2.5/5.5
2.5/5.5
Parameter box support arm
5/11
5/11
5/11
Working surface/ writing table
20/44
5/11
5/11
4 vertical shafts
10/22 per shaft *
10/22 per shaft *
5/11 per shaft
o
o
* Applies when using a single arm per system attached to 1 or 2 shafts and with a load at a maximum distance of 500 mm from the system.
4
Horizontal rails for hanging accessories
3/6.6
3/6.6
3/6.6
Additional arm
12/26
12/26
12/26
Backup gas rack
7/15 per cylinder
7/15 per cylinder
N/A
Extra backup gas holder (incl. full gas cylinder)
7/15
7/15
7/15
Top shelf
20/44
20/44
20/44
Vaporizer holder
4/8.8
4/8.8
4/8.8
Universal bracket
N/A
30/66
N/A
Universal bracket (C20)
30/66
N/A
N/A
Cable support arm
0.5/1.1
0.5/1.1
0.5/1.1
GE TINGE • FLOW- I
Standards – safety and functionality
Power supply
Safety
IEC 60601-1:2005 + A1:2012 IEC 60601-1-2:2014 IEC 60601-1-8:2006 + A1:2012 ISO 80601-2-13:2011 + A1:2015, IEC 62304:2006 + Cor1:2008 + A1:2015 ISO 5360:2016
Electromagnetic compatibility
IEC 60601-1-2:2014
Respiratory gas monitoring
ISO 80601-2-55:2011
Anesthetic gas delivery
ISO 80601-2-13:2011 + A1:2015
Usability
IEC 62366-1:2015
Cleaning
IEC 60601-1:2005 + A1:2012 ISO 80601-2-13:2011 + A1:2015
Class I equipment
According to the type of protection against electrical shock
Type B equipment
According to the degree of protection against electrical shock
Continuous operation
According to the mode of operation (no applicable to the lift, 10% duty cycle)
Classification according to EU Medical Directive 93/42/EEC
The anesthesia system is classified as IIb
Classification according to IEC 60529 Ingress Protection Rating (IP)
IP21
Mains power Mains power
100–120 V, 220–240 V, AC 50–60 Hz
Power consumption (C30)
560 VA (auxiliary power outlet not included)
Power consumption (patient monitor and maximum auxiliary configuration)
1250 VA
Battery Type
Sealed acid-lead rechargeable
Capacity
• 18 Ah for devices with serial numbers above 20 000 • 38 Ah for devices with serial number below 20 000
Operating time
Appr. 90 minutes
Charging time
Appr. 6 hours
Auxiliary power outlets (option)
GE TINGE • FLOW- I
Power outlet
All auxiliary outlets and the patient monitor outlet are connected to an isolation transformer. Voltage depends on mains power supply
Type of electrical outlet 3 × IEC outlets 1 × IEC patient monitor power cable 3 × 15A NEMA 5-15R (Option)
Max load from each 2 A (230 V)/4 A (110 V) 1 A (230 V)/2 A (110 V)
Max load total 2 A (230 V)/4 A (110 V) 1 A (230 V)/2 A (110 V)
2 A–1 A–1 A (110 V)
2 A–1 A–1 A (110 V)
Type of auxiliary power outlet Type of patient monitor outlet Type of use Auxiliary power outlets with protective earth Total current
Country specific IEC cable Electronic circuit breakers: 3x1 A and 1x3 A 3 (max 1 A per outlet) Max 3 A
5
Gas supply inlets and gas outlets
Central gas Supply pressure inlet
Air/O2/N2O
250–600 kPa/ 2.5–6.0 bar/ 36–87 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
AGA DISS NIST French standard
Maximum levels
Air H2O <7 g/m3 Oil <0.5 mg/m3 Chlorine must not be detectable
Maximum inlet gas temperature
<35oC (<95oF)
O2 H2O <20 mg/m3
Gas supply outlets O2 outlet
Dependent on central gas supply pressure or cylinder inlet pressure
Air outlet
Dependent on central gas supply pressure or cylinder inlet pressure
Backup gas supply (option) Pin Index cylinders (5 l)
Electronically measured cylinder pressure, Quick-release system for docking and release
Weight and size (backup gas rack)
Appr. 20 kg/44 lbs excluding gas cylinders, 320 mm × 730 mm × 220 mm (12.6" × 28.8" × 8.7") (WxHxD)
Cylinder configuration (backup gas rack)
Max 2 cylinders: O2/N2O or O2/Air
Cylinder configuration (backup gas holder)
N2O, O2
Cylinder pressure, O2/Air
Max. 20,000 kPa/200 bar/2900 PSI
Cylinder pressure, N2O
Max. 8,000 kPa/80 bar/1160 PSI
Cylinder safety valve opening pressure
Air/ O2 and N2O
650 kPa/6.5 bar/94 PSI
All gases and anesthetic agents must conform to the European and American Pharmacopeia Required minimum concentration of oxygen supplied to the system is 99.5 vol. % of O2
Anesthetic Gas Scavenging System (AGSS)
6
Type
Passive system (including a flow indicator) integrated into the system
Scavenging flow
Minimum 25 l/min, or 10 l/min over the set minute volume, whichever is greater
Outlet connections
• 30 mm ISO 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
GE TINGE • FLOW- I
AGC parameters (option)
Target FiO2 concentration
30%–80%, MAX * * MAX is approximately 100% –current inspiratory anesthetic agent concentration
Setting resolution
1%
Target EtAA concentration
Isoflurane: OFF, 0, 0.3%–MAX * Sevoflurane: OFF, 0, 0.3%–MAX Desflurane: OFF, 0, 1.0%–MAX * Highest allowable setting corresponds to a MACage of 2.0
Setting resolution
0.1%
Speed parameter
1–8, MAX
Setting resolution
1
maxFiAA
Isoflurane: Min *–5% Sevoflurane: Min–8% Desflurane: Min–18% * Must be set higher than target EtAA
Setting resolution
0.1%
minFGF
0.1–2.0 l/min
4
Individually set for each agent, and No agent’ 4
AGC ventilation parameters (option)
Recruitment maneuvers (option)
Setting resolution
0.1 l/min
Tidal Volume
100–800 ml
Minute Volume
1–10 l/min
Respiratory Rate
8–35 breaths/min * * RR is limited by Tinsp and Texp
Tinsp
>0.6 s
Texp
>1.0 s
Pressure above PEEP
5–40 cmH2O
Monitoring and trends End inspiratory pressure (EIP)
Breath-by-breath
Positive end expiratory pressure (PEEP)
Breath-by-breath
Dynamic compliance (Cdyn)
Breath-by-breath
RM trends timescale
5 or 20 minutes
Set Ppeak alarm limit
The level is plotted with the pressure curves.
Breath count
The number of breaths is counted at a certain level of PEEP or PC above PEEP until a further change of these parameters is made.
Recruit maneuvers parameters
GE TINGE • FLOW- I
Ppeak target
30 to 45 cmH2O
PEEP target
15 to 40 cmH2O
PEEP after RM
5 to 20 cmH2O
Ppeak increase per step
2 to 10 cmH2O
Breaths per step
1 to 10
Breaths at target
3 to 30
I:E during RM
1:3.0 to 3.0:1
7
Fresh gas flow
Breathing system
Gas mix
Air/O2 O2/N2O
Electronic Servo controlled Electronic Servo controlled
Fresh gas flow range
• MAN = 0.1–20 l/min • AUTO = 0.1–20 l/min (FGF delivery depending on set MV) • AFGO = 1.0–20 l/min
Fresh gas O2/Air Flow (numerical/bargraph)
Selectable
Fresh gas O2/N2O Flow (numerical/bargraph)
Selectable
Preset O2 concentration
Air/ O2 O2/N2O
O2 Flush
• Appr. 50 l/min • 2 cmH2O expiratory resistance when APL is set to SP
O2 Guard
If the system detects an inspiratory oxygen concentration below a certain level, it will initiate several actions to mitigate the situation. The gas mix is set to Air/O2, the fresh gas flow and oxygen concentration are both adjusted. A dialog window appears informing of the alterations. These changes remain in effect until new settings are made.
Pause function
• Yes
21%–100% ±5% 28%–100% ±5%
Type
Circle system with Volume Reflector
System volume (incl. absorber, without patient tubings and manual breathing bag)
Appr. 2.9 l
The patient circuit configurations are intended to provide the following range of inspired tidal volumes
• Adult: 22 mm tubing, Tidal Volumes 100 – 2000 ml. • Infant: 15 mm tubing, Tidal Volumes 25–350 ml. • Infant: 10–12 mm tubing, Tidal Volumes 5–100 ml * * VC: 20–100 ml, PC: 5 –100 ml
Drive gas
O2
CO2 absorber
Volume Absorbent material
Patient tube connections
22/15 mm ISO cone
Type of material (breathing circuit system)
• PPSU (Polyphenylsulphone) • SBC (Styrene-butadiene copolymer) • PP (Polypropylene)
System compliance (volume of gas lost due to internal compliance - manual mode only)
Appr. 3 ml/cmH2O
Appr. 0.7 l Sofnolime™
Manual ventilation Electronic APL valve
Spontaneous breathing (SP) and adjustable pressure up to 80 cmH2O
AFGO- Additional Fresh Gas Outlet (option) Type
22 mm coaxial/15 mm conical outlet connections Pneumatic powered SW controlled (from control panel)
Emergency backup ventilation
8
Emergency APL valve
SP–80 cmH2O
O2 emergency flow
0–10 l/min
GE TINGE • FLOW- I
Ventilator
Respiratory monitoring
Type
Pneumatic powered Servo controlled
Patient range
Neonatal to Adult
Ventilation modes
• Manual/Bag • AFGO (option) • Volume Control (VC) • Pressure Control (PC) • Pressure Support (PS, option) • Pressure Regulated Volume Control (PRVC, option) • Synchronized Intermittent Mandatory Ventilation (SIMV, option)
Tidal volume (VT)
20–2000 ml ±10% of actual value or 10 ml, whichever is greater. Note that the Flow-i delivers tidal volumes down to 5 ml when using Pressure Control.
Tidal volume setting range
Infant range: 20–350 ml, resolution 1 ml Adult range: 100–2000 ml, resolution 10 ml
Minute volume setting range
Infant range: 0.3–20 l/min Adult range: 0.5–60 l/min
Inspiratory pressure (pressure controlled modes)
0–120 cmH2O
Inspiratory pressure setting range
Infant range: 0–80 cmH2O, resolution 1 cmH2O Adult range: 0–120 cmH2O, resolution 1 cmH2O
Compressible volume compensation
Yes
Inspiratory flow
Maximum 3.3 l/s (200 l/min)
Breathing frequency
4–100 ±1 breaths/minute
I:E (VC, PC)
1:8.3–4:1
PEEP
0–50 cmH2O
Trigger
Flow/Pressure
Inspiratory pause (VC)
0 to 30% or 0–1.5 s
Predicted body weight setting
Yes
Inspiratory and expiratory hold function
Yes
Administered breaths
1–100 ±1 breath/minute
Loops
Flow–Volume Volume–Pressure
±15% or ±2 cmH2O, whichever is greater
Additional display options include having a reference loop and/or the last two loops shown together with the real-time loop
GE TINGE • FLOW- I
Lung characteristics
Airway resistance (Rdyn) Compliance (Cdyn) Elastance (Edyn)
Inspiratory Minute Volume
0.3–60 l/min ±15% or ±15 ml multiplied by the breathing frequency, whichever is greater
Expiratory Minute Volume
0.3–60 l/min ±15% or ±10 ml multiplied by the breathing frequency, whichever is greater
Inspiratory Tidal Volume
5–2000 ml
9
Respiratory monitoring (continued)
Alarms
10
Accuracy Insp. Tidal Volume
±4 ml (5–20 ml range) * ±15% or 10 ml, whichever is greater (20–2000 ml range) * Accuracy valid for O2/Air gas mix, O2 concentration at 60%, RR at 30 and I:E ≥1:2.
Expiratory Tidal Volume
5–2000 ml
Accuracy Exp. Tidal Volume
+7/-4 ml (5–20 ml range) 6 ±15% or 15 ml, whichever is greater (20–2000 ml range)
Mean Airway Pressure
0–100 cmH2O
Airway Pressure
-40–140 cmH2O
Airway pressure accuracy (applicable to all pressure measurements)
±5% of actual value or ±2 cmH2O, whichever is greater
Airway pressure: High
10–120 cmH2O
Expiratory Minute Volume: High
0.01–60 l/min
Expiratory Minute Volume: Low
0.01–40 l/min
Excessive leakage (automatic mode only)
The difference between the maximum and minimum pressures during inspiration is too low
Continuous APL pressure (manual mode only)
Activated when the measured airway pressure exceeds predefined values for more than 15 seconds. Predefined values depend on current APL setting.
High continuous pressure (automatic mode only)
Airway pressure is constant above set PEEP level +15 cmH2O more than 15 seconds
Negative airway pressure
Measured airway pressure is below -10 cmH2O for more than one second
Regulated Pressure Limited (PRVC mode only)
Permissible pressure limits pre-set tidal volume
PEEP: High
0–55 cmH2O
PEEP: Low
0–47 cmH2O
Respiratory Rate: High
1–140 B/min and OFF
Respiratory rate: Low
1–140 B/min and OFF
Apnea
5–45 s. and OFF
Long apnea (manual mode only)
No breath detection for up to 120 s
Backup ventilation
Pressure controlled administered breath detected in pressure support backup mode due to time out of the backup respiratory rate parameter
Check breathing circuit
Activated when inspiratory and expiratory pressures fail to meet preset requirements
Limited battery capacity
Less than 18 minutes left of battery operation
No battery capacity
Less than 3 minutes left of battery operation
Water trap missing/ Replace water trap
The gas analyzer has detected that a water trap replacement is needed
GE TINGE • FLOW- I
Gas alarms
Vaporizer
Lower limit setting range
Upper limit setting range
Inspiratory O2 concentration alarm
18–99%
23–99% and OFF
Expiratory O2 concentration alarm
10–99% and OFF
13–99% and OFF
Inspiratory CO2 concentration alarm
---
0.1–10%
Expiratory CO2 concentration alarm
0.1–9.9% and OFF
0.1–10%
Inspiratory AA concentration alarm
0.1–5.0% and OFF (ISO) 0.1–8.0% and OFF (SEV) 0.1–18% and OFF (DES)
0.1–5.0% (ISO) 0.1–8.0% (SEV) 0.1–18% (DES)
Expiratory AA concentration alarm
0.1–4.0% and OFF (ISO) 0.1–6.0% and OFF (SEV 0.1–12% and OFF (DES)
0.1–5.0% and OFF (ISO) 0.1–8.0% and OFF (SEV) 0.1–18% and OFF (DES)
Agent mixture: MAC >3
The MAC of the secondary agent is ≥0.6 and the total MAC value is ≥3
High continuous MAC
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
Agent mixture
The second agent is MAC ≥0.6 and the total MAC value is <3
Insp N2O: High
Inspiratory N2O gas supply >80%
Occlusion in sampling line
Detected occlusion reported from Y-piece gas analyzer
Agents
Isoflurane, Sevoflurane and Desflurane
Type
Electronic Injector
Weight (full)
Appr. 3.2 kg/7.1 lbs
Dimensions (mm/inch.)
70x215x178 (2.8"x8.5"x7.0")
Capacity
300 ml
Residual capacity
30 ml (triggering the low level alarm)
Setting range
Isoflurane Sevoflurane Desflurane
Accuracy
±15% of set value or ±5% of maximum possible user setting (whichever is greater)
Filling system
Isoflurane Sevoflurane Desflurane
GE TINGE • FLOW- I
0, 0.3–5%, OFF 0, 0.3–8%, OFF 0, 1.0–18%, OFF
• Maquet filling adapter • Quik Fil® , Maquet filling adapter and SAFE-T-SEAL filling adapter • SAFE-FILTM
Vaporizer filling speed
Appr. 4 ml/s
Overfill protection
Overfilling prevention systems built into the vaporizer
Tank liquid level
Optical and electronic
Agent usage tracking
• Individual agent usage for each of the last 20 patient cases • Total agent usage since last user reset
11
Patient gas analyzer
Measuring technology
O2 Agents, CO2, N2O
Paramagnetic sensor IR sensor
Warm-up time
ISO standard accuracy Full accuracy
Within 60 s Within 10 minutes
Sampling flow and tolerance
225 ml/min ±10% (Return to circuit), BTPS condition
Measured parameters
Patient suction and auxiliary O2 module (option)
12
Resp. rate
2–100 breaths/minute
Respiration rate measurement accuracy
<60 breaths/minute >60 breaths/minute
±1 breath/minute Unspecified
Gas measuring range
O2 N2O CO2 Isoflurane Sevoflurane Desflurane
0–100% 0–80% 0–10% 0–5% 0–8% 0–18%
Inspiratory and End-Tidal O2 Concentration
Yes
Inspiratory and End-Tidal CO2 Concentration
Yes
Inspiratory and End-Tidal N2O Concentration
Yes
MAC Y (age dependent)
Yes
MAC Brain (age dependent)
Yes
Inspiratory and End-Tidal Agent Concentration
Yes
Automatic AA identification
Yes. Agent mixtures are displayed containing a Primary and Secondary agent (classification depending on relative agent concentration)
Weight
Appr. 2.2 kg/4.9 lbs
Patient suction supply pressure (Air)
250–600 kPa/2.5–6.0 bar/36–87 PSI
Auxiliary O2 supply pressure
250–600 kPa/2.5–6.0 bar/36–87 PSI
Auxiliary O2 flow range
0–15 l/min
Max. vacuum (suction)
-0.9 to -0.6 bar (-90 to -60 kPa), at a supply pressure equivalent to patient suction supply pressure (Air)
Max. suction flow
28 Nl/min Note that normal liter (Nl) is the volume of gas given ambient conditions, e.g. current atmospheric pressure
GE TINGE • FLOW- I
Misc. optional equipment
Vaporizer holder Weight
Appr. 0.8 kg/1.8 lbs
Weight including full vaporizer
Appr. 4.0 kg/8.8 lbs
Dimensions
90 × 220 × 215 mm/3.5" × 8.7" × 8.5" (WxHxL)
Universal bracket for C20 Weight
Appr. 2 kg/4.4 lbs
Maximum load
30 kg/66 lbs
Manual breathing bag support arm
External communication
Weight
Appr. 1.0 kg/2.2 lbs
Maximum load
1.0 kg/2.2 lbs
Serial ports
2 × RS232
USB
1
Video out
1 VGA
Ethernet
1 Network connection for service use
FCI protocol
Ordering information Flow-i Anesthesia System and accessories: See separate information in “System flowchart, Flow-i”, mx-6928.
GE TINGE • FLOW- I
13
Dimensional drawings C20 and C30 models
C40 model
14
GE TINGE • FLOW- I
Notes
GE TINGE • FLOW- I
15
Getinge is a global provider of innovative solutions for operating rooms, intensive care units, sterilization departments and for life science companies and institutions. Based on our firsthand experience and close partnerships with clinical experts, healthcare professionals and medtech specialists, we are improving the everyday life for people, today and tomorrow. Manufacturer · Maquet Critical Care AB · Röntgenvägen 2 SE-171 54 Solna · Sweden · +46 (0)10 335 73 00
www.getinge.com
© Maquet Critical Care AB 2019 · Maquet Flow-i and AGC are trademarks by Maquet Critical Care AB · Subject to modifications · MX-7501 Rev01 · English · 2019-04
Flow-i may be pending regulatory approvals to be marketed in your country. Contact your Getinge representative for more information. This document is intended to provide information to an international audience outside of the US.