FLOW-i 4.7 Datasheet Rev 01 April 2019

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

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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.